On Thursday, February 23, 2012, the Centers for Medicare and Medicaid Services (CMS), pursuant to the Health Information Technology for Economic and Clinical Health (HITECH) Act, released a 455-page Proposed Rule specifying the Stage 2 criteria that eligible professionals (EPs), eligible hospitals and critical access hospitals (CAHs) must meet in order to qualify for Medicare and/or Medicaid incentives related to electronic health records (EHRs). The Proposed Rule also proposes to modify certain Stage 1 criteria, as well as criteria that apply regardless of Stage, as previously published in the Final Rule on July 28, 2010 in the Federal Register. The proposed provisions related to Medicaid (calculations of patient volume and hospital eligibility) would take effect shortly after the finalization of the Proposed Rule and would not be subject to the proposed one-year delay for Stage 2 meaningful use of a certified EHR. The Proposed Rule states that the changes to Stage 1 would take effect for 2013, but that most changes would be optional until 2014. Last but not least, the Proposed Rule addresses the Medicare payment adjustments that will take place for EPs, eligible hospitals and CAHs who fail to demonstrate a meaningful use of certified EHRs by 2015 and proposed exceptions to such adjustments.
Electronic Health Records
Early Meaningful Users Promised Stage 2 Extension
On November 30, 2011, U.S. Department of Health and Human Services (HHS) Secretary Kathleen Sebelius issued a press release announcing proposed steps to encourage physicians and hospitals to adopt electronic health records (EHRs) this year and receive incentive payments made available under the Health Information Technology for Economic and Clinical Health (HITECH) Act), which was part of the American Recovery and Reinvestment Act of 2009 (ARRA).
Under the HITECH Act, physicians and hospitals have the opportunity to earn financial incentives from Medicare and Medicaid if they demonstrate the adoption and meaningful use of certified EHRs in a series of three stages. Under the current rules, physicians and hospitals that adopt EHRs in 2011 and attest to meeting Stage 1 meaningful use standards by February 28, 2012 must meet Stage 2 standards in 2013. If they wait until 2012 to attest to Stage 1, providers could delay Stage 2 compliance until 2014. To encourage more providers to adopt EHRs in 2011, instead of waiting until 2012, HHS proposes to allow providers who qualify for Stage 1 meaningful use in 2011 an extension until 2014 to meet Stage 2 standards. HHS clarified that providers first attesting to meaningful use in 2011 qualify for both 2011 and 2012 incentive payments.
These proposed steps are consistent with June 2011 recommendations from the Health IT Policy Committee (HITPC). As we reported this summer, HITPC advocated that providers who begin to attest to meaningful use in 2011 be provided an extra year “to phase in the stage 2 expectations (i.e., Stage 2 for those who attest in 2011 would begin in 2014).” HHS listened!
HHS intends to publish this extension in the Stage 2 meaningful use Notice of Proposed Rulemaking (NPRM) in February 2012.
At the same time, HHS also released new data from the Centers for Disease Control and Prevention (CDC) showing increased adoption of EHRs by physicians. The CDC report documented that physicians’ adoption of health information technology (IT) doubled in two years, and 52% of physicians intend to apply for meaningful use incentives, up from 41% in 2010. Click here to access additional information about achieving meaningful use, including the CDC report.
Final Rule on ACOs encourages EHR adoption but eliminates “meaningful use” requirement
The Centers for Medicare and Medicaid Services (CMS) announced today, October 20, 2011, that the use of certified electronic health records (EHRs) will be the highest-weighted quality measure for an Accountable Care Organization (ACO) under the new Medicare Shared Savings Program.
ACOs are designed to encourage primary care doctors, specialists, hospitals, and other health care providers to coordinate their care. The CMS Final Rule on ACOs bases the amount of shared savings that an ACO may receive for its performance on four domains of quality: 1) quality standards on patient experience; 2) care coordination and patient safety; 3) preventive health; and 4) at-risk populations. To earn shared savings the first performance year, providers must report across all four domains of quality, which include a total of 33 quality measures. Providers will begin to share in savings based on how well they perform on 23 of the 33 quality measures in the second performance year and on 32 of the 33 measures in the third performance year.
Measure 20 of the 33 quality measures requires ACOs to report the percentage of primary care providers (PCPs) who successfully qualify for an EHR Incentive Program payment. CMS expanded the scope of PCPs who can be counted in this measure by eliminating the requirement that the PCP be a “meaningful EHR user” as defined in 42 C.F.R. § 495.4 of the Health Information Technology for Economic and Clinical Health (HITECH) Act of 2009. CMS stated that it “decided to . . . expand [measure 20] to include any PCP who successfully qualifies for an EHR Incentive Program incentive rather than only including those deemed meaningful users.”
ONC Releases Model Privacy Notice for Personal Health Records
After the passage of the Health Information Technology for Economic and Clinical Health (HITECH) Act in 2009, the interest in storing and accessing health information online increased, prompting increased concerns about the privacy and security of such information. In September 2011, the Office of the National Coordinator for Health Information Technology (ONC) released a Personal Health Record (PHR) Model Privacy Notice for public use. This Model Notice meets ONC’s initial goal in a multi-phased, consumer project to increase consumer awareness of PHR companies’ data practices. The next phase seeks to empower consumers by providing them with an easy way to compare the data practices of two or more PHR companies. Continue reading
Proposed Federal Regulation Requires HIPAA-Covered Labs to Release Test Results to Patients
On September 12, 2011, the Office of National Coordinator (ONC) for the United States Department of Health & Human Services (HHS) announced a Proposed Rule that will enable direct access to laboratory test results by patients. Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), laboratories must hold a CLIA certificate in order to perform one of three levels of complex laboratory tests regulated by CLIA. Even before the passage of the Health Information Technology for Economic and Clinical Health Act (HITECH Act), concerns have been expressed regarding the lack of clarity under state law, and the literal prohibition in some states, regarding whether a CLIA laboratory that is independent (as opposed to hospital based) may release laboratory test results directly to a patient. Continue reading
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