Physician's Weekly

JUNE 19, 2025

Reform: Needed & Possible The authors noted that while bias against mental health and SUD histories still shapes some emergency encounters, targeted education, objective protocols, and integrated behavioral services can narrow the gap between expected and delivered care, improving outcomes for a vulnerable, high‑utilization population.

Mental Health 52

Mental Health Physicals Patient-Centered Patients 52

Today's Hospitalist

MAY 9, 2025

At its core, the technology utilizes sophisticated speech recognition to transcribe a conversation in the exam room or at the bedside. These systems also provide a consistent note structure, which can improve the overall readability and utility of patient records. This isn’t about replacing your clinical judgment.

Patient-Centered 52

Patient-Centered Telemedicine Clinic Electronics 52

CDOCS

MARCH 15, 2021

By the utilization of patient financing strategies, we can help to facilitate a means of affordability for the everyday patient.</span></span></p> Reinforce the motivation for treatment by utilizing the same interdisciplinary vocabulary amongst offices. link] Dated June 2019. Accessed February 2021.</span></p>

Patients 52

Patients Finance Education Utilities 52

FDA Law

AUGUST 4, 2022

On June 27, 2019, Pfizer sought an OIG advisory opinion to ensure that its proposal would not run afoul of federal law. Pfizer, Inc. Department of Health and Human Services et al. July 25, 2022. Whether the Beneficiary Inducement Statute (BIS) is relevant to interpreting the AKS (essentially, no). Pfizer appealed to the Second Circuit.

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Manufacturing Medical Government IT 98

FDA Law

MAY 13, 2024

Based on a review of premarket submissions made in 2012 through 2019, FDA identified 90 examples of 510(k)s, De Novos, HDEs, and PMAs approved/cleared which utilized RWE in support of regulatory decision-making. But by their very nature, RWD/RWE will have some gaps compared to randomized controlled trials. percent of examples.

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Medical Clinic Patients IT 111

FDA Law

NOVEMBER 6, 2022

In June 2019, Pfizer sought an OIG advisory opinion to ensure that its proposal would not run afoul of federal law. Now, after an unfavorable HHS Office of the Inspector General (OIG) advisory opinion and two defeats in court, Pfizer has appealed the Second Circuit’s decision to the Supreme Court. Background.

Manufacturing 83

Manufacturing Patient-Centered Healthcare Utilities 83

The Clinical Problem Solvers

DECEMBER 16, 2020

Tsai has seen race-based medicine play out in clinical practice 10:45 What role should race play in making clinical decisions? 13:16 Status of the current conversation on removing race from eGFR calculators: why is it so contentious? Poet Marge Piercy has written, “The work of the world is as common as mud.”

Clinic 52

Clinic Education Clinical Practice Patient-Centered 52

FDA Law

SEPTEMBER 11, 2023

More recently, in 2019, FDA announced a push for predicate modernization ( link ) following a 2018 plan to modernize the 510(k) program by eliminating use of old predicates, sunsetting older predicates, and establishing the Safety and Performance Based Pathway ( link ). Baumhardt, Senior Medical Device Regulation Expert & Adrienne R.

Medical 64

Medical Electronics Manufacturing Utilities 64

FDA Law

NOVEMBER 7, 2024

One less utilized method (and for good reason) to gain more certitude is the 513(g) Request for Information. By Véronique Li, Senior Medical Device Regulation Expert & Jeffrey N. 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).

Provider 69

Provider IT Consulting Utilities 69

FDA Law

FEBRUARY 2, 2023

Alternative methods will require significant research investment to demonstrate their utility for a particular context of use and inform regulatory decision-making. In 2019, FDA formed an agency-wide Alternative Methods Working Group indicating that it viewed the applicable scope of alternative methods to go beyond just toxicology research.

Clinic 64

Clinic IT Utilities Government 64

FDA Law

JUNE 3, 2021

In addition, Texas recently passed HB 1033 to update its prescription drug price disclosure law that took effect in 2019. As we initially reported here , Texas enacted a law in June 2019 requiring manufacturers to submit two types of reports beginning in January 2020. A summary of these new state law developments is included below.

Manufacturing 52

Manufacturing Supply Chain Insurance Provider 52

FDA Law

OCTOBER 14, 2021

FDA issued the same type of warning regarding RAS devices and mastectomy back in February 2019 suggesting that FDA believes the problem has persisted. This view of FDA’s role in regulating RAS devices is strange. The essence of RAS devices is to aid surgeons in conducting surgery. Therefore, it makes sense that FDA would review data on intra?operative

Patient-Centered 52

Patient-Centered Healthcare Provider Manufacturing 52

FDA Law

FEBRUARY 28, 2022

The Guidance provides practical advice for device manufacturers to utilize patient engagement in clinical studies. For additional information on planning patient engagement, please see the CDRH’s Patient Science and Engagement Program. Finally, mark your calendars for the upcoming March 22, 2022 FDA webinar about this Guidance.

Patients 52

Patients Clinic Medical Patient-Centered 52

PEMBlog

SEPTEMBER 27, 2023

For more specific recommendations related to diagnosis and management of SARS-CoV-2, please see www.aap.org/en/pages/2019-novel-coronavirus-covid-19-infections/ ) · Hospitalized patients where tests impacts cohorting decisions, like in intensive care. A positive test does not exclude a secondary bacterial infection or co-infection.

