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Q:

Are there any Medicare guidelines for when it is appropriate to bill hydration therapy?

A:

Yes, there are some. Novitas, the Medicare Administrative Contractor (MAC) for Jurisdictions H and L (JH and JL); Palmetto (JJ and JM MAC), and Noridian (JE and JF MAC) all have coverage articles that address hydration therapy. In addition, Novitas (JH/JL) has a Local Coverage Determination (LCD) for Hydration Therapy, which contains the most exhaustive listing of indications and limitations for hydration.

In May, HMS, the Recovery Auditor for Region 4, posted approved RAC issue 0137, Intravenous Hydration Administration: Medical Necessity and Documentation Requirements. The details of this issue state:

• “Necessity for administration of hydration should be supported within medical documentation. Routine administration of IV fluids, pre/post operatively while the patient is NPO for example, without documentation supporting signs and/or symptoms including those of dehydration or fluid loss is not supported as medically necessary. It is important to distinguish the medical necessity of hydration from the use of fluid administration intended only to initiate flow or to keep the vein open. When the sole purpose of the IV fluid administration is to establish and/or maintain vascular access or patency of the IV line, the service is neither diagnostic nor therapeutic and must not be separately reported.”

The Noridian article includes this statement:

• “Medical necessity is supported in the evaluation performed by the provider (usually on the same day) and involves the clinical assessment of the patient. Documentation of the assessment should describe symptoms warranting HYDRATION, such as those associated with dehydration, the inability to ingest fluids, abnormal fluid losses, abnormal vital signs, and/or abnormal laboratory studies, such as an elevated BUN, creatinine, glucose or lactic acid. Nausea itself does not necessarily indicate fluid volume depletion nor support necessity of fluid repletion.”

Even if you are a provider in another jurisdiction, hydration therapy must be medically necessary as this is required of all Medicare services. You can use the information from the MAC and RAC sources mentioned above for guidance and direct any specific questions concerning coverage of hydration therapy to your regional MAC.

In the August 20, 2019 Wednesday@One, we published an article about Appropriate Use Criteria (AUC) which will enter the Educational and Operations Testing Period beginning January 1, 2020. During this phase, providers are encouraged to participate, but claims will not be denied for lack of AUC claim elements. In that article, I stated, “It is confusing to me why applicable settings include hospital emergency departments when patients with an emergency medical condition are exempt.” I reached out to CMS for further clarification and they directed me to the CY 2019 Physician Fee Schedule final rule on page 59699 (https://www.govinfo.gov/content/pkg/FR-2018-11-23/pdf/2018-24170.pdf) for more information about this exception. I appreciated their prompt response and I think it actually did answer my question.

After reading the above reference and the section of the Social Security Act which it references, I determined that the difference in the exception versus all services provided in a hospital emergency department depends on differing definitions of the term “emergency.”

The exception for following the AUC guidelines does not apply to section 1867(a) of the Act which is where the requirement for an appropriate medical screening examination is set forth. This section states,

• “In the case of a hospital that has a hospital emergency department, if any individual (whether or not eligible for benefits under this title) comes to the emergency department and a request is made on the individual’s behalf for examination or treatment for a medical condition, the hospital must provide for an appropriate medical screening examination within the capability of the hospital’s emergency department, including ancillary services routinely available to the emergency department, to determine whether or not an emergency medical condition (within the meaning of subsection (e)(1)) exists.”

We all know that many patients present to the emergency department for conditions that are not really “emergencies” as defined further in the Act. Advanced imaging services provided for these types of conditions will be required to follow the AUC guidelines.

It is only those “serious jeopardy” emergency conditions as defined in section 1867(e)(1) of the SSA that are exempt from the AUC requirements. This section of the Act defines “emergency medical condition” to mean

• a medical condition manifesting itself by acute symptoms of sufficient severity (including severe pain) such that the absence of immediate medical attention could reasonably be expected to result in—
• placing the health of the individual (or, with respect to a pregnant woman, the health of the woman or her unborn child) in serious jeopardy,
• serious impairment to bodily functions, or
• serious dysfunction of any bodily organ or part; or
• with respect to a pregnant woman who is having contractions—
• that there is inadequate time to effect a safe transfer to another hospital before delivery, or
• that transfer may pose a threat to the health or safety of the woman or the unborn child.

The discussion in the 2019 MPFS Final Rule does clarify that the exception to using AUC includes “instances where an emergency medical condition is suspected, but not yet confirmed. This may include, for example, instances of severe pain or severe allergic reactions. In these instances, the exception is applicable even if it is determined later that the patient did not in fact have an emergency medical condition.”

Even though I think I understand the distinction between less severe conditions of ED patients and those with conditions placing the patient’s health in serious jeopardy, impairment or dysfunction, I am curious to see how CMS will make this determination for payment purposes once consultation and reporting of use of AUC is required. For example, an ED claim with a diagnosis of GERD could have been a patient presenting with chest pain, a condition that could potentially place the patient’s health in serious jeopardy. Is CMS going to perform a complex review to determine if AUC is required or not? If so, what documentation would they expect to see in the ED record to support that an emergency medical condition was suspected? I guess we will just have to wait and see how it all plays out.

Medicare has National Coverage Determinations (NCDs) that describe the requirements that must be performed and documented for the cardiac services of Transcatheter Aortic Valve Replacement (TAVR), Left Atrial Appendage Closure (LAAC), and Transcatheter Mitral Valve Repair (TMVR). Be sure to read the other article in this week’s Wednesday@One that discusses these requirements. Hopefully your cardiology department is familiar with the NCDs and has implemented processes to ensure the documentation in your records supports Medicare’s requirements. But isn’t it frustrating if all the requirements are met and appropriately documented, to have your Medicare claim denied, rejected, or returned due to missing claim elements? And in addition to the frustration, your facility is delaying or missing out on your Medicare DRG payments.

Claims for these services obviously must include the appropriate procedure codes and diagnosis codes. In addition, since all of these cardiac services are covered under Coverage with Evidence Development (CED), the claims must include a secondary diagnosis code, condition code, and value code related to the clinical trial/registry. All three of these procedures are inpatient-only procedures and would be billed on an inpatient claim, type of bill, 11x and paid under a Medicare DRG payment.

Specifically, for each procedure the following is required on the institutional inpatient claim:

Left Atrial Appendage Closure (LAAC) (Watchman procedure):

• Procedure Code - 02L73DK (Occlusion of Left Atrial Appendage with Intraluminal Device, Percutaneous Approach)
• One of the following diagnosis codes –
• I48.0 - Paroxysmal Atrial Fibrillation
• I48.1 - Persistent Atrial Fibrillation
• I48.2 - Chronic Atrial Fibrillation
• I48.91 - Unspecified Atrial Fibrillation
• Secondary diagnosis code – Z00.6 - Encounter for examination for normal comparison and control in clinical research program
• Condition Code 30 - Qualified Clinical Trial
• Value Code D4 and corresponding 8-digit clinical trial number (Clinical trail and/or registry numbers can be found on Medicare’s CED website.)

