Life Science Compliance Update

August 18, 2017

CMS Issues Proposed Rule on EHR Reporting Requirements

ROH Electronic Health Records Essay Photo

A recent Centers for Medicare & Medicaid Services (CMS) proposed rule would ease EHR reporting requirements over the next two years. The proposed regulation, which covers the 2018 Medicare payments for hospital inpatient services, relaxes data reporting requirements for Clinical Quality Measures (CQMs) that are part of the EHR Incentive program. In 2017, eligible hospitals demonstrating meaningful use for the first time would need to submit two self-selected quarters of CQM data and report at least six selected CQMs, down from eight. CMS offered similar flexibility when it released its Hospital Outpatient Prospective Payment System Rule in November 2016.

Meaningful Use

For the EHR Incentive Program, CMS has proposed that the reporting period in CY 2017 will be two self-selected quarters. For CY 2018 the reporting period will be the first three quarters of 2018. For both CYs 2017 and 2018, hospitals must report on at least six Clinical Quality Measures. In CY 2018, for those hospitals only participating in the Medicare EHR Incentive Program, electronic CQM submission will be available for the two months following the close of the year ending on February 28, 2019. For eligible professionals reporting electronically, CMS proposes to modify the EHR Incentive Program reporting period from a full year to a minimum of a continuous 90-day period during the year. The Proposed Rule also aligns CQMs with the measures available under the Merit-based Incentive Payment System.

Additionally, CMS proposes that no payment adjustment will be made for professionals who render “substantially all” of their services in an ambulatory surgical center (ASC). CMS seeks public comment on the following two alternative definitions to determine the final definition regarding ASC services:

  • An EP who furnishes 75 percent or more of his or her covered professional services in sites of service identified by the codes used in the HIPAA standard transaction as an ASC setting in the calendar year that is two years before the payment adjustment year; and
  • An EP who furnishes 90 percent or more of his or her covered professional services in sites of service identified by the codes used in the HIPAA standard transaction as an ASC setting in the calendar year that is two years before the payment adjustment year.

Other Areas of Proposed Rule

CMS proposes to use data from its National Health Expenditure Accounts instead of data from the Congressional Budget Office to estimate the percent change in the rate of uninsurance, which is used in calculating the total amount of uncompensated care payments available to Medicare disproportionate share hospitals. CMS said this proposed change would result in DSH payments increasing by $1 billion in fiscal year 2018.

Additionally, CMS proposes using worksheet S-10 data to determine uncompensated care payments and distribution beginning in FY 2018. The agency further proposes to implement the socioeconomic adjustment approach mandated by the 21st Century Cures Act for the FY 2019 Hospital Readmissions Reduction Program.  Finally, CMS proposes removing one measure in FY 2019 and adopting one new measure in FY 2022 and another in FY 2023.

February 23, 2017

Providers May Have More Time to Submit Electronic Clinical Quality Measures


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.


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