Myriad Genetics

MARCH 13, 2024

The NORD report notes: “Genetic testing…is being increasingly utilized to help diagnose rare diseases, the majority of which are genetic in origin. Knowing Which one of those 17 doctors ultimately was able to pull together the pieces of Alex’s health picture and suggest a diagnosis? None of them. It was the AI program ChatGPT.

Diagnose 52

Diagnose Screening Diagnosis Family 52

The Clinical Problem Solvers

DECEMBER 16, 2020

Our guests explain how we can incorporate race-conscious medicine in clinical settings, medical education, and biomedical/epidemiological research to responsibly recognize and address the harms of racial inequality. These factors include a high-protein diet, muscle mass, creatinine generation, and certain medications. link] Tsai J.

Clinic 52

Clinic Education Clinical Practice Patient-Centered 52

Today's Hospitalist

MAY 9, 2025

But these early systems often struggled with complex medical terminology and the natural flow of conversation. For many of us, the emergence of medical scribes, both in-person and remote, provided a valuable solution, offloading documentation and allowing us to have more focused patient interactions. Dragon Medical One.

Patient-Centered 52

Patient-Centered Telemedicine Clinic Electronics 52

FDA Law Blog

AUGUST 4, 2022

Further, “there is little utility in comparing the language of the BIS to that of the AKS.”. Most of these cases have settled out of court (see, for example, Actelion Pharmaceuticals , 2018; Astellas Pharma and Amgen , 2019; Gilead Sciences , 2020). OIG disagreed. The Lesson of this Case.

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Manufacturing Medical Government IT 98

FDA Law Blog

DECEMBER 16, 2024

Lenz, Principal Medical Device Regulation Expert FDA recently released 510(k) Third Party Review Program and Third Party Emergency Use Authorization (EUA) Review which finalizes the draft guidance of the same title issued in December 2023. The Agency has reportedly been trying to improve the program, as we discussed in 2018 and 2020.

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Consulting Manufacturing Utilities Provider 52

FDA Law Blog

NOVEMBER 6, 2022

In September 2020, the OIG issued an unfavorable advisory opinion to Pfizer, concluding that the proposal was “highly suspect” under the AKS because one purpose of the program, and perhaps the primary purpose, would be to induce Medicare beneficiaries to purchase Pfizer’s federally reimbursable medication. Pfizer’s Petition to SCOTUS.

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Manufacturing Patient-Centered Healthcare Utilities 83

FDA Law Blog

NOVEMBER 7, 2024

By Véronique Li, Senior Medical Device Regulation Expert & Jeffrey N. One less utilized method (and for good reason) to gain more certitude is the 513(g) Request for Information. Gibbs — In most instances, it is clear if a product will be considered a “device” under the Federal Food, Drug, and Cosmetic Act (FD&C Act).

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Provider IT Consulting Utilities 69

Physician's Practice

JUNE 9, 2025

Physicians, whether in small practices or employed by hospitals, face a daunting challenge when trying to get a payer to approve a medication, procedure or imaging study. I sent them articles from the medical literature that confirmed the office procedure had outcomes equivalent to the surgical procedure.

Management 52

Management Healthcare Experience Patients Hospital 52

Physician's Practice

JUNE 26, 2025

Reynolds Feature Video Introducing Neil Baum, MD, Professor of Clinical Urology at Tulane Medical School in New Orleans, Louisiana, and the author of multiple books. He has also written The Complete Business Guide to a Successful Medical Practice, which was published in 2015. Now is your chance to get to know them.

Management 52

Management Diabetes Patients Insurance 52

FDA Law Blog

JUNE 22, 2022

In the second case, occurring from January to May 2020, a registered nurse, admitted to daily tampering of fentanyl vials and hydromorphone injectables wherein she removed the drugs from the vials replacing them with saline solution. See Sovah Non-Prosecution Agreement, Addendum A, Agreed Facts, ¶2. 4, 2022).

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Board-Certified Provider Government Management 52

FDA Law Blog

JULY 4, 2023

The CARES Act also provides for an administrative hearing process that may be utilized under certain conditions following the formal dispute resolution process. The draft Monograph FDR Guidance clarifies that FDR is appropriate only when there is a scientific and/or medical dispute related to a final order.

Utilities 52

Utilities Provider Individual IT 52

PEMBlog

SEPTEMBER 13, 2023

Selecting the appropriate medications, if necessary, is of paramount importance. The lack of utility of laboratory testing in children with an unprovoked generalized seizure, or a simple febrile seizure is supported by several observational studies. Occult trauma Any trauma that is not seen on your physical (e.g. 2000; 55(5):616-623.

Patients 52

Patients Screening Illness Physicals 52

The Clinical Problem Solvers

MAY 2, 2022

Valtis is a 4th year Med-Peds Resident at Brigham & Women’s Hospital and Boston Children’s Hospital, and his research focuses on race and the utilization of security responses in the inpatient hospital setting. Race and the Utilization of Security Responses in a Hospital Setting. Orlando, FL.

Healthcare 52

Healthcare Utilities Hospital Internal Medicine 52

PEMBlog

MAY 15, 2023

Your history and medication reconciliation will assist in determining acquired vs congenital variants. Acquired long QT can be caused by electrolyte disorders, eating disorders and/or medications. Addressing these may require medical intervention or pacing depending on the etiology (medication related vs structural).

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Utilities Screening Physicals Medical 97

The Clinical Problem Solvers

FEBRUARY 8, 2023

Pearls: In 2020, American Indian and Alaska Native (Indigenous) communities experienced the highest drug overdose mortality rate of any racial or ethnic group, also surpassing rates among the non-Hispanic white population.

