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When we think of copycat products, we often picture the nefarious character flipping open his overcoat to reveal a row of “Rolex” watches available at bargain basement prices - in other words, counterfeit products of a lesser quality and illegally bearing a trademark name. But in the world of biological drugs, legitimate but costly copycat products offer physicians and patients other options for treatment. With appropriate payment policies, the United States biosimilar product marketplace can continue to grow resulting in cost savings and those additional treatment options. In the 2018 Medicare Physician Fee Schedule Final Rule (MPFS), CMS changed the payment policy for biosimilars to separately code and determine payment for each biological biosimilar product under Medicare Part B.

The original policy addressing biosimilars was from the 2016 MPFS rule. At that time CMS decided to base the payment amount for a biosimilar biological product on the average sales price (ASP) of all biosimilars for one reference product and to assign one payment code (HCPCS code) to all biosimilars for the same reference product. “In general, this means that products that rely on a common reference product’s biologics license application (that is, FDA’s previous finding of safety, purity, and potency for the common reference product) are grouped into the same payment calculation for determining a single ASP payment limit and that a single HCPCS code is used for such biosimilar products. The regulation went into effect on January 1, 2016.” Biosimilars sharing the same HCPCS code, but produced by different manufacturers, were distinguished by HCPCS modifiers.

There were varying opinions about Medicare’s payment policy for biosimilars from the beginning – some stakeholders supporting the use of one HCPCS code and others opposing it. In the 2018 MPFS FR, CMS notes, “The biosimilar product marketplace has continued to grow, and four biosimilar biological products that are paid under Part B have been licensed, including one product approved in 2017 that is sharing a HCPCS code with another previously licensed biosimilar biological product. Based on the number of biosimilar biological products that are reported to be nearing approval and the approvals made over the past 2 years, CMS anticipates that several more biosimilar biological products will be licensed for use in the United States during the next year and that during the following years, the marketplace will continue to grow steadily, provided that the approved products are marketed without delay. …CMS is aware of concerns that current Medicare policy may discourage development of new biosimilars and other innovation in this area potentially resulting in higher costs over time due to a lack of competition in the market place.”

As usual for CMS rules, the topic was discussed in great detail in the 2018 MPFS Final Rule (starting on page 53182). Some of the more interesting points of the discussion include,

Facts about Biosimilars:

• Biosimilars are similar, but not identical, to their reference products, and due to these subtle differences, they may have different therapeutic and adverse effects on patients, requiring clinical distinctions between the products.
• None of the currently available biosimilars are approved as interchangeable. The current biosimilar approval process does not compare biosimilar biological products to each other, rather, only similarity to a reference product is established and the licensing of a biological product under the biosimilar pathway does not mean that the products are interchangeable.
• Biosimilar biological products may be approved for fewer indications than the reference product and the approved indications within a group of biosimilar biological products with the same reference product may vary.
• These products are likely to be expensive and may have different acquisition costs. The development costs for these products and their manufacturing facilities are estimated to be in the hundreds of millions of dollars.

Stakeholders’ Comments

• Grouping (biosimilars) for payment could lead to prescribing choices based on cost rather than clinical considerations.
• The current policy may impair access to biosimilars, could potentially limit the introduction of biosimilars to the US market, and would fail to maximize competition and savings.
• Grouping products for payment that do not have all the same indications could cause clinicians and patients to think the products are interchangeable or could lead to off-label use.
• Blended payment could be a significant financial risk to the provider because the products that would be the best choice for a patient may not be paid above acquisition cost.
• ‘‘Race to the bottom’’ pricing competition would result from shared codes and lead to prices that could not sustain educational efforts and other activities associated with marketing new and complex biological products, ultimately resulting in manufacturers leaving the United States marketplace.
• Determining a payment for each biosimilar product by using individual HCPCS codes would drive and reward innovators, producing the potential cost savings of at least 10–15 percent compared to the reference biologic ASP necessary for biosimilar products to compete with the reference biological.

Because of the above facts and concerns, CMS has “become increasingly concerned about the relationship between cost, prices and competition; specifically, many commenters’ continued unease regarding the effects of our payment policy on patient and provider choices, as well as the biosimilar marketplace. We have also considered how the payment policy could affect market entry of new biosimilar manufacturers. If payment amounts limit manufacturers’ willingness to invest in the development of new biosimilars, it could in the long term, decrease the number of biosimilar biological products that are available to prescribe and thus impair price competition. Given that the United States’ biosimilar biological product marketplace is still relatively new, we believe that it is important to maintain a payment policy innovation as well as reasonable pricing for consumers. We agree that it is important to consider and effect policy changes early, as this portion of the drug marketplace develops, in order to support a robust marketplace that provides choices for providers and patients while maximizing savings.”

