Knowledge Base Article

Attention, this is not a late April Fools’ Day Joke, Palmetto GBA has published a Spinal Fusion LCD and it differs from other MACs Spinal Fusion LCDs. In their March 22, 2019 Daily e-Newsletter, Palmetto posted a new Local Coverage Determinations (LCDs) Notice Period, LCD Revisions and LCD Article updates: Part A and Part B. Highlighted below are the new LCDs, related Coding and Billing Articles, and Response to Comments Articles.  

‍Background

The Jurisdiction J MAC (Alabama, Georgia and Tennessee) transition from Cahaba GBA to Palmetto GBA was complete as of February 26, 2018. Prior to the transition, Cahaba GBA had a Spinal Fusion LCD. LCDs from both MACs were consolidated during the transition. Cahaba’s Spinal Fusion LCD (L35942) did not make the cut leaving the Jurisdiction J MAC without a Spinal Fusion LCD, until now.

In January of this year the Supplemental Medical Review Contractor (SMRC) Noridian Healthcare Solutions, LLC (Noridian) posted a notice of their current Spinal Fusions (MS-DRGs 459 and 460) medical review project. At that time, MMP wrote an article detailing past Spinal Fusion Audits and current medical review audits. This article highlights the new Palmetto GBA Spinal Fusion Local Coverage Determination (LCD). 

Cahaba vs Palmetto LCD Compare

Cahaba’s LCD: Surgery Fusion for Degenerative Joint Disease of the Lumbar Spine (L35942) was initially effective for services performed on or after 10/01/2015 and was officially retired 2/25/2018. Palmetto GBA’s new LCD: Lumbar Spinal Fusion (L37848) has a future effective date for services performed on or after 5/6/2019.

Cahaba GBA Coverage Indications

1. Spinal stenosis for a single level (for example, L4-L5) with associated spondylolisthesis and symptoms of spinal claudication and radicular pain. Pain must represent significant functional impairment despite 3 months of conservative therapy.
2. Spondylolisthesis
3. Spondylolysis
4. Repeat Lumbar Fusion following prior fusion for associated spondylolisthesis
5. Treatment of pseudoarthrosis at the same level after 12 months from prior surgery.

Palmetto GBA Coverage Indications

1. Radiographic or clinical evidence of instability due to one of the following: congenital deformities, trauma, fractures, chronic degenerative conditions, tumor, infection, erosive conditions, space-occupying lesions or iatrogenic causes.
2. Symptomatic spinal deformity in the absence of instability or neural compression which meets the following criteria:
3. Functional limitation in daily activities due to back pain or discomfort and
4. Nonresponsive to at least one year of non-operative management.
5. Revision surgery for pseudoarthrosis following an initial spine surgery
6. Symptomatic compression of neural elements for which disc excision is necessary for decompression.

Cahaba GBA Documentation Requirements

1. “Documentation must support CMS ‘signature guidelines, as described in the Medicare Program Integrity Manual (Pub. 100-08), Chapter 3. Medical record documentation maintained by the physician must support the above indications and must include the following:

• Office notes/hospital record, including history and physical by the attending/treating physician
• Documentation of the history and duration of unsuccessful conservative therapy (non-surgical medical management). Failure of non-surgical medical management can be historical and does not have to be under the direction of the operating surgeon.

1. Medical record documentation must be made available to Medicare upon request. When the documentation does not meet the criteria for the service(s) rendered or the documentation does not establish the medical necessity for the service(s), such service(s) will be denied as not reasonable and necessary under Section 1862(a)(1)(A) of the Social Security Act. The hospital (FISS claim) and physician services (MCS claim) can be denied.”

Palmetto GBA Documentation Requirement

“Documentation must demonstrate that the patient met at least one of the indications for the procedure…where possible, there must be documented shared decision making with the patient or the individual who is serving as the proxy decision maker for the patient with the appropriate discussion of anticipated risks and benefits of the procedure.”

Palmetto’s LCD requirements end with “Associated Information” that “medical record documentation should be legible, relevant and sufficient to justify services billed. This documentation should be maintained in the patient’s medical record and must be made available to the A/B MAC upon request.”

Note, there is no statement indicating that the physician’s services could be denied in this policy, even though the new LCD applies to both Part A (hospital) and Part B (physicians’ services).

Shared Decision Making

Palmetto’s shared decision making requirement is not as specific as what is required in the recently revised NCD 20.4, Implantable Cardiac Defibrillators (ICDs). NCD 20.4 requires a formal shared decision-making encounter between the patient and physician or qualified non-physician practitioner using an evidenced-based decision tool on ICDs prior to initial ICD Implantation. In a related Decision Memo, CMS responded to a comment stating that shared decision making is a critical step in empowering patient choice in his/her treatment plan and requires the use of an evidence-based tool to ensure topics like the patients’ health goals and preferences are covered prior to ICD implantation.

