CMS Transmittal R13804DEMO: Update to GUIDE Model Appendices for July 2026
Policy CMS-T-R13804DEMO • Multi-specialty
CriticalThe CMS has issued a transmittal R13804DEMO updating the GUIDE Model Appendices, which will be effective starting July 6, 2026. Billing teams should review and prepare for any changes detailed in the
Federal Register Notice: Agency Information Collection Activities: Submission for OMB Review; Comment Request
Policy FR-2026-12328 • Multi-specialty
HighThis notice announces CMS's intention to collect information from the public, providing an opportunity for comment. The potential impact on billing and reimbursement remains indirect, as the focus is
Federal Register Proposed Rule: Request for Information (RFI): Pharmacy Benefit Manager Compensation and Data Collection
Policy FR-2026-12344 • Multi-specialty
HighThis RFI seeks input on pharmacy benefit managers (PBMs) and potential restrictions on their compensation related to covered Part D drugs, which may affect future reimbursement practices in Medicare P
FDA Approval: DEXTROSE (DEXTROSE MONOHYDRATE) — Type 5 - New Formulation or New Manufacturer
Policy FDA-NDA016673 • Multi-specialty
CriticalThe recent approval of Dextrose (Dextrose Monohydrate) as an injectable drug indicates it will be billed under Medicare Part B, likely with an assigned J-code. The billing teams should monitor for the
FDA Approval: DEXTROSE (DEXTROSE MONOHYDRATE) — Type 5 - New Formulation or New Manufacturer
Policy FDA-NDA016694 • Multi-specialty
CriticalThe new injectable formulation of Dextrose Monohydrate may receive a specific J-code assignment for billing under Medicare Part B. Since it is an injectable drug, it might also qualify for pass-throug
CMS Transmittal R13833MSP: Creating Additional Medicare Secondary Payer (MSP) Error Codes to Better Identify Incoming MSP…
Policy CMS-T-R13833MSP • Multi-specialty
CriticalNew Medicare Secondary Payer (MSP) error codes will be implemented to enhance the identification of incoming MSP cases. Billing teams need to review and update their systems to accommodate these new c
CMS Transmittal R13792CP: October 2026 (2027 File) Update of the International Classification of Diseases, Tenth Revision…
Policy CMS-T-R13792CP • Multi-specialty
CriticalThe October 2026 update for the ICD-10 codes will go into effect on October 5, 2026. Billing teams should prepare to incorporate these new codes into their billing practices as they will impact claims
CMS Transmittal R13701CP: Update to Several Sections of the Internet-Only Manual (IOM) Publication (Pub.) 100-04,…
Policy CMS-T-R13701CP • Multi-specialty
CriticalThis transmittal informs billing teams of updates to several sections of the Internet-Only Manual (IOM) Publication 100-04. Teams should review the impacted sections to ensure compliance and update th
Federal Register Proposed Rule: Medicare Drug Price Negotiation Program and Medicare Prescription Drug Benefit Program
Policy FR-2026-12059 • Multi-specialty
RoutineThis proposed rule aims to implement the Medicare Drug Price Negotiation Program, which will likely influence drug pricing and reimbursement processes under Medicare. Additionally, it plans to modify
Federal Register Final Rule: Medicare Program; Strengthening Oversight of Accrediting Organizations (AOs) and Preventing AO Conflicts of Interest, and Related Provisions
Policy FR-2026-12069 • Multi-specialty
CriticalThe final rule strengthens oversight of Medicare accrediting organizations, which could impact the reimbursement process indirectly by ensuring more consistent standards and reducing conflicts of inte
Federal Register Notice: Agency Information Collection Activities: Submission for OMB Review; Comment Request
Policy FR-2026-12105 • Multi-specialty
RoutineThis notice from CMS is a public opportunity for comment related to information collection under the Paperwork Reduction Act, which may indirectly influence billing processes by defining the quality a
CMS Transmittal R243SOMA: Revisions to State Operations Manual (SOM), Chapter 5
Policy CMS-T-R243SOMA • Multi-specialty
HighThe revisions to the State Operations Manual (SOM), Chapter 5, may impact billing practices for facilities by requiring updated compliance procedures. Billing teams are advised to review their operati
CMS Transmittal R13785FM: The Fiscal Intermediary Shared System (FISS) Submission of Copybook Files to the Provider…
Policy CMS-T-R13785FM • Multi-specialty
CriticalThe transmittal updates the process for submitting copybook files to the Fiscal Intermediary Shared System, impacting claims submission protocols. Billing teams should prepare for the implementation o
