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OIG Overpaid $636 Million for Neurostimulator Implantation Surgeries
Published on Oct 20, 2021
 | Billing 
 | Coding 
 | OIG 

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.

Beth Cobb

October 2021 P.A.R. Pro Tips: Neurostimulator Implantation Surgeries
Published on Oct 20, 2021
 | Billing 
 | Coding 
 | OIG 

MMP’s Protection Assessment Report (P.A.R.) combines current Medicare Fee-for-Service review targets (i.e. MAC, RAC, OIG, etc.) with hospital specific paid claims data made possible through a collaboration with RealTime Medicare Data (RTMD). Monthly, our newsletter spotlights current review activities in this P.A.R. Pro Tips article. This month’s focus is on neurostimulator implantation surgeries.

Did You Know?

Effective for services on or after July 1, 2021, implanted spinal neurostimulator procedures was one of two new procedures added to the list of procedures included in the Prior Authorization for Certain Hospital Outpatient Department (OPD) Services program (">link).

On October 5, 2021, the Office of Inspector General released the report Medicare Overpaid More Than $636 Million for Neurostimulator Implantation Surgeries (link). The OIG made several recommendations to CMS in response to the review findings. One recommendation being that MACs conduct provider outreach and education.

Pro Tip: MAC Neurostimulation Implantation Surgery Provider Outreach and Education Efforts

In response to neurostimulation implantation being added to the Prior Authorization for Certain OPD Services program and to recommendations made by the OIG in their report, the MACs have been conducting provider outreach and education. This article highlights resources available by the different MACs. You can read more about the OIG report in a related article in this week’s newsletter.

CGS (Jurisdiction 15)

The CGS OPD Prior Authorization webpage (link) includes medical record documentation needed to meet coverage criteria for all procedures in this program including implanted spinal neurostimulators.

First Coast Service Options, Inc. (Jurisdiction N)

First Coast published the article Implantation of spinal neurostimulator in their October 13, 2021, First Coast eNews article (link).

You can also find general documentation requirements and links to Local Coverage Determination (LCD) and Local Coverage Article (LCA) for Spinal Cord Stimulation for Chronic Pain on their PA Program general documentation requirements webpage (link).

National Government Services (J6 and JK MAC)

In July, NGS posted a news article (link) to their website highlighting information about prior authorization for implanted spinal neurostimulators including:

  • The applicable HCPCS code,
  • Documentation Requirements, and
  • Links to related content.

You will find a link to the required coversheet to request prior authorization for performing an implanted spinal neurostimulator procedure and National Coverage Determination (NCD) 160.7 Electrical Nerve Stimulators on the NGS Prior Authorization Documentation webpage (link) includes a

Noridian (JE and JF MAC)

Both Noridian JE (link) and Noridian JF (link) have an article posted under Medical Review on their website, that provides general documentation requirements and links to their LCD and LCA for Spinal Cord Stimulators for Chronic Pain.

Novitas Solutions Jurisdiction (JH and JL MAC)

Novitas recently published the article Prior Authorization: Implantation of Spinal Neurostimulator in (link), highlighting the components of the spinal cord neurostimulator system, documentation requirements, best practice documentation feedback/tips and links to related content including their LCD and LCA titled Spinal Cord Stimulation.

In July 2021, Novitas updated their Prior Authorization Program for certain hospital outpatient department services general documentation requirements article to include guidance for implanted spinal neurostimulators (trial or permanent) and cervical fusion with disc removal (link).

Finally, in case you missed it, you can view a September 8, 2021 webinar (link) recording focused on reviewing the two new services requiring PA effective dates of service on and after July 1, 2021.

Palmetto GBA (JJ and JM MAC)

On October 12, 2021, Palmetto GBA updated their article titled Implantation of Spinal Neurostimulator. You can find this article on their Outpatient Department Prior Authorization (PA) webpage (link). Additional resources available on the Palmetto website includes:

  • A Documentation Checklist (link) highlighting the documentation requirements for trial or permanent implanted spinal neurostimulators,
  • An on-demand webinar video (link) highlighting the two services added to Outpatient PA program effective July 1, 2021 (implanted spinal neurostimulators and cervical fusion with disc removal), and an
  • Links LCD (L37632) and LCA (A56876) for Spinal Cord Stimulators for Chronic Pain (link).

WPS (J5 and J8 MAC)

WPS has published an article (link) highlighting the July 1, 2021 addition of implanted spinal neurostimulators to the hospital outpatient department Prior Authorization Program.

On August 18, 2021, WPS posted a YouTube video (link) detailing the process for submitting a prior authorization request for implanted spinal neurostimulators.

WPS also has a live event scheduled for October 26, 2021, titled Prior Authorization – Understanding Implanted Spinal Neurostimulators in the Hospital Outpatient Department (">link). They note in the announcement that this teleconference will answer questions on:

  • Inpatient Psychiatric Facility (IPF),
  • Inpatient Rehabilitation Services,
  • Routine Foot Care, and
  • Wound care in a Critical Access Hospital (CAH).

What Can You Do?

Take advantage of resources made available by your MAC related to implanted spinal neurostimulators.

Beth Cobb

Medicare Quarterly Provider Compliance Newsletter and a Tangled Web
Published on Sep 29, 2021
 | CERT 
 | OIG 
“Oh, what a tangled web we weave…when first we practice to deceive.”
- Sir Walter Scott

“Oh, what a tangled web we weave…. when first we practice to protect.” Changing just one word in this quote from “deceive” to “protect” makes it become an apt description of the numerous medical review contractors that are part of the CMS Medical Review and Education Program (link).

This premise is supported by CMS’ stated purpose for this interconnected web of medical review contractors as being to “identify errors through claims analysis and/or medical review activities. Contractors use this information to help ensure they provide proper Medicare payments (and recover any improper payments if the claim was already paid.) Contractors also provide education to help ensure future compliance.”

