Knowledge Base Category -

MEDICARE TRANSMITTALS – RECURRING UPDATES

July 2019 Quarterly Average Sales Price (ASP) Medicare Part B Drug Pricing Files and Revisions to Prior Quarterly Pricing Files

https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/downloads/MM11225.pdf

Changes to the Laboratory National Coverage Determination (NCD) Edit Software for July 2019

https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/downloads/MM11224.pdf

Quarterly Update to the National Correct Coding Initiative (NCCI) Procedure-to-Procedure (PTP) Edits, Version 25.2 Effective July 1, 2019

https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/downloads/MM11227.pdf

OTHER MEDICARE TRANSMITTALS

Billing for Hospital Part B Inpatient Services

Provides billing instructions for hospital Part B inpatient services.

https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/downloads/MM11181.pdf

Evaluation and Management (E/M) When Performed with Superficial Radiation Treatment – REVISED

Revised to clarify that providers need to bill the 25 modifier when performing E/M services with CPT code 77401.

https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/downloads/MM11137.pdf

Pub. 100-04, Chapter 29 – Appeals of Claims Decisions – Revisions

Incorporates the following policy updates to the Medicare Claims Processing Manual:

• The policy on use of electronic signatures
• Timing of signatures on transfer of appeal rights and the appointment of representative forms
• Tolling an adjudication timeframe when trying to cure a defective appointment form
• Limiting scope of redetermination review in certain instances
• Application of good cause for late filing involving beneficiary accessibility
• Application of good cause where there is a declared disaster

https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/downloads/MM11042.pdf

New Waived Tests

Informs MACs of new Clinical Laboratory Improvement Amendments of 1988 (CLIA) waived tests approved by the Food and Drug Administration (FDA).

https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/downloads/MM11231.pdf

MEDICARE SPECIAL EDITION ARTICLES

Activation of Systematic Validation Edits for OPPS Providers with Multiple Service Locations

Claim information for Outpatient Prospective Payment System (OPPS) providers that have multiple service locations.

https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/downloads/SE19007.pdf

MEDICARE COVERAGE UPDATES

CMS Proposes Updates to Coverage Policy for Transcatheter Aortic Valve Replacement (TAVR)

CMS is updating the coverage criteria for hospitals and physicians to begin or maintain a TAVR program.

https://www.cms.gov/newsroom/press-releases/cms-proposes-updates-coverage-policy-transcatheter-aortic-valve-replacement-tavr

MEDICARE EDUCATIONAL RESOURCES

Medicare Fast Facts

Medicare Fast Facts resources this month include:

• Proper Coding for Specimen Validity Testing Billed in Combination with Urine Drug Testing
• Provider Minute Video: The Importance of Proper Documentation

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

OTHER MEDICARE UPDATES

April 2019 Patients Over Paperwork Newsletter

Updates on ongoing work to reduce administrative burden and improve the customer experience for hospitals.

https://www.cms.gov/Outreach-and-Education/Outreach/Partnerships/Downloads/April2019PoPNewsletter.pdf

GAO Report for Medicare and Medicaid:
CMS Should Assess Documentation Necessary to Identify Improper Payments

GAO examined: (1) Medicare and Medicaid documentation requirements and factors that contribute to improper payments due to insufficient documentation; and (2) the extent to which Medicaid reviews provide states with actionable information.

https://www.gao.gov/products/GAO-19-277

On March 26, 2019 CMS published a Proposed Decision Memo for Transcatheter Aortic Valve Replacement (TAVR) (CAG-00430R). In a related CMS Press Release CMS noted they would continue to cover TAVR under Coverage with Evidence Development (CED) when furnished according to an FDA-approved indication.

TAVR Background

CMS first released National Coverage Determination (NCD) 20.32 Transcatheter Aortic Valve Replacement (TAVR) with an effective date of May 1, 2012. At that time, TAVR was considered a new technology for use in treating patients with aortic stenosis where a biprosthetic valve is inserted percutaneously using a catheter and implanted in the orifice of the native aortic valve.

TAVRs are performed in a cardiac catheterization lab or a hybrid operating room/cardiac catheterization lab with advanced quality imaging and with the ability to safely accommodate complicated cases that may require conversion to an open surgical procedure. The interventional cardiologist and cardiothoracic surgeon jointly participate in the intra-operative technical aspects of TAVR.

NCD 20.32 allows for coverage of the TAVR Procedure under Coverage with Evidence Development (CED) with specific conditions being met, appropriate volume requirements and a heart team and hospitals participation in a prospective, national, audited registry. For indications not approved by the FDA, CMS covers TAVR under CED when a patient is enrolled in a qualifying clinical study.

Registry and Clinical Study Approvals by CMS can be found on the CMS Coverage with Evidence Development TAVR webpage. https://www.cms.gov/Medicare/Coverage/Coverage-with-Evidence-Development/TAVR.html

TAVR Hospital Volumes

TAVR procedures are on the Medicare Inpatient Only Procedure List and sequence to the MS-DRG Pair 266 and 267 (Endovascular Cardiac Valve Replacement with MCC and without MCC respectively). In CMS Fiscal Year (FY) 2015 through 2017, this MS-DRG pair also included ICD-10-PCS codes for replacement of pulmonary valves. In FY 2018 an additional 4 mitral valve codes and 8 new tricuspid valve codes were also added to this MS-DRG pair.