Effective January 1, 2018, newly approved biosimilar biological products with a common reference product will no longer be grouped into the same HCPCS code. Each biosimilar will be assigned a unique HCPCS code and payment will be based on the ASP for that individual biosimilar. Biosimilar HCPCS codes in use prior to January 1, 2018 are being changed and replaced to be in compliance with the new payment policy.  This is described on the Medicare Biosimilar webpage and addressed in the April 2018 OPPS Update MLN Matters Article.  Effective April 1, 2018, the descriptor for HCPCS code Q5101 (filgrastim biosimilar) is being changed to “Injection, zarxio.”  HCPCS code Q5102 (infliximab biosimilar) is being replaced effective April 1, 2018 with HCPCS codes Q5103 (Injection, inflectra) and Q5104 (Injection, renflexis).  The new biosimilar payment policy also makes the use of modifiers that describe the manufacturer of a biosimilar product unnecessary. Therefore, modifiers ZA, ZB, and ZC will be discontinued for dates of service on or after April 1, 2018. However, please note that HCPCS code Q5102 and the requirement to use applicable biosimilar modifiers remain in effect for dates of service prior to April 1, 2018.  

Q:

What codes would be assigned for an endarterectomy of the left common carotid artery, left internal carotid artery and the left external carotid artery?

A:

First let’s review the new Body Parts General Guideline for FY2018:

B4.1c:  If a procedure is performed on a continuous section of a tubular body part, code the body part value corresponding to the furthest anatomical site from the point of entry.

Based on this guideline, procedure codes for endarterectomy of the left internal carotid artery and the left external carotid artery would be assigned because these two arteries are branches of the common carotid artery and the furthest from the point of entry.

Extirpation of Matter from Left Internal Carotid Artery, Open Approach (03CL0ZZ)

Extirpation of Matter from Left External Carotid Artery, Open Approach (03CN0ZZ)

References:

Body Part, General Guidelines, 2018 ICD-10-PCS

Highlights of ICD-10-CM & PCS, Changes for FY 2018 and Other Hot Topics, AAHIM Coding Symposium, Joy King Ewing, RHIA, CCS

In recent news, a pedestrian bridge under construction on the Florida International University campus collapsed killing 6 people and injuring many others - a terrible tragedy and an engineering failure. Humans are fallible, and objects built by man, big or small, are subject to failure. Sadly, medical devices that save millions of lives are not exempt from the propensity to fail.  In February, Medtronic issued a recall for Cardiac Resynchronization Therapy with Defibrillation (CRT-Ds) and Implantable Cardiovert-Defibrillators (ICDs). The Federal Drug Administration (FDA) identified this as a Class I recall, with the potential to cause serious injuries or death. According to the FDA Recall information “a defect in the manufacturing process … may prevent the device from delivering the electrical shock needed to pace a patient’s heartbeat or revive a patient in cardiac arrest. The delay or inability to deliver a shock to a patient in cardiac arrest or pace a patient’s heart whose heartbeat is too slow could result in serious injury and/or death.” This is a scary life-threatening prospect for patients with one of these devices and replacements will be occurring fast and furious.

Though not nearly as concerning as a fatal heart attack, providers must be concerned with the correct reporting to Medicare of the replacement of these devices for their Medicare patients. Reporting of device credits is an area historically fraught with errors. Almost every Office of Inspector General (OIG) Hospital Compliance Review includes a few inpatient and/or outpatient errors associated with device credit reporting.  This trend continued when a September 2017 OIG report identified that Medicare paid for many device replacement procedures incorrectly. And more recently, a March 2018 OIG Report found that “All 296 payments reviewed for recalled cardiac medical devices did not comply with Medicare requirements for reporting manufacturer credits. Medicare contractors incorrectly paid hospitals $7.7 million for cardiac device replacement claims rather than the $3.3 million they should have been paid, resulting in potential overpayments of $4.4 million.”

Why so many errors? The process of identifying patients receiving applicable no-cost or reduced-cost devices, knowing when credits are received or should be received, the amount of such credits, and coordination between various departments to get this information onto the Medicare claim can be daunting. The OIG states that along with lack of hospital policies, procedures and controls, the need to involve various hospital departments and personnel contributes to the lack of identification, tracking, and reporting of these credits on Medicare claims. The March 2018 OIG report identifies the hospital challenges and discusses them in detail. Here are some of the OIG comments, but I encourage providers to read the entire report as the OIG offers specific suggestions, such as holding claims or submitting adjustment claims when it is not known if a credit will be received for a replacement device.

