Regulatory
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. Currently, 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, rather than 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.
Deadline for comments on both proposed rules is September 11. Read CMS Expand Behavioral Health Access Proposed Rule and CMS Increase Hospital Price Transparency and Enforcement Proposed Rule.
HHS Proposed Rule to Advance Non-discrimination in HHS Programs for LGBTQI+ Community
The proposed rule from Health and Human Services (HHS) would protect LGBTQI+ people from discrimination in important health and human services programs with 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).
Deadline for comments on the proposed rule is September 11. See full proposed rule text.
Medicare Promoting Interoperability Program Basics Webinar
The Centers for Medicare & Medicaid Services (CMS) will host a Medicare Promoting Interoperability Program 101 webinar on Thursday, July 20 from 1:00 p.m.-2:30 p.m. ET. During the webinar, participants will not only review basics of the program, but cover important updates for the 2023 calendar year.
The webinar will cover the following topics:
- Program background
- History of the EHR incentives programs
- Transition to the Medicare Promoting Interoperability Program
- Requirements for the 2023 calendar year
- Data submission, hardship exception, and payment adjustment information
- Q&A
Prior to the webinar, please send your questions to CMSQualityTeam@ketchum.com. Register today.
National Stakeholder Call with the CMS Administrator
Administrator of the Centers for Medicare & Medicaid Services (CMS) Chiquita Brooks-LaSure and her leadership team will provide an update on recent accomplishments and advancing the CMS Strategic Plan on July 18 from 1:00 p.m.-2:00 p.m. ET. During this call, you can learn more about how to partner with CMS to help implement their Strategic Plan and key initiatives. Register now for tomorrow's update.
HITAC Request for Nominations
The Government Accountability Office (GAO) is now accepting nominations for Health Information Technology Advisory Committee (HITAC) appointments that will begin January 1, 2024. Members serve three-year terms, with the terms subject to renewal, for a total not to exceed six years of service on the committee. From these nominations, GAO expects to appoint two-to-three new HITAC members. Potential appointees' backgrounds should have an emphasis on patients or consumers, health plans or purchasers, and researchers.
Send nomination letters and resumes to HITCommittee@gao.gov by July 31. Check out the Federal Register Announcement for more details.
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.
Read AMIA's 2020 Comment Letter to FTC and see the proposed amendment.
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
Members Back Last Week After Two-week Recess
House FY24 Appropriations Bill
The House Appropriations Committee released the text of its Fiscal year 2024 (FY24) Labor, Health and Human Services, Education, and Related Agencies (Labor-HHS) appropriations bill. Section 510, the ban on a unique patient identifier, was included. AMIA alongside the Patient ID Now coalition has historically been a proponent of a unique patient identifier and plan to advocate for its inclusion. The House bill will also fully eliminate the Agency for Healthcare Research and Quality (AHRQ). AMIA Public Policy will continue to monitor and update membership. View the full bill text.
House Energy and Commerce Committee
The Health Subcommittee hearing on “Innovation Saves Lives: Evaluating Medicare Coverage Pathways for Innovative Drugs, Medical Devices, and Technology" will be held on Tuesday, July 18 at 10:30 a.m. ET. Watch live.
Around the Web
- Sequoia Project Launches ‘Data Usability Taking Root’ Effort; HCI
- Swapping Data Management Recipes; NLM
- July Virtual Meeting for the AHRQ Software Developers Meeting - Common Formats; AHRQ
- New HHS Initiative Aims to Strengthen Nation’s Health Workforce; HHS
- June 2023 OCR Cybersecurity Newsletter; HHS
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.