CMS Seeks Comments on Next Stage of Meaningful Use

March 2, 2012

On Thursday, Feb. 23, 2012, the Centers for Medicare & Medicaid Services (CMS) announced a proposed rule for Stage 2 criteria for the Medicare and Medicaid Electronic Health Record (EHR) Incentive Programs. Under the Health Information Technology for Economic and Clinical Health (HITECH) Act, part of the American Recovery and Reinvestment Act of 2009, eligible professionals (EPs), eligible hospitals (EHs), and Critical Access Hospitals (CAHs) can qualify for incentive payments when they demonstrate “meaningful use” of Certified EHR Technology by meeting certain objectives. The incentives are part of the federal government’s effort to facilitate the adoption of a nationwide health information network. Publication of the proposed rule in the Federal Register is expected on March 7, 2012. CMS is providing a 60-day period after the date of publication to allow the public to comment on the proposed rule. A final rule is expected to be published this summer.

In addition, on Friday, Feb. 24, 2012, the Office of the National Coordinator for Health Information Technology (ONC) released companion proposed revisions to the Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology. McGuireWoods will issue a separate summary of the companion rule.

HHS announced in February that the number of hospitals utilizing health information technology (IT) more than doubled over 2010 and 2011. To date, 2,000 hospitals and more than 41,000 physicians have received $3.1 billion in incentive payments for ensuring meaningful use of health IT.

Below is a brief outline of some of the overarching elements of the proposed rule.

Stage 2 Criteria

Meaningful use includes both a core set and a menu set of objectives that are specific to EPs or EHs and CAHs. CMS proposes retaining the Stage 1 core and menu structure for Stage 2. CMS proposes that EPs be required to meet, or qualify for an exclusion to, 17 core objectives and three of five menu set objectives. Stage 1 required EPs to meet 15 core objectives and five of 10 menu set objectives. EHs and CAHs would be required to meet, or qualify for exclusion to, 16 core objectives and two of four menu set objectives. Stage 1 required these providers to meet 14 core objectives and five of 10 menu set objectives.

The functionality measures proposed for Stage 2 build upon Stage 1 criteria. For example, CMS proposes to require that 60 percent of all medication, laboratory, and radiology orders be recorded using computerized provider order entry (CPOE). Stage 1 required only 30 percent of an EP’s orders be entered using CPOE. Moreover, the proposed rule also requires that 65 percent—increased from 40 percent under Stage 1—of all permissible prescriptions written by an EP be compared to at least one drug formulary and transmitted electronically using Certified EHR Technology. More than 50 percent of all patients seen by the EP during a reporting period must be provided online access to their health information within four business days after the information is available to the EP, subject to the EP’s discretion to withhold certain information. Stage 1 required only a menu set objective of 10 percent of patients being provided this information. For hospitals, this objective would require more than 50 percent of all inpatient or emergency department patients of an EH or CAH to have information available online within 36 hours of discharge.

Unlike Stage 1, which placed an emphasis on functionality, Stage 2 places more emphasis on direct patient engagement. Stage 2 requires providers not only to provide patients the ability to view online, download, and transmit their health information, but also to provide patients with clinical summaries for each office visit, to use Certified EHR Technology to identify patient-specific education resources and provide those resources to the patient, and to use secure electronic messaging to communicate with patients on relevant health information, using the electronic messaging function of Certified EHR Technology.

EPs, EHs, and CAHs would continue to be required to report on clinical quality measures (CQMs) that align with the existing quality programs—such as measures for the Physician Quality Reporting System and CMS Shared Savings Program—in order to qualify for incentive payments. Specifically, EPs must report 12 CQMs, and EHs and CAHs must report 24 CQMs. The proposed rule specifies that CQM data would be submitted electronically, although the method for submission is open for commentary.

Changes to Stage 1 Criteria

Although many core and menu objectives are retained for Stage 2, CMS proposes some changes to existing Stage 1 criteria for meaningful use. Changes include modification to measurement of meaningful use of EHR for medication orders, the elimination of age limits for requirements to measure height and weight, and raising the age to begin recording blood pressure from two to three years old. These changes are optional in 2013, but will be required in order to meet Stage 1 criteria in 2014.