“Different hospital personnel are responsible for contacting the manufacturer, tracking the availability of the credit, and determining whether an adjustment claim needs to be submitted to pass along the credit to Medicare. …Furthermore, hospital staff submitting Medicare claims must

be aware of credits that are at least 50 percent of the price the facility paid for the replacement device, and staff must report the credit as a deduction on a submitted claim. However, hospitals may not know whether they will receive a credit or how much that credit will be at the time of billing for the device replacement procedure. … Specifically, hospitals attributed their incorrect billings to inadequate policies and procedures for reporting manufacturer credits, lack of awareness of warranties and credit availability, and hospital misapplication of the credit amounts.”

Medicare’s device credit policy only applies to implantable, high-cost devices when the OPPS device off-set amount exceeds 40% of procedure payment and for inpatients, select DRGs. This includes, but is not limited to, devices such as cardiac pacemakers and defibrillators, neurostimulators, prostheses, and intraocular lens. For such devices, credit reporting is required when:

• a hospital furnishes without cost an initial placement of a medical device as part of a clinical trial or a free sample medical device or
• when a hospital furnishes a new replacement device due to warranty, recall, or field action
• without cost or
• with a credit of 50% or more of the cost of a new replacement from a manufacturer.

Hospitals must report on the Medicare claim

• Value code “FD” (Credit Received from the Manufacturer for a Medical Device)
• The amount of the device credit in the amount portion for value code FD, and
• One of the following condition codes
• 49 - Product Replacement within Product Lifecycle—Replacement of a product earlier than the anticipated lifecycle.
• 50 - Product Replacement for Known Recall of a Product—Manufacturer or FDA has identified the product for recall and therefore replacement.
• 53 - Initial placement of a medical device provided as part of a clinical trial or free sample—Code is for outpatient claims that have received a device credit upon initial medical device placement in a clinical trial or a free sample.

As complicated as it already is, it may get worse. CMS is concerned about the overall cost and health impact of recalled or prematurely failed medical devices. In the OIG September 2017 report, the OIG determined that Medicare costs related to the replacement of recalled or prematurely failed medical devices could not be identified and tracked using only claim data. They recommended a Device Identifier

(DI) be included on the next version of claim forms which is under consideration as a policy by CMS. The OIG maintains “that by including the DI on claim forms and expanding the use of condition codes, CMS could more effectively identify and track Medicare’s aggregate costs related to recalled or prematurely failed devices, reduce Medicare costs by identifying poorly performing devices more quickly, facilitate device recipients’ chances of receiving timely follow-up care, and protect beneficiaries from unnecessary costs.” It would be hard to argue this is not a good idea, but the additional paperwork burden would fall on hospitals submitting the claims. Hospitals who already are not getting the required reporting right.

It is also worth noting the different approach the OIG took for the March 2018 report referenced above.  For this audit, the OIG obtained a list of warranty credits that two device manufacturers issued to hospitals for five cardiac medical devices that had been recalled or had high failure rates. Auditing the at-risk claims identified based on the list, resulted in the OIG finding errors for all claims reviewed as noted above. Providers may want to follow the OIG’s lead and work with their vendors to obtain lists of credits issued. This could help in initial correct claim reporting and identifying prior reporting errors so a corrected adjustment claim could be submitted.

The best practice first step and necessary action is to bring key stakeholders together to consider all the different factors and develop a process together that includes policies, procedures, and controls. First you have to identify the involved departments and personnel – clinical departments of cardiology and surgery, materials management, accounts payable, billing, physicians who may implant such devices, compliance, and maybe others.

If your facility hasn’t already addressed this issue, it is good to do so now. As long as the OIG can identify over $4 million in overpayments, it is not going away.

Q:

Can we give Medicare patients an Advance Beneficiary Notice (ABN) and bill them when services are denied for exceeding a Medically Unlikely Edit (MUE)?

A:

No. Medically Unlikely Edits (MUEs) define correct coding and therefore the denials are coding denials. This means the provider is liable. Advance Beneficiary Notices (ABNs) are to be used when the provider expects denials related to the medical necessity of services. Since an MUE denial is a coding denial and not a medical necessity denial, an ABN is not appropriate.  The Medicare patient cannot be billed for services denied for exceeding MUE limits.

