ABIM

JUNE 12, 2025

Expanding ABIM’s engagement with stakeholder communities such as early career physicians, specialty societies and patient-focused organizations. Representatives from the American Geriatrics Society (AGS) and the Gerontological Society of America (GSA) joined for a portion of the meeting*. Community Practice in ABIM Governance* Erica N.

Board-Certified 52

Board-Certified Internal Medicine Government Community 52

FDA Law Blog

FEBRUARY 2, 2025

The rules were implemented to enhance patient safety protections via revised drug handling, packaging, and delivery requirements. Now, all nonresident pharmacies will need to be licensed in order to dispense prescription drugs to patients in Massachusetts. The most common drug Californians may be looking for this winter is Paxlovid.

Primary Care Physician 59

Primary Care Physician Primary Care Diagnosis Provider 59

FDA Law Blog

OCTOBER 13, 2024

No rare pediatric disease vouchers could be awarded even to designated applications after September 30, 2026. Tobolowsky — The Rare Pediatric Disease Priority Review Voucher program has had a bit of a tumultuous history in its 12 short years of existence. The program, however, has always had a scheduled sunset date.

Government 64

Government IT Education Individual 64

FDA Law Blog

SEPTEMBER 22, 2024

Complaints FDA discussed how LDT developers should handle the transition from the current Quality System Regulation (QSR)(21 CFR Part 820) to the recently promulgated Quality Management System Regulation (QMSR) that is scheduled to take effect on February 2, 2026. Gonzalez & Lisa M. It should be noted that 21 CFR 803.18(b)(1)(ii)

Manufacturing 64

Manufacturing Electronics Provider Management 64

FDA Law Blog

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 Blog

APRIL 14, 2022

The draft MDUFA V commitment letter starts with a 70% goal in FY 2023, but if the de novo decision goal is met in FY 2023 and the fee revenue amount provided for FY 2026 and 2027 is adequate to support performance improvements, FDA plans to increase the goal to 80% in FY 2026. By McKenzie E.

Provider 40

Provider Clinic Medical IT 40

ABIM

JUNE 11, 2025

Expanding ABIM’s engagement with stakeholder communities such as early career physicians, specialty societies and patient-focused organizations. Representatives from the Infectious Diseases Society of America (IDSA) and the Society for Healthcare Epidemiology of America (SHEA) joined for a portion of the meeting*.

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. Annie 02:31 So if you go to the A G S meeting every year, you know that this group of three individuals comprises the AGS literature update. So this is something. This is the plenary to attend. It is a sold out crowd. Of course. We will step aside. Go Cubs, go.

IT 64

IT Hospital Screening Patients 64

ABIM

JUNE 4, 2025

Expanding ABIM’s engagement with stakeholder communities such as early career physicians, specialty societies and patient-focused organizations. They also noted a distinction in telehealth practices between remote consultations in different states and using telehealth to treat patients who live nearby.

Diabetes 52

Diabetes Board-Certified Telehealth Government 52

ABIM

JUNE 24, 2025

Expanding ABIM’s engagement with stakeholder communities such as early career physicians, specialty societies and patient-focused organizations. A representative from the American Society of Hematology (ASH) joined for a portion of the meeting*. The following is a summary of the spring meeting. Above all, ABIM remains focused on its mission.

Board-Certified 40

Board-Certified Board-Certified Physicians Government Community 40

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. Senate SB 43 – Patient Price Transparency Bill What’s in the Bill: Sponsored by Sen.

Insurance 130

Insurance Management Hospital Vaccination 130

ABIM

MAY 30, 2025

Expanding ABIM’s engagement with stakeholder communities such as early career physicians, specialty societies and patient-focused organizations. Enhancements made to the LKA in response to feedback from physicians who identified areas for improvement, which are intended to keep the program relevant and effective.

Board-Certified 40

Board-Certified Government Internal Medicine Private Practice 40

FDA Law Blog

JULY 7, 2024

Complaint Handling CLIA regulations, with which all clinical laboratories must already comply, state that a clinical laboratory must “have a system in place to ensure that it documents all complaints and problems reported to the laboratory,” and must “conduct investigations of complaints, when appropriate”. [1]

Manufacturing 64

Manufacturing Provider Physicals Electronics 64

FDA Law Blog

JUNE 14, 2023

In FY 2026 – FY 2027, continue to support products enrolled in previous fiscal years and expand to enroll up to 100 additional products each fiscal year within existing OHTs or expand to additional OHTs, depending on lessons learned from FY 2023 – FY 2025 experience (i.e., up to 125 total products enrolled through FY 2025).

Manufacturing 45

Manufacturing Medical Appointment Patient-Centered 45

FDA Law Blog

NOVEMBER 17, 2022

patients are “first in the world” to receive innovative medical devices that are of “high-quality, safe, and effective” through “early, frequent, and strategic communications between the FDA and medical device sponsors.” Devices in the Safer Technologies Program (STeP) will be included in FY 2026. See Announcement.

Patient-Centered 69

Patient-Centered Provider Medical IT 69

FDA Law Blog

NOVEMBER 21, 2022

patients are “first in the world” to receive innovative medical devices that are of “high-quality, safe, and effective” through “early, frequent, and strategic communications between the FDA and medical device sponsors.” Devices in the Safer Technologies Program (STeP) will be included in FY 2026. See Announcement.

Medical 59

Medical Patient-Centered Provider IT 59

FDA Law Blog

AUGUST 14, 2022

The number will begin in 2026 with 10 drug covered under Medicare Part D and will increase annually to 20 Part B and 20 Part D drugs by 2029 and thereafter, with the selected drugs accumulating from year to year.

Manufacturing 98

Manufacturing Government Vaccination Utilities 98

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

Physician's Weekly

JUNE 26, 2025

He directed the patients to seek local help. While it’s possible that Nath’s patients suffered covid vaccine injuries, Marks said, their symptoms were so varied it was hard to characterize a possible syndrome. The HHS budget proposal for fiscal year 2026 makes no mention of vaccine safety programs. Kennedy Jr.

Vaccination 52

Vaccination Patient-Centered Government IT 52

FDA Law Blog

FEBRUARY 20, 2025

Interestingly, counsel focused his arguments exclusively on parrying legal attacks, rather than arguing why the rule was necessary to protect patients. FDA had been scheduled to hold a webinar on the Stage 2 (May 2026) requirements related to the investigational device requirements for LDTs later this month. By Allyson B. It did not.

Patient-Centered 102

Patient-Centered Consulting Government Clinic 102

FDA Law Blog

SEPTEMBER 14, 2021

Under all of these programs, patient co-insurance would be calculated based on the MFP so that patients receive the benefit of that price. In the coverage gap phase, the patient would continue to pay 25% coinsurance but manufacturers would subsidize 10% of the remaining cost through the new CGDP. 8126 with a lower MFP.

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. During IVF, a patient’s eggs are retrieved, combined with sperm in a lab, and then transferred to a person’s uterus. A single cycle can total around $25,000 , out of reach for many.

Insurance 52

Insurance Patient-Centered Provider Management 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. Last Thursday, the U.S.

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Manufacturing Supply Chain Patient-Centered Utilities 98