California Academy of Family Physicians (CAFP)

MAY 14, 2025

Key Health Care Budget Proposals: Proposed Medi-Cal Cuts and Enrollment Changes Medi-Cal, California’s Medicaid program, is typically funded through a partnership between the state and the federal government. Medi-Cal Minimum Medical Loss Ratio – Increases the minimum medical loss ratio for managed care plans, commencing January 1, 2026.

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Healthcare Family Physician Management Individual 204

Physician's Weekly

JUNE 19, 2025

Diamond was caught in a fairly common coverage snag: People who have group health insurance when they become eligible for Medicare sometimes find themselves on the hook for their medical bills because their group plan stops paying. As secondary payer, Diamond’s employer policy picked up 20% of what Medicare would have paid.)

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Insurance Patient-Centered Government Provider 52

Medical Xpress

MARCH 15, 2023

Trust in information given out by the government on cancer fell sharply among the Black population—by almost half—during the COVID-19 pandemic, findings of a national U.S. study have shown.

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Government 69

Annals of Family Medicine

NOVEMBER 20, 2024

Context: Health Technology Assessment (HTA) organizations determine the value of health technologies such as medical devices, lab tests, or medications. learning), the use of guideline-based information in clinical practice, and subsequent patient health outcomes. Health organization outcomes.

General Practitioner 130

General Practitioner Lab Testing Relationship Family Physician 130

FDA Law Blog

JANUARY 18, 2022

Cato — On December 10, 2021, FDA issued a discussion paper titled 3D Printing Medical Devices at the Point of Care seeking feedback on FDA regulatory oversight of various 3D-printing scenarios, in order to inform future policy development. products intended for medical purposes). products intended for medical purposes).

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FDA Law Blog

APRIL 10, 2025

While much of the focus has been on how these cuts may impact application review timelines and industry engagement, see earlier post about the effect on generic drugs, another quieter consequence is emerging a significant slowdown in the availability of information that FDA is required to produce under the Freedom of Information Act (FOIA).

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FDA Law Blog

OCTOBER 24, 2023

By Dara Katcher Levy — Yesterday, FDA published a new Draft Guidance, “ Communications from Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products Questions and Answers ” (SIUU Guidance or Draft Guidance).

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Clinic Clinical Practice Provider Utilities 64

The Physicians Foundation

FEBRUARY 14, 2025

Misplaced Training Dollars: Lack of funding for community-based training impacting the primary care physician pipeline Hospital-based graduate medical education (GME) receives significantly more funding than community-based programs, a disparity linked to fewer new primary care physicians entering the workforce. In 2022, only 24.4%

Primary Care 52

Primary Care Chronic Disease Primary Care Physician Nurse Practitioner 52

Physician's Weekly

JUNE 17, 2025

Tianeptine is sold in a number of countries as a government-approved treatment for depression. But the FDA has never approved it for any medical condition in the U.S. “You never quite know what’s in that bottle,” Dr. Diane Calello of the New Jersey Poison Information and Education System told the AP.

Medical 52

Medical IT Hospital Government 52

PEMBlog

JUNE 7, 2023

There are protocols in place that assist highly trained Emergency Medical Service providers in assuring that agitated children are safely transported to their destination. Government. NASEMSO: Clinical care and restraint of agitated or combative patients by emergency medical service practitioners. Prehosp Emerg Care.

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Transportation Patient-Centered Management Finance 122

FDA Law Blog

MAY 9, 2023

The risks she described caught our attention because two of the risk profiles she cited included things that touched on FDA-related entities, such as medical devices that transmit data. The news wasn’t all bad for the government, but FTC’s now has some decisions to make. intent may also exploit that information.

Medical 59

Medical Government IT Relationship 59

FDA Law Blog

JANUARY 18, 2022

Cato — On December 10, 2021, FDA issued a discussion paper titled 3D Printing Medical Devices at the Point of Care seeking feedback on FDA regulatory oversight of various 3D-printing scenarios, in order to inform future policy development. products intended for medical purposes). products intended for medical purposes).

Medical 75

Medical Manufacturing Healthcare Government 75

FDA Law Blog

MARCH 12, 2023

These government measures included granting temporary exemptions from certain FDA and DEA legal requirements. By almost all accounts, these exemptions also improved prescribing and dispensing of medication to patients that need them. When the public health emergency ends on May 11, 2023 , so do these exemptions.