On a personal note, I totally agree with the concept of shared decision making prior to Lumbar Fusion. My mom recently underwent a repeat Spinal Fusion and was fused from L1 to S1. My mom is widowed and lives alone. I live out of state three hours away. Thank goodness it is only a 45 minute commute for my brother. The week prior to surgery I asked her what her plan was after surgery. She had not thought about it. She had not thought about the fact that she couldn’t drive, lift more than five pounds, bend-over to put on her shoes and socks, let alone put clothes from the washer into the dryer or bend down to get frozen food out of the freezer section of her refrigerator. Also, when I asked her what exactly she was having done during surgery, she said “they were going to take something out, crush it up, mix it with something and reinsert it into her spine.”

As her patient advocate and having an understanding boss, I was with her the day of surgery and the following week while she was in the hospital. Post-op day one I made it clear to the surgeon’s nurse that she lived alone and that would not be an immediate post-op option for her. She agreed and quickly got Physical and Occupational Therapy involved in my mom’s care. Unfortunately, my mom’s stay was complicated with the inability to void requiring a Foley catheter that remained in until her second week at the skilled nursing unit. The inability to void post-operatively is another potential complication of surgery that she was not prepared for.

I want to preface the rest of this paragraph with a disclaimer that the Surgeon and Hospital staff provided excellent care. However, she was not prepared for how involved the surgery was, the fact that the pain down her legs would not be immediately better, or for the month she spent in a Skilled Nursing Unit for rehabilitation. She has been home a little over two weeks now and was not prepared that she still has not been “released” by the Surgeon and Home Physical and Occupational Therapists to walk up and down stairs unsupervised, do laundry or drive. I can tell she is feeling better because she mentions the things she isn’t supposed to do almost every time I talk to her. So yes, taking the time to provide a shared decision making interaction with the patient is a critical step in empowering patient choice.

Palmetto’s Spinal Fusion LCD does not specify who would provide this patient interaction or what they would expect to see documented in the record. However, the third indication for Lumbar Fusion is a revision surgery for pseudoarthrosis following an initial spine surgery. This indication includes the following statements about shared decision making:

“Outcomes for fusion in revision surgery, usually do not lead to pain relief and as such fusion is considered a last resort treatment option only when all other treatment options have failed. This information must be communicated to the patient prior to surgery to allow for appropriate shared decision making with a well-informed patient. The medical record must reflect that this counseling was done and that the patient wished to undergo surgery with the appropriately informed consent.”

Following is another important piece of information that could be shared with a patient. The following paragraph can be found in the Summary of Evidence section of the Palmetto’s LCD.

“Persistent Back Pain Following Previous Spine Surgery

One of the largest studies to date examining the outcomes of surgical fusion following an initial spinal surgery reviewed 100 cases of “failed back surgery syndrome” (Arts 2012). All patients had at least one year of persistent pain refractory to conservative treatments after their initial spine surgery and were treated with pedicle screw fixation and interbody fusion in the revision surgery. Etiologies of failed back surgery syndrome specifically identified included previous discectomy, previous laminectomy, adjacent level disease and instability. The primary outcome measure was a dichotomous patient self-report regarding recovery with options of “good recovery” or “bad recovery”. Mean follow-up time after revision surgery with fusion was 14.7 months. On the primary outcome 35% of patients reported good recovery and the remaining 65% reported bad recovery.”

Moving Forward

Spinal Fusion audits are not new. The documentation expectation to support the medical necessity of the procedure has been made known by several different auditors. Now that Palmetto has published an LCD I would anticipate that a Targeted Probe and Educate review of Spinal Fusions will begin at some point in the near future. Steps you can take now to prepare:

• Read the Lumber Spinal Fusion LCD (L37848) and related Article: Billing and Coding: Lumbar Spinal Fusion (A56396)
• Also, take the time to read the Article: Response to Comments: Lumbar Spinal Fusion (A56397). A word of caution before reading this article, it has the potential to provide insight into Palmetto’s reasons for inclusions or exclusions in the policy, and to totally frustrate you at the same time.
• Perform an internal audit to see if documentation supports one of the indications for the procedure.
• Provide a copy of all of the source documents to Key Stakeholders (i.e. Chief Medical Officer, Surgeon, Case Management staff, Physician office staff).
• You could also share the more general CMS Provider Compliance Video containing pointers to help provide proper documentation when billing for Lumbar Spinal Fusion with your Surgeons. You can find a link to this YouTube video on the CMS website.