To provide you with a glimpse into these types of procedures, I utilized Medicare Fee-for-Service paid claims data from our sister company RealTime Medicare Data (RTMD) for CMS FY 2015 through 2018. The following table highlights an increase in volumes and average charges and a decrease in actual average payment and average length of stay (ALOS) for Medicare Fee-for-Service paid claims in Alabama, Georgia and Tennessee.

‍Proposed Decision Memo: Changes and CMS’ Request for Comments

The Decision Memo proposes to update “the coverage criteria for hospitals and physicians to begin or maintain a TAVR program. The proposed decision provides more flexibility in how providers can meet the requirements performing TAVR, while continuing to ensure good health outcomes for patients receiving the procedure.”

The CMS Press Release notes they are also seeking to gather additional information and specifically proposed “a question regarding the relationship between other metrics and patient health outcomes, which could inform a future change to replace the volume criteria with a different metric.”

Key stakeholders at your hospital should take the time to read the Proposed Decision Memo and provide public comments. There is a 30-day public comment period ending April 25th and a final decision will be issued no later than 60 days after the conclusion of the 30-day public comment period. All public comments may be submitted at https://www.cms.gov/medicare-coverage-database/indexes/nca-open-for-public-comment-index.aspx.

Link to NCD 20.32: https://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=355&ncdver=1&bc=AAAAgAAAAAAAAA%3d%3d&

CMS released MLN Matters Article MM11181 titled “Billing for Part B Hospital Inpatient Services” on March 22, 2019. This is not a new rule at all, but has been around since 2013. In the 2014 Inpatient Prospective Payment System (IPPS) Final Rule CMS-1599-R, effective October 1, 2013, CMS first allowed the billing of certain Part B services when an inpatient hospital admission is determined to not be reasonable and necessary for payment under Medicare Part A. Prior to this rule change, the billing of Part B inpatient services on a 12x type of bill (TOB) was limited to those occasions when the Medicare beneficiary did not have Part A coverage or the Part A benefits were exhausted.

The new policy specifically stated, “Medicare will allow payment under Part B of all hospital services that were furnished and would have been reasonable and necessary if the patient had been treated as a hospital outpatient, rather than admitted to the hospital as an inpatient.” The determination that the patient did not meet inpatient criteria could have been from 1) a denial by Medicare or 2) the result of a hospital “self-audit” after the patient was discharged. There are rules for the hospital self-audit.

• It must follow Medicare Conditions of Participation UR guidelines (42 CFR 428.30);
• It must be made by a physician member of the UR committee if the attending physician concurs, or by 2 physician members of the UR committee if the attending does not concur;
• The attending physician must be consulted; and
• The patient must be notified of the decision in writing within 2 days.

CMS also expanded what could be billed on a 12x TOB under Part B for these “reasonable and necessary inpatient admission denials” to include surgeries, drugs and therapeutic services such as coronary and peripheral interventions. Services requiring an outpatient status such as observation services and ED visits, and routine inpatient services cannot be billed under Part B inpatient billing. Note that the routine inpatient services include drug administrations, blood transfusions, and nebulizer treatments provided by floor nurses and should not be reported on a Part B inpatient claim. CMS provides a list of revenue codes that should not be submitted on a “reasonable and necessary inpatient denial” 12x TOB in section 240.1 of chapter 4 of the Medicare Claims Processing Manual. When a revenue code can be sometimes covered and sometimes not covered, providers should use Medicare guidance and the HCPCS code to determine if the service is covered.

If the “reasonable and necessary inpatient denials” Part B rebilling rule is six years old, what was the purpose of this latest MLN article? Again, CMS did not really change any rules, but added verbiage to the Claims Processing Manual clarifying the need for a Part A claim prior to submitting the Part B claim. In order to submit a Part B 12x claim after a hospital self-audit, the hospital must:

• Submit a Part A claim indicating that the provider is liable under section 1879 of the Act for the cost of the Part A services. This is a no-pay inpatient claim, type of bill 110. If the hospital has already submitted a regular inpatient claim (111 TOB), it must adjust the Part A claim to make the provider liable.
• The Part B 12x type of bill may be submitted for these “reasonable and necessary inpatient denials” only after the Part A claim is denied or a no-pay claim is submitted.

Also, the Part B inpatient claim is subject to the timely filing requirements described in the Medicare Claims Processing Manual, Chapter 1, Section 70.

This new MLN Matters Article (MM11181) also makes some modifications to the list of revenue codes that are not allowed on a 12x TOB for “other circumstances.” These circumstances would be for Medicare patients who are not entitled to benefits under Part A, have exhausted their Part A benefits, or receive services not covered under Part A. Part B inpatient claims for these circumstances restrict the types of services that can be billed much more than the “reasonable and necessary inpatient denials” Part B rebilling.

