FDA Law Blog

JANUARY 6, 2022

Wasserstein — “EKRA” refers to the Eliminating Kickbacks in Recovery Act, which was part of the Substance Use – Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act of 2018. These lab tests are performed for physicians, substance abuse treatment centers and other types of organizations.

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Lab Testing Individual Referral Patient-Centered 40

FDA Law Blog

JUNE 23, 2021

Valentine — For the last 13 years, this blogger has been at the center of what has now been dubbed “patient-focused drug development.” For 6 years, I served as a patient liaison within FDA in what was then called the Office of Special Health Issues. By James E. The practice of medicine was viewed as paternalistic.

Patients 52

Patients Patient-Centered Clinic IT 52

GeriPal

JUNE 8, 2023

When I’m on palliative care consults and attending in our hospice unit we have to counsel patients about deprescribing and de-intensifying diabetes medications. Our last podcast was with Laura Petrillo in 2018 – 5 years ago seems ancient history – though many of the points still apply today (e.g. Goldilocks zone).

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Diabetes Management Patient-Centered Families 74

FDA Law Blog

SEPTEMBER 20, 2021

From new initiatives to facilitate faster reviews for new indications under the Split Real Time Application Review (STAR) pilot program, to bringing new meetings under PDUFA goals, to continued support for rare diseases and incorporation of the patient voice, the goals letter revealed a good number of welcome announcements.

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Patient-Centered Manufacturing Clinic Provider 52

The Clinical Problem Solvers

FEBRUARY 8, 2023

There is a special emphasis on the use of public health models that prioritize harm reduction and person-centered care to prevent drug-related fatalities and curb the opioid epidemic along lines of race and class. This discussion is hosted by Ashley Cooper, Sudarshan Krishnamurthy, and new team member Gillette Pierce.

Community 52

Community Patient-Centered Mental Health Board-Certified 52

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. Going into patient’s homes was eye opening. And yet, after assisting the older adult to their feet, the EMS providers would leave.

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Community Transportation IT PCP 116

GeriPal

MARCH 2, 2023

The FDA-approved indications for gabapentin are only for treating patients with partial seizures or postherpetic neuralgia. valproic acid and gabapentin), in nursing homes, particularly patients with Alzheimer’s disease and related dementias. There are a lot of reasons that may explain the massive increase in use of these drugs.

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Patient-Centered IT Healthcare Medical 96

BMJ

FEBRUARY 8, 2021

Two out of three drug overdose deaths in 2018 involved an opioid – be it prescription opioids, heroin, or synthetic opioids. 6 As a result of these and many other actions, the death toll from opioid overdose fell by more than 4% between 2017 and 2018. 2 Opioids contribute a large share of this overdose crisis.

Medical 40

Medical Holistic Care Healthcare Healthcare Professional 40

The Clinical Problem Solvers

MAY 30, 2022

This discussion is hosted by Naomi Fields, MD, Chioma Onuoha, and Victor Lopez-Carmen MPH, as they interview Dr. Kozhimannil—the Distinguished McKnight University Professor in the Division of Health Policy and Management at the University of Minnesota and Director of the Rural Health Research Center.

Community 52

Community Patient-Centered Families Family 52

GeriPal

AUGUST 17, 2023

However, as noted in our editorial published with the donanemab trial , the modest benefits of amyloid antibodies would likely not be questioned by patients, clinicians, or payers if amyloid antibodies were low risk, inexpensive, and simple to administer. However, they are none of these. Welcome back to the GeriPal podcast, Jason.

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Patient-Centered IT Clinic Patients 98

GeriPal

FEBRUARY 6, 2025

He is associate professor at the University of Wisconsin and medical director of their Alzheimer’s Disease Research Center. That screening influences kind of further treatment, actually, probably more importantly, patient outcomes. And when I asked the patient, well, what happened, the test was sprung on them.

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Primary Care Diagnosis Screening IT 97

GeriPal

MARCH 24, 2022

2018 Systematic Review of Systematic Reviews on ACP. Alex: We are delighted to welcome to the GeriPal podcast, Susan Hickman, who is professor at the Indiana University schools of nursing and medicine, and is director of the IU Center for Aging Research at the Regenstrief Institute. Alex: What did it changed to after 2018?

Illness 73

Illness IT Healthcare Patient-Centered 73

GeriPal

APRIL 24, 2025

We and our guests have noticed that in our clinical practices, patients and caregivers seem to be asking for such treatments more frequently. If its potentially unsafe, but has robust evidence, well thats most of the treatments we offer seriously ill patients! Think chemotherapy to imminently dying patients, or CPR. Think chemo.

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Patient-Centered IT Patients Illness 79

GeriPal

MARCH 3, 2022

This idea that for critically ill patients in the ICU, geriatric conditions like disability, frailty, multimorbidity, and dementia should be viewed through a wider lens of what patients are like before and after the ICU event was transformative for our two guests today. I want to say like 2017, 2018, something like that.

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Patient-Centered Patients IT Illness 96

GeriPal

OCTOBER 3, 2024

Alex 00:08 UCSF’s Division of Palliative Medicine are looking to build on their research and clinical programs and are interviewing candidates for the associate chief of research position and for full time physician faculty to join them in the in-patient and out-patient settings. Frank, welcome to the GeriPal podcast.

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IT Patient-Centered Patients Relationship 123

GeriPal

MAY 12, 2022

When we think about palliative care delivered here, like individuals with chronic pain, non-serious illness chronic pain, non-life threatening illness, oftentimes if we get consulted on them, we don’t even see them, may just be discontinued in most palliative care places. They have nothing to do with that.

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Community IT Relationship Healthcare 116

GeriPal

MARCH 27, 2025

Only 5% of intervention patients received the facilitator-led component of the intervention (there were other components, facilitator-led was the most engaged component). I’m hearing dementia patients or patients with dementia. Eric 09:15 And then who were the patients just with dementia or were they. Is that right?

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Primary Care IT Clinic Illness 80

Physicians News Digest

APRIL 3, 2025

The episodes turned both women into advocates for patients and spurred research that made American health care safer. Haskell, of Columbia, South Carolina, has done research and helped write AHRQ-published surveys and guidebooks on patient engagement for hospitals. It also has published tools and guidelines to enhance patient safety.

Patient-Centered 52

Patient-Centered Hospital Diagnose Medical 52

FDA Law Blog

SEPTEMBER 13, 2021

In 2018, Trump’s Department of Health and Human Services (HHS) released its Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs , but the edifice envisioned by the Blueprint largely failed to materialize. Controlling Medicare Part D Patient Out-of-Pocket Costs and Total Drug Costs. Controlling Drug Price Increases.

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Manufacturing Supply Chain Patient-Centered Utilities 98