FDA Law Blog

NOVEMBER 1, 2023

The PR first sets out to establish that it has authority to regulate in vitro diagnostic “test systems” as devices, and not just the system’s individual components, such as reagents, instruments, specimen collection devices, and software. Premarket Approval or De Novo pathways).

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GeriPal

NOVEMBER 9, 2023

The initial RCT published on physician coaching in JAMA in 2019 showing that coaching improves quality of life. Summary Transcript Summary Coaching is in. When I was a junior faculty, coaching wasn’t a thing. We address: What is coaching? How does it differ from therapy? link] Transcript Eric: Welcome to the GeriPal podcast. Indeed, matey.

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FDA Law Blog

JANUARY 6, 2022

A “health care benefit program” is defined as “any public or private plan or contract, affecting commerce, under which any medical benefit, item, or service is provided to any individual, and includes any individual or entity who is providing a medical benefit, item, or service for which payment may be made under the plan or contract.”

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FDA Law Blog

FEBRUARY 28, 2022

This Guidance embodies the Agency’s belief that: “Successful adoption of legally marketed medical devices increasingly depends on patient acceptance of that technology and patients being more engaged in the healthcare process, along with demonstrated public health benefits.”. The FDA webinar information can be found here.

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Patients Clinic Medical Patient-Centered 52

FDA Law Blog

JANUARY 31, 2022

The United States filed a Complaint against Texas entities Zarzamora Healthcare LLC, Rite-Away Pharmacy and Medical Supply #2– and its Pharmacist-in-Charge (PIC), and part owner. attorneys’ offices since 2019, the Complaint seeks monetary and permanent injunctive relief ( see 21 U.S.C. §§ 832(f)(1) and 882(a)).

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FDA Law Blog

JANUARY 6, 2022

A “health care benefit program” is defined as “any public or private plan or contract, affecting commerce, under which any medical benefit, item, or service is provided to any individual, and includes any individual or entity who is providing a medical benefit, item, or service for which payment may be made under the plan or contract.”

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Lab Testing Individual Referral Patient-Centered 40

The Clinical Problem Solvers

DECEMBER 20, 2021

Fields Guests: Thu Quach, PhD, and Tung Nguyen, MD Time Stamps 00:00 Introduction 04:00 How Dr. Thu Quach’s and Dr. Tung Nguyen’s journeys shape their work 11:40 Policy work as a way of mitigating burnout 12:55 Balancing individual and communal focus (include?) provision in only English +/- Spanish), limitations of medical technology (i.e.,

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Community Patient-Centered Relationship Healthcare 52

The Clinical Problem Solvers

APRIL 5, 2022

Dr. Kushel and Mr. Watts remind healthcare providers to speak out about the structural causes of homelessness. Push back against individual narratives that blame individuals for systemic injustice. National Healthcare for the Homeless Council, Who We Are. Published April 5, 2019. January 18, 2019.

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Community Patient-Centered Emergency Room Medical 52

GeriPal

MARCH 2, 2023

AFP 2019 Gabapentin for chronic neuropathic pain in adults. By 2015 that number increased to 4% of US adults. There are a lot of reasons that may explain the massive increase in use of these drugs. One thing is clear, it is not because people are using it for FDA approved indications. Cochrane Database of Systematic Reviews Review.

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Patient-Centered IT Healthcare Medical 96

The Clinical Problem Solvers

OCTOBER 11, 2021

individual bias or bigotry that leads to a failure to sell a home to a person of color) and personal choices ( e.g. Black people prefer to live among other Black people) is referred to as de facto segregation. These gaps are not a product of lifestyle choices, biology or individual behaviors. 2020;324(3):231-232. doi:10.1001/jama.2020.9289

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GeriPal

MARCH 24, 2023

We also have Joe Shega, who is a hospice physician, and he is a Chief Medical Officer and Vice President at VITAS Healthcare. For others, this piece, while painful to read, gave voice to what they have been feeling over the last decade – hospice has in some ways lost its way in a quest of promoting profit over care. I’m excited.

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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. These narratives have vilified individuals who would benefit from comprehensive, person-centered substance use treatment, rather than incarceration and other adverse harms.

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Annals of Family Medicine

NOVEMBER 20, 2024

Context: Significant structural barriers exist concerning access to healthcare for transgender (TG) individuals. Setting or Dataset: Secondary analysis of the CDC state-specific Behavioral Risk Factor Surveillance System (BFRSS) surveys conducted from 2019 to 2022. TG who had depression were approximately 4.4

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GeriPal

MAY 18, 2023

We’ve invited two members who helped update the criteria including Todd Semla and Mike Steinman. We discuss a little history of the Beers criteria, including the original Beers Criteria that was published by the late Dr. Mark Beers, and how it has evolved over the last three decades. Alex: We’re having Beers. We’ll learn about that.

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Medical IT Patients Clinic 97

GeriPal

NOVEMBER 2, 2023

I’ve seen this question come up a lot since finishing fellowship nearly two decades ago. Historically, answers generally lamented the ever increasing need for geriatrics without a corresponding growth in the number of specialists in the field. Mike, welcome to GeriPal. Mike: Great to be here. Alex: We’ll take any Warriors we can get.

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BMJ

FEBRUARY 8, 2021

The proximity to campus health clinics may also afford college students greater accessibility to healthcare providers for prescription medications such as stimulants which could end up being misused. Besides the risks to an individual, there are also population-level harms from normalizing certain harmful behaviors (e.g., 2019-1372.