For more information about Part B Inpatient billing, see sections 240.1 and 240.2 of Chapter 4 of the Medicare Claims Processing Manual and sections 10.1 and 10.2 of Chapter6 of the Medicare Benefits Policy Manual. And remember for Part B rebillling, it is always A before B.

Attention, this is not a late April Fools’ Day Joke, Palmetto GBA has published a Spinal Fusion LCD and it differs from other MACs Spinal Fusion LCDs. In their March 22, 2019 Daily e-Newsletter, Palmetto posted a new Local Coverage Determinations (LCDs) Notice Period, LCD Revisions and LCD Article updates: Part A and Part B. Highlighted below are the new LCDs, related Coding and Billing Articles, and Response to Comments Articles.  

‍Background

The Jurisdiction J MAC (Alabama, Georgia and Tennessee) transition from Cahaba GBA to Palmetto GBA was complete as of February 26, 2018. Prior to the transition, Cahaba GBA had a Spinal Fusion LCD. LCDs from both MACs were consolidated during the transition. Cahaba’s Spinal Fusion LCD (L35942) did not make the cut leaving the Jurisdiction J MAC without a Spinal Fusion LCD, until now.

In January of this year the Supplemental Medical Review Contractor (SMRC) Noridian Healthcare Solutions, LLC (Noridian) posted a notice of their current Spinal Fusions (MS-DRGs 459 and 460) medical review project. At that time, MMP wrote an article detailing past Spinal Fusion Audits and current medical review audits. This article highlights the new Palmetto GBA Spinal Fusion Local Coverage Determination (LCD). 

Cahaba vs Palmetto LCD Compare

Cahaba’s LCD: Surgery Fusion for Degenerative Joint Disease of the Lumbar Spine (L35942) was initially effective for services performed on or after 10/01/2015 and was officially retired 2/25/2018. Palmetto GBA’s new LCD: Lumbar Spinal Fusion (L37848) has a future effective date for services performed on or after 5/6/2019.

Cahaba GBA Coverage Indications

1. Spinal stenosis for a single level (for example, L4-L5) with associated spondylolisthesis and symptoms of spinal claudication and radicular pain. Pain must represent significant functional impairment despite 3 months of conservative therapy.
2. Spondylolisthesis
3. Spondylolysis
4. Repeat Lumbar Fusion following prior fusion for associated spondylolisthesis
5. Treatment of pseudoarthrosis at the same level after 12 months from prior surgery.

Palmetto GBA Coverage Indications

1. Radiographic or clinical evidence of instability due to one of the following: congenital deformities, trauma, fractures, chronic degenerative conditions, tumor, infection, erosive conditions, space-occupying lesions or iatrogenic causes.
2. Symptomatic spinal deformity in the absence of instability or neural compression which meets the following criteria:
3. Functional limitation in daily activities due to back pain or discomfort and
4. Nonresponsive to at least one year of non-operative management.
5. Revision surgery for pseudoarthrosis following an initial spine surgery
6. Symptomatic compression of neural elements for which disc excision is necessary for decompression.

Cahaba GBA Documentation Requirements

1. “Documentation must support CMS ‘signature guidelines, as described in the Medicare Program Integrity Manual (Pub. 100-08), Chapter 3. Medical record documentation maintained by the physician must support the above indications and must include the following:

• Office notes/hospital record, including history and physical by the attending/treating physician
• Documentation of the history and duration of unsuccessful conservative therapy (non-surgical medical management). Failure of non-surgical medical management can be historical and does not have to be under the direction of the operating surgeon.

1. Medical record documentation must be made available to Medicare upon request. When the documentation does not meet the criteria for the service(s) rendered or the documentation does not establish the medical necessity for the service(s), such service(s) will be denied as not reasonable and necessary under Section 1862(a)(1)(A) of the Social Security Act. The hospital (FISS claim) and physician services (MCS claim) can be denied.”

Palmetto GBA Documentation Requirement

“Documentation must demonstrate that the patient met at least one of the indications for the procedure…where possible, there must be documented shared decision making with the patient or the individual who is serving as the proxy decision maker for the patient with the appropriate discussion of anticipated risks and benefits of the procedure.”

Palmetto’s LCD requirements end with “Associated Information” that “medical record documentation should be legible, relevant and sufficient to justify services billed. This documentation should be maintained in the patient’s medical record and must be made available to the A/B MAC upon request.”

Note, there is no statement indicating that the physician’s services could be denied in this policy, even though the new LCD applies to both Part A (hospital) and Part B (physicians’ services).

Shared Decision Making

Palmetto’s shared decision making requirement is not as specific as what is required in the recently revised NCD 20.4, Implantable Cardiac Defibrillators (ICDs). NCD 20.4 requires a formal shared decision-making encounter between the patient and physician or qualified non-physician practitioner using an evidenced-based decision tool on ICDs prior to initial ICD Implantation. In a related Decision Memo, CMS responded to a comment stating that shared decision making is a critical step in empowering patient choice in his/her treatment plan and requires the use of an evidence-based tool to ensure topics like the patients’ health goals and preferences are covered prior to ICD implantation.

