FDA Law

JUNE 15, 2022

Kirschenbaum — In 2017, the Centers for Medicare & Medicaid Services (“CMS”) issued a final rule to significantly decrease the rate the government will reimburse 340B hospitals in 2018 for outpatient prescription drugs from average sales price (“ASP”) plus 6% to ASP minus 22.5%. 52494 (Nov. CMS estimated a savings of $1.6 See 42 U.S.C.

Hospital 52

Hospital Government Provider IT 52

FDA Law

JANUARY 5, 2023

Claud — As we turn into the New Year, we offer a few items of interest in digital and telehealth regulation, enforcement, and compliance that may provide some helpful guideposts for stakeholders. Digital providers and manufacturers not only have the concerns of the FDA to consider, but those of the FTC as well. By John W.M.

Manufacturing 59

Manufacturing Patient-Centered Provider Telehealth 59

FDA Law

JULY 5, 2023

Outsourcing facilities are not exempt from FDA’s cGMP for drug manufacturers (as lightly tweaked via cGMP Guidance for outsourcing facilities ) or adverse event reporting requirements , and are subject to regular inspection by FDA. Section II at 2. Draft Guidance III.B.2(e) Draft Guidance III.B.2(d)

Supply Chain 52

Supply Chain Manufacturing Physicals Healthcare 52

FDA Law

JUNE 22, 2023

He also identified “Next-Generation Home-based Testing Technologies, including new IVDs, Digital Lateral Flow Readers, and Reporting Technologies” as an opportunity to “extend care from the hospital and clinic into the home setting.” seeking treatment). This makes seeking clearance of an OTC home test a risky business endeavor.

Manufacturing 59

Manufacturing Clinic IT Transportation 59

GeriPal

MAY 5, 2022

COVID-19, masks, and hearing difficulty: Perspectives of healthcare providers. Association of Sensory and Cognitive Impairment With Healthcare Utilization and Cost in Older Adults. And nurses and other healthcare practitioners knew nothing about it. My own work focuses on hospitalization and health utilization over time.

IT 102

IT Screening Hospital Clinic 102

Alabama Academy of Family Physicians

FEBRUARY 19, 2025

As the 2025 legislative session swings into full gear, the Alabama Academy of Family Physicians (AAFP) has set its sights on a cadre of pivotal bills set to shape the healthcare landscape for years to come. Under this program, qualifying hospitals would receive gifts to support their provision of acute care services to rural populations.

Insurance 130

Insurance Management Hospital Vaccination 130

GeriPal

MARCH 2, 2023

Eric: And we have Tasce Bongiovanni, who is an acute care trauma surgeon at UCSF and the San Francisco General Hospital. Eric: Any other interesting tidbits or facts that we should know as providers about gabapentin or Lyrica dosing or pharmacology? Welcome to the GeriPal podcast, Nisha. Nisha: Thank you so much. Happy to be here.

Patient-Centered 96

Patient-Centered IT Healthcare Medical 96

FDA Law

OCTOBER 17, 2023

Compared to the previous version, the new guidance document highlights that the Breakthrough Devices Program may also be applicable to certain devices that benefit populations impacted by health and/or healthcare disparities and to certain non-addictive medical products to treat pain or addiction. 360e-3)).”

Medical 53

Medical Diagnosis Healthcare Clinic 53

GeriPal

MARCH 24, 2022

Susan: I’ll just say, I think that could happen outside of the healthcare setting pretty easily and frequently does. So it’s an example of something that can start outside of the healthcare system and move its way in. Eric: Anybody else’s thoughts on that? I think Bob also noted documenting it. Rebecca: Agreed.

Illness 72

Illness IT Healthcare Patient-Centered 72

FDA Law

JANUARY 18, 2024

whether growing or not; its seeds; resin extracted from any part; and every compound, manufacture, salt, derivative, mixture, or preparation of the plant, its seeds or resin. “Marijuana,” subject to the rescheduling recommendation, means all parts of the plant Cannabis sativa L., 21 U.S.C. § 802(16)(A). 21 U.S.C. § 802(16)(B).

Medical 69

Medical Physicals IT Healthcare Professional 69

GeriPal

MAY 8, 2025

Vincent’s Hospital in Melbourne, Australia. Alex 06:03 Is psilocybin that’s used for medicinal purposes in your studies, for example, is that manufactured or is it derived directly from mushrooms? We dedicated team working with cancer and palliative medicine in our hospital. James, welcome to the GeriPal Podcast.

Illness 107

Illness IT Patient-Centered Patients 107

GeriPal

DECEMBER 7, 2023

And so we do see hospital admissions for heat exposure and certainly cardiovascular and respiratory problems related to air pollution with climate change and also cognitive problems. What do we do to very concretely provide heat shelters and cool shelters? Why is it up to the healthcare system? Ruth: Yeah. Ruth: Yeah.

Healthcare 129

Healthcare IT Education Community 129

FDA Law

MAY 21, 2024

The Attorney General also released DOJ’s Office of Legal Counsel (“OLC”) opinions providing the rationale and support for the NPRM. Schedules of Controlled Substances: Rescheduling of Marijuana, 89 Fed. 44,597 (May 21, 2024). Basis at 7-8; NPRM at 44,614. Basis at 61; NPRM at 44,615. *

Physicals 69

Physicals Medical Clinic Emergency Room 69

GeriPal

OCTOBER 31, 2024

But it feels the same in that I was on call a lot over the summer, and I took care of a lot of people behind those hospital walls. And we don’t see hospitals being strained as much anymore. You know, of course, serious disease, hospitalization and death. And, you know, some people are still getting very sick.

Vaccination 127

Vaccination IT Patient-Centered Patients 127