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08/18/2025

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Clinical Laboratory Improvement Amendments (CLIA)
What's New & Important

Act Now: Make the Switch by March 1, 2026

Laboratories must switch to email notifications to start receiving electronic CLIA fee coupons and certificates. After March 1, 2026, paper fee coupons and CLIA certificates will no longer be available. Don’t miss this important transition to paperless.

Help us spread the word. Download this toolkit, which provides ready-to-use messaging for your outreach to laboratories and providers, plus these materials you can share: Fact Sheet Poster 

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2023 Medicare Fee-for-Service Supplemental Improper Payment Data
Summary of high-level findings
This document supplements improper payment information in the annual HHS AFR. PIIA requires improper payment reporting in the HHS AFR. The improper payment rate calculation complies with the requirements of OMB Circular A-123, Appendix C. CMS measures the Medicare FFS improper payment rate through the CERT program.

  • 92.62% Accuracy Rate and 7.38% Improper Payment Rate
  • Common Causes of Improper Payments
    • Insufficient documentation: 62.8% 
    • Medical necessity: 15%
    • Incorrect billing: 11.6%
    • Other: 6.9%
    • No documentation: 3.7%

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FY 2026 Hospice Wage Index and Payment Rate Update and Hospice Quality Reporting Program Requirements Final Rule (CMS-1835-F)
On August 1, 2025, the Centers for Medicare & Medicaid Services (CMS) issued a final rule (CMS-1835-F) that updates Medicare hospice payment rates and the aggregate cap amount for fiscal year (FY) 2026 in accordance with existing statutory and regulatory requirements. This fact sheet outlines the key provisions of the final rule.

This rule finalizes in the hospice payment regulations that the physician member of the interdisciplinary group (IDG) may recommend admission to hospice care, which aligns with the certification of terminal illness payment regulations and medical director Conditions of Participation (CoPs) regulations. The rule also clarifies that hospice face-to-face encounter attestations must include the signature and date of the signature of the physician or nurse practitioner and adds additional flexibility by allowing a signed and dated clinical note to satisfy the attestation requirement.

In addition, the rule finalizes a regulatory text change for the Hospice Quality Reporting Program, as discussed further below. 

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HHS Publishes a Federal Register Notice on Requirements for the National Plan and Provider Enumeration System (NPPES) Data Changes
The Department of Health and Human Services (HHS) is sending this announcement to inform interested parties of the Federal Register notice that displayed on July 30, 2025, and published today, July 31, 2025, in the Federal Register. This notice provides information on changes to data elements collected by the National Plan and Provider Enumeration System (NPPES) when a provider applies for a National Provider Identifier (NPI). This change impacts public-facing data available in NPPES downloadable files and the query-only database on the internet.

Background/Context
This notice announces updates to the  name, description, and values for the data element “provider gender code” in accordance with the Presidential memorandum of January 20, 2025, titled EO 14168, “Defending Women from Gender Ideology Extremism and Restoring Biological Truth to the Federal Government.” 

On January 23, 2004, HHS published a final rule (69 FR 3434) that adopted the NPI as the standard unique health identifier for health care providers (hereinafter referred to as the NPI final rule). The NPI final rule established that HIPAA-covered entities must use NPIs to identify health care providers in electronic transactions for which the Secretary has adopted a standard. Covered entities include health plans, health care clearinghouses, and health care providers who transmit any health information in electronic form in connection with a transaction for which the Secretary has adopted a standard. 

The NPI final rule identified that NPIs are assigned to providers through the National Provider System (NPS). The preamble to the NPI final rule includes an “NPS Data Elements Table” (69 FR 3455) that lists the data elements expected to be collected about a health care provider and included in the NPS. The NPS is now contained within NPPES.

The NPPES assigns NPIs by identifying health care providers through an application process and creating a record for each one. The records are updated when health care providers furnish updates to the NPPES.

On March 4, 2024, HHS issued a federal register notice (89 FR 15581) clarifying the requirements expanding data elements for gender information that aligned with Executive Order 14075 “Advancing Equality for Lesbian, Gay, Bisexual, Transgender, Queer, and Intersex Individuals” (87 FR 37189) (hereinafter, Executive Order 14075). 

Executive Order 14075 was rescinded on January 20, 2025, by Executive Order 14168, titled “Defending Women from Gender Ideology Extremism and Restoring Biological Truth to the Federal Government” (90 FR 8615) (referred to as "Defending Women EO"). The “Defending Women EO” directed HHS to provide to the U.S. Government, external partners, and the public clear guidance expanding on the sex-based definitions it set forth. HHS’s guidance recited the definition of sex provided in the Defending Women EO as a person’s immutable biological classification as either male or female, stating there are only two sexes because there are only two types of gametes. This policy affects a change in position from what HHS articulated in the March 2024 notice.

What This Notice Does
This notice announces the revision of the name of the data element “provider gender code” to “provider sex code” and announces that the code description is revised by replacing the word “gender” with “sex.”  Additionally, the selection of sex code options is now limited to “M” and “F.” These changes align with HHS efforts consistent with the policy described in the Defending Women EO, which sets forth the Federal Government’s prospective approach to male/female classifications.

NPPES will also disseminate the sex code options of “M” and “F” to promote improved accuracy in publicly available data. Provider gender code selections made after March 4, 2024, that are no longer available in accordance with the Defending Women EO will now appear as blank (will have no value selected) in public facing files.

You can find this Federal Register notice here: https://www.federalregister.gov/documents/2025/07/31/2025-14478/national-plan-and-provider-enumeration-system-nppes-data-changes.



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