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Congress Avoids Government Shutdown, as Infrastructure and Reconciliation Talks Continue

The House and Senate voted last Thursday to approve a short-term government funding bill that keeps federal agencies funded at current levels through December 3 and holds off a partial government shutdown; President Biden signed the bill later that day. Passing the measure was a relatively minor hurdle to clear so that negotiations could continue on the Senate-passed Infrastructure Investment and Jobs Act and the much larger $3.5 trillion reconciliation package that would expand the social safety net and combat climate change. House leadership delayed the vote on the bipartisan legislation on Friday, as a group of progressives pledged to not back the bill unless there was an agreement to pass the reconciliation package. Senate moderates – most prominently Sens. Kyrsten Sinema (D-AZ) and Joe Manchin (D-WV) – have sought to bring down the price tag of the bill, which can pass the Senate without a Republican filibuster if it can garner the support of all 50 Senate Democrats.

Included in the infrastructure bill is $65 billion for expanding broadband Internet access, which dedicates funding for additional network deployments, subsidies for low-income Americans, and digital training and literacy. The budget reconciliation package, meanwhile, could include an additional $3 billion to fund the creation of the Advanced Research Projects Agency for Health (ARPA-H), as well as a slew of provisions to strengthen the nation’s public health infrastructure. Additional areas recommended for inclusion in the package by the House Energy & Commerce Committee can be found here. Negotiations on the size of the bill and when to vote on the infrastructure bill will continue this week.

Administration

CMS Delays Payer-To-Payer Interoperability Rule Enforcement

Centers for Medicare and Medicaid Services (CMS) will indefinitely delay enforcement of payer-to-payer data exchange requirements of the Interoperability and Patient Access rule until it conducts a rulemaking in the future on how to move data among payers. The interoperability rule, finalized in May 2020, required CMS-regulated payers such as Medicare Advantage plans, fee-for-service programs, Medicaid managed care, and Children’s Health Insurance Program fee-for-service programs to implement and maintain an API for sharing data with apps. In a set of newly-updated frequently asked questions, the agency announced that “[a]s a matter of enforcement discretion, [it] will not take action to enforce compliance with these specific provisions until future rulemaking is finalized.” CMS cited the fact that “multiple impacted payers have indicated […] that the lack of technical specifications for the payer-to-payer data exchange requirement is creating challenges for implementation, which may lead to differences in implementation across industry, poor data quality, operational challenges, and increased administrative burden.”

In comments on the Interoperability and Patient Access proposed rule in 2019, AMIA urged a phased approach to requiring health plan data to be made available via open API, recognizing at the time that formal implementation guides (IGs) had not yet been available for health plans. In December 2020, CMS sought to enhance payer-to-payer data exchange by proposing to require a FHIR-based API, as well as conformance with specific IGs in its “Reducing Provider and Patient Burden by Improving Prior Authorization Processes, and Promoting Patients’ Electronic Access to Health Information” proposed rule. This rule, however, is still under review by the Biden administration, as it was finalized in the waning days of the Trump administration.

FTC Warns Health Apps to Follow Breach Notification Rule 

On September 15, the Federal Trade Commission (FTC) issued a press release warning health app developers and connected device companies to comply with the Health Breach Notification Rule, which requires the notification of consumers and others when their health data is breached. The rule applies specifically to entities not covered by HIPAA. The release states that “In a policy statement adopted during an open meeting, the Commission noted that health apps, which can track everything from glucose levels for those with diabetes to heart health to fertility to sleep, increasingly collect sensitive and personal data from consumers. These apps have a responsibility to ensure they secure the data they collect, which includes preventing unauthorized access to such information.”

This announcement may be the result of the FTC’s request for public comment from last May when it was doing its periodic review of the regulation. AMIA at the time recommended that the agency subject username/password information to the Rule and expand its purview to provide warning to health apps that provide inadequate transparency into its data use, reuse, and exchange. AMIA further urged FTC to address the “data syphoning” phenomenon and noted impediments to consumer reporting of data breaches. Keep an eye out for more FTC action on consumer data privacy, as it seeks to leverage its statutory authority absent comprehensive consumer data privacy regulations.

ONC Announces Public Health IT Workforce Development Awardees

Last week, the Office of the National Coordinator for Health IT (ONC) announced that it has awarded $73 million in cooperative agreements as part of its Public Health Informatics & Technology Workforce Development Program (PHIT Workforce Program), which aims to train health IT talent to equip the nation for future public health challenges. Funded through the American Rescue Plan, the workforce development program aims to increase representation of underrepresented communities within the public health IT industry.

The 10 awardees include Historically Black Colleges and Universities, Hispanic Serving Institutions, Asian American and Native American Pacific Islander-Serving Institutions, other minority-serving institutions, as well as other institutions of higher education. Each awardee is tasked with forming consortia to collectively train more than 4,000 individuals over four years through an interdisciplinary approach to public health IT. The consortia will develop curricula, recruit and train participants, secure paid internship opportunities, and assist in career placement at public health agencies or other public health-based organizations. Awardees are:

  • Bowie State University, Bowie, MD
  • California State University, Long Beach Research Foundation, Long Beach, CA
  • Dominican College of Blauvelt, Inc., Orangeburg, NY
  • Jackson State University, Jackson, MS
  • Norfolk State University, Norfolk, VA
  • Regents of The University of Minnesota, Minneapolis, MN
  • The University of Texas Health Science Center at Houston, Houston, TX (AMIA Academic Forum Member)
  • University of Massachusetts at Lowell, Lowell, MA
  • University of California, Irvine, Irvine, CA (AMIA Academic Forum Member)
  • University of the District of Columbia, Washington, D.C.

AMIA News & Notes

Addressing Data Issues Key to Tackling SDOH, AMIA Tells Newly-Formed Caucus

In comments submitted to the new Congressional Social Determinants of Health Caucus (SDOH) Caucus, AMIA stressed that data issues, including standards, systems, policies, access, privacy, ethics, and analysis, must be top of mind when discussing any bipartisan legislative efforts to address SDOH challenges. AMIA’s response to the Caucus’ request for information (RFI) outlined AMIA members’ diverse experiences with SDOH challenges, ideas for improving alignment among current and potential SDOH initiatives, other experiences with SDOH best practices and opportunities, and ideas for transformative actions to address SDOH.

Read AMIA’s full comments here.

Event Announcement: Health IT Leadership Roundtable: Vision for the Future of Health IT

The COVID-19 pandemic has brought renewed attention to longstanding infrastructure challenges and issues in the U.S. health care and public health systems. On Tuesday, October 5, from 9:00 a.m. to 12:00 p.m. EDT, join leaders from across the health care system in a virtual discussion of needed changes and investments in health IT to achieve desired health outcomes.

Speakers and panelists will discuss how data access, data standardization, interoperability, privacy and security can improve care coordination, increase access, and transform health care delivery; describe technology innovations and tools that address health equity; and discuss what policies will be needed to ensure adequate privacy and security protections of health care, public health, and social needs data.

See the full agenda here and register here.

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