Sound Physicians

NOVEMBER 5, 2024

For smaller or rural hospitals, this can mean supplementing patient care with tele-ICU clinicians, available 24/7, to keep our providers from stretching too thin. Sound also supports residency programs, which guarantee a consistent pool of new critical care clinicians who can provide support in the ICU.

Management 52

Management Hospital Telemedicine Board-Certified 52

Today's Hospitalist

MAY 9, 2025

Since the mid-1990s, our capacity for innovation has never stopped as hospitalists navigate a complex landscape of acute illnesses, interprofessional collaborations and the imperative to provide efficient, high-quality care. We have seen explosive growth and become a cornerstone of modern health care systems.

Patient-Centered 52

Patient-Centered Telemedicine Clinic Electronics 52

FDA Law Blog

MAY 13, 2024

Further, FDA has stated that enabling advanced data analytics, including RWD, is one of the objectives incorporated in the FDA’s Information Technology Strategy for FY 2024-2027. Rather than looking at how RWD/RWE provide meaningful information on safety and effectiveness, reviewers often focus on perceived gaps. percent of examples.

Medical 111

Medical Clinic Patients IT 111

FDA Law Blog

SEPTEMBER 16, 2024

FDA-2024-N-3945 ] announcing the publication of a draft strategy document, for public comment, outlining specific actions FDA plans to take to facilitate the use of innovative manufacturing technologies. with the goal of providing better service to stakeholders interested in early engagement regarding innovative manufacturing technologies.

Manufacturing 59

Manufacturing IT Supply Chain Provider 59

PEMBlog

NOVEMBER 21, 2024

I am excited to share the recording of the AAP Section on Emergency Medicine Fall Virtual Education Session , originally held on Tuesday, November 19, 2024 focused on delivering timely and actionable feedback, along with strategies to develop and implement sustainable feedback programs.

Education 52

Education Utilities Provider 52

FDA Law Blog

APRIL 30, 2024

This hardly provides clarification and seems to limit the topics that could utilize this method of feedback. However, Table 1 states that if the SIR request is received within 60 days of the FDA “marketing submission letter” FDA would, resources permitting, have the meeting or provide written feedback within 21 days.

Utilities 64

Utilities Provider Medical IT 64

FDA Law Blog

DECEMBER 12, 2023

The recommendations in the draft guidance address: The wording of UTH claims based on RSS for use on adult maintenance cat food labeling; The RSS criteria to substantiate those UTH claims; and The study data that CVM recommends to demonstrate the utility and target animal safety of the cat food. Upper bound of 95% CI ≤ 2.5 CaOx: Mean RSS ≤ 6.0;

Utilities 59

Utilities Manufacturing Provider Individual 59

FDA Law Blog

NOVEMBER 7, 2024

One less utilized method (and for good reason) to gain more certitude is the 513(g) Request for Information. As an example, we filed a 513(g) request in December 2024. 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 Blog

JULY 17, 2022

Currently, a health care provider identifies any discarded quantity from such a vial in the claim using a JW modifier, and Medicare Part B pays for both the utilized and the discarded amount. The following example is provided in the preamble: If Part B paid a total of $1.5 million).

Manufacturing 52

Manufacturing Utilities Government Provider 52

FDA Law Blog

DECEMBER 6, 2024

Valentine On November 19, 2024, FDA released a draft guidance titled Frequently Asked Questions Developing Potential Cellular and Gene Therapy Products. This could occur during an End-of-Phase 2 (EOP2) meeting if a Phase 2 study is expected to provide primary evidence of safety and effectiveness. Tobolowsky & Charles G.

Clinic 59

Clinic Provider IT Electronics 59

FDA Law Blog

SEPTEMBER 20, 2021

FDA will discuss the goals letter and field public comments, on September 28, 2021 (announcement here ), as well as a separate workshop on meetings management practices, which is to be held by July 30, 2024. Pandemic influences aside, the FY 2023-2027 goals letter contained many notable new initiatives, announcements, and commitments.

Patient-Centered 52

Patient-Centered Manufacturing Clinic Provider 52

Physician's Practice

JUNE 16, 2025

This April 2024 article by Neil Baum, MD , on being an on-time physician gives this tip: Instruct new patients to arrive 20-30 minutes before their appointment to fill out paperwork or complete the paperwork online if your website provides the forms for patient demographics and a health care questionnaire.

Management 52

Management Private Practice Patients Medical 52

FDA Law Blog

JUNE 16, 2023

The statement must itemize the cost components related to production of the drug, identify increases in materials or manufacturing costs, and provide other information that the manufacturer believes relevant to determining whether a violation has occurred. SF 2744 also provides a private right of action to enforce the prohibition.

Manufacturing 45

Manufacturing Provider Consulting IT 45

FDA Law Blog

JUNE 27, 2024

50,372 , 50,377 (June 13, 2024). Public Interest Factors The Controlled Substances Act provides that DEA may suspend or revoke a registration upon finding that the registrant has committed acts that would render the registration inconsistent with the public interest. Coconut Grove Pharmacy; Decision and Order, 89 Fed. 21 U.S.C. §

Insurance 52

Insurance Patients Utilities Chronic Condition 52

The Motivated MD

SEPTEMBER 19, 2024

For the better half of 2024, I have been periodically writing posts that are individual articles that double as potential chapters to a future book. ’ Though it often does not come with the attending salary, medical trainees are getting paid to perform a service, and hospitals provide retirement plans to these individuals.

