Annals of Family Medicine

NOVEMBER 20, 2024

Context: The COVID pandemic disrupted global healthcare, impacting academic medical centers (AMCs) in the United States, necessitating a comprehensive understanding of its effects on healthcare delivery and utilization. Study Design: This retrospective case series analysis utilizes Vizient’s clinical database data.

Healthcare 130

Healthcare Utilities Patient-Centered Illness 130

Barton Associates

JUNE 19, 2025

There’s a lot that goes into running a healthcare facility , from managing patient care to ensuring adequate coverage around the clock. In these complex and ever-changing environments, staffing challenges can quickly become a critical issue, impacting both patient care quality and operational efficiency.

Healthcare 52

Healthcare Healthcare Professional Provider Community 52

Annals of Family Medicine

NOVEMBER 20, 2024

Objectives: We explored how to design a system to provide near real-time feedback on context and impacts to inform health system innovations; and how to operationalize data collection across diverse patient populations and providers. Setting: Alberta, Canada from May 2022 to October 2023.

Healthcare 130

Healthcare Referral Provider Utilities 130

Annals of Family Medicine

NOVEMBER 20, 2024

Study Design: We analyzed eleven interviews with primary care providers recruited from ABFM diplomates who completed a recertification exam in 2023. Instrument: Interviews were semi-structured and conducted in Summer 2023. Results: Participants conceptualized professionalism as individualized and highly focused on patient care.

Family Physician 130

Family Physician Family Families Patient-Centered 130

Annals of Family Medicine

NOVEMBER 20, 2024

We utilized AI tools in the qualitative software program Atlas.ti This analysis was part of a larger implementation study called PATHWEIGH, which provides a toolset embedded in the EpicTM electronic health record and other supportive services to help practices provide weight management to their patients.

Primary Care 130

Primary Care Electronics Provider Management 130

Family Physicians of Greeley

JUNE 16, 2023

Navigating the complexities of insurance and healthcare costs can be overwhelming for patients. In this blog, we will provide you with practical tips to help you navigate insurance and healthcare costs effectively. Review the coverage provided, including deductibles, co-pays, and co-insurance.

Insurance 40

Insurance Healthcare Patients Provider 40

FDA Law Blog

SEPTEMBER 11, 2023

Lenz, Principal Medical Device Regulation Expert — On September 6, 2023, FDA announced its latest efforts to modernize the 510(k) process, outlining FDA’s latest improvements to strengthen the 510(k) Program and announcing release of three draft guidance documents. In a statement released at the time, CDRH Director Jeffrey Shuren, M.D.,

Medical 64

Medical Electronics Manufacturing Utilities 64

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. Beyond time savings, ambient AI can enhance the quality of our patient interactions. The result?

Patient-Centered 52

Patient-Centered Telemedicine Clinic Electronics 52

FDA Law Blog

MAY 13, 2024

FDA recognizes the potential of RWE to support regulatory submissions of medical devices and to inform benefit-risk analysis of such products, while assuring patients have timely access to devices. Rather than looking at how RWD/RWE provide meaningful information on safety and effectiveness, reviewers often focus on perceived gaps.

Medical 111

Medical Clinic Patients IT 111

FDA Law Blog

SEPTEMBER 20, 2021

When FDA published the fiscal years (FY) 2023-2027 goals letter at the end of August, making known their commitments and planned initiatives for the coming years, we were both excited by many of the announcements, while recognizing the real success will come from how the Agency implements them.

Patient-Centered 52

Patient-Centered Manufacturing Clinic Provider 52

PEMBlog

SEPTEMBER 6, 2023

This is a blog post designed to disseminate the important work of Choosing Wisely , an initiative of the the American Board of Internal Medicine Foundation, the goal of which is the spark conversations between clinicians and patients about what tests, treatments, and procedures are needed – and which ones are not.

