FDA Law

NOVEMBER 6, 2023

The excellent work of these and other professionals at HPM is why we’ve maintained a high level of client service for 43 years,” said JP Ellison, HPM’s managing director. Our knowledge of the laws and regulations governing drugs, medical devices, foods, dietary supplements, and cosmetics is unparalleled in breadth and depth.

Government 40

Government Provider Medical Management 40

FDA Law

JANUARY 6, 2022

220 and was described on HP&M’s blog here. C) the amount billed to or received from, in part or in whole, the health care benefit program from the individuals referred to a particular recovery home, clinical treatment facility, or laboratory. EKRA is codified at 18 U.S.C. § 18 U.S.C. § 24(b) (emphasis added). 18 U.S.C. §

Lab Testing 40

Lab Testing Referral Individual Patient-Centered 40

FDA Law

OCTOBER 10, 2022

You can find our preliminary blog post on the release of this guidance here , and our blog posts on the draft CDS guidances here and here. While the final guidance continues to borrow some IMDRF concepts, it no longer limits Non-Device CDS to software that informs clinical management (per the IMDRF guidelines).

Clinic 52

Clinic Medical Provider Patients 52

ABIM

JUNE 11, 2025

Visit the ABIM Blog for reports of prior meetings. Community Practice in ABIM Governance* Erica N. She also sought input on overlapping aspects of community practice across the disciplines of internal medicine to inform ABIM’s recruitment efforts for broad physician representation in governance roles.

Board-Certified 52

Board-Certified Government Community Education 52

FDA Law

APRIL 8, 2024

What about government factors that cause drug shortages? pharmacy benefit managers (PBMs), group purchasing organizations (GPOs), wholesale distributors) play before a finished product ever makes it to a patient. Section I.C Two such factors come to mind: FDA inspections and DEA quotas.

Supply Chain 59

Supply Chain Manufacturing Government Hospital 59

FDA Law

OCTOBER 17, 2023

In October 2022, FDA released the draft guidance entitled “Select Updates for the Breakthrough Devices Program Guidance: Reducing Disparities in Health and Healthcare,” as previously discussed in our blog. FDA will consider if technologies and device features “address unmet needs in these populations” when evaluating criterion one.

Medical 53

Medical Diagnosis Healthcare Clinic 53

FDA Law

FEBRUARY 9, 2022

DEA regulations state that a pharmacist has a corresponding responsibility not to fill a prescription unless it is issued for a “legitimate medical purpose by an individual practitioner acting in the usual course of [their] professional practice.” Improper Dosing for Pain Management. at 72,730. at 72,730. Long Distances Traveled.

IT 40

IT Insurance Government Patients 40

GeriPal

JANUARY 11, 2024

You get me with one-finger-chords on the guitar if you’re watching on YouTube (best I could manage). The last time we had you on the podcast, Bill, you talked about your cancer diagnosis and a personal experience with MAID, which you also, we’ll have a link to your blog post too about this as well.

Illness 144

Illness IT Medical Provider 144

FDA Law

FEBRUARY 11, 2024

We blogged on the December 5, 2023, letter from six Democratic governors to President Biden). The regulated cannabis marketplace brings in billions of dollars in revenue into state and federal governments, with predictions that cannabis sales will exceed $53 billion by 2027.

Medical 59

Medical Healthcare Professional Community IT 59

FDA Law

AUGUST 3, 2021

Department of Health and Human Services in December 2020 to prevent Medicare Part D and Medicaid Managed Care plans from receiving rebates from manufacturers unless the rebates are passed through to pharmacies to reduce patient out-of-pocket expenses. The rule was estimated to cost the federal government around $196 billion over ten years.

Manufacturing 52

Manufacturing Transportation Government Management 52

FDA Law

SEPTEMBER 14, 2021

This bill, which addresses numerous areas of the economy, public health, and government regulation, includes Subtitle E, Drug Pricing. Subtitle E is a slightly modified version of H.R. 3, the Elijah E. The AIM price is the volume-weighted average price of the drug in Australia, Canada, France, Germany, Japan, and the U.K.

Manufacturing 52

Manufacturing Insurance Government Patients 52

FDA Law

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.

Manufacturing 98

Manufacturing Supply Chain Patient-Centered Utilities 98