Transcatheter Aortic Valve Replacement (TAVR):

• Procedure Code – One of the following procedure codes –
• 02RF37Z (Replacement of Aortic Valve with Autologous Tissue Substitute, Percutaneous Approach),
• 02RF38Z (Replacement of Aortic Valve with Zooplastic Tissue, Percutaneous Approach),
• 02RF3JZ (Replacement of Aortic Valve with Synthetic Substitute, Percutaneous Approach),
• 02RF3KZ (Replacement of Aortic Valve with Nonautologous Tissue Substitute, Percutaneous Approach),
• 02RF37H (Replacement of Aortic Vavle with Autologous Tissue Substitute, Transapical, Percutaneous Approach),
• 02RF38H (Replacement of Aortic Valve with Zooplastic Tissue, Transapical, Percutaneous Approach),
• 02RF3JH (Replacement of Aortic Valve with Synthetic Substitute, Transapical, Percutaneous Approach), or
• 02RF3KH (Replacement of Aortic Valve with Nonautologous Tissue Substitute, Transapical, Percutaneous Approach)
• Procedure Code - X2A5312 (Cerebral Embolic Filtration, dual filter in innominate artery and left common carotid artery, percutaneous approach) when used
• One of the following diagnosis codes –
• I35.0 - Nonrheumatic aortic (valve) stenosis
• T82.222A - Displacement of biological heart valve graft, initial encounter (Code for when a previously placed valve was malpositioned or became displaced)
• T82.857A - Stenosis of cardiac prosthetic devices, implants and grafts, initial encounter (Code for when the previously placed valve developed stenosis prematurely)
• T82.223A - Leakage of biological heart valve graft, initial encounter (Code for when the previously placed valve developed regurgitation prematurely)
• Z45.09 - Encounter for adjustment and management of other cardiac device (Code for when the previously placed valve developed stenosis or regurgitation as an expected occurrence as it degenerates towards end-of-life)
• Secondary diagnosis code – Z00.6 - Encounter for examination for normal comparison and control in clinical research program
• Condition Code 30 - Qualified Clinical Trial
• Value Code D4 and corresponding 8-digit clinical trial number

Transcatheter Mitral Valve Repair (TMVR) (MitraClip procedure):

• One of the following Procedure Codes
• 02UG3JZ - Supplemental Mitral Valve with Synthetic Substitute, Percutaneous approach
• 02QG3ZE - Repair Mitral Valve created from Left Atrioventricular Valve, Percutaneous Approach
• 02QG4ZE - Repair Mitral Valve created from Left Atrioventricular Valve, Percutaneous Endoscopic Approach
• 02UG37E - Supplement Mitral Valve created from Left Atrioventricular Valve with Autologous Tissue Substitute, Percutaneous Approach
• 02UG38E - Supplement Mitral Valve created from Left Atrioventricular Valve with Zooplastic Tissue, Percutaneous Approach
• 02UG3JE - Supplement Mitral Valve created from Left Atrioventricular Valve with Synthetic Substitute, Percutaneous Approach
• 02UG3KE - Supplement Mitral Valve created from Left Atrioventricular Valve with Nonautologous Tissue Substitute, Percutaneous Approach
• 02UG3KZ - Supplement Mitral Valve with Nonautologous Tissue Substitute, Percutaneous Approach
• 02UG47E - Supplement Mitral Valve created from Left Atrioventricular Valve with Autologous Tissue Substitute, Percutaneous Endoscopic Approach
• 02UG48E - Supplement Mitral Valve created from Left Atrioventricular Valve with Zooplastic Tissue, Percutaneous Endoscopic Approach
• 02UG4JE - Supplement Mitral Valve created from Left Atrioventricular Valve with Synthetic Substitute, Percutaneous Endoscopic Approach
• 02UG4KE - Supplement Mitral Valve created from Left Atrioventricular Valve with Nonautologous Tissue Substitute, Percutaneous Endoscopic Approach
• 02WG37Z - Revision of Autologous Tissue Substitute in Mitral Valve, Percutaneous Approach
• 02WG38Z - Revision of Zooplastic Tissue in Mitral Valve, Percutaneous Approach
• 02WG3JZ - Revision of Synthetic Substitute in Mitral Valve, Percutaneous Approach
• 02WG3KZ - Revision of Nonautologous Tissue Substitute in Mitral Valve, Percutaneous Approach
• One of the following diagnosis codes –
• I34.0 - Nonrheumatic mitral (valve) insufficiency
• I34.1 - Nonrheumatic mitral valve prolapse
• Secondary diagnosis code – Z00.6 - Encounter for examination for normal comparison and control in clinical research program
• Condition Code 30 - Qualified Clinical Trial
• Value Code D4 and corresponding 8-digit clinical trial number

MACs will fully reject inpatient claims for these cardiac procedures when billed without the appropriate procedure, diagnosis, or clinical trial codes. Hospitals that perform these procedures need to put processes in place for communication between the clinical department, coding, and the billing office so that the appropriate claim elements are added. Internal claim processing edits to halt claims with one of the applicable procedure codes may be an option to verify appropriate diagnosis codes and allow the addition of the clinical trial codes.

Refer to the NCDs and corresponding claims processing instructions for complete Medicare requirements.

NCD 20.32 TAVR,  NCD 20.33 TMVR, and NCD 20.34 LAAC. 

What is Structural Heart Disease?

In recent years, we have seen several of our clients expand their Cardiology Services into the field of Structural Heart. So, what exactly is structural heart disease? In my quest for understanding, I found several different definitions of structural heart disease, the two most pertinent to the focus of this article are from the Journal of American College of Cardiology and the Cardiovascular Research Foundation.

“The term “structural heart disease” entered the adult cardiology lexicon in 1999 and currently encompasses the base of knowledge and competencies surrounding noncoronary cardiac procedures such as transcatheter aortic valve replacement (TAVR), percutaneous mitral repair, and left atrial appendage exclusion.”

• Structural Heart Disease, Curt J. Daniels, Michael J. Landzberg, Robert H. Beekman ,Journal of the American College of Cardiology May 2015, 65 (20) 2260-2261; DOI: 10.1016/j.jacc.2014.12.075

The Cardiovascular Research Foundation defines structural heart disease as covering “a wide range of cardiac conditions, including valvular heart disease and defects in the muscular structure of the heart. The disease may be congenital, as well as acquired. As the American population ages, acquired disease, such as calcific (senile) aortic stenosis and mitral regurgitation has increased in importance, with 12% of adults over the age of 75 being diagnosed with the disease. The past two decades have seen a revolution in the treatment of structural heart disease with transcatheter therapies being developed for valve repair and replacement, closure of defects such as ASD (atrial septal defects), and isolation of the left atrial appendage to reduce embolic risk in atrial fibrillation. Patients who previously could only undergo high risk surgical aortic valve replacement or were completely inoperable can now be treated with a transcatheter approach, often with only a one night stay in the hospital.”

Structural Heart Procedures

With an understanding of structural heart disease, the rest of this article focuses on Medicare Fee-for-Service documentation requirements for the three procedures described in the Journal of the American College of Cardiology’s definition of structural heart disease, specifically:

• Left Atrial Appendage Closure (LAAC) or WATCHMAN™ Procedure,
• Transcatheter Aortic Valve Replacement (TAVR), and
• Transcathater Mitral Valve Repair (TMVR) or MitraClip Procedure.

In addition to documentation requirements, there are very specific billing requirements for the claims to be paid. You can read about the billing requirements in the related article in this week’s newsletter.

Left Atrial Appendage Closure “WATCHMAN™”

The FDA approved the WATCHMAN™ closure technology in March of 2015. This procedure is indicated to reduce the risk of thromboembolism from the Left Atrial Appendage in patients with non-valvular atrial fibrillation (NVAF). CMS published the National Coverage Determination (NCD) for Percutaneous Left Atrial Appendage Closure (20.34) with an effective date of February 8, 2016.

