Bigger focus on compliance needed in EMR marketplace
Reed Gelzer, MD, MPH, CHCC, Advocates for Documentation Integrity and Compliance, said “it is immensely complex to get a sense of the industry” during his presentation at “Analyzing the Latest EMR Developments” last week.

Gelzer said he is concerned about EMRs and compliance. “Whatever the format, the health record must meet the requirements of the legal and business record for the organization,” he said. “If it doesn’t, the EHR leaves the user at high medical/legal risk, possibly at higher risk than their current state.”

The basis for medical records acceptance/admissibility as legal records derives from their validity as business records. It is the rules and regulations for business records, particularly those on computers that stand currently as the fundamental determinant of functional requirements. If an EHR system cannot meet these requirements, it cannot stand as a legal business record, whether for billing, coding, or reimbursement use or for admissibility in court for any reason.

The medical/legal risk of EHRs is below the radar in the marketplace, Gelzer said. “Today a product that supports medical records compliance is a market-distinguishing quality but tomorrow it is a necessity,” he said. However, regulatory and oversight bodies are gearing up for more critical review of EHR functions and documentation, said Gelzer. They are aware that many EMR systems allow for canned documentation which physicians can then use to bill for a level of service that was not delivered.

The burden for due diligence is on the buyer, Gelzer said. He is not surprised that the rate of EMR adoption is less than 20 percent. “It’s realistic to be cautious. It’s hard to verify the EMR as a valid legal record.” He also discussed the problems that most EMRs have with compliance. Most have an audit function that is not very robust and some systems let users turn off the audit function. A valid time-stamp is critical, he said. “You have to be able to demonstrate in a court of law that documentation happened at the time of the encounter which you are documenting.”

Because of these compliance problems and the inability of EMR systems to prove information has not been altered, the Department of Justice has proposed updates to the Federal Rules of Evidence that are much more meticulous in addressing business records on computers. This is justified, said Gelzer, because “healthcare fraud is enormous and growing.”

Few consumers ask about risk when they shop for EMRs, Gelzer said. With an EMR, “a physician can earn a million dollars more a year but what about the legal and liability risk?” Through the False Claims Act, each individual false claim is fined between $5,500 and $11,000. Gelzer said he is waiting for the “Pinto Event”—where someone is using an EMR system properly but the system itself is designed to fail in court or validation won’t distinguish between falsified information and authenticated information. Unfortunately, he said, very few consumers are asking vendors about shared risk and how systems prevent these problems.

The other challenge is that EMR shoppers, typically smaller practices, don’t have a medical records policies and procedures manual. Without one, they haven’t outlined the functions that an EMR is supposed to fulfill, Gelzer points out. That makes a successful purchase virtually impossible.
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