Patients 52

Patients Hospital Illness Management 52

Physician's Practice

JUNE 25, 2025

Dr. Baum has published a book, The Business Basics of Building and Managing a Healthcare Practice, (Springer 2019), which emphasizes the importance of being involved in the business of a medical practice. Baum is Professor of Clinical Urology at Tulane Medical School in New Orleans, Louisiana.

Patients 52

Patients Private Practice Management Healthcare 52

FDA Law

JUNE 22, 2022

In one case, between 2017 and 2019, a Sovah pharmacy technician diverted more than 11,000 schedule II drugs and 1,900 schedule III and IV drugs by indicating in the computer system that they were moved to a location no longer used by the hospital and she destroyed required drug movement forms. 4, 2022).

Board-Certified 52

Board-Certified Provider Government Management 52

FDA Law

JUNE 7, 2021

Subpart H) pathway in 2014, then issued it as final guidance in January 2019. Valentine — Yesterday’s FDA approval of Biogen’s Alzheimer’s drug, Aduhelm (aducanumab-avwa), is historic and is of a magnitude that it may be harbinger for future Agency actions, especially in neuropsychiatric conditions. What do we mean?

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Clinic IT Private Practice Utilities 98

The Clinical Problem Solvers

APRIL 5, 2022

Published April 5, 2019. January 18, 2019. Our guests remind us to ask our patients about their housing status using non-judgmental and non-stigmatizing language. If we do not know the housing status of our patients, then we do not know one of the most fundamental things that is going to affect their health and wellbeing. 2.

Community 52

Community Patient-Centered Emergency Room Medical 52

The Clinical Problem Solvers

FEBRUARY 8, 2023

Between 2007 – 2019, Black individuals experienced a higher death rate for opioid overdose deaths than any other racial or ethnic group. Dr. Jordan then questions the utility and continued operation of methadone clinics, especially as the United States largely moves on from the COVID-19 pandemic. Published September 2019.

Community 52

Community Patient-Centered Mental Health Board-Certified 52

FDA Law

SEPTEMBER 30, 2024

Penalties for “Misclassification” The Medicaid Services Investment and Accountability Act of 2019 added new penalties to the Medicaid rebate statute for knowingly misclassifying a covered outpatient drug. pricing, among other things. The most noteworthy are the following: 1. See 42 U.S.C. 1396r-8(b)(3)(C)(iii).

Manufacturing 59

Manufacturing Utilities Provider IT 59

GeriPal

AUGUST 25, 2022

I had looked at a research article that had recently evaluated the prevalence of private equity transactions in the hospice market and noted that there was a pretty substantial uptick in the past decade, and really over the course of say around 2015 to 2019. We’re going to be talking about each one of these papers. Is it you, Melissa?

Family 106

Family Families IT Patients 106

BMJ

MAY 10, 2022

Immunization, 2019. Primary care visits increase utilization of evidence-based preventative health measures. Intention of nurses to accept coronavirus disease 2019 vaccination and change of intention to accept seasonal influenza vaccination during the coronavirus disease 2019 pandemic: A cross-sectional survey.

Vaccination 40

Vaccination Healthcare Professional Healthcare Primary Care 40

PEMBlog

APRIL 26, 2023

From 2019 to 2020, the rate of firearm related deaths among children increased by 30%. Studies demonstrate that utilizing one of these storage methods can reduce the suicide and unintentional gun deaths in children by up to 54%. [ Kristen ] Great question. I’m here with my co-resident, Dr. Humphrey. Thank you for hosting us, Brad!

Family 52

Family Families Mental Health Healthcare 52

FDA Law

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

FDA Law

AUGUST 21, 2023

Further, FDA has utilized a variety of strategies to call attention to safety issues through Dear Doctor letters or other forms of communication, even if directing changes to labeling is difficult. Koblitz & Deborah L. Agency officials estimated that it took at least 6 years to complete the required rulemaking process.”

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Manufacturing Consulting Healthcare Professional IT 40

New South Family Medicine and MedSpa

SEPTEMBER 17, 2019

Then take a moment to reflect on your unique plate. How closely does your current diet and lifestyle reflect the above plate? Whole​ ​wheat​ ​bread,​ ​brown​ ​rice,​ ​and​ ​whole-wheat​ ​pasta​ ​are also​ ​good​ ​sources​ ​of​ ​carbohydrates. However,​ ​their​ ​whole​ ​grains​ ​are​ ​processed​ ​, and​ ​therefore,​ ​some nutrients​ ​are​ ​lost.​

Referral 40

Referral DO Family Medicine Primary Care 40

FDA Law

OCTOBER 29, 2023

This occurred in January 2022 when the Departments issued additional guidance , which discussed reports of denial of coverage in violation of the ACA requirement and provided a reminder to plans and issuers of their responsibilities under the statute and 2019 HRSA Guideline (FAQ Part 51, Q9).

Individual 45

Individual Insurance Healthcare Provider 45

PEMBlog

APRIL 4, 2024

But there are some challenges when it comes to the utilization of FOAM: – Decentralization of FOAM resources – Concerns about the quality of information being presented The Solution: The Systematic Online Academic Resource, or SOAR, review was created in an effort to address some of these limitations.

Education 59

Education Utilities Vaccination IT 59

FDA Law

SEPTEMBER 13, 2021

A May 2019 CMS final rule that would have required drug TV advertisements to disclose the WAC of the drug was challenged by a group of pharmaceutical companies and vacated on statutory grounds by the D.C. Medicare negotiation authority; encourage biosimilars and generic drug utilization). Last Thursday, the U.S.

Manufacturing 98

Manufacturing Supply Chain Patient-Centered Utilities 98