Checklist for hospitals performing WATCHMAN™ procedure

• This procedure is on the Medicare Inpatient-Only Procedure (IPO) List
• The patient must have non-valvular atrial fibrillation,
• The patient must have a CHADS2 score ≥ 2 OR CHA2DS2-VASc score ≥3,
• The patient must participate in a formal Shared Decision Making Encounter (SDM) with an independent non-interventional physician using an evidence based decision tool on oral anti-coagulation in patients with non-ventricular atrial fibrillation prior to procedure.
• Documentation of the SDM must be in the medical record.
• The patient must be suitable for short-term Warfarin but deemed unable to take long-term anticoagulation following the conclusion of the SDM encounter.
• The patient must be under the care of Multidisciplinary Team (MDT) of medical professionals.
• The procedure must be performed by an interventional cardiologist, electrophysiologist, or cardiovascular surgeon who meets the criteria outlined in the NCD to perform the procedure.
• The patient must be enrolled in, and the MDT must participate in a prospective, national audited registry.
• Read the NCD carefully and make sure you are following all of Medicare’s requirements.

Transcatheter Aortic Valve Replacement (TAVR)

TAVR is for the treatment of symptomatic aortic valve stenosis where a biprosthetic valve is inserted percutaneously using a catheter and implanted in the orifice of the native aortic valve. CMS published the National Coverage Determination (NCD) Transcatheter Aortic Valve Replacement (TAVR) (20.32) in May 2012. In June of this year, CMS published a Final Decision Memo making updates to the NCD. One significant change was to change the requirement that two cardiac surgeon’s document a face-to-face encounter with the patient prior to the procedure to requiring a cardiac surgeon and an interventional cardiologist. You can read more about the new decision memo in a related MMP article by Debbie Rubio in a July 2019 edition of the Wednesday@One. The following excerpt is from that article:

Checklist for hospitals that perform the TAVR procedure:

• This procedure is on the Medicare IPO List.
• The patient must have symptomatic aortic valve stenosis;
• The patient must be under the care of a heart team and the heart team's interventional cardiologist(s) and cardiac surgeon(s) jointly participate in the intra-operative technical aspects of TAVR;
• The hospital must have the appropriate infrastructure for the procedure;
• Your medical record must contain documentation of the face-to-face patient examinations by a cardiac surgeon and an interventional cardiologist (experienced in the care and treatment of aortic stenosis) evaluating the patient’s suitability for surgical aortic valve replacement (SAVR), TAVR or medical or palliative therapy;
• Assess your hospital and heart team volumes to be sure you meet the requirements for performing the procedure under the new Decision Memo; and
• Read the new Decision Memo carefully and make sure you are following all of Medicare’s requirements.

Transcatheter Mitral Valve Repair (TMVR) MitraClip

The FDA approved the first TMVR device on October 24, 2013. Abbott Vascular’s MitraClip® was approved “for the percutaneous reduction of significant symptomatic mitral regurgitation (MR ≥ 3+) due to primary abnormality of the mitral apparatus [degenerative MR] in patients who have been determined to be at prohibitive risk for mitral valve surgery by a heart team, which includes a cardiac surgeon experienced in mitral valve surgery and a cardiologist experienced in mitral valve disease, and in whom existing comorbidities would not preclude the expected benefit from reduction of the mitral regurgitation.” CMS published the National Coverage Determination (NCD) for Transcatheter Mitral Valve Repair (TMVR) (20.33) with an effective date of August 7, 2014.

On August 14, 2019, at the request of the Society of Thoracic Surgeons (STS), the American College of Cardiology (ACC), the American Association for Thoracic Surgery (AATS), and the Society for Cardiovascular Angiography & Interventions (SCAI), CMS opened a National Coverage Analysis (NCA) Tracking Sheet for Transcatheter Mitral Valve Repair (TMVR) (CAG-00438R). The expected release of a Proposed Decision Memo is February 14, 2020.

The issue identified in the NCA is that currently this procedure is covered for the treatment of degenerative (primary) mitral regurgitation (MR) involving a structural abnormality. However, there are two types of MR and currently this procedure is not covered for the treatment of functional (secondary) MR which is a distinct condition that generally results from left ventricular dysfunction.

Checklist for hospitals that perform the TMVR procedure:

• This procedure is on the Medicare IPO list.
• The ICD-10-CM diagnoses supporting medical necessity for service provided both describe a nonrheumatic condition. Documentation in the medical record must specify if the valve insufficiency is Nonrheumatic or rheumatic as the Second Quarter 2019 Coding Clinic guidance advises that ICD-10-CM assumes aortic and mitral valve disease is rheumatic in nature when it is not described as non-rheumatic.
• Currently, the procedure is approved for the treatment of significant symptomatic degenerative MR.
• The patient must have a face-to-face encounter by a cardiothoracic surgeon experienced in mitral valve surgery and a cardiologist in mitral valve disease. The encounter must evaluate the patient’s suitability for mitral valve surgery and determination of prohibitive risk, and both must have documented their rationale for their clinical judgement in the medical record.
• The patient must be under the care MDT of healthcare professionals.
• Assess your hospital infrastructure and heart team volumes to be sure you meet the requirements for performing this procedure.
• The heart team’s interventional cardiologist or a cardiothoracic surgeon must perform the TMVR.
• Read the NCD carefully and make sure you are following all of Medicare’s requirements.

This article is meant to help providers with a structural heart program perform a self-assessment to validate that your claims support the medical necessity requirements outlined in the NCDs. This article is also meant to be a starting point for those providers considering or in the early stages of a structural heart program become knowledgeable about the CMS medical necessity. Additionally, MMP has developed procedure specific tip sheets. Click here to download the tip sheet for Left Atrial Appendage Closure (LAAC), here for Transcatheter Aortic Valve Replacement (TAVR), and here for Transcatheter Mitral Valve Repair (TMVR).

CMS Administrator Seema Verma is quoted as saying in an April 23rd Press Release that “transformative technologies are coming to the private market, but Medicare’s antiquated payment systems have not contemplated these technologies…I am particularly concerned about cases that have been reported to the agency in which Medicare’s inadequate payment has led hospitals to curtail access to needed therapies. We must continually update our policies in response to the rapid pace of advancement in medical science.”

Over the past two weeks we have covered finalized changes to ICD-10-CM diagnosis code severity designation and MS-DRGs found in the FY 2020 IPPS Final Rule. This week we examine the finalized New Technology Add-On Payments.

Background

Annually, CMS addresses applications for new technology add-on payments in the IPPS proposed rule. They do not make proposals, instead the proposed rule describes any concerns they may have about an applicant meeting the criteria for payment as a new technology and seeks additional information as needed to make a decision in the IPPS final rule. To be eligible for an add-on payment a new technology must meet the following three criteria:

• The medical service or technology must be new;
• The medical service or technology must be costly such that the DRG rate otherwise applicable to discharges involving the medical service or technology is determined to be inadequate; and
• The service or technology must demonstrate a substantial clinical improvement over existing services or technologies.

Once a new technology add-on payment status is granted hospitals are eligible to receive the payment for up to three years.

Increasing Add-On-Payment Amount

For FY 2019, the calculation for add-on payments is based on cost to hospitals for the new medical service or technology. Specifically, Medicare makes an add-on payment equal to the lesser of the following:

• 50% of the costs of the new medical service or technology, or
• 50% of the amount by which the costs of the case exceed the standard DRG payment.

In response to concerns from commenters and stakeholders, CMS agrees “that capping the add-on payment amount at 50 percent could, in some cases, no longer provide a sufficient incentive for the use of the technology.” As such, for discharges on or after October 1, 2019, CMS finalized their proposal to make the add-on payment be equal to the lesser of the following:

• 65% of the costs of the new medical service or technology, or
• 65% of the amount by which the costs of the case exceed the standard DRG payment.

