FDA Law Blog

AUGUST 12, 2021

Yet, even with the first interchangeable biosimilar approval, it’s not quite clear when patients will see those savings. typically have launched with initial list prices 15% to 35% lower than comparative list prices of the reference products,” but this 15 to 35% is not a huge relief for patients given the high cost of biologics.

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The Clinical Problem Solvers

APRIL 3, 2023

Although healthcare services are publicly funded, access to medications depends on private or public insurance and is linked with employment. Providing our patients with more space and ensuring our patients feel human again is a great first step. Cambridge: Cambridge University Press; 2019:185-194. BMC Public Health.

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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. However, Graves’s clients were physicians/physician offices — not individual patients in need of lab services.

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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. However, Graves’s clients were physicians/physician offices — not individual patients in need of lab services.

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Lab Testing Individual Referral Patient-Centered 40

The Health Policy Exchange

OCTOBER 21, 2020

President in November support a "Medicare for All" style single-payer health insurance program, this issue emerged during the Democratic primary debates as one option for extending coverage to the uninsured and reducing health care administrative costs. Although neither of the major party nominees for U.S. He pointed out that 93% of U.S.

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Physician's Weekly

JUNE 19, 2025

In this first installment of a two-part series, “An Arm and a Leg” shares lessons from Bob’s experience navigating a maze of pharmacies and insurance companies to get his daughter the medicine she needs. Bob’s journey here begins in 2019 — the first day of high school for his daughter, Mary. That happens a lot.

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GeriPal

FEBRUARY 27, 2025

We address: Why is caring for patients with this overlap so hard? Sach Kale set up an outpatient clinic focused on substance use disorder for patients with cancer. Who follows the patient once the cancer goes into remission? Why am I having difficulty with this patient? Why am I feeling frustrated with this patient?

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FDA Law Blog

FEBRUARY 9, 2022

DEA’s expert opined that proper pharmacologic dosing of pain management patients receiving both long-acting and short-acting opioids is to use larger, scheduled doses of long-acting opioids to control chronic pain with smaller, as-needed doses of short-acting opioids for breakthrough pain. Id. Gul Med at 72,703. at 72,730. at 72,730.

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IT Insurance Government Patients 40

GeriPal

MARCH 9, 2023

Early data on efficacy in patients with anxiety and demoralization are promising. Two of our guests today, Stacy Fischer and Brian Anderson, are involved in large multicenter trials of psychedelics for patients with advanced cancer (Fischer) or life-limiting illness (Anderson). Research is exploding. You’ve been trained?

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FDA Law Blog

JANUARY 11, 2022

The Court, however, would not dismiss similar allegations as applied to health insurer. Specifically, Amarin alleged that Hikma’s label “teaches CV risk reduction” due to “a notice regarding side effects for patients with CV disease” and an absence of a statement that the generic “should not be used for the CV indication….”

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FDA Law Blog

JANUARY 11, 2022

The Court, however, would not dismiss similar allegations as applied to health insurer. Specifically, Amarin alleged that Hikma’s label “teaches CV risk reduction” due to “a notice regarding side effects for patients with CV disease” and an absence of a statement that the generic “should not be used for the CV indication….”

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Insurance Patients IT Manufacturing 52

GeriPal

DECEMBER 5, 2024

We talked with Thor Ringler, who helped found the My Life My Story Project at the VA and beyond, and Heather Coats about the evidence base for capturing patient stories. Because we all interface with it at the end of the day as patients. Today’s podcast is both similar and different. Is that a theme that you’re working on?

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IT Community Patients Families 107

GeriPal

APRIL 18, 2024

We discuss, among other things: Findings that in several studies AI was rated by patients as more empathetic than human clinicians (not less, that isn’t a typo). The experience of both patients and clinicians isn’t very good. Alex: In 2019 … You wrote two viewpoints about AI recently in JAMA, relatively recently.

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FDA Law Blog

OCTOBER 29, 2023

Butler — Just over two years ago, I wrote about the challenges with implementation of the contraceptive mandate in the Patient Protection and Affordable Care Act (ACA). By Michelle L.

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Individual Insurance Healthcare Provider 45

FDA Law Blog

SEPTEMBER 8, 2022

Wasserstein — Three patient advocate groups have sued the Department of Health and Human Services (HHS) and the Centers for Medicare and Medicaid Services (CMS), challenging HHS’s 2020 Notice of Benefits and Payment Parameters (NBPP) rule. The patient, on the other hand, is no closer to meeting their deductible than before.

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Physician's Weekly

JUNE 17, 2025

But that’s when his family began fighting another adversary: their health insurer, which decided the treatment was “not medically necessary,” according to insurance paperwork. Health insurers issue millions of denials every year. For most patients, though, the process works seamlessly. Senate report.

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Physicians News Digest

APRIL 1, 2025

Elberg said considerable fraud in Medicare and Medicaid exists largely because the programs’ “pay-and-chase models” prioritize paying for patient care first and tracking down stolen dollars second. For example, Trump granted a commutation to Philip Esformes, a Florida health care executive convicted in 2019 of a $1.3

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