Approvals· September 3, 2026 · 34 min read
Injectafer's Phosphate Boxed Warning Does Not Rewrite J1439, AP Generics, or Oral-Iron PAs
By Ran Chen#Boxed Warning#Label Warnings#FDA Approval
Topic
Medicare Part B
Medicare Part B drug reimbursement, ASP methodology, buy-and-bill, J-codes, and provider-administered drug billing.
Policy· August 31, 2026 · 18 min read
CMS RAPID Is an IDE Presubmission NCD Clock, Not Post-Authorization Coverage
Policy· August 30, 2026 · 17 min read
FDA Licensed XFG COVID Vaccines: Part B Differs from ACIP and ACA 2713
Specialty· August 30, 2026 · 23 min read
Libre Duo's Dual Glucose-Ketone De Novo Is Not a Medicare CGM Coverage Decision
Policy· August 25, 2026 · 15 min read
Wound PFDD Does Not Reset Skin-Substitute Pay; 351 BLAs Would Face Rebates
By Ran Chen#Medicare Part B#CMS#Drug Pricing
Policy· August 24, 2026 · 20 min read
HHS Vaccine-Category RFI: What SCDM Means for ACA and VFC Coverage Clocks
By Ran Chen#Policy#Coverage Access#Payer Policy
Policy· August 23, 2026 · 16 min read
CMS-10110 Turns Quarterly ASP Into a Part B MFP Compliance Feed: Comments Oct 20
By Ran Chen#CMS#ASP#Medicare Part B
Pricing & Access· August 22, 2026 · 17 min read
CMS's 340B OPPS Cut: ASP Minus 33.4%, the 2026 Survey, and August 31 Clock
By Ran Chen#340B#CMS#Medicare Part B
Specialty· August 15, 2026 · 25 min read
Kidney Transplant Immunosuppression: Part B-ID Cliff, Tacrolimus, & Access
By Ran Chen#Nephrology#Medicare Part B#Coverage Access
Approvals· August 12, 2026 · 39 min read
MK-6240 (Florquinitau F-18) Tau PET: PDUFA, Tauvid, and CMS Coverage Gap
By Ran Chen#FDA Approval#PDUFA Date#Medicare