AMIA Webinar: Public Comment Process and Public Policy Updates
AMIA Public Policy explains the typical federal government public commenting process and timeline, how AMIA fits within the government’s constraints, and how you can get involved. We will breakdown AMIA’s process for developing a public comment letter with a step-by-step guide on where you fit in the timeline. Lastly, the webinar will provide public policy updates and what to look for in the future.
USCDI v4 Released: Time to submit USCDI v5 Submissions
The United States Core Data for Interoperability (USCDI) Version 4 was released July 20. ONC added one new data class and 20 new data elements.
New Data Class:
- Facility Information
- Facility Identifier
- Facility Type
- Facility Name
New Data Elements:
- Allergies and Intolerances
- Substance (Non-medication)
- Encounter Information
- Encounter Identifier
- Goals and Preferences
- Treatment Intervention Preference
- Care Experience Preference
- Health Status Assessments
- Alcohol Use
- Substance Use
- Physical Activity
- Result Unit of Measure
- Result of Reference Range
- Result Interpretation
- Specimen Source Site
- Specimen Identifier
- Specimen Condition Acceptability
- Medication Instructions
- Medication Adherence
- Performance Time
- Vital Signs
- Average Blood Pressure
Deadline for new submissions for USCDI v5: September 20
Last Call: FTC Health Breach Notification Rule
The Federal Breach Trade Commission (FTC) is proposing changes to the current Health Breach Notification Rule (HBNR) addressing the 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. The public comment period ends August 8.
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. AMIA made several successful recommendations to FTC, which FTC is addressing in the proposed HBNR, including expanding on the concept of “unauthorized access” under the definition of “breach of security,” to be presumed when a personal health record or PHR related entity fails to adequately disclose to individuals how user data is accessed, processed, used, reused, and disclosed.
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
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.
Legislation and Politics
House Ways and Means Committee passed the "Improving Seniors’ Timely Access to Care Act”
On July 26, 2023, the House Ways and Means Committee passed the "Improving Seniors’ Timely Access to Care Act," which the bill is part the Health Care Price Transparency Act of 2023. The bill now advances to the full House of Representatives for consideration.
The "Improving Seniors’ Timely Access to Care Act" would make it easier for seniors to get the care they need and improve health outcomes. The bill would modernize the antiquated prior authorization process in Medicare Advantage, which often still requires faxing documents to insurance companies. The bill would:
This is a big (incremental) win. The Act is not law yet, but it is moving and wouldn’t be able to without support from AMIA.
Around the Web
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.
- View the CMS Expand Behavioral Health Access proposed rule.
- View the CMS Increase Hospital Price Transparency and Enforcement proposed rule.
- Establish an electronic prior authorization process.
- Require the U.S. Department of Health & Human Services (HHS) to establish a process for “real-time decisions” for items and services that are routinely approved.
- Improve transparency by requiring Medicare Advantage plans to report to the Centers for Medicare & Medicaid Services on the extent of their use of prior authorization and the rate of approvals or denials.
- Encourage plans to adopt prior authorization programs that adhere to evidence-based medical guidelines in consultation with physicians.
- Fed Health IT Officials Discuss IT Alignment Goals; MeriTalk
- ONC Adds 20 New Data Elements to USCDI v4 to Drive Interoperability; EHR Intelligence
- ONC Tech Forum: Clinical Decision Support Series; HealthIT
- Next Session: The Future of Clinical Decision Support – Wednesday, September 27, 2023, 11:00 am – 4:00 pm ET
- New HHS Initiative Aims to Strengthen Nation’s Health Workforce; HHS
- Medical data sharing: Are we there yet?; Computerworld