New Technology Add-On Payment for Qualified Infectious Disease Products

CMS received comments and concerns related to antimicrobial resistance and its serious impact on Medicare beneficiaries and public health overall and finalized that for medical products designated as a Qualified Infectious Disease Product (QIDP) by the FDA, “if the costs of a discharge involving a new medical service or technology exceed the full DRG payment…Medicare will make an add-on payment equal to the lesser of (1) 75 percent of the costs of the new medical service or technology; or (2) 75 percent of the amount by which the costs of the case exceed the standard DRG payment.”

CMS Finalizes Proposal to Modernize Payment Policies for Medical Devices Meeting FDA’s Breakthrough Devices Designation

In December 2018 the U.S. Food and Drug Administration (FDA) implemented the Breakthrough Devices Program. At that time, the FDA indicated this “is a voluntary program for certain medical devices and device-led combination products that provides for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions…this program is intended to help patients have more timely access to these medical devices by expediting their development, assessment, and review, while preserving the statutory standards for premarket approval, 510(k) clearance, and De Novo marketing authorization, consistent with the Agency’s mission to protect and promote public health.”

CMS finalized the proposal that “for applications received for IPPS new technology add-on payments for FY 2021 and subsequent fiscal years, if a medical device is part of the FDA’s Breakthrough Devices Program and received FDA marketing authorization, such a device would be considered new and not substantially similar to an existing technology for purposes of new technology add-on payment under the IPPS.” CMS also finalized extending this proposal to products designated by the FDA as a QIDP.

Applications for New Technology Add-On Payments for FY 2020

• For FY 2020, CMS proposed to continue 10 of 13 technologies receiving NTAP in FY 2019.
• The remaining 3 of 13 technologies receiving NTAP in FY 2019 were no longer considered “new” and have been discontinued for FY 2020.
• There were 17 new applicants for new technology add-on payment for FY 2020
• Eight of the 17 new applicants discussed in the proposed rule either withdrew their application, did not receive FDA approval by the deadline of July 1 or after evaluation CMS found they did not meet the criteria to be considered a new technology.
• Effective October 1, 2019, there will be 19 New Technologies eligible for Add-On Payments.

CMS estimates the payment amounts for new technology add-on payments in the Final Rule based on the applicant’s estimates. This amount and the estimated number of patients is highlighted in the following table:  

‍For Your Consideration

While the number of patients estimated to receive one of the FY 2020 technologies approved for add-on payments is relatively small, this is an opportunity not to be missed for those hospitals providing the service. Looking at paid claims data in RealTime Medicare Data (RTMD), it appears that not all hospitals are taking advantage of the additional payment opportunity by not including a code for these medical services or technologies on the claim. That said, some questions come to mind for you to think about:

• Is your hospital providing any of these medical services or technology?
• Who needs to be aware of what the new technologies are? (i.e. Physicians, Pharmacy, Coding Professionals, Clinical Documentation Integrity Specialists, Case Managers)
• What process do you have in place to alert your Coding Staff of the need to code the new technologies?

To help you get started, I have put together a document detailing each New Technology including a description of the technology, the ICD-10-PCS code(s) and code description and the maximum new technology add-on payment in FY 2019 and for FY 2020. To download this document, click here.

Back in 2017, I wrote the section below about changes to the laboratory date-of-service policy changes from the 2018 OPPS Final Rule. The importance of laboratory date of service (DOS) requirements is that they are used to determine whether a hospital bills Medicare directly for a clinical diagnostic laboratory test (CDLT) or whether the laboratory performing the test bills Medicare. Remember, most CDLTs are conditionally packaged under OPPS, and are only paid separately to the hospital when they are: (1) the only service provided to a beneficiary on a claim; (2) considered a preventive service; (3) a molecular pathology test; or (4) an advanced diagnostic laboratory test (ADLT) that meets certain criteria. Preventive services, molecular pathology tests, and ADLTs are assigned an OPPS status indicator (SI) of “A” and paid under the Clinical Lab Fee Schedule (CLFS). CDLTs with an SI of “Q4” are paid separately under the CLFS when they are the only types of services on the claim, but payment is bundled when they appear with other outpatient services.

Excerpt from Prior Wednesday@One Article on Laboratory Date of Service Rule

“Laboratory date of service (DOS) rules start simple:

1. The DOS for clinical diagnostic laboratory services generally is the date the specimen is collected.
2. For archived lab specimens that are stored for more than 30 days before testing, the DOS is the date the specimen was obtained from storage.

Now this is where it starts getting complicated with what is known as the 14-day rule.

3. The DOS is the date the test was performed (instead of the date of collection) if the following conditions are met:
4. The test is ordered by the patient’s physician at least 14 days following the date of the patient’s discharge from the hospital;
5. The specimen was collected while the patient was undergoing a hospital surgical procedure;
6. It would be medically inappropriate to have collected the sample other than during the hospital procedure for which the patient was admitted;
7. The results of the test do not guide treatment provided during the hospital stay; and
8. The test was reasonable and medically necessary for the treatment of an illness.
9. Another 14-day rule applies to chemotherapy sensitive tests performed on live tissue under the same conditions as described above with only slight variation to the first condition:
10. The decision regarding the specific chemotherapeutic agents to test is made at least 14 days after discharge;

Both of these 14-day rules apply to hospital inpatients and outpatients and the key point is that the test is ordered at least 14 days after discharge.  These DOS requirements determine whether the hospital bills Medicare for a clinical diagnostic laboratory test (CDLT) or whether the laboratory performing the test bills Medicare directly. When the 14-day rule applies, laboratory tests are not bundled into the hospital stay, but are instead paid separately under Medicare Part B to the testing laboratory.

Stakeholders expressed concerns about the current (2017) DOS policy because it requires hospitals to bill for tests they did not perform and that may have no relationship to or bearing on treatment received by the patient while in the hospital and it creates billing difficulties for the hospital. CMS agreed with these concerns and modified the date of service rule for hospital outpatients for molecular pathology tests and advanced diagnostic laboratory tests (ADLTs) that are not packaged under OPPS.  These types of lab test have a Status Indicator of “A” on Addendum B.

The new rule (from the 2018 OPPS Final Rule) states that in the case of a molecular pathology test or an ADLT, the DOS of the test must be the date the test was performed only if—

• The test was performed following a hospital outpatient’s discharge from the hospital outpatient department;
• The specimen was collected from a hospital outpatient during an encounter (as both are defined in 42 CFR 410.2);
• It was medically appropriate to have collected the sample from the hospital outpatient during the hospital outpatient encounter;
• The results of the test do not guide treatment provided during the hospital outpatient encounter; and
• The test was reasonable and medically necessary for the treatment of an illness.

This new exception to the laboratory DOS policy does not apply to ADLT or molecular pathology tests when performed on a specimen collected from a hospital inpatient.

This new laboratory DOS policy will enable laboratories performing ADLTs and molecular pathology tests excluded from the OPPS packaging policy to bill Medicare directly for those tests, instead of requiring them to seek payment from the hospital outpatient department.  In fact, for molecular pathology tests and ADLTs meeting the above requirements, the DOS must be the date the test was performed and the test must be billed by the performing laboratory. Hospital laboratories cannot bill for these tests unless they perform them.”

Although the “new” lab DOS rule from the 2018 OPPS Final Rule described above was originally set to be implemented July 2, 2018, many hospitals and laboratories reported to CMS they were having administrative difficulties implementing the DOS exception. For that reason, CMS has repeatedly exercised enforcement discretion regarding the new rule, with the latest enforcement discretion in effect until January 2, 2020.

