FDA Law Blog

DECEMBER 4, 2023

Houck — Separate decisions by federal district courts in Texas and Puerto Rico in the past two months provide cautionary tales for every pharmacy and wholesale distributor dispensing or distributing controlled substances. The government asserted additional allegations that are outside our scope. By Larry K. Zarzamora Press Release.

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Annals of Family Medicine

NOVEMBER 20, 2024

Context: Adults with complex needs require health and social services from a variety of providers, which can lead to frequent use of services. Outcome Measures: Organizational and governance factors influencing the implementation of ICP, and recommendations to facilitate scale-up. Study Design: A qualitative multiple-case study design.

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Physician's Weekly

JUNE 19, 2025

Had she signed up for the government insurance plan when she turned 65, Diamond could have avoided a financially perilous situation that left her unexpectedly responsible for the medical costs she incurred during that time. Some of those providers are now seeking payment from her. “It’s horrifying,” she said.

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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. To fill that gap, California has chosen to use state-only funds to provide certain Medi-Cal benefits to undocumented Californians.

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The Direct Doctors Difference

AUGUST 18, 2021

​ ​The strength of the movement comes from a grassroots force of physicians who are unhappy with the care they can provide in the traditional fee-for-service model of medicine which depends on the patient coming in for a visit and being billed through insurance for each encounter.

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My Green Doctor

APRIL 4, 2025

In This Issue : New Research: Teaching Patients about Climate Resilience Make the Pledge Today to Go Green Get Ready for Earth Day 2025 (part 2)! It tells your office colleagues and patients that your healthcare practice or clinic is committed to forging a healthier work space and community. The healthcare sector contributes 8.5%

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Family Physicians of St. Joseph

SEPTEMBER 25, 2018

Larger companies now dominate the healthcare landscape, yet through innovation and a dedication to exceptional patient care, Family Physicians of St. They have remained independent and committed to caring for patients as a small practice, all the while introducing new ideas and setting new standards in Michigan’s Great Southwest.

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FDA Law Blog

SEPTEMBER 28, 2021

Richardson — On September 24, 2021, the owner of a pharmacy in Puerto Rico pleaded guilty to participating in a felony conspiracy to convert government property and to commit health care fraud in connection with the illegal vaccination of minors between the ages of 7 to 11 with the Pfizer-BioNTech COVID-19 vaccine. By Kalie E.

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Vaccination Individual Government Provider 98

BMJ

AUGUST 20, 2021

doi: 10.1136/fmch-2020-000845 The appetite for and ability to collect accurate digital patient-level data in low-resource settings has fueled numerous massive global health initiatives. As impressive as these large numbers may be, the question that is less often asked is “How much of that big data is actually helping us do better?”

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Patient-Centered Clinic Provider Patients 40

33 Charts

OCTOBER 2, 2021

More recently health professionals have seen a rise in MyChart messages coming in through the Epic patient portal. According to Epic, the number of patient messages spiked 151 percent nationally from the period covering the first 11 weeks of 2020 through the end of the year. And individual practice styles are fine. Absolutely.

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Patients IT Provider Family Doctor 75

ABIM

APRIL 24, 2025

Expanding ABIM’s engagement with stakeholder communities such as early career physicians, specialty societies and patient-focused organizations. Dr. McDonald explained that the LKA provides MOC points for questions answered correctly, but since ABIM is not an accreditation organization, it does not offer CME credit.

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Board-Certified Board-Certified Physicians Community Government 40

My Green Doctor

MAY 3, 2025

This isn’t just about saving the planet—it’s also about saving money, protecting patients, and strengthening our healthcare systems from the inside out. Latest news & breaking headlines And, in many countries, governments offer financial incentives to install solar panels and even backup batteries.

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Healthcare Healthcare Professional Consulting Management 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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FDA Law Blog

MAY 19, 2025

86, 72703 (December 22, 2021), DEA emphasized in the Gulf Med decision that prescribing [r]ed flags are circumstances surrounding a prescription that cause a pharmacist to take pause, including signs of diversion or the potential for patient harm. Patients filling prescriptions at the same time at multiple pharmacies. 81, 86, 251.

