Implants, Implant Components, Medical and Surgical Supplies for all Procedures

Policy No: 125
Originally Created: 03/01/2015
Section: Administrative
Last Reviewed: 12/01/2023
Last Revised: 12/01/2023
Approved: 12/14/2023
Effective: 01/01/2024
Policy Applies to: Group and Individual & Medicare Advantage

The policy applies to inpatient hospitals, outpatient hospitals, ambulatory surgical centers, physicians, and other qualified health care professionals.

Implant
An object, device or material that is inserted surgically, or embedded via surgical or nonsurgical means, or grafted into the body and remains in the body either indefinitely for prosthetic and/or therapeutic purposes or remains in the body for a temporary or provisional period of time for diagnostic and/or therapeutic purposes. An external fixation device is considered an implant.

Integral to a Procedure
Items integral to a procedure are those items that must be used, for the procedure to be performed.

Implant Components
Implant integral parts (e.g., screws, plates, rods) remaining in the body used in conjunction with the primary implant.

Implant Supplies
Elements (e.g., supplies and/or tools) of implant kits or implant systems used to place or remove implants, but do not remain in the body.

Medical and Surgical Supplies
Medical and/or Surgical supplies that are used as an integral part of a procedure.

Provisional Implants
An implant which is intended to be placed temporarily or on a short-term basis; that is expected to be removed and replaced with a permanent implant.

Our health plan may review documentation, including, but not limited to, itemized bills, invoices, and medical records, to determine whether items reported with implant revenue codes meet our health plan’s definition of an implantable device. Our health plan requires providers to make such documentation available to our health plan upon request. Contracted providers will be expected to comply with documentation requests per provider contract. Our health plan does not reimburse an implant revenue code if the item does not satisfy our health plan’s definition of an implantable device.

When supplying an invoice, units must be clearly indicated on the manufacturer invoice to be considered for reimbursement.

Fees such as shipping and handling will not be reimbursed unless specified in the provider's contract.

For claims with case rate reimbursement methodology at the time of service, implants and implant components implanted and remaining in the patient will not be eligible for separate reimbursement.

For claims paid to any other reimbursement methodology, implants and implant components implanted and remaining in the patient will be paid according to the stipulations of the contract our health plan has with the provider at the time of service.

Notwithstanding the above, implants and implant components are not eligible for reimbursement when:

• Implants, implant components are opened and then found to be incorrect and not used.
• Implants, implant components that are inadvertently dropped from the sterile field and cannot be used again.
• Implants or implant components that are implanted then removed (e.g., implant screw removed and replaced when the wrong length of screw is used on a plate.)
• Implants or implant components that malfunction and are replaced during implantation.

• Provisional or temporary implants removed during the operative session.

Medical, surgical, diagnostic, and implant supplies are an integral part of the procedure and included in the surgical room or operating room charge and anesthesia charges; except as otherwise provided in this policy, are not eligible for other reimbursement.

Examples of such supplies that are not eligible for reimbursement include, but are not limited to, the following:

• Specialized implant placement instruments (e.g., Forceps, scissors, needle holder or other instruments)
• Specialized drill bits, saw blades and others.
• Anesthesia supplies
• Monitoring supplies (e.g., temperature, EKG leads, BP cuffs, O2 saturation monitors, catheters)
• OR packs, procedural trays
• Gowns (surgical and patient), surgical gloves
• Skin prep, towels, drapes
• Surgical instruments, including forceps, scissors, needle holder or other instruments whether or not reusable.
• Needles (sterile), syringes, dressings, gauze, tape
• Intravenous supplies
• Heparin, saline flushes and any type of IV flush or diluent to administer substances or drugs
• Suction/irrigation supplies and additives
• Vascular clips, hemostasis agents (e.g., Flowseal®)
• Staplers (surgical), staples, sutures and skin glue
• Casting and splinting supplies
• Leg compression system
• Guide wires, introducers, catheters
  

For a medical, surgical, diagnostic, and implant supply to be eligible for separate reimbursement outside of the reimbursement for the surgical room/OR charge, our health plan must determine that the following criteria are met:

• Customized for the individual patient
  • Specific documentation and rationale to support the need for the customization
  • Not reusable or representative of a cost for each preparation

Centers for Medicare & Medicaid Services (CMS), Medicare Claims Processing Manual, Chapter 14 - Ambulatory Surgical Centers

Centers for Medicare & Medicaid Services (CMS), Provider Reimbursement Manual, Part 1, Chapter 22 - Determination of Cost of Services to Beneficiaries

Administrative Manual, Facility Guidelines, ASC Facility Fee Services

US Code of Regulations, CFR 42 Chapter IV Section 416.164

US Code of Regulations, CFR 42 Chapter IV Section 419.62

U.S. Food and Drug Administration (FDA), IDE Definitions and Acronyms

Global Days

Reimbursement of Facility Room and Board

Reimbursement of Chest X-Rays and Radiologic Guidance for Facilities