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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.

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. 

A recent story by National Public Radio (NPR) discussed the delay in the implementation of the law requiring physicians to consult clinical guidelines before ordering certain imaging tests. The story notes that critics believe the delay has resulted in unnecessary costs and radiation exposure. I am not agreeing or disagreeing with any of the concerns raised by the story, but I want to point out a few things I know based on my understanding of the new requirements and my experience in healthcare. First, not all physicians order unnecessary tests. The article quotes studies that have found widespread overuse, including one study that reported 26% of the CTs and MRIs they reviewed were inappropriate. However, this was at a large academic medical center, so hopefully most physicians use their training to appropriately order advanced imaging exams.

A fallacy in the story in my opinion is how easy the new process will be – “4 clicks on the computer – or less than a minute.” I am skeptical that the ordering physician’s process will be that easy and there are numerous requirements on the back end, i.e. the performing entity and the interpreting professional claim requirements. Beginning July 1, 2018 through December 31, 2019, providers could voluntarily participate in the program. January 1, 2020 through December 31, 2020 is the Educational and Operations Testing Period in which providers are encouraged to participate, but claims will not be denied. These voluntary and testing periods are beneficial to providers to work out the kinks in what is an anything-but-simple process.

On July 26, 2019, CMS released a transmittal that details the requirements for the Testing Period in 2020. The basic premise of the program - Appropriate Use Criteria (AUC) for Advanced Diagnostic Imaging is:

Step One – When an advanced imaging service is ordered for a Medicare beneficiary, the ordering professional must consult a qualified Clinical Decision Support Mechanism (CDSM), an interactive, electronic tool that assists practitioners in making the most appropriate treatment decision for a patient’s specific clinical condition. The CDSM will provide the ordering professional with a determination of whether the order adheres to AUC, does not adhere to AUC, or if there is no AUC applicable (for example, no AUC is available to address the patient’s clinical condition).

Step Two – The ordering physician must communicate the status and outcome of use of the CDSM to the furnishing entity and physician.

Step Three – The furnishing providers and practitioners must report on their Medicare claim, modifiers describing the CDSM status and decision, if applicable, and when appropriate, a HCPCS indicating which CDSM was used.

The AUC program applies to:

• Advance imaging services such as computed tomography (CT), Positron emission tomography (PET), Nuclear medicine (NM), and Magnetic resonance imaging (MRI). The specific CPT/HCPCS codes affected are listed in the transmittal.
• The following settings:
• Physician offices
• Hospital outpatient departments (including emergency departments)
• Ambulatory Surgical Centers (ASCs)
• Independent diagnostic testing facilities
• Services paid under the Medicare Physician Fee Schedule (MPFS), the Hospital Outpatient Prospective Payment System (OPPS), or the Ambulatory Surgical Center (ASC) fee schedule

CMS does allow exceptions to participation in the program for ordering professionals with a significant hardship (such as limited access to the internet, etc.), patients with an emergency medical condition, and inpatients paid under Medicare Part A. It is confusing to me why applicable settings include hospital emergency departments when patients with an emergency medical condition are exempt. I have submitted a question to CMS for clarification regarding this and will share through the Wednesday@One newsletter any information I receive.

The modifiers to be reported (MA-MH and QQ) describe whether a CDSM was consulted or not and if not, the reason, or if so, the outcome/decision. The modifier is to be appended to the advanced imaging line item code on the claim. If a modifier is reported that indicates a CDSM was consulted (ME, MF or MG), then the claim should additionally contain a G-code (on a separate claim line) to report which qualified CDSM was consulted. These are informational-only G-codes that will not result in any payment, similar to the codes previously required for Functional Limitation Reporting for therapy services. Providers will have to deal with the same issues of submitting a $0 or minimal charge for these codes. The transmittal includes descriptions of all the modifiers and G-codes.

The plan at this time is to fully implement the requirements of AUC effective January 1, 2021. Upon full implementation, claims for the affected imaging services will be denied if they do not contain information regarding the ordering professional’s consultation with CDSM, or exception to such consultation. The ultimate goal of the program is to identify professionals with outlier-ordering patterns and require those practitioners to obtain prior authorizations for these tests. That requirement will likely be several more years down the road.