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Individual Patients Provider Medical 64

FDA Law Blog

APRIL 10, 2025

federal law enacted in 1967 to promote transparency and accountability in the federal government by granting the public the right to request access to government records, subject to certain exemptions. FOIA is a U.S.

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Government Provider Community Individual 59

BMJ

JULY 17, 2020

A multilayered view of stigmatizing discourses lays the foundation for eliciting a series of suggestions for quelling stigma, to be implemented at the individual, community, and national levels, as suggested by the WHO. How to reduce the negative psychological impact MRSA isolation on patients. Scholars such as Wen et al.

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Community Individual Physicals Finance 40

FDA Law Blog

JANUARY 31, 2023

So when patients led by Abbey Meyer and Marjorie Guthrie (Woody Guthrie’s widow) had championed the 1983 law to create incentives for developing drugs for those with rare conditions, the FDA was excited at this once-in-a-generation new law as this was FDA’s 3ed major drug law in nearly half a century.

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Patients Patient-Centered Government IT 59

FDA Law Blog

MAY 7, 2025

Two recent cases from the Fifth and Seventh Circuits, however, support the legality of these arrangements in the absence of the government proving certain circumstances. Mallory , 988 F.3d 3d 730 (4th Cir. Sorenson follows the Fifth Circuits decision last year in United States v. Marchetti, 96 F.4th Marchetti, 96 F.4th Medicare or Medicaid).

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The Clinical Problem Solvers

NOVEMBER 22, 2021

Tom Sequist, member of the Taos Pueblo Tribe and Chief Patient Experience and Equity Officer at Mass General Brigham, and Dr. Sophie Neuner, proud member of the Karuk Tribe, and a Research Associate at the Johns Hopkins Center for American Indian Health. This flawed measure can be harmful for many reasons.

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Community Patient-Centered Medical Student Medical 52

FDA Law Blog

JANUARY 6, 2022

Wasserstein — “EKRA” refers to the Eliminating Kickbacks in Recovery Act, which was part of the Substance Use – Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act of 2018. EKRA is codified at 18 U.S.C. § 220 and was described on HP&M’s blog here. 18 U.S.C. § 18 U.S.C. § 18 U.S.C. §

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Lab Testing Referral Individual Patient-Centered 52

GeriPal

JULY 19, 2024

What should we use to screen individuals? Joe 03:55 You know, my thoughts are screening is important for a variety of reasons, and certainly Doctor Boris and Soo and Anna, Doctor chodos can provide a lot greater clinical insight than I. Who should get it if anyone? What happens after they test positive? Joe, your thoughts?

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Screening Primary Care Patient-Centered IT 120

FDA Law Blog

OCTOBER 13, 2024

Designed to incentivize the development of drugs for pediatric rare diseases where such development may not otherwise have occurred, vouchers may be granted for drugs for serious or life-threatening rare diseases where the serious or life-threatening manifestations primarily affect individuals aged from birth to 18 years.

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Government IT Education Individual 64

FDA Law Blog

NOVEMBER 6, 2022

In its petition filed earlier this month, Pfizer challenges HHS’s interpretation of the AKS as “staggeringly overbroad,” contrary to the congressional intent behind the AKS, and a threat to “almost any activity that facilitates patient access to federally funded healthcare.”

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Manufacturing Patient-Centered Healthcare Utilities 83

FDA Law Blog

OCTOBER 10, 2022

The final guidance therefore may have significant implications for a wide range of stakeholders, including not only software developers but also health care providers, hospitals, patients and payors. Medical information about a patient. Interpretation of Statutory Criteria Under the Final Guidance.

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Clinic Medical Provider Patients 52

FDA Law Blog

JANUARY 6, 2022

Wasserstein — “EKRA” refers to the Eliminating Kickbacks in Recovery Act, which was part of the Substance Use – Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act of 2018. EKRA is codified at 18 U.S.C. § 220 and was described on HP&M’s blog here. 18 U.S.C. § 18 U.S.C. § 18 U.S.C. §

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Lab Testing Individual Referral Patient-Centered 40

FDA Law Blog

SEPTEMBER 6, 2022

As the new Federal Register notice explains, FDA issued the 2016 Guidance in question and answer format to respond to the most frequently asked questions about charging for investigational drugs provided under an IND for either clinical trials or expanded access for treatment use under 21 CFR section 312.8. Changes from the 2016 Guidance.