Because of continued concerns about the readiness of labs and hospitals to implement the new rule and additional concerns that some entities performing molecular pathology testing subject to the laboratory DOS exception, such as blood banks and blood centers, may not be enrolled in the Medicare program and may not have established a mechanism to bill Medicare directly, CMS is rethinking this DOS rule. In the 2020 OPPS Proposed Rule, they are seeking comments on three options for potential changes to the laboratory DOS exception.

1. Changing the Test Results Requirements – Under this option, the test would be considered a hospital service unless the ordering physician determines that the test does not guide treatment during a hospital outpatient encounter.

2. Limiting the Laboratory DOS Exception to ADLTs

3. Excluding Blood Banks and Blood Centers from the Laboratory DOS Exception

These options would only affect the new lab DOS exception put forth in the 2018 OPPS Final Rule that applies to molecular pathology tests and ADLTs. The basic lab DOS rules and the 14-day rule DOS exception and the chemotherapy sensitivity test DOS exception would not be affected.

I encourage hospitals and laboratories affected by these date of service rules to read the discussion in the Proposed Rule and to submit comments to CMS. (Lab DOS Policy section begins on page 201 of 247 pages of the pdf printed version.)

Q:

Our hospital laboratory sometimes sends an employee to a patient’s home or to a nursing home to collect a specimen. What are the Medicare billing requirements for this service?

A:

WPS, the Medicare Administrative Contractor (MAC) for Jurisdictions 5 and 8, recently published an article about Travel Allowance for Phlebotomy and Specimen Collection. Medicare will pay a travel allowance at a per mile rate for distances that are greater than 20 miles (HCPCS code P9603) or at a flat rate for distances of 20 miles or less (HCPCS code P9604). The lab employee must actually collect a specimen by venipuncture or catheterization; Medicare does not reimburse for travel to pick up a pre-collected specimen. For the travel to be covered, the associated laboratory test must be reimbursed. To ensure coverage of the lab test, be sure to have a signed and dated physician’s order or progress note that specifies the test(s) requested, the lab results, a medical diagnosis and relevant signs and symptoms, documentation supporting medical necessity, and documentation that the physician used the lab results in treating the patient.

One of the more stringent requirements for coverage of the travel allowance is that “the patient must be in a nursing facility where there was no qualified staff to collect the specimen or homebound” according to the WPS article. Should a claim for travel allowance be reviewed by a Medicare contractor, there must be documentation supporting one of these requirements. The article provides further details on what makes a patient considered “homebound.”

Another thing to keep in mind is that services must be pro-rated depending on the number of patients for each trip, including both Medicare and non-Medicare patients. For example, if a technician goes to a nursing home and collects from 5 patients, of which 4 are Medicare patients, then the total round-trip miles and/or travel charge would be divided by 5 to determine the mileage or amount that could be billed to each of the four Medicare patients. The WPS article includes specific examples to help providers understand this requirement.

If you have additional questions about the travel allowance, contact your regional MAC.

At least annually, DRG classifications and relative weights are adjusted to reflect changes in treatment patterns, technology, and other factors that may change the relative use of hospital resources. This week is the second article in our series about the 2020 IPPS Final Rule. This week highlights finalized changes to specific MS-DRG Classifications.

Pre-MDC

Extracorporeal Membrane Oxygenation (ECMO)

In FY 2019, three new procedure codes were finalized describing different types of ECMO treatments being used (central and peripheral). However, the codes were not finalized prior to the release of the FY 2019 IPPS Proposed Rule meaning there was no proposed Major Diagnostic Category (MDC), MS-DRG or O.R. vs. Non-O.R. designation made for the new codes.  

Given this unique situation, CMS Clinical Advisors reviewed the predecessor central ECMO code (5A15223) and determined the new peripheral codes should not sequence to Pre-MDC MS-DRG 3 where the central ECMO code is assigned.

Instead the new Peripheral ECMO codes were designated as Non-O.R. Procedures impacting MS-DRG assignment for specific medical MS-DRGs. The following table reflects the differences in ECMO Procedures DRG assignment:

In the FY 2020 IPPS Proposed Rule, stakeholders expressed the following concerns:

• MS-DRG assignment for ECMO should not be based on how the patient is cannulated as most of the cost can be attributed to a patient’s severity of illness,
• There was a lack of opportunity for public comment on the final MS-DRG assignments,
• Patient access to ECMO treatment and programs is now at risk because of inadequate payment, and
• CMS did not appear to have access to enough patient data to evaluate for appropriate MS-DRG assignment.

In the Final Rule CMS finalized the following proposals:

• Reassign the procedure codes describing peripheral ECMO procedures from their current MS-DRG assignments to Pre-MDC MS-DRG 003,
• Maintain the designation of the peripheral ECMO procedures as non-O.R., and
• Make changes to the titles for MS-DRGs 207, 291, 296, and 870 to no longer reflect the ECMO terminology in the title.

Allogenic Bone Marrow Transplant

A request was made to create new MS-DRGs for cases that would identify patients undergoing an allogeneic hematopoietic cell transplant (HCT) procedure according to the donor source (related or unrelated donor source). The requester indicated this would more appropriately recognize the clinical characteristics and cost differences in allogeneic HCT cases.

CMS data analysis of MS-DRG 014 cases reporting HCT related donor source, HCT unrelated donor source and unspecified donor source had comparable average length of stay and average costs. Thus, no proposal was made to create new MS-DRGs.

However, as a result of CMS’ review of procedure codes they proposed and finalized:

• The reassignment of 4 ICD-10-PCS codes for HCT procedures specifying autologous cord blood stem cell as the donor source from MS-DRG 014 to MS-DRGs 016 and 017, and
• Delete 128 clinically invalid codes from the transfusion table describing arterial access as transfusion procedures always use venous access rather than arterial access.

Chimeric Antigen Receptor (CAR) T-Cell Therapy

“Chimeric Antigen Receptor (CAR) T-cell therapy is a cell-based gene therapy in which a patient’s own T-cells are genetically engineered in a laboratory and used to assist in the patient’s treatment to attack certain cancerous cells. Blood is drawn from the patient and the T-cells are separated. The laboratory then utilizes the CAR process to genetically engineer the T-cells, resulting in the addition of a chimeric antigen receptor that will bind to a certain protein on the patient’s cancerous cells. The CAR T-cells are then administered to the patient by infusion.”

Two CAR T-cell therapy drugs received FDA approval in 2017 (KYMRIAH™ manufactured by Novartis Pharmaceuticals Corporation and YESCARTA™ manufactured by Kite Pharma, Inc.). Current ICD-10-PCS procedures codes involving the CAR T-cell therapy drugs includes:

• XW033C3 (Introduction of engineered autologous chimeric antigen receptor t-cell immunotherapy into peripheral vein, percutaneous approach, new technology group 3), and
• XW043C3 (Introduction of engineered autologous chimeric antigen receptor t-cell immunotherapy into central vein, percutaneous approach, new technology group 3).

Both ICD-10-PCS procedure codes became effective October 1, 2017 and are designated as non-O.R. procedures impacting MS–DRG assignment.

In FY 2019 CMS finalized the assignment of these procedure codes to Pre-MDC MS-DRG 016, revise the title of MS-DRG 016 to include “or T-cell immunotherapy,” and Car T-cell therapy was approved for a new technology add-on payment.

In the FY 2020 IPPS Proposed Rule, a request was made to create new MS-DRGs for CAR T-cell therapy. CMS does not believe enough data is available to make a change at this time. However, CMS has finalized the continuation of CAR-T cell therapy being eligible for new technology and add-on payments for FY 2020.