Just thinking of the processes hospitals and radiologists will have to put into place to make this happen makes my head spin. And that is all after the process the ordering practitioner goes through – (no need to worry about that though as it is only 4 clicks on the computer). Now is the time, during this Testing phase, for hospitals to develop and implement the necessary processes for this program – how will you receive, document, and internally communicate the information from the ordering practitioner; how will the correct modifier get on the claim line item; and how will the appropriate G-code get added to the claim. And still to be worked out is how institutional providers will report line level ordering physician information on the institutional claim since that capability is not currently available.

Sometimes there are good reasons for delaying a well-intentioned idea.

CMS proposed significant changes to the current severity designation of diagnosis codes in the FY 2020 Inpatient Prospective Payment System (IPPS) Proposed Rule. Most significant were the proposed changes to current Major Comorbidities and Complications (MCCs) diagnosis codes.  

RealTime Medicare Data (RTMD) paid claims data helped to quantify the potential impact of the proposed MCC changes. Specifically, analysis of FY 2018 Medicare fee-for- service paid claims data for the state of Alabama provided answers to the following questions: 

• What are the Top 10 diagnosis codes proposed for a new severity designation from MCC to CC or Non-CC?
• What is the volume of claims and actual payment for claims that had been paid where the MS-DRG required an MCC and there was only one MCC coded, and
• What is the volume of claims and actual payment further drilled down by MCCs with a proposed change to CC and MCCs with a proposed change to Non-CC?

This first table highlights the top 10 MCCs proposed for a severity designation change to CC or Non-CC.

This next table compares all Alabama paid claims for FY 2018 to claims with MCCs proposed for severity designation change.

‍Finalized Severity Changes for FY 2020

In the Final Rule many “commenters expressed concern that the extensive changes proposed to the severity level designations…would no longer appropriately reflect resource use for patient care and could have a significant unintended or improper adverse financial impact.”

CMS listened and in general did not finalize the proposed changes. Changes that were made include the following:

• Table 6I.1 – Additions to MCC List: Five diagnosis codes were added to this list,
• Table 6I.2 – Deletions to the MCC List: No diagnosis codes were deleted for FY 2020,
• Table 6J.1 – Additions to the CC List: Seventy-five diagnosis codes were added to this list; and
• Table 6J.2 – Deletions to the CC List: Five diagnosis codes were removed from the CC List.

In addition to the above tables, the Complete MCC List (Table 6I) and the Complete CC List (Table 6J can be found on the CMS FY 2020 IPPS Final Rule Home Page. Also, click here for download from this article is a document highlighting the FY 2020 additions and deletions to the MCC and CC lists for FY 2020.

MEDICARE ADMINISTRATIVE CONTRACTORS (MACS)

There were no new Targeted Probe and Educate (TPE) medical reviews affecting hospitals announced by the Medicare Administrative Contractors (MACs) recently. Novitas JH and JL did release some additional TPE results recently including results for Denosumab, IVIG, HBO, therapy services and DRG validation. Error rates for all of the Novitas reviews were low.

Providers should look for learning opportunities associated with the TPE program on their MACs’ websites or listservs. For example, the Novitas findings referenced above include reasons claims for these services were denied. MACs also sometimes offer educational webinars or teleconferences related to the TPE topics. Palmetto GBA is hosting a Part A Ask the Contractor Teleconference (ACT) on Wednesday, September 18, 2019, at 11 a.m. ET about DRG 682 – Renal Failure. For more information see this Palmetto link.

RECOVERY AUDITORS (RACS)

All Recovery Auditors added a complex review issue for Intravenous Immune Globulin for the Treatment of Autoimmune Blistering Diseases: Medical Necessity and Documentation Requirements. According to the Cotiviti website, “Medical documentation will be reviewed to determine if the use of intravenous immune globulin meets Medicare coverage criteria and is medically reasonable and necessary.” Cotiviti lists the issue twice but indicates both listings are for Region 2. This is likely a typographical error.

SUPPLEMENTAL MEDICAL REVIEW CONTRACTOR (SMRC)

Noridian, the current SMRC, added issues for outpatient hyperbaric oxygen therapy (HBO) and for spinal cord stimulators. They also added some issues for ambulance services. You can view all the current SRMC issues here.

