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Timing is Everything: Best Practices in Timing Coverage , Coding & Payment. Stephanie Mensh Michael J. Ruggiero, Esq. Ron Geigle The Medical Device Regulatory and Compliance Congress Harvard University March 30, 2006. Calendars count in Medicare.
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Timing is Everything:Best Practices in Timing Coverage, Coding & Payment Stephanie Mensh Michael J. Ruggiero, Esq. Ron Geigle The Medical Device Regulatory and Compliance Congress Harvard University March 30, 2006
Calendars count in Medicare • Medicare reimbursement is complex …with parallel, overlapping and multiple program deadlines. • Coverage, coding, and payment systems have individual and interdependent schedules. • Reimbursement planning covers 12–18 months or more.
Looks innocent, doesn’t it? Coverage Patient FDA CMS Coding Payment
Coverage Coding FDA Patient Payment CMS
RVS HIP HOP ASC Labs DME
Payment Coding • CMS must issue a decision memorandum in national coverage decisions within 6 months, if it seeks no external review • CMS must issue a decision memorandum in national coverage decisions within 9 months, if CMS seeks external reviews • In both cases, CMS must allow 30 days comment on the draft decision memo; then complete the final within 60 days National or Local? If national… Coverage If local… • Informal? • Formal LMRP?
We will discuss strategy for coverage, coding, and payment, keeping the calendar in mind…
Developing a coverage strategy • Determine benefit category • Indicated for Medicare population • Utilization & budget implications • Timeline issues: • Does the product need a coverage decision? • Are there related LCDs or NCDs?
Developing a coding strategy • Determine current coding & timetable • Indications = diagnosis code = ICD-9 (Vol I-II) • Physician & facilities must use a diagnostic code • Physician = surgeon’s time = CPT-4 • CPT maintained by AMA • Category 1: Physician services • Category 3: New medical devices, temporary • Inpatient hospital = ICD-9 (Vol. III) • Track to DRGs • Outpatient hospital = HCPCS (Levels 1-2) • Level 1 = CPT • Level 2 = Codes developed by CMS • C-codes: Outpatient new device categories, temporary • G-codes: Coverage/utilization, temporary
Developing a payment strategy • Medicare payment systems updated annually: • Hospital Inpatient: • Proposed in May; Final in August; Effective October 1 • Hospital Outpatient: • Proposed in July; Final in November; Effective January 1 • Physician Fee Schedule: • Proposed in July; Final in November; Effective January 1
Important facts on payment.… • Provisions for devices • Hospital inpatient • Special DRG assignment/special payment • Hospital outpatient • Device category code/new tech APC/APC assignment • Physician fee schedule • Practice expense component
Pulling it all together… • Looking at the year ahead • First quarter • Second quarter • Third quarter • Fourth quarter • Following year