FDA Law Blog

SEPTEMBER 20, 2021

FDA will discuss the goals letter and field public comments, on September 28, 2021 (announcement here ), as well as a separate workshop on meetings management practices, which is to be held by July 30, 2024. 31, 2022; CDRP start, FY 2023; Public workshop, by July 31, 2025; Strategy document published, by April 30, 2026.

Patient-Centered 52

Patient-Centered Manufacturing Clinic Provider 52

Alabama Academy of Family Physicians

FEBRUARY 19, 2025

It then establishes a new Rural Physician Income Tax Credit program, effective January 1, 2026, that provides a $10,000 annual tax credit to qualifying rural physicians for up to four tax years. SB 93 – PBM Bill What’s in the Bill : SB 93 , sponsored by Sen. SB 99 – PBM Bill #2 What’s in the bill: Sponsored by Sen.

Insurance 130

Insurance Hospital Management Vaccination 130

FDA Law Blog

DECEMBER 3, 2023

On November 17th, CMS issued its final guidance on the Discount Program in which it responded to public comments and provided updated guidance for the Discount Program for 2025 and 2026. CMS will require participating manufacturers to submit and attest to this ownership information in the Health Plan Management System (HPMS).

Manufacturing 105

Manufacturing Provider IT Electronics 105

ABIM

JUNE 4, 2025

Pamela Kaliski, Manager, Exam Innovations for ABIM, shared more about ABIM’s goal of prioritizing security pertaining to AI use, avoiding redundancies and helping physician Item-Writers create insightful questions that test clinical knowledge and judgment.

Diabetes 52

Diabetes Board-Certified Telehealth Government 52

FDA Law Blog

JUNE 14, 2023

Review teams already appoint a lead reviewer to each submission and sometimes assign a project manager to an extensive project. up to 225 total products enrolled through FY 2026 and up to 325 total products enrolled through FY 2027). up to 125 total products enrolled through FY 2025).

Manufacturing 45

Manufacturing Medical Appointment Patient-Centered 45

ABIM

JUNE 11, 2025

Members pointed to challenges in access to care and medication in states that rely heavily on federal funding, health program funding cuts that affect HIV prevention and treatment, and managing fear and uncertainty in patients, particularly those in rural and underserved communities.

Board-Certified 52

Board-Certified Government Community Education 52

GeriPal

APRIL 3, 2025

I will always, as always, say, you know, you’re welcome to do this in 2026. Ken 12:14 I’ll remind you, Nancy, that this is an honor for companies that manage to make lots of money despite having a product that’s worthless or doesn’t. I honestly thought probably not for 2026 because it’s virtual.

IT 64

IT Hospital Screening Patients 64

FDA Law Blog

NOVEMBER 16, 2021

First, section 90006 imposes a moratorium on HHS’s implementation of an HHS OIG final rule, published on November 30, 2020, which amends the Federal health care program antikickback statute safe harbors as they apply to drug rebates paid to Medicare Part D plans and Medicaid Managed Care plans (or their PBMs).

Manufacturing 40

Manufacturing Utilities Management Provider 40

FDA Law Blog

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. We previously explained the rebate rule and its likely impact on patients and payors here.

Manufacturing 52

Manufacturing Transportation Government Management 52

FDA Law Blog

SEPTEMBER 14, 2021

30, 2020, the Trump HHS published a final rule amending the safe harbors under the Federal health care program antikickback statute as they apply to manufacturer rebates paid to Medicare Part D plans, Medicaid Managed Care plans, and their PBMs.

Manufacturing 52

Manufacturing Insurance Government Patients 52

Physician's Weekly

JUNE 26, 2025

Gavin Newsom has asked lawmakers to push the implementation date to January 2026, leaving patients, insurers, and employers in limbo. If this does not happen before July 1, Arrezola said, the Department of Managed Health Care would enforce the mandate as it exists. They did not respond to requests for comment.

Insurance 52

Insurance Patient-Centered Provider Management 52

Physician's Weekly

JUNE 25, 2025

Dangerous changes loomed: To compensate for tax cuts for the wealthy, Trump’s “big, beautiful” bill and budget proposal for fiscal year 2026 threaten to curtail Medicaid, which provides health coverage for people with low incomes and disabilities. About 40% of adults with HIV rely on it for their lifesaving treatments. .’”

Government 52

Government Community Families Family 52

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.

Manufacturing 98

Manufacturing Supply Chain Patient-Centered Utilities 98