MDC 1: Diseases and Disorders of the Nervous System

Carotid Artery Stent Procedures

Current logic for case assignment to MS-DRGs 034, 035, and 036 (Carotid Artery Stent Procedures with MCC, with CC, and without CC/MCC respectively) “is comprised of two lists of logic that include procedure codes for operating room (O.R.) procedures involving dilation of a carotid artery (common, internal or external) with intraluminal device(s).”

CMS identified 46 ICD-10-PCS procedures codes in the second list that do not describe dilation of a carotid artery with intraluminal device. CMS finalized the proposal to remove these 46 codes from MS-DRGs 034, 035 and 036.

These 46 ICD-10-PCS codes are also assigned to MS-DRGs 037, 038, and 039 (Extracranial Procedures with MCC, with CC, and without CC/MCC, respectively.) Therefore, CMS also examined claims data for this MS-DRG group and finalized their proposals to:

• Remove 96 ICD-10-PCS procedure codes describing dilation of a carotid artery with an intraluminal device from the logic for MS-DRG group 037-038 and 039,
• Reassign 6 ICD-10-PCS procedure codes describing dilation of a carotid artery with an intraluminal device from MS-DRG group 037, 038 and 039 to MS-DRG group 034, 035, and 036,
• Delete 48 procedure codes from MS-DRGs 037, 038, and 039 that include the qualifier term “bifurcation;” and
• Combining all procedure codes identifying a carotid artery stent procedure within MS-DRGs 034, 035, and 036 into one list entitled “Operating Room Procedures” to better reflect the definition of the MS-DRGs.

MDC 4: Diseases and Disorders of the Respiratory System

Pulmonary Embolism

A request was made to reassign the following three ICD-10-CM diagnosis codes for Pulmonary Embolism (PE) with acute core pulmonale from MS-DRG 176 (PE without MCC) to MS-DRG 175 (PE with MCC):

• I26.01 – Septic pulmonary embolism with acute cor pulmonale,
• I26.02 – Saddle embolus of pulmonary artery with acute cor pulmonale, and
• I26.09 – Other pulmonary embolism with acute cor pulmonale.

The requestor noted with the FY 2019 IPPS Final Rule special logic change where a Principal Diagnosis could no longer be its own CC or MCC this resulted in these three codes being assigned to MS-DRG 176 when no other MCC is present. The requestor stated MS-DRG 176 does not appropriately account for cost and resource utilization associated with these cases.

CMS claims analysis supported the requestor’s statement about cost and resource utilization. CMS has finalized their proposals to:

• Reassign cases reporting diagnosis codes I26.01, I26.02 and I26.09 to MS-DRG 175, and
• Revise the MS-DRG 175 title to “Pulmonary Embolism with MCC or Acute Cor Pulmonale.”

The difference in relative weight (RW) and Geometric Mean Length of Stay (GMLOS) are reflected in the following table.

‍MDC 5: Diseases and Disorders of the Circulatory System

Transcatheter Mitral Valve Repair (TMVR) with Implant

CMS received a request to modify the current MS-DRG assignment for TMVR with implant procedures (MS-DRG 228 and 229: Other Cardiothoracic Procedures with MCC and without MCC, respectively). The requestor believed that TMVR is more similar to the replacement procedures in MS-DRGs 266 and 267 compared to other procedures currently assigned to MS-DRGs 228 and 229 and “noted that both TMVR procedures and endovascular cardiac valve replacements use a percutaneous approach, treat cardiac valves, and use an implanted device for purposes of improving the function of the specified valve.”

In the Proposed Rule CMS indicated “Our clinical advisors continue to believe that transcatheter cardiac valve repair procedures are not the same as a transcatheter (endovascular) cardiac valve replacement.

However, they agree with the requestor and, based on our data analysis, that these procedures are more clinically coherent in that they also describe endovascular cardiac valve interventions with implants and are similar in terms of average length of stay and average costs to cases in MS-DRGs 266 and 267 when compared to other procedures in their current MS-DRG assignment. For these reasons, our clinical advisors agree that we should propose to reassign the endovascular cardiac valve repair procedures (supplement procedures)…to the endovascular cardiac valve replacement MS-DRGs.”

CMS finalized the following proposals:

• Modify the structure of MS-DRGs 266 and 267 by reassigning the procedure codes describing transcatheter cardiac valve repair (supplement) procedure,
• Revise the title of MS-DRG 266 from “Endovascular Cardiac Valve Replacement with MCC” to “Endovascular Cardiac Valve Replacement and Supplement Procedures with MCC,”
• Revise the title of MS-DRG 267 from “Endovascular Cardiac Valve Replacement without MCC” to “Endovascular Cardiac Valve Replacement and Supplement Procedure without MCC,”
• Create two new MS-DRGs with a two-way severity split for the remaining (non-supplement) transcatheter cardiac valves.
• MS-DRG 319 (Other Endovascular Cardiac Valve Procedures with MCC), and
• MS-DRG 320 (Other Endovascular Cardiac Valve Procedures without MCC).

Pacemaker Leads

CMS noted that ICD-10-PCS procedure code 02H60JZ (Insertion of pacemaker lead into right atrium, open approach) was inadvertently omitted from the GROUPER logic for MS-DRGs 260, 261, and 262. They finalized adding this procedure code to the list of Non-O.R. procedures that would impact MS-DRGs 260, 261, and 262 when reported as a stand-alone procedure code.

MDC 8: Diseases and Disorders of the Musculoskeletal System and Connective Tissue

Knee Procedures with Principal Diagnosis of Infection

In FY 2019 ICD-10-CM diagnosis codes M00.9 (Pyogenic arthritis, unspecified) and A54.42 (Gonococcal arthritis) grouped to MS-DRGs 488 and 489 (Knee Procedures without Principal Diagnosis of Infection with and without CC/MCC, respectively) when a knee procedure is reported on the claim.

CMS received a request to add these two codes to the list of principal diagnoses for MS-DRGs 485, 486, 487 (Knee Procedure with Principal Diagnosis of Infection with MCC, with CC, and without CC/MCC, respectively).  

CMS finalized the following:

• Add both codes to the list of principal diagnosis codes for MS-DRGs 485, 486 and 487,
• Add 10 additional ICD-10-CM diagnosis codes specific to the knee and describing an infection; and
• Remove 8 ICD-10-CM diagnosis codes from the list of principal diagnosis for MS-DRG 485, 486 and 487 as they do not describe an infection of the knee.

Scoliosis: Neuromuscular and Secondary Scoliosis and Kyphosis

Requests were made to add ICD-10-CM diagnosis codes describing neuromuscular scoliosis, secondary scoliosis and secondary kyphosis to the list of principal diagnosis codes for MS-DRGs 456, 457, and 458 (Spinal Fusion except Cervical with Spinal Curvature or Malignancy or Infection or Extensive Fusions with MCC, with CC, without CC/MCC, respectively).

CMS finalized their proposals to:

• Add 5 codes describing neuromuscular scoliosis and 8 codes describing secondary scoliosis and secondary kyphosis to the list of principal diagnosis codes for MS-DRGs 456, 457, and 458; and
• Remove 34 ICD-10-CM diagnosis codes describing conditions involving the cervical region from MS-DRGs 456, 457, and 458.

MDC 11: Diseases and Disorders of the Kidney and Urinary Tract

Extracorporeal Shock Wave Lithotripsy (ESWL)

Data analysis revealed a steady decline in inpatient cases reporting urinary stones and an ESWL procedure over the past five years. CMS indicated in the proposed rule that due to an ESWL procedure being a Non-O.R. procedure and the decreased usage of this procedure in the inpatient setting, clinical advisors believe there is no longer a reason to subdivide the MS-DRGs for urinary stones (MS-DRGs 691 &692, and 693 & 694) based on ESWL procedures.

