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When I was growing up, there were lots of television commercials about cigarettes (remember the Marlboro man?), but none about prescription drugs. Things change. Today television commercials featuring tobacco products are banned, but the airwaves are inundated with advertisements for prescription medications. I am not sure that is any wiser choice than the cigarette commercials, but that is the way it is. You may also notice that the generic name of a large number of the medicines advertised end with the letters “mab.” This means the drug is a monoclonal antibody. Even if there had been television advertisements for drugs when I was growing up, they would not have been MABs, because those drugs were not even developed back then. I am sure there are a lot of things that can be said about monoclonal antibodies, but two such statements could be - first, they offer new hope to many with certain conditions and second, “cha-ching!” meaning of course they are expensive drugs.

As a payor of healthcare services, specifically drugs in this case, Medicare wants to ensure the drugs they are paying for are appropriate (medically necessary), administered to the patient, and follow Medicare and evidence-based guidelines. Add this to the high costs of some of these drugs and it is not surprising that a number of Medicare Administrative Contractors (MACs) are auditing certain drugs under their Targeted Probe and Educate (TPE) audits. Specifically, Palmetto GBA (Jurisdictions J and M) and Novitas (Jurisdictions H and L) include the review of several drugs in their TPE Medical Reviews. As the name indicates, TPE reviews focus on individualized provider education. The MACs also offer educational resources that are available to all through their websites. Palmetto has recently added the following “checklists” for drugs to their website as well as an article about Prolia (Denosumab).

Neulasta Checklist

Prolia Checklist 

Rituxan Checklist 

Remicade Checklist 

Avastin Checklist 

These checklists include the basic requirements for the billing of any drug administered to outpatients –

• A signed and dated physician’s order that includes the dosage, frequency, and route of administration
• Documentation supporting the need for the drug and the patient’s diagnosis – this may require the hospital to obtain the physician’s office notes discussing the patient’s condition and treatment
• The units billed, the units ordered, and the units administered to the patient must all match
• A protocol was followed as specified in the package insert (FDA approved) or in accepted drug compendia for off-label uses
• Medicare and MAC-specific coverage requirements for the drug are met
• The medical record includes documentation of the administration of the drug with date, time, route, dose, and patient response

Some drugs require additional documentation such as the patient’s weight or body surface area to calculate dosage or other documentation based on coverage requirements. For example, the drug Prolia (denosumab) requires documentation the patient is taking calcium and vitamin D supplements or the reasons why not and documentation the patient has had an x-ray or DEXA scan.

The benefit of these checklists is that if you use them and make sure you submit all of the required documentation upon request for records for Medicare review, your chances of being paid by Medicare are much better than if you didn’t follow a checklist. Is this a Medicare contractor being nice to providers?!? Well, things change.

The kicker to the saying that “time flies when you’re having fun,” is that time also flies when you are not. However, I have been extremely fortunate over the past 10 years to actually enjoy my job. Last October marked my 10-year anniversary as an employee of Medical Management Plus, Inc. (MMP). Yes, it is nerdy that I actually enjoy reading Medicare regulations, but I do. I enjoy even more writing articles, such as this one, which I hope share Medicare and related guidance in an easy-to-read and understandable format and help our readers do their own challenging healthcare jobs better. The rapid passing of time is relevant because the very first article I wrote at MMP over ten years ago was about the 2008 AHIMA (American Health Information Management Association) article, “Managing an Effective Query Process.”

In February of this year, the Association of Clinical Documentation Improvement Specialists (ACDIS) and the American Health Information Management Association (AHIMA) jointly produced “Guidelines for Achieving a Compliant Query Practice (2019 Update).”  This Practice Brief is the recommended industry standard for provider queries and describes best practices for coding and clinical documentation improvement (CDI) professionals performing query functions. It supersedes the 2016 and all prior versions.

Coders and CDI professionals should carefully review and follow the practices described in this Brief, but other healthcare team members also need to be aware of this guidance. For example, case management, quality management professionals, and infection control clinicians educate physicians to document a certain way. Since these interactions could ultimately affect coding, these healthcare professionals need to be aware of and comply with query compliance standards. Other healthcare professionals, such as compliance, revenue cycle, patient financial services, physician groups, facility leaders, and any who work with documentation and coding also need to be familiar with this guidance. The Brief also points out that it serves as a resource for external reviewers, such as the Office of Inspector General (OIG), government contractors, payor review agencies, and others.

