Barton Associates

JUNE 19, 2025

In fact, hospitals, clinics, and other facilities are already reeling from a shortage of providers and it’s hurting patients— according to the United States Department of Health and Human Services (HHS) , tens of millions of Americans live in areas with shortages of primary care, dental, and mental health professionals.

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FDA Law

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510(k) process, outlining FDA’s latest improvements to strengthen the 510(k) Program and announcing release of three draft guidance documents. Baumhardt, Senior Medical Device Regulation Expert & Adrienne R.

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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. We have seen explosive growth and become a cornerstone of modern health care systems.

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Patient-Centered Telemedicine Clinic Electronics 52

FDA Law

SEPTEMBER 16, 2024

This FR Notice and draft strategy document are part of FDA’s commitment under the Prescription Drug User Fee Act (PDUFA) Reauthorization Performance Goals and Procedures for Fiscal Years 2023-2027 (PDUFA VII), wherein FDA committed to advance the use and implementation of innovative manufacturing.

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Family Physicians of Greeley

JUNE 16, 2023

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. Understand the network of healthcare providers covered by your plan and any limitations or restrictions.

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FDA Law

MARCH 27, 2023

Such codes need to be placed on device labels and packages to allow devices to be easily identified and tracked throughout their lifecycle, except where the rule provided for an exception or alternative. So, what is special about September 24, 2023? Most of the compliance dates have been passed. Emphasis added.) It is not far off!

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FDA Law

MAY 13, 2024

Rather than looking at how RWD/RWE provide meaningful information on safety and effectiveness, reviewers often focus on perceived gaps. However, based on our experience reviewing device premarket submissions and engaging with FDA, we have found that reviewers have not embraced it in practice. percent of examples.

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FDA Law

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.

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Patient-Centered Manufacturing Clinic Provider 52

FDA Law

NOVEMBER 7, 2024

One less utilized method (and for good reason) to gain more certitude is the 513(g) Request for Information. According to the latest MDUFA performance report , only 25% of 513(g)s in fiscal year 2023 met the 60-day statutory time frame. By Véronique Li, Senior Medical Device Regulation Expert & Jeffrey N.

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FDA Law

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.

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Consulting Manufacturing Utilities Provider 52

FDA Law

JUNE 27, 2023

On June 12, 2023, FDA issued a public notice to solicit comments on the information collection related to the voluntary submission of allegations of regulatory misconduct to CDRH. Any comments to the public notice must be submitted by August 11, 2023. FDA does not define, however, when information submitted is deemed to be “complete.”

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FDA Law

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. We take this date with a grain of salt given the frequency with which these dates are missed and given the volume of comments filed.

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IT Medical Patient-Centered Provider 69

FDA Law

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.

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Patient-Centered Clinic Medical Utilities 52

The Clinical Problem Solvers

DECEMBER 16, 2020

Fields Time Stamps 00:00 Mission, vision, and introductions of hosts 01:30 Background on three-episode series 02:26 Introductions of guests 04:16 How Dr. Tsai has seen race-based medicine play out in clinical practice 10:45 What role should race play in making clinical decisions?

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Clinic Education Clinical Practice Patient-Centered 52

FDA Law

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. On July 8, as part of its annual physician fee schedule update for 2023, CMS issued a proposed regulation to implement the new refund.

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Manufacturing Utilities Government Provider 52

FDA Law

NOVEMBER 15, 2022

In this blog post, we provide a primer on user fees and the Small Business Program. These fees supplement the annual funding Congress provides for FDA. While the fees provide funding for a review, meeting the timeline 100% is not guaranteed and the performance goals do account for this potential. Exemptions or Waivers.

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Medical Provider IT Manufacturing 59

FDA Law

MAY 15, 2023

The goal of this positive list is to provide harmonization, consistency, and transparency. AAFCO is requesting stakeholders, such as veterinarians, animal nutritionists, consumer groups, and the public, to provide feedback on the initial CFI by June 2, 2023. AAFCO develops model regulations, that serve as model for the states.

