CMS Provides Updates on Targeted Probe and Educate Program Regarding Hyaluronate Injections

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According to the Centers for Medicare & Medicaid Services (CMS), the Targeted Probe and Educate (TPE) program is intended to educate physicians on documentation requirements, errors in claim submissions, medical necessity of services (typically found in Local Coverage Determinations [LCDs]), and other identified areas of opportunity. The more common errors in documentation, claim submissions, and medical necessity are not new to the world of joint arthroplasty procedures; LCDs have been in place for years for both Part A and Part B service providers. However, recent changes related to Healthcare Common Procedure Coding System (HCPCS) coding for drug administration have led to hospital and physician audits related to joint arthroplasty procedures. This article addresses how recent TPE reviews may have recently come to light in adult reconstruction practices.

The following is an overview of how the TPE program works:

1. CMS finds an unusual billing practice and sends a letter to the physician requesting documentation related to the service(s). This letter typically informs the physician that CMS will review 20 to 40 claims and supporting medical records.
2. If documentation for the 20 to 40 claims meets all requirements (e.g., documentation of service, medical necessity, billing), the physician is typically free from additional review for a year, unless an unusual billing practice arises in that period.
3. If the documentation is not considered to support the services reported, the physician is “invited” to take part in a one-on-one education session with the CMS Medicare Administrative Contractor (MAC) coding staff.
4. The physician often then moves from the first round of review to the second round. The second round typically occurs at least 45 days after the education if the physician agrees to take part, or at the end of the notice if the physician chooses to forgo education.

Recent CMS changes related to TPEs
On July 1, 2023, CMS began requiring the use of one of two HCPCS modifiers on J codes where drugs are administered from a single dose vial: JW (drug wasted) or JZ (zero drug wasted). The modifiers are intended to indicate whether the entire vial was administered (JZ) or whether there was wastage of drug (JW) from the vial. This change has implications in knee osteoarthritis (OA) related to hyaluronate drugs.

Toward the end of 2023, CMS began sending letters to physicians asking for medical record documentation related to hyaluronate claims sent without the JW or JZ modifier. Claims were originally paid without the JW or JZ modifier, which would meet the “unusual billing practice” element of the TPE program.

Although CMS’ initial focus was reviewing joint-injection claims with hyaluronate drugs, this process opened the door for CMS to review all documentation for the service to ensure that requirements were met. In some practices, CMS found that LCD documentation requirements for hyaluronate injections were not always met, at which point a physician entered the education and re-review process. Practices moved from having claims reviewed for missing the JW/JZ modifiers to LCD requirements for hyaluronate injections to review for joint arthroplasty procedures (total knee arthroplasty secondary to the first review).

Correcting this billing issue is an easy fix if the practice was not aware of the requirement. Practices can place an edit on all hyaluronate J codes to ensure that the proper modifier is linked prior to claim submissions. Submit claims appropriately if any drug was wasted from a single-dose vial. Assign a staff member the responsibility to review the MAC’s Coding and Billing Article for JW and JZ billing guidelines if unsure.

LCDs: Hyaluronate injections
Finding the LCD for one’s MAC may be a bit more challenging than finding other LCDs. LCD 39260, “Hyaluronic Acid Injections for Knee Osteoarthritis,” may be found in the Medicare Coverage Database in the LCD section. However, this LCD may not be specific to every MAC.

The following indications are excerpted only from the LCD 39260. Please note the asterisk below, referencing the key statement. Practices must download the FDA prescribing information for each hyaluronate product used in the practice.

“Various Hyaluronan preparations (viscosupplementation) for intra-articular injections of the knee are considered reasonable and necessary when ALL of the following criteria documented in the medical record are met:

1. Symptomatic OA of the knee. Pain that interferes with functional activities (such as ambulation and prolonged standing).
2. The diagnosis is supported by radiographic evidence of OA of the knee, for example, joint space narrowing, subchondral sclerosis, osteophytes, and subchondral cysts.
3. Trial and failure or contraindication of at least 3 months of conservative therapy:
   • Nonpharmacologic therapy (e.g., physical therapy, exercise, weight management, self-management programs, knee brace, cane)
   • Pharmacologic therapy (e.g., acetaminophen, nonsteroidal anti-inflammatory drugs [NSAIDs] [oral, topical], topical capsaicin)
   • Failure of or contraindication to intra-articular glucocorticoid injections.
     • For patients who have responded to a prior series, a REPEAT* series of viscosupplement therapy is considered reasonable and necessary when ALL of the following are met:
   • Patient continues to meet initial criteria
   • Symptoms have recurred
   • Patient has experienced improvement in pain and functional capacity following the previous series of injections
   • At least 6 months have elapsed since the prior series of injections”

*A series is defined as a set of injections for each joint and each treatment as per the FDA prescribing information.