According to the Brief, a query is a communication tool “used to clarify documentation in the health record for documentation integrity and accurate code assignment.” In addition to ensuring a medical record that accurately reflects patient complexity and the facts of the encounter, an effective query process ensures appropriate reimbursement and accurate risk-adjustment and quality of care statistics derived from claims data.

The Practice Brief states, “The objective of a query is to ensure the reported diagnoses and procedures derived from the health record documentation accurately reflect the patient’s episode of care.” Among other functions, some of the main uses of queries are to:

• Determine if a clinical condition is present when supported by clinical indicators within the record,
• Clarify conflicting documentation,
• Add specificity in certain situations,
• Establish “cause and effect” relationships, and
• Clarify when a documented diagnosis does not appear to be clinically supported.

I am not going to list all of the requirements of a compliant query and encourage those affected to read the entire Practice Brief for all the guidance provided. Here are some of the main points from the Brief that caught my attention.

Leading Queries

Bearing in mind that my background is compliance, I will start with the rule that queries should not be leading – they should not “lead” the physician or other practitioner to the preferred answer or to a specific diagnosis or procedure. Multiple choice queries are acceptable, but be sure to include options that allow the provider to explain other clinical options or to reply that the answer may be clinically undetermined. In the words of the Brief, “the choices provided as part of the query must reflect reasonable conclusions specific to the clinical scenario of the individual patient.”

Impact on Reimbursement

At one time, reimbursement seemed to be the major driver of the query process. This should not be – querying is about obtaining accurate documentation and coding, which often can affect a facility’s payment. However, keep your focus on accuracy and completeness and never include the impact on reimbursement or on quality measures in the query. It is best not to even discuss the effects of querying on reimbursement or quality measures with your physicians or others. If your records are accurate and complete, your facility will receive the appropriate reimbursement and accurate quality measures.

Specificity

Queries can be helpful for determining a more specific code in some situations. However, bear in mind “that code accuracy is not the same as code specificity.” Although some payors resist unspecified codes, there are times when unspecified codes are appropriate based on the clinical situation.

Clinical Indicators

When querying for documentation of medical diagnoses or conditions that are clinically evident, be sure to include clinical indicators that:

• “Are specific to the patient and episode of care
• Support why a more complete or accurate diagnosis or procedure is sought
• Support why a diagnosis requires additional clinical support to be reportable”

Clinical indicators can be such things as the physical exam and assessment, diagnostic findings, and treatments. Clinical indicators should be relevant and clearly support the clinical condition. More is not always better, as the Brief states, “The quality of clinical indicators—how well they relate to the condition being clarified—is more important than the quantity of clinical indicators.”

Patient History and Prior Encounters

Coding from prior encounters without documentation in the current record is not allowed, but generating a query based on information from a prior encounter may be acceptable, but only if the information is clinically pertinent to the current encounter. The Brief includes a list of example situations where information from a prior encounter could be used to query, such as specificity, baseline status, present on admission (POA) status, cause and effect, and etiology. The Brief cautions that “it is inappropriate to “mine” a previous encounter’s documentation to generate queries not related to the current encounter.”

Documentation and Retention of Queries

Sometimes it is easier to explain a situation to a provider in person. Verbal queries are acceptable, but the exchange, including the provider’s response, should be documented and maintained. And like written queries, conversations should not be leading. When documenting these interactions, be sure to include the same components you would include in a written query – the details of the discussion, the reason for the query, the clinical indicators, options discussed and the provider’s decision. Also, date, time, and sign your documentation.

It is recommended the query be part of the permanent medical record. Another option is to keep queries as part of the business record. They should be easily retrievable for auditing, monitoring, and compliance. Facilities should have a policy that addresses query retention and it should apply to all queries, regardless of provider response.

