The Washington Download - Vol. 8 Issue 16 | AMIA - American Medical Informatics Association

Provide Your Feedback: AMIA Public Policy North Star Survey

AMIA has been working hard to advocate for the field of Informatics and AMIA members. As part of these efforts, the need for three-to-four high-level, guiding priorities has been identified. These "North Star" priorities need to be relevant to AMIA’s existing Policy Principles, issues that are hot topics in Washington, DC, and topics that support the field of Informatics over any one particular profession.

Priorities relevant to AMIA’s existing Principles, of interest to federal offices, and where AMIA will be the best leaders, include:

Support the healthcare workforce by advancing the field of informatics and reducing burden on clinicians.
Advocate for health IT solutions that ameliorate systemic biases and discrimination.
Advocate for evidence-based care and decision-support through machine-learning and AI.
Advocating for ongoing funding for the field, including informatics research.

AMIA wants to hear from members like you. Please take a moment to rate your organization's North Star priorities. AMIA hopes to have survey results to membership by the end of the year and begin implementing work on these priorities in 2024.

Complete this brief members-only survey by August 22.

AMIA Public Policy Webinar in August

Join your colleagues and the AMIA Public Policy team for an upcoming webinar. During the webinar, you will learn more about the typical federal government public commenting process and timeline, how AMIA fits within the government’s constraints, and how you can get involved. Staff will breakdown AMIA’s process for developing a public comment letter with a step-by-step guide on where you fit in the timeline. Additionally, the webinar will provide public policy updates and what to look for in the future.

Regulatory

USCDI v4 Released: Data Element Added from AMIA’s Recommendation

The United States Core Data for Interoperability (USCDI) Version 4 was released on July 20, 2023. The Office of the National Coordinator for Health Information Technology (ONC) added one new data class and 20 new data elements. Under the Laboratory data class, the data element Result Reference Range was added. This addition came after AMIA’s recommendation!

Check out the latest updates to USCDI v4 in the ONC Health IT Standards Bulletin Issue 2023-2.

Time to submit USCDI v5 Draft Submissions

Based on the USCDI v4, ONC opened the comment period for updates and recommendations to USCDI v5 draft.

The deadline for new submissions is September 20. Submit now.

AMIA Submits Public Comment Letter to FTC Health Breach Notification Rule

The Federal Trade Commission (FTC) is proposing changes to the current Health Breach Notification Rule (HBNR) addressing applicability to health applications and other direct-to-consumer health technology. Essentially, the FTC is looking to modernize and improve HBNR to fit the current landscape of healthcare.

In 2020, AMIA submitted a public comment to the FTC’s regular 10-year review of the HBNR and made near- and long-term recommendations. FTC is addressing AMIA's recommendations in their proposed HBNR, including to expand on the concept of “unauthorized access” under the definition of “breach of security”.

In AMIA’s Public Comment Letter, AMIA encourages the FTC to ensure that HBNR and HIPAA are aligned such that there are no gaps in regulation over the covered entities and other non-covered entities that work with PHRs; to align definitions with other agencies, including the definition of PHR; and to provide clarity around whether a non-health data source is being used in a health context and qualifies for coverage under the HBNR. AMIA also strongly encourages interagency coordination on such issues, particularly regarding standardizing definitions of terms and processes of addressing breaches. Some recommendations included clarification of entities covered, clarification regarding types of breaches subject to the rule and revised scope of PHR related entities.

View the public comment.

Legislative

After Reports, Congress Calls for More Transparency of MA Plans

Led by Rep. Lloyd Doggett (D-Texas), House of Rep. Democrats are pushing for Centers for Medicare and Medicaid Services to reexamine Medicare Advantage plans (MA) following reports of insurers using AI algorithms denying Medicare claims that should have been approved.

Concerns Raised About Access to Medically Necessary Care

The Office of Inspector General found in their April 2022 report that Medicare Advantage Organizations denied prior authorization requests using their own clinical criteria that are not contained in the Medicare coverage rules creating increased burden. This caused providers to appeal denial requests and increased documentation.

See the report.

