FDA Approval: NDA 220106 — Type 1 - New Molecular Entity
Policy FDA-NDA220106 • Multi-specialty
HighThis new molecular entity from Priovant Therapeutics (NDA220106) received Priority Review and Orphan Drug designation, but the FDA label has not yet published, leaving the drug name, route of administ
FDA Approval: NDA 221443 — Type 4 - New Combination
Policy FDA-NDA221443 • Multi-specialty
HighGilead Sciences received FDA approval for a new combination drug (NDA221443) on August 27, 2026, but the FDA label has not yet been published, leaving the route of administration, dosage form, and pha
CMS Transmittal R13943CP: October 2026 Quarterly Update to Healthcare Common Procedure Coding System (HCPCS) Codes Used…
Policy CMS-T-R13943CP • Multi-specialty
CriticalThis transmittal implements the October 2026 quarterly HCPCS code update effective October 5, 2026, with changes to procedure codes used in Medicare claims processing. Billing teams must update their
Federal Register Notice: Agency Information Collection Activities: Submission for OMB Review; Comment Request
Policy FR-2026-17970 • Multi-specialty
HighCMS is publishing a Paperwork Reduction Act notice seeking public comment on a proposed information collection activity. This is an administrative notice with no direct changes to billing rates, cover
Federal Register Notice: Agency Information Collection Activities: Proposed Collection; Comment Request
Policy FR-2026-17875 • Multi-specialty
HighCMS is publishing a standard Paperwork Reduction Act notice seeking 60-day public comment on a proposed information collection activity. This is an administrative procedural notice with no direct chan
CMS Transmittal R13934OTN: Health Insurance Portability and Accountability Act (HIPAA) Electronic Data Interchange(EDI)…
Policy CMS-T-R13934OTN • Multi-specialty
CriticalThis one-time notification addresses HIPAA Electronic Data Interchange (EDI) requirements under CR 14429, effective October 5, 2026. Billing teams should review their EDI transaction systems and tradi
LCD L39051: Cosmetic and Reconstructive Surgery — WPS
Policy LCD-L39051 • Multi-specialty
HighThis final LCD from WPS (J5/J8) governs coverage criteria for cosmetic versus reconstructive surgery across Iowa, Missouri, Kansas, Nebraska, Indiana, and Michigan, effective August 27, 2026. It estab
CMS Transmittal R13904CP: Updates to Chapter One of the Medicare Claims Processing Manual (Publication (Pub.) 100-04) to…
Policy CMS-T-R13904CP • Multi-specialty
CriticalTransmittal R13904CP (CR 14574) updates Chapter 1 of the Medicare Claims Processing Manual (Pub. 100-04), effective for implementation on September 28, 2026. The subject line is truncated and the full
CMS Transmittal R13938CP: Instructions for Downloading the Healthcare Common Procedure Coding System (HCPCS) Files for the…
Policy CMS-T-R13938CP • Multi-specialty
CriticalThis transmittal provides instructions for downloading updated HCPCS files effective January 4, 2027. Billing teams should prepare to download and implement the new HCPCS code files when released. Sys
Federal Register Notice: Agency Information Collection Activities: Proposed Collection; Comment Request
Policy FR-2026-17484 • Multi-specialty
RoutineCMS is publishing a routine Paperwork Reduction Act notice inviting 60-day public comment on a proposed information collection activity. This notice does not introduce new billing codes, coverage poli
FDA Approval: TAKHZYRO (LANADELUMAB-FLYO) — Type 1 - New Molecular Entity
Policy FDA-BLA761090 • Multi-specialty
HighTakhzyro (lanadelumab-flyo) is a subcutaneously administered plasma kallikrein inhibitor approved for prophylaxis of hereditary angioedema (HAE), billed under Medicare Part B given its subcutaneous ro
FDA Approval: BLA 761508 — Type 1 - New Molecular Entity
Policy FDA-BLA761508 • Multi-specialty
HighPASATRU (garetosmab-grts), approved August 19, 2026 as a new molecular entity via intravenous route, falls under Medicare Part B billing, consistent with provider-administered intravenous drugs reimbu
CMS Transmittal R13881CP: October 2026 Quarterly Update to Healthcare Common Procedure Coding System (HCPCS) Codes Used…
Policy CMS-T-R13881CP • Multi-specialty
CriticalThis transmittal implements the October 2026 quarterly HCPCS code update effective October 5, 2026, affecting claims processing systems. Billing teams must update their chargemasters, claim edits, and