The MUE program began in January 2007 and was implemented to reduce the Medicare paid claims error rate. The MUE is a limit on the number of units Medicare will adjudicate. MUE values are adjudicated either against units reported on a line item of a claim or on an entire date of service. For date of service (DOS) MUEs, if units reported for a HCPCS code for one day exceed the MUE limit, no payment will be made for that code unless the denial is overturned on a provider-initiated appeal.

The type of MUE can be determined by the “MUE adjudication indicator” (MAI) in the MUE edit table. These indicators describe the type of MUE and how it is adjudicated.

• An MAI of “1” is a claim line edit. The MUE may be by-passed when appropriate by reporting units exceeding the MUE on separate lines with an acceptable modifier.
• An MUE with an indicator of “2” is an absolute date of service edit. Units of service exceeding the MUE value are considered “impossible” because they are contrary to statute, regulation or sub-regulatory guidance, including correct coding policies. Denials for services with an MAI of “2” will not be overturned on appeal.
• MUEs for HCPCS codes with an MAI of “3” are date of service edits based on clinical guidelines. These edits will cause an automatic denial if the units for a date of service exceed the limit, but the denial may be overturned on appeal if there is adequate documentation of medical necessity of correctly reported units.

A recent article by Palmetto GBA (the Medicare Administrative Contractor (MAC) for Jurisdictions J and M) discusses MUE denials and ABNs.  Additional information on MUEs can be found on CMS’s NCCI/MUE website at https://www.cms.gov/Medicare/Coding/NationalCorrectCodInitEd/index.html including an NCCI FAQs download that addresses questions about procedure-to-procedure (PTP) edits and MUEs. Much of the discussion above was from a prior Wednesday@One article that readers may also find helpful. 

For more information on ABNs, see the MLN Booklet Medicare Advance Written Notices of Noncoverage.

MEDICARE TRANSMITTALS

ICD-10 and Other Coding Revisions to National Coverage Determinations (NCDs) – (Revised 3/1/18)

A maintenance update of the ICD-10 conversions and other coding updates specific to National Coverage Determinations (NCDs).

https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/downloads/MM10473.pdf

Appropriate Use Criteria for Advanced Diagnostic Imaging – Voluntary Participation and Reporting Period - Claims Processing Requirements – HCPCS Modifier QQ

New HCPCS modifier (QQ) that may be reported with CPT code for an advanced diagnostic imaging service when the ordering physician consults appropriate use criteria.

https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/Downloads/MM10481.pdf

April 2018 Integrated Outpatient Code Editor (I/OCE) Specifications Version 19.1

The modifications of the I/OCE for the April 2018 V19.1 update.

https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/Downloads/MM10514.pdf

April 2018 Update of the Hospital Outpatient Prospective Payment System (OPPS)

Changes to the OPPS to be implemented in the April 2018 update.

https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/downloads/MM10515.pdf

Quarterly Healthcare Common Procedure Coding System (HCPCS) Drug/Biological Code Changes - April 2018 Update

The HCPCS code set is updated on a quarterly basis. Change Request (CR) 10454 informs MACs of the April 2018 updates of specific biosimilar biological product HCPCS code, modifiers used with these biosimilar biologic products and an autologous cellular immunotherapy treatment.

https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/Downloads/MM10454.pdf

Clarification of Instructions Regarding the Intensive Level of Rehabilitation Therapy Services Requirements

Instructions for conducting medical review of Inpatient Rehabilitation Facility (IRF) claims when reviewing the requirements for the intensive level of rehabilitation therapy services.

https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/2018Downloads/R771PI.pdf

Correction to Pub. 100-04, Chapter 5

Updates the list of Types of Bill subject to application of the therapy caps and related policies to Critical Access Hospital (CAH) claims in accordance with CR 8426.

https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/2018Downloads/R3995CP.pdf

Quarterly Update for Clinical Laboratory Fee Schedule and Laboratory Services Subject to Reasonable Charge Payment – (Revised 3/15/18)

Changes in the April 2018 quarterly update to the Clinical Laboratory Fee Schedule (CLFS).

https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/Downloads/MM10445.pdf

Internet Only Manual Update to Pub 100-04, Chapter 16, Section 40.8 -Date of Service Policy

Manualizes the additional exception to the current laboratory DOS regulations from the CY 2018 OPPS/ASC final rule published December 14, 2017, so that the DOS for Advanced Diagnostic Laboratory Tests and molecular pathology tests excluded from OPPS packaging policy is the date the test was performed if certain conditions are met. This new exception to the laboratory DOS policy is effective beginning on January 1, 2018.

https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/2018Downloads/R4000CP.pdf

