“Computerized behavioral therapy device for the
treatment of fibromyalgia symptoms”
Source: U.S. Federal Register
Vol. 90, #134, pp 32352-33261
Date: July 16, 2025
URL:
https://www.federalregister.gov/doc...es-under-the-physician-fee-schedule-and-other
https://www.govinfo.gov/content/pkg/FR-2025-07-16/pdf/2025-13271.pdf
[A Proposed Rule by the Centers for Medicare & Medicaid Services]
Medicare and Medicaid Programs; CY 2026 Payment Policies Under the
Physician Fee
Schedule and Other Changes to Part B Payment and Coverage Policies;
Medicare
Shared Savings Program Requirements; and Medicare Prescription Drug
Inflation
Rebate Program
--------------------------------------------------------------------------------
This document has a comment period that ends in 57 days. (09/12/2025).
Summary
This major proposed rule addresses: changes to the physician fee
schedule (PFS); other changes to Medicare Part B payment policies to
ensure that payment systems are updated to reflect changes in medical
practice, relative value of services, and changes in the statute;
codification of establishment of new policies for: the Medicare
Prescription Drug Inflation Rebate Program under the Inflation Reduction
Act of 2022; the Ambulatory Specialty Model; updates to the Medicare
Diabetes Prevention Program expanded model; updates to drugs and
biological products paid under Part B; Medicare Shared Savings Program
requirements; updates to the Quality Payment Program; updates to
policies for Rural Health Clinics and Federally Qualified Health Centers
update to the Ambulance Fee Schedule regulations; codification of the
Inflation Reduction Act and Consolidated Appropriations Act, 2023
provisions; updates to the Medicare Promoting Interoperability Program.
(...)
I. Policies To Improve Care for Chronic Illness and Behavioral Health
Needs
1. Updates to Payment for Digital Mental Health Treatment (DMHT) and
Comment Solicitation on Payment Policy for Software as a Service (SaaS)
a. Updates to Payment for DMHT
(...)
Additionally, we welcome comments on whether we should establish coding
and payment policies for devices classified under the following FDA
regulation sections that were recommended to us by interested parties:
Computerized behavioral therapy devices for treating symptoms of
gastrointestinal conditions at paragraph 876.5960; Digital therapy
devices to reduce sleep disturbance for psychiatric conditions at
paragraph 882.5705; and Computerized behavioral therapy device for the
treatment of fibromyalgia symptoms to be codified at paragraph 882.5804.
(...)
BILLING CODE 4120-01-P
BILLING CODE 4120-01-C
[FR Doc. 2025-13271 Filed 7-14-25; 4:15 pm]
BILLING CODE 4210-01-P