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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.)

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.

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

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.