Lab Testing 52

Lab Testing Medical Patients Mental Health 52

FDA Law Blog

JUNE 21, 2023

According to the announcement, enabling patients to access medical devices beyond traditional clinical settings can help close the healthcare gap by delivering care “directly to patients, wherever they are – at home, at work, in cities, in rural communities.” and remote or wearable patient monitoring devices (e.g.,

Medical 45

Medical Patients Healthcare Electronics 45

The Clinical Problem Solvers

DECEMBER 16, 2020

Moreover, center patients not only in discussions about individual decision-making but in constructing and drawing meaning from the research. While there indubitably exists a need to advance scholarship and theory, we must also ground ourselves in the day-to-day actions that can bring comfort and kindness to our patients.

Clinic 52

Clinic Education Clinical Practice Patient-Centered 52

FDA Law Blog

AUGUST 23, 2023

This blog provides an update on the DHT-related PDUFA VII goals that were targeted for completion in the first two quarters of FDA’s Fiscal Year (FY) 2023, including: By the end of Q2 FY 2023, FDA will establish a DHT framework document to guide the use of DHT-derived data in regulatory decision-makings for drugs and biological products.

Patient-Centered 52

Patient-Centered Clinic Medical Utilities 52

FDA Law Blog

JULY 17, 2022

An example of such a drug is a single-use vial of an injectable cancer drug that is dosed based upon weight, and therefore might not be entirely used for a lighter weight patient. On July 8, as part of its annual physician fee schedule update for 2023, CMS issued a proposed regulation to implement the new refund.

Manufacturing 52

Manufacturing Utilities Government Provider 52

FDA Law Blog

DECEMBER 11, 2023

In fact, as of November 2023, the CMS’s Standards and Certification’s (S&C’s) Quality, Certification and Oversight Reports (QCOR) CLIA Laboratory Lookup Database shows 17,206 CLIA-certified laboratories. Thus, it is wholly unrealistic for the Third-Party Review Program to provide any meaningful reduction in Agency workload.

IT 69

IT Medical Patient-Centered Provider 69

FDA Law Blog

JUNE 27, 2024

After issuing an Order to Show Cause and Immediate Suspension of Registration in September 2022, and an administrative hearing in March 2023, DEA adopted the hearing Administrative Law Judge’s (“ALJ’s”) Recommended Decision to revoke Coconut Grove’s registration based on the public interest factors of 21 U.S.C. 72,694, 72,703 (Dec.

Insurance 52

Insurance Patients Utilities Chronic Condition 52

Annals of Family Medicine

NOVEMBER 20, 2024

Context Palliative medicine focuses on quality of life for patients with serious illnesses. Historically, palliative care has been predominantly provided in the inpatient setting, but there is a growing awareness that patients may also benefit from outpatient care. Results The patients in the SMC had a mean age of 71.

Patients 130

Patients Diagnosis Patient-Centered Utilities 130

FDA Law Blog

APRIL 23, 2023

This Draft Guidance focuses on the use of patient-level data from other clinical trials or from RWD sources. The goal is to select similar patients in the treatment and external control groups. The Draft Guidance also states that sponsors must include in their marketing applications relevant patient-level data for both arms.

Patient-Centered 49

Patient-Centered Clinic Patients Provider 49

Annals of Family Medicine

NOVEMBER 20, 2024

Objective: 1) Demonstrate the feasibility of collecting data from prescription drug monitoring programs (PDMPs) for population health reporting, 2) analyze trends in PDMP and electronic health record patient data relative to CDC guidelines and 3) identify use of patient-centered measures for pain management in primary care.

Patients 130

Patients Patient-Centered Primary Care Electronics 130

Annals of Family Medicine

NOVEMBER 20, 2024

In Ontario, Canada, pharmacists were given authority to deliver service for 19 MAs as of October 1, 2023. Setting: Ontario, Canada Study Design and Analysis: This study used linked health administrative data, including pharmacist billing for MA services, patient demographics, and physician and hospital billing data, collected for 15.4

Primary Care 130

Primary Care Management Utilities Vaccination 130

PEMBlog

MAY 15, 2023

Our role as providers is to identify the patients who have a life-threatening etiology to their syncope. History and physical examination are critical components to any emergency department evaluation but are especially helpful in syncope patients. A review of red-flag symptoms can be found in the linked PEMBlog post.

