GINA Regulations – How to Handle Genetic Information Privacy

by Jason E. Lopata, Esq.

Effective in November 2009, new regulations are in place under the Genetic Information Non-Discrimination Act (GINA) that effect all businesses with 15 or more employees.  Originally enacted to prohibit the use of genetic information for the purpose of making employment-related decisions, the recently effective legislation now extends to restricting employers from acquiring or disclosing genetic information and more broadly defines what continues genetic information.  Most relevantly, GINA prohibits health plans and employers from offering financial incentives or rewards for participating in health risk assessments (HRA) that request information about family medical histories.

While such HRAs have been used in trying to incentivize employer-led wellness or disease- management programs (and in turn, better rates or premiums from insurers), such rewards must immediately cease.  However, sponsors or administrators may still obtain and use results of genetic tests to aid in payment determinations as long as they request the minimum amount of information necessary to make that determination (as set forth in the HIPAA Privacy Rule).  In such an instance, such medical information about an individual employee MUST be kept separate from the employee’s personnel file, as such information is protected under the medical confidentiality provisions of the ADA.  This is due to the fact that the laws prohibit the use of any type of genetic information for the purposes of making employment decisions.  Failure to abide by the new regulations can lead to fines upwards of $500,000 for the violation, which includes even an inadvertent disclosure or use of such genetic medical information.  So even an “innocent” mistake can be quite costly to your practice!!

So how might these new regulations affect your practice?  If you are using any type of HRA for your own employees, or are asked to complete such an assessment for a third-party, review those assessments and eliminate any mandatory acquisition of the newly protected information.  Such revised HRAs should only contain questions about the individual’s own medical history, and nothing about the individual’s family medical history.   Practices will want to review and make the necessary changes to not only HRAs and the programs using theses assessments, but also to enrollment procedures and group health plan documents.  Taking just a few moments to review these documents and procedures can save your practice from an expensive misstep.

What You Need To Know About Meaningful Use

by Jason E. Lopata, Esq.

You’ve heard the term “meaningful use” being used – but what does it mean? The Centers for Medicare & Medicaid Services (CMS) have issued new regulations that are designed to lay the groundwork for physicians and hospitals to further implementation and use of electronic health records (EHR).  Specifically, the CMS has issued a proposed rule detailing what constitutes “meaningful use” of the new technologies available for the maintenance and protection of EHR.   These rules were posted on January 13, 2010 and will be open for public comment for 60 days before being finalized.  The first stage of the incentives program is scheduled to start in 2011.

As part of the American Recovery and Reinvestment Act of 2009, Medicare wanted to reward “meaningful users,” defined as any eligible professional who “demonstrates use of certified EHR technology in a meaningful manner.”  The regulations are designed to improve the quality of health care by promoting care coordination and the use of certified EHR technology.  Part of its intent is also to bring about standard formats for clinical summaries and prescriptions, as well as standard terms being used to describe clinical issues nationwide.  Lastly, it seeks to increase the security measures used to transmit personal health information over the Internet.

So why is this important now, if the incentives program doesn’t begin until 2011?  In a word…money!  Don’t wait until next year to have a plan in place.  The incentives currently are set at reimbursements (over a period of up to 6 years) totaling $44,000 under Medicare and up to $63,750 under the Medicaid programs (however, qualified professionals would not be able to receive monies under both programs).   Even if you’re not interested in working toward those incentive dollars (and frankly, why wouldn’t you?), eligible medical professionals will start being penalized, in 2015, for failure to meet the standards of “meaningful use.”  So as you can see, failure to “get with the program” will have a negative financial impact on your practice.

While the CMS is still defining what will constitute “meaningful use,” it currently has outlined 25 objectives for physicians (23 for hospitals) which will be measured starting in 2011.  These include the use of computerized provider order entries, having the ability for a 48 hour turnaround on patient medical record requests, and maintaining a certain percentage of clinical lab tests in electronic format.  Other criteria will include checking public and private insurance eligibility electronically, submitting claims electronically, and maintaining active medications lists.

Where do you begin to become a “meaningful user”?  If you already have an EHR system in place, an assessment should be done to see if it means the requirement of “meaningful use,” using as many of the criteria that the CMS has published.  If you do not yet have any form of EHR system in your practice, physicians should immediately start their due diligence on competent vendors able to bring EHR systems to their practices (and that also comply with all HIPAA rules and regulations).  In working with any EHR vendors, practices may consider having language placed in vendor contracts to include a “meaningful use” standard to help insure compliance with the relevant standards.

Either way, it is prudent to stay informed of the final regulations that come out later this year.  There is no turning back the clock on the use of EHR – so you must either get with the program NOW, or risk getting further behind in the coming years.  Even if your practices’ record keeping has “always been done that way,” it’s time to move toward a reliable, certified EHR system while the government helps offset the capital investment needed to do so.