CMS Transmittal R13825FM: Updates to the Internet Only Manual, Publication 100-06, Chapter 3, Overpayments, Section 140-…
Policy CMS-T-R13825FM • Multi-specialty
CriticalThe recent CMS transmittal updates the Internet Only Manual regarding overpayments, specifically addressing Section 140. Billing teams should review the overpayment protocols and ensure their procedur
CMS Transmittal R13826CP: Medicare Beneficiary Date of Death - Manual Update
Policy CMS-T-R13826CP • Multi-specialty
CriticalThis transmittal outlines the new manual update process for Medicare beneficiaries' dates of death, effective July 13, 2026. Billing teams need to ensure that accurate death dates are used in claims s
Federal Register Notice: Statement of Organization, Functions, and Delegations of Authority
Policy FR-2026-11743 • Multi-specialty
RoutineThe establishment of the Office of Health Technology and Products (OHTP) at CMS aims to enhance healthcare technology modernization and digital services pertaining to Medicare and Medicaid programs. T
CMS Transmittal R13821PI: Updates of Chapters 3, 4, and Exhibits in Publication (Pub.) 100-08, Including Updates to the…
Policy CMS-T-R13821PI • Multi-specialty
HighBilling teams need to review the updates to Chapters 3 and 4 of Pub. 100-08, which will impact various billing processes. Make sure to implement the changes by the effective date of February 26, 2026,
Federal Register Notice: Announcement of the Approval of COLA as an Accreditation Organization for the Specialty of Histocompatibility Under the Clinical Laboratory Improvement Amendments of 1988
Policy FR-2026-11618 • Multi-specialty
RoutineThe approval of COLA as an accreditation organization may indirectly influence laboratory billing practices, especially for services related to histocompatibility testing. As COLA gains this deeming a
Federal Register Notice: Agency Information Collection Activities: Proposed Collection; Comment Request
Policy FR-2026-11638 • Multi-specialty
RoutineCMS is seeking public comments regarding its proposed information collection activities, which may influence administrative reporting requirements but do not directly impact billing or reimbursement p
Federal Register Notice: Agency Information Collection Activities: Submission for OMB Review; Comment Request
Policy FR-2026-11643 • Multi-specialty
RoutineThis notice pertains to CMS's intention to collect information under the Paperwork Reduction Act. While it does not directly impact billing or reimbursement, it does open a window for public commentar
Federal Register Notice: Agency Information Collection Activities: Proposed Collection; Comment Request
Policy FR-2026-11647 • Multi-specialty
RoutineThis notice from CMS indicates the intention to collect information from the public under the Paperwork Reduction Act. While there is no direct billing impact, the notice suggests that stakeholders ca
FDA Approval: CHILDRENS ALLEGRA ALLERGY (FEXOFENADINE HYDROCHLORIDE) — Type 3 - New Dosage Form
Policy FDA-NDA021909 • Multi-specialty
HighChildren's Allegra Allergy (fexofenadine hydrochloride) is an oral medication that falls under Medicare Part D coverage. As it is a new dosage form, billing teams should ensure they are familiar with
Medicare Coverage Database - New Items
Policy AUTO-1780928129216 • Multi-specialty
RoutineThe CMS Medicare Coverage Database page is currently experiencing technical issues, preventing access to its content. This may impact providers who rely on the database for billing, coding, and covera
CMS MAC Archives
Policy AUTO-1780928120570 • Multi-specialty
RoutineThe CMS MAC Archives page indicates various updates and changes regarding Medicare billing, reporting, and coding practices. Stakeholders need to review updated guidelines and requirements concerning
Medicare Coverage Database - New Items
Policy AUTO-1780852653857 • Multi-specialty
RoutineThe CMS Medicare Coverage Database page is currently malfunctioning due to JavaScript issues, preventing access to certain functionalities. As a result, providers might experience difficulties in retr
CMS MAC Archives
Policy AUTO-1780852647456 • Multi-specialty
RoutineThe CMS MAC Archives page provides a comprehensive overview of various Medicare policies and updates related to coding and billing. There are mentions of coverage determinations and regulations affect
FDA Approval: AFINITOR DISPERZ (EVEROLIMUS) — Type 3 - New Dosage Form
Policy FDA-NDA203985 • Multi-specialty
HighNew FDA approval: AFINITOR DISPERZ (EVEROLIMUS) by Novartis Pharmaceuticals Corporation. Oral — likely Part D.