Utilities 97

Utilities Screening Physicals Medical 97

FDA Law Blog

JANUARY 4, 2023

By Dara Katcher Levy — A win for patient access! Prescription drug and medical device Pre-Approval Information Exchange (PIE) now has specific legal protection allowing for sponsors to proactively communicate to payors certain information about products in development to help expedite patient access upon product approval.

Patients 64

Patients Provider IT Utilities 64

FDA Law Blog

SEPTEMBER 30, 2024

Gaulkin — In May 2023, we posted about a CMS proposed regulation that sought to make a wide variety of changes to the Medicaid Drug Rebate Program (MDRP), including a new “price verification survey,” and a controversial proposal to require “stacking” of discounts to different customers when determining best price. Kirschenbaum & Sophia R.

Manufacturing 59

Manufacturing Utilities Provider IT 59

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. Updated 2023 Jul 17]. Therefore understanding these diseases, their presentations and their evaluation is critical for emergency medicine providers. References Jeanmonod R, Asuka E, Jeanmonod D.

Consulting 59

Consulting Individual Families Family 59

PEMBlog

APRIL 26, 2023

Kit Carney and Dr. Kristen Humphrey discuss gun violence, its impact on our patients and their families, as well as practical tips on advocating for safe storage of firearms, and how we can support victims of violence. In our current environment, it can feel overwhelming as a healthcare provider to discuss firearms.

Family 52

Family Families Mental Health Healthcare 52

GeriPal

APRIL 6, 2023

Today we have a star-studded lineup, including Lexy Torke of Indiana University, who discusses her RCT of a chaplaincy intervention for surrogates of patients in the ICU , published in JPSM and plenary presentation at AAHPM/HPNA. Thanks to my son Kai for playing the guitar part in 5/4 with strange chords on Riverman by Nick Drake!

IT 99

IT Patient-Centered Families Family 99

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

FDA Law Blog

AUGUST 21, 2023

After all, the labeling is intended to do exactly that: it informs patients and prescribers of the risks to ensure the product is used effectively and in a manner that mitigates risks, according to FDA’s understanding of the relevant science. FDA, in other words, directed, and continues to direct, pregnant women to a learned intermediary.

Manufacturing 40

Manufacturing Consulting Healthcare Professional IT 40

FDA Law Blog

AUGUST 14, 2022

The negotiations will result in a Maximum Fair Price (“MFP”) that the manufacturer must make available to providers furnishing the drug under Medicare Part B or pharmacies dispensing the drug under Part D. The same will be required under state Medicaid and CHIP programs by October 1, 2023.

Manufacturing 98

Manufacturing Government Vaccination Utilities 98

GeriPal

JULY 13, 2023

On that podcast he and collaborators tested a combined patient and clinician facing communication priming intervention to promote goals of care conversations. Randy died February 26, 2023. And if I remember that study correctly, it was priming both patients and providers in the outpatient setting to do goals of care conversations.

Patient-Centered 83

Patient-Centered IT Patients Hospital 83

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.” Everything.

Patient-Centered 125

Patient-Centered IT Families Family 125

FDA Law Blog

SEPTEMBER 14, 2021

Under all of these programs, patient co-insurance would be calculated based on the MFP so that patients receive the benefit of that price. 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. 8126 with a lower MFP.

Manufacturing 52

Manufacturing Insurance Government Patients 52

FDA Law Blog

JUNE 1, 2025

Senator Durbins letter references a January 2023 study from the Journal of the American Medical Association, which found that more than two-thirds of drugs advertised on television were considered to have low therapeutic value. Maximizing patient clinical outcomes and quality of life may ultimately minimize healthcare resource utilization.

Healthcare Professional 59

Healthcare Professional Manufacturing Healthcare Utilities 59

GeriPal

JULY 20, 2023

Clinicians could care for patients across state lines, could prescribe opioids without in person visits, could bill at higher rates for telemedicine than previous to the pandemic. Many patients benefited, not only those isolating due to covid, but also patients in rural areas, patients who are homebound, and many others.

Telemedicine 73

Telemedicine Telehealth Patient-Centered Board-Certified 73