OFFICE OF INSPECTOR GENERAL (OIG)

The August update of the OIG Work Plan included several issues relative to services that could be performed in and billed by hospitals.

• Review of the Medicare DRG Payment Window – “Outpatient services directly related to an inpatient admission are considered part of the inpatient payment and are not separately payable by Medicare.”
• Medicare Part B Services to Medicare Beneficiaries Residing in Nursing Homes During Non-Part A Stays – “An opportunity for fraudulent, excessive, or unnecessary Part B billing exists because NHs may not be aware of the services that the providers bill directly to Medicare, and because NHs provide access to many beneficiaries and their records.”
• Review of Medicare Facet Joint Procedures – “We will review whether payments made by Medicare for facet joint procedures billed by physicians complied with Federal requirements.”

Q:

Does Medicare cover HBO for arterial insufficiency?

A:

Yes and no – Medicare does not cover chronic arterial insufficiency, but does cover acute peripheral arterial insufficiency.  According to the HBO Local Coverage Determination (LCD) from First Coast (FC), the Medicare Administrative Contractor (MAC) for Jurisdiction N, “acute peripheral arterial insufficiency (APAI) is acute onset of ischemia of an extremity secondary to arterial embolus or thrombus.” HBO for APAI is to be used following a definitive surgical procedure for the condition, such as re-implantation, embolectomy, thrombectomy, decompression of a compartment syndrome or removal of the flow limiting condition of the limb. Immediate surgical intervention is necessary if the extremity is to be saved following APAI.

The FC LCD also states that, “HBO is indicated within the first 4-6 hours of the acute event, and only after documented restoration of the blood circulation.” A recent Palmetto HBO Training Module indicates that treatments for APAI may occur up to three times per day immediately after surgery before dropping to once daily within 24-48 hours.  The HBO reduces edema and enhances oxygen at the tissue level to counter reactive edema that often presents after surgical restoration of blood flow. This helps prevent or lessen the likelihood of secondary complications such as infection, non-healing wounds, fracture non-union, and necrosis with subsequent amputation.

Medicare medical review of HBO services is widespread:

• It is part of the OIG Work Plan.
• It is on the list of Targeted Probe and Educate (TPE) reviews for First Coast JN, Novitas JH and JL, Palmetto JM, and WPS J5 and J8.
• It is an approved and posted issue for complex review for all 4 Recovery Auditor regions. Details from the Cotiviti issue are “Medical records will be reviewed to determine if Hyperbaric Oxygen Therapy (HBOT) is medically necessary according to Medicare coverage indications.”
• It was one of the first issues reviewed by Strategic Health Solutions, the first CMS Supplemental Medical Review Contractor (SMRC) with an error rate of 58%.

In addition to First Coast’s LCD, there is a National Coverage Determination (NCD 20.29) and Novitas has a coding and billing article.

The Palmetto education module mentioned above includes the expected documentation for HBO for APAI

• Origin of the condition such as reconstruction/graft thrombosis, iatrogenic trauma, native thrombosis, embolism, or peripheral aneurysm with embolism or thrombosis;
• Diagnostic testing such as arteriogram, CT angiogram, and/or MRI angiogram; and
• Previous treatments such as anticoagulation and percutaneous aspiration or mechanical thromboembolectomy.

Also, there must be a detailed physician’s order for the HBO and a treatment plan with expected goals for HBO therapy.

Remember HBO treatment for chronic arterial insufficiency is not considered medically reasonable and necessary for coverage.

On August 7, 2019, CMS released a Final Coverage Decision Memorandum concerning CAR-T Therapy for Cancers.  Per the memo, CMS covers autologous treatment for cancer with T-cells expressing at least one chimeric antigen receptor (CAR) when:

• Administered at healthcare facilities enrolled in the FDA risk evaluation and mitigation strategies (REMS), and
• Used for either an FDA-approved indication (according to the FDA-approved label for that product), or
• Used for other uses when the product has been FDA-approved and the use is supported in one or more CMS-approved compendia.

The policy also continues coverage for routine costs in clinical trials that use CAR T-cell therapy as an investigational agent that meet the requirements listed in NCD 310.1.