Clinical Validation and Escalation

Sometimes it may appear that a documented diagnosis is not clinically supported. These clinical validation queries can be more challenging than other types of queries. AHIMA has developed a separate Practice Brief to address these concerns titled “Clinical Validation: The Next Level of CDI.” AHIMA members can view this Brief in the AHIMA HIM Body of Knowledge at http://bok.ahima.org.  

Clinical validation may be a good time to involve a physician advisor or the chief medical officer. Facilities should have a documented escalation policy for certain situations, which may include clinical validation situations, failure to respond, or other issues. There should also be policies defining the role and expectations of those issuing the queries and the responders.

Again, this is a high-level overview of the Practice Brief on Compliant Queries. The Brief contains much more information, including query examples in Appendix B, which I found to be particularly enlightening. Be sure to read the entire Brief carefully – study it, discuss it with other stakeholders within your facility, and use it to develop your policies, procedures and practices. Be sure to include initial training for new employees and on-going education for all employees. Also, watch for updated guidance - I will not promise to be around in another 10 years to share the information.

On March 26, 2019 CMS published a Proposed Decision Memo for Transcatheter Aortic Valve Replacement (TAVR) (CAG-00430R). In a related CMS Press Release CMS noted they would continue to cover TAVR under Coverage with Evidence Development (CED) when furnished according to an FDA-approved indication.

TAVR Background

CMS first released National Coverage Determination (NCD) 20.32 Transcatheter Aortic Valve Replacement (TAVR) with an effective date of May 1, 2012. At that time, TAVR was considered a new technology for use in treating patients with aortic stenosis where a biprosthetic valve is inserted percutaneously using a catheter and implanted in the orifice of the native aortic valve.

TAVRs are performed in a cardiac catheterization lab or a hybrid operating room/cardiac catheterization lab with advanced quality imaging and with the ability to safely accommodate complicated cases that may require conversion to an open surgical procedure. The interventional cardiologist and cardiothoracic surgeon jointly participate in the intra-operative technical aspects of TAVR.

NCD 20.32 allows for coverage of the TAVR Procedure under Coverage with Evidence Development (CED) with specific conditions being met, appropriate volume requirements and a heart team and hospitals participation in a prospective, national, audited registry. For indications not approved by the FDA, CMS covers TAVR under CED when a patient is enrolled in a qualifying clinical study.

Registry and Clinical Study Approvals by CMS can be found on the CMS Coverage with Evidence Development TAVR webpage. https://www.cms.gov/Medicare/Coverage/Coverage-with-Evidence-Development/TAVR.html

TAVR Hospital Volumes

TAVR procedures are on the Medicare Inpatient Only Procedure List and sequence to the MS-DRG Pair 266 and 267 (Endovascular Cardiac Valve Replacement with MCC and without MCC respectively). In CMS Fiscal Year (FY) 2015 through 2017, this MS-DRG pair also included ICD-10-PCS codes for replacement of pulmonary valves. In FY 2018 an additional 4 mitral valve codes and 8 new tricuspid valve codes were also added to this MS-DRG pair.

To provide you with a glimpse into these types of procedures, I utilized Medicare Fee-for-Service paid claims data from our sister company RealTime Medicare Data (RTMD) for CMS FY 2015 through 2018. The following table highlights an increase in volumes and average charges and a decrease in actual average payment and average length of stay (ALOS) for Medicare Fee-for-Service paid claims in Alabama, Georgia and Tennessee.

‍Proposed Decision Memo: Changes and CMS’ Request for Comments

The Decision Memo proposes to update “the coverage criteria for hospitals and physicians to begin or maintain a TAVR program. The proposed decision provides more flexibility in how providers can meet the requirements performing TAVR, while continuing to ensure good health outcomes for patients receiving the procedure.”

The CMS Press Release notes they are also seeking to gather additional information and specifically proposed “a question regarding the relationship between other metrics and patient health outcomes, which could inform a future change to replace the volume criteria with a different metric.”

Key stakeholders at your hospital should take the time to read the Proposed Decision Memo and provide public comments. There is a 30-day public comment period ending April 25th and a final decision will be issued no later than 60 days after the conclusion of the 30-day public comment period. All public comments may be submitted at https://www.cms.gov/medicare-coverage-database/indexes/nca-open-for-public-comment-index.aspx.

