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PPACA: Feds Issue Electronic Health Record Regs (Updated)

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The U.S. Department of Health and Human Services (HHS) is ramping up efforts to get doctors, hospitals and other care providers to computerize patient records.

But HHS officials say they have decided against including two key electronic health record (EHR) use objectives from their first batch of EHR incentive program standards. One objective eliminated would have called for providers to submit claims to both public and private health plans electronically, and the other would have required providers to verify both public and private health plan eligibility electronically.


The Centers for Medicare and Medicaid Service, an arm of HHS, has sent an 864-page draft of thefinal rule for the “Medicare and Medicaid Programs; Electronic Health Record Incentive Program” to the Office of the Federal Register for publication.

Managers at the office expect to publish the final rule, which is based on an interim final rule released in January, in the Federal Register July 28.

HHS itself has sent the Federal Register office a 228-page final rule relating to “Health Information Technology: Initial Set of Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology” and a 234-page notice of proposed rulemaking for “Modifications to the HIPAA Privacy, Security, and Enforcement Rules under the Health Information Technology for Economic and Clinical Health Act.”

The Federal Register is set to publish the proposed rule Wednesday and the final rule July 28. The final rule is based on an interim final rule that came out in December 2009.

The CMS final rule implements the Health Information Technology for Economic and Clinical Health (HITECH) Act provisions of the American Recovery and Reinvestment Act of 2009. The HITECH Act provisions are supposed to give physicians, hospitals and other eligible Medicaid and Medicare health care providers financial incentives to adopt EHR systems.

The CMS final rule and the HHS final rule, developed by the HHS Office of the National Coordinator for Health Information Technology, will help create a set of standards for implementing “Stage 1″ of the shift to EHR standards. Regulators are supposed to use the criteria to determine whether providers are making enough “meaningful use” of EHR systems to qualify for incentive payments.

The proposed rule will help HHS implement the new EHR incentive system by updating existing health information privacy standards, health data security standards, and related compliance rules.

The CMS final rule is scheduled to take effect 60 days after the Federal Register publication date, and the HHS final rule is scheduled to take effect 30 days after the Federal Register publication date.

Doctors can qualify for tens of thousands of dollars in EHR incentives, and hospitals can qualify for millions of dollars in EHR incentives.


Karen Ignagni, president of America’s Health Insurance Plans, Washington, has put out a statement welcoming the release of the HHS and CMS EHR regulations.

“Broad adoption and meaningful use of health information technology by providers is essential to creating an efficient, high-performing 21st-century health care system,” Ignagni says. “Health plans and providers share the responsibility of making the investments needed to enhance efficiency and improve health outcomes.”

Many plans already are rewarding providers for shifting to EHR systems and using other electronic systems to improve the quality and efficiency of care, Ignagni says.


The HITECH Act is not officially part of the Affordable Care Act – the legislative package that includes the Patient Protection and Affordable Care Act (PPACA) and the Health Care and Education Reconciliation Act – but the same entities that developed the ACA package developed the HITECH package, and, in practice, federal agencies are having to coordinate HITECH Act implementation with ACA implementation, as if the HITECH Act were another part of the ACA package.

CMS officials will wait until ACA programs are implemented before develop Stage 2 EHR adoption standards, and the ACA administrative simplification provisions aimed at health plans and health plan clearinghouses will probably help shape the EHR standards, officials say.

Federal officials call commercial health insurers, health maintenance organizations and self-funded employer health plans “private payers.” “Private payers” have generally supported HITECH Act EHR efforts, arguing that strong support for standardized EHR systems by Medicaid and Medicare will boost private payer EHR programs and hold down administrative costs.


CMS says it plans to release EHR incentive program meaningful use criteria in a total of 3 stages, with the second batch coming out at the end of 2011 and the third by the end of 2013.

The Stage 1 criteria focus “on electronically capturing health information in a structured format; using that information to track key clinical conditions and communicating that information for care coordination purposes (whether that information is structured or unstructured, but in structured format whenever feasible); implementing clinical decision support tools to facilitate disease and medication management; using EHRs to engage patients and families and reporting clinical quality measures and public health information,” officials say. “Stage 1 focuses heavily on establishing the functionalities in certified EHR technology that will allow for continuous quality improvement and ease of information exchange.”

The Stage 2 criteria will “encourage the use of health IT for continuous quality improvement at the point of care and the exchange of information in the most structured format possible,” and the Stage 3 criteria will “focus on promoting improvements in quality, safety and efficiency leading to improved health outcomes, focusing on decision support for national high priority conditions, patient access to self management tools, access to comprehensive patient data through robust, patient-centered health information exchange and improving population health.”

While the Stage 1 criteria are in effect, providers must meet 15 core requirements and 5 of 10 additional objectives to qualify as meaningful EHR users.


CMS officials report in a discussion of “Stage 1 Criteria for Meaningful Use” that about 75% of the commenters who commented on electronic claim submission and electronic eligibility verification objectives included in the proposed rule wanted them eliminated from the final rule.

Commenters said, for example, that electronic claim submission and eligibility check processes are not part of traditional EHR technology, that adding them to EHR systems would not improve the quality of care, and that payers often interfere with standardization by customizing transactions that meet Health Insurance Portability and Accountability Act (HIPAA) transaction standards.

In the area of electronic insurance eligibility verification, “payers do not guarantee their eligibility results,” and “many payers are still not in compliance with the HIPAA 270/271 electronic eligibility standard,” commenters said.

The commenters who complained about lack of payer eligibility guarantees and lack of compliance with the HIPAA 270/271 standard said the electronic eligibility verification objective should be kept only if health plan compliance with the standard could be guaranteed.

CMS officials believe that the claims submission and eligibility verification objectives are within the HITECH “meanginful use” definition, and they believe the HITECH Act requires HHS to promote use of EHR systems to improve administrative efficiency as well as to improve health care quality, officials say.

“However, we recognize there is not current agreement as to which systems constitute an EHR and that many entities may view their practice management system to be outside their EHR,” officials say. “We also acknowledge that we do not have the ability to impose additional requirements on third-party payers to participate in this exchange beyond what is required by HIPAA.”

Outside payers can modify the standard transactions and do not have to guarantee eligibility verification results, officials say.

“We agree with commenters that this significantly devalues the results of this objective,” officials say.

The CMS officials say they decided to leave the claims submission and eligibility verification check objectives out of the Stage 1 meaningful use standards because of the practical obstacles to implementation.

But “we believe that inclusion of administrative simplification in meaningful use is an important long-term policy goal for several reasons,” officials say in a response to the comments. “First, administrative simplification can improve the efficiency and reduce unnecessary costs in the health care system as a whole; the small percentage of paper claims submitted represent a disproportionate administrative cost for health plans; the reconciliation of billing charges for services not eligible for payment creates a significant burden for providers, health plans, and most significantly, for patients. Second, the integration of administrative and clinical information systems is necessary to support effective management and coordinated care in physician practices.”

CMS will include the administrative simplification objectives in the Stage 2 meaningful use standards, officials say.


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