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Telemedicine Government Patients Medical 98

ABIM

APRIL 24, 2025

Upgrades to the ABIM website and Physician Portal for 2025 designed to make it easier for both physicians and the public to find information. Chrostowski, DNP, APR-N, ANP-C , asked whether ABIM will offer continuing medical education (CME) credits through the LKA.

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Board-Certified Board-Certified Physicians Community Government 40

Family Physicians of St. Joseph

MARCH 14, 2018

From the Detroit News If there’s any more argument to be made about getting third-party insurers — whether government or private insurance — out of most routine health care, here’s one. The bill arrived in late January, informing me in no uncertain terms I now owe $219.41. And it’s a true story. Zane had the blood drawn on Dec.

Insurance 52

Insurance Medical Primary Care Government 52

Permanente Medicine

MAY 20, 2025

Khang Nguyen, MD, chief transformation officer of the Southern California Permanente Medical Group, discusses how AI can increase clinicians’ joy in medicine and improve patient outcomes with Chris Grant, chief operating offer and executive vice president of Kaiser Permanente, The Permanente Federation, and host of the Permanente Medicine Podcast.

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Patient-Centered Patients IT Medical 52

Medical Xpress

DECEMBER 5, 2022

As the UK Government reviews proposals to raise the SPA, a study led by the ESRC Centre for Society and Mental Health at King's outlines how delaying the state pension age would lead to a reduction in the supply of informal care, particularly from women who traditionally provide the majority of care for their older parents.

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Mental Health Government Provider Medical 74

FDA Law Blog

MARCH 3, 2024

This proposed legislation should be of interest to any biotechnology companies that want to do business with the federal government in the future. Scope Part 2 —Is reimbursement under Medicaid a grant of funds by the federal government, such that they are governed by the Act? House of Representatives ( H.B.

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Manufacturing Government Consulting IT 102

FDA Law Blog

FEBRUARY 20, 2023

This case was the latest example of government regulators punishing a company that refused to live up to its promises of consumer data protection. That Rule requires data companies to notify consumers and regulators of unauthorized disclosures of consumers’ personal health information. The penalty of $1.5 million is, well, not a lot.

Patient-Centered 105

Patient-Centered Telehealth IT Government 105

FDA Law Blog

NOVEMBER 6, 2023

A phone call to FDA requested information about the number of Remote Interactive Evaluations (RIEs) that FDA has performed at drug manufacturing facilities since it announced in April 2021 that it would start using them as an alternative to on-site inspections. We should explain what RIEs are.

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Manufacturing Clinic IT Utilities 105

BMJ

JULY 17, 2020

4 This short article draws on lessons learnt from other infectious disease outbreaks, such as HIV and Ebola, to help inform approaches to COVID-19-related stigma within China. 8 For example, prestigious medical schools and hospitals could use official WeChat accounts to share information and news with the general public.

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Community Individual Physicals Finance 40

FDA Law Blog

NOVEMBER 15, 2022

By Véronique Li, Senior Medical Device Regulation Expert & Philip Won — In our last blog post , we advised medical device companies to consider applying to FDA’s Small Business Program to help with the noticeably higher user fees for FY2023. Any application from a State or Federal Government entity. Exemptions or Waivers.

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Medical Provider IT Manufacturing 59

PEMBlog

JUNE 14, 2023

This episode is a co-production of the Emergency Medical Services for Children Innovation and Improvement Center whose mission is to minimize morbidity and mortality of acutely ill and injured children across the emergency continuum. Government.

Mental Health 98

Mental Health Management Patient-Centered Illness 98

PEMBlog

MAY 31, 2023

However, medications can be adjuncts to non-pharmacologic means to help keep agitated children safe from harm. Government. When we think of managing agitated patients we think of medicines – but that shouldn’t be our first option. It is also episode 3 in a 5 episode series focused on agitation in children and adolescents.

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Management Patient-Centered Transportation Finance 89

BMJ

AUGUST 20, 2021

Donors, government ministries, agencies and academic partners regularly cascade requests for data that multiply and complicate the simple interaction into a complex, and often redundant, set of data requirements for the same singular interaction. Mobile phone penetration has finally exceeded 90% in low- and middle-income countries.

