Knowledge Base Article

I have recently noticed a resurgence of a favorite commercial from my childhood featuring a little boy, Mr. Turtle, Mr. Owl, and a tootsie roll pop (link). Although it’s a given that we will never know how many licks it takes to get to the center of a Tootsie Roll pop, it’s no mystery as to why the OIG believes CMS has paid millions in overpayments for neurostimulator implantation surgeries. Let’s unwrap this OIG report (link) and get to the center of it.

Why This Audit was Conducted

CMS analysis revealed that claims for spinal neurostimulator implantation surgeries increased by nearly 175 percent between 2007 and 2018. “CMS researched possible causes for the increased volume of these procedures that would indicate the services are increasingly necessary, but CMS did not find any plausible reason for the increase in services and concluded that a financial motivation was the most likely cause for the increase.”

Strategic Health Solutions, the first Supplemental Medical Review Contractor (SMRC), was tasked with reviewing post-payment claims of Medicare Part B spinal neurostimulator implantation surgeries. They reviewed claims with dates of service from January through September of 2014 and identified a 72% error rate.

Without a “plausible reason for the increase in services” and the SMRC review’s high error rate, the OIG conducted this review to “determine whether health care providers complied with Medicare requirements when they billed for neurostimulator implantation surgeries.”

What are Neurostimulators?

• What is it? A battery-powered electronic device enclosed in a small metal container that is surgically implanted under a patient’s skin and connected to wires called leads
• Types of Neurostimulators: Spinal cord, deep brain, and vagus nerve stimulator (VNS) devices.
• Conditions that can be treated with neurostimulator: chronic pain, Parkinson’s disease, essential tremor, dystonia, obsessive-compulsive disorder, seizures, and epilepsy.

Medicare Coverage Requirements for Neurostimulators

As noted above, there are several conditions where treatment with a neurostimulator implant may be warranted. Medicare has several National Coverage Determinations (NCDs) related to neurostimulators that detail the indications and limitations of coverage, including:

• NCD 160.2: Treatment of Motor Function Disorders with Electrical Nerve Stimulation,
• NCD 160.7: Electrical Nerve Stimulators,
• NCD 160.18 – Vagus Nerve Stimulation, and
• NCD 160.24 – Deep Brain Stimulation for Essential Tremor and Parkinson’s Disease.

OIG Claims Selection by the Numbers

• 2016-2017: The audit period for this review,
• $1.4 billion: The Medicare payments made to providers during the audit period,
• 58,213: The number of beneficiaries who had at least one neurostimulator implantation during the audit period.
• HCPCS Codes 61885, 61886, or 63685: The codes used to identify beneficiaries who had undergone a neurostimulator implantation surgery.
• 124 claims: The stratified random sample of claims reviewed in this audit.
• $1,000: All claims reviewed were for paid amounts greater than $1,000.
• $3.4 million: The amount paid to 102 providers for the 124 claims in the audit sample.
• Audit sample claim specific indication for neurostimulator:
• 87 claims were for treatment of chronic pain,
• 4 claims were for treatment of seizures, and
• 13 claims were for essential tremors and Parkinson’s disease.
• Note, the remaining two claims involved a neurostimulator implant with an investigational device exemption.

Audit Error Rates

The OIG found that 40% of health care provided did not comply with Medicare requirements. Based in this finding, they estimated that:

• Providers received $636 million in unallowable Medicare payments, and
• Medicare beneficiaries paid $54 million in related unnecessary coinsurance amounts.

An independent contractor reviewed the medical records and determined that 48 (49%) of the 106 claims did not contain documentation supporting compliance with the applicable NCD indications. The OIG report lists types of missing/incomplete documentation by NCD, for example:

• NCD 160.7:
• No documentation of other failed treatment modalities or that other treatment prior to a neurostimulator was felt to be unsuitable or contraindicated, and
• No documentation of the multidisciplinary screening includes a psychological evaluation.

OIG Audit Conclusions & Recommendations

The “tootsie-roll center” of this audit are the OIG’s audit conclusions and recommendations. Both lay the groundwork for steps for providers moving forward. The OIG concluded that:

• Medical records lacked documentation to support the NCD coverage requirements for neurostimulator implants,
• There were limited instances when providers “stated that they did not fully understand these Medicare coverage requirements,”
• These claims did not require prior authorization, nor were they subject to pre-payment reviews, and
• There is no edit in the CMS software to initiate such a review.
• It was not until after the completion of this audit that CMS published the CY 2021 OPPS Final Rule that added prior authorization of spinal neurostimulators to the Prior Authorization for Certain Hospital Outpatient Department Services program effective for services on or after July 1, 2021(link). The OIG notes that this final rule does not include claims for neurostimulator implantation for Parkinson’s disease or seizure disorders.
• Note, in May of 2021, the CMS limited the prior authorization requirement to CPT code 63650 (implantation of spinal neurostimulator electrodes, accessed through the skin).

Based on their conclusions, the OIG recommended that CMS instruct the Medicare Administrative Contractors:

• Recover overpayments,
• Advise applicable providers to exercise reasonable diligence to identify, report, and return over-payments in accordance with the 60-day rule,
• Conduct provider outreach and education regarding Medicare coverage requirements, and
• Require prior authorization for procedures for Parkinson’s disease and seizures.

CMS agreed with all recommendations but indicated that neurostimulator implantation for Parkinson’s disease and seizure disorders are currently on the Medicare Inpatient Only (IPO) Procedure List and their prior authorization authority does not extend to inpatient services. The OIG noted that “CMS’s inability to implement this control for inpatient claims…leaves this area vulnerable to future overpayments.”

Steps Moving Forward

I encourage you to:

• Become familiar with the Medicare coverage requirements at the National and Local MAC level,
• Identify the documentation deficiencies by NCD detailed in this OIG report,
• Work with your Physician’s offices to ensure all documentation needed to support the medical necessity of the procedure is in the medical record, and
• Learn about current MAC specific provider outreach and education activities in a related article in this week’s newsletter.