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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.

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.

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.

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.

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.

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

DECISION

CMS posted a Final Decision Memo on February 15, 2018 for the National Coverage Determination (NCD) for Implantable Automatic Defibrillators (20.4). CMS finalized what they describe as “minimal changes” to the ICD NCD from the 2005 reconsideration. After you have finished reading this article I will leave it to you to decide if you agree with their definition of “minimal changes.”

DECISION SUMMARY OF THE CHANGES

Patient Criteria

• Add cardiac magnetic resonance imaging (MRI) to the list of diagnostic imaging studies that can evaluate left ventricular ejection fraction (LVEF).
• Note: Prior approved diagnostic imaging studies included echocardiography, radionuclide (nuclear medicine) imaging, and catheter angiography.
• Require patients who have severe non-ischemic dilated cardiomyopathy but no personal history of sustained ventricular tachyarrhythmia or cardiac arrest due to ventricular fibrillation to have been on optimal medical therapy (OMT) for at least 3 months.
• Require a patient shared decision making (SDM) interaction prior to ICD implementation for certain patients.
• Note: This includes all patient’s receiving an ICD for primary prevention.

Additional Patient Criteria

• Remove the Class IV heart failure requirement for cardiac resynchronization therapy (CRT)

Exceptions to Waiting Periods

• Add an exception for patients meeting CMS coverage requirements for cardiac pacemakers, and who meet the criteria for an ICD;
• Add an exception for patients with an existing ICD and qualifying replacement
• End the data collection requirement

Evidence

When developing a National Coverage Determination (NCD), CMS in general “evaluates relevant clinical evidence to determine whether or not the evidence is of sufficient quality to support a findings that an item or service falling within a benefit category is reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.”

The evidence review primarily focused “on randomized controlled trials that assess the clinical utility of defibrillators compared to optimal medical therapy, and relevant formal Technology Assessments and professional society guidelines. While reading through this part of the Decision Memo, some of the conclusions were reminiscent of statements made when Jack Handy shared “Deep Thoughts” on Saturday Night Live in the 1990’s. The following table highlights four of the studies.

‍PUBLIC COMMENTS

A significant portion of this Decision Memo was dedicated to detailing public comments received and CMS responses. The following table highlights comments and responses related to the “minimal changes” being made.

‍ANALYSIS

Patient Shared Decision Making

In addition to the example SDM tool for ICDs, CMS notes that a website was also developed “which leads patients step-by[step through some information on ICDs designed to increase patients’ knowledge of their medical condition, the risks and benefits of available treatments and to empower patients to become more involved in the decision-making process. https://patientdecisionaid.org/icd/.

CONSIDERATIONS MOVING FORWARD

Shared Decision Making

There are now 6 covered indications listed in the NCD. All patients receiving an ICD for primary prevention must be provided SDM. “For these patients…a formal shared decision making encounter must occur between the patient and a physician (as defined in Section 1861(r)(1)) or qualified non-physician practitioner (meaning a physician assistant, nurse practitioner, or clinical nurse specialist as defined in §1861(aa)(5)) using an evidence-based decision tool on ICDs prior to initial ICD implantation.  The shared decision making encounter may occur at a separate visit.”

Questions to Consider:

• Who will be the healthcare provider to provide the SDM encounter?
• What tool will you utilize?
• When will this SDM be done? For example, the patient meeting Pacemaker and ICD indications that has been admitted for an AMI, Stent or CABG and placement is advised prior to the patient’s discharge.
• Since the SDM encounter can occur at a separate visit, what will be your process to make sure this information makes it into the medical record when the patient receives an ICD?

Optimal Medical Therapy

Patients who have severe non-ischemic dilated cardiomyopathy but no personal history of sustained ventricular tachyarrhythmia or cardiac arrest due to ventricular fibrillation must have been on optimal medical therapy (OMT) for at least 3 months prior to ICD placement.

Questions to Consider:

• Who is the healthcare provider providing optimal medical therapy? Is it a patient’s Internal Medicine Doctor, Cardiologist, Electrophysiologist?
• Similar to SDM, what will be your process to make sure this information makes it into the medical record when the patient receives an ICD?

MMP strongly encourages key stakeholders take the time to read the entire Decision Memo.

MEDICARE TRANSMITTALS

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

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

E/M Service Documentation Provided By Students (Manual Update)

Allows the teaching physician to verify in the medical record any student documentation of components of E/M services, rather than re-documenting the work.

https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/Downloads/MM10412.pdf

Quarterly Update to the National Correct Coding Initiative (NCCI) Procedure-to-Procedure (PTP) Edits, Version 24.1, Effective April 1, 2018

https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/Downloads/MM10472.pdf

Medicare Fee-for-Service Recovery Audit Program Additional Documentation Limits for Medicare Institutional Providers (i.e. Facilities)

New ADR limits for the Recovery Audit Program.

https://www.cms.gov/Research-Statistics-Data-and-Systems/Monitoring-Programs/Medicare-FFS-Compliance-Programs/Recovery-Audit-Program/Downloads/Institutional-Provider-Facilities-ADR-Limits.pdf