On a personal note, I totally agree with the concept of shared decision making prior to Lumbar Fusion. My mom recently underwent a repeat Spinal Fusion and was fused from L1 to S1. My mom is widowed and lives alone. I live out of state three hours away. Thank goodness it is only a 45 minute commute for my brother. The week prior to surgery I asked her what her plan was after surgery. She had not thought about it. She had not thought about the fact that she couldn’t drive, lift more than five pounds, bend-over to put on her shoes and socks, let alone put clothes from the washer into the dryer or bend down to get frozen food out of the freezer section of her refrigerator. Also, when I asked her what exactly she was having done during surgery, she said “they were going to take something out, crush it up, mix it with something and reinsert it into her spine.”

As her patient advocate and having an understanding boss, I was with her the day of surgery and the following week while she was in the hospital. Post-op day one I made it clear to the surgeon’s nurse that she lived alone and that would not be an immediate post-op option for her. She agreed and quickly got Physical and Occupational Therapy involved in my mom’s care. Unfortunately, my mom’s stay was complicated with the inability to void requiring a Foley catheter that remained in until her second week at the skilled nursing unit. The inability to void post-operatively is another potential complication of surgery that she was not prepared for.

I want to preface the rest of this paragraph with a disclaimer that the Surgeon and Hospital staff provided excellent care. However, she was not prepared for how involved the surgery was, the fact that the pain down her legs would not be immediately better, or for the month she spent in a Skilled Nursing Unit for rehabilitation. She has been home a little over two weeks now and was not prepared that she still has not been “released” by the Surgeon and Home Physical and Occupational Therapists to walk up and down stairs unsupervised, do laundry or drive. I can tell she is feeling better because she mentions the things she isn’t supposed to do almost every time I talk to her. So yes, taking the time to provide a shared decision making interaction with the patient is a critical step in empowering patient choice.

Palmetto’s Spinal Fusion LCD does not specify who would provide this patient interaction or what they would expect to see documented in the record. However, the third indication for Lumbar Fusion is a revision surgery for pseudoarthrosis following an initial spine surgery. This indication includes the following statements about shared decision making:

“Outcomes for fusion in revision surgery, usually do not lead to pain relief and as such fusion is considered a last resort treatment option only when all other treatment options have failed. This information must be communicated to the patient prior to surgery to allow for appropriate shared decision making with a well-informed patient. The medical record must reflect that this counseling was done and that the patient wished to undergo surgery with the appropriately informed consent.”

Following is another important piece of information that could be shared with a patient. The following paragraph can be found in the Summary of Evidence section of the Palmetto’s LCD.

“Persistent Back Pain Following Previous Spine Surgery

One of the largest studies to date examining the outcomes of surgical fusion following an initial spinal surgery reviewed 100 cases of “failed back surgery syndrome” (Arts 2012). All patients had at least one year of persistent pain refractory to conservative treatments after their initial spine surgery and were treated with pedicle screw fixation and interbody fusion in the revision surgery. Etiologies of failed back surgery syndrome specifically identified included previous discectomy, previous laminectomy, adjacent level disease and instability. The primary outcome measure was a dichotomous patient self-report regarding recovery with options of “good recovery” or “bad recovery”. Mean follow-up time after revision surgery with fusion was 14.7 months. On the primary outcome 35% of patients reported good recovery and the remaining 65% reported bad recovery.”

Moving Forward

Spinal Fusion audits are not new. The documentation expectation to support the medical necessity of the procedure has been made known by several different auditors. Now that Palmetto has published an LCD I would anticipate that a Targeted Probe and Educate review of Spinal Fusions will begin at some point in the near future. Steps you can take now to prepare:

• Read the Lumber Spinal Fusion LCD (L37848) and related Article: Billing and Coding: Lumbar Spinal Fusion (A56396)
• Also, take the time to read the Article: Response to Comments: Lumbar Spinal Fusion (A56397). A word of caution before reading this article, it has the potential to provide insight into Palmetto’s reasons for inclusions or exclusions in the policy, and to totally frustrate you at the same time.
• Perform an internal audit to see if documentation supports one of the indications for the procedure.
• Provide a copy of all of the source documents to Key Stakeholders (i.e. Chief Medical Officer, Surgeon, Case Management staff, Physician office staff).
• You could also share the more general CMS Provider Compliance Video containing pointers to help provide proper documentation when billing for Lumbar Spinal Fusion with your Surgeons. You can find a link to this YouTube video on the CMS website.

MEDICARE TRANSMITTALS – RECURRING UPDATES

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

The new HCPCS codes for 2019 that are subject to and excluded from Clinical Laboratory Improvement Amendments (CLIA) edits.

https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/downloads/MM11135.pdf

April 2019 Integrated Outpatient Code Editor (I/OCE) Specifications Version 20.1

https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/downloads/MM11192.pdf

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

https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/downloads/MM11204.pdf

April 2019 Update of the Hospital Outpatient Prospective Payment System (OPPS)

Describes changes to, and billing instructions for, various payment policies implemented in the April 2019 OPPS update.

