Policy· October 1, 2026 · 24 min read
Part B Self-Administered Drug Exclusions: Checking the Local Policy
By Ran Chen
Section
Policy
CMS, FDA, HHS, Federal Register, and payer-policy moves that change the rules under commercial teams.
58 articles · Last updated
Policy· September 24, 2026 · 24 min read
JW and JZ Modifiers: Mapping Discarded Drug Amounts to Documentation
By Ran Chen
Policy· September 19, 2026 · 28 min read
340B Orphan Drug Exclusion: How Entity Type and Designation Apply
By Ran Chen
Policy· September 7, 2026 · 34 min read
EClinCloud AI-Assisted Study Build: What Sponsors Must Accept Before EDC Go-Live
By Ran Chen#FDA#Regulatory#Clinical Trials
Policy· August 31, 2026 · 16 min read
CMS Part D 340B Repository: Voluntary Files Do Not Replace Prescriber Math
By Ran Chen#340B#Medicare Part D#IRA Negotiation
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
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 · 18 min read
FDA's Expedited IND Pilot: 30-Day Safe-to-Proceed Clock and QRI Review
By Ran Chen#FDA Approval#Clinical Evidence#Pipeline
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