FDA Law Blog

FEBRUARY 21, 2022

Dr. Unger is a cardiologist and former Director of the Office of Drug Evaluation-I in FDA’s Office of New Drugs in the Center for Drug Evaluation and Research (“CDER”). He completed his cardiology training at The Johns Hopkins Hospital in 1987. Unger has joined the firm as a Principal Drug Regulatory Expert.

Patient-Centered 40

Patient-Centered Management Hospital Medical 40

FDA Law Blog

JUNE 22, 2022

Moreover, the non-prosecution agreement resulting from the criminal investigation illustrates the extent of liability for hospitals and other health care entities and the importance to maintain robust controls and oversight over employee activities related to dispensing and administering controlled substances. 4, 2022).

Board-Certified 52

Board-Certified Provider Government Management 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. 220 and was described on HP&M’s blog here. The EKRA issue in this case centered on how Graves was compensated.

Lab Testing 40

Lab Testing Individual Referral Patient-Centered 40

Common Sense Family Doctor

FEBRUARY 1, 2025

Since the turn of the century, the rise of hospitalists and the corresponding decline in the number of office-based family physicians who provide inpatient care for their own patients has magnified the value of optimizing the handoff from hospital-based teams to primary care physicians.

Hospital 52

Hospital Management Primary Care Primary Care Physician 52

FDA Law Blog

JUNE 10, 2024

Houck — It seems as though we cannot get through a week without hearing about controlled substance diversion by employees at another hospital or healthcare facility. DEA, Palomar Hospital Pays $250,000 for Diverting Fentanyl ( June 3, 2024 ). DEA, Palomar Hospital Pays $250,000 for Diverting Fentanyl ( June 3, 2024 ).

Management 59

Management Patient-Centered Hospital Healthcare 59

FDA Law Blog

MARCH 17, 2022

Houck — The Centers for Disease Control and Prevention (“CDC”) issued a voluntary practice guideline on opioid prescribing for clinicians treating chronic pain five years ago. (We We blogged on the final 2016 guideline here on March 17, 2016). By Larry K. Proposed 2022 CDC Clinical Practice Guideline for Prescribing Opioids, 87 Fed.

Patient-Centered 75

Patient-Centered Clinical Practice Patients Management 75

GeriPal

DECEMBER 8, 2022

Clinicians “catching” patient life stories. . Our patients aren’t “the 76 year old with heart failure in room 202,” as Heather Coats astutely noted. Storytelling Helps Hospital Staff Discover The Person Within The Patient. Integration of Person-Centered Narratives Into the Electronic Health Record: Study Protocol.

Patient-Centered 115

Patient-Centered Illness Healthcare IT 115

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. Clinicians are able to shape the environment in which people give birth by caring for the earth and their patients.

Community 52

Community Patient-Centered Family Families 52

ABIM

JUNE 11, 2025

Visit the ABIM Blog for reports of prior meetings. Expanding ABIM’s engagement with stakeholder communities such as early career physicians, specialty societies and patient-focused organizations. The following is a summary of the spring meeting.

Board-Certified 52

Board-Certified Government Community Education 52

FDA Law Blog

MAY 16, 2024

Houck — Employee diversion of controlled substances from hospitals has been an issue since at least 1986 when I became a diversion investigator with the Drug Enforcement Administration (“DEA”). A registered nurse also admitted she replaced fentanyl and hydromorphone with saline solution for administration to patients.

Hospital 59

Hospital Patient-Centered Medical Provider 59

GeriPal

JANUARY 18, 2024

We start off the conversation by talking about whether patients with cancer and cancer pain are really that different, and their paper that was just published on January 11 th in JAMA Oncology showing that substance use disorder is not uncommon in individuals with cancer. Katie, welcome back to GeriPal. Jessie, welcome back to GeriPal.

Illness 136

Illness Patient-Centered Screening IT 136

GeriPal

APRIL 14, 2022

Adapting Palliative Care Skills to Provide Substance Use Disorder Treatment to Patients With Serious Illness . Management of chronic pain in the elderly: focus on transdermal buprenorphine. So I have thought about this for months, maybe years since your 2016, cycle blog, but we have picked Under Pressure by David Bowie and Queen.

Illness 102

Illness Patient-Centered IT Patients 102

GeriPal

DECEMBER 15, 2022

Along the way we address: Is this degree of slowed cognitive decline meaningful to patients or care partners? Eric: So patient narrative storytelling, independent of what we call it, I’d like to turn to both of you and just how you got interested in this as a subject. She was a heart failure patient.

