FDA Law Blog

JANUARY 6, 2022

Clinical treatment facility” is defined as “a medical setting, other than a hospital, that provides detoxification, risk reduction, outpatient treatment and care, residential treatment, or rehabilitation for substance use, pursuant to licensure or certification under State law.” 18 U.S.C. § 18 U.S.C. § 18 U.S.C. § 24(b) (emphasis added).

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FDA Law Blog

JANUARY 6, 2022

Clinical treatment facility” is defined as “a medical setting, other than a hospital, that provides detoxification, risk reduction, outpatient treatment and care, residential treatment, or rehabilitation for substance use, pursuant to licensure or certification under State law.” 18 U.S.C. § 18 U.S.C. § 18 U.S.C. § 24(b) (emphasis added).

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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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FDA Law Blog

JANUARY 11, 2022

The Court, however, would not dismiss similar allegations as applied to health insurer. Hikma countered that the notice of side effects for patients with CV disease is a warning, not an instruction to use the product in CV patients, and that Hikma has no duty to provide a statement discouraging an infringing use. In the wake of GSK v.

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FDA Law Blog

JANUARY 11, 2022

The Court, however, would not dismiss similar allegations as applied to health insurer. Hikma countered that the notice of side effects for patients with CV disease is a warning, not an instruction to use the product in CV patients, and that Hikma has no duty to provide a statement discouraging an infringing use. In the wake of GSK v.

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GeriPal

MARCH 9, 2023

In our prior podcast with Ira Byock on psychedelics in 2019 we talked primarily about the potential of psychedelics. We’re going to work with training up the providers that already work in these clinical settings to make it a little bit more, essentially, ask this question of how is this going to work in the real world?

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GeriPal

FEBRUARY 27, 2025

But, you know, I’ve talked to a lot of palliative care providers, a lot of people caring for people with serious illness. Like if a person has an issue, struggle with alcohol, I’m not their alcohol provider, but I may be their opioid provider. First one responds gets the first response. That’s right.

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FDA Law Blog

OCTOBER 29, 2023

Since that blog post, an important step forward was the decoupling of the coverage requirement from the FDA Birth Control Guide in the guidance provided by the Department to plans and issuers.

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FDA Law Blog

SEPTEMBER 8, 2022

As it stands, the rule allows insurers and pharmacy benefit managers (PBMs) to broadly use copay accumulator programs, which have long been criticized by patient advocacy groups as padding insurers’ pockets while leaving patients high and dry. 156.130(h) to explicitly allow insurers to broadly use copay accumulator programs.

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Physician's Weekly

JUNE 12, 2025

An “improper” payment refers to payments made erroneously to beneficiaries and their providers or without sufficient documentation. Every year, the Centers for Medicare & Medicaid Services publishes official numbers for the share of improper Medicaid payments, and in other federal health insurance programs the agency oversees.

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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. “They’re, like, not accountable to anyone.” Senate report.

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Physicians News Digest

APRIL 1, 2025

Since returning to the White House, Trump has said he will target fraud in Medicare, Medicaid, and Social Security, and his Republican allies in Congress have made combating fraud a key argument in their plans to slash spending on Medicaid, which provides health care for millions of low-income and disabled Americans.

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