The Medicare Quarterly Provider Compliance Newsletter is one tool used for provider education. This quarterly newsletter’s aim is to provide guidance to address billing errors identified by Medicare Administrative Contractors (MACs) and other contractors such as Recovery Auditors, the Comprehensive Error Rate Testing (CERT) Review Contractor, and the Supplemental Medical Review Contractor (SMRC). Other governmental organizations, such as the Office of Inspector General (OIG), also conduct reviews and identify issues. The CMS recently announced the release of the July 2021 edition of this newsletter (link).

July 2021 Newsletter Topics:

  • the Comprehensive Error Rate Testing (CERT) program review of glucose testing supplies,
  • Recovery Auditor Issue 0181: Bone Marrow or Stem Cell Transplant: Medical Necessity and Documentation Requirements
  • Recovery Auditor Issue 0081: Negative Pressure Wound Therapy: Medical Necessity and Documentation Requirements.

As I read through the newsletter, I noted that the CERT findings include background information, examples of improper payments and resources. Likewise, the Recovery Auditor review of negative pressure wound therapy includes a problem description, background information, recommendations to prevent denials and improper payments and resources. However, the Recovery Auditor review of bone marrow or stem cell transplant is lacking examples of improper payments and/or recommendations to prevent denials and improper payments. This lack of information led me to the CMS RAC webpage in search of additional information related to the RAC issue 0181. Much to my surprise this issue is no longer on the list of approved RAC issues and is no longer on the individual RACs list of approved issues.

Inpatient Bone Marrow and Stem Cell Transplant Procedures Medical Review Timeline
February 2016: OIG Review

The OIG noted in a February 2016 report (link) that Medicare had paid hospitals $185.9 million for inpatient claims related to bone marrow and stem cell transplant procedures. The OIG identified two hospitals that did not always comply with the Medicare billing requirements for inpatient claims for stem cell transplants that resulted in approximately $4 million in overpayments. In general, lengths of stay (LOS) for these claims ranged from 10 to 21 days. However, the LOS for claims reviewed were one to two days. Based on findings from the two hospitals, the OIG conducted a nationwide review of 143 claims and found that 133 (93%) of the claims did not comply with Medicare billing requirements. The two reasons cited by the OIG for noncompliance included:

  • Hospitals incorrectly billing Medicare Part A for stays that should have been billed as outpatient, or outpatient with observation services, and
  • Hospitals billing an incorrect Medicare Severity-Diagnosis Related Group (MS-DRG).
January 2019: New Review Project for SMRC

In response to the OIG report, the CMS tasked the SMRC (Noridian) with reviewing inpatient bone marrow and stem cell transplant procedures to determine compliance with statutory, regulatory, and sub-regulatory guidance. The SMRC reviewed claims billed on dates of service from January 1, 2017, through December 31, 2017. Specific MS-DRGs requested included:

  • MS-DRG 014: Allogenic bone marrow transplant,
  • MS-DRG 016: Autologous bone marrow transplant with a complication or comorbidity (CC), and
  • MS-DRG 017: Autologous bone marrow transplant without a CC or major CC (MCC).

For this project, Noridian included the following list of specific documentation requirements in each Additional Documentation Request (ADR) sent to providers:

  1. Documentation to support the beneficiary was expected to require an inpatient level of care for at least 2-Midnights
  2. Documentation to support an inpatient level of care was expected and provided. Documentation should include, but is not limited to: Medication Administration Records (MAR), History & Physical, Physician Progress Notes, Nursing Notes, Discharge Summary, Procedure Notes
  3. Inpatient admission order from attending physician
  4. Physician or Non-Physician Practitioner (NPP) order for the stem cell transplant for the dates of service
  5. Medical documentation that supports the beneficiary met criteria for one of the following covered services:
    1. Allogenic Hematopoietic Stem Cell Transplantation (HSCT)
    2. Autologous Stem Cell Transplantation (AuSCT)
  6. Documentation to support enrollment in an approved Clinical Research Study, if applicable
  7. Full detailed itemization of services, including diagnosis codes
  8. Legible handwritten physician and/or clinician signatures
    1. Signature logs and Signature Attestation Statement should be submitted when physician and/or clinician signatures are illegible
  9. Valid electronic physician and/or clinician signatures
  10. Advance Beneficiary Notice of Noncoverage (ABN), if applicable

Results of this review were posted to the SMRC website in October 2019. The error rate for the SMRC Project 01-006 (link) was 86%. Common reasons for denial cited by the SMRC included:

  • Documentation received did not support medical necessity of an inpatient stay,
  • No response by a provider to the documentation request,
  • Signature requirements not being met, and
  • Incorrect coding.
March 2020: RAC Approved Issue 0181: Complex Review of Hospital Inpatient Bone Marrow or Stem Cell Transplants

Six months later, further proof of the interconnected web of medical review contractors concept, a review of bone marrow and stem cell transplants became a RAC approved issue. Each of the 4 RAC Regions added Issue 0181 to their list of Issues in March of 2020 (link). Even Though RAC Issue 0181 is no longer listed on the RAC websites, if your hospital performs these procedures, I encourage you to perform a review of these inpatient records for documentation supporting medical necessity of the procedure and the inpatient stay.

Moving Forward

In July of this year, each of the RACs posted the following notice: “The Centers for Medicare & Medicaid Services (CMS) is required to protect the Medicare Trust Fund against inappropriate payments which pose a risk to the Trust Fund. Therefore, we are resuming Medicare Fee-for-Service medical review activities. The COVID-19 Public Health Emergency (PHE) continues to be monitored very closely.”

It is important to be aware of who your review contractors are, what issues they are focused on, and respond to ADRs in a timely manner. If you are unsure of who your review contractors are you can find out by using the CMS Review Contractor Directory – Interactive Map (link).