Finance 52

Finance Individual Education Healthcare Professional 52

AMMD

FEBRUARY 14, 2025

The American Cancer Society predicts roughly 2,001,140 new cancer cases and 611,720 cancer deaths in 2024 (1). This order involves cellular creation, utilization, division, regulation, and disintegration. What is cancer, and why is it developing in younger populations? We used to think cancer was genetic. What Is Cancer?

IT 130

IT Chronic Disease Patient-Centered Utilities 130

GeriPal

FEBRUARY 15, 2024

The insight started when Carmen, an orthopedic surgeon-researcher, and Katie, a physical therapist- researcher participated in ride-alongs with EMS providers to patient’s homes. And yet, after assisting the older adult to their feet, the EMS providers would leave. ABIM MOC credit will be offered to subscribers in November, 2024.

Community 115

Community Transportation IT PCP 115

PEMBlog

JUNE 2, 2025

Before your blood pressure rises as well, know that this PEMBlog article is here to provide an overview of the recognition and management of hypertensive emergencies. Additionally, hydralazine is another agent that was previously utilized in pediatric hypertensive emergencies.

Hypertension 75

Hypertension Management Physicals Lab Testing 75

GeriPal

JANUARY 25, 2024

Accreditation In support of improving patient care, UCSF Office of CME is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team. David: Yeah.

Patient-Centered 122

Patient-Centered IT Illness Patients 122

FDA Law Blog

SEPTEMBER 30, 2024

CMS did not finalize the price verification survey, which would have required manufacturers of 10 costly drugs selected annually to provide clinical information as well as information on production, distribution, research, and marketing costs, revenue and profit, and ex-U.S. pricing, among other things.

Manufacturing 59

Manufacturing Utilities Provider IT 59

GeriPal

JUNE 5, 2025

JAGS 2024 Nursing Home Palliative Care Referral Process, Barriers, and Proposed Solutions: A Qualitative Study. So usually they’ll make recommendations, maybe some medication adjustments or something like that, and then the provider that’s caring for them in house will take over from there. Eric 13:49 Right.

Nurse Practitioner 78

Nurse Practitioner Referral Consulting Board-Certified 78

FDA Law Blog

JULY 9, 2024

The deadline for the Draft Guidance was December 29, 2023, so the draft, issued on June 26, 2024, is about 6 months late under FDORA’s mandate. DAP Goal Rationales The sponsor must also provide a rationale for the study’s proposed enrollment goals, including information and analysis to explain how these goals were determined.

Clinic 59

Clinic Provider Individual IT 59

PEMBlog

MARCH 27, 2024

She did her MD/PhD at Columbia University, where she investigated the diagnostic utility of exome sequencing for kidney disease. Treasure Island (FL): StatPearls Publishing; 2024 Jan-. Therefore understanding these diseases, their presentations and their evaluation is critical for emergency medicine providers. Pediatr Rev.

Consulting 59

Consulting Individual Families Family 59

GeriPal

FEBRUARY 2, 2024

Accreditation In support of improving patient care, UCSF Office of CME is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team. Eric: Yeah.

Consulting 121

Consulting Hospital Patient-Centered IT 121

New South Family Medicine and MedSpa

NOVEMBER 24, 2022

Direct primary care offers you and your family top-notch health care, and so much more.like a high patient and provider satisfaction with an improved quality of care. Providers at New South Family Medicine and MedSpa can address the patient's deeper needs, rather than trying to rush through a hectic day full of too-brief appointments.

Family Medicine 40

Family Medicine DO Family Families 40

GeriPal

APRIL 6, 2023

To provide context, we are joined by Karen Steinhauser, a social scientist at Duke who has been studying spirituality for years (and published one of the most cited papers in palliative care on factors considered important at the end of life , as well as one of my favorite qualitative papers to give to research trainees ). Lexy: Well, so no.

IT 99

IT Patient-Centered Families Family 99

GeriPal

SEPTEMBER 19, 2024

So, basically, with a stepped care model, the goal is to tailor care delivery to the patient’s needs while at the same time utilizing less clinician resources. So at our cancer center, we have physicians, advanced practice providers. As Pahlavi said, you could refer to other providers. Jennifer 04:25 I can take that on.

Patient-Centered 119

Patient-Centered IT Patients Hospital 119

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.” Eric: Okay.

Patient-Centered 125

Patient-Centered IT Families Family 125

Physician's Weekly

JUNE 11, 2025

A 2021 study published in Frontiers in Public Health indicated that even online memory cafes during the pandemic provided social support for both patients and their family members. In 2024, the Alzheimer’s Association issued a report projecting a jump in dementia cases in the U.S. from an estimated 6.9 million people by 2060. .

Patients 52

Patients Families Family Diagnosis 52

FDA Law Blog

JUNE 1, 2025

While FDA has historically looked at manufacturer promotion, the language in the Federal Food, Drug, and Cosmetic Act (FDCA) provides that it is a prohibited act to cause the misbranding of a drug in interstate commerce. Maximizing patient clinical outcomes and quality of life may ultimately minimize healthcare resource utilization.

Healthcare Professional 59

Healthcare Professional Manufacturing Healthcare Utilities 59

FDA Law Blog

SEPTEMBER 14, 2021

A manufacturer that failed to provide access to the MFP would be subject to a civil monetary penalty of ten times the excessive price charged. The new CGDP (with new agreements) would become effective on January 1, 2024, and the current CGDP would simultaneously sunset. PART 2: INFLATION REBATES UNDER MEDICARE PARTS B AND D.

Manufacturing 52

Manufacturing Insurance Government Patients 52