Life Science Compliance Update

February 23, 2017

Providers May Have More Time to Submit Electronic Clinical Quality Measures

Imgres

Eligible hospitals and critical access hospitals participating in the Hospital Inpatient Quality Reporting program and/or the Medicare EHR Incentive Program will have extra time for submission of electronic clinical quality measures. In a January 17, 2017 blog post, Kate Goodrich, MD, director of CMS' Center for Clinical Standards and Quality, said those hospitals submitting eCQM data for the 2016 reporting period (pertaining to the FY 2018 payment determination) will now have until Monday, March 13, at 11:59 p.m. PT, rather than the last day of February.

Inpatient Prospective Payment System

CMS also has plans to make some modifications to eCQM requirements as laid out in the FY 2017 Inpatient Prospective Payment System final rule. According to CMS, in order to help reduce reporting burdens while supporting the long-term goals of these programs, it intend to include proposals regarding the 2017 eCQM reporting requirements for the Hospital IQR and EHR Incentive Programs for eligible hospitals and critical access hospitals in the FY 2018 IPPS proposed rule that we anticipate to be published in the late spring of 2017.

Specifically, in the FY 2018 IPPS proposed rule, CMS plans to address stakeholder concerns regarding challenges associated with hospitals transitioning to new EHR systems or products, upgrading to EHR technology certified to the 2015 Edition, modifying workflows, and addressing data element mapping, as well as the time allotted for hospitals to incorporate updates to eCQM specifications in 2017. CMS is also considering to propose in future rulemaking to modify the number of eCQMs required to be reported for 2017 as well as to shorten the eCQM reporting period.

Goodrich said CMS is also mulling a modification of the number of eCQMs that have to reported for 2017, and a potential shortening of the reporting period.

"We believe that these efforts reflect the commitment of CMS to create a health information technology infrastructure that elevates patient-centered care, improves health outcomes, and supports the healthcare providers who care for patients," she wrote. "We continuously strive to work in partnership with hospitals and the provider community to improve quality of care and health outcomes of patients, reduce cost, and increase access to care."

Hospital Outpatient Prospective Payment System

This comes as the final Hospital Outpatient Prospective Payment System rule for 2017 unveiled eased several requirements for participants in the Meaningful Use program. For 2016 and 2017, all returning participants to the program will only have to attest to the meaningful use of electronic health records for 90 consecutive days, as opposed to an entire year. CMS, in its proposed rule, called for a shortened reporting period for eligible providers (EP), eligible hospitals (EH) and critical access hospitals (CAH).

The rule also eliminates clinical decision support and computerized order entry objectives for EHs and CAHs under the Medicare EHR Incentive Program beginning in 2017. What’s more, CMS is finalizing an application process for a one-time significant hardship exception for EPs from penalties in 2018. The hardship is available to EPs new to the EHR program and who are transitioning to the Merit-Based Incentive Payment System (MIPS) under the Medicare Access and CHIP Reauthorization Act (MACRA). Additionally, CMS notes that providers must demonstrate as part of Modified Stage 2 and Stage 3 of Meaningful Use that only a single patient viewed, downloaded and transmitted their records.

“These additions both increase flexibility, lower the reporting burden for providers and focus on the exchange of health information and using technology to support care,” CMS says in its announcement for the rule.

April 25, 2016

Office of National Coordinator Seeks Input on MACRA Interoperability

The Office of the National Coordinator for Health IT (ONC) released a new request for information (RFI) in which they are seeking the public's thoughts on how to measure interoperability. The Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) sets an objective to achieve the widespread exchange of health information through the use of interoperable certified electronic health records and directs the Department of Health and Human Services (HHS) to establish metrics in consultation with the health IT community and to see if that objective has been met. The public comment period closes on June 3, 2016. Comments can be submitted electronically and ONC specifically states it prefers comments in the Microsoft Word format. Additional information about submitting comments can be found on the Federal Register page.

Specifically, ONC is seeking input on:

  • What populations and elements of information flow should we measure?
  • How can we use current data sources and associated metrics to address the MACRA requirements?
  • What other data sources and metrics should HHS consider to measure interoperability more broadly?

Jodi Daniel, formerly the ONC policy chief, now at the Washington, D.C. law firm of Crowell & Moring, co-authored a short overview of the RFI. The law firm's summary notes: "The RFI presents an opportunity for stakeholders and the public to weigh in on how policy makers understand interoperability. Congress and HHS likely will make both policy and funding decisions based on the goals and measurements that are established in response to feedback received through the RFI."

The directive to establish secure and seamless health data sharing also flows from the Federal Health IT Strategic Plan, the Nationwide Interoperability Roadmap, and pledges from private sector market leaders, the ONC notes, and follows a commitment announced this year by HHS Secretary Sylvia Mathews Burwell toward easing interoperability as well as EHR use.