MEDICARE SPECIAL EDITION ARTICLES

Billing Requirements for OPPS Providers with Multiple Service Locations

Enforcement editing requirements for hospitals operating off-campus, outpatient, provider-based departments of a hospital’s facilities (facility address and appropriate modifiers).

https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/Downloads/SE18002.pdf

MEDICARE COVERAGE UPDATES

MEDICARE PRESS RELEASES

CMS finalizes coverage of Next Generation Sequencing tests, ensuring enhanced access for cancer patients

CMS finalized a National Coverage Determination that covers diagnostic laboratory tests using Next Generation Sequencing (NGS) for patients with advanced cancer (i.e., recurrent, metastatic, relapsed, refractory, or stages III or IV cancer).

https://www.cms.gov/Newsroom/MediaReleaseDatabase/Press-releases/2018-Press-releases-items/2018-03-16.html?DLPage=1&DLEntries=10&DLSort=0&DLSortDir=descending

Trump Administration Announces MyHealthEData Initiative to Put Patients at the Center of the US Healthcare System

The MyHealthEData initiative will work to make clear that patients deserve to not only electronically receive a copy of their entire health record, but also be able to share their data with whomever they want, making the patient the center of the healthcare system.

https://www.cms.gov/Newsroom/MediaReleaseDatabase/Press-releases/2018-Press-releases-items/2018-03-06.html?DLPage=1&DLEntries=10&DLSort=0&DLSortDir=descending

MEDICARE EDUCATIONAL RESOURCES

OTHER MEDICARE UPDATES

Enforcement Instruction on Supervision Requirements for Outpatient Therapeutic Services in Critical Access Hospitals and Small Rural Hospitals

https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/Downloads/Supervision-Moratorium-on-Enforcement-for-CAHs-and-Certain-Small-Rural-Hospitals.pdf

February Patients Over Paperwork Newsletter

Update on CMS’s initiative to evaluate and streamline regulations with a goal to reduce unnecessary burden, to increase efficiencies, and to improve the beneficiary experience.

https://www.cms.gov/Outreach-and-Education/Outreach/Partnerships/Downloads/FebruaryPoPNewsletter022218.pdf

Website for Providers about New Medicare Cards

New Medicare cards start going out in April and providers must be able to accept them. This website has information and other resources on the new cards.

https://www.cms.gov/Medicare/New-Medicare-Card/Providers/Providers.html

January 1, 2020 – that is the date currently planned for full implementation of the required consultation of Appropriate Use Criteria (AUC) for ordering advanced diagnostic imaging services and the required claim reporting of such. Though that seems a long time away, Medicare is making first steps towards this implementation. And once here, the process will require coordination of several providers, so planning ahead is a good idea for all involved. 2020 will be here before you know it.

This new program was established by the Protecting Access to Medicare Act (PAMA) of 2014, to ensure advanced diagnostic imaging services are being ordered appropriately.  The program will require ordering physicians/practitioners to consult appropriate use criteria (AUC) through a qualified electronic portal (known as a Clinical Decision Support Mechanism (CDSM)) prior to ordering advanced imaging services. The CDSM lets the ordering professional know whether the order adheres, or does not adhere, to AUC, or if there is no AUC applicable. The final part of the requirement is that the furnishing professional (e.g. the radiologist) and the performing facility must report consultation information on their respective claims.  Per CMS, “Ultimately, this program will result in identified outlier ordering professionals being subject to prior authorization.”

The program applies to advanced imaging services –

• Specifically, computerized tomography (CT), positron emission tomography (PET), nuclear medicine (NM), and magnetic resonance imaging (MRI);
• Furnished in physician offices, hospital outpatient departments (including emergency departments), ambulatory surgical centers, and any other outpatient setting determined appropriate in the future; and
• Paid under the physician fee schedule (PFS), the hospital outpatient prospective payment system(OPPS), or the ambulatory surgical center payment system.

There are exceptions to the requirements for ordering professionals with significant hardships, patients with emergency medical conditions, and inpatients paid under Part A.

MLN Matters MM10481 announces a new modifier for voluntary reporting. “Effective July 1, 2018, HCPCS modifier QQ (Ordering Professional Consulted A Qualified Clinical Decision Support Mechanism For This Service And The Related Data Was Provided To The Furnishing Professional) is available for this reporting. The modifier may be:

• Used when the furnishing professional is aware of the result of the ordering professional’s consultation with a CDSM for that patient,
• Reported on the same claim line as the CPT code for an advanced diagnostic imaging service furnished in an applicable setting and paid for under an applicable payment system, and,
• Reported on both the facility and professional claim.”

