FDA Law Blog

JUNE 3, 2021

Schlanger — While federal efforts to address prescription drug prices are debated, states have continued to pursue their own measures that require drug manufacturers and other entities in the drug supply chain to disclose information about pricing. By Serra J. See our previous coverage of such state laws here , here and here.)

Manufacturing 52

Manufacturing Supply Chain Insurance Provider 52

FDA Law Blog

SEPTEMBER 12, 2021

This new law requires prescription drug manufacturers to report the current wholesale acquisition cost (WAC) information for drugs sold in or into the state on a quarterly basis. The new law also requires manufacturers to submit WAC price increase reports and new drug WAC reports.

Manufacturing 52

Manufacturing Insurance Provider IT 52

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.

Manufacturing 52

Manufacturing Insurance Patients IT 52

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.

Insurance 40

Insurance Manufacturing Patient-Centered Individual 40

FDA Law Blog

OCTOBER 6, 2021

By Faraz Siddiqui — Last week, we blogged about a growing list of drug manufacturers that have refused to follow a 2010 guidance issued by the Health Resources and Services Administration (“HRSA”), which permits 340B covered entities to contract with multiple pharmacies to dispense drugs to covered entity patients. 23-92-604(c)(1), (2).

Manufacturing 52

Manufacturing Insurance IT Community 52

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.

Management 52

Management Telemedicine Patients Insurance 52

FDA Law Blog

AUGUST 7, 2023

Participation is encouraged from: Companies Academia Clinical facilities Medical device incubators and accelerators Health insurers Health technology assessment groups Others, including previous participants in the ELP or the FDA’s other site visit programs. One noticeable difference from years past is the option for virtual site visits.

Patient-Centered 40

Patient-Centered Insurance Manufacturing Provider 40

FDA Law Blog

SEPTEMBER 30, 2022

The 4th Circuit three-judge panel decision relied heavily on the Supreme Court’s decision in Safeco Insurance Co. CMS itself has recognized this by repeatedly inviting manufacturers to use reasonable assumptions where a question is not addressed in the statute, regulations, or CMS guidance. of America v. Burr , 551 U.S.

Insurance 40

Insurance Manufacturing Government Specialization 40

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.

Insurance 52

Insurance IT Board-Certified Medical 52

GeriPal

MAY 5, 2022

And I’m using these personal sound amplification products, these PSAPs for young adults who are in their mid twenties, transitioning off of their parents’ insurance, or they’re going to college and they no longer qualify for Medicaid as a child, and they don’t have hearing aids anymore. Five big manufacturers.

IT 102

IT Screening Hospital Clinic 102

FDA Law Blog

MARCH 29, 2023

Emergent will need time to manufacture and distribute NNS with the new OTC labeling, so the public should not expect to be able to walk into their local pharmacy and grab a box off the shelf in the coming days. When OTC NNS will become commercially available is ultimately determined by the sponsor of the drug—Emergent BioSolutions.

Insurance 105

Insurance Manufacturing Individual Physicals 105

Alabama Academy of Family Physicians

FEBRUARY 19, 2025

Tim Melson SB 43 protects patient access to cost and treatment information by prohibiting health insurers from restricting physicians, health care providers, and pharmacists from discussing the cost of treatments or medications, including lower-cost alternatives.

Insurance 130

Insurance Management Hospital Vaccination 130

FDA Law Blog

JANUARY 11, 2022

The Court, however, would not dismiss similar allegations as applied to health insurer. Taking induced infringement for skinny labeling in a different direction, Amarin also sued health insurer Health Net. In the wake of GSK v. The procedural background of Amarin v. Hikma (unlike that of GSK v.

Insurance 52

Insurance Patients IT Manufacturing 52

FDA Law Blog

JANUARY 11, 2022

The Court, however, would not dismiss similar allegations as applied to health insurer. Taking induced infringement for skinny labeling in a different direction, Amarin also sued health insurer Health Net. In the wake of GSK v. The procedural background of Amarin v. Hikma (unlike that of GSK v.

Insurance 52

Insurance Patients IT Manufacturing 52

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.

Insurance 83

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. 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.

Manufacturing 52

Manufacturing Insurance Government Patients 52

FDA Law Blog

AUGUST 10, 2021

Use of international reference pricing as a target for Medicare to negotiate prices with drug manufacturers appears in H.R. It is possible that CMS will issue a new proposed rule to impose international reference pricing in the future, but it is far more likely that the initiative will move to Congress. 3 , the “Elijah E.

Finance 52

Finance Insurance Manufacturing IT 52

FDA Law Blog

MAY 19, 2022

By Faraz Siddiqui — Last June, we blogged about a lawsuit brought by the Pharmaceutical Research and Manufacturers of America (PhRMA) challenging CMS’s ill-conceived Accumulator Adjustment Rule (“final rule”), which amended the Medicaid Rebate best price regulation. On Tuesday, May 17, 2022, the D.C. See 42 C.F.R. §§ 447.505(c)(8)-(12).

Manufacturing 40

Manufacturing Patients Insurance Government 40

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. After speaking with an insurance agent, he decided against enrolling in an Affordable Care Act plan because he was concerned about the potential cost. Then the bill came.

Insurance 52

Insurance Screening Hospital Patient-Centered 52

FDA Law Blog

JULY 12, 2021

Among the Order’s mandates for DHHS are several relating to prescription drugs. Prior to this Executive Order, the Biden Administration seemed to be ambivalent about drug importation.

Supply Chain 52

Supply Chain Government Insurance Manufacturing 52