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GeriPal

MARCH 9, 2023

In our prior podcast with Ira Byock on psychedelics in 2019 we talked primarily about the potential of psychedelics. Theora Cimino conducted an observational study (publication in the works) of marginally housed/homeless persons many of whom had experience with psychedelics. And yet there are reasons for caution. Alex: Yeah, yeah, it does.

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Patient-Centered Community IT Medical 91

The Clinical Problem Solvers

MAY 30, 2022

As healthcare providers, we must listen to our patients and use the power of our presence to see birthing people’s full humanity and empowerment. She urges us to recognize that maternal mortality changes the life trajectories of individuals and communities. Published January 16, 2019. Published April 10, 2019. Healthcare.

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Community Patient-Centered Family Families 52

GeriPal

MAY 8, 2025

Summary Transcript CME Summary Weve covered psychedelics on the podcast beforefirst in 2019 with Ira Byock, where we explored their potential role in medicine , and then again in 2023 with Stacy Fischer, Brian Anderson, and Theora Cimino, focusing on the reasons to approach psychedelic use in patients with caution. It’s there.

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Illness IT Patient-Centered Patients 107

FDA Law Blog

FEBRUARY 9, 2022

DEA regulations state that a pharmacist has a corresponding responsibility not to fill a prescription unless it is issued for a “legitimate medical purpose by an individual practitioner acting in the usual course of [their] professional practice.” at 62,341; see Jones Total Healthcare Pharmacy, L.L.C. Holiday CVS, 77 Fed. 27, 2010).

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GeriPal

APRIL 13, 2023

Summary Transcript Summary Social connections impact our health in profound ways, whether it is the support we receive from family and friends in navigating serious illness, the joy from shared social activities, or connecting with our community. Welcome back, Ashwin. Ashwin Kotwal: Excited to be back. Eric: Now, it’s interesting. Alex: Great.

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IT Community Patient-Centered Medical 99

GeriPal

FEBRUARY 27, 2025

Do you need to be an addiction medicine trained physician to start such a clinic (no: Sach is not). See Sachs write up about setting up this clinic in JPSM. What is harm reduction and how can we implement it in practice? Who follows the patient once the cancer goes into remission? Who will prescribe the buprenorphine then? Oh, my goodness.

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Patients Clinic Patient-Centered Illness 72

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?

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BMJ

MAY 10, 2022

Introductory article to İkİIşik H, Sezerol MA, Taşçı Y, et alCOVID-19 vaccine hesitancy and related factors among primary healthcare workers in a district of Istanbul: a cross-sectional study from TurkeyFamily Medicine and Community Health 2022;10:e001430. Individuals over 65 years of age at home Yes 23 (65.7) 150 (54.3) 126 (45.7)

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FDA Law Blog

FEBRUARY 16, 2023

Many states already have standing orders that allow for the dispensing of naloxone without an individual prescription and other public health initiatives to increase naloxone access. FDA is also reviewing an application for OTC naloxone under the trade name RiVive submitted by Harm Reduction Therapeutics last year.

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FDA Law Blog

AUGUST 21, 2023

Thus, Defendants argued that FDA already required the warning for pregnancy, rendering the decision to use it during pregnancy to a healthcare professional, and that FDA had considered the risks of in utero exposure and rejected the addition of those risks to the labeling. Koblitz & Deborah L.

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New South Family Medicine and MedSpa

SEPTEMBER 17, 2019

However, people need to understand what works best for them individually. Food has the power to regenerate the new you! The world of diets and dietary theories is complicated and can be overwhelming. Eating a diet made of whole foods, and no, not just anything you purchase from the Whole Foods grocery store.

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FDA Law Blog

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).

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Individual Insurance Healthcare Provider 45

BMJ

AUGUST 20, 2021

We used the first six years of the dataset to form a predictive model using Holt-Winters forecasting (a time series predictive method based on trends and seasonality), and then compared the observed data from November 2019 to November 2020 with the model to assess the impact of the COVID-19 pandemic on prescribing.

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FDA Law Blog

DECEMBER 18, 2023

Both methods were included in Phexxi’s own prescribing information as well as in FDA’s draft 2019 guidance on establishing effectiveness for hormonal contraceptives (note: Phexxi is not a hormonal contraceptive). Notably, Evofem provided considerable context around its 99% claim.

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Healthcare Professional Provider IT Patients 59

FDA Law Blog

SEPTEMBER 8, 2022

In a common example of this practice, the drug manufacturer issues a coupon to an insured individual to present at the pharmacy. The pharmacy bills all or most of the individual’s copayment or coinsurance—which the patient would otherwise pay the pharmacy directly—to the manufacturer.

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The Clinical Problem Solvers

MAY 2, 2023

[link] CPSolvers: Antiracism in Medicine Series Episode 21 – Psychosocial and Cultural Considerations for Providing Healthcare to Immigrant and Refugee Populations Show Notes by Kiersten T. A lot of compounding trauma occurs at the border that has potential downstream mental health implications for individuals and their families.

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Healthcare Provider Clinical Practice Clinic 52

GeriPal

APRIL 17, 2025

Summary Transcript CME Summary I read Farah Stockmans article in the NYT on why attacks on DEI will cost us all , and thought, Yes, and everyone includes harm to our healthcare workforce, our patients, and their families. And Ken Covinsky, avid baseball fanatic, joins us and notes that the day we record (April 15) is Jackie Robinson day.

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