Updating regulations in recognition of changing technology
Use of Telemedicine to Increase Access
CMS provides for access to care for beneficiaries in rural and critical access areas through telemedicine. CMS permits hospitals to use telemedicine to obtain services from a practitioner credentialed at a 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 and, by not requiring providers to be credentialed at by every facility in which they are providing a service via telemedicine, it will reduce provider burden. CMS estimates that roughly $13.6 million in net savings will result from this initiative, which it published as a final rule on May 5, 2011.
FDA’s Bar Code Rule
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 National Drug Code 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 system was intended to 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 prevent nearly 500,000 adverse events and transfusion errors over 20 years. FDA estimated the economic benefit of avoiding these adverse events to be $93 billion over the same period.
Because the Rule has been in effect for almost eight years, FDA has determined that it is a good candidate for retrospective review to assess the estimated savings and impact on adverse events. The goal of the review will be to evaluate the costs and benefits of the existing Rule and to determine if it should be modified to take into account changes in technology that have occurred since the Rule went into effect. FDA intends to publish by the end of August 2011 a request for comment to initiate the review of this Rule and help FDA evaluate alternative technologies.
Increase Use of Electronic Reports and Submissions
FDA is embarking on a major campaign to revise its regulations to increase 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.
Aligning the Electronic Health Record Incentive Program with Other Electronic Reporting Systems
CMS intends to eliminate outdated or redundant quality measures and standardize reporting methods. In particular, CMS is looking at aligning the reporting for electronic prescribing requirements under the electronic prescribing program and EHR Incentive Program in Medicare. This initiative should reduce confusion in the physician community and reduce the reporting and paperwork burdens throughout the industry. The proposed rule was issued on June 1, 2011, and CMS intends to publish the final rule in September 2011.