 

Link to NCD 20.32: https://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=355&ncdver=1&bc=AAAAgAAAAAAAAA%3d%3d&

The expression 'the writing is on the wall' is used whenever an inevitable result or imminent danger has become apparent. It comes from the biblical story in the book of Daniel of God writing a warning to King Belshazzar on the wall. The Phrase Finder website

Local Coverage Determinations (LCDs) are determinations by Medicare Administrative Contractors (MACs) as to whether or not a particular item or service is covered in accordance with section 1862(a)(1)(A) of the Social Security Act. LCDs may expand on the requirements of a National Coverage Determination or address certain services that do not have an NCD but for which the MAC has concerns about the efficacy and necessity of the service. In other words, the MAC may need to describe the particular requirements that must be met and documented in the medical record to support the medical necessity of the service. Sometimes you can tell a lot about the potential risk of non-compliance simply by the number of MACs that have a coverage policy for a particular service – sort of “the writing on the wall” for providers. One such service is facet joint injections – all 12 MAC jurisdictions have an LCD describing coverage requirements for this service.

The reasons for this widespread concern about facet injections can be found in the LCD Introduction paragraph from the Palmetto LCD:

“Facet joint injection techniques are used in the diagnosis and/or treatment of chronic neck and back pain. However, the evidence of clinical efficacy and utility has not been well-established in the medical literature, which is replete with non-comparable and inadequately designed studies. Further, there is a singular dearth of long-term outcomes reports. This is particularly problematic given the steroid dosages administered. These drugs alone may develop the relief experienced by patients but are associated with serious adverse health events and could as well be administered orally. Hence, ongoing coverage requires outcomes reporting as described in this LCD to allow future analysis of clinical efficacy.”

 

This basically says that the efficacy of this procedure is not proven and there are serious risks so, in order for facet injections to be covered, providers must have documented proof of the need and outcomes that show the treatment works. There is variation between the policies, so be sure to read the LCD for your jurisdiction and follow the requirements of that policy. However, it is often helpful to review other policies for a better understanding of the procedure and potential concerns.

Demonstrating Need

Almost all of the policies require an initial evaluation that includes history and an appropriately focused musculoskeletal and neurological physical examination, as well as pertinent diagnostic tests or procedures justifying the possible presence of facet joint pain. Be sure to include in this documentation:

• Documentation of pain – A pain severity description (mild, moderate, or severe) or a numeric pain scale rating (1-10) is generally required – check your local LCD to determine which specific pain description the policy requires. For example, Palmetto requires the pain to be moderate or severe while the Novitas policy requires average pain levels of 6 or greater. Also address the duration of the pain (usually 3 months), and make sure it complies with your jurisdiction’s LCD requirements.
• The pain results in a functional impairment – if the pain is bad enough to justify the procedure, it is bad enough to cause a functional impairment – difficulty with walking, bending, lifting, or some other specific activity of daily living.
• Conservative treatments have been tried and failed – be specific on what was tried – drugs, therapy, etc. If there are contraindications that prevented trying some conservative treatments, document that also.
• The pain is facet in nature. Some policies require that the pain be predominately axial and not associated with radiculopathy or neurogenic claudication or non-facet pathology.

Demonstrating Efficacy

Because of the concerns noted above about the risks and efficacy of facet joint injections, diagnostic injections must be done first to show the patient will receive relief.

From the Palmetto LCD:

• Dual medial branch blocks (a series of two MBBs) are necessary to diagnose facet pain due to the unacceptably high false positive rate of single MBB injections.
• A second confirmatory MBB is allowed if documentation indicates the first MBB produced significant relief of primary (index) pain ≥ 50% as evidenced by documented functional improvement, increased range of motion, a decreased requirement for pain medications and duration of relief is consistent with the agent employed.
• Intra-articular facet block will not be reimbursed as a diagnostic test unless medial branch blocks cannot be performed due to specific documented anatomic restrictions.

Again, confirm the requirements for diagnostic injections and the required outcome for your local LCD.

In addition, there are requirements for the percent and duration of pain relief from therapeutic injections that must be met before Medicare will cover a repeat injection if needed.