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Clinic Manufacturing Patients IT 52

FDA Law Blog

JUNE 27, 2024

Prescribing Red Flags In the Gulf Med decision, DEA emphasized that “[r]ed flags are circumstances surrounding a prescription that cause a pharmacist to take pause, including signs of diversion or the potential for patient harm.” The expert specifically found that: Patient A.R. The expert specifically found that: Patient A.R.

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Insurance Patients Utilities Chronic Condition 52

FDA Law Blog

NOVEMBER 2, 2023

These standards would be developed outside the Federal government, leveraging the expertise of the private sector. These meetings have a question-and-answer format to provide clarity to sponsors about the particular topics at hand.

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Provider Screening IT Government 59

FDA Law Blog

JUNE 16, 2023

The statement must itemize the cost components related to production of the drug, identify increases in materials or manufacturing costs, and provide other information that the manufacturer believes relevant to determining whether a violation has occurred. SF 2744 also provides a private right of action to enforce the prohibition.

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The Clinical Problem Solvers

FEBRUARY 14, 2022

[link] CPSolvers: Anti-Racism in Medicine Series Episode 14: Race, Place, and Health: Clinician and Community Perspectives Show Notes by Alec Calac February 15th, 2022 Summary: This episode highlights how racism manifests in the built environment, and how community and individual-level efforts can mitigate these inequities. Be curious.

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Community Individual Mental Health IT 52

GeriPal

JUNE 19, 2025

Just today (June 17th) as we record this podcast: Ezra Klein released a wonderful interview with Sarah McBride , the first openly transgender member of congress A judge ruled that cuts to NIH grants focused on minority groups, including transgender people, were illegal and ordered the government to restore funding. And we also need it.

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Individual Community IT Chronic Condition 82

ABIM

JUNE 11, 2025

Expanding ABIM’s engagement with stakeholder communities such as early career physicians, specialty societies and patient-focused organizations. Community Practice in ABIM Governance* Erica N. Upgrades to the ABIM website and Physician Portal for 2025 designed to make it easier for both physicians and the public to find information.

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ABIM

JUNE 24, 2025

Expanding ABIM’s engagement with stakeholder communities such as early career physicians, specialty societies and patient-focused organizations. Community Practice in ABIM Governance* Erica N. Upgrades to the ABIM website and Physician Portal for 2025, designed to make it easier for both physicians and the public to find information.

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Board-Certified Board-Certified Physicians Government Community 40

Medical Xpress

JUNE 16, 2025

In a study published in Nature Communications , led by researchers at National Taiwan University (NTU) and National Tsing Hua University (NTHU), scientists used the deepest-ever two-photon calcium imaging in awake mice to directly observe how individual SCN neurons respond to light. The content is provided for information purposes only.

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Provider Medical Complication Diabetes 109

Vida Family Medicine

JUNE 29, 2022

I want to respond to the many strong emotions and fears expressed by many of my patients regarding the recent Supreme Court decision overturning of the Roe v. I try as much as possible to avoid political and polarizing topics with my patients because I recognize that we all have different beliefs, and that is okay. What Roe v.

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Family Physician Families Family Healthcare Professional 52

FDA Law Blog

NOVEMBER 18, 2021

The tests are very accurate in detecting individuals with a relatively high viral load (symptomatic or not). On the minus side, a rapid antigen test may miss an infected individual with a low viral load (e.g., True, these tests will never provide the same diagnostic quality results as RT?PCR, A follow up laboratory?run

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Screening Healthcare IT Manufacturing 98

GeriPal

MARCH 2, 2023

The FDA-approved indications for gabapentin are only for treating patients with partial seizures or postherpetic neuralgia. valproic acid and gabapentin), in nursing homes, particularly patients with Alzheimer’s disease and related dementias. There are a lot of reasons that may explain the massive increase in use of these drugs.

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Patient-Centered IT Healthcare Medical 96