CMS finalized their proposals to:

• Delete MS-DRGs 691 and 692 (Urinary Stones with ESW Lithotripsy with CC/MCC and without CC/MCC respectively); and
• Revise the MS-DRG title for MS-DRGs 693 and 694 from “Urinary Stones without ESW Lithotripsy with MCC” and “without MCC”, respectively to “Urinary Stones with MCC” and “Urinary Stones without MCC.”

MDC 12: Diseases and Disorders of the Male Reproductive System

In FY 2019, four ICD-10-CM diagnosis codes (R93.811, R93.812, R93.813, and R93.819) describing body parts with male anatomy grouped to in MS-DRGs 302 and 303 (Atherosclerosis with MCC and without MCC, respectively) in MDC 5 (Diseases and Disorders of the Circulatory System).

Based on a request and claims data analysis, CMS finalized the reassignment of these four codes from MDC 5 in MS-DRGs 302 and 303 to MS-DRGs 729 and 730 (Other Male Reproductive System Diagnosis with CC/MCC and without CC/MCC, respectively) in MDC 12.

MDC 14: Pregnancy, Childbirth and the Puerperium

Reassignment of Diagnosis Code 099.89 (Other specified Diseases and Conditions complicating pregnancy, childbirth and the puerperium)

CMS finalized their proposal to reclassify ICD-10-CM diagnosis code 099.89 (Other specified diseases and conditions complicating pregnancy, childbirth and the puerperium) from a postpartum condition to an antepartum condition.

Coding logic will now assign a case with an O.R. procedure and this code to MS-DRGs 817, 818, or 819 (Other Antepartum Diagnoses with O.R. Procedure with MCC, with CC, and without CC/MCC, respectively). When no O.R. procedure is reported on the claim, the logic will assign the case to MS-DRGs 831, 832, and 833 (Other Antepartum Diagnoses without O.R. Procedure with MCC, with CC, and without CC/MCC, respectively).

MDC 23: Factors Influencing Health Status and Other Contacts with Health Services

Assignment of Diagnosis Code R93.89 (Abnormal finding on diagnostic imaging of other specified body structures)

There was a request to reassign ICD-10-CM diagnosis code R93.89 from MS-DRGs 302 and 303 (Atherosclerosis with MCC and without MCC, respectively) in the Circulatory MDC 5 to MDC 23.

CMS finalized their proposal to reassign this diagnosis code to MS-DRGs 947 and 948 (Signs and Symptoms with MCC and without MCC, respectively).

Review of Procedure Codes in MS-DRGS 981 through 983 and 987 through 989

Adding Procedures Codes Currently Grouping to MS-DRGS 981 – 983 and 987 – 989 into MDCs

Annually, CMS conducts a review of procedures resulting in assignment to the O.R. and non-extensive O.R. Procedures Unrelated to Principal Diagnosis MS-DRG Groups (981-983 and 987-989). This review is done on the basis of volume, by procedure, to see if it is more appropriate to move a procedure to a surgical MS-DRG for the MDC where the Principal Diagnosis falls.

Several proposals were made and finalized for FY 2020 to move diagnosis and procedure codes back into a specific MDC including:

• Gastrointestinal stromal tumors (GIST),
• Peritoneal dialysis catheter complications codes,
• Bone excision with pressure ulcers codes,
• Lower extremity muscle and tendon excision codes,
• Insertion of feeding device code,
• Basilic vein reposition in chronic kidney disease codes; and
• Colon Resection with Fistula code 0DTN0ZZ.

You can access the Final Rule and related tables on the FY 2020 IPPS Final Rule Home Page. 

In the 2020 Outpatient Prospective Payment System (OPPS) Proposed Rule, CMS puts forth new proposed requirements for hospitals to make public a list of their standard charges. The basic requirement from the Public Health Services Act “requires each hospital operating within the United States for each year to establish (and update) and make public a list of the hospital’s standard charges for items and services provided by the hospital, including for diagnosis-related groups.” The 2019 OPPS Final Rule required “hospitals to make available a list of their current standard charges via the Internet in a machine-readable format and to update this information at least annually, or more often as appropriate.”

I encourage those who will be dealing with the implementation of whatever requirements become final to read the proposed rule because understanding the reasoning and considerations behind the decisions is often beneficial. The discussion in the 2020 proposed rule includes the details and all the whys and wherefores of the proposals, but let’s start with some of the facts. The basics of the new proposal is an expansion of hospital charge display requirements to include charges and information based on negotiated rates and for common shoppable items and services, in a manner that is consumer-friendly.

Definitions

CMS includes numerous definitions throughout their discussion for additional clarity to the requirements. Some of these include:

• Hospital – an institution licensed as a hospital or approved as meeting licensing standards pursuant to State/local law.
• This includes critical access hospitals (CAHs), inpatient psychiatric facilities (IPFs), sole community hospitals (SCHs), and inpatient rehabilitation facilities (IRFs).
• It does not include entities such as ambulatory surgical centers (ASCs) or other non-hospital sites-of-care from which consumers may seek health care items and services. CMS encourages such sites to make their charges public, but it is not required.
• It also does not apply to federally-owned or operated hospitals, such as VA hospitals, because these facilities do not provide services to the general public and the established payment rates for services are not subject to negotiation.
• Items and Services – all items and services, including individual items and services and service packages, that could be provided by a hospital to a patient in connection with an inpatient admission or an outpatient department visit for which the hospital has established a standard charge.
• This includes supplies, procedures, room and board, use of the facility and other items (generally described as facility fees), services of employed physicians and non-physician practitioners (generally reflected as professional charges), and any other items or services for which a hospital has established a charge.
• It does not include physicians and nonphysician practitioners who are not employed by the hospital because they are practicing independently, establish their own charges for services, and receive the payment for their services.
• Chargemaster – the list of all individual items and services maintained by a hospital for which the hospital has established a standard charge.
• Standard charges mean “gross charges” and “payer-specific negotiated charges.”
• Gross charges are the charges for individual items or services that are reflected on a hospital’s chargemaster.
• A “payer-specific negotiated charge” is the charge the hospital has negotiated with a third-party payer for an item or service. Payer negotiated charges would include those charges negotiated with Medicare Advantage plans, but would not include Medicare Fee-for-Service rates since they are not negotiated.

Requirements for Standard Charges

The Proposed Rule is prescriptive about the type of information that should be displayed online in a single digital file that is machine readable to ensure uniformity.

• The file should include the item, service, or service package description; applicable codes, such as CPT, HCPCS, DRG, or NDC codes; revenue codes; the gross charge; and all payer-specific negotiated charges for that item/service linked with the name of the third-party payer.
• Examples of machine-readable formats include, but are not limited to, .XML, JSON and .CSV formats. A PDF is not an acceptable format.
• Hospitals can choose where to post the file as long as it is on a publicly-available webpage, is prominently displayed and clearly identifies the hospital location. The charge data must be easily accessible and digitally searchable. The proposed rule further defines some of these terms.
• The files must be updated at least annually and hospitals should indicate the date of the last update.

Requirements for “Shoppable Services” Charges

In addition to the posting of Standard Charges in a machine-readable format as described above, CMS is also proposing that hospitals post their payer-specific negotiated rates for a set of common “shoppable services.” Shoppable services are defined as a service package that can be scheduled by a patient in advance. The “service package” includes charges for the primary service plus charges for ancillary items and services that are customarily provided with the primary service, such as labs, x-rays, drugs, room charges, therapy, employed professional services, etc. The posting of these shoppable services must be in easily-understandable language and searchable by service, code, or payer.