CMS has not yet provided detailed claim-reporting instructions for the future beyond the voluntary reporting of the QQ modifier.  CMS indicates the ordering practitioner’s National Provider Identifier (NPI) and the specific CDSM consulted will have to be reported once the program is fully implemented. CMS will publish claim instructions prior to any additional reporting requirements. The MLN article includes a list of applicable CPT codes, though for now the modifier may be used on codes outside the specified ranges. The new modifier is voluntary and Medicare will continue to pay for advanced imaging services with or without the modifier.

CMS has a website about the Appropriate Use Criteria program with more information.  The website includes a definition of AUC as “criteria that are evidence-based (to the extent feasible) and assist professionals who order and furnish applicable imaging services to make the most appropriate treatment decisions for a specific clinical condition.”  The website also includes a list of qualified CDSMs and priority clinical areas.

Appropriate consultation and claim reporting will require coordination between the ordering professional, the furnishing physician (radiologist) and the facility providing the service. For example, how will the ordering physician convey to the performing facility and furnishing physician that he/she has consulted a CDSM, which CDSM was consulted, and what the results were? How will the facility and furnishing physician get modifiers and other required information on the claim? A lot to consider and plan – 2020 will be here before you know it.

When I provided patient care years ago, we had a young patient whose mother was overbearing, demanding, and well-informed. As difficult as it was to deal with this parent, due to the child’s age and mental capacity, she needed a healthcare advocate. In recent years, I have had to be such an advocate for my parents’ healthcare. Thankfully it is much easier to be well-informed these days than it was years ago for that mother. Television ads promote a drug for everything, Facebook includes posts on numerous medical technologies such as TAVR and IMRT, and the internet allows research of any condition and any treatment. This is good and bad – knowledgeable and educated patients can make wiser healthcare decisions, but overzealous and ill-advised patients may make demands that are not the best choice for their healthcare. In today’s environment, I can easily envision a patient demanding of their oncologist, “I want some of that IMRT.”

Intensity Modulated Radiation Therapy (IMRT) is not for everyone. Healthcare providers have to keep up with the latest treatment protocols and the coverage requirements of numerous payers.  With the transition of the Jurisdiction J MAC from Cahaba to Palmetto, Palmetto elected to adopt the Cahaba Local Coverage Determination (LCD) for IMRT for both jurisdictions JJ and JM. Palmetto JM had not previously had a coverage policy for IMRT. This policy became effective on January 29, 2018. Several other MACs also have policies addressing the coverage of IMRT.

IMRT is generally reserved for treatment of tumors when adjacent structures need to be protected from the radiation dose or to deliver higher doses than commonly used. There are certain types of tumors that due to their location, shape, or dose requirements support the use of IMRT.  The LCDs describe the specific circumstances and types of tumors for which IMRT may be indicated. Some LCDs also include limitations where the use of IMRT is not supported, such as clinical urgency, palliative treatments, motion concerns, or “where IMRT does not offer an advantage over conventional or three-dimensional conformal radiation therapy techniques that deliver good clinical outcomes and low toxicity.”

There are also documentation requirements in the LCDs for IMRT.  The rationale of the advantage of IMRT versus the use of other radiation therapy methods must be documented in the medical record. In addition to this rationale, relevant medical history, physical examination, and results of pertinent diagnostic tests or procedures, there are documentation requirements specific to IMRT.  For example, the Palmetto LCD indicates the following components must be included:

• Prescription defining the goals and requirements of the treatment plan, including the specific dose constraints for the target(s) and nearby critical structures
• Signed and dated IMRT inverse plan that meets prescribed dose constraints
• Target verification methodology including documentation of the clinical treatment volume (CTV) and the planning target volume (PTV), immobilization and patient positioning, and means of dose verification
• Documentation of fluence distributions re-computed in a phantom or an equivalent methodology
• Documentation that accounts for structures moving in and out of high and low dose regions created by respiration
• Documentation for clinical treatment planning (77261-77263) should evidence the criteria are met which are outlined in “The ASTRO/ACR Guide to Radiation Oncology Coding 2015”

Note: This is not a complete list or descriptions of all the Palmetto LCD documentation requirements. Please see the Palmetto IMRT LCD or your MAC’s LCD for complete documentation requirements. 

As you can see, just the partial requirements for IMRT treatment and documentation are daunting. It is good that patients are more involved in their healthcare choices, but hopefully they will understand the complexity of treatment decisions and defer to their physician’s judgement.

