Updating regulations in recognition of changing technology
FDA’s Bar Code Rule
FDA has been considering which economically significant rule to subject to a cost-benefit reassessment and has tentatively concluded that the “Bar Code Rule” is the best candidate for this review. The Bar Code Rule dates from February 2004 and requires certain human drug and biological products to have on their labels a linear bar code that contains, at a minimum, the drug's NDC number. The rule also requires the use of machine-readable information on blood and blood component labels.
Bar codes on drugs allow health care professionals to use bar code scanning equipment to verify that the right drug (in the right dose and right route of administration) is being given to the right patient at the right time. This new system is intended to help reduce the number of medication errors that occur in hospitals and health care settings. FDA estimated that the bar-code rule, when fully implemented, would help prevent nearly 500,000 adverse events and transfusion errors over 20 years. FDA estimates the economic benefit of avoiding these adverse events to be $93 billion over the same period.
The goal to the review will be to assess the costs and benefits and to determine if the rule should be modified to take into account changes in technology that have occurred since the rule went into effect.
Increase Use of Electronic Reports and Submissions
FDA is embarking on a major campaign to revise its regulations to increase the use of electronic information in the way it conducts business. On its immediate agenda are regulatory revisions to permit electronic submission of clinical study data for drug trials, post-market reporting for drugs and biological products, and registration and listing of drugs and medical devices. FDA is also looking to require electronic package inserts for human drug and biological products.
Similarly, ACF is moving to an electronic information and record management system for its child support program that will ease burdens on and provide greater flexibility to states implementing this program, especially with respect to case transfer among states and tribes. The program will also move to accept electronic signatures to facilitate ease of reporting.
Use of Telemedicine to Increase Access
CMS intends to improve access to care for beneficiaries in rural and critical access areas by increasing the ability of a hospital to use telemedicine to obtain services from a practitioner credentialed at a distant hospital by permitting the hospital to accept the credentials of a practitioner credentialed at the distant hospital so long as the distant hospital is also a Medicare participating entity and there is a written telemedicine agreement in place between hospitals. This change will improve the ability of rural and critical access hospitals to provide a broader spectrum of care and services to their patients.
The comment period closes June 30, 2011, after which HHS will finalize its Plan.