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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. The pre-existing statutory language did not require animal testing. In our experience, FDA is inherently an empirically driven body of scientists, physicians, and policy-makers.

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Clinic IT Utilities Government 64

FDA Law

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. By Deborah L. This is the third topic included in the new draft guidance. This significant opportunity under the Existing FDR Guidance is not offered for monograph FDRs.

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Utilities Provider Individual IT 52

FDA Law

JUNE 21, 2023

enable individuals to have virtual consultations with healthcare providers through video calls or online platforms), at-home diagnostics (e.g., enable individuals to have virtual consultations with healthcare providers through video calls or online platforms), at-home diagnostics (e.g., By Philip Won & McKenzie E.

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FDA Law

APRIL 23, 2023

If sponsors do not own the data used for the external control arm, they should structure agreements with the data owner to ensure that patient-level data can be provided to FDA. This Draft Guidance focuses on the use of patient-level data from other clinical trials or from RWD sources.

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Patient-Centered Clinic Patients Provider 49

FDA Law

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. By Larry K. 823(g)(1).

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Insurance Patients Utilities Chronic Condition 52

PEMBlog

SEPTEMBER 6, 2023

They carry existing diagnoses and are followed by outpatient mental health providers. Attention to any toxidromes, any abnormal vital signs or mental status, eye findings, and neurologic examination provide the greatest help in narrowing the differential diagnosis. Hosp Pediatr (2023) 13 (1): 66–71 Health Aff (Millwood).

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Lab Testing Medical Patients Mental Health 52

PEMBlog

MAY 15, 2023

Our role as providers is to identify the patients who have a life-threatening etiology to their syncope. Pre-Publication Peer Review This post underwent pre-publication peer review on Thursday May 11, 2023. Syncope is described as a brief loss of consciousness and postural tone caused by transient global cerebral hypoperfusion.

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The Motivated MD

SEPTEMBER 19, 2024

’ 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. Saving $23,000 when the national average unweighted resident salary in 2023, according to AAMC data , was $63,800. So yes, humans make mistakes.

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Finance Individual Education Healthcare Professional 52

FDA Law

JANUARY 4, 2023

2617, the “ Consolidated Appropriations Act, 2023 ,” was signed into law by President Biden on December 29. The provision amends the Federal Food, Drug, and Cosmetic Act section 502 to provide explicit protection for conveying certain information about products in development to payors, including unapproved uses of approved products. .

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Patients Provider IT Utilities 64

FDA Law

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.

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Manufacturing Utilities Provider IT 59

FDA Law

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.

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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.

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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. It meets in-person, once a month, over nine sessions. First, the lyrics, that’s the main reason why I chose it.

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IT Patient-Centered Families Family 99

PEMBlog

APRIL 26, 2023

Listen Gun Violence and Safety (2023) – Brad Sobolewski, MD, MEd – featuring Kit Carney, MD & Kristen Humphrey, MD – PEM Currents: The Pediatric Emergency Medicine Podcast [link] Subscribe Advocacy and education resources Be SMART Campaign Be SMART emphasizes the importance of responsible gun ownership and secure gun storage.

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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.

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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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New South Family Medicine and MedSpa

SEPTEMBER 17, 2019

Eating fruit provides excellent health benefits and is part of a healthy plate. Fruits provide nutrients vital for health and maintenance of your body. Fiber containing foods such as fruits help provide a feeling of fullness with fewer calories. Then take a moment to reflect on your unique plate. What similarities do you notice?

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GeriPal

JULY 13, 2023

Randy died February 26, 2023. Today we discuss a new paper in JAMA that tests a stripped down version of the clinician only facing intervention in a pragmatic randomized trial for older adults with serious illness and those 80+. They found a difference of 4% in documented goals of care discussions. Is 4% meaningful? Alex: I love that song.

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Patient-Centered IT Patients Hospital 83

FDA Law

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.

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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.” Malaz: I love it.

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