Does J1643 require prior authorization?

No, J1643 does not require prior authorization (high confidence). Covered without prior authorization.

What is the Medicare reimbursement rate for J1643?

Medicare facility rate: N/A. Non-facility rate: N/A. Work RVU: 0.00.

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`J1643`, Injection, heparin sodium (pfizer), not therapeutically equivalent to j1644,

HCPCS/CPT

Prior Authorization

No Prior Auth Required

Covered without prior authorization (high confidence)

Medicare Pricing

Work RVU

0.00

Facility

N/A

Non-Facility

N/A

Documentation Required

Physician prescription is required for home hemodialysis and for use of portable/home hemodialysis systems (NxStage, Tablo).
When using devices or modalities with limited evidence (portable machines, wearable devices, bioengineered vessels, DCB angioplasty, BCM, ViE-m, HIF-PHIs), documentation should include indication, supporting clinical rationale, and acknowledgment of current evidence limitations (implicit from text recommending further study and noting limitations).

Records supporting the need for specific equipment or supplies (e.g., demonstration of home water quality to justify a water softening system when RO is used).

Documentation of initiation circumstances if emergency reserve supplies are provided (one-time allowance up to 1 month).

Documentation of duration of dialysis (for purposes of rental vs purchase calculations, i.e., the first 30 months rule referenced for Medicare primary coverage) where applicable.

For home hemodialysis, a care plan must be prepared and periodically reviewed by a physician; periodic monitoring of the member's condition by a nurse (skilled nursing visit) must be in accordance with that care plan.

Key Coverage Criteria

Hemodialysis or intermittent peritoneal dialysis for renal failure up to 3 times per week.
Hemodialysis and intermittent peritoneal dialysis performed more than 3 times per week for renal failure when one or more of the following conditions are present and refractory to dialysis 3 times per week: hyperkalemia (E87.5), hypophosphatemia (E83.39), pregnancy (O00.0-O9A.53; Z33.1; Z33.3; Z3A.00-Z3A.49), fluid overload (E87.70-E87.79), acute pericarditis (I30.0-I30.9), congestive heart failure (I50.1-I50.9), pulmonary edema (J81.0-J81.1), or severe catabolic state/age-related physical debil [...]
Home hemodialysis when prescribed by a physician for members with end-stage renal disease (N18.6).
Up to 1 month's supplies in reserve in case of emergency are considered medically necessary; this is a one-time allowance.
CPT codes covered if selection criteria is met: 90935, 90937, 90999, 99512 (hemodialysis-related codes).
Tablo Hemodialysis System ... is FDA cleared for use in patients with acute and/or chronic renal failure, with or without ultrafiltration, in an acute or chronic care facility. ... The Tablo Hemodialysis System is also indicated for use in the home (FDA, 2020).

1 Active Policy

AETNA-CPB-0541, Dialysis

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J1643, Injection, heparin sodium (pfizer), not therapeutically equivalent to j1644,