Patient-Centered 40

Patient-Centered Provider Clinic Patients 40

The Clinical Problem Solvers

NOVEMBER 22, 2021

10:37 “Blood quantum” and the burden of proof 18:05 Challenges of Indigenous Peoples in medical spaces 24:50 COVID-19 and climate change’s impact on Indigenous Peoples 30:27 Racism in academia and creating safe spaces 41:22 “Data genocide” 50:11 What can listeners do going forward?

Community 52

Community Patient-Centered Medical Student Medical 52

FDA Law Blog

JUNE 2, 2025

Mullen At midnight on Friday, May 30, 2025, the governments deadline to notice an appeal from the U.S. District Court for the Eastern District of Texass decision vacating the LDT Rule lapsed without the government doing so. By Steven J. Gonzalez & Allyson B.

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IT Manufacturing Government Clinic 64

FDA Law Blog

MARCH 4, 2024

This essential event for regulatory professionals in the biopharmaceutical and medical device industries will take place March 12-13, 2024, in Arlington, VA. For complete information on the conference, click here. FDA Law Blog readers can use the discount code 24SPKR150 for reduced registration fees.

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Government Provider Medical 59

33 Charts

OCTOBER 2, 2021

Medicine is facing a crisis of information. Beyond the increase of biomedical information are rising demands for physician response to portal messaging (MyChart messages) and review of wearable generated data. And in my experience the exchange of information from the Cures Act Final Rule has added new dialog around test results.

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Patients IT Provider Family Doctor 75

FDA Law Blog

OCTOBER 10, 2022

The CDS Guidance interprets the “medical software” carve-out of the 21st Century Cures Act (2016) as it pertains to Clinical Decision Support (CDS) software functions. The CDS Guidance interprets the Cures Act’s definition of “medical software” that is excluded from the statutory “device” definition, as it relates to CDS software.

Clinic 52

Clinic Medical Provider Patients 52

FDA Law Blog

FEBRUARY 26, 2024

With over 26 years of dedicated service to the pharmaceutical and medical device industries, Ms. Walsh has garnered acclaim for her passionate efforts in assisting companies with preventing or responding to government investigations, conducting internal investigations to ensure compliance, and defending against DOJ prosecutions.

Government 59

Government IT Medical 59

PEMBlog

MAY 17, 2023

Why then do we persist with the “is it medical/organic or psych” question? Government. Most children who present to Pediatric Emergency Departments these days with mental health concerns – including agitation – have a known psychiatric problem or diagnosis.

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Patient-Centered Mental Health Management Transportation 68

FDA Law Blog

MAY 7, 2025

Gonzalez There has been increased enforcement against medical device companies that engage in the pervasive practice of paying third party sales agents based on their volume of sales. In that decision, a medical laboratory paid Marchetti percentage-based compensation for successful referrals of Medicare patients to the laboratory.

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Referral Relationship Government Healthcare 59

FDA Law Blog

FEBRUARY 13, 2025

Baumhardt, Principal Medical Device Regulatory Expert FDA recently released its final guidance for Predetermined Change Control Plans (PCCPs) for Artificial Intelligence-Enabled Device Software Functions (AI-DSF). FDA may request additional information during the review of the PCCP.

Manufacturing 71

Manufacturing Management Specialization Provider 71

FDA Law Blog

SEPTEMBER 17, 2023

By Philip Won & Véronique Li, Senior Medical Device Regulation Expert — Over the last three and a half years, meetings with FDA were conducted virtually. If you are driving, stop at the vehicle screening facility and inform security that you are attending a meeting. Getting to Building 66 Most CDRH meetings occur in Building 66.

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Screening Transportation Provider Electronics 59

FDA Law Blog

NOVEMBER 6, 2023

Hyman Phelps & McNamara received the following honors: Tier 1 FDA: Pharmaceutical Tier 1 FDA: Medical Device Additionally, eight professionals are included in LMG’s coverage: Robert A. WASHINGTON, DC — Hyman, Phelps & McNamara, P.C. Dormer (Hall of Fame), Jeffrey N. Gibbs (Hall of Fame), John A. Gilbert , Gail H. Javitt , Kurt R.

Government 40

Government Provider Medical Management 40

FDA Law Blog

OCTOBER 25, 2021

The Medical Device Amendments of 1976 created the initial premarket application (PMA) review and 510(k) substantial equivalence review processes. Only a year later, in 1977, FDA promulgated regulations governing 510(k) reviews (21 C.F.R. befitted a very important pathway to market for novel medical devices.

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Manufacturing Government Specialization IT 52