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.

Lab Testing 52

Lab Testing Referral Individual Patient-Centered 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).

Diabetes 74

Diabetes Management Patient-Centered Families 74

The Clinical Problem Solvers

AUGUST 25, 2020

Her definition centers the idea that Black individuals did not inherit the diseases they disparately suffer from, but they inherited a disadvantaged system that creates the stark health disparities we see today. Essien, MD, MPH Hosts: Dereck Paul, MS, Utibe R.

Community 52

Community Patient-Centered Relationship Education 52

FDA Law Blog

DECEMBER 11, 2023

This is based on FDA’s reported 2018 review of the CLIA database. [2] This is 50% greater than the 2018 numbers relied upon by FDA in its estimates. [3] Mullen — With comments due on the proposed LDT rule last week, FDA wasted no time updating the Unified Agenda to indicate that a final rule may be published in April ( here ).

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IT Medical Patient-Centered Provider 69

PEMBlog

MAY 11, 2023

Some general recommendations to reduce pain during LP include: Comfortable Positioning: The patient should be instructed to lie on their side with their knees drawn up to their chest and their chin tucked in, or sit upright with their head and upper back forward (often on a bedside table with a pillow). Is there evidence for the J-Tip?

Patient-Centered 52

Patient-Centered Provider IT Patients 52

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.

Patient-Centered 52

Patient-Centered Manufacturing Clinic Provider 52

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.

Lab Testing 40

Lab Testing Individual Referral Patient-Centered 40

GeriPal

SEPTEMBER 7, 2023

Does it improve outcomes that patients, caregivers, and clinicians care about? hint: 80% can be done in advance by patients or caregivers) Why is it that some oncologists are resistant to conducting a geriatric assessment, yet have no problem ordering tests that cost thousands of dollars? But does the geriatric assessment do anything?

Patient-Centered 129

Patient-Centered IT Patients Clinic 129

GeriPal

OCTOBER 10, 2024

And they begin on today’s podcast with one clinical ask: everyone should be a generalist and a specialist. They are looking to build on both their research and clinical programs and are interviewing candidates for the Associate Chief of Research and for full-time physician faculty to join them in the inpatient and outpatient setting.

Screening 120

Screening IT Families Family 120

GeriPal

OCTOBER 24, 2024

If you believe the evidence for efficacy to manage symptoms like neuropathic pain, how do you even start to think about recommending these products to patients? If you believe the evidence for efficacy to manage symptoms like neuropathic pain, how do you even start to think about recommending these products to patients?

Medical 99

Medical IT Patient-Centered Healthcare 99

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

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.

Patient-Centered 96

Patient-Centered IT Healthcare Medical 96

GeriPal

FEBRUARY 15, 2024

Going into patient’s homes was eye opening. They were stunned by the number of calls for lift assistance for older adults who had fallen. There were trip hazards, loose carpets, some people were hoarders. And yet, after assisting the older adult to their feet, the EMS providers would leave. Their job was done. Alex: That is true.

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Community Transportation IT PCP 115

GeriPal

FEBRUARY 6, 2025

He is associate professor at the University of Wisconsin and medical director of their Alzheimer’s Disease Research Center. To start things off, Nate’s a returning guest. Nate, welcome back to the GeriPal Podcast. Nate 00:25 Thanks for having me. Great to be back. And my wife went to over, I want to say, 20 concerts. I loved it.

Primary Care 96

Primary Care Diagnosis Screening IT 96

GeriPal

AUGUST 17, 2023

Praised by the FDA, Alzheimer’s Association (AA), and Pharma as a “game changer”, but derided by others for the drug’s lack of clinical efficacy, risk of severe adverse effects, absence of diversity in trial populations, high costs, and an FDA approval process that was in the kindest words “rife with irregularities”.

Patient-Centered 98

Patient-Centered IT Clinic Patients 98

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. and a professor.”

Community 52

Community Patient-Centered Families Family 52

GeriPal

MARCH 24, 2022

2018 Systematic Review of Systematic Reviews on ACP. 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.

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.

Patient-Centered 77

Patient-Centered IT Patients Illness 77

PEMBlog

JUNE 5, 2024

It was inspired by a hot-off-the-presses publication from the Pediatric Emergency Care Applied Research Network (PECARN) focused on clinical decision rules for cervical spine imaging in children. Guidelines for field triage of injured patients: recommendations of the National Expert Panel on Field Triage, 2011. MMWR Recomm Rep.