Beth Cobb

June 2021 PAR Focus: OIG Workplan
Published on Jun 16, 2021

Prior to 2017, the Office of Inspector General’s (OIG) Work Plan was published on an annual and sometimes semi-annual basis. The OIG began updating the Work Plan on a monthly basis effective June 15, 2017. The change was made as the OIG acknowledged that the “work planning process is dynamic, and adjustments are made throughout the year to meet priorities and to anticipate and respond to emerging issues with the resources available.” The Work Plan includes items for several agencies (i.e., Centers for Medicare & Medicaid Services (CMS), Administration for Children and Families, Office of Civil Rights (OCR)). There are two recent additions to the Work Plan that I would like to share with you.

Active Work Plan Item: Impact of Expanding the Hospital Transfer Payment Policy for Early Discharges to Post-acute Care

This item (link) was added to the Work Plan in May 2021. The OIG plans to determine the impact for Medicare and hospitals if the Post-Acute Care (PAC) MS-DRG list was expanded to include all MS-DRGs. In the detail of this Work Plan item, the OIG notes that “Analysis of Medicare claims data demonstrates significant occurrences of early discharges from hospitals to PAC facilities for MS-DRGs that are not currently subject to the PAC transfer payment policy. Medicare pays a full prospective payment system (PPS) rate to hospitals for these early discharges.”

The Post-Acute Care Transfer (PACT) Policy was implemented to prevent Medicare from paying for the same care twice. This policy currently reduces reimbursement to a hospital when:

  • A hospitalization codes to an MS-DRG designated as a Transfer MS-DRG,
  • The patient’s length of stay (LOS) is at least 1 day less than the geometric mean length of stay (GMLOS) for the MS-DRG, and
  • The patient is discharged to one of the “qualified discharges” (03-Skilled Nursing Facility (SNF), 05-Children’s Hospital or Designated Cancer Center, 06-Home with Home Health within 3 days of discharge, 50-Discharges/Transferred to Hospice Home, 51-Discharged/Transferred to Hospice, General Inpatient Care or Inpatient Respite, 62-Inpatient Rehabilitation Facilities & Units, 63-Long Term Care Hospitals, and 65-Psychiatric Hospitals & Units)

Annually, CMS publishes a list of MS-DRGs subject to the PACT policy in Table 5 of the applicable Fiscal Year IPPS Final Rule. For FY 2021 there are 765 MS-DRGs and 280 (36.6%) have been designated a PACT MS-DRG.

Discharge Dispositions hospice home (50) and hospice general inpatient care/respite (51) were added to this policy in FY 2019 as required by the Bipartisan Budget Act of 2018. At that time, CMS actuaries estimated that the change would “generate an annual savings of approximately $240 million in Medicare payments in FY 2019, and up to $540 million annually by FY 2028.” With these estimates it is no wonder the OIG has added this item to their Work Plan. The OIG has an expected issue date for a report in FY 2022.

Active Work Plan Item: Audit of the Effectiveness of HHS’s Governance to Ensure Hospitals Implement Measures to Prevent, Detect, and Recover from Cyberattacks

This item (link) was also added to the Work Plan in May 2021. As an active member of MMP’s HIPAA/HITECH Privacy Committee, I felt it was important to make our readers aware of this item. If you listen to the news, this is a very timely item as hospitals are constantly under threat of the theft of electronic protected health information (ePHI) by ransomware, malware, insider threats, and even honest mistakes.

“In October 2020, the Cybersecurity and Infrastructure Security Agency, Federal Bureau of Investigation, and Department of Health and Human Services (HHS) issued a joint cybersecurity advisory (link) regarding ransomware activity targeting the health care and public health sector. The advisory stated that threat actors have continued to develop new functionality and tools, thereby increasing the ease, speed, and profitability of ransomware attacks.”

OIG Audit Plan
  • “Audit HHS's governance over its programs to determine whether HHS's Office of Civil Rights (OCR) has performed periodic audits of hospitals to assess compliance with Health Insurance Portability and Accountability Act (HIPAA) Security, Privacy, and Breach Notification rules and determine whether these audits effectively assessed ePHI protections.”
  • “Determine whether CMS's certification process for participation in the Medicare program requires hospitals participating in the Medicare program to implement minimum security safeguards to prevent and detect cyberattacks, ensure continuity of patient care, and protect beneficiary data.”
  • Conduct security assessments at 10 U.S. hospitals to determine whether they have adequately implemented HIPAA security requirements or effective cybersecurity measures to prevent, detect, and recover from cyberattacks.”

The OIG has an expected issue date for a report in FY 2022.

2016-2017 OCR HIPAA Audits Industry Report

As mentioned above, the OIG plans to determine if the OCR has performed periodic audits of hospitals. On December 17, 2020, the Office for Civil Rights (OCR) released its 2016-2017 HIPAA Audits Industry Report. The Health Information Technology for Economic and Clinical Health (HITECH) Act requires HHS to periodically audit covered entities (CEs) and business associates (BAs) for compliance with the HIPAA Rules. This Industry Report was published to share overall findings from audits conducted with 166 CEs and 41 BAs. To provide insight into what was included in the audit, following is the summary of audit findings from the December HHS Press Release (link):

  • Most covered entities met the timeliness requirements for providing breach notification to individuals,
  • Most covered entities that maintained a website about their customer services or benefits satisfied the requirement to prominently post their Notice of Privacy Practices on their website,
  • Most covered entities failed to provide all the required content for a Notice of Privacy Practices,
  • Most covered entities failed to provide all the required content for breach notification to individuals,
  • Most covered entities failed to properly implement the individual right of access requirements such as timely action within 30 days and charging a reasonable cost-based fee,
  • Most covered entities and business associates failed to implement the HIPAA Security Rule requirements for risk analysis and risk management.

The HHS Press Release ended with the following statement from OCR Director Roger Severino, “The audit results confirm the wisdom of OCR’s increased enforcement focus on hacking and OCR’s Right of Access initiative…We will continue our HIPAA enforcement initiatives until health care entities get serious about identifying security risks to health information in their custody and fulfilling their duty to provide patients with timely and reasonable, cost-based access to their medical records.”

