December 17, 2013

Drill Down: Herceptin Multi-dose Vial Waste Targeted by OIG and WellPoint

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It’s been a slow month for the RAC contractors, with only RAC Region A Performant and RAC Region C Connolly posting issues for December. However, I’d like to discuss with you how a previously posted issue by RAC contractors Performant Connolly and HDI are reverberating through the payer industry at large.

On September 10, 2013, RAC Region A contractor Performant posted complex reviews of Trastuzumab (Herceptin®), Multi-dose Vial Waste for both Physician/Non-Physician Practitioners and Outpatient Hospitals provider types.

Performant listed in its issues that “per the packaging, (Herceptin®) Trastuzumab is supplied in 440 mg multi-dose vials. Multi-use vials are not subject to payment for discarded amount of the drug or biological.”

Herceptin® is a costly breast cancer drug and an effective chemotherapy drug. Certain dosages of this drug may be causing providers to double-bill. In an analysis published recently by HHS’ watchdog office, an error rate of 77 percent of Medicare claims for Herceptin® multi-use vials found $24 million in extra payments between 2008 and 2011. The Office of Inspector General (OIG) concluded that many doctors and hospitals were billing the government for full vials of Herceptin® even though reviews of about 26,000 patient records show the treatment called for lower doses.

The drug is sometimes sold in vials of 440 milligram quantities that are intended to allow for multiple doses to be administered. The OIG analysis turned up 19,954 cases where 440-milligram units were used when the patient record didn't reflect a need for exactly that amount.

The drug is good for 28 days and it is unlikely that the remainder of drug from a multi-use vial will be discarded. This is an opportunity to review billing systems and coding flags for multi -use vials for Herceptin® as well as other multi-use drugs to ensure proper dosing.

WellPoint, which is one of the nation’s largest commercial insurers, opened 86 investigations in the past three years regarding Herceptin®, including four cases in Georgia this past week. By using analytics, the director of enterprise investigations at WellPoint noticed a spike and targeted the drug.

The Centers for Medicaid and Medicare Services (CMS) has urged the OIG to bring to its attention provider billing for full vials for other drugs that may exist.

Last week, RAC Region C contractor Connolly also posted prepayment reviews for Trastuzumab (Herceptin), J9355 - multi-dose vial waste for Physician and Outpatient provider types.

RAC Issues for the Week of December 16 – December 20, 2013:

RAC Region A Performant

Physician/Non-Physician Practitioner

  • Evaluation and Management Per Diem Codes, Excess Units – JK - Initial hospital care and subsequent hospital care codes are "per diem" services and may be reported only once-per-day by the same physician.
  • Observation Care for Fewer Than 8 Hours – JK - When a patient receives observation care totaling fewer than 8 hours on the same calendar date, the physician shall report Initial Observation Care E/M codes, from CPT code range 99218 – 99220. Payment for CPT codes 99217, 99234, 99235, and/or 99236 billed for observation care for fewer than 8 hours on the same date of service will be denied.

RAC Region C Connolly

DME

  • Prepayment Review: DME Group 2 - Pressure Reducing Support Services - Group 2 Pressure Reducing Support Services claims that do not meet the indications of coverage and/or medical necessity related to local coverage determinations within each applicable jurisdiction.

Home Health

  • Prepayment Review: Home Health - Medical Necessity & Conditions to Qualify for Services - The medical record will be reviewed to validate that the Home Health services provided were both reasonable and medically necessary and that the patient met the conditions to qualify for home health services.
  • Prepayment Review: Skilled Nurse Length of Stay - Medicare covers skilled nursing services when they are reasonable and necessary. Extended nursing care for observation and assessment may not be covered. Due to the home health prospective payment system consisting of increased payment for late episodes of care, the incentive exists for home health agencies to provide skilled nursing services in the home longer than is considered medically necessary per Medicare guidelines. Claims for nursing services into the third episode and after will be reviewed to determine if all Medicare coverage criteria were met.

Inpatient Hospital

  • Prepayment Review: Cancelled Elective Surgeries - When an inpatient hospital admission is based on the expectation that a patient will have elective surgery, but that surgery does not occur, the hospital may bill for the admission only if it remains reasonable and necessary despite the surgery's cancellation.
  • Prepayment Review: Blepharoplasty - IP - Blepharoplasty is the plastic repair of the eyelid, and usually refers to an operation in which redundant skin, muscle, and/or fat are excised. Functional blepharoplasty usually involves the excision of skin and orbicularis muscle. This procedure is usually done to correct a deficit in the upper or peripheral field of vision or as noted on forward gaze by skin resting on the upper eyelashes. When blepharoplasty repair is done for cosmetic purposes it does not meet the criteria of the functional visual impairment parameters and is considered not reasonable and medically necessary and therefore will denied. In addition to blepharoplasty procedures, Brow Ptosis, Belpharoptosis and Ptosis Repairs done for cosmetic purposes that do not meet the criteria of the functional visual impairment parameters and are considered not reasonable and medical necessary will be denied.