Patient-Centered 52

Patient-Centered Patients IT Hospital 52

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.

Patient-Centered 96

Patient-Centered Patients IT Illness 96

GeriPal

OCTOBER 3, 2024

How the act of drawing can help us sloooow down, pay attention to the people and world around us, and ultimately let go… The possibility of incorporating drawings in research and even clinical care. Some highlights from our conversation: The role of art in humanizing the dying process. Sit down and draw each other for only one minute.

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IT Patient-Centered Patients Relationship 122

GeriPal

JULY 13, 2023

Summary Transcript Summary Today’s podcast is a follow up to our 2018 podcast with Randy Curtis about the Jumpstart intervention. On that podcast he and collaborators tested a combined patient and clinician facing communication priming intervention to promote goals of care conversations. Is 4% meaningful? Welcome, Bob. Bob: Thank you.

Patient-Centered 84

Patient-Centered IT Hospital Patients 84

GeriPal

MARCH 27, 2025

Summary Transcript CME Summary A pragmatic trial evaluates the effectiveness of a treatment or intervention in real-world clinical practice. Only 5% of intervention patients received the facilitator-led component of the intervention (there were other components, facilitator-led was the most engaged component). Jasmine, is it you?

Primary Care 79

Primary Care IT Clinic Illness 79

GeriPal

APRIL 21, 2022

Poetry holds us in that liminal space so many of our patients are in. Alex: We also have Mike Rabow, who is director of palliative care at the Cancer Center at UCSF. The impossiblity which is life, which is everything, and death, which is the end of life. To let it go. . Welcome to the GeriPal podcast, Redwing. Redwing: Thank you.

Patient-Centered 93

Patient-Centered IT Community Illness 93

GeriPal

FEBRUARY 24, 2022

Since then there has been a lot of back and forth, with even a couple of podcasts from us, several JAMA viewpoints, and most recently a series of published replies from leaders in the field on why ACP is still valuable (see below for references). . Despite all of these publications, I’m still left at a loss of what to think about it all.

Illness 98

Illness Patient-Centered IT Families 98

Common Sense Family Doctor

MARCH 23, 2025

This post first appeared on March 6, 2018, during the first Trump administration's failed attempt to eliminate the Agency for Healthcare Research and Quality (AHRQ). Nonetheless, its work has often been politically unpopular and unheralded outside of a small community of health services researchers and patient advocates.

Healthcare 52

Healthcare Patient-Centered Primary Care Illness 52

Pamela Wible MD

JUNE 19, 2025

Drawing from her experience running a physician suicide helpline , she speaks candidly about the emotional toll of assembly-line medicine , the link between overwork and doctor suicide , and the revolutionary joy of reclaiming your career by launching your own ideal clinic. But is it really burnout—or something more serious? To be real.

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Clinic Nurse Practitioner IT Medical 246

Physician's Weekly

JUNE 25, 2025

Insurers also pledged to use clear language when communicating with patients and promised that medical professionals would review coverage denials. “The pledge is not a mandate,” Mehmet Oz, administrator of the Centers for Medicare & Medicaid Services, said during a news conference.

Insurance 52

Insurance Patient-Centered Government Patients 52

Physician's Weekly

JUNE 17, 2025

Until recently, the only treatment was growth hormone therapy to help patients stay leaner and grow taller, but it didn’t address appetite. This breakthrough for these patients comes as other drugs are revolutionizing how doctors treat obesity, which affects more than 40% of American adults. “All of a sudden, they flip.”

Patient-Centered 52

Patient-Centered Emergency Room Insurance Patients 52

PEMBlog

MAY 9, 2024

2018 Nov;142(5):e20181009. Epub 2018 Oct 8. Both the motor movements and characteristics of the seizure, as well as the duration, are really hard to assess in a patient’s home. Murata S, Okasora K, Tanabe T, Ogino M, Yamazaki S, Oba C, Syabana K, Nomura S, Shirasu A, Inoue K, Kashiwagi M, Tamai H. Pediatrics.

Illness 59

Illness Vaccination Families Family 59

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. Last Thursday, the U.S.

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Manufacturing Supply Chain Patient-Centered Utilities 98