LCDs: Joint arthroplasty
All Medicare contractors have LCDs related to joint arthroplasty. Assign a staff person the responsibility of ensuring that the practice and physicians are kept informed of the requirements. One example is Noridian’s LCD L36575. This LCD and the associated Billing and Coding Article (A57685) provide the resources necessary to meet the LCD medical necessity and documentation requirements. The following is an excerpt from the Noridian LCD (36575). This is an excerpt only and does not offset review of the documents in their entirety.

“Total Knee Arthroplasty (TKA) Indications: Noridian will consider total knee replacement surgery medically necessary in the following circumstances:

Advanced joint disease demonstrated by:

• Radiographic supported evidence or when conventional radiography is not adequate, magnetic resonance imaging (MRI) and/or computed tomography (CT) (in situations when MRI is non-diagnostic or not able to be performed) supported evidence (subchondral cysts, subchondral sclerosis, periarticular osteophytes, joint subluxation, joint space narrowing, avascular necrosis); and
• Pain or functional disability from injury due to trauma or arthritis of the joint; and
• If appropriate, history of unsuccessful conservative therapy (non-surgical medical management) that is clearly addressed in the pre-procedure medical record. (If conservative therapy is not appropriate, the medical record must clearly document why such approach is not reasonable). Nonsurgical medical management is usually but not always implemented prior to scheduling total joint surgery. Nonsurgical treatment as clinically appropriate for the patient’s current episode of care typically includes one or more of the following:
  • anti-inflammatory medications or analgesics, or
  • flexibility and muscle strengthening exercises, or
  • supervised physical therapy [activities of daily living (ADLs) diminished despite completing a plan of care], or
  • assistive device use, or
  • weight reduction as appropriate, or
  • therapeutic injections into the knee as appropriate.

In some circumstances, for example, if the patient has bone on bone articulation, severe deformity, pain, or significant disabling interference with activities of daily living, the surgeon may determine that nonsurgical medical management would be ineffective or counterproductive, and that the best treatment option, after explaining the risks, is surgical. If medical management is deemed inappropriate, the medical record should indicate the rationale for and circumstances under which this is the case.

• Failure of a previous osteotomy; or
• Distal femur fracture; or
• Malignancy of the distal femur, proximal tibia, knee joint, or adjacent soft tissues; or
• Failure of previous unicompartmental knee replacement; or
• Avascular necrosis of the knee; or
• Proximal tibia fracture”

Please note that the documentation related to the nonsurgical management is for the “current” episode of treatment.

Next steps
The following are steps that orthopaedic surgeons can take to ensure correct claim submissions:

1. Ensure all medications administered from a single dose vial are sent to Medicare with the JW or JZ modifier.
2. Figure out whether private payers are also requiring these modifiers.
3. Review the LCD requirements for hyaluronate and total joint arthroplasty.
4. Develop an internal audit process to ensure that documentation meets the requirements.
5. Obtain an Advanced Beneficiary Notice (ABN) and append the proper ABN modifier if a part of the LCD is not met and the patient wishes to go ahead with the injection or surgery.

Mary LeGrand, RN, MA, CCS-P, CPC, is a senior consultant with KZA. 

References

1. Centers for Medicare & Medicaid Services: Local Coverage Determination: Hyaluronic Acid Injections for Knee Osteoarthritis. Available at: https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdId=39260&ver=5. Accessed May 22, 2024.
2. Centers for Medicare & Medicaid Services: Local Coverage Determination: Total Knee Arthroplasty. Available at: https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?LCDId=36575. Accessed May 22, 2024.