Diagnosis Code Update for Add-on Payments for Blood Clotting Factor Administered to Hemophilia Inpatients

Updates to diagnosis codes required in order to allow add-on payments under the Inpatient Prospective Payment System (IPPS) for blood clotting factor administered to hemophilia inpatients.

https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/Downloads/MM10474.pdf

Quarterly Update for Clinical Laboratory Fee Schedule and Laboratory Services Subject to Reasonable Charge Payment

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

Replacement of Mammography HCPCS Codes, Waiver of Coinsurance and Deductible for Preventive and Other Services, and Addition of Anesthesia and Prolonged Preventive Services – REVISED

https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/Downloads/MM10181.pdf

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

Revised to add HCPCS code G0475 as a code that is subject to CLIA edits effective, April 13, 2015.

https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/Downloads/MM10446.pdf

Modifications to the Implementation of the Paperwork (PWK) Segment of the Electronic Submission of Medical Documentation (esMD) System

Enables MACs to receive unsolicited documentation (also known as paperwork (PWK)) via the Electronic Submission of Medical Documentation (esMD) system.

https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/Downloads/MM10397.pdf

Update to the Medicare Physician Fee Schedule Database (MPFSDB) - April 2018 Update

https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/Downloads/MM10488.pdf

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

Updates the Remittance Advice Remark Codes (RARC) and Claims Adjustment Reason Code (CARC) lists and instructs Medicare Shared System Maintainers (SSMs) to update Medicare Remit Easy Print (MREP) and PC Print.

https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/Downloads/MM10489.pdf

ICD-10 and Other Coding Revisions to National Coverage Determinations (NCDs)

A maintenance update of the International Classification of Diseases, Tenth Revision (ICD-10) conversions and other coding updates specific to National Coverage Determinations (NCDs). These NCD coding changes are the result of newly available codes, coding revisions to NCDs released separately, or coding feedback received.

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

MEDICARE COVERAGE UPDATES

Supervised Exercise Therapy (SET) for Symptomatic Peripheral Artery Disease (PAD)

Effective May 25, 2017, new NCD to cover Supervised Exercise Therapy (SET) for beneficiaries with Intermittent Claudication (IC) for the treatment of symptomatic Peripheral Artery Disease (PAD).

https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/Downloads/MM10295.pdf

Decision Memo for Implantable Cardioverter Defibrillators (CAG-00157R4)

Changes to the ICD NCD from the 2005 reconsideration.

https://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=288&TimeFrame=7&DocType=All&bc=AgAAYAAAQAAA&

OTHER MEDICARE UPDATES

Medicare Fee-for-Service Recovery Audit Program Additional Documentation Limits for Medicare Institutional Providers (i.e. Facilities)

https://www.cms.gov/Research-Statistics-Data-and-Systems/Monitoring-Programs/Medicare-FFS-Compliance-Programs/Recovery-Audit-Program/Downloads/Institutional-Provider-Facilities-ADR-Limits.pdf

Correction: Hospital Outpatient Prospective Payment (OPPS) and Ambulatory Surgical Center (ASC) Payment Systems and Quality Reporting Programs

https://www.gpo.gov/fdsys/pkg/FR-2018-01-31/pdf/C1-2017-27949.pdf

Targeted Probe and Educate (TPE) Website Update

New resources available on the TPE website.

https://www.cms.gov/Research-Statistics-Data-and-Systems/Monitoring-Programs/Medicare-FFS-Compliance-Programs/Medical-Review/Targeted-Probe-and-EducateTPE.html

MEDICARE EDUCATIONAL RESOURCES

Transition to New Medicare Numbers and Cards FACTSHEET

https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/Downloads/TransitiontoNewMedicareNumbersandCards-909365.pdf

“If you have an apple and I have an apple and we exchange these apples then you and I will still each have one apple. But if you have an idea and I have an idea and we exchange these ideas, then each of us will have two ideas.”

-George Bernard Shaw

Probe & Educate Target: Emergency Room Services

This past November, the Medicare Administrative Contractor (MAC) WPS announced that they would begin reviewing facilities billing emergency room services (CPT codes 99281-99285) as part of the Targeted Probe and Educate (TPE) review process.

The TPE process includes MACs utilizing data analysis to identify:

• Providers and suppliers who have high claim error rates or unusual billing practices, and
• Items or services that have high national error rates and are a financial risk to Medicare.

WPS provides the following guidance in the announcement for a successful review of emergency department visits for facility services (Type A Emergency Rooms):

• The number and type of interventions under the facility charge,
• The visit record showing the signs/symptoms that support medical necessity for the interventions, and
• The internal guidelines used to determine the HCPCS equivalent CPT code (99281-99285) for the hospital resources being billed.

WPS is currently the MAC for Jurisdiction 5 (IA, KS, MO, and NE Providers) and Jurisdiction 8 (IN, MI Providers). For those of you in a different MAC Jurisdiction, take note now as in general when one MAC targets a specific service it is not long before other MACs follow suit.

