Proposed Rules Issued Extending Protections of Electronic Health Record Donations

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 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 regulations.gov. 1. Electronically to 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
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 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
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.