CMS Estimates 23,000 Labs Performing More Than 7 Billion Tests Will be Affected by New Provisions
LIGHTNING RELEASES: WASHINGTON, DC (3/20/2014) – In order to provide perspective and impact analysis for clinical laboratory professionals regarding a recently announced rule by the Centers for Medicare and Medicaid Services (CMS) that would allow consumers direct access to their lab results, the American Clinical Laboratory Association (ACLA) and G2 Intelligence, an organization reporting on the diagnostic industry for more than 30 years, will sponsor a webinar titled, “The Devil Is in the Details: What Labs Need to Know About Providing Test Results to Patients.”
“ACLA supports the patients’ rights rule and recognizes that to meet the rule requirements, thousands of labs will be responsible for developing and implementing new policies and procedures to ensure patient privacy and rights,” said Alan Mertz, President of the ACLA. “We look forward to partnering with G2 Intelligence to present the most accurate and timely information to clinical labs across the country that will be adhering to this rule for the first time.”
Effective October 6, 2014, clinical laboratories covered by the Health Insurance Portability and Accountability Act (HIPAA) will be required to provide patients or their authorized representatives with access to their completed test reports upon request. The rule will preempt more restrictive laws in some states that previously limited patient access and will alleviate any ambiguity and confusion for health care consumers. Labs must ensure that requests are acted on within 30 days and that results are provided only to individuals who are authorized.
The webinar, scheduled for March 25 from 2:00 p.m. to 3:30 p.m. ET, will focus on questions clinical laboratory professionals have as they plan to meet the October 6, 2014 start date. Answers will be provided by one of the CMS policy experts responsible for writing the rule, as well as a legal expert in clinical laboratory issues.
Questions expected to be addressed include:
- How does a lab authenticate the identity of the person requesting test results and what is the liability if labs provide results to the wrong person?
- Will labs need to offer any interpretation of test results?
- Does the rule apply to reference labs?
- Will labs have to provide access to old test reports?
- Are there any exceptions for sensitive tests, such as HIV or genetic tests? Can labs charge patients for providing the test results?
Webinar expert speakers, Karen Dyer, MT (ASCP), Deputy Director, Division of Laboratory Services, Survey and Certification Group for CMS and Peter Kazon, Esq., Senior Counsel at Alston & Bird and counsel to the ACLA, will impart information to participants to assist them in learning the following:
- The impetus behind the new rule requiring labs to provide patients with direct access to their test results
- How CLIA and privacy laws are affected by the patient access rule
- To whom the rule applies, how to authenticate the identity of requestors, whether there are any exceptions, and what labs will need to do to meet the rule’s requirements
- What policies and procedures labs will need to put in place to respond to requests
ACLA and G2 Intelligence are encouraging participants to take advantage of the opportunity to engage with the webinar’s top policy and legal expert presenters so they are appropriately prepared when the rule takes effect.
“While laboratories will make this information available, as required, ACLA encourages patients to work closely with their physicians and health care providers to understand the meaning of what is often very complex medical information,” noted Mertz. “This will be especially important for more sophisticated tests producing results that could cause anxiety to patients who may have difficulty understanding the meaning or implications. The clinical lab industry will continue to do its part by protecting patient privacy and rights.”
To register for the ACLA-G2 Intelligence March 25th webinar titled, “The Devil Is in the Details: What Labs Need to Know About Providing Test Results to Patients,” click here.