"Electronic health records help doctors provide higher quality patient care, improved efficiency and with less hassle," Leavitt said in a release. "By removing barriers, these regulation changes will help physicians get these systems in place and working for patients faster."
Electronic prescribing enables a physician to transmit a prescription electronically to the patient's choice of pharmacy or ancillary provider. It can improve patient safety by decreasing prescription errors due to hard-to- read physician handwriting and communication errors, automating the process of checking for drug interactions and allergies and eliminating duplicative laboratory and diagnostic tests.
Electronic health records technology, when interoperable among health care providers in various settings, offers benefits similar to the benefits of electronic prescribing in terms of reducing medical errors, coordinating care and improving efficiency.
Interoperable electronic health records will allow information to be more portable, said HHS in a release, moving with consumers from one point of care to another. In addition, the implementation of interoperable electronic health records technology is a critical step in achieving secure and seamless information exchange and improving the health care system.
The final rules displayed today by the Centers for Medicare & Medicaid Services (CMS) and the Office of the Inspector General (OIG) create new exceptions and safe harbors to two key federal fraud and abuse laws for arrangements involving the donation of certain electronic health information technology and services.
The CMS rule creates two new exceptions to the physician self-referral law, which prohibits a physician from referring Medicare patients for certain designated health services (DHS) to entities with which the physician has a financial relationship, unless an exception applies. The law also prohibits the health care entity from billing for Medicare services that are furnished as a result of a prohibited referral.
Similar to the CMS rule, the OIG rule establishes two new safe harbors under the federal anti-kickback statute. Arrangements involving the provision of items and services that meet the requirements of the safe harbors are exempt from enforcement action under the federal anti-kickback statute related to electronic prescribing as well as electronic health records systems.
The rules finalize an exception and safe harbor for the provision of electronic health records information that is more expansive than the exception and safe harbor proposed by CMS and OIG on Oct. 11, 2005. The Medicare Prescription Drug, Improvement, and Modernization Act (MMA) mandated exception and safe harbor for arrangements involving the provision of electronic prescribing technology and services were finalized as proposed.
The exceptions and safe harbors establish the conditions under which:
- 1. Entities furnishing DHS (and certain other entities under the safe harbor) may donate to physicians (and certain other recipients under the safe harbor) interoperable electronic health records software, information technology and training services.
- 2. Hospitals and certain other entities may provide physicians (and certain other recipients under the safe harbor) with hardware, software, or information technology and training services necessary and used solely for electronic prescribing.
Among other conditions, the final rules for arrangements involving the donation of electronic health records technology include a cost-sharing requirement. Recipients are required to pay 15 percent of the cost of the electronic health records technology items and services. In addition, consistent with the president's goal of adoption of electronic health records technology by 2014, the exception and safe harbor protecting arrangements involving the donation of electronic health records will sunset on Dec. 31, 2013.