Federal Register Notice: Agency Information Collection Activities: Proposed Collection; Comment Request
Policy FR-2026-17112 • Multi-specialty
RoutineCMS is publishing a routine Paperwork Reduction Act (PRA) notice seeking 60-day public comment on a proposed information collection activity. This is an administrative notice with no direct changes to
Federal Register Notice: Agency Information Collection Activities: Proposed Collection; Comment Request
Policy FR-2026-17128 • Multi-specialty
RoutineCMS is publishing a routine Paperwork Reduction Act notice seeking 60-day public comment on a proposed information collection activity. This notice does not introduce new billing codes, coverage polic
FDA Approval: NDA 218524 — Type 5 - New Formulation or New Manufacturer
Policy FDA-NDA218524 • Multi-specialty
HighThis Type 5 approval represents a new formulation or manufacturer for intravenous sodium bicarbonate solution (NDA218524, Baxter Healthcare Corp), an established drug class with a known intravenous ro
FDA Approval: LIDOCAINE (LIDOCAINE HYDROCHLORIDE) — Type 5 - New Formulation or New Manufacturer
Policy FDA-NDA017584 • Multi-specialty
HighThis Type 5 submission represents a new formulation or manufacturer approval for injectable lidocaine hydrochloride (Fresenius Kabi USA, LLC), an established local anesthetic and antiarrhythmic agent
LCD L40326: Allergy Diagnostic Testing — CGS
Policy LCD-L40326 • Multi-specialty
CriticalCGS (J15) is finalizing coverage policy for allergy diagnostic testing in Kentucky and Ohio, effective October 4, 2026. As a Final LCD, the comment period has closed, but providers should review cover
CMS Transmittal R13933OTN: Fiscal Intermediary Shared System (FISS) - Modify the Expert Claims Processing System (ECPS) to…
Policy CMS-T-R13933OTN • Multi-specialty
CriticalThis one-time notification (CR 14454) directs modifications to the Fiscal Intermediary Shared System (FISS) and its Expert Claims Processing System (ECPS), with implementation set for January 4, 2027.
FDA Approval: ZUBSOLV (BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE) — Type 5 - New Formulation or New Manufacturer
Policy FDA-NDA204242 • Multi-specialty
HighZubsolv (buprenorphine/naloxone) is a sublingual tablet approved for opioid dependence, billing under Medicare Part D as a self-administered oral/sublingual formulation. This Type 5 approval represent
FDA Approval: SUBOXONE (BUPRENORPHINE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE) — Type 4 - New Combination
Policy FDA-NDA022410 • Multi-specialty
HighSuboxone (buprenorphine/naloxone) sublingual/buccal film is approved for opioid use disorder and follows a Part D billing pathway as a self-administered oral/mucosal film. Medicare billing occurs thro
CMS Transmittal R13910OTN: International Classification of Diseases, 10th Revision (ICD-10) and Other Coding Revisions to…
Policy CMS-T-R13910OTN • Multi-specialty
CriticalThis CMS transmittal (CR 14464) implements ICD-10 and other coding revisions effective October 5, 2026, aligning with the annual ICD-10 code set update cycle. Billing teams must update their charge ma
CMS Transmittal R13923OTN: International Classification of Diseases, 10th Revision (ICD-10) and Other Coding Revisions to…
Policy CMS-T-R13923OTN • Multi-specialty
CriticalCMS is issuing ICD-10 and other coding revisions effective January 4, 2027, via CR 14570. Billing teams should prepare for updated diagnosis code sets and related coding changes that will impact claim
LCD L40324: Allergy Diagnostic Testing — Noridian
Policy LCD-L40324 • Multi-specialty
CriticalThis final LCD from Noridian (JE/JF) governs coverage criteria for allergy diagnostic testing across 15 western states, effective September 27, 2026. Billing managers should prepare now for updated do
LCD L40341: Allergy Diagnostic Testing — WPS
Policy LCD-L40341 • Multi-specialty
CriticalThis final LCD from WPS (J5/J8) establishes coverage criteria for allergy diagnostic testing across six Midwestern states, effective September 27, 2026. Providers performing allergy testing must ensur
LCD L40328: Allergy Diagnostic Testing — Palmetto GBA
Policy LCD-L40328 • Multi-specialty
