On October 1st, 2021, a report from the Office of Inspector General (OIG) was released regarding the Centers for Medicare and Medicaid Services (CMS) coverage violation of insertion or replacement of Neurostimulator Implantation surgeries. CMS had performed an analysis of prior Part B claims data and identified concerns and thus directed a supplemental post-payment medical review for provider claims for compliance with Medicare requirements. This review did identify several “vulnerabilities” and thus the OIG followed with an audit focusing on providers who billed neurostimulator surgeries with Current Procedure Terminology (CPT) codes 61885, 61886, 63685 during 2016 and 2017.
The OIG audit was conducted from 2018 to June 2021 and the sample consisted of outpatient hospital claims and Part B ambulatory surgery center (ASC) claims, which totaled 61,125 claims with a Medicare paid amount of approximately $1.4 billion. The OIG report overpayment announcement regarding “Neurostimulator Implantation Surgeries” can be located at: https://oig.hhs.gov/oas/reports/region1/11800500.asp
The specific CPT codes for the neurostimulator implantation surgeries have the following descriptions:
- CPT 61885 Insertion or replacement of cranial neurostimulator pulse generator, or receiver, direct or inductive coupling; with connection to a single electrode array
- CPT 61886 Insertion or replacement of cranial neurostimulator pulse generator, or receiver, direct, or indicative coupling; with connection to two or more electrode array
- CPT 63685 Insertion or replacement of cranial neurostimulator pulse generator, or receiver, direct or inductive coupling
CMS has developed several National Coverage Determinations (NCDs) for surgically implanted neurostimulators. The following are the NCD numbers and titles from the OIG detailed report:
Under NCD 160.7 the medical record documentation requirements are very specific and include the following (several of which were found missing from the audited medical records):
- documentation that other treatment modalities have been tried and did not prove satisfactory or were judged to be unsuitable or contraindicated for the patient,
- documentation that the patient underwent a multidisciplinary screening
- documentation that the multidisciplinary screening included a psychological evaluation; and,
- documentation that the patient demonstrated pain relief with a temporarily implanted electrode prior to permanent implantation.
Under NCD 160.18 the medical record documentation requirements are specifically for seizures and include the following (several of which were found missing from the audited medical records):
- documentation that the patient did not have medically refractory partial onset seizures with failed or not recommended surgery; and
- documentation that the claim included a diagnosis code listed in the Medicare Claims Processing Manual is required.
Under NCD 160.24 the medical record documentation requirement are specific for Parkinson’s disease and essential tremor and include the following (several of which were found missing from the audited medical records):
- documentation that the diagnosis was based on kinetic tremors of the hands without other neurologic signs or a diagnosis of idiopathic Parkinson’s disease,
- documentation of a marked disabling tremor on an appropriate scale; and
- documentation of advanced idiopathic Parkinson’s disease using an appropriate scale.
The OIG identified several action items and recommendations for CMS:
(1) recover the portion of the $1,205,654 in identified Medicare potential overpayments for the 54 incorrectly billed claims that are within the 4-year reopening period;
(2) instruct the 46 providers identified with the incorrectly billed claims to refund $115,206 in coinsurance amounts that have been collected from the 48 sampled beneficiaries for claims within the 4-year reopening period;
(3) determine which of the remaining 58,107 claims in our sampling frame were incorrectly billed, recover Medicare overpayments that are within the 4-year reopening period, and instruct the providers to refund beneficiary coinsurance amounts; and
(4) notify the providers with potential overpayments estimated at $636,498,547, so they can exercise reasonable diligence to identify, report, and return any overpayments in accordance with the 60-day rule.
We also recommend that CMS:
(1) conduct provider outreach and education regarding the Medicare coverage requirements for neurostimulator implantation surgeries; and
(2) require prior authorization for neurostimulator implantation surgeries for Parkinson’s disease and seizure disorders.
On July 1, 2021, CMS published a final rule and began to require prior authorization for the implanted neurostimulators, however, this rule did not include implantation neurostimulator surgeries for Parkinson’s disease and seizure disorders.
As with other OIG healthcare related reports, this report gives the provider community a heads up on a new documentation and coding compliance area to focus on. Start by running a report on these three CPT codes and identify the frequency, provider, dates of service and total charges. In addition, review carefully documentation that supports prior authorization and medical necessity (per NCD) according to Medicare regulations. Remember that if any overpayments are identified that the rebilling of these claims needs to be completed without a 60 day period in accordance with CMS regulations.
Physician providers and their staff should review closely the NCDs and the documentation requirements. In addition, ensure that copayments are required under the Medicare regulations and if copayments were incorrectly collected, establish the steps for these to be refunded to the beneficiaries. Since the Medicare contractors will be taking steps to recover overpayments, watch for MAC (Medicare Administrative Contractor) communication.
The full OIG report is available at: https://oig.hhs.gov/oas/reports/region1/11800500.pdf
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