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

EHR Meaningful Use Audits – Coming Soon to an Office Near You!

by Ann F. Triebsch

businessman looking over his glasses with clipboard on hand - frAs we indicated in a posting last October and in a more recent August post , audits are now underway to verify that providers who received incentive monies from the Centers for Medicare and Medicaid Services (CMS) under the Health Information Technology for Economic and Clinical Health (HITECH) Act for implementation of a certified electronic health record (EHR) have indeed met the “meaningful use” (MU) criteria. The Office of the National Coordinator for Health Information Technology (ONC) has contracted with Garden City, NY-based Fagliozzi and Company to conduct these audits.  The audits are designed to verify that providers receiving incentive payments are using certified EHR technology in a meaningful way. These audits can be a hassle, and there are risks if you cannot promptly provide what is requested—even if you are complying with the MU criteria.

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ONC revokes two EHR product certifications — review your vendor contract warranties!

man planningOn April 25, 2013, the Officer of National Coordinator for Health Information Technology (ONC) announced that it had revoked certification for two electronic health record (EHR) products that the ONC had previously certified for use as part of the incentive program implemented pursuant to the Health Information Technology for Economic and Clinical Health Act of 2009 (HITECH Act).   The products for which ONC revoked certification are EHRMagic-Ambulatory and EHRMagic-Inpatient.  The ONC’s press release with additional information is available here.

Whether the providers who purchased these products in reliance on the previous ONC certification will be able to recoup their investment in these products may depend on the terms of any vendor agreement signed between the parties.  For providers who are purchasing ONC-certified products, this development highlights the importance of examining the provider’s EHR vendor agreement to ensure that it contains adequate warranty and indemnification provisions that will protect the provider in case the vendor’s product is de-certified by the ONC.  Importantly, without “certified EHR technology”, the provider will not qualify for the HITECH Act’s meaningful use incentive payments.

New EHR Exemptions Proposed

Doctor Speaking with PatientA new bill entitled the “Electronic Health Records Improvement Act” has been introduced in the U.S. House of Representatives. Its stated purpose is to “amend certain requirements and penalties implemented under the Medicare and Medicaid programs by the HITECH Act of 2009, which would otherwise impede eligible professionals from adopting electronic health records to improve patient care.” Most notably, this bill proposes two new exemptions to the requirements to be a meaningful user of electronic health records (“EHRs”) that will be beneficial to solo physician practices and physicians nearing retirement:

  • Eligible Professionals in Small Physician Practices.  A physician who is a solo practitioner in 2015 would be exempt from the application of the downward payment adjustment for not demonstrating EHR meaningful use during the payment years 2015-2017.  Implementing EHRs require significant investments in time for vendor selection, capital, and staff resources—and solo practitioners typically do not have the necessary resources to invest in EHRs.  This exemption allows undercapitalized solo practitioners an additional three years to become a meaningful EHR user.
  • Exception for Certain Physicians Near Retirement Age.  A physician who will be eligible for Social Security by December 31, 2015 (or will be eligible during the 5-year period following that date) is also exempt from the application of the downward payment adjustment for not demonstrating EHR meaningful use during the payment years 2015-2017.  This exemption will encourage physicians nearing retirement to continue practicing medicine for several more years instead of retiring early to avoid implementing an EHR.  (Because this section of the Bill uses the terms “eligible professional” (in the text) and “physician” (in the title), there is some question as to whether this exception applies only to physicians nearing retirement or also applies to other types of eligible professionals, such as dentists, chiropractors, podiatrists, and optometrists.  Hopefully, this confusion will be clarified if this Bill progresses into law.)

Here is a link to H.R. 1331. This Bill is currently in committee, and we will watch its progress closely.

Update (1/31/2015):  Unfortunately, H.R. 1331 died in Committee.

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