FDA Law

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

FDA Law

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] Unless FDA provides timely responses to pre-submissions, laboratories (and current IVD manufacturers) will not be able to submit applications that address FDA’s expectations.

IT 69

IT Medical Patient-Centered Provider 69

PEMBlog

APRIL 20, 2023

Cristina Tarango, director of the Hemophilia Treatment Center at Cincinnati Children’s and Lisa Littner, Project Manager at Cincinnati Children’s who helped me research and write this post. Emicizumab (Hemlibra) was approved in 2018 for routine bleeding prophylaxis in hemophilia A with or without inhibitors.

Individual 52

Individual Patient-Centered Patients IT 52

FDA Law

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

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

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.

Community 114

Community Transportation IT PCP 114

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

The Clinical Problem Solvers

MAY 30, 2022

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. This policy reflects a societal belief that humans are not valuable unless they provide a service.

Community 52

Community Patient-Centered Family Families 52

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? Welcome back, William. Delighted to be here.

Patient-Centered 129

Patient-Centered IT Patients Clinic 129

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? And then I met a patient in clinic once who asked me a lot of really intelligent questions about medical cannabis, what it does. They just kept at it.

Medical 98

Medical IT Patient-Centered Healthcare 98

FDA Law

MAY 16, 2024

UMHS agreed to resolve the allegations in August 2018 for $4,300,000 and compliance with a three-year Memorandum of Agreement (“MOA”). A registered nurse also admitted she replaced fentanyl and hydromorphone with saline solution for administration to patients. The tech’s husband distributed the drugs in the community.

Hospital 59

Hospital Patient-Centered Medical Provider 59

GeriPal

FEBRUARY 6, 2025

On todays podcast, weve invited Nathaniel Chin back to the GeriPal podcast to talk about what primary care needs to manage this new world of Alzheimers disease effectively. He is associate professor at the University of Wisconsin and medical director of their Alzheimer’s Disease Research Center. Nate 00:25 Thanks for having me.

Primary Care 95

Primary Care Diagnosis Screening IT 95

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 Hospital 96

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.

Patient-Centered 77

Patient-Centered IT Patients Illness 77

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.

Patient-Centered 98

Patient-Centered IT Clinic Patients 98

PEMBlog

JUNE 5, 2024

Sasser SM, Hunt RC, Faul M, Sugerman D, Pearson WS, Dulski T, Wald MM, Jurkovich GJ, Newgard CD, Lerner EB; Centers for Disease Control and Prevention (CDC). Guidelines for field triage of injured patients: recommendations of the National Expert Panel on Field Triage, 2011. Let’s go ahead and pivot to initial management.

Patient-Centered 52

Patient-Centered Patients IT Hospital 52

Tiny Physician

MARCH 30, 2022

Archana Sharma committed suicide because of the harassment by the bystanders of the patient who died at her hospital. However, she found herself in trouble when one of her patients, whom she treated at her hospital, died due to postpartum hemorrhage (bleeding from the birth canal after delivery). Is this a case of medical negligence?

Hospital 52

Hospital Government Patient-Centered Medical 52

GeriPal

MAY 12, 2022

In this podcast, we cover a great deal of ground, including: Early challenges Dr. Raj faced in pain management: access to opioids, corruption, a system that doesn’t see addressing suffering as a priority. It was wonderful for me, as a rehab doctor, to be able to see patients with spinal cord injuries and how they were living in their homes.

Community 115

Community IT Relationship Healthcare 115

GeriPal

APRIL 21, 2022

Poetry puts us in our patient’s shoes. Poetry holds us in that liminal space so many of our patients are in. To the deeper emotions – of loss and grief, of wonder and transcendence – that are at the heart of the complex care we provide. As Redwing’s poem says, “why not live as long as possible?” . AlexSmithMD .

Patient-Centered 93

Patient-Centered IT Community Illness 93

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?

Primary Care 79

Primary Care IT Clinic Patient-Centered 79

GeriPal

FEBRUARY 24, 2022

We see our patients and our families throughout the illness trajectory into the hospital. And maybe we should have more patient-centered conversations. We want to do meaningful work and so we want to know that the conversations we have impact patient care. Eric: Well, how about just with the debate? We see how hard it is.

Illness 98

Illness Patient-Centered IT Patients 98

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. Reform efforts aren’t new.

Insurance 52

Insurance Patient-Centered Patients Government 52

Physicians News Digest

APRIL 2, 2025

By Julie Appleby Tim Winard knew he needed to buy health insurance when he left his management job in manufacturing to launch his own business. We were so nervous about not being on a company-provided plan,” Winard said. His plan says it covers colon cancer screening at 80% after patients meet their deductible.

Insurance 52

Insurance Screening Hospital Patient-Centered 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. So what’s the evaluation and management for simple febrile seizures? How do we evaluate and manage them? Pediatrics.

Illness 59

Illness Vaccination Family Families 59

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

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.

Manufacturing 98

Manufacturing Supply Chain Patient-Centered Utilities 98