The March 1, 2018 edition of the Medicare Learning Network e-newsletter mlnconnects, includes a list of new and revised Provider Compliance Tips Fact Sheets. This article focuses on the new Provider Compliance Tips for Bariatric Surgery Fact Sheet.

Provider Compliance Tips for Bariatric Surgery Fact Sheet

CMS notes there is a National Coverage Determination (NCD) 100.1 for Bariatric Surgery for Treatment of Obesity. As a matter of fact this NCD is now in its 5th iteration with the first version having an effective date of 10/1/1979.  

Bariatric procedures are performed to treat the comorbid conditions associated with morbid obesity and a beneficiary must meet all of the following Medicare coverage criteria:

• Have a Body-Mass Index (BMI) of ≥ 35 kg/m2,
• At least one comorbidity related to obesity, and
• Had prior unsuccessful medical treatment for obesity.

Bariatric surgery as treatment for obesity alone remains non-covered by Medicare.

Reasons for denials cited in the fact sheet include insufficient documentation, documentation fails to support procedures as reasonable and necessary, and Providers do not comply with signature requirements.

Bariatric Surgery Medical Necessity Reviews

Bariatric Surgery is not new, so the question for me is why a Fact Sheet now? More importantly, for hospitals performing bariatric procedures, have you self-audited medical record documentation to validate that procedures being performed are reasonable and necessary? If not, you should because what I have found in writing this article is that Medicare Auditors have and continue to review these procedures for medical necessity.

Comprehensive Error Rate Testing (CERT)
The Fact Sheet includes the July 2014 edition of the Medicare Quarterly Compliance Newsletter as a resource for more information about bariatric surgery. The newsletter includes an overview of a special study of HCPCS codes for bariatric surgery (43644 and 43770) conducted by the CERT. They found that insufficient documentation (something was missing from the record) caused approximately 98 percent of the improper payments. The newsletter also provides examples of improper payments for bariatric surgery.

Supplemental Medical Review Contractor (SMRC): Completed Project 2015-0216 Bariatric Surgery

The SMRC completed a review of bariatric surgery for the treatment of morbid obesity at the direction of CMS as a result of the 2014 CERT special study. The Project included a review of claims with dates of service from January 1, 2014 through December 31, 2014.

In their report they noted that CMS identified Type 2 diabetes mellitus as being one co-morbidity related to obesity and go on to indicate that CMS delegated the authority to determine additional co-morbidities and whether coverage will be extended to other types of bariatric surgery than outlined in NCD 100.1 to the Medicare Administrative Contractors (MACs).

At the time this project was completed, co-morbidities covered by one or more MAC included:

• Refractory hypertension (HTN),
• Obesity-induced cardiomyopathy,
• Clinically significant obstructive sleep apnea,
• Obesity-related hypoventilation,
• Pseudo tumor cerebri (documented idiopathic intracerebral HTN),
• Severe arthropathy of spine or weight-bearing joints, and
• Hepatic steatosis without prior evidence of active inflammation.

The Project overall error rate was 35 percent. This included claims recommended for denial due to providers not submitting the requested records and claims recommended for denial after review. Specific examples of insufficient documentation provided in the report included:

• Lack of documentation to support that the beneficiary had been previously unsuccessful with medical attempts (supervised dieting, exercise) at weight loss prior to surgical intervention,
• The submitted documentation did not include a signed operative report, and
• The submitted documentation did not include preoperative psychological evaluation with clearance for surgery and if treatable metabolic causes for obesity, such as adrenal or thyroid disorders, had been ruled out.

Recovery Auditors approved issue: Bariatric Surgery

Complex reviews for medical necessity of bariatric surgery is a current review issue for all four Recovery Audit Regions in the country. The approval date for this issue varies among the four Regions from November 2016 to February 1, 2017. Remember that the Recovery Audit look back period is three years. 

Office of Inspector General (OIG) Work Plan: Review of Medicare Payments for Bariatric Surgeries

In October 2017, the OIG added the Review of Medicare Payments for Bariatric Surgeries to their Active Work Plan Issues. As with the SMRC, the OIG referenced the CERT special study in the announcement. The OIG indicated that they will be reviewing “supporting documentation to determine whether the bariatric services performed met the conditions for coverage and were supported in accordance with Federal requirements.”

Next Step: Know the Coverage Requirements

While the new Fact Sheet references NCD 100.1 it does not reference additional guidance by the MACs. Do you know if your MAC has published additional guidance? The following table details the MACs that have published a Local Coverage Determination (LCD) or Coverage Article.  