OTHER MEDICARE TRANSMITTALS

Evaluation and Management (E/M) When Performed with Superficial Radiation Treatment

Allows providers to bill E/M codes 99211, 99212, and 99213 for Levels I through III, when performed with superficial radiation treatment delivery.

https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/downloads/MM11137.pdf

MEDICARE SPECIAL EDITION ARTICLES

Medicare Part B Clinical Laboratory Fee Schedule: Revised Information for Laboratories on Collecting and Reporting Data for the Private Payor Rate-Based Payment System

Assist the laboratory community in meeting the requirements under Section 1834A of the Social Security Act (the Act) for the Medicare Part B Clinical Laboratory Fee Schedule (CLFS). Includes clarifications for determining

• whether a hospital outreach laboratory meets the requirements to be an “applicable laboratory,”
• the applicable information (that is, private payor rate data) that must be collected and reported to CMS,
• the entity responsible for reporting applicable information to CMS,
• the data collection and reporting periods, and
• the schedule for implementing the next private payor-rate based CLFS update.

https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/downloads/SE19006.pdf

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

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

MEDICARE COVERAGE UPDATES

National Coverage Determination (NCD90.2): Next Generation Sequencing (NGS)

CMS covers diagnostic laboratory tests using next generation sequencing when performed in a Clinical Laboratory Improvement Amendments- certified laboratory when ordered by a treating physician and when specific requirements are met.

https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/downloads/MM10878.pdf

MEDICARE PRESS RELEASES

CMS Updates Consumer Resources for Comparing Hospital Quality

CMS updated hospital performance data on the Hospital Compare website and on data.medicare.gov. This data includes specific measures of hospitals’ quality of care, many of which are updated quarterly, and the Overall Hospital Star Ratings, which were last updated in December 2017. The data are collected through CMS’s Hospital Quality Initiative programs.  

https://www.cms.gov/newsroom/press-releases/cms-updates-consumer-resources-comparing-hospital-quality

CMS Updates Drug Dashboards with Prescription Drug Pricing and Spending Data

Updated with 2017 data.

https://www.cms.gov/newsroom/press-releases/cms-updates-drug-dashboards-prescription-drug-pricing-and-spending-data

MEDICARE EDUCATIONAL RESOURCES

Medicare Fast Facts

Medicare Fast Facts resources this month include:

• Bill Correctly for Device Replacement Procedures

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

OTHER MEDICARE UPDATES

KEPRO Winter 2019 Care Review Connections Newsletter

A quarterly e-newsletter from your Beneficiary and Family Centered Care Quality Improvement Organization (BFCC-QIO).

https://www.keproqio.com/providers/winter-2019-acute-newsletter/

Guidelines for Achieving a Compliant Query Practice—2019 update

“Guidelines for Achieving a Compliant Query Practice” was produced through the joint effort of the Association of Clinical Documentation Improvement Specialists (ACDIS) and the American Health Information Management Association (AHIMA). Both associations collaborated on the creation of this practice brief and approved its contents, and as such it represents the recommended industry standard for provider queries.

This practice brief supercedes one published in 2016 and all previous versions.

https://acdis.org/resources/guidelines-achieving-compliant-query-practice%E2%80%942019-update 

A healthcare claim form is a form which providers of services (hospitals, physicians, etc.) use to tell payors of services (Medicare, Medicaid, commercial payors, etc.) what items, tests, and services were provided to the patient and to request payment for those services. In other words, it is a communication tool between the provider of services and the payor of services that says, “this is what we did; please pay us.” In addition to this basis request for payment, it is sometimes used to communicate other information about the services that may affect payment immediately, or may allow the payors to gather data they could use to affect payment down the road. Medicare, as the largest healthcare payor, provides lots of claim-processing instructions, such as the quarterly updates to the Medicare Outpatient Prospective Payment System (OPPS).

Two of the bigger news items from the April 2019 OPPS Update are instructions on billing for (CAR) T-cell Therapy and reporting of the ER modifier for services performed in an off-campus provider-based emergency department. Along with these items are the other code updates and changes of the types that usually appear in the quarterly updates.

Chimeric Antigen Receptor (CAR) T- Cell Therapy

Chimeric Antigen Receptor (CAR) T- Cell Therapy is a new cancer treatment. To understand billing, you have to have an idea of how the therapy works. The CMS transmittal describes it as:

(CAR) T-cell therapy is a cell-based gene therapy in which T-cells are collected and genetically engineered to express a chimeric antigen receptor that will bind to a certain protein on a patient’s cancerous cells. The CAR T-cells are then administered to the patient to attack certain cancerous cells and the individual is observed for potential serious side effects that would require medical intervention.

In February, CMS released a proposed decision memo that would allow coverage of (CAR) T-Cell therapy under Coverage with Evidence Development (CED) (see a prior Wednesday@One article for more information on the proposed coverage). Until that decision memo is made final, there is no national Medicare policy for covering CAR T-cell therapy, so local Medicare Administrative Contractors (MACs) have discretion over whether to pay for it. The drugs associated with this treatment are currently payable as pass-through drugs and there is also a payable code for the administration of CAR T-cells in the hospital outpatient setting.