CMS would require hospitals to post a listing of 300 shoppable services. Those must include services selected by CMS if those services are performed by the hospital. These 70 CMS-selected services are listed in the proposed rule. The hospital will select the remaining shoppable services up to the total of 300 services. In addition to the plain-language description, code, and payer charge, the hospital must include a list of the associated ancillary services with payer charges, and the location where the service is provided (such as the clinic name, if applicable). The hospital must also have a paper copy of this information for shoppable services, like a brochure or booklet, that can be provided to patients within 72 hours of the patient’s request.

Monitoring, Penalties, and Appeals

Finally, CMS is proposing to establish a mechanism for monitoring and the application of penalties for noncompliance. CMS will rely mainly on complaints and consumer reports of non-compliance for now, but may consider audits in the future. For hospitals that are non-compliant, CMS would issue a written warning and request a corrective action plan (CAP) from the hospital. “If the hospital fails to respond to CMS’ request to submit a CAP or comply with the requirements of a CAP, CMS may impose a CMP (up to $300 per day) on the hospital and publicize the penalty on a CMS website.” Hospitals will have the right to appeal CMS’s decision to impose penalties.

Those are the facts, but what is the reality of these proposals? If you have read any articles about this topic, you are aware there are many concerns about CMS’s requirements and even their understanding of the whole process of hospital charges and negotiated rates. For example, one sentence from the Proposed Rule states, “The hospital’s billing and accounting systems maintain the negotiated charges for service packages which are commonly identified in the hospital’s billing system by recognized industry standards and codes.” That statement is not usually true. Hospitals generally negotiate payment rates, not charges. The claims that go out to payers contain the standard charges from the chargemaster. The payer then pays based on negotiated payment rates. Hospitals often do not even know what the payer will be paying until the remittance. This is especially true for payers that pay based on service packages, such as DRGs or other groupings.

Other concerns with CMS’s proposals are legal concerns regarding publishing negotiated prices, the effect of published rates on hospital price decisions, the large volume of different negotiated rates and the fact that associated services are likely to vary from patient to patient based on the patient’s condition and needs. The hospital charge and payment system is complicated. I am no fonder of the current system than many others, but maybe we need to address the system itself first before we try to publicize something that is basically too complicated to communicate.

CMS is accepting comments on the Proposed Rule until 5 p.m. EST on September 27, 2019. I encourage those with concerns about the price transparency proposal to submit their comments.

MEDICARE TRANSMITTALS – RECURRING UPDATES

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

Quarterly update.

https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/downloads/MM11406.pdf

October Quarterly Update to 2019 Annual Update of HCPCS Codes Used for Skilled Nursing Facility (SNF) Consolidated Billing (CB) Enforcement

Updates the lists of HCPCS codes that are subject to the consolidated billing provision of the SNF Prospective Payment System (PPS).

https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/downloads/MM11381.pdf

Inpatient Psychiatric Facilities Prospective Payment System (IPF PPS) Updates for Fiscal Year (FY) 2020

Changes from IPF Final Rule applicable to discharges occurring from October 1, 2019, through September 30, 2020 (FY 2020).

https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/downloads/MM11420.pdf

International Classification of Diseases, 10th Revision (ICD-10) and Other Coding Revisions to National Coverage Determination (NCDs) – January 2020 Update

Relevant NCD coding changes for:

• NCD20.7 Percutaneous Transluminal Angioplasty
• NCD110.18 Aprepitant
• NCD110.23 Stem Cell Transplantation
• NCD150.3 Bone Mineral Density Studies
• NCD220.4 Mammography
• NCD220.13 Percutaneous Image-Guided Breast Biopsy
• NCD270.3 Blood Derived-Products for Chronic, Non-Healing Wounds

https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/downloads/MM11392.pdf

Quarterly Healthcare Common Procedure Coding System (HCPCS) Drug/Biological Code Changes - October 2019 Update

https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/downloads/MM11422.pdf

Claim Status Category and Claim Status Codes Update

https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/downloads/MM11393.pdf

Healthcare Provider Taxonomy Codes (HPTCs) October 2019 Code set Update

https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/downloads/MM11418.pdf

OTHER MEDICARE TRANSMITTALS

Documentation of Medical Necessity of the Home Visit; and Physician Management Associated with Superficial Radiation Treatment - REVISED

Removes the requirement that the medical record show a home visit was medically necessary instead of an office or outpatient visit and allows billing E/M codes (99211, 99212, and 99213) for levels I through III with modifier 25 when performed for the purpose of reporting physician work associated with radiation therapy planning, radiation treatment device construction, and radiation treatment management when performed on the same date of service as superficial radiation treatment delivery.

https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/downloads/MM11273.pdf

Oxygen Policy Update

Implements a new policy and coding for oxygen content.

https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/downloads/MM10837.pdf

Instructions for Use of Informational Remittance Advice Remark Code Alert on Laboratory Service Remittance Advices

To assist in reminding laboratories of their reporting obligations, the following new alert RARC code will appear on remittances:

• N817: ALERT-Applicable laboratories are required to collect and report private payor data and report that data to CMS between January 1, 2020 - March 31, 2020

https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/downloads/MM11369.pdf

Bypassing Payment Window Edits for Donor Post-Kidney Transplant Complication Services

https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/downloads/MM11312.pdf

Manual Update to Sections 1.2 and 10.2.1 in Chapter 18 of the Medicare Claims Processing Manual

Adds a link to the current influenza codes and payment rates.

https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/downloads/MM11403.pdf

MEDICARE SPECIAL EDITION ARTICLES

Medicare Coverable Services for Integrative and Non-pharmacological Chronic Pain Management

Given the issues associated with using opioids for acute and chronic pain, this article summarizes some other treatment options to consider when you treat Medicare patients for chronic pain.

https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/downloads/SE19008.pdf

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

Use MBIs now for all Medicare transactions.

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

New Documentation Requirements for Filing Medicare Cost Reports

The FY 2019 Medicare IPPS final rule changed the required supporting documentation that providers must submit with the Medicare cost report.

https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/downloads/SE19015.pdf

MEDICARE COVERAGE UPDATES

Decision Memo for Chimeric Antigen Receptor (CAR) T-cell Therapy for Cancers (CAG-00451N)

Posted final decision memo.

https://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=291

Medicare Press Releases

MEDICARE EDUCATIONAL RESOURCES

Medicare Fast Facts

Medicare Fast Facts resources this month include:

• Ambulance Fee Schedule and Medicare Transports
• Skilled Nursing Facility 3-Day Rule Billing

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

Skilled Nursing Facility 3-Day Rule Billing

MLN Fact Sheet

https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/Downloads/SNF3DayRule-MLN9730256.pdf

Ambulance Fee Schedule and Medicare Transports Booklet

MLN Booklet

https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/Downloads/Medicare-Ambulance-Transports-Booklet-ICN903194.pdf

OTHER MEDICARE UPDATES

FY 2020 Coding Updates

ICD-10-CM Coding Guidelines - https://www.cdc.gov/nchs/icd/icd10cm.htm

ICD-10-CM (Diagnosis Codes) - https://www.cms.gov/Medicare/Coding/ICD10/2020-ICD-10-CM.html

ICD-10-PCS (Procedure Codes) - https://www.cms.gov/Medicare/Coding/ICD10/2020-ICD-10-PCS.html

2020 Advance Beneficiary Notice (ABN) Forms

https://www.cms.gov/Medicare/Medicare-General-Information/BNI/ABN.html