HHS Amends CLIA to Broaden the Patient’s Access Rights to Lab Test Results

by Kathie McDonald-McClure and Elizabeth O’Keeffe

lab_specimensAs we have previously reported on the Wyatt HITECH Law blog on September 14, 2013 and September 23, 2011, the Department of Health and Human Services (HHS) has had in the works, for over two years now, revisions to the Clinical Laboratory Improvement Act of 1988 (CLIA) regulations concerning whether a lab may release test results directly to patients.  On February 3, 2013, HHS announced the release of a Final Rule (Final Rule) amending the CLIA regulations to allow laboratories to give a patient, or a person designated by the patient, his or her “personal representative”, access to the patient’s completed test reports upon the patient’s or patient’s personal representative’s request.  The Final Rule was issued jointly by three agencies within HHS: the Centers for Medicare & Medicaid Services (CMS), which is generally responsible for laboratory regulation under CLIA, the Centers for Disease Control and Prevention (CDC), which provides scientific and technical advice to CMS related to CLIA, and the Office for Civil Rights (OCR), which is responsible for enforcing the HIPAA Privacy Rule. Continue reading

November 30th Meaningful Use Deadline for Hospitals

clip_image002Saturday, November 30, 2013, is the last day for hospitals and critical access hospitals (CAHs) to register and attest to receive an incentive payment for FY2013 under the Medicare Electronic Health Record (EHR) Incentive Program.  In the flurry of Thanksgiving activities, holiday travel and Black Friday shopping, don’t forget to take advantage of this deal.  The Centers for Medicare and Medicaid Services (CMS) has posted a reminder of these deadlines on its Medicare & Medicaid EHR Incentive Program Registration & Attestation System webpage.
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Kentucky Health Information Exchange Underwriting CeRT Early Adopter Licenses for One Year

incentive paymentsKentucky Health Information Exchange (KHIE) sends out alert on Thursday, April 18, 2013, indicating that it will accept applications from 13 providers who are seeking financial assistance to qualify for the HITECH Act’s Meaningful Use incentive payments.

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The New HIPAA Rules are Out!

by Ann F. Triebsch

(Updated January 27, 2013)

On January 17, 2013, the Department of Health & Human Services (HHS), Office for Civil Rights (OCR), released the final HIPAA Omnibus Rule (Omnibus Rule) implementing the HITECH Act of 2009 and the Genetic Information Nondiscrimination Act of 2008 (GINA). The Omnibus Rule greatly enhances a patient’s privacy protections, provides individuals new rights to their health information, and strengthens the government’s enforcement capabilities. The regulations are published in the January 25, 2013 Federal Register, and will be effective on March 26, 2013, with compliance required by September 23, 2013.

We will discuss the highlights of the new regulations, topic by topic, in this blog over the next few weeks, but we begin with a key piece of information relevant to existing business associate agreements. The new regs substantially increase the privacy responsibilities of a business associate that receives protected health information, such as contractors and subcontractors. Business associates may also be liable for increased penalties for noncompliance based on the level of negligence, up to a maximum penalty of $1.5 million.

All of the new requirements will need to be reflected in business associate agreements (BAAs). If your current business associate agreement was signed on or before January 24, 2013, it will be deemed HIPAA compliant through September 23, 2014 (at which time the agreement will need to have been amended for compliance with the Omnibus Rule). After January 24, 2013, any new BAAs signed should comply with the Omnibus Rule, and be in place by September 23, 2013.

To read the Omnibus Rule, click here.

House Calls for Suspension of EHR Incentive Payments under HITECH Act

Hands on keyboard in circleOn Thursday, October 4, 2012, in a letter to Secretary Sebelius of the United States Department of Health & Human Services (HHS), the United States House GOP called on HHS to suspend incentive payments for the adoption and implementation of electronic health records (EHRs) otherwise authorized under the Health Information Technology for Economic and Clinical Health Act of 2009 (HITECH Act).  The GOP also asked HHS to delay the imposition of penalties on providers who choose not to use EHRs in their practice (such penalties that pursuant to the HITECH Act provisions are to take the form of reductions in Medicare reimbursements in 2015).  Continue reading