Procedure Requirements

A dated, signed and legible procedure note must describe the details of the facet injection, including “a description of the techniques employed, nerves injected and sites(s) of injections, drugs and doses with volumes and concentrations, as well as pre and post-procedural pain assessments.”

Other requirements from the Palmetto LCD include:

• Facet joint interventions (diagnostic and/or therapeutic) must be performed under fluoroscopic or computed tomographic (CT) guidance.
• Hard or digital copy images documenting the needle position and contrast medium flow must be retained and submitted if requested.
• Limits on the volume and dosage of drugs.
• Limits on the number of injections in a specified time frame.
• Performed by appropriately trained providers whose qualifications meet the requirements of the LCD.

You may also want to read a prior Wednesday@One article that discussed the findings of a Noridian medical review of facet joint injections. The Noridian articles referenced in the W@1 article are no longer available, but the article includes details of Noridian’s education.

As you can see, there are a lot of requirements and supporting documentation necessary to meet the facet joint injection LCDs. Would your facility’s medical records hold up to the scrutiny of a Medicare reviewer? If not, you may be at risk of claim denials or recoupments should you be reviewed. My recommendation is to be proactive by reading your MAC’s LCD and then making sure you follow the requirements and document appropriately. Seven MACs for 12 Jurisdictions with eight Facet Joint LCDs (Noridian assigns separate LCD ID numbers to each of their 2 jurisdictions) – the writing is on the wall.

CMS released MLN Matters Article MM11181 titled “Billing for Part B Hospital Inpatient Services” on March 22, 2019. This is not a new rule at all, but has been around since 2013. In the 2014 Inpatient Prospective Payment System (IPPS) Final Rule CMS-1599-R, effective October 1, 2013, CMS first allowed the billing of certain Part B services when an inpatient hospital admission is determined to not be reasonable and necessary for payment under Medicare Part A. Prior to this rule change, the billing of Part B inpatient services on a 12x type of bill (TOB) was limited to those occasions when the Medicare beneficiary did not have Part A coverage or the Part A benefits were exhausted.

The new policy specifically stated, “Medicare will allow payment under Part B of all hospital services that were furnished and would have been reasonable and necessary if the patient had been treated as a hospital outpatient, rather than admitted to the hospital as an inpatient.” The determination that the patient did not meet inpatient criteria could have been from 1) a denial by Medicare or 2) the result of a hospital “self-audit” after the patient was discharged. There are rules for the hospital self-audit.

• It must follow Medicare Conditions of Participation UR guidelines (42 CFR 428.30);
• It must be made by a physician member of the UR committee if the attending physician concurs, or by 2 physician members of the UR committee if the attending does not concur;
• The attending physician must be consulted; and
• The patient must be notified of the decision in writing within 2 days.

CMS also expanded what could be billed on a 12x TOB under Part B for these “reasonable and necessary inpatient admission denials” to include surgeries, drugs and therapeutic services such as coronary and peripheral interventions. Services requiring an outpatient status such as observation services and ED visits, and routine inpatient services cannot be billed under Part B inpatient billing. Note that the routine inpatient services include drug administrations, blood transfusions, and nebulizer treatments provided by floor nurses and should not be reported on a Part B inpatient claim. CMS provides a list of revenue codes that should not be submitted on a “reasonable and necessary inpatient denial” 12x TOB in section 240.1 of chapter 4 of the Medicare Claims Processing Manual. When a revenue code can be sometimes covered and sometimes not covered, providers should use Medicare guidance and the HCPCS code to determine if the service is covered.

If the “reasonable and necessary inpatient denials” Part B rebilling rule is six years old, what was the purpose of this latest MLN article? Again, CMS did not really change any rules, but added verbiage to the Claims Processing Manual clarifying the need for a Part A claim prior to submitting the Part B claim. In order to submit a Part B 12x claim after a hospital self-audit, the hospital must:

• Submit a Part A claim indicating that the provider is liable under section 1879 of the Act for the cost of the Part A services. This is a no-pay inpatient claim, type of bill 110. If the hospital has already submitted a regular inpatient claim (111 TOB), it must adjust the Part A claim to make the provider liable.
• The Part B 12x type of bill may be submitted for these “reasonable and necessary inpatient denials” only after the Part A claim is denied or a no-pay claim is submitted.

