January 15, 2014

Exception to the Physician Self-Referral Law for the Donation of Electronic Health Records Items and Services

Exception to the Physician Self-Referral Law for the Donation of Electronic Health Records Items and Services

On December 23, CMS issued a final rule that revises the exception to the physician self-referral law (section 1877 of the Social Security Act) that permits certain arrangements involving the donation of electronic health records items and services.

Extension of Expiration Date
Under current regulations, the exception expires on December 31, 2013. The final rule extends the expiration date of the exception for an additional eight years to December 31, 2021.

The final rule updates the provision under which electronic health records software is deemed interoperable. Additionally, in the rule, CMS clarifies the requirement prohibiting any action that limits or restricts the use, compatibility, or interoperability of donated items and services. The revised regulation states that software is deemed to be interoperable if it is certified to an edition of the electronic health record certification criteria identified in the then-applicable version of 45 CFR part 170. In addition, the regulation is revised to identify the National Coordinator for Health Information Technology as the office that authorizes certifying bodies for purposes of certifying electronic health records software.

Covered Entities
Under this final rule any entity furnishing designated health services other than a laboratory company is permitted to donate electronic health records items and services. CMS is finalizing the exclusion of laboratory companies from the types of entities that may donate electronic health records items and services. The final rule does not prohibit donations by any other type of entity. Any arrangements for ongoing or continued donations between laboratory companies and referring physicians must be terminated before the effective date of the final rule.

Electronic Prescribing
Previous regulations required that donated electronic health records items and services must have the capability for electronic prescribing. In response to public comment, CMS is removing that requirement. Software donated prior to the effective date of the regulatory modifications set forth in the final rule must satisfy all of the requirements of the existing exception at 42 CFR § 411.357(w), including the requirement in § 411.357(w)(11).

Additional information is available in the fact sheet.

Emergency Preparedness Standards for Medicare and Medicaid Participating Providers and Suppliers
CMS issued a proposed rule (CMS-3178-P) to establish consistent emergency preparedness requirements for health care providers participating in Medicare and Medicaid, increase patient safety during emergencies, and establish a more coordinated response to natural and man-made disasters. This notice of proposed rulemaking would establish national emergency preparedness requirements to ensure that health care facilities adequately plan for disasters and coordinate with Federal, state, tribal, regional, and local emergency preparedness systems to make sure that providers and suppliers are adequately prepared to meet the needs of patients during disasters and emergency situations.

Proposed Requirements
Upon review of the current Medicare emergency preparedness requirements for both providers and suppliers, CMS found that regulatory requirements were not comprehensive enough to address the complexities of emergency preparedness. For example, the requirements did not address the need for: communication to coordinate with other systems of care within cities or states; contingency planning; and training of personnel. In consultation with experts in emergency response and health care facilities, CMS has identified four specific areas that are central to an effective system. The proposed rule would require participating providers and suppliers to meet these four standards:

  • Emergency plan: Based on a risk assessment, develop an emergency plan using an all-hazards approach focusing on capacities and capabilities.
  • Policies and procedures: Develop and implement policies and procedures based on the plan and risk assessment.
  • Communication plan: Develop and maintain a communication plan that complies with both Federal and State law. Patient care must be well-coordinated within the facility, across health care providers, and with State and local public health departments and emergency systems.
  • Training and testing program: Develop and maintain training and testing programs, including initial and annual trainings, conducting drills and exercises or participate in an actual incident that tests the plan.
The proposed requirements are adjusted to reflect the characteristics of each type of provider and supplier. CMS is seeking comment on whether additional modifications are required for each type of provider. Additional information is available in the fact sheet .”

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