As you can see, it is pretty clear why a Fact Sheet now and MMP, Inc. encourages you to become familiar with the NCD, any applicable MAC guidance, use the new Fact Sheet and Medicare Quarterly Compliance Newsletter as teaching tools and make sure your records support the medical necessity for the procedure.

Q:

During a Posterior Lumbar Interbody Fusion (PLIF) of L4-L5, the surgeon also placed autograft and allograft in the “gutters”.  Where are the “gutters” located on the spine and is there a corresponding PCS code for this procedure?

A:

The term “gutter” is referring to the Transverse Process of the spine, which is part of the posterior column.  Therefore, bone graft placed in the gutter(s) of L4-L5 is assigned a PCS code for Posterior Lumbar Fusion with a Qualifier of ‘1’ for Posterior Approach, Posterior Column.

It is common for both a PLIF and a Posterior Lumbar Fusion to be performed together.  In addition, we have Spinal Fusion Guidelines specifying that both types of fusions should be reported when performed together:

• PCS Guideline B3.10b: A separate procedure code is assigned for each vertebral joint that uses a different device and/or qualifier.

For this scenario, the following fusion codes would be assigned:

• Fusion of Lumbar Vertebral Joint with Interbody Fusion Device, Posterior Approach, Anterior Column, Open Approach (0SG00AJ)
• Fusion Lumbar Vertebral Joint with Autologous Tissue Substitute, Posterior Approach, Posterior Column, Open Approach (0SG0071)

Resources:

• ICD-10-PCS Coding of Complicated Spinal Fusions: Qualifier J, Posterior Approach to Anterior Column, Lynn Kuehn, RHIA, CCS-P, FAHIMA
• 2018 Coding Handbook, Spinal Fusion and Refusion
• ICD-10-PCS Coding Guidelines for Fusion Procedures of the Spine

Many things have changed in the last century, but none more than the ways we communicate. This newsletter for example – it comes to you conveniently through email and the internet. You didn’t have to go out to a newsstand and buy it, you didn’t have to wait on a postal delivery, and you don’t have to worry about misplacing it among the clutter on your desk – it is still there on the internet for reference today, tomorrow, or months later. Personal communication is revolutionary also – my younger grandchildren couldn’t imagine not being able to FaceTime their parents or grandparents whenever they have news to share; my older granddaughter is in constant (and I mean constant!) communication with her friends. We still communicate through the written word, but more often than not, this is accomplished electronically with assistance on everything from grammar to content. This audience certainly appreciates the joys and heartaches of the templates and canned text of electronic medical records. The changing world of communication and documentation requires frequent updates to the rules to keep up with new innovations and practices.

Medicare recently addressed two issues related to communication and offered a little relief while maintaining control on certain aspects. A good idea, since a plan without checks would allow common sense and risks to be ignored - trumped by convenience.

The first issue relates to communication via texting in a medical environment. CMS recognized that texting has become an essential and valuable means of communication among healthcare team members, but wants to ensure providers “utilize and maintain systems/platforms that are secure, encrypted, and minimize the risks to patient privacy and confidentiality as per HIPAA regulations.” In a memo to State Survey Directors on December 28, 2017, CMS now allows texting of patient information (protected health information - PHI) among members of the healthcare team through a secure platform. They drew the line however, concerning patient orders – texting of patient orders is prohibited regardless of the platform utilized. The preferred method for entering orders is through a computerized provider order entry (CPOE). Practitioners can still hand write orders into a medical record, but the CPOE has the advantages of an immediate download into the provider’s electronic health records (EHR), automatically dated, timed, and authenticated. To minimize the potential risks associated with the texting of PHI, CMS expects “providers/organizations will implement procedures/processes that routinely assess the security and integrity of the texting systems/platforms that are being utilized.”

The second issue addressed by Medicare is documentation by medical students. MLN Matters Article MM10412 explains the new rule that allows teaching physicians to verify in the medical record any student documentation of components of evaluation and management (E/M) services, rather than re-documenting the work. This will be a huge timesaver for teaching physicians and is not likely to have any effect on the quality of the medical record. Like with the texting rule change above, there are some limitations to this rule change:

• The teaching physician must verify in the medical record all student documentation or findings, including history, physical exam and/or medical decision making;
• The teaching physician must personally perform (or re-perform) the physical exam;
• The teaching physician must personally perform (or re-perform) medical decision-making activities of the E/M service being billed; but
• The teaching physician can verify student documentation of the physical exam and medical decision-making rather than re-documenting.

Both of the above rule changes provide a little relief to healthcare providers that hopefully will result in time savings and better communication while still protecting patient privacy and accurate medical records.