Beth Cobb

New OIG Work Plan Items
Published on Jan 28, 2019
 | FAQ 
 | OIG 

The mission of the Office of the Inspector General (OIG) is “to protect the integrity of Department of Health & Human Services (HHS) programs as well as the health and welfare of program beneficiaries” with most of their resources focused on oversight of Medicare and Medicaid. I believe this is a noble mission as these programs provide benefits to our elderly and others in need of healthcare. On a personal note, I am getting closer to the day when I will be a Medicare beneficiary and I am even more thankful that agencies such as the OIG have worked hard over the years to protect the Medicare Trust Fund so benefits remain.

Hospitals often feel the sting of OIG investigations, especially when findings indicate a need to refund payments. The benefit of even these investigations, other than protecting the integrity of the programs, is that the reports provide guidance to all hospitals furnishing the same or similar services. The OIG also examines practices of the Medicare and Medicaid agencies themselves and the contractors who administer the programs. The OIG added several new issues to their Work Plan website in January 2019, some of which focus on outcomes from program changes, recommended actions from prior audit findings, and expansion of a prior review in a new direction.

Laboratory Tests Payment Rates

In 2018, CMS began paying for clinical laboratory services under a new system mandated by the Protecting Access to Medicare Act (PAMA) of 2014. Lab payment rates under the new system are set based on the current charges in the private health-care market (as reported to CMS by applicable reporting laboratories). PAMA also requires an annual publicly reported analysis of the top 25 laboratory tests by expenditures by the OIG. In 2019, the OIG will release an analysis of the first year of payments made under the new system for setting payment rates.

Post-Acute-Care Transfer Policy (PACT Policy)

Prior OIG audits identified issues where incorrect discharge dispositions reported on hospital inpatient claims resulted in Medicare overpayments. Under the PACT policy, select Medicare MS-DRG payments for hospital inpatient stays discharged to certain post-acute care settings are paid a prorated rate instead of the full MS-DRG payment amount that would be paid if the patient was discharged to home. Medicare has common working file (CWF) edits that should be able to identify when discharges to these post-acute care settings occur and are reported incorrectly. Then Medicare can notify the hospital to correct the discharge status on the claim so they will receive an accurate payment. The prior audits revealed that Medicare’s edits were not working properly. This follow-up audit will determine whether CMS corrected the CWF edits and ensured they are working properly.

It is important to note that it is not always a coding error that results in an incorrect discharge status code. Often the assigned discharge code matches the documentation in the medical record, but circumstances change at or shortly after discharge that result in the patient going somewhere other than home. This is why it is important to have processes in place to follow up on discharged Medicare patients. For more information on the PACT policy and suggestions on how best to handle this, please see this September 2018 Wednesday@One PACT Article.

Outlier Payments and Device Credit Policy

For years and throughout many different audits, the OIG has found problems with hospitals not reporting appropriately under the device credit policy. The device credit policy requires hospitals to report information on the claim notifying Medicare when they have received certain devices at no or significantly reduced cost. Medicare then reduces the outpatient or inpatient payment amount by the device credit amount reported. This newly announced Work Plan item is a twist on an old issue. For no-cost devices, Medicare instructs providers to report the device line item with a minimal charge (such as $0 or $1), but there is no guidance from Medicare on the charges reported for partial-credit devices. The new OIG audit will look for overstated Medicare charges on outpatient claims with a reported medical device credit that have an outlier payment. Specifically, they would look for elevated charge amounts, such as too large an amount on the partially credited device or device procedure that results in an inappropriate outlier payment. The OIG “will determine whether Medicare payments for replaced medical devices and their respective outlier payments were made in accordance with Medicare requirements.”

For this last issue on the device credit policy, hospitals may want to assess what charges they report for partially credited devices and make sure the charge amounts are appropriate and would not lead to inappropriate outlier payments. Also, this may be a good time to review your entire procedure for complying with the device credit policy, which is a difficult endeavor.  The other two new audit issues are more reviews of CMS actions than hospital actions, but again a good time to review your internal policies for determining and reporting discharge status.

There is nothing hospitals can do about the new laboratory prices. It is a good time to remind hospitals that for 2019, CMS changed the definition of an applicable reporting laboratory required to report lab private-payor data to Medicare. This was done to include more hospital laboratories in the reporting. Under the new definition, hospital outreach laboratories that have over $12,500 of Medicare lab revenues in a six-month period under the 14x type of bill (non-patients) are required to report. You can find more information about PAMA and applicable reporting labs at Medicare Lab PAMA webpage.

Debbie Rubio

Are You Coding Correctly?
Published on Dec 04, 2018

At this time of year, do you try to get your children or grandchildren to behave better by telling them “Santa Claus is watching?” Santa is watching the kids, but for medical coders, Medicare is watching and not just at Christmas time.

Medicare medical review activity is often the subject of the articles in this newsletter. A lot of the audits and their associated denials focus on the medical necessity of services and documentation to support that. But coders and Medicare reviewers also know that inaccurate coding can often result in improper payments for Medicare services. In November, the Office of Inspector General (OIG) added a new topic to their Work Plan that will examine hospital inpatient coding - Assessing Inpatient Hospital Billing for Medicare Beneficiaries.  Here is the OIG’s description of the new Work Plan item:

“In 2016, hospitals billed Medicare $114 billion for inpatient hospital stays, accounting for 17 percent of all Medicare payments. The Centers for Medicare & Medicaid Services and the Office of Inspector General have identified problems with upcoding in hospital billing: the practice of mis- or over-coding to increase payment. We will conduct a two-part study to assess inpatient hospital billing. The first part will analyze Medicare claims data to provide landscape information about hospital billing. We will determine how inpatient hospital billing has changed over time and describe how inpatient billing varied among hospitals. We will then use the results of this analysis to target certain hospitals or codes for a medical review to determine the extent to which the hospitals billed incorrect codes.”

