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Cures 2.0 Sponsors Want to Establish ARPA-H by Year’s End

House Energy & Commerce (E&C) Committee leaders say they hope to get Cures 2.0 passed by the end of the year, so that President Joe Biden’s proposed Advanced Research Projects Agency for Health (ARPA-H) can get up and running as soon as possible. Democrats included $3 billion for ARPA-H in the reconciliation bill that passed out of the committee last Wednesday. E&C’s $3 billion would supplement the $3 billion appropriated for ARPA-H that was included in the House-passed appropriations bill in July. If both bills pass Congress with their respective $3 billion funding provisions, that would bring the total amount for ARPA-H to $6 billion, much closer to Biden’s $6.5 billion funding request.

Any proposed funding, however, is contingent on Congress passing legislation to establish the agency. Lawmakers did not include authorizing language in the reconciliation bill because it would have violated the Byrd rule, which prohibits the Senate from considering extraneous matters as part of a reconciliation package. Thus, Cures 2.0 co-sponsors Fred Upton (R-MI) and Diana DeGette (D-CO) plan to include more robust authorizing language for ARPA-H as part of the Cures 2.0 bill.

Last month, incoming AMIA Board Chair and President-elect Gretchen Purcell Jackson, MD, PhD, FACS, FACMI, FAMIA, gave a statement on behalf of AMIA to officials from the National Institutes of Health (NIH) and the White House Office of Science and Technology (OSTP) about informatics priorities for ARPA-H. A recording can be found here, with Dr. Jackson’s statement beginning at 43:30.


CMS Moving Towards Repeal of Medicare Breakthrough Device Rule

Last week, the Centers for Medicare and Medicaid Services (CMS) proposed to repeal the Trump-era Medicare breakthrough device coverage rule, due to concerns the rule could pose patient safety risks by forcing CMS to immediately cover devices going through the expedited FDA approval path. The coverage rule, first proposed a year ago, created a new reimbursement pathway for certain new medical devices, dubbed Medicare Coverage of Innovative Technology (MCIT). It allowed Medicare coverage for devices designated “breakthrough” devices by the Food and Drug Administration (FDA) the same day they are given FDA market authorization. Per the 21st Century Cures Act, a breakthrough device is one that provides for more effective treatment or diagnosis of either a life-threatening or irreversibly debilitating human disease or condition. It must also meet at least one part of a second criterion, such as offering a treatment option when no other cleared or approved alternatives exist.

The Biden administration initially moved the MCIT rule’s effective date from March 15 until May 15, so it could collect more comments. It then pushed the rule back until mid-December, before opting last Monday to propose fully repealing the rule. Writing in an agency blog post, CMS Chief Medical Officer and Director of the Center for Clinical Standards and Quality Lee Fleisher said that “many important considerations were raised through the public comment process, including concerns regarding lack of information as to whether the device would be beneficial or harmful to Medicare beneficiaries.” He writes that if the repeal is finalized, CMS will issue future rules to explore expedited coverage pathways for breakthrough technologies, including “how the agency can create new coverage pathways or use existing ones to provide an appropriate balance of access to new technologies with necessary patient protections.”

Legislation & Politics

VA Awards Additional Funding for EHR Modernization

The Department of Veterans Affairs (VA) has awarded Cerner $113 million in funding as part of an 18-month assignment to provide it with Wave G Deployment of its EHR implementation; the task falls under Cerner’s existing EHR Modernization (EHRM) contract. The 10-year, $10 billion modernization project was announced in 2018, following the Department of Defense’s own EHR update rollout a few years prior.

In July, the VA announced that it had paused its EHR implementation through the end of 2021 after a report from the Office of the Inspector General (OIG) revealed that VA officials underestimated the projections for the EHRM project by $2.5 billion. A separate OIG review found issues regarding EHR training at the project’s pilot site, Mann-Grandstaff VA Medical Center in Spokane, Washington. As outlined at congressional committee hearings this summer, a separate VA review found several issues, including patient safety, productivity, governance and management, cost, schedule and performance, patient portal experience, data, and change management and training. VA officials told lawmakers that the agency was “reimagining” its approach to the modernization.

AMIA News & Notes

AMIA Joins AHIMA, EHRA in Releasing Preliminary Report on Operationalizing Definition of ‘Electronic Health Information’

AMIA, the American Health Information Management Association (AHIMA), and the Electronic Health Record Association (EHRA) announced today the release of a preliminary report examining key issues related to the operationalization of the definitions of electronic health information (EHI) and designated record set (DRS). How these definitions will be operationalized by clinicians and developers are critical to successful compliance with the Cures Act Final Rule. The Cures Act Final Rule includes interoperability requirements related to information blocking and health IT certification, both of which rely on the definition of EHI, which is grounded in the definition of the designated record set as defined by HIPAA.

Read the full press release here and preliminary report here.

AMIA Calls for MIPS Focus on Certified Health IT, Public Health Measure Alignment in Physician Fee Schedule Proposed Rule

In comments submitted to CMS, AMIA continued to support the transition to the MIPS Value Pathways (MVPs) reporting mechanism, while also calling on CMS to center the use of certified health IT in MVP design. AMIA also urged CMS to align Promoting Interoperability public health measure reporting requirements with those recently finalized in the IPPS final rule.

Read AMIA’s full comments here.

AMIA Applauds EHR Reporting Program Measures, Urges Additional Focus on Public Health and EHR Safety

In response to a request for public feedback on a set of draft developer-reported measures for the Electronic Health Record Reporting Program, AMIA recommended elevating an additional public health-focused measure to the first set of measures for the program. AMIA additionally recommended that and EHR safety measure that leverages the SAFER Guides be prioritized, to align with recent CMS policies.

Read AMIA’s full comments here.

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AMIA's Washington Download is your source for health informatics policy news and information from around the Beltway, covering action from the Hill, the Administration and important AMIA collaborators.