On April 10, 2013, the Department of Health and Human Services (DHHS), Office of Inspector General (OIG) and the DHHS, Centers for Medicare & Medicaid Services (CMS) each issued a proposed rule relating to the donation of interoperable electronic health records software or information technology and training services (EHR). The rules propose to:

  • Extend by three years the protections of the Stark law exception (42 C.F.R. § 411.357(w)) and the Anti-Kickback safe harbor (42 C.F.R. § 1001.952(y)) to December 31, 2016 (the “sunset” provisions);
  • Eliminate the requirements that a donated EHR include electronic prescribing capability; and
  • Update the provisions that qualify an EHR for protection under the exception and safe harbor (the “deeming” provisions).

In addition to the proposed rules, the OIG and CMS are requesting public comment on other changes the agencies are considering, including:

  • Limiting the scope of protected donors;
  • Adding or modifying conditions to limit the risk of data and referral lock-in; and
  • Clarifying the items and services that fall within the scope of the exception and safe harbor.

Comments must be received no later than 5:00 p.m. on June 10, 2013 and may be submitted as follows:

OIG Proposed Rule:Medicare and State Health Care Programs: Fraud and Abuse; Electronic Health Records Safe Harbor under the Anti-Kickback Statute

1. Electronically to http://www.regulations.gov

2. By regular, express, or overnight mail: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, DC 20201

3. By hand or courier to:Patrice Drew Office of Inspector General Department of Health and Human Services Cohen Building, Room 5541C 330 Independence Avenue, SW Washington, DC 20201

CMS Proposed Rule:Medicare Program; Physicians’ Referrals to Health Care Entities With Which They Have Financial Relationships: Exception for Certain Electronic Health Records Arrangements

1. Electronically to http://www.regulations.gov.

2. By regular mail:Centers for Medicare & Medicaid Services Department of Health and Human Services Attention: CMS-1454-P P.O. Box 8013 Baltimore, MD 21244-8013

3. By express or overnight mail:Centers for Medicare & Medicaid Services Department of Health and Human Services Attention: CMS-1454-P Mail Stop C4-26-05 7500 Security Boulevard Baltimore, MD 21244-1850.4. By hand or courier.

For delivery in Washington, DC:

Centers for Medicare & Medicaid Services Department of Health and Human Services Room 445-G Hubert H. Humphrey Building 200 Independence Avenue, SW. Washington, DC 20201

(Leave comments in the CMS drop slots in the main lobby.)

For delivery in Baltimore, MD:

Centers for Medicare & Medicaid Services Department of Health and Human Services 7500 Security Boulevard Baltimore, MD 21244-1850.