Health Care Law Reform : Health Care Lawyer & Attorney : McDermott Will & Emery Law Firm : Managed Care, Product Regulations

The Facts 

On January 13, 2010, the U.S. Department of Health and Human Services (HHS) proposed requirements for hospitals, physicians and other eligible providers to earn incentives for the adoption and “meaningful use” of “certified electronic health record (EHR) technology.”  Incentives in the form of enhanced Medicare and Medicaid reimbursement are received by demonstrating meaningful use of certified EHR technology.  The incentives start in 2011, but become penalties by 2015 through reduced reimbursements for those who do not achieve meaningful use.  This initial set of standards is intended to begin to define “a common language to ensure accurate and secure health information exchange across different EHR systems.”  Certified EHR technology can be either a “complete EHR or a combination of EHR modules" to enable providers to adapt to innovations in a rapidly evolving industry while ensuring access to a wide array of technology options, from vendor-based products, to homegrown technology, to hosted services on a subscription basis, to open source products.  For more information, see McDermott Will & Emery’s White Paper “HHS Establishes the Initial Pathway for Qualifying for HITECH Act Incentives Dollars for Meaningful Use of Certified Electronic Health Record Technology.”

What’s at Stake

Eligible hospitals and professionals may receive incentive payments for achieving and may avoid penalties for failing to achieve meaningful use of certified EHR technology.  Some hospitals and doctors have already expressed concern about the all or nothing structure of the proposed rule, which requires providers to meet 23 criteria at once, or fail to qualify at all.  Vendors of EHR systems or EHR modules must ensure their products have the features and functionality to be certified and to enable meaningful use although the certifying bodies have yet to be certified.

Steps to Consider

Providers, vendors of health information technology and other interested parties should consider submitting comments to HHS prior to the March 15, 2010, deadline.  

In selecting an EHR, ensure that the EHR product by itself or combined with other EHR modules will achieve, or be modified by the vendor to achieve, certification.  Assess interoperability of modules.  Consider contractual commitments covering interoperability, certification and meaningful use. 

Vendors should develop a road map or work-around to ensure that products will be certified and that they will enable meaningful use.  Vendors should be ready to address customer demand for assurances.   

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The Facts

The Office of the National Coordinator for Health Information Technology’s HIT Policy Committee has taken another important step towards defining “meaningful use” under the American Recovery and Reinvestment Act of 2009 (ARRA). Hospitals and eligible providers must meet the requirements for “meaningful use” of certified electronic health records (EHRs) in order to qualify for Medicare incentive payments under ARRA. Recently, the HIT Policy Committee approved revised recommendations for an initial definition of “meaningful use.” These recommendations are outlined in a lengthy matrix, which sets forth measures for meeting specified objectives for each of the years 2011, 2013 and 2015:

• Goal for 2011 objectives – Capacity to electronically capture in coded format and report health information, and use that information to track key clinical conditions
• Goal for 2013 objectives – Ability to guide and support care processes and care coordination
• Goal for 2015 objectives – Capability to achieve and improve performance and support care processes and key health system outcomes

The HIT Policy Committee also recommended that the incentives be paid according to an “adoption year” timeframe rather than a calendar year timeframe. Accordingly, the objectives and measures for the year 2011 would apply to an organization’s first adoption year, if an organization is not ready for incentive payments until after 2011. The U.S. Department of Health and Human Services (HHS) will use the recommendations to develop regulations to implement the incentive payments under ARRA. 

What’s at Stake

Hospitals and eligible providers that meet the requirements of “meaningful use” of certified EHRs will be eligible for Medicare incentive payments beginning in 2011. Medicare payments may be reduced to hospitals and providers that do not meet the requirements for “meaningful use” of certified EHRs by 2015.

Steps to Consider

Evaluate how the 2011 Objectives and Measures in the Meaningful Use Matrix may require changes in the operations of your organization, anticipating that some form of the objectives and measures may ultimately be included in the regulations promulgated by HHS. Monitor regulatory actions by HHS regarding the definition of “meaningful use” and Medicare incentive payments under ARRA.

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The Facts
The American Recovery and Reinvestment Act authorizes the Centers for Medicare & Medicaid Services (CMS) to provide incentives to certain physicians and hospitals who achieve “meaningful use” of a certified electronic health record (EHR) system.

The act established the Health Information Technology (HIT) Policy Committee, which issued a draft definition of “meaningful use” at its June 16, 2009, meeting.  The committee recommended a progressive definition, where “meaningful use” is ultimately linked to achieving measurable outcomes in patient engagement, care coordination and population health.  The 2011 objectives are intended to establish a foundation for affecting a more comprehensive set of health outcomes in the future.  By 2015, the objectives are to achieve and improve performance and support care processes.  A matrix including the full proposed definition of “meaningful use” is available at http://healthit.hhs.gov/.

The committee has asked a workgroup of the committee to submit a new set of recommendations for “meaningful use” at the committee’s July meeting.  The committee is currently accepting comments regarding the proposed draft, but it is not clear whether it will offer a comment period after the revised draft.  The committee’s recommendations are non-binding, but will provide guidance to CMS, which will ultimately establish the definition for “meaningful use.”

What’s at Stake
Beginning in 2011, those physicians and hospitals who can demonstrate “meaningful use” of a certified EHR system will receive incentive payments through additional Medicare reimbursement.  Beginning in 2015, those who have not achieved “meaningful use” will be subject to certain downward adjustments in their Medicare reimbursement rates.

Steps to Consider

• Consider submitting comments to the Department of Health and Human Services (HHS) on the draft definition of “meaningful use.”  Comments are due by 5 pm Eastern time, June 26, 2009.
• If your organization does not have an EHR system, consider options for EHR technology that fit within your organization’s structure and that will assist you in capturing data to meet evolving “meaningful use” requirements.
• If your organization already has an EHR, examine the systems and consider internal and external steps necessary to implement flexibility in capturing data required for an evolving definition of “meaningful use.”
• Obtain contractual commitments from EHR system vendors to assist you in achieving “meaningful use.”

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