Although there are CPT codes for the collection and preparation of the CAR T-cells, Medicare does not generally pay separately for each step used to manufacture a drug or biological. The drug codes above also clearly specify that leukapheresis and dose preparation are included. Because of this, the collection and preparation codes were assigned a status indicator of “B” (Codes that are not recognized by OPPS) and were not to be reported on an outpatient hospital Part B bill type (12x and 13x). Medicare has now decided that in order to track utilization and cost data, they will allow the reporting of these non-payable codes on the claim as non-covered services.  Effective for claims received on or after April 1, 2019, providers should report the following CPT codes, associated revenue codes, and value code when these services are provided.

These services may be reported as non-covered charges on the outpatient claim. Also, hospitals may report the CAR T-cell related revenue codes 087X (Cell/Gene Therapy) and 089X (Pharmacy) as well as new value code 86 (Invoice Cost) established by the NUBC on hospital outpatient department claims.

The transmittal even gives examples of what should be reported in different scenarios:

• CAR T-cells collected, prepared and given in hospital outpatient department
• Report the appropriate drug code (Q2041 or Q2042) and the administration code (0540T) as covered services
• Report 0537T, 0538T, and 0539T codes and charges as non-covered
• CAR T-cells collected and prepared in hospital outpatient department, but not given
• Report 0537T, 0538T, and 0539T codes and charges as non-covered
• CAR T-cells collected and prepared in hospital outpatient department, given in subsequent inpatient admission
• Report charges associated with services described by CPT codes 0537T, 0538T, and 0539T under revenue code 0891 (Special Processed Drugs – FDA Approved Cell Therapy - Charges for Modified cell therapy) on inpatient claim (11x type of bill)
• Do NOT report drug codes (Q20140 or Q2042) when CAR T-cells are given to inpatients

Modifier “ER”

Another new reporting requirement solely for the benefit of allowing Medicare to collect utilization data is the new modifier “ER.” Hospitals are required to report this modifier on all services provided in an off-campus provider-based emergency department. Additional information about the “ER” modifier:

• Effective January 1, 2019;
• Report on every claim line that contains a CPT/HCPCS code for an outpatient hospital service furnished in an off -campus provider-based emergency department;
• Report on UB-04 (Form 1450) for hospital outpatient services;
• Not required to be reported by critical access hospitals (CAHs);
• For off-campus provider-based emergency departments that meet the definition of “a dedicated emergency department”, that is they are:
• Licensed by the State as an emergency department; OR
• Held out to the public (by name, posted signs, advertising, or other means) as a place that provides care for emergency medical conditions on an urgent basis without requiring a previously scheduled appointment; OR
• They provide at least one-third of all of their outpatient visits for the treatment of emergency medical conditions on an urgent basis without requiring a previously scheduled appointment.

As if it is not hard enough to report all the codes for which you do get paid, Medicare sometimes requires that we report codes for which there is no payment. Bummer! 

In keeping with March being National Social Work Month, this article focuses on CMS’s Transfer Policy. Medicare’s Transfer policy applies to transfers from an IPPS hospital to another hospital. It also applies to transfers from an IPPS hospital to specific post-acute care settings for specific MS-DRGs, which is known as the Post-Acute Care Transfer (PACT) Policy. This article focuses on the PACT policy, the addition of two new discharge dispositions to the policy and the potential financial implication for hospitals. 

Background

CMS’s PACT Policy was implemented to prevent Medicare from paying for the same care twice. This policy reduces reimbursement to a hospital when:

• A hospitalization codes to an MS-DRG designated as a Transfer MS-DRG,
• The patient’s length of stay (LOS) is at least 1 day less than the geometric mean LOS (GMLOS) for the MS-DRG, and
• The patient is discharged to one of the “qualified discharges” in the following table.

Annually, CMS publishes a list of MS-DRGs subject to the PACT policy in Table 5 of the applicable Fiscal Year IPPS Final Rule. For FY 2019 there are 280 transfer DRGs.

The Bipartisan Budget Act of 2018 required the addition of discharges/transfers to Hospice Home (Discharge Disposition Code 50) and discharges/transfers to Hospice, General Inpatient Care or Inpatient Respite (Discharge Disposition Code 51) be added to the list of qualified discharge dispositions included in the Post-Acute Transfer (PACT) Policy. This change was finalized in the FY 2019 IPPS Final Rule with an effective date of October 1, 2018. CMS actuaries estimated this change in the PACT policy will “generate an annual savings of approximately $240 million in Medicare payments in FY 2019, and up to $540 million annually by FY 2028.”

Transfer MS-DRG Payment

A transferring hospital is generally paid based on a graduated per diem rate for each day of stay, not to exceed the full MS-DRG payment that would have been made if the patient had been discharged without being transferred. A per diem rate is calculated for each transfer DRG based on the following formula:

• MS-DRG Payment ÷ GMLOS = Per Diem Rate

For Transfer MS-DRGs, a hospital is reimbursed twice the per diem amount for the first day of the hospitalization and an additional single per diem rate for subsequent days up to the full MS-DRG payment.

CMS noted in the 2019 IPPS Final Rule, “(t)he rational for per diem payment as part of our transfer policy is that the transferring hospital generally provided only a limited amount of treatment. Therefore, payment of the full prospective payment rate would be unwarranted.” (49 FR 244)… Our longstanding view is the policy addresses the appropriate level of payment once clinical decisions about the most appropriate care in the most appropriate setting have been made.” 