According to an FDA website “A Risk Evaluation and Mitigation Strategy (REMS) is a drug safety program that the U.S. Food and Drug Administration (FDA) can require for certain medications with serious safety concerns to help ensure the benefits of the medication outweigh its risks. … REMS are designed to help reduce the occurrence and/or severity of certain serious risks, by informing and/or supporting the execution of the safe use conditions described in the medication's FDA-approved prescribing information.”  Certain REMS may require providers to enroll in the REMS, complete training, document counseling of patients, enroll patients, perform monitoring, and/or document compliance with certain safe use conditions. The requirements for a specific drug can be found on the FDA website.

Remember that Decision Memos are not binding on contractors until they have been manualized as a National Coverage Determination (NCD).  Be on the lookout for a Medicare transmittal announcing the NCD and any associated claim instructions. The transmittal(s) will include effective and implementation dates for the new coverage rules.

Q:

Is it still true that when a patient with a previous history of sick sinus syndrome (SSS), which is currently being controlled by a pacemaker, is admitted for an unrelated condition, only the presence of the pacemaker is assigned?  My understanding is that since the condition is controlled by the device, SSS would not be considered an active condition.

A:

No.  This is an old rule which was addressed in previous Coding Clinics 3rd Qtr. 2010 page 9-10 and 5th Issue 1993 page 12.   Coders are now instructed that it is appropriate to report a code for both the sick sinus syndrome and presence of a pacemaker.  This is according to updated guidelines found in Coding Clinic 1st Qtr. 2019 page 33 (effective with discharges from March 20, 2019 forward).  The SSS is still present and is a reportable chronic condition.  A pacemaker only controls the heart rate.  It does not cure the condition itself.

The Calendar Year (CY) 2020 Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System Proposed Rule was finally released on July 29th. This week MMP highlights proposed changes to the Inpatient Only (IPO) List, a related 2-Midnight Rule Proposal and the ASC Covered Procedures List (CPL).  

Inpatient Only List

CMS utilizes the following specific criteria when determining whether or not a procedure should be removed from the IPO List and assigned to an Ambulatory Payment Category (APC) group for payment under the OPPS when provided in the hospital outpatient setting:

1. Most outpatient departments are equipped to provide the services to the Medicare population.
2. The simplest procedure described by the code may be performed in most outpatient departments.
3. The procedure is related to codes that we have already removed from the IPO list.
4. A determination is made that the procedure is being performed in numerous hospitals on an outpatient basis.
5. A determination is made that the procedure can be appropriately and safely performed in an ASC, and is on the list of approved ASC procedures or has been proposed by CMS for addition to the ASC list.

CMS does not require that all five criteria be met to remove a procedure from the IPO List.

CY 2020 Procedure Proposed for Removal

For several years now, CMS has discussed the removal of total hip arthroplasty (THA) as well as partial hip arthroplasty (PHA) from the IPO List. Both procedures were on the original IPO List in CY 2001.

In response to the CY 2018 Proposed Rule, several surgeons and other stakeholders believe that, “given thorough preoperative screening by medical teams with significant experience and expertise involving hip replacement procedures, the THA procedure could be provided on an outpatient basis for some Medicare beneficiaries.”

CMS stated in the CY 2018 OPPS/APC Proposed Rule that “Both PHA and THA need to be tailored to the individual patient’s needs. Patients with a relatively low anesthesia risk and without significant comorbidities who have family members at home who can assist them may likely be good candidates for an outpatient PHA or THA procedure…on the other hand, patients with multiple medical comorbidities, aside from their osteoarthritis, would more likely require inpatient hospitalization and possible postacute care in a skilled nursing facility or other facility.”

CMS believes that CPT code 27130 (Arthroplasty, acetabular and proximal femoral prosthetic replacement (total hip arthroplasty) with or without autograft or allograft) meets criterion 2 and 3 for removal from the IPO List and “believe that appropriately selected patients could have this procedure performed on an outpatient basis.” Therefore, CMS is proposing the following:

• Remove THA from the IPO List, and
• Assign the THA procedure (CPT code 27130) to C-APC with status indicator “J.”