ONC 2023 Interoperability Standards Advisory

On August 8, ONC opened the comment period for the 10th Annual ISA Reference Edition. The Interoperability Standards Advisory (ISA) is the model ONC uses to coordinate the identification, assessment, and public awareness of interoperability standards and implementation specifications that can be used by the healthcare industry to address specific interoperability needs including, but not limited to, interoperability for clinical, public health, and research purposes.

Comment period ends October 6. Learn more about ISA and get the latest updates.

CMS FY 2024 Hospital IPPS and LTCH PPS Final Rule

On August 1, CMS issued the Final Rule for Hospital Inpatient Prospective Payment System (IPPS) and Long-Term Care Hospital Prospective Payment System (LTCH PPS). The Final Rule updates the fee-for-service payment rates and policies for inpatient hospitals and LTCHs for FY 2024. Under the Final Rule, CMS also made updates to the Social Determinant of Health Diagnosis Codes, Hospital Inpatient Quality Reporting Program, and Medicare Promoting Interoperability Program.

Read the Final Rule.

Dr. Jeanne Marrazzo Appointed Director of NIAID

Beginning in Fall 2023, Jeanne Marrazzo, MD, will lead the National Institutes of Health’s National Institute of Allergy and Infectious Diseases (NIAID) office that supports research to advance the understanding, diagnosis and treatment of infectious, immunologic and allergic diseases. She will resplace Hugh Auchincloss, Jr., MD, who served as acting director after long-time director Anthony S. Fauci, MD, stepped down in December 2022. Currently, Dr. Marrazzo is the director of the Division of Infectious Diseases at the University of Alabama at Birmingham.

See announcement on Dr. Marrazzo’s appointment.

FDA CDRH Public Comment Opportunity: Increase Patient Access to At-home Use Medical Devices

The U.S. Food and Drug Administration’s (FDA’s) Center for Devices and Radiological Health (CDRH) is looking to find ways to assure individuals have access to medical technologies. This commitment involves facilitating access to medical devices designed to be safe and effective when used in the home or outside of the traditional clinical setting.

Public comments must be submitted by August 30. Find out more about the request for comment.

ICYMI: In Case You Missed It

Medicare Program: Calendar Year 2024 Home Health Prospective Payment System Rate Update; Home Health Quality Reporting Program Requirements

This proposed rule would set forth routine updates to the Medicare home health payment rates for calendar year 2024 in accordance with existing statutory and regulatory requirements. This rule would provide information on home health utilization trends and solicits comments regarding access to home health aide services; implement home health payment-related changes; rebase and revise the home health market basket and revise the labor-related share. In addition, it proposes changes to the Home Health Quality Reporting Program (HH QRP) requirements and the expanded Home Health Value-Based Purchasing (HHVBP) Model; and to revise Medicare provider and supplier enrollment requirements.

Public Comments due August 29. View the proposed rule.

CMS Proposed Rules to Expand Behavioral Health Access and Increase Hospital Price Transparency

The Centers for Medicare & Medicaid Services (CMS) is proposing to expand access to behavioral health services through coverage of intensive outpatient services. CMS is seeking comments on potential payment adjustments to hospitals for the additional costs of establishing and maintaining a buffer stock of essential medicines in hopes to support practices curtail shortages of essential medicines.

Additionally, CMS is proposing new policies to improve and streamline its enforcement capabilities, including certification by hospital officials as to the accuracy and completeness of data; requiring hospital acknowledgement of warning notices; reserving the right for CMS to communicate directly with health system leadership about all of its hospitals, not just one hospital at a time; and publishing other enforcement activities, in addition to civil monetary penalties, on a CMS website. In this proposed rule, CMS is also promoting equity and taking actions to support Indian Health Service and tribal facilities.

Comments for both proposed rules due September 11:

Health and Human Services (HHS) Proposed Rule to Advance Non-discrimination in HHS Programs for LGBTQI+ Community

The proposed rule would protect LGBTQI+ people from discrimination in important health and human services programs with HHS’ interpretation of the prohibition of discrimination on the basis of sex to include (1) discrimination on the basis of sexual orientation and (2) discrimination on the basis of gender identity, consistent with the Supreme Court's decision in Bostock v. Clayton County (2020).

Comments for the proposed rule due September 11. See full proposed rule text.

FDA CDRH Public Comment Opportunity

Increase Patient Access to At-home Use Medical Devices