Although this description uses the phrase “the practice of mis- or over-coding to increase payment,” healthcare providers and coders know that usually increased payment from coding errors is just that – an error, without intent to defraud anyone. That is why hospitals need to make sure their coders are knowledgeable, well-trained, and receive appropriate on-going education. They also need to have processes in place for over-sight such as routine internal and/or external audits of coding.

The OIG is not the only Medicare reviewer currently looking at hospital inpatient coding accuracy. All four of the Recovery Auditors (RACs) have an approved issue for MS-DRG Validation audits:

“MS-DRG Coding requires that diagnostic and procedural information and the discharge status of the beneficiary, as coded and reported by the hospital on its claim, matches both the attending physician description and the information contained in the beneficiary's medical record. Reviewers will validate MS-DRGs for principal and secondary diagnosis and procedures affecting or potentially affecting the MS-DRG assignment.”

Medicare Administrative Contractors (MACs) Novitas (Jurisdictions H and L) and WPS (J5 and J8) also have DRG Validation listed as one of their Targeted Probe and Educate (TPE) medical review topics. Palmetto JJ and JM have TPE DRG Validation (coding) reviews for Heart Failure and Shock with MCC or CC (MS-DRGs 291 and 292). The guidelines for inpatient diagnosis coding are found in the ICD-10-CM Official Guidelines for Coding and Reporting and for procedure coding in the ICD-10-PCS Official Guidelines for Coding and Reporting. On-going guidance is provided through updates in the American Hospital Association (AHA)’s Coding Clinic.

Medicare reviewers also examine coding accuracy for outpatient claims. For outpatient diagnosis coding, coders follow the guidance of Diagnostic Coding and Reporting Guidelines for Outpatient Services. Since outpatient claims are paid based on procedure codes, this area is also ripe for audit. Specifically, all four RACs have APC Validation approved audits – “APC coding requires that procedural information, as coded and reported by the hospital on its claim, match both the attending physician description and the information contained in the beneficiary's medical record. Reviewers will validate the APC by reviewing the procedures affecting or potentially affecting the APC assignment.”

Outpatient procedures are reported with CPT and HCPCS codes. The American Medical Association (AMA) CPT Manual, CPT Assistant and the AHA’s Coding Clinic for HCPCS provide guidance on appropriate CPT coding. CMS creates and maintains alpha-numeric HCPCS codes and often provides guidance on their usage through transmittals and manual instructions. In addition, CMS follows the guidance of the National Correct Coding Initiative (NCCI) so coders also have to be aware of these instructions. NCCI instructions may or may not be consistent with CPT instructions making the coder’s job even harder. There are numerous audit issues that look at individual coding requirements from CPT and/or NCCI as evidenced by these RAC issues:

  • Shoulder arthroscopy procedures include a limited debridement (e.g., CPT code 29822).
  • Reporting multiple cataract removal codes for the same eye.
  • Coding right heart catheterization with an endomyocardial biopsy.
  • Add-on codes reported without primary code.
  • A diagnostic endoscopy HCPCS/CPT code shall not be reported with a surgical endoscopy code. (recently added RAC issue)

As you can see, coders have a lot to keep up with to ensure accurate coding. Santa may be watching all the children to see if they are naughty or nice, but Medicare is watching coders to see if they are coding correctly.

Debbie Rubio

Post-Acute Care Transfer Policy Issues
Published on Sep 04, 2018
 | FAQ 
 | Billing 
 | Coding 
 | OIG 

If you are a frequent reader of our newsletter, you often see the acronyms “OPPS” and “IPPS.” These refer respectively to the outpatient and inpatient prospective payment systems. Medicare describes a Prospective Payment System (PPS) as “a method of reimbursement in which Medicare payment is made based on a predetermined, fixed amount. The payment amount for a particular service is derived based on the classification system of that service (for example, diagnosis-related groups (DRGs) for inpatient hospital services).” This means for a particular DRG, a hospital always receives the same payment. Well, that is, until they don’t. Under Medicare’s transfer policies, DRG payments are prorated (reduced) when a patient transfers to another hospital or to select post-acute care settings. The specific regulations regarding transfer policies can be found in Chapter 4 of the Medicare Claims Processing Manual, Section 40.2.4.

The transfer policies bring in yet another acronym - the post-acute care transfer (PACT) policy. In recent weeks, two issues have come up related to the PACT policy. Before discussing these issues, let’s do a quick review of the policy.

  • PACT policy only applies to certain MS-DRGs. The list of DRGs to which the policy applies is updated annually as Table 5 of the IPPS Final Rule.
  • PACT policy only applies when the patient is transferred to certain post-acute care settings:
  • Inpatient rehab facilities and units (discharge status code 62)
  • Long term care hospitals (code 63)
  • Psychiatric hospitals and units (code 65)
  • Children’s and Cancer hospitals (code 05)
  • Skilled nursing facilities (code 03)
  • Home with a home health plan of care that begins within 3 days (code 06)
  • Medicare identifies transfers to the affected settings by the discharge status code on the claim. If Medicare receives a claim from a post-acute care provider for days immediately after discharge, they will ask the transferring hospital to adjust their discharge status code as needed.
  • Payment is only reduced if a patient stays fewer days than expected in the first (transferring) hospital for a particular DRG (the geometric mean length of stay or GMLOS).
  • Payment is reduced to the transferring hospital. A per diem rate is calculated by dividing the MS-DRG rate by the GMLOS. The transferring hospital is paid 2 x the per diem rate for the first day and the per diem rate for subsequent days up to the full MS-DRG payment.
  • There are special pay MS-DRGs (also noted in Table 5) that are paid differently, with a higher payment percentage for the first day of hospitalization.
  • Transfer cases are eligible for outlier payments

Also see MLN Matters Article SE1411 for more information about discharge status and Medicare transfer policies.