In the RFI, ONC specifically notes that its currently available data sources might not be sufficient to fully measure and determine whether the goal of widespread exchange of health information through interoperable certified EHR technology has been achieved. ONC's currently available data sources are largely limited to eligible professionals, eligible hospitals, and CAHs as defined under the current Medicare and Medicaid EHR Incentive Programs. Therefore, ONC is requesting input on these measures and data sources, and is requesting feedback on additional national data sources which may be available for this purpose.

ONC also lays out several measures currently under consideration:

  • Proportion of health care providers who are electronically sending, receiving, finding, and easily integrating key health information, such as summary of care records. This can be a composite measure (engaging in all four aspects of interoperable exchange) or separate, individual measures.
  • Proportion of health care providers who use the information that they electronically receive from outside providers and sources for clinical decision-making.
  • Proportion of health care providers who electronically perform reconciliation of clinical information (e.g. medications).

 

"ONC recognizes this will require collaboration and coordination with federal entities and stakeholders across the ecosystem including entities that enable exchange and interoperable health information use, such as technology developers, Health Information Organizations (HIOs) and Health Information Service Providers (HISPs)," ONC states.

March 16, 2016

Office of the National Coordinator for Health Information Technology Proposes Rule on Information Blocking

The United States Department of Health and Human Services released a proposed rule last week that would permit the Office of the National Coordinator for Health Information Technology (ONC) to review certified health IT products for information blocking, in addition to potential risks to patient safety and public health. The proposed rule also gives ONC increased power to regulate authorized certification-testing bodies.

Background

The ONC Health IT Certification Program was established as a Temporary Certification Program in June 2010, and was later transitioned into a Permanent Certification Program in January 2011. In September 2012, certification criteria were established to provide a clear implementation direction to ONC-Authorized Certification Bodies for certifying Health IT Modules.

In October 2015, HHS published a final rule that identified how health IT certification can support the establishment of an interoperable nationwide health information infrastructure through the certification and use of adopted new and updated vocabulary and content standards for structured recording and exchange of health information. This final rule also included provisions to increase the transparency of information related to health IT certified under the program.

The impetus behind this proposed rule is that as certified capabilities interact with other capabilities in certified health IT and with other products, it is important to ensure that concerns within the scope of the Program can be appropriately addressed.

The Health Information Technology for Economic and Clinical Health (HITECH) Act amended the Public Health Service Act (PHSA) in an attempt to improve the quality, safety, and efficiency of health care through the promotion of health IT and electronic health information exchange. The HITECH Act also required the National Coordinator for Health Information Technology perform specific statutory duties, including keeping or recognizing a program for the voluntary certification of health information technology.

This proposed rule proposes to expand the ONC's role in the Program to encompass the ability to directly review health IT certified under the Program and address non-conformities found in certified Health IT, as well as propose processes for ONC to timely and directly address testing issues. According to the drafters of the Rule, increased transparency and publication of identifiable surveillance results would support further accountability of health IT developers to their customers and users of certified health IT.

The Proposed Rule

The proposed rule asks to expand the ONC's role to encompass the ability to directly review health IT certified under the Program, independently of reviews conducted by ONC-ACBs. These reviews would extend beyond the continued conformance of the certified health IT's capabilities with specific certification criteria, test procedures, and certification requirements and would also extend to the interaction of certified and uncertified capabilities within the certified health IT.

ONC would also have broad discretion to review certified health, though the drafters of the rule anticipate that such a review would be relatively infrequent and would focus on situations that pose a risk to public health or safety.

The proposed rule also gives authority to ONC to initiate a direct review whenever it becomes aware of information, whether from the general public, interested stakeholders, ONC'ACBs, or by any other means, that certified health IT may not conform to the requirements of its certification.

The rule also proposes to require ONC-ACBs to make identifiable surveillance results publicly available on their websites on a quarterly basis. The rule drafters believe that by publishing "positive" surveillance results, as well as "negative" ones, will provide a more complete context of surveillance.

Analysis and Conclusion

According to Sherilyn Pruitt, director of ONC's Office of Programs and Engagement, "our goal is to work with developers. Our goal is not to get to decertification." Ms. Pruitt expects the office to work with noncompliant vendors to develop action plans to fix their products and practices.

The proposed rule follows announcements by dozens of health IT vendors, major health systems, and other industry organizations, that they will provide wider consumer access to health data, avoid information blocking, and adopt federally recognized interoperability standards. In announcing the interoperability pledge, HHS Secretary Sylvia Mathews Burwell stated, "we must demand interoperability. We have to work together to unblock data."

The proposed rule also comes after the Precision Medicine Initiative Summit at the White House, where data liquidity was in focus. According to national health IT coordinator Dr. Karen DeSalvo, "the president of the United States has a keen interest in seeing that data moves. We would like to see change [to interoperability] as rapidly as possible, but as safely and securely as possible."

Comments will be accepted on the proposed rule through May 2, 2016, and can be submitted via the Federal eRulemaking Portal or the mail.

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