CriticalPalmetto GBA's final LCD L40328 establishes coverage criteria for allergy diagnostic testing under Part A and Part B across seven southeastern states, effective September 27, 2026. Billing teams shoul
LCD L40330: Allergy Diagnostic Testing — Wellpoint Federal
Policy LCD-L40330 • Multi-specialty
CriticalThis final LCD from Wellpoint Federal governs coverage criteria for allergy diagnostic testing under Medicare Part A and Part B, effective September 27, 2026. It will establish documentation and medic
Federal Register Notice: Agency Information Collection Activities: Proposed Collection; Comment Request
Policy FR-2026-16455 • Multi-specialty
RoutineCMS is publishing a standard Paperwork Reduction Act notice seeking 60-day public comment on a proposed information collection activity. This is an administrative notice with no direct changes to bill
Federal Register Notice: Medicare Program; Alternative Payment Model (APM) Incentive Payment Advisory for Clinicians-Request for Current Billing Information for Qualifying APM Participants
Policy FR-2026-16472 • Multi-specialty
HighCMS is alerting Qualifying APM Participants (QPs) who are eligible for 2026 APM Incentive Payments that their current billing information is missing, preventing payment disbursement. Affected clinicia
Federal Register Notice: Agency Information Collection Activities: Proposed Collection; Comment Request
Policy FR-2026-16386 • Multi-specialty
RoutineCMS is publishing a standard Paperwork Reduction Act notice requesting 60-day public comment on a proposed information collection activity. This is an administrative notice with no direct changes to b
Federal Register Notice: Medicare Program; Regulatory Alignment for Predictable and Immediate Device (RAPID) Coverage Pathway
Policy FR-2026-16368 • Multi-specialty
HighCMS is proposing the RAPID (Regulatory Alignment for Predictable and Immediate Device) coverage pathway to provide accelerated, expedited national Medicare coverage for new innovative medical technolo
CMS Transmittal R13903OTN: International Classification of Diseases, 10th Revision (ICD-10) and Other Coding Revisions to…
Policy CMS-T-R13903OTN • Multi-specialty
CriticalCMS is implementing ICD-10 and other coding revisions effective January 4, 2027, via CR 14570. Billing teams must update their code sets and claim submission processes to incorporate the new ICD-10 co
CMS Transmittal R13906OTN: International Classification of Diseases, 10th Revision (ICD-10) and Other Coding Revisions to…
Policy CMS-T-R13906OTN • Multi-specialty
CriticalCMS is issuing ICD-10 and other coding revisions effective January 4, 2027, requiring billing teams to update their code sets and charge masters ahead of the implementation date. This one-time notific
Federal Register Notice: Privacy Act of 1974; Matching Program
Policy FR-2026-15861 • Multi-specialty
RoutineCMS is re-establishing a data matching program with the Department of War to verify eligibility for Minimum Essential Coverage (MEC) under the ACA through Department of War health benefit plans. This
FDA Approval: CELLCEPT (MYCOPHENOLATE MOFETIL) — Type 3 - New Dosage Form
Policy FDA-NDA050723 • Multi-specialty
HighCellCept (mycophenolate mofetil) received approval for a new dosage form including an intravenous formulation, which supports a Part B billing pathway for the IV route administered in outpatient or ph
FDA Approval: CELLCEPT (MYCOPHENOLATE MOFETIL) — Type 1 - New Molecular Entity
Policy FDA-NDA050722 • Multi-specialty
HighCellCept (mycophenolate mofetil) is an established immunosuppressant approved for prophylaxis of organ transplant rejection, available in both intravenous and oral capsule formulations. The intravenou
FDA Approval: NDA 220381 — Type 2 - New Active Ingredient
Policy FDA-NDA220381 • Multi-specialty
HighGLYCOPHOS (sodium glycerophosphate), approved as an injectable drug under NDA220381, is administered via injection and follows a Part B billing pathway. As a new active ingredient approval, no existin
Federal Register Notice: Healthcare Advisory Committee (HAC); Announcement of the HAC Meetings for Fiscal Year 2026-2027
Policy FR-2026-15786 • Multi-specialty
RoutineCMS announces virtual public meetings of the Healthcare Advisory Committee (HAC) for fiscal year 2026-2027. The Committee advises the HHS Secretary and CMS Administrator on healthcare system improveme
FDA Approval: MYFORTIC (MYCOPHENOLIC ACID) — Type 2 - New Active Ingredient