Also, the Part B inpatient claim is subject to the timely filing requirements described in the Medicare Claims Processing Manual, Chapter 1, Section 70.

This new MLN Matters Article (MM11181) also makes some modifications to the list of revenue codes that are not allowed on a 12x TOB for “other circumstances.” These circumstances would be for Medicare patients who are not entitled to benefits under Part A, have exhausted their Part A benefits, or receive services not covered under Part A. Part B inpatient claims for these circumstances restrict the types of services that can be billed much more than the “reasonable and necessary inpatient denials” Part B rebilling.

For more information about Part B Inpatient billing, see sections 240.1 and 240.2 of Chapter 4 of the Medicare Claims Processing Manual and sections 10.1 and 10.2 of Chapter6 of the Medicare Benefits Policy Manual. And remember for Part B rebillling, it is always A before B.

Q:

Our hospital has had Implantable Cardiac Defibrillator (ICD) claims denied by our Medicare Administrative Contractor (MAC) for what appears to be a missing Q0 modifier. The Q0 modifier was required for ICDs implanted for primary prevention to attest the patient was in a clinical trial or the data was reported to a qualifying data registry. We thought this requirement went away with the update to the ICD National Coverage Determination (NCD) which was effective for dates of service on and after February 15, 2018. Why are our claims being denied and is there anything we can do about it?

A:

You are correct that the updated NCD removed this requirement. Here are two statements from MLN Matters Article MM10865 which addressed the updated ICD NCD:

“Effective February 15, 2018, coverage policy is no longer contingent on participation in a trial/study/registry. Therefore, claims with a Date of Service (DOS) on an after February 15, 2018, no longer require any trial-related coding.”

The reason you have had claim denials for this requirement after it was no longer effective is due to the implementation date of the NCD. Once a new or revised NCD is announced, it takes Medicare contractors a while to implement the business requirements, including revising any claims processing system edits they have in place. That is why the transmittals announcing the changes include both an effective date and an implementation date. For a more thorough discussion of decision memos and NCD effective and implementation dates, see our prior Wednesday@One article, Effective Dates of New ICD NCD Rules.

A provider’s options when new NCD rules are released are to:

• Continue to follow the guidelines of the old NCD for claim submission until the implementation date,
• Follow the new NCD guidelines, but hold your claims until the implementation date for submission, or
• Submit your claims following the new NCD guidelines, but realize they may be denied under the old NCD requirements and you will have to appeal these claims to obtain proper payment.

Since your claims have been denied, you will have to appeal the denial or you may be able to resubmit the claim. Palmetto GBA, the MAC for jurisdictions J and M, recently released the following instructions.

Clinical Trial Implantable Defibrillator Claims

Issue Identified: 3/22/2019

Current Status

Claims reporting Implantable Cardiac Defibrillators (ICDs) related to National Coverage Determination (NCD) 20.4, with dates of service on or after February 15, 2018, previously rejected due to absence of clinical trial/study/registry codes may be submitted after March 26, 2019. Please refer to Palmetto GBA Medical Policy Article A56343   regarding applicable billing/coding changes.

Situation
CMS revised Change Request (CR): 10865   (PDF, 113 KB),

"National Coverage Determination (NCD) 20.4 Implantable Cardiac Defibrillators (ICDs)". The implementation date for Medicare Administrative Contractor (MAC) local edits is to March 26, 2019. Effective February 15, 2018, NCD 20.4 is no longer contingent on participation in a clinical trial/study/registry. Therefore, claims with dates of service on an after February 15, 2018, no longer require any trial-related coding.”

https://www.palmettogba.com/palmetto/providers.nsf/ls/JJ%20Part%20A"BAHQ6T4283?opendocument

If you are in another MAC Jurisdiction and have received denials for lack of reporting the Q0 modifier on ICD claims with dates of service on and after February 15, 2018, check with your MAC to see if you can resubmit those claims after March 26, 2019 (the implementation date).  If you have to go the appeal route and send in your medical records, be sure the ICD procedure meets all the requirements of this complex NCD and that your medical record contains the appropriate supporting documentation. Hopefully, this is something for which you already have processes in place and will not be an issue. The ICD procedure has a significant Medicare payment, so whatever you do, be persistent with your MAC in obtaining your proper payment. 