FDA Approval: OZEMPIC (SEMAGLUTIDE) — Type 1 - New Molecular Entity
Policy FDA-NDA209637 • Multi-specialty
HighNew FDA approval: OZEMPIC (SEMAGLUTIDE) by Novo Nordisk Pharmaceutical Industries, LP. Injectable — likely Part B J-code.
FDA Approval: AFINITOR (EVEROLIMUS) — Type 1 - New Molecular Entity
Policy FDA-NDA022334 • Multi-specialty
HighNew FDA approval: AFINITOR (EVEROLIMUS) by Novartis Pharmaceuticals Corporation. Oral — likely Part D.
FDA Approval: SAXENDA (LIRAGLUTIDE) — Type 10 - New Indication Submitted as Distinct NDA - Not Consolidated
Policy FDA-NDA206321 • Multi-specialty
HighNew FDA approval: SAXENDA (LIRAGLUTIDE) by Novo Nordisk. Injectable — likely Part B J-code.
FDA Approval: TIOCYSTIN (TIOPRONIN) — Type 5 - New Formulation or New Manufacturer
Policy FDA-NDA212927 • Multi-specialty
HighThe billing pathway for Tiocystin (Tiopronin) will follow Part D due to its oral route of administration as a tablet. This means it will likely be reimbursed under the outpatient prescription drug ben
FDA Approval: FUROSEMIDE (FUROSEMIDE) — Type 5 - New Formulation or New Manufacturer
Policy FDA-NDA018569 • Multi-specialty
HighNew FDA approval: FUROSEMIDE (FUROSEMIDE) by Marlex Pharmaceuticals, Inc. Oral — likely Part D.
FDA Approval: BRENZAVVY (BEXAGLIFLOZIN) — Type 1 - New Molecular Entity
Policy FDA-NDA214373 • Multi-specialty
HighNew FDA approval: BRENZAVVY (BEXAGLIFLOZIN) by TheracosBio, LLC. Oral — likely Part D.
FDA Approval: FARXIGA (DAPAGLIFLOZIN) — Type 1 - New Molecular Entity
Policy FDA-NDA202293 • Multi-specialty
HighNew FDA approval: FARXIGA (DAPAGLIFLOZIN) by AstraZeneca Pharmaceuticals LP. Oral — likely Part D.
FDA Approval: STEGLUJAN (ERTUGLIFLOZIN AND SITAGLIPTIN) — Type 4 - New Combination
Policy FDA-NDA209805 • Multi-specialty
HighNew FDA approval: STEGLUJAN (ERTUGLIFLOZIN AND SITAGLIPTIN) by Merck Sharp & Dohme LLC. Oral — likely Part D.
FDA Approval: STEGLATRO (ERTUGLIFLOZIN) — Type 1 - New Molecular Entity
Policy FDA-NDA209803 • Multi-specialty
HighNew FDA approval: STEGLATRO (ERTUGLIFLOZIN) by Merck Sharp & Dohme LLC. Oral — likely Part D.
