View Page As PDF
Share Button
Tweet Button

The current Stark exception and safe harbor under the Medicare and Medicaid anti-kickback law permitting the donation of up to 85 percent of certain eligible electronic medical record (“EMR”) expenses to referral sources is scheduled to sunset on December 31, 2013. However, the government has proposed extending the expiration date of the Stark exception and anti-kickback safe harbor through December 31, 2016. In proposed notices of rule making with respect to both the Stark exception and the anti-kickback safe harbor, the government is soliciting comments from the public for the next 60 days regarding whether the extension should be made and whether there should be any restrictions on certain types of donations. In particular, the government is requesting comments as to whether donations by laboratories should be excluded in light of concerns that have been raised regarding the use of EMR donations in exchange for referrals for laboratory testing.

Laboratories and pathology providers who are concerned about the extension of the Stark exception and anti-kickback safe harbor should submit comments expressing their concerns within the next 60 days to the addresses set forth below. Comments regarding the Stark exception should be submitted to the Centers for Medicare and Medicaid Services and comments regarding the anti-kickback safe harbor should be submitted to the Office of the Inspector General. It is important for concerned commenters to elaborate upon the widespread abuse of EMR donations in exchange for referrals, emphasizing that the abuse involves both laboratories and individual pathology providers. Even if the federal government decides to extend the Stark exception and the anti-kickback safe harbor, there is a possibility that the final regulations could exclude donations by laboratories and pathology providers, if sufficient comments are received regarding this issue.

Comments regarding the Stark exception should be submitted to the following addresses, noting file code CMS-1454-P on the comments:

  1. Electronically. You may submit electronic comments on this regulation at the Regulations.gov website. Follow the “submit a comment” instructions.
  2. Regular Mail. You may mail written comments to the following address:

    Centers for Medicare and Medicaid Services
    Department of Health and Human Services
    Attention: CMS-1454-P
    P.O. Box 8013
    Baltimore, MD 21244-8013
  3. Overnight Mail. You may send written comments to the following address:

    Centers for Medicare and Medicaid Services
    Department of Health and Human Services
    Attention: CMS-1454-P
    Mail Stop C4-26-05
    7500 Security Boulevard
    Baltimore, MD 21244-1850

Comments regarding the anti-kickback safe harbor should be submitted to:

  1. Electronically. You may submit electronically through the Federal eRulemaking portal at the Regulations.gov website. (Attachments should be in Microsoft Word, if possible.)
  2. Regular, Express or Overnight Mail. You may mail your printed or written submissions to the following address:

    Patrice Drew
    Office of Inspector General
    Department of Health and Human Services
    Attention: OIG-404-P, Room 5541C
    Cohen Building
    330 Independence Avenue, SW
    Washington, D.C. 20201

For more information, please contact:

Jane Pine Wood
508.385.5227
jwood@mcdonaldhopkins.com

McDonald Hopkins has a large and diverse healthcare practice, which is national in scope. The firm represents a wide variety of healthcare providers, facilities, vendors, technology companies and associations. Our diverse experience enables us to give our clients a unique perspective on the issues that may confront them in the rapidly evolving healthcare environment.

COMMENT
+