Special Payment MS-DRGs

To account for MS-DRGs subject to the PACT Policy that have exceptionally higher shares of costs very early in the hospital stay, CFR 412.4(f) also includes a special payment methodology. For these MS-DRGs hospitals receive 50 percent of the full MS-DRG payment, plus the single per diem payment, for the first day of the stay, as well as a per diem payment for subsequent days (up to the full MS-DRG payment).

PACT Policy Payment Examples

To help understand the policy payment, following are examples of a Transfer MS-DRG and a Special Pay Transfer MS-DRG.

PACT Policy

MS-DRG 470 (Major hip and knee joint replacement or reattachment procedures of the lower extremity with MCC without MCC) has been designated as Transfer MS-DRGs. Below is an example of payment utilizing FY 2018 IPPS Final Rule data. 

‍Special Pay MS-DRGs

MS-DRG 266 (Endovascular cardiac valve replacement with MCC) has been designated as Special Pay MS-DRGs. Below is an example of payment utilizing FY 2018 IPPS Final Rule data. 

Case Study

With the addition of Hospice to the PACT Policy and the estimated savings by CMS actuaries, what could this mean for individual hospitals? MMP conducted this case study with the objective of answering this question.

How Case Study Conducted

The first step was to select a group of short term acute care hospitals in Alabama both urban and rural. The second step was to use paid claims data from our sister company RealTime Medicare Data (RTMD) RealHealth Analytics database. Specifically, MMP used a report available in the Inpatient Compliance-RAC-Quality options titled Your Post-Acute Care Transfer Risks.

Specific parameters selected to run the report included:

• Hospital Name,
• Dates of Service: FY 2018 (October 1, 2017 through September 30, 2018), and
• Discharge Status Codes for Hospice Only.

Data Elements utilized from the report to identify potential financial impact included:

• DRG and DRG Description,
• Identified if Transfer DRG was also a Special Pay DRG,
• GMLOS,
• National Average Reimbursement for the DRGs,
• Length of stay for each claim; and
• Hospital specific unadjusted reimbursement.

Case Study Findings:

The following table depicts Transfer MS-DRG Volumes for FY 2018 where the discharge was to hospice, the hospital actual unadjusted reimbursement, the national average reimbursement, what the new national average payment would be when applying PACT policy payment methodology and the payment reduction the hospital could anticipate in FY 2019.

Hospitals in this case study can anticipate a 25-40% reduction in reimbursement due to the addition of discharge to hospice to the PACT Policy. It is important to understand the potential shift in hospital revenue. However, I believe it is more important to ensure your patients receive the right care, at the right time and in the right setting.

As I write this article, it is a beautiful day with warm temperatures and lots of sunshine – a hint that spring is on its way though the weather forecast includes a drop back to frigid temperatures in the next few days, a harsh reminder that Winter is not yet finished. The intermittent warmth has caused new plant growth and already my lawn needs mowing to control the weeds and errant grasses. Time to pull out the lawn mower or call the lawn service. If you use a lawn service, you would not want to pay them for cranking their lawn mowers in addition to paying them for cutting the grass. Cranking the lawn mower is an inherent part of the service. Years ago, Medicare realized they should not be paying separately for services inherent in another procedure or groups of procedures and “developed the National Correct Coding Initiative (NCCI) to promote national correct coding methodologies and to control improper coding leading to inappropriate payment in Part B claims. CMS developed the NCCI coding policies based on coding conventions defined in the American Medical Association's CPT Manual, national and local policies and edits, coding guidelines developed by national societies, analysis of standard medical and surgical practices, and a review of current coding practices.” (Medicare NCCI webpage)

The NCCI includes:

• Procedure-to-Procedure (PTP) Edits – The PTP Column One/Column Two Correct Coding Edit Table contains edits which are pairs of HCPCS/CPT codes that in general should not be reported together. Each edit has a column one and column two HCPCS/CPT code. If a provider reports the two codes of an edit pair, the column two code is denied, and the column one code is eligible for payment. However, if it is clinically appropriate to utilize an NCCI-associated modifier, both the column one and column two codes are eligible for payment.
• Medically Unlikely Edits (MUEs) - MUEs prevent payment for an inappropriate number/quantity of the same service on a single day. An MUE for a HCPCS/CPT code is the maximum number of units of service (UOS) under most circumstances reportable by the same provider for the same beneficiary on the same date of service. The ideal MUE value for a HCPCS/CPT code is one that allows the vast majority of appropriately coded claims to pass the MUE.
• The NCCI Policy Manual for Medicare Services - A general reference tool that explains the rationale for NCCI edits.

