FDA Law Blog

DECEMBER 4, 2023

Pharmacists’ Corresponding Responsibility A controlled substance prescription, to be valid, must be issued for “a legitimate medical purpose by an individual practitioner acting in the usual course of [their] professional practice.” The government asserted additional allegations that are outside our scope. Complaint ¶ 58. Complaint ¶ 59.

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ABIM

APRIL 24, 2025

Visit the ABIM Blog for reports of prior meetings. Johnson, MD, FACP, FIDSA , Senior Vice President for Academic Affairs, added that ABIM provides program directors with aggregate performance data in their programs and, with permission, individual graduate data so that program directors can make adjustments to the programs as needed.

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FDA Law Blog

OCTOBER 9, 2023

We previously blogged about this lawsuit last year. The ACA sets an annual cap on the amount that insurers can require insured individuals to pay out of pocket for their medical expenses. The insurer still accepts the manufacturer payment, but also collects the full deductible from the patient.

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Insurance Manufacturing Patient-Centered Individual 40

FDA Law Blog

JANUARY 6, 2022

220 and was described on HP&M’s blog here. C) the amount billed to or received from, in part or in whole, the health care benefit program from the individuals referred to a particular recovery home, clinical treatment facility, or laboratory. EKRA is codified at 18 U.S.C. § 18 U.S.C. § 24(b) (emphasis added). 18 U.S.C. §

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FDA Law Blog

MAY 19, 2025

For a controlled substance prescription to be effective, that is valid, it must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of their professional practice. 81, 86, 251. 81, 89, 251. Patients traveling long distances to the prescriber and/or to the pharmacy.

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Individual Patients Provider Medical 64

FDA Law Blog

JUNE 27, 2024

Alternating Between Cash and Insurance According to the government’s expert, patients paying for prescriptions with insurance and for others with cash is a red flag for those paid with cash. paid for some medications with insurance while paying for other controlled medications in cash, and Patient M.W. By Larry K. Patient J.C.’s

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FDA Law Blog

JANUARY 6, 2022

220 and was described on HP&M’s blog here. C) the amount billed to or received from, in part or in whole, the health care benefit program from the individuals referred to a particular recovery home, clinical treatment facility, or laboratory. EKRA is codified at 18 U.S.C. § 18 U.S.C. § 24(b) (emphasis added). 18 U.S.C. §

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Lab Testing Individual Referral Patient-Centered 40

PEMBlog

OCTOBER 2, 2024

In individuals with celiac disease, gluten intake leads to an immune mediated inflammatory response that damages the small intestine’s mucosal lining, specifically the villi. I’ll take an email, a comment on the blog, a direct message on X or another social media platform. It kind of blunts them down.

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Diagnosis Management IT Patient-Centered 52

FDA Law Blog

MARCH 29, 2023

I previously blogged on the cancellation of the Joint Meeting scheduled on March 20 to discuss the direct-to-OTC application for 3 mg naloxone nasal spray submitted by Harm Reduction Therapeutics under the trade name RiVive. Additionally, 8 mg naloxone nasal spray (N212045) is also still a prescription drug.

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Insurance Manufacturing Individual Physicals 105

Common Sense Family Doctor

MAY 30, 2025

Despite private and public insurance plans fully covering lung cancer screening in the United States, only 10% to 30% of eligible individuals in were receiving it in a recent state-by-state survey.

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Primary Care Screening Family Physician Family Medicine 59

FDA Law Blog

MARCH 17, 2022

We blogged on the final 2016 guideline here on March 17, 2016). As explained more fully below, CDC concedes that states, insurers, pharmacies and pharmacy benefit managers have implemented laws, regulations and policies that have misapplied the 2016 guideline. 7,838 (Feb. 10, 2022); Dowell, Deborah, MD., at 95-96. “[B]efore

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ABIM

JUNE 24, 2025

Visit the ABIM Blog for reports of prior meetings. Topics that came up in discussion included concerns around limited clinical trial access for patients in underserved populations, escalating costs and insurance challenges, such as shifting coverage policies. Learn More Subscribe to the ABIM Blog to stay on top of the latest news.

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FDA Law Blog

NOVEMBER 29, 2022

We blogged on the 2016 guideline here in March 2016, and the proposed guideline here on March 18th). 50 MME/day, clinicians should pause and carefully reassess evidence of individual benefits and risks. 2022 Guideline at 15. (We 2022 Guideline at 3. Different benefits and risks apply to reducing opioid dosages. “[B]efore

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Patients Patient-Centered ER Individual 52

FDA Law Blog

OCTOBER 28, 2021

The imposition of insurance-related hurdles beyond FDA approval, such as time-consuming prior authorizations or costly co-payments, can impede access to critical health care, such as contraceptives. In some instances, however, this is only the first hurdle to make innovative products available to patients. 300gg-13(a)(4).

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GeriPal

JANUARY 18, 2024

We start off the conversation by talking about whether patients with cancer and cancer pain are really that different, and their paper that was just published on January 11 th in JAMA Oncology showing that substance use disorder is not uncommon in individuals with cancer. And you wrote, actually, a beautiful GeriPal blog about it a while ago.

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Illness Patient-Centered Screening IT 136

FDA Law Blog

FEBRUARY 9, 2022

DEA regulations state that a pharmacist has a corresponding responsibility not to fill a prescription unless it is issued for a “legitimate medical purpose by an individual practitioner acting in the usual course of [their] professional practice.” at 72,729-30. Payment in Cash.

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IT Insurance Government Patients 40

GeriPal

APRIL 14, 2022

So I have thought about this for months, maybe years since your 2016, cycle blog, but we have picked Under Pressure by David Bowie and Queen. Janet: And Katie has a great CAPC blog too that kind of summarizes a lot of additional evidence and references online if you have access to that too. Eric: And why Under Pressure.

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Illness Patient-Centered IT Patients 102

FDA Law Blog

SEPTEMBER 6, 2021

As she did in the vacated decision, Judge Prost vehemently dissented to the Majority Opinion stating frankly: “I write in this case because far from being a disagreement among reasonable minds about the individual facts, this case signals that our law on this issue has gone awry.” Par also has filed similar litigation.

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IT Provider ER Insurance 52

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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Insurance Patients Manufacturing Patient-Centered 83

FDA Law Blog

SEPTEMBER 14, 2021

PART 1: MAXIMUM FAIR PRICE PAYMENT LIMITATION UNDER MEDICARE PARTS B AND D AND THE COMMERCIAL INSURANCE MARKET. Under all of these programs, patient co-insurance would be calculated based on the MFP so that patients receive the benefit of that price. the amount Part D plans pay pharmacies for the drugs). 8126 with a lower MFP.

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Manufacturing Insurance Government Patients 52