The proposed rule eliminates some Stage 1 criteria entirely. Current Stage 1 criteria require providers to give patients electronic copies of health information, such as test results, on request. Believing that continued online access to health information is more valuable than a one-time provision of an electronic copy, CMS proposes replacing this objective with a Stage 2 objective giving patients the ability to “view online, download and transmit” their health information.

CMS also proposes to eliminate the core Stage 1 objective requiring “capability to exchange key clinical information” in favor of a “transitions of care” core objective in Stage 2 that requires electronic exchange of summary of care documents to the receiving provider, or when the patient has been referred to another provider while remaining under the care of the referring provider. Transitions of care are the movement of patients from one setting of care (hospital, primary care practice, specialty care practice, long-term care, home health, or rehabilitation facility) to another. The proposed rule references the ONC proposed rule on standards and certification, which includes standard fields required to populate the summary of care document, so Certified EHR Technology would be able to include required information. CMS also proposes to describe a care plan as the structure used to define the management actions for various conditions, problems, or issues. For meaningful use, a care plan must include, at a minimum, the problem, the goal, and any instructions that the provider has given to the patient.

In addition, the proposed rule would require imaging results and information be accessible through Certified EHR Technology. CMS believes this objective will increase utility and efficiency of imaging services, as well as reduce costs and radiation exposure from tests that are repeated solely because a prior test is not available to the provider. The measure for this objective would be more than 40 percent of all scans and tests ordered by the EP or an authorized provider of the EH or CAH for patients admitted to its inpatient or emergency department during a reporting period be accessible through Certified EHR Technology. The rule does not propose any additional image retention requirements.

Payment Adjustments and Exceptions

CMS proposes that prior reporting periods determine whether providers are subject to downward payment adjustments, which begin in 2015 for providers that are not meaningful users of EHR technology. Specifically, any successful meaningful user in 2013 would avoid payment adjustment in 2015. In addition, any Medicare provider that first meets meaningful use in 2014 would avoid the penalty if they are able to demonstrate meaningful use at least three months prior to the end of the calendar or fiscal year, and meet the registration and attestation requirement by July 1, 2014 (for EHs) or Oct. 1, 2014 (for EPs).

Providers located in rural areas without sufficient internet access, newly practicing EPs, and providers faced with unforeseen circumstances, such as natural disasters, would be eligible for exceptions to the penalty.

Modifications to the Medicaid EHR Incentive Program

CMS proposes to expand the definition of what constitutes a Medicaid patient encounter by including individuals enrolled in a Medicaid program, including Title XXI-funded Medicaid expansion (but not separate CHIP programs). In addition, the look-back period for patient volume would be over 12 months preceding attestation, not tied to the prior calendar year. The rule also proposes including 12 children’s hospitals that have not been able to participate because they do not have a CMS Certification Number because they do not bill Medicare.

The Medicaid EHR incentive program has different rules from the Medicare EHR incentive program regarding the number of payment years available. Medicaid EPs and EHs can receive a Medicaid EHR incentive payment for adopting, implementing, and upgrading (AIU) to Certified EHR Technology for their first payment year. For example, a Medicaid EP who earns an incentive payment for AIU in 2013 would have to meet Stage 1 of meaningful use in his or her next two payment years (2014 and 2015).

Timeline Changes

Consistent with its announcement in November, CMS also proposes a one-year extension of Stage 1 applicability to EPs, EHs, and CAHs. The proposed rule would delay Stage 2 criteria for providers from 2013 to 2014 and, thus, would provide additional time for vendors to develop Certified EHR Technology to meet the new criteria.

Security of Protected Health Information

CMS also highlighted in this proposed rule that providers must conduct a security risk analysis in accordance with the requirements of the HIPAA Security Rule. Citing the large number of breaches that have occurred based on lost or stolen devices, CMS emphasizes that a provider heed the HIPAA Security Rule, including reviewing its practices on encryption/security of data at rest. Moreover, in order to meet the meaningful use standards, providers would need to conduct a review for each EHR reporting period, and any security updates and deficiencies that are identified should be included in the provider’s risk management process and implemented or corrected as dictated by that process.

For assistance drafting comments to CMS or with any other HITECH matter, please contact the authors.

McGuireWoods’ Healthcare Group offers a knowledgeable team of more than 50 lawyers experienced in serving the needs of the healthcare sector. We understand the daunting array of legal and business issues that our clients face and we work to find effective solutions to their daily challenges. We have a wide array of experience with complex healthcare issues, including extensive experience with HITECH matters.

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