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.

Q:

A Colonoscopy was performed to identify the source of GI bleeding in a patient.  The physician diagnosed arteriovenous malformation (AVM) of the large intestine.  However, this condition is assigned to a congenital code, Arteriovenous Malformation of Digestive System Vessel (Q27.33), which is not specifically documented in the record.  In prior ICD-9-CM Coding Clinics, we did not use the congenital codes and were instructed to code AVM to Angiodysplasia.  Is this still the case in ICD-10-CM?

A:

Yes, assign a code for Angiodysplasia of Colon with Hemorrhage (55.21) for the bleeding AVM of the large intestine.  These codes are not assigned to a congenital code as they are believed to be degenerative in nature.

Vascular Ectasias, also known as Angiodysplasias and Arteriovenous Malformations are dilated vessels that develop in the cecum and ascending colon.  They occur in people >60 years of age and are the most common cause of lower GI bleeding.  They appear as bright red, can be flat or raised and covered by thin tissue.

References:

Coding Clinic:

                3rd Quarter 2018, page 21

                4th Quarter 1990, page 4

                3rd Quarter 1996, page 9-10

Vascular GI Lesions – Gastrointestinal Disorders Merck Manual 

Q:

I am new to Case Management and am searching for resources to help me understand more about Medicare and Medicare Policies for hospitals.

A:

Hospital Conditions of Participation (CoP)

As a new Case Manager, I would first direct you to the Conditions of Participation (CoP) for Utilization Review and Discharge Planning that can be found in the electronic Code of Federal Register: (eCFR) Title 42 Public Health

• Part 482 (482.1 – 482.104) Conditions of Participation for Hospitals
• §482.30 CoP: Utilization Review
• §482.43 CoP: Discharge Planning

To help you better understand CMS’ expectations you can view their Survey Protocol in the CMS State Operations Manual Appendix A – Survey Protocol, Regulations and Interpretive Guidelines for Hospitals.

 

CMS.gov website

There are several useful webpages available on the www.CMS.gov website. I would start with the Medicare Learning Network® (MLN) Home page.  

Medicare Learning Network® (MLN) Homepage

The Medicare Learning Network® provides free educational materials for health care professionals on CMS programs, policies, and initiatives. From the Homepage you can link to:

• Publications &Multimedia,
• Events & Training, and
• News & Updates.

MLN Publications & Multimedia

One example available are MLN Articles. These articles explain national Medicare policy in an easy-to-understand format with a focus on coverage, billing, and payment rules for specified provider types. Just posted to this webpage is an index of MLN Matters® Article from 2017-2019 in pdf format. One interesting section allows you to search articles specific to individual HCPCS codes.

MLN Events & Training

In this section you will find MLN Web-Based Training page provides you free 24/7 access to web-based training (WBT) courses.

MLN News & Updates

This section provides you access to the MLN Connects weekly e-newsletter for health care professionals. CMS notes this newsletter is your single source for:

• CMS program and policy details,
• Updates and announcements,
• Press Released,
• Upcoming Educational Event Registration and Reminders,
• Claims, Pricer, and Code Information, and
• Updates on New and Revised MLN Publications.

Medicare Quarterly Provider Compliance Newsletter Archive

Another great resource is the Medicare Quarterly Provider Compliance Newsletter that provides education regarding how to address common billing errors and other claims review findings. You can search newsletters by common keywords, phrases, and claim review findings.

CMS National Training Program (NTP)

One additional resource to consider is the NTP website. This site provides materials and educational opportunities to help you better understand and educate others about Medicare, Medicaid, the Children’s Health Insurance Program (CHIP), and the Federally-facilitated Health Insurance Marketplace.