Are you an Outlier?

The question is, how do your E.R. levels codes compare to other facilities? Now, the Program for Evaluating Payment Patterns Electronic Report for short-term acute care hospitals (ST PEPPER) can assist you in analyzing your volume of emergency room services claims and comparing your data to your state, MAC jurisdiction and at the national level.

As of the 4th Quarter of the 2017 CMS IPPS Fiscal Year (July – September 2017), Emergency Department Evaluation and Management Visits (ED E&M) is a new PEPPER Target Area.

Target areas are approved by CMS because they have been identified as prone to improper payments. The Twenty-fourth Edition of the ST PEPPER User’s Guide notes that “concerns with overuse/misuse of higher level E&M codes have been prevalent for several years. The Office of Inspector General identified increasing trends of E&M coding for higher-level services (https://oig.hhs.gov/oei/reports/oei-04-10-00180.pdf ) as well as improper payments associated with E&M coding errors (https://oig.hhs.gov/oei/reports/oei-04-10-00181.pdf).”

PEPPER Recommendations for Outliers?

High Outliers could represent coding and billing errors related to over-coding of CPT code 99285. Appendix 5 of the User’s Guide notes attributes CPT 99285 as when “usually, the presenting problem(s) are of high severity and pose an immediate significant threat to life or physiologic function.” The ST PEPPER recommends reviewing a sample of claims coded to 99285 to validate the code is supported by documentation in the medical record.

Low Outliers could represent coding errors related to under-coding 99285. The ST PEPPER recommends reviewing a sample of claims coded to 99281, 99282, 99283 or 99284 should be reviewed to validate the code level is supported by documentation in the medical record.

Related article about the ST PEPPER: http://www.mmplusinc.com/news-articles/item/pepper-resources-guide-updates.

To learn more about the TPE Review Process visit the CMS TPE webpage at: https://www.cms.gov/Research-Statistics-Data-and-Systems/Monitoring-Programs/Medicare-FFS-Compliance-Programs/Medical-Review/Targeted-Probe-and-EducateTPE.html

It is that time of year when the winter season tries its best to hang on while spring makes faltering attempts to assert itself.  The intermittent but increasing days of warmer weather are accompanied by spring rains, spring fever, spring breaks, and oh don’t forget taxes. If you have family or friends in the accounting business, you experience first hand that it is also the “busy season” for tax accountants.  Income taxes are one of the prime examples of the government taking away. In the recent Bipartisan Budget Act (BBA) of 2018, an example of our government giving and taking relates to rehabilitative therapy services and the infamous therapy cap.

Since the Balanced Budget Act of 1997, there has been an annual limitation on the amount Medicare will pay for rehabilitative therapy services for a beneficiary.  This is known as the therapy caps. There has been one therapy cap for outpatient occupational therapy (OT) services and another separate therapy cap for physical therapy (PT) and speech-language pathology (SLP) services combined.  Finally, however, the therapy cap is gone.  The BBA signed into law on February 9, 2018 repealed the therapy cap effective for claims on and after January 1, 2018.

There are a few catches to the repeal. Providers must continue to report the KX modifier for therapy services that exceed the dollar amount previously known as the therapy cap.  That amount remains $2,010 for 2018 – one $2,010 limit for physical therapy and speech-language services combined and another $2,010 limit for occupational therapy.  The KX modifier is attestation the services above this dollar amount are reasonable and necessary and that there is documentation of medical necessity for the services in the patient’s medical record. Since there is not technically a therapy cap, it is not yet known if therapy services exceeding the dollar amount reported without a KX modifier will be denied.  Such details should be forthcoming from CMS in sub-regulatory guidance.  All types of therapy providers, including those in a hospital outpatient setting, are affected by the new rules.

There will also continue to be targeted medical reviews of therapy services that exceed a threshold amount.  The BBA lowered that threshold amount for 2018 through 2028 from $3,700 to $3,000 – again, one threshold for PT/Speech combined and a separate threshold for OT.  Not all therapy services exceeding the new, lower threshold will be reviewed.  Targeted reviews for therapy exceeding the threshold will be selected based on such factors as therapy providers with a high claims denial rate for therapy services or with aberrant billing practices compared to their peers. The Supplemental Medical Review Contractor (SMRC) currently performs these types of reviews for CMS.

The bad news (i.e. the taking away) for therapy providers from the Bipartisan Budget Act relates to payment rates for services provided by therapy assistants. The BBA mandates that for PT and OT services furnished on and after January 1, 2022, the payment rate will be 85% of the usual payment when the services are provided in whole or in part by a therapy assistant.  A modifier will be created to be reported when therapy services are provided by a therapy assistant to trigger the reduced payment rate. 

This requirement for reduced payment for therapy assistant services offsets the excitement of the therapy cap repeal. At least there are a few years prior to any reduction in payment for assistant services.  A lot can happen between now and then – maybe even another incident of the “government giveth.” We can always hope.