The first new PACT issue is that the 2019 IPPS Final Rule added discharges to hospice to the PACT policy. This change was made in accordance with amendments to the Social Security Act by the Bipartisan Budget Act of 2018. The new law requires a discharge to hospice care provided by a hospice program to be a qualified discharge under PACT. This means qualifying DRGs with a Patient Discharge Status code of 50 (Discharged/Transferred to Hospice—Routine or Continuous Home Care) or 51 (Discharged/Transferred to Hospice, General Inpatient Care or Inpatient Respite) are subject to the post-acute care transfer policy effective for discharges occurring on or after October 1, 2018.

The second issue related to the PACT policy is a new item added to the August update of the Office of Inspector General (OIG) Work Plan:

“Hospitals' Compliance with Medicare's Transfer Policy With the Resumption of Home Health Services and the Use of Condition Codes

Medicare payments to acute care hospitals for inpatient stays under Medicare Part A are made on the basis of prospectively set rates. Normally, Medicare pays a hospital discharging a beneficiary the full amount for the corresponding diagnosis-related group (DRG). In contrast, a hospital that transfers a beneficiary to another facility or to home health services is paid a graduated per diem rate, not to exceed the full DRG payment. When transferring a patient to home health services, the hospital can apply specific condition codes to the claim and receive the full DRG payment. The hospital is responsible for coding the bill on the basis of its discharge plan for the patient or adjusting the claim if it finds out that the patient received postacute care after the discharge. We will determine whether Medicare appropriately paid hospitals' inpatient claims subject to the postacute care transfer policy when (1) patients resumed home health services after discharge or (2) hospitals applied condition codes to claims to receive a full DRG payment.”

The PACT policy applies when patients are discharged to “home under a written plan of care for the provision of home health services from a home health agency and those services occur within 3 days after the date of discharge - Patient Discharge Status Code 06 (or 86 when an Acute Care Hospital Inpatient Readmission is planned)” with some exceptions. One exception is when the home health services are not related to the reason for the inpatient admission hospital stay. In this case, condition code 42 is reported on the claim with a discharge status code 06, and the hospital will receive full payment based on the MS-DRG and not a per diem payment. This may occur when there is a resumption of home care services the patient was receiving before hospital admission, if the reason for the home health services is not related to the reason for hospital care.

A hospital can also receive full payment if the home health services do not begin within 3 days of the inpatient discharge. If home care was started more than three days after discharge from the hospital, the hospital would report condition code 43 on the claim. Again, in this case, the hospital will receive full payment based on the MS-DRG and not a per diem payment.

Hospitals should definitely be reporting these condition codes when applicable so as to receive appropriate Medicare payments. But they also need to be sure they are using the codes correctly and only when the required conditions apply. The tricky part about discharge status coding is that the hospital staff may not always know what actually happens when the patient leaves the hospital. It is a good practice to have someone verify with the patient if and exactly what and when post-discharge care occurred. For example, if home health services were planned to begin on day 4 after discharge, but actually began on day 3, it would not be appropriate to report condition code 43. Or the reverse could happen – home health planned for day 2 but does not begin until day 4 after discharge, in which case reporting condition code 43 could result in a higher, appropriate payment.

Another key is communication between case management/discharge planners, coders, and the billing office. Case management documentation is usually the most reliable source for post-discharge plans. If something changes after discharge, and the case managers have followed up to know that, they need to amend documentation and inform the coders and billers if the account has already been coded and/or billed. One last recommendation is a compliance review of discharge status every now and then. This was a huge issue when I started in hospital compliance many years ago and as you can see by the new OIG Work Plan item, it continues to be so. Here is a list of the tips noted above plus a few more to ensure accurate discharge status coding, billing, and appropriate payments:

  • Make sure coders know and understand correct use of the discharge status code,
  • Make sure coders know where in the record to find the most accurate information concerning discharge status and whom to ask if they have questions,
  • Have a system in place to follow up after discharge to verify what post-discharge care the patient actually received,
  • Have processes for clear and timely communication between case management, coders and billers concerning discharge status,
  • Have a procedure to handle Medicare requests to change discharge status (this can occur when Medicare receives claims from other hospitals or post-acute care providers for services immediately following a hospital discharge), and
  • Perform periodic audits of discharge status.

Following these recommendations may prevent the OIG from NYTTW (nailing you to the wall) should your claims be audited.

Debbie Rubio

OIG Finds IMRT Planning Overpayments
Published on Aug 28, 2018
 | FAQ 
 | Billing 
 | OIG 

Some bundles are great – a bundle may refer to a “bundle” of money; you can have bundles of fun; or expecting parents look forward to their little bundle of joy. Other bundles – not so great. One such bundle that is not a bundle of fun is the bundled payment Medicare makes for Intensity-Modulated Radiation Therapy (IMRT) planning services. Payment bundles are fairly common in the Medicare world, but the onus is on providers to understand appropriate billing rules so they are not overpaid for bundled services. A recent Office of Inspector General (OIG) report found errors in IMRT planning billing that resulted in over $25 million in Medicare overpayments for the audit period (2013-2015). The report recommended education for providers on billing IMRT planning services correctly, and edits in Medicare’s billing system to prevent overpayments.

IMRT uses advanced computer programs to plan and deliver radiation to difficult-to-reach tumors with high precision while reducing exposure to surrounding healthy tissue. IMRT includes planning and delivery services. IMRT planning is a multistep process in which imaging, calculations, and simulations are performed to develop an IMRT treatment plan. Radiation is then delivered to a patient’s tumor at the various intensity levels prescribed in the IMRT treatment plan.