Community 52

Community Patient-Centered Mental Health Board-Certified 52

FDA Law Blog

JUNE 7, 2021

As an aside, we have found this inconsistency between which accelerated approval therapies are saddled with this sentence to be a paradoxical FDA policy as there is but a single standard for surrogate endpoints to be utilized for purposes of every Accelerated Approval (i.e., be “reasonably likely to predict” ultimate clinical benefit).

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Clinic IT Private Practice Utilities 98

GeriPal

OCTOBER 19, 2023

And we have Scott Halpern, who is Professor of Medical Ethics and Health Policy and Director of the Palliative and Advanced Illness Research Center or Payer Center at the University of Pennsylvania. So now it’s just POLST, the word POLST, Portable Medical Orders. Hey, it’s National POLST Collaborative now. Good to know.

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Patient-Centered IT Patients Illness 126

GeriPal

JANUARY 25, 2024

Summary Transcript Summary In a JAMA 2020 systematic review of palliative care for non-cancer serious illness, Kieran Quinn found many positives, as we discussed on our podcast and in our editorial. However, its main predictors are age, comorbidity, and healthcare utilization. These were general medical nurses or social workers.

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Patient-Centered IT Illness Patients 122

GeriPal

OCTOBER 26, 2023

Within hours of recording this podcast, I joined a family meeting of an older patient who had multiple medical problems including cancer, and a slow but inexorable decline in function, weight, and cognition. But rarely does the podcast and clinical reality meet in the same day. Very excited to be here. Tamra, welcome to the GeriPal podcast.

Patient-Centered 132

Patient-Centered Hospital Patients IT 132

FDA Law Blog

JULY 9, 2024

Tobolowsky & Véronique Li, Senior Medical Device Regulation Expert & Sarah Wicks & Deborah L. DAP Content In developing DAPs, the Draft Guidance recommends that sponsors consider whether certain demographic groups may have a different response to a medical product regarding either effectiveness or safety. 360j(g)(9)(A)).

Clinic 59

Clinic Provider Individual IT 59

GeriPal

JANUARY 20, 2023

You were on a National Academy of Sciences committee started in 2020? As somebody who works in a nursing home, I can barely read a nursing home note anymore because if it’s on electronic medical record, it’s usually a bunch of check boxes, several pages. From a medical director standpoint, how do you think about that?

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Finance Board-Certified IT Provider 95

FDA Law Blog

AUGUST 21, 2023

Brand drugs, generic drugs, and medical devices alike have all been the target of state failure-to-warn litigation; in a recent case, OTC acetaminophen is the target. Most OTC drugs, particularly drugs that have been around for a while, are primarily marketed pursuant to OTC monographs.

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Manufacturing Consulting Healthcare Professional Vaccination 40

FDA Law Blog

JUNE 2, 2023

For 10 high-cost single source covered outpatient drugs selected annually by CMS, manufacturers would be required to respond to a so-called “price verification survey” by providing not only clinical and utilization information about the drug, but also costs of production, distribution, research, and marketing; revenue and profit; and ex-U.S.

Manufacturing 59

Manufacturing Vaccination Government Diagnosis 59

GeriPal

APRIL 10, 2025

It was really at the level of the ED across 33 EDs in random order, and then tried to see if we could make a difference in healthcare utilization, primarily the primary outcome was admission to the hospital, acute care admission. Do they have documents in the record like medical orders for life sustaining treatment or a healthcare proxy?

Patient-Centered 77

Patient-Centered Hospital IT Patients 77

PEMBlog

APRIL 26, 2023

I’m Dr. Carney and I am a pediatric resident at Cincinnati Children’s Hospital Medical Center. From 2019 to 2020, the rate of firearm related deaths among children increased by 30%. Children’s Defense Fund. 2022, March 18). Retrieved October 7, 2022, from [link] Episode Transcript [Kit] Hello! Thank you for hosting us, Brad!

Family 52

Family Families Mental Health Healthcare 52

GeriPal

FEBRUARY 13, 2025

And resource utilization was very low in all the groups. Eric 14:24 So it’s hard to improve resource utilization for these people where some of them didn’t sound like the sickest of people admitting them to the hospital, but all had some type of serious illness. We are going to have healthcare utilization data as well.

Consulting 63

Consulting Community Patient-Centered Families 63

GeriPal

JULY 6, 2023

Not just with our aging and independent services, but also with our behavioral health services, with our public health services, with our medical care services, to really have everyone see older people as part of their work. 60% of all medical costs have nothing to do with your health diagnosis.

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Community Nurse Practitioner Provider IT 89

FDA Law Blog

AUGUST 14, 2022

Starting July 1, 2023, the IRA will also limit to $35 the total monthly contribution by a Medicare Part B beneficiary for insulin purchased through a durable medical equipment (“DME”) supplier. In return for providing the MFP, manufacturers of selected drugs do receive coverage, but high utilization drugs are certain to have coverage anyway.

Manufacturing 98

Manufacturing Government Vaccination Utilities 98

GeriPal

DECEMBER 21, 2023

Don’t get me wrong, the evidence points to cost savings, but as Chris Callahan and Kathleen Unroe pointed out in a JAGS editorial in 2020 “in comprehensive dementia care models, savings may accrue to Medicare, but the expenses accrue to a fluid and unstable network of local service providers, patients, and their families.” Diane: Fantastic.

Patient-Centered 125

Patient-Centered IT Families Family 125

FDA Law Blog

NOVEMBER 8, 2023

The rule established a new category of OTC hearing aids for individuals with mild to moderate hearing loss, allowing them to purchase hearing aids directly from stores or online retailers without the need for a medical examination, prescription, or fitting adjustment by an audiologist. However, FDA missed that deadline.

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Utilities IT Engineering Appointment 64