IT 105

IT Patient-Centered Healthcare Illness 105

FDA Law Blog

NOVEMBER 29, 2022

CDC received some 5,500 comments from patients, caregivers, clinicians and interested organizations to the proposed guideline update it issued in February. We blogged on the 2016 guideline here in March 2016, and the proposed guideline here on March 18th). They do apply, however, to prescribing for pain management upon discharge.

Patients 52

Patients Patient-Centered ER Individual 52

GeriPal

MARCH 3, 2022

A little over a decade ago, Ken Covinsky wrote a GeriPal post about a Jack Iwashyna JAMA study finding that older adults who survive sepsis are likely to develop new functional and cognitive deficits after they leave the hospital. Shunichi Nakagawa’s Tweet that went viral on responding a patient request to drink ice water before death.

Patient-Centered 96

Patient-Centered Patients IT Illness 96

PEMBlog

JULY 10, 2024

Labudde, Jane Lee; A Review of Syphilis Infection in Pediatric Patients. link] Centers for Disease Control and Prevention. ” Centers for Disease Control and Prevention, 2021. Centers for Disease Control and Prevention. ” Centers for Disease Control and Prevention, 2021. . Pediatr Rev.

Patient-Centered 52

Patient-Centered Patients IT Physicals 52

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

GeriPal

MARCH 30, 2023

Liz wrote a fabulous perspectives piece in the NEJM titled “ Deciding on My Dimples ” which talks about her experience as a patient doing shared decision making during neurosurgery for resection of an astrocytoma. But my piece in the New England Journal is about being a patient right before awake brain surgery.

IT 95

IT Patient-Centered Patients Healthcare 95

GeriPal

DECEMBER 19, 2024

We invited Dani Chammas , a palliative care physician and psychiatrist at UCSF (and a frequent guest to the GeriPal podcast), as well as Brent Kious , a psychiatrist at the Huntsman Mental Health Institute, focusing on the management of severe persistent mental illnesses. For more details, please click here. (AP AP Recruit Job No.

Illness 101

Illness Mental Health IT Patient-Centered 101

GeriPal

SEPTEMBER 22, 2022

Have you ever had that moment when talking to a patient, when you realized that the phrase you just uttered, which you’ve uttered a hundred times before, came out rote and scripted? And in response, the family or patient looked at you like you were from another planet? Summary Transcript Summary. Yeah, I’ve been there too.

Illness 101

Illness IT Patient-Centered Patients 101

GeriPal

JANUARY 11, 2024

In further contrast to the United States, MAID in Canada is almost entirely administered by a clinician, whereas in the United States patients must self administer. You get me with one-finger-chords on the guitar if you’re watching on YouTube (best I could manage). Leonie, welcome to GeriPal. Leonie: Thanks for having me.

Illness 144

Illness IT Medical Provider 144

PEMBlog

APRIL 26, 2023

Kit Carney and Dr. Kristen Humphrey discuss gun violence, its impact on our patients and their families, as well as practical tips on advocating for safe storage of firearms, and how we can support victims of violence. I’m Dr. Carney and I am a pediatric resident at Cincinnati Children’s Hospital Medical Center. 2022, March 18).

Family 52

Family Families Mental Health Healthcare 52

GeriPal

SEPTEMBER 19, 2024

Give too much, it may cause harm (even if the higher dose had no significant side effects, it would require patients to take a lot of unnecessary additional pills as well as increase the cost.) So, what is the effective dose of palliative care? Give too little – it may not work. This is Eric Widera. Jennifer 04:25 I can take that on.

Patient-Centered 119

Patient-Centered IT Patients Hospital 119

FDA Law Blog

NOVEMBER 8, 2022

Torres also shared that the eSTAR program, which we most recently blogged about here , is being developed with Health Canada. To paraphrase from our blog post , EUAs are triggered by an EUA declaration; FDA will publish advanced notice for an EUA declaration and provide a 180 day notice before the implementation of the transition plan.

Medical 59

Medical Manufacturing Patient-Centered Provider 59

FDA Law Blog

SEPTEMBER 13, 2021

A final OIG rule to change the structure of manufacturer rebates to Medicare Part D and Medicaid Managed Care plans and their PBMs is enmeshed in litigation and is likely to be at least postponed until 2026 (see our post ), and perhaps prevented from implementation altogether, by Congressional mandate. Controlling Drug Price Increases.

Manufacturing 98

Manufacturing Supply Chain Patient-Centered Utilities 98