The basic rule for the bundling of IMRT planning services is found in section 200.3.1 of Chapter 4 of the Medicare Claims Processing:

  • “Payment for the services identified by CPT codes 77014, 77280, 77285, 77290, 77295, 77306 through 77321, 77331, and 77370 are included in the APC payment for CPT code 77301 (IMRT planning). These codes should not be reported in addition to CPT code 77301 when provided prior to or as part of the development of the IMRT plan. In addition, CPT codes 77280-77290 (simulation-aided field settings) should not be reported for verification of the treatment field during a course of IMRT.”

As evidenced by the OIG’s recommendations, the primary reasons for overpayments were that hospitals were unfamiliar with or misinterpreted CMS guidance and claim processing edits did not prevent overpayments. One of the biggest challenges for both hospitals and CMS is the bundling applies even to services billed on a different date of service than the comprehensive IMRT planning code (CPT 77301). CMS’s NCCI procedure-to-procedure edits applicable to IMRT planning services only applied to planning services billed on the same date of service as the billing of CPT code 77301 for the bundled payment. This application of bundling to different dates of service may also have caused some confusion for hospitals. The services in the OIG sample were billed on a different date of service from the IMRT planning CPT code 77301.

In analyzing payment data, the OIG noted that complex simulations billed using CPT code 77290 made up approximately 84% of the potential overpayments so that is the code they reviewed. They found that “In each case, a complex simulation was billed with CPT code 77290 on a different date of service from the IMRT planning code (i.e., up to 14 days before CPT code 77301 was billed). However, both services were performed for the same treatment site (e.g., the prostate). According to the independent medical review contractor, for each sampled line item, the complex simulation was performed as a part of the beneficiary’s overall IMRT treatment planning and therefore should not have been billed separately.”

The Claims Processing Manual guidance quoted above was updated after the OIG audit period to clarify that complex simulations are included in the APC payment for IMRT planning services “when provided prior to or as part of the development of the IMRT plan” (emphasis added). That was a step in the right direction but the OIG further recommended that CMS:

  • Implement an edit to prevent improper payments for IMRT planning services that are billed before (e.g., up to 14 days before) IMRT planning CPT code 77301 is billed, and
  • Work with the Medicare contractors to educate hospitals on properly billing Medicare for IMRT planning services.

Hospitals need to evaluate their billing practices for IMRT services now and verify they are not inappropriately billing separately for services included in IMRT planning. After all, a little OIG audit would not be a bundle of joy.

Debbie Rubio

Appropriate Billing for Ophthalmology Services
Published on May 29, 2018
 | Billing 
 | OIG 

The relationship between physicians and hospitals could be described as a symbiotic partnership, that is, a mutually beneficial relationship between different groups. Physicians need hospitals to provide the resources and personnel to care for their patients and hospitals need physicians to refer patients to the hospitals for such care when medically necessary. Physicians direct a patient’s care and decide when and what services are necessary. It also often falls on the physicians’ documentation to support that services and care provided and paid for by Medicare meet the requirements of being medically necessary. Unfortunately for hospitals, it is often their payment at risk if a physician provides a service in the hospital setting that is not medically necessary or fails to document sufficiently to support the medical necessity of the service. Because directing the patient’s care is the physician’s responsibility, many Medicare education resources about compliance are directed to the physicians. Likewise, hospitals must work with physicians to ensure services are appropriately provided and documented. Such is the case for ophthalmology services.

Though a number of ophthalmology services determined by the Office of Inspector General (OIG) to be at risk of “questionable billing” are more likely to be performed in a physician office setting, there are also services that could be performed in a hospital setting. Hospitals need to be aware of the concerns and requirements for these types of ophthalmology services.

A December 2014 OIG audit found that Medicare paid $22 million for ophthalmology claims in 2012 that were potentially inappropriate, according to national and local coverage requirements. The three eye conditions for which Medicare pays the most each year are cataracts, wet age-related macular degeneration (wet AMD), and glaucoma. The concerns for inappropriate payments related to these conditions are:

  • Cataracts
  • Medicare has a national requirement stating that it will not routinely cover more than one comprehensive eye examination and scan for beneficiaries whose only diagnosis was cataracts.
  • It is medically impossible to perform more than one cataract surgery on the same eye because an eye’s natural lens will never grow back.
  • Submitting disproportionately more claims for complex than standard cataract surgery.
  • Wet AMD
  • Some Medicare Administrative Contractors (MACs) have local coverage determinations (LCDs) limiting the number of wet AMD diagnostic or evaluation services for which a provider may bill annually.
  • Medicare paid providers substantially more for treating wet AMD with the expensive biologic Lucentis instead of other biologic treatments that are similarly effective.
  • Some MACs have LCDs specifying that Lucentis injections are not covered more frequently than once per month per eye. These guidelines are in keeping with the Food and Drug Administration (FDA)-approved dosing guidelines that Lucentis injections should be administered between once monthly and once every 3 months.
  • Medicare has a national requirement that it covers each step of ocular photodynamic therapy only when both steps are performed on the same date. These steps are billed separately, but they must be performed within 30 minutes of one another.
  • Glaucoma
  • A national requirement states that Medicare covers either of two types of screening services once every 12 months for beneficiaries at high risk for glaucoma.

A September 2015 follow up OIG report found Medicare paid $171 million for services associated with the measures on which certain providers demonstrated questionable billing.

Prior to these OIG reports, the Recovery Auditors identified overpayments associated to outpatient hospital providers billing more than one unit of cataract removal for the same eye for the same date of service. CMS published MLN Special Edition Article SE1319 in response to these findings. It reminded providers,

“According to the “National Correct Coding Initiative (NCCI) Policy Manual for Medicare Services,” Chapter 8, Section D #3, cataract removal codes are mutually exclusive of each other and can only be billed once for the same eye. Because CPT codes describing cataract extraction (66830-66984) are mutually exclusive of one another, providers may not report multiple codes for the same eye even if more than one technique is used or more than one code could be applicable. Only one code from this CPT code range may be reported for an eye.”

