Bill Summaries: H652 (2015-2016 Session)

Tracking:
  • Summary date: Jul 2 2015 - View summary

    AN ACT ESTABLISHING A RIGHT TO TRY ACT TO PROVIDE EXPANDED ACCESS TO INVESTIGATIONAL DRUGS, BIOLOGICAL PRODUCTS, AND DEVICES FOR PATIENTS DIAGNOSED WITH TERMINAL ILLNESS. Enacted July 2, 2015. Effective October 1, 2015.


  • Summary date: Apr 20 2015 - View summary

    House committee substitute makes the following changes to the 1st edition.

    Amends the definition of eligible patient in GS 90-325.1 to require the documentation from the physician that the individual meets the criteria for the definition to also include an attestation from the treating physician that the physician was consulted in the creation of the consent. 

    Makes additional clarifying and technical changes. 


  • Summary date: Apr 13 2015 - View summary

    Enacts new Article 23A in Chapter 90 which authorizes, but does not require, a manufacturer of an investigational drug, biological product, or device to make it available to certain terminally ill patients (defined as eligible patients). Authorizes the manufacturer to provide the investigational treatment with or without charge to the eligible patient but relieves heirs of any outstanding debt related to the treatment if the eligible patient dies.

    Prohibits licensing boards and entities responsible for Medicare certification from taking action against a provider solely because the provider recommended the investigational treatment to the eligible patient. 

    Prohibits state officials, employees, and agents from blocking or attempting to block access to investigational treatment.

    Prohibits private causes of action against manufacturers or people involved with the treatment for harm caused to an eligible patient who participates in the treatment as long as the manufacturer or person made a good-faith effort to comply with the law.

    Provides that the law does not affect a health plan's obligation to provide coverage for investigative treatments.

    Effective October 1, 2015.