a surgical procedure when performed in an ASC. While there are quite a few non-opioid drugs administered for post- surgical pain, Exparel, or bupivacaine liposome injectable suspension, is cur- rently the only non-opioid drug covered under Medicare Part B that functions as a supply when used in a surgical pro- cedure. Since Exparel meets CMS’ criteria, the drug will receive separate payment in an ASC. Exparel, however, has not been approved for separate pay- ment when used in a surgical procedure in a hospital outpatient setting. CMS has indicated that decision was made based on insufficient evidence that the OPPS packaging policy for Exparel had not deterred or prevented the use of this drug in the hospital setting. CMS is continuing to review other non-opioid drugs for separate payment consider- ation in the future.

Reimbursement The

Federal Drug Administration

(FDA) approved Exparel in 2011 for local administration to provide post- surgical analgesia, but it was not until 2018 that Exparel was approved for use in interscalene brachial plexus nerve block for post-surgical regional anal- gesia for shoulder surgery in adults. Single-dose. According to the Cen- ters for Disease Control and Prevention, single-dose vials are meant for use in a single patient for a single case/pro- cedure/injection and any leftover con- tents should not be combined with other leftover contents of single-dose or single-use vials.

Exparel is indicated and approved for single-dose infiltration in adults to produce post-surgical local analge- sia and is available in 133 milligrams (mg) or 10 milliliters (ml) or 266 mg or 20 ml single-dose vials. Reporting. Exparel is reported using the Healthcare Common Proce- dure Coding System (HCPCS) code C9290, Injection, bupivacaine lipo- some, 1 mg with a “per mg” CMS reim- bursement rate of approximately $1.22

RESOURCES National Safety Counsel

CMS Regulations and Guidance Manuals

CMS Chapter 14 ASC Billing Manual

Medicare Claims Processing Manual Chapter 17 Drugs and Biologicals

CMS Final Rule—Federal Register

per mg pending a surgery center’s phys- ical location/geographical wage index. The specific amount and dose adminis- tered during a surgical procedure must be documented for accurate billing. HCPCS reporting is specific for mg not ml, so physicians and/or clinical staff should habitually document doses in mg, particularly when only a portion of either single-dose vial is used. Keep in mind, Exparel can be

expanded to increase volume up to a total of 300 ml when mixed, for example, with normal saline. Only the amount of Exparel administered is billed and not the total of 300 ml. Prior to billing Exparel, if the amount admin- istered is not documented, question that amount. Question any amount docu- mented that exceeds the maximum rec- ommended dose of Exparel, 266 mg or 20 ml if no breakdown is provided. Documentation.

Description of

the infiltration of Exparel within the surgical site should be documented within the operative report to include the amount/dose administered. From

a liability standpoint, omission of the written description of any aspect of a surgery can be called into question should complications arise. The med- ical record must contain the specific amount administered and wasted. Some Medicare Administrative Contractors (MAC) or commercial payers might have varying interpreta- tions of the CMS Final Rule for the indications of Exparel. ASCs should review both CMS and commercial payers’ provider, documentation and reporting directives to ensure that the reporting of Exparel is allowed, par- ticularly in cases when the procedure in which Exparel is administered may itself be considered bundled or pack- aged within another surgical procedure during the same operative session. Wastage. Drugs should routinely

be administered in a manner that maxi- mizes efficiency with minimal wastage. Any unused portion of a single-dose vial must be documented in the patient’s medical record with the date, time and quantity wasted pursuant to the surgery center’s policies and procedures for drug wastage. Some payers may reim- burse for the unused or discarded por- tion of a single-dose vial. ASCs should review their payer policies for drug wastage documentation and reporting requirements when allowed. For example, a payer might direct

the reporting of a single-dose vial with the HCPCS code for the drug twice on the claim (drug portion adminis- tered/drug portion wasted). One-line item would reflect the HCPCS code for the amount administered during the procedure with the specific mg usage indicated within the units col- umn of the claim. An additional line item would reflect the same HCPCS code with applicable modifier for the drug amount wasted (or report spe- cific modifier as recognized by the payer) and actual mg wasted within the units column of the claim. If the payer allows the reporting of the dis- carded portion of the drug, both lines

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