The NCCI Policy Manual chapter and section noted above addresses 25 other correct coding guidelines for ophthalmology services of which providers should be aware.

For another ophthalmology service, CMS clarified in a 2005 ruling that a Medicare beneficiary may request insertion of a presbyopia-correcting intraocular lenses (IOLs) in place of a conventional IOL following cataract surgery. However, if the Medicare patient selects a presbyopia-correcting IOL, he/she is responsible for payment of that portion of the charge for the presbyopia-correcting IOL and associated services that exceed the charge for insertion of a conventional IOL following cataract surgery. The MLN Article describing this ruling included payment policies for facilities and physicians.  The policy relevant to hospital services states:

  • For an IOL inserted following removal of a cataract in a hospital, on either an outpatient or inpatient basis, that is paid under the hospital outpatient prospective payment system (OPPS) or the inpatient prospective payment system (IPPS), respectively;
  • Payment for the IOL is packaged into the payment for the surgical cataract extraction/lens replacement procedure. Medicare does not make separate payment to the hospital for an IOL inserted following removal of a cataract.
  • For a presbyopia-correcting IOL inserted following removal of a cataract in a hospital, on either an outpatient or inpatient basis, that is paid under the OPPS or the IPPS, respectively;
  • The facility will bill for removal of a cataract with insertion of a conventional IOL, regardless of
  • whether a conventional or presbyopia-correcting IOL is inserted.
  • When a beneficiary receives a presbyopia-correcting IOL following removal of a cataract, hospitals and ASCs shall report the same CPT code that is used to report removal of a cataract with insertion of a conventional IOL.
  • There is no Medicare benefit category that allows payment of facility charges for services and supplies required to insert and adjust a presbyopia-correcting IOL following removal of a cataract that exceed the facility charges for services and supplies required for the insertion and adjustment of a conventional IOL.
  • There is no Medicare benefit category that allows payment of facility charges for subsequent treatments, services and supplies required to examine and monitor the beneficiary who receives a presbyopia-correcting IOL following removal of a cataract that exceed the facility charges for subsequent treatments, services and supplies required to examine and monitor a beneficiary after cataract surgery followed by insertion of a conventional IOL.

The article also addresses coding requirements, beneficiary liability and notification requirements for these services.

Both hospitals and physicians must be aware of and follow the Medicare requirements for providing and billing ophthalmology services. Working together to “get it right” keeps the relationship between physicians and hospitals mutually beneficial for both parties and for Medicare.  

Debbie Rubio

OIG Finds Overpayments for Specimen Validity Testing
Published on May 22, 2018
 | FAQ 
 | Billing 
 | OIG 

“No payment may be made under (Medicare) part A or part B for any expenses incurred for items or services — which, …, are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member, …”Social Security Act 1862(a)(1)(A)

If your work involves knowledge of Medicare requirements, you are likely very familiar with the above statement that is the basis for the concept of “medical necessity” for covered healthcare services. But do you actually consider the implications of this statement when billing Medicare for services?

It appears a large number of providers did not assess their services against this statement before billing Medicare for specimen validity testing as a recent Office of Inspector General (OIG) report found $66.3 million in overpayments for this type of testing. Specimen validity testing is used to analyze urine specimens prior to drug testing to determine whether the specimens have been adulterated or tampered with. Although necessary to assure the legitimacy of the drug testing, these tests themselves are not used to provide a diagnosis or treatment to a patient.

As the OIG report explains, the requirements for laboratory testing are that tests meet the requirement for medical necessity as described above and more specifically, to be covered under Medicare Part B, clinical laboratory tests must:

  • Be ordered by a physician who is treating a beneficiary for a specific medical problem;
  • Be related to the patient’s illness, injury, symptom or complaint; and
  • The results must be used in the management of the patient’s problem.

The overpayments occurred because the same tests used for specimen validity testing may be medically necessary if used to diagnose certain conditions. “For example, tests for urinary pH and specific gravity may be performed to diagnose diseases of the kidney and urinary system. If these tests are used for diagnosis, treatment, or management, they may be Medicare-covered services. However, when used for the purpose of determining whether a specimen is adulterated, the test results are not being used to manage a beneficiary’s specific medical problem. In these cases, specimen validity testing is not a separately billable Medicare-covered service.” 

Providers should have known this because, over the years, Medicare and their contractors have addressed this issue numerous times. Almost all the Medicare Administrative Contractors (MACs) have a Local Coverage Determination (LCD) for drug testing that includes direction that tests to validate urine specimens are not separately billable. The first such LCD instruction was in 2010 and in 2015 the Medicare National Correct Coding Initiative (NCCI) manual included the statement, “Providers performing validity testing on urine specimens utilized for drug testing should not separately bill the validity testing.” Beginning in 2016, new HCPCS codes for urine drug testing include specimen validity testing in their code descriptions and payments, regardless of whether specimen validity testing is performed or not. And in April 2016, NCCI edits were created to prevent payment for the type of lab tests performed for validity testing when billed on the same date of service as a urine drug test unless modified by the provider to indicate a “separate and distinct” service.

Although the number of overpayments dramatically decreased from 2014 to 2016, the OIG thinks further actions by CMS could reduce the risk of estimated overpayments of $12,146,760 over a 5-year period. The OIG recommends CMS “strengthen its system edits to prevent improper payments for specimen validity tests and instruct the Medicare contractors to educate providers on properly billing for specimen validity and urine drug tests.” Also, be warned that CMS may be recouping the overpayments identified in the OIG audit.

Now is a good time to investigate your billing practices for specimen validity testing with the understanding that if you have been separately billing these services, you owe the government some money back. Going forward, be sure to first apply the Social Security Act standard in determining whether to bill for services – i.e., to be paid under Medicare, a service must be reasonable and necessary for the diagnosis or treatment of illness or injury. After that, there are a lot more coverage rules that need to be considered, but it is a good place to start.

Debbie Rubio

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