MEDICARE TRANSMITTALS – RECURRING UPDATES

 

Healthcare Common Procedure Coding System (HCPCS) Codes Subject to and Excluded from Clinical Laboratory Improvement Amendments (CLIA) Edits

The new HCPCS codes for 2019 that are subject to and excluded from Clinical Laboratory Improvement Amendments (CLIA) edits.

https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/downloads/MM11135.pdf

April 2019 Integrated Outpatient Code Editor (I/OCE) Specifications Version 20.1

https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/downloads/MM11192.pdf

Remittance Advice Remark Code (RARC), Claims Adjustment Reason Code (CARC), Medicare Remit Easy Print (MREP) and PC Print Update

https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/downloads/MM11204.pdf

April 2019 Update of the Hospital Outpatient Prospective Payment System (OPPS)

Describes changes to, and billing instructions for, various payment policies implemented in the April 2019 OPPS update.

 

OTHER MEDICARE TRANSMITTALS

 

Evaluation and Management (E/M) When Performed with Superficial Radiation Treatment

Allows providers to bill E/M codes 99211, 99212, and 99213 for Levels I through III, when performed with superficial radiation treatment delivery.

https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/downloads/MM11137.pdf

 

MEDICARE SPECIAL EDITION ARTICLES

 

Medicare Part B Clinical Laboratory Fee Schedule: Revised Information for Laboratories on Collecting and Reporting Data for the Private Payor Rate-Based Payment System

Assist the laboratory community in meeting the requirements under Section 1834A of the Social Security Act (the Act) for the Medicare Part B Clinical Laboratory Fee Schedule (CLFS). Includes clarifications for determining

• whether a hospital outreach laboratory meets the requirements to be an “applicable laboratory,”
• the applicable information (that is, private payor rate data) that must be collected and reported to CMS,
• the entity responsible for reporting applicable information to CMS,
• the data collection and reporting periods, and
• the schedule for implementing the next private payor-rate based CLFS update.

https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/downloads/SE19006.pdf

New Medicare Beneficiary Identifier (MBI) Get It, Use It

https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/Downloads/SE18006.pdf

 

MEDICARE COVERAGE UPDATES

 

National Coverage Determination (NCD90.2): Next Generation Sequencing (NGS)

CMS covers diagnostic laboratory tests using next generation sequencing when performed in a Clinical Laboratory Improvement Amendments- certified laboratory when ordered by a treating physician and when specific requirements are met.

https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/downloads/MM10878.pdf

 

MEDICARE PRESS RELEASES

 

CMS Updates Consumer Resources for Comparing Hospital Quality

CMS updated hospital performance data on the Hospital Compare website and on data.medicare.gov. This data includes specific measures of hospitals’ quality of care, many of which are updated quarterly, and the Overall Hospital Star Ratings, which were last updated in December 2017. The data are collected through CMS’s Hospital Quality Initiative programs.  

https://www.cms.gov/newsroom/press-releases/cms-updates-consumer-resources-comparing-hospital-quality

CMS Updates Drug Dashboards with Prescription Drug Pricing and Spending Data

Updated with 2017 data.

https://www.cms.gov/newsroom/press-releases/cms-updates-drug-dashboards-prescription-drug-pricing-and-spending-data

 

MEDICARE EDUCATIONAL RESOURCES

 

Medicare Fast Facts

Medicare Fast Facts resources this month include:

• Bill Correctly for Device Replacement Procedures

https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/Fast-Facts.html?DLSort=1&DLEntries=10&DLPage=1&DLSortDir=descending

 

OTHER MEDICARE UPDATES

 

KEPRO Winter 2019 Care Review Connections Newsletter

A quarterly e-newsletter from your Beneficiary and Family Centered Care Quality Improvement Organization (BFCC-QIO).

https://www.keproqio.com/providers/winter-2019-acute-newsletter/

Guidelines for Achieving a Compliant Query Practice—2019 update

“Guidelines for Achieving a Compliant Query Practice” was produced through the joint effort of the Association of Clinical Documentation Improvement Specialists (ACDIS) and the American Health Information Management Association (AHIMA). Both associations collaborated on the creation of this practice brief and approved its contents, and as such it represents the recommended industry standard for provider queries.

This practice brief supercedes one published in 2016 and all previous versions.

https://acdis.org/resources/guidelines-achieving-compliant-query-practice%E2%80%942019-update