Outpatient

  • Prepayment Review: Trastuzumab (Herceptin), J9355 - multi-dose vial waste - OP - Per its Package Label, Trastuzumab (Herceptin) is supplied by the manufacturer in a 440 mg multi-dose vial. Per Medicare Claims Processing Manual (100-04) Chapter 17, Section 40: "When a physician, hospital or other provider or supplier must discard the remainder of a single use vial or other single use package after administering a dose/quantity of the drug or biological to a Medicare patient, the program provides payment for the amount of drug or biological discarded as well as the dose administered, up to the amount of the drug or biological as indicated on the vial or package label. Note: Multi-use vials are not subject to payment for discarded amounts of drug or biological." The JW modifier cannot be used on claims for multi-use vials.

Outpatient Hospital

  • Prepayment Review: Blepharoplasty - OP - Blepharoplasty is the plastic repair of the eyelid, and usually refers to an operation in which redundant skin, muscle, and/or fat are excised. Functional blepharoplasty usually involves the excision of skin and orbicularis muscle. This procedure is usually done to correct a deficit in the upper or peripheral field of vision or as noted on forward gaze by skin resting on the upper eyelashes. When blepharoplasty repair is done for cosmetic purposes it does not meet the criteria of the functional visual impairment parameters and is considered not reasonable and medically necessary and therefore will denied. In addition to blepharoplasty procedures, Brow Ptosis, Belpharoptosis and Ptosis Repairs done for cosmetic purposes that do not meet the criteria of the functional visual impairment parameters and are considered not reasonable and medical necessary will be denied.
  • Prepayment Review: Rituximab (Rituxan), 100 mg - Dose vs. Units Billed - Rituximab (Rituxan), 100 mg (J9310) should be billed one (1) unit for every 100 mg per patient administered. Hospitals need to ensure that units of drugs administered to patients are accurately reported in terms of dosage specified in the full HCPCS code descriptor.

Physician

  • Prepayment Review: Trastuzumab (Herceptin), J9355 - multi-dose vial waste - Carrier - Per its Package Label, Trastuzumab (Herceptin) is supplied by the manufacturer in a 440 mg multi-dose vial. Per Medicare Claims Processing Manual (100-04) Chapter 17, Section 40: "When a physician, hospital or other provider or supplier must discard the remainder of a single use vial or other single use package after administering a dose/quantity of the drug or biological to a Medicare patient, the program provides payment for the amount of drug or biological discarded as well as the dose administered, up to the amount of the drug or biological as indicated on the vial or package label...Note: Multi-use vials are not subject to payment for discarded amounts of drug or biological." The JW modifier cannot be used on claims for multi-use vials.
  • Prepayment Review: Blepharoplasty - Carrier - Blepharoplasty is the plastic repair of the eyelid, and usually refers to an operation in which redundant skin, muscle, and/or fat are excised. Functional blepharoplasty usually involves the excision of skin and orbicularis muscle. This procedure is usually done to correct a deficit in the upper or peripheral field of vision or as noted on forward gaze by skin resting on the upper eyelashes. When blepharoplasty repair is done for cosmetic purposes it does not meet the criteria of the functional visual impairment parameters and is considered not reasonable and medical necessary and therefore will denied. In addition to blepharoplasty procedures, Brow Ptosis, Belpharoptosis and Ptosis Repairs done for cosmetic purposes that do not meet the criteria of the functional visual impairment parameters and are considered not reasonable and medical necessary will be denied.

SNF

  • Prepayment Review: Skilled Nursing Facility and Coding Validation - Skilled Nursing Facility claims will be reviewed to determine the extent to which the Minimum Data Set (MDS) is accurate and supported by the patient's medical record. The entire benefit period will be reviewed to determine if the patient's level of care was appropriately billed.

About the Author

Dr. Margaret Klasa is the medical director for Context4 Healthcare. She is responsible for the company’s business knowledge discovery unit for medical context as it relates to the daily development of data products and software for medical claims editing and coding, with an emphasis on clinical and regulatory guidelines for Medicare, Medicaid and commercial payers.

Contact the Author

Margaret.Klasa@context4.com

To comment on this article please go to editor@racmonitor.com

Margaret Klasa, DC, APN, Bc

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