FDA Approval: QTERN (DAPAGLIFLOZIN) — Type 4 - New Combination
Policy FDA-NDA209091 • Multi-specialty
HighNew FDA approval: QTERN (DAPAGLIFLOZIN) by ASTRAZENECA AB. Oral — likely Part D.
FDA Approval: INVOKANA (CANAGLIFLOZIN) — Type 1 - New Molecular Entity
Policy FDA-NDA204042 • Multi-specialty
HighNew FDA approval: INVOKANA (CANAGLIFLOZIN) by Janssen Pharmaceuticals, Inc. Oral — likely Part D.
CMS Transmittal R13551CP: Updates to the Internet Only Manual (IOM) Publication …
Policy CMS-T-R13551CP • Multi-specialty
HighUpdates to the Internet Only Manual (IOM) Publication …
CMS Transmittal R13553CP: National Fee Schedule for Vaccine Administration Quarterly Update - January 2026
Policy CMS-T-R13553CP • Multi-specialty
HighNational Fee Schedule for Vaccine Administration Quarterly Update - January 2026
CMS Transmittal R13556CP: Quarterly Update to Home Health (HH) Grouper
Policy CMS-T-R13556CP • Multi-specialty
HighQuarterly Update to Home Health (HH) Grouper
CMS Transmittal R13545CP: Quarterly Update to the National Correct Coding Initiative (NCCI) Procedure-to-Procedure (PTP)…
Policy CMS-T-R13545CP • Multi-specialty
HighQuarterly Update to the National Correct Coding Initiative (NCCI) Procedure-to-Procedure (PTP)…
CMS Transmittal R13538CP: Cardiac Contractility Modulation (CCM) for Heart Failure (HF)
Policy CMS-T-R13538CP • Multi-specialty
HighCardiac Contractility Modulation (CCM) for Heart Failure (HF)
CMS Transmittal R13538NCD: Cardiac Contractility Modulation (CCM) for Heart Failure (HF)
Policy CMS-T-R13538NCD • Multi-specialty
HighCardiac Contractility Modulation (CCM) for Heart Failure (HF)
CMS Transmittal R13519CP: Calendar Year 2026 Update for Durable Medical Equipment, Prosthetics, Orthotics and Supplies (…
Policy CMS-T-R13519CP • Multi-specialty
HighCalendar Year 2026 Update for Durable Medical Equipment, Prosthetics, Orthotics and Supplies (…
CMS Transmittal R13532CP: April 2026 Quarterly Average Sales Price (ASP) Medicare Part B Drug Pricing Files and Revisions…
Policy CMS-T-R13532CP • Multi-specialty
HighApril 2026 Quarterly Average Sales Price (ASP) Medicare Part B Drug Pricing Files and Revisions…
CMS Transmittal R13536CP: January 2026 Annual Rural Emergency Hospital (REH) Monthly Facility Payment Amount
Policy CMS-T-R13536CP • Multi-specialty
HighJanuary 2026 Annual Rural Emergency Hospital (REH) Monthly Facility Payment Amount
CMS Transmittal R13560OTN: Editing for Hospital Services Provided to Hospice Enrollees
Policy CMS-T-R13560OTN • Multi-specialty
HighEditing for Hospital Services Provided to Hospice Enrollees
CMS Transmittal R13555OTN: Editing for Duplicate Processing for Practitioner Professional…
Policy CMS-T-R13555OTN • Multi-specialty
HighEditing for Duplicate Processing for Practitioner Professional…
CMS Transmittal R13460CP: Update to the Internet Only Manual (IOM) for Inpatient Billing of Chimeric Antigen Receptor (CAR…
Policy CMS-T-R13460CP • Multi-specialty
HighUpdate to the Internet Only Manual (IOM) for Inpatient Billing of Chimeric Antigen Receptor (CAR…