Solicitation of Comments for Potential Removal of Procedures from IPO List

CMS has received several comments on additional codes believed to meet the criterion for removal from the IPO List. CMS is seeking comments on the removal of the following procedures from the IPO List.

• CPT 22633: Arthrodesis, combined posterior or posterolateral technique with posterior interbody technique including laminectomy and/or discectomy sufficient to prepare interspace (other than for decompression), single interspace and segment; lumbar
• CPT 22634: Arthrodesis, combined posterior or posterolateral technique with posterior interbody technique including laminectomy and/or discectomy sufficient to prepare interspace (other than for decompression), singe interspace and segment; lumbar; each additional interspace and segment
• CPT 23265: Laminectomy for excision or evacuation of intraspinal lesion other than neoplasm, extradural; cervical
• CPT 63266: Laminectomy for excision or evacuation of intraspinal lesion other than neoplasm, extradural; thoracic
• CPT 63267: Laminectomy for excision or evacuation of intraspinal lesion other than neoplasm, extradural; lumber
• CPT 63268: Laminectomy for excision or evacuation of intraspinal lesion other than neoplasm, extradural; sacral.

Short Inpatient Hospital Stays

It’s hard to believe come this October, it will have been six years since CMS finalized the Two-Midnight Rule clarifying when an inpatient admission is considered reasonable and necessary for purposes of Medicare Part A payment in the FY 2014 IPPS/LTCH PPS Final Rule.

This policy established a benchmark for when a patient is considered appropriate for inpatient hospital admission and payment. CMS also clarified that “when a beneficiary enters a hospital for a surgical procedure not designated as an inpatient-only (IPO) procedure as described in 42 CFR 419.22(n), a diagnostic test, or any other treatment, and the physician expects to keep the beneficiary in the hospital for only a limited period of time that does not cross 2 midnights, the services would be generally inappropriate under Medicare Part A.”

In the CY 2016 OPPS/ASC Final Rule, CMS revised the previous rare and unusual exceptions policy “and finalized a proposal to allow for case-by case exceptions to the 2-midnight benchmark, whereby Medicare Part A payment may be made for inpatient admissions where the admitting physician does not expect the patient to require hospital care spanning 2 midnights, if the documentation in the medical record supports the physician’s determination that the patient nonetheless requires inpatient hospital care.” The following criteria are relevant to making this determination:

• Complex medical factors such as history and comorbidities;
• The severity of signs and symptoms;
• Current medical needs; and
• The risk of an adverse event.

Proposed Change for Medical Review of Certain Inpatient Hospital Admissions under Medicare Part A for CY 2020 and Subsequent Years

The 2-Midnight benchmark is applicable once procedures have been removed from the IPO list. These surgical claims are also subject to initial medical reviews of claims for short-stay inpatient admissions conducted by the Beneficiary and Family-Centered Care Quality Improvement Organization (BFCC-QIO).

BFCC-QIO’s may “refer a provider to the Recovery Audit Contractors (RACs) for further medical review due to exhibiting persistent noncompliance with Medicare payment policies, including, but not limited to:

• Having high denial rates;
• Consistently failing to adhere to the 2-midnight rule; or
• Failing to improve their performance after QIO educational intervention.”

For CY 2020 and subsequent years, CMS is “proposing to establish a 1-year exemption from site-of-service claim denials, BFCC-QIO referrals to RACs, and RAC reviews for “patient status” (that is, site-of-service) for procedures that are removed from the IPO list under the OPPS beginning on January 1, 2020. We encourage BFCC-QIOs to review these cases for medical necessity in order to educate themselves and the provider community on appropriate documentation for Part A payment when the admitting physician determines that it is medically reasonable and necessary to conduct these procedures on an inpatient basis. We note that we will monitor changes in site- of-service to determine whether changes may be necessary to certain CMS Innovation Center models.”

As a provider, it is important to be mindful that the exemption is specific to site-of-service claim denials. This exemption does not include medical necessity based on a National or Local Coverage Determination meaning irrespective of site-of-service, a short stay claim can still be denied for lack of documentation supporting medical necessity of the procedure.

