Life Science Compliance Update

March 12, 2018

US Health IT Policy Lags Behind

Health Data

As described in a recent opinion article, Health IT Now and the Bipartisan Policy Center convened a work group of organizations representing clinicians, patients, hospitals, and technology companies to assess the current regulatory landscape, identify the most pressing needs of users, and develop consensus on the ideal future role of government in a post-meaningful use era, and a rapidly evolving delivery system and technology environment. Their report can be accessed and read here.

“For too long, federal regulation of health IT favored reporting and process over care and treatment. HHS must create a new era in which government rules provide tangible benefit to consumers; doctors see patients, not computer screens; and the private sector propels our health care system into the future without fear of an outdated regulatory framework holding us in the past. We have envisioned a system that is suited for the health IT challenges and opportunities of tomorrow. We want to make sure Washington sees that vision, too,” writes Janet Marchibroda, director of the Health Innovation Initiative for the Bipartisan Policy Center, and Joel White, executive director of Health IT Now.

Report and Recommendations

The work group members came together with the common understanding that while robust specifications were helpful in the early stages of HITECH implementation, over time, the level of prescriptiveness regarding health information technology (IT) contained within the Centers for Medicare and Medicaid Services (CMS) Electronic Health Record (EHR) Incentive Programs, CMS’ Merit-based Incentive Payment System (MIPS), and the Office of the National Coordinator for Health Information Technology (ONC) Health IT Certification Program, have contributed to dissatisfaction and increased burden among technology users and developers.

As a result, the work group’s report made several recommendations. Broadly, they encourage the federal government to provide assurances that protect consumer protections while leaving the evolution of products to the private sector. Additionally, the federal government’s role should continue playing a role in non-regulatory ways, like funding research to identify successful practices and adopting standards within health IT to signal government support.

The work group agreed on the following key principles for an ideal oversight framework for health IT and digital health:

  1. Encourage innovation by being flexible, technologically neutral, and not overly prescriptive; encouraging good development processes, rather than specific features and functions; supporting minimally necessary standards and baseline protections; and avoiding creation of unreasonable barriers to entry.
  2. Be risk-based, assuring that the level of oversight is based on the risk of harm to patients.
  3. Be stable and predictable, meaning that any changes must be implemented with sufficient notice and not create or add to uncertainty.
  4. Be accountable to the public and enforceable, by gaining considerable input, making performance transparent, and assuring enforcement, as applicable.
  5. Reflect the principles of a learning health system, by undergoing continuous improvement and innovation and embedding best practices as new knowledge is captured through experience.

The oversight framework should address the following six technology outcomes:

  1. Interoperability. Technology should facilitate interoperability and information sharing, which play a critical role—along with other technology outcomes—in advancing higher quality, more cost-effective, patient-centered care.
  2. Usability. Technology should reflect evidence-based, user-centered design principles; human factors science; and best practices. It should not create unnecessary burden on end users. It should be culturally competent, enabling access by users with diverse languages and abilities.
  3. Safety. Technology should not create patient harm. Instead, it should help reduce patient harm by supporting the delivery of safer care.
  4. Security. Technology should assure that information is available and accessible only to authorized individuals and processes and also provide assurance that information is not altered or destroyed in an unauthorized manner.
  5. Patient Access to Information. Technology should enable and not create barriers to patients’ access to their own health information.
  6. Support for an Evolving Health Care System. Technology should be adaptable and flexible enough to meet the changing needs of users and an evolving health care system.



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.


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