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CMS and ONC Release Stage 3 Meaningful Use and EHR Certification Final Rules – On October 6, 2015, CMS released the final Stage 3 Meaningful Use Rule that, among other provisions, sets forth the requirements that eligible professionals (EPs), eligible hospitals, and critical access hospitals (CAHs) must satisfy to qualify for Medicare and Medicaid incentive payments and avoid payment cuts under the Medicare Electronic Health Record (EHR) Incentive Program. The Stage 3 criteria are optional for providers beginning in CY 2017 and become mandatory in CY 2018. The same day, the HHS Office of the National Coordinator for Health Information Technology (ONC) released a final rule (ONC Final Rule) that makes changes to the ONC Health IT Certification Program, releases the new 2015 edition of health IT certification criteria (2015 Edition), and finalizes a new Base EHR definition specific to the 2015 Edition. Both final rules are scheduled to be published in the Federal Register on October 16, 2015. The Stage 3 Final Rule is effective 60 days after publication in the Federal Register, and, with the exception of certain provisions that are effective on April 1, 2016, the ONC Final Rule is effective 90 days after Federal Register publication.
The Stage 3 Final Rule finalizes provisions in the proposed rule issued on March 30, 2015 regarding Stage 3 of the of the EHR Incentive Program, as well as a subsequent proposed rule issued on April 9, 2015. CMS states that it intends Stage 3 Final Rule to ease the reporting burdens on providers. To that end, CMS decreases the number of reporting objectives for EPs, eligible hospitals, and CAHs, modifies the objectives and measures of the EHR Incentive Programs in 2015 through 2017 to align with Stage 3, and adopts flexible reporting periods beginning in 2015.
Specifically, CMS will move all providers to a calendar-year EHR reporting period. For CY 2015, EPs may choose any continuous 90-day period from January 1, 2015, through December 31, 2015, and eligible hospitals and CAHs may choose any continuous 90-day period from October 1, 2014, through December 31, 2015. For CY 2016, CMS finalized a 90-day reporting period for all EPs, eligible hospitals and CAHs that have not demonstrated Meaningful Use prior to CY 2016 and the entire CY 2016 for those who already successfully demonstrated meaningful use in a prior year. Finally, for CY 2017 and 2018, with the exception of a 90-day EHR reporting period for a provider’s first payment year based on Meaningful Use for EPs and eligible hospitals in the Medicaid EHR Incentive Program and a few other exceptions, CMS finalized a reporting period of the entire calendar year.
The CMS Final Rule also announces a 60-day comment period requesting comments on the phasing out of the EHR Incentive Programs and the transition to the Merit-Based Incentive Payment System (MIPS) for physicians. CMS expects to issue a proposed rule regarding MIPS in the spring of 2016. The CMS Final Rule is available here.
According to ONC, the ONC Final Rule responds to comments received on the proposed rule by attempting to reduce the burden on providers and health IT developers. The ONC Final Rule modifies several existing 2014 Edition certification criteria and adopts several new certification criteria, such as new Application Access, Common Clinical Data Set Summary Record, Data Segmentation for Privacy, and Care Plan certification criteria. In addition to adopting a new Base EHR definition, and modifies the definition of “Common MU Data Set” and changes the name to “Common Clinical Data Set.” Finally, the ONC Final Rule also makes several changes the ONC HIT Certification Program (renamed the ONC Health IT Certification Program). The ONC Final Rule is available here.
Reporter, Kate Stern, Atlanta, +1 404 572 4661, kstern@kslaw.com.
GAO Releases Report on Initial Results of CMS’s Hospital Value-Based Purchasing Program – The U.S. Government and Accountability Office (GAO) issued an October 2015 report (available here) to congressional committees concluding that the initial results of the Hospital Value-Based Purchasing (HVBP) program show “no apparent shift” in hospitals’ performance trends on the quality measures included in the HVBP. GAO analyzed the first three years of the HVBP program, 2013 – 2015, and found that the bonuses and penalties received by the nearly 3,000 eligible hospitals for the program totaled less than 0.5 percent of applicable Medicare payments each year.
Enacted in 2010 as part of the Affordable Care Act, the HVBP program adjusts payments to hospitals under the inpatient prospective payment system (IPPS) based on the quality of care they provide to patients, as defined by reference to certain consensus-based measures, and enacts performance standards that are linked to value-based incentive payments and penalties.
GAO analyzed data on bonuses and penalties given to hospitals in fiscal years 2013 – 2015 and data on hospital quality measures collected by CMS from 2005 through 2014 to evaluate the initial effects of the HVBP program on the following three areas: (1) Medicare payments to hospitals; (2) quality of care provided by hospitals; and (3) certain hospitals’ quality improvement efforts. GAO also interviewed officials in eight hospitals that participated in the HVBP program. These officials shared certain of the factors that impacted their hospital’s quality improvement overall, including electronic health records and IT systems, however these factors were not specifically linked to implementation of the HVBP program.
GAO explained that although the initial results of the HVBP program show no apparent shift in hospitals’ quality practices, “shifts in quality trends could emerge in the future as the HVBP program continues to evolve,” and especially as new quality measures are added with an increased emphasis on clinical process measures.
Reporter, Juliet M. McBride, Houston, +1 713 276 7448, jmcbride@kslaw.com.
OIG Warns Information Blocking May Affect Safe Harbor Protection – In an alert published October 6, 2015, the OIG reminded the public that “information blocking”—generally described as individuals or entities knowingly and unreasonably interfering with the exchange or use of electronic health information—may affect safe harbor protection under the Federal anti-kickback statute. In the alert, the OIG discussed situations in which a hospital provides software or information technology to an existing or potential referral source, such as a physician practice. The OIG warned that such an arrangement “potentially implicates the Federal anti-kickback statute because the software or information technology is potential remuneration to the referral source.”
While the electronic health records (EHR) safe harbor provides protections for certain arrangements in which interoperable EHR software or information technology and training services are provided to a potential or existing referral source, the OIG reminded the public that to fall within the exception, any sort of EHR arrangement must comply with all safe harbor conditions—including one directly relevant to information blocking. That safe harbor condition generally requires that the technology donor not restrict interoperability of the provided items or services with other EHR systems. As illustrations of situations that would be suspect and may not qualify for safe harbor protection, the OIG provided a few examples, such as arrangements in which donors work with EHR technology vendors that agree to charge high interface fees to non-recipient providers or suppliers or to competitors. The OIG’s alert may be found here, and additional information on information blocking may be found here.
Reporter, Christina A. Gonzalez, Houston, +1 713 276 7340, cagonzalez@kslaw.com.
ALSO IN THE NEWS
King & Spalding to Host Roundtable on Options for Dealing with Competitors Illegally Gaining Business Advantages – On Tuesday, October 20, 2015, King & Spalding will host a roundtable event analyzing strategic options that healthcare and life sciences companies may consider when faced with credible evidence that a competitor is breaking the law to gain an unfair business advantage. The event will be in-person in the Atlanta office and will also be offered via webinar. For additional information and to register for the event, please click here.
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