Policy FDA-NDA050791 • Multi-specialty
RoutineMyfortic (mycophenolic acid) is an oral delayed-release tablet approved for transplant rejection prophylaxis, billing under Medicare Part D as a self-administered oral medication. Because it is orally
FDA Approval: CELLCEPT (MYCOPHENOLATE MOFETIL) — Type 3 - New Dosage Form
Policy FDA-NDA050759 • Multi-specialty
HighCellCept (mycophenolate mofetil) received approval for an intravenous dosage form under NDA050759, expanding an existing oral immunosuppressant used primarily in transplant medicine. As an intravenous
FDA Approval: CELLCEPT (MYCOPHENOLATE MOFETIL HYDROCHLORIDE) — Type 3 - New Dosage Form
Policy FDA-NDA050758 • Multi-specialty
HighCellCept (mycophenolate mofetil hydrochloride) was approved as an injectable dosage form under NDA050758, expanding the existing oral CellCept franchise with an intravenous route of administration. As
FDA Approval: QLONILIK (CLONIDINE HYDROCHLORIDE) — Type 5 - New Formulation or New Manufacturer
Policy FDA-NDA221094 • Multi-specialty
RoutineQlonilik (clonidine hydrochloride) is a new oral solution formulation of an established generic drug, approved under NDA221094 as a Type 5 new formulation. As an oral drug, it follows a Part D billing
FDA Approval: MYHIBBIN (MYCOPHENOLATE MOFETIL) — Type 5 - New Formulation or New Manufacturer
Policy FDA-NDA216482 • Multi-specialty
RoutineMYHIBBIN is an oral suspension formulation of mycophenolate mofetil approved under NDA216482, following a Type 5 new formulation pathway. As an oral drug, it falls under Medicare Part D for outpatient
CMS Transmittal R13890PI: Revisions to Chapter 12 (The Comprehensive Error Rate Testing (CERT) Program) and Exhibit 46 in…
Policy CMS-T-R13890PI • Multi-specialty
HighThis transmittal revises Chapter 12 of the CERT Program guidelines and updates Exhibit 46, effective August 28, 2026. Billing teams should review the updated CERT documentation requirements to ensure
CMS Transmittal R13891FM: Update to the Internet Only Manual (IOM) Publication (Pub.) 100-06 Chapter 8, Contractor…
Policy CMS-T-R13891FM • Multi-specialty
RoutineThis transmittal updates IOM Publication 100-06 Chapter 8, which governs contractor financial management and cost reporting procedures. Billing teams should review the updated Chapter 8 guidance to en
Federal Register Notice: Agency Information Collection Activities: Submission for OMB Review; Comment Request
Policy FR-2026-15550 • Multi-specialty
RoutineCMS is publishing a Paperwork Reduction Act notice seeking public comment on a proposed information collection activity. This is an administrative notice with no direct changes to billing rates, cover
FDA Approval: ANTISEPTIC SKIN CLEANSER (CHLORHEXIDINE GLUCONATE) — Type 3 - New Dosage Form
Policy FDA-NDA019125 • Multi-specialty
RoutineChlorhexidine gluconate topical solution is a long-established antiseptic skin cleanser with a well-known Part D billing pathway, consistent with its topical, self-administered dosage form. As a gener
CMS Transmittal R13888OTN: Send 'Reason for Denial' Value in Prior Authorization Data to the Integrated Data Repository…
Policy CMS-T-R13888OTN • Multi-specialty
CriticalCMS is requiring that 'Reason for Denial' values from Prior Authorization data be transmitted to the Integrated Data Repository (IDR) effective October 5, 2026. This is a systems/data reporting change
Federal Register Final Rule: Medicare Program; Updates to the Master List of Items Potentially Subject to Face-to-Face Encounter and Written Order Prior to Delivery and/or Prior Authorization Requirements; Updates to the Required Face-to-Face Encounter and Written Order Prior to Delivery List; and Updates to the Required Prior Authorization List
Policy FR-2026-15446 • Multi-specialty
HighCMS updates three key DMEPOS lists effective October 28, 2026: the Master List of items potentially subject to face-to-face encounter and written order prior to delivery requirements, the Required Fac
FDA Approval: FOAMING HAND WASH (CHLORHEXIDINE GLUCONATE) — Type 3 - New Dosage Form
Policy FDA-NDA019422 • Multi-specialty
RoutineThis topical chlorhexidine gluconate foaming hand wash, approved under NDA019422, follows a Part D billing pathway as a topical solution. Given its antimicrobial/antiseptic nature and topical route, i