Ambulatory Surgical Center (ASC) – Proposals

In the CY 2019 OPPS Final Rule, CMS finalized the “proposal to define a surgical procedure under the ASC payment system as any procedure described within the range of Category I CPT codes that the CPT Editorial Panel of the American Medical Association (AMA) defines as “surgery” (CPT codes 10000 through 69999) (72 FR 42478), as well as procedures that are described by Level II HCPCS codes or by Category I CPT codes or by Category III CPT codes that directly crosswalk or are clinically similar to procedures in the CPT surgical range that we have determined are not expected to pose a significant risk to beneficiary safety when performed in an ASC, for which standard medical practice dictates that the beneficiary would not typically be expected to require an overnight stay following the procedure, and are separately paid under the OPPS.”

CMS conducted a review of HCPCS codes currently paid under the OPPS but are not included on the ASC CPL. Based on this review, the following table highlights the proposed procedures to be added to the ASC CPL.

Specific to the proposal to add Total Knee Arthroplasty (TKA) to the ASC CPL, CMS notes in the Proposed Rule that “we agree with commenters that there is a small subset of Medicare beneficiaries who may be suitable candidates to receive TKA procedures in an ASC setting base on their clinical characteristics. For example, based on Medicare Advantage encounter data, we estimate over 800 TKA procedure were performed in an ASC on Medicare Advantage enrollees in 2016. We believe that beneficiaries not enrolled in an MA plan should also have the option of choosing to receive the TKA procedure in an ASC setting based on their physicians’ determinations.”

Further, CMS notes “TKA procedures are still predominantly performed in the inpatient hospital setting in CY 2018 (82 percent of the time) based on professional claims data, and we are cognizant of the fact that the majority of beneficiaries may not be suitable candidates to receive TKA in an ASC setting. We believe that appropriate limits are necessary to ensure that Medicare Part B payment will only be made for TKA procedures performed in an ASC setting when the setting is clinically appropriate. Therefore, we are soliciting public comment on the appropriate approach to provide safeguards for Medicare beneficiaries who should not receive the TKA procedure in an ASC setting.”

CMS is accepting comments on the proposed rule no later than 5 p.m. EST on September 27, 2019.

You can read more about the Proposed Rule in a CMS Fact Sheet at: https://www.cms.gov/newsroom/fact-sheets/cy-2020-medicare-hospital-outpatient-prospective-payment-system-and-ambulatory-surgical-center

The Proposed Rule is scheduled to be published in the Federal Register on August 9, 2019. In the meantime you can access a pre-published copy on the CMS website at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/Hospital-Outpatient-Regulations-and-Notices-Items/CMS-1717-P.html?DLPage=1&DLEntries=10&DLSort=2&DLSortDir=descending

Finally, you can keep reading the Wednesday@One as we will have more information on the proposed rule next week.

Q:

Are there any guidelines for what is expected for an electronic signature for Medicare?

A:

National Government Services (NGS), the Medicare Administrative Contractor (MAC) for Jurisdictions 6 and K, recently published an article concerning electronic signatures. The article references section 3.3.2.4 of the Medicare Program Integrity Manual, that states, “For medical review purposes, Medicare requires that services provided/ordered/certified be authenticated by the persons responsible for the care of the beneficiary in accordance with Medicare’s policies.”

The article provides a list of examples of electronic signatures that would be acceptable. There are various ways to say the documentation is “approved,” “accepted,” or “verified” but the constant is that all electronic signatures must contain the provider’s name.

The article further states the following about sending your policy for electronic signatures.

“When you submit medical records to a Medicare contactor with an electronic signature, you must also include a copy of the electronic signature protocol/procedure. The protocol/procedure should describe the requirements that the physician uses his own ID and password to enter the system to sign the medical records. The Medicare contractor will keep a copy of the protocol/procedure on file for each provider for future documentation request, so only one copy will need to be submitted.”

The Program Integrity Manual does not contain this requirement so it may be specific to NGS. Check with your local MAC to determine if they require this also.

Also remember that Medicare reviewers will accept a signature log for initials or illegible signatures. For some types of documentation, they will accept an attestation of authorship if a signature is missing. However, this does not apply to orders – “If the signature is missing from an order, MACs, SMRC, and CERT shall disregard the order during the review of the claim (e.g., the reviewer will proceed as if the order was not received).”