FDA Law Blog

MAY 31, 2021

One of these amendments was a poorly thought-out rule that, if implemented, will render virtually unusable the current best price exclusion for manufacturer patient savings programs in the form of coupons, patient rebates/refunds, copay assistance, vouchers, and free drug programs. The effective date of this amendment is January 1, 2023.

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FDA Law Blog

OCTOBER 9, 2023

The ACA sets an annual cap on the amount that insurers can require insured individuals to pay out of pocket for their medical expenses. Once an individual reaches this annual cap, the insurer is solely responsible for covering the individual’s remaining medical expenses that year.

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FDA Law Blog

AUGUST 7, 2023

Through ELP, CDRH staff visit sites that provide formal training and enhance understanding on topics such as how products are developed and how they fit into the larger healthcare system. The visits are intended purely to provide a training perspective, and not for CDRH staff to opine on any regulatory functions.

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Physician's Practice

JUNE 9, 2025

Insurance Denials and Prior Authorizations (00:11:26)** Challenges with insurance coverage, prior authorizations, and evolving insurer policies for GLP-1 prescriptions. Conclusion and Closing Remarks (00:25:02)** Thanking the guest, closing the episode, and providing subscription information.

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GeriPal

MAY 5, 2022

COVID-19, masks, and hearing difficulty: Perspectives of healthcare providers. So this is a podcast going at the geriatricians and palliative care providers. Hearing aids, you had six big manufacturers of hearing aids. Five big manufacturers. Over-the-counter hearing aids: What will it mean for older Americans?

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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. Because… Dan: Bob’s new job meant… a new insurance plan for the family. He left without it.

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FDA Law Blog

MARCH 29, 2023

While many states have had standing orders that allow for the dispensing of naloxone without an individual prescription, “harm reduction programs” that provide products and services to at-risk individuals still faced logistical difficulties in acquiring naloxone due to its prescription-only status which I discussed in this October 2022 blog post.

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Alabama Academy of Family Physicians

FEBRUARY 19, 2025

What Happened: Passed out of the House of Representatives HB 46 – Rural Physicians Tax Credit What’s in the Bill: HB 46 terminates the existing Rural Physician Tax Credit program in Alabama, which provided tax credits to physicians practicing in rural areas, effective December 31, 2025.

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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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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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FDA Law Blog

AUGUST 10, 2021

Predictably, PhRMA, BIO, and numerous provider organizations took advantage of the procedural irregularity to challenge the rule on APA grounds in three separate lawsuits, and succeeded in obtaining injunctions blocking the rule from taking effect on January 1, 2021 (as we reported here and here ). 3 , the “Elijah E.

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FDA Law Blog

SEPTEMBER 14, 2021

PART 1: MAXIMUM FAIR PRICE PAYMENT LIMITATION UNDER MEDICARE PARTS B AND D AND THE COMMERCIAL INSURANCE MARKET. The MFP would be established through negotiations between HHS and the manufacturer and would incorporate foreign pricing benchmarks, as further described below. The four parts of Subtitle E are summarized in turn below.

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Physicians News Digest

APRIL 2, 2025

By Julie Appleby Tim Winard knew he needed to buy health insurance when he left his management job in manufacturing to launch his own business. We were so nervous about not being on a company-provided plan,” Winard said. When he needed a colonoscopy, Winard, 57, called his insurance company. Then the bill came.

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