As noted above, both codes in some PTP code pairs can be paid if reported with an applicable modifier. Each PTP code pair includes a modifier indicator that specifies if modifiers are allowed to by-pass the NCCI edit or not. A modifier indicator of “0” means you cannot add a modifier to that code pair to by-pass the edit, while an indicator of “1” means a modifier is allowed. Providers should NEVER append a modifier solely to bypass an NCCI PTP edit if the clinical circumstances do not justify its use. Generally, the use of modifiers is related to circumstances such as separate patient encounters, separate anatomic sites or separate specimens. Some of the more common modifiers for by-passing NCCI PTP edits are the 59 and associated XE, XS, XP, and XU modifiers. For years, the instructions have been that the modifier must be appended to the column two code of a PTP edit to bypass the edit. That was just confusing and required extra time and effort to verify which code of the pair was the “column two code.” Claims data sometimes showed that even the Medicare contractors couldn’t get it right and paid both codes even when the modifier was reported on the column one code. Finally, Medicare is addressing this issue and effective July 1, 2019, Medicare will allow modifiers 59, XE, XS, XP, or XU on column one and column two codes to bypass the edit as communicated in MLN Matters Article MM11168.

In related news, there is a new Medicare contractor for the NCCI program. On February 1, 2019, CMS awarded the NCCI contract to Capitol Bridge LLC. The transition of the contract from the incumbent contractor, CCS WP LLC/Correct Coding Solutions LLC, to Capital Bridge started on February 3, 2019, and will end on March 15, 2019.  An announcement of the new contract can be found on the Medicare NCCI webpage in the Downloads section.

On November 21, 2018, CMS issued Transmittal 211 regarding revisions made to the Implantable Cardiac Defibrillator (ICD) National Coverage Determination (NCD 20.4) through a February 15, 2018 Final Decision Memo. Transmittal 211 indicated the revisions effective date was February 15, 2018 and the implementation date was to be February 26, 2019.

New Implementation Date: March 26, 2019

Almost two weeks ago on February 15th, CMS rescinded Transmitted 211 and replaced it with Transmittal 213. The only change made in the Transmittal was to change the implementation date from February 26, 2019 to March 26, 2019 (for MAC local edits). All other information remained the same.

Summary of Significant NCD Revisions

The delay in implementation affords providers an opportunity to make last minute adjustments to their systems and/or provide additional education to key stakeholders to ensure compliance with the NCD revisions. Following is a summary review of the significant changes in the NCD revision:

• MRI has been added to the list of imaging studies that can be performed to evaluate left ventricular ejection fraction (LVEF);
• At least three months of Optimal Medical Therapy (OMT) is a new requirement for patients who have severe non-ischemic dilated cardiomyopathy and no personal history of sustained ventricular tachyarrhythmia or cardiac arrest due to ventricular fibrillation;
• A Shared Decision Making (SDM) interaction must happen prior to ICD implantation for certain patients. (Note: This includes all patients receiving an ICD for primary prevention);
• The Class IV heart failure requirement for cardiac resynchronization therapy (CRT) has been removed,
• An exception to the waiting period has been added for patients meeting CMS coverage requirements for cardiac pacemakers, and who meet the criteria for an ICD;
• An exception to the waiting period has also been added for patients with an existing ICD and qualifying replacement; and
• There is no longer a data collection requirement (e.g. a registry).

Additional information about the NCD Revisions and Effective and Implementation dates can be found in related Wednesday@One articles (http://mmplusinc.com/news-articles/item/ncd-20-4-implantable-cardiac-defibrillators-icds and http://mmplusinc.com/news-articles/item/effective-dates-of-new-icd-ncd-rules).

Implantable Automatic Defibrillator – Coding and Billing Local Coverage Article

CMS A/B MACs have been instructed to implement the NCD at the local level. At the time information for this article was compiled, all but two MACs (WPS and CGS) had posted or announced their plan to post an Implantable Automatic Defibrillator – Coding and Billing Local Coverage Article. The following table provides links to the currently available Future Articles.

The Articles provide coding and billing instructions for the implementation of NCD 20.4, including the ICD-10-CM codes that must be billed for the now six covered indications. In addition to meeting one of the covered indications, there are additional criteria that must be met. The first one being, “patients must be clinically stable (e.g., not in shock, from any etiology).” Indications 2, 3 and 4 are for patients with a low LVEF (≤ 30 or ≤ 35%). Per the Coverage Articles, one of the heart failure codes in the following table must be billed.

Note this list of heart failure ICD-10-CM codes does not include I50.9 Heart failure, unspecified. From auditing records, physicians still have a tendency to document congestive heart failure without further clarification and CDI Professionals in turn continue to query to clarify the type of congestive heart failure. Without the clarification, unspecified heart failure would not meet the coding requirement outlined in the coverage article.

The next issue that raised a question for me was the “patients must be clinically stable” requirement. While ICD’s are not an inpatient only procedure and are in general performed as an outpatient, there are instances where an ICD is implanted during an inpatient admission. Can an inpatient undergoing ICD placement due in part to a low LVEF be in acute heart failure and clinically stable at the same time? Or, could the acute systolic heart failure inpatient admission be long enough for the patient to stabilize and be clinically stable at the time of ICD implant? At this time I have questions with no answers and a plan to seek clarification from Palmetto. Stay tuned for an answer……

On February 15, 2018, CMS issued a national coverage Decision Memo that contained some significant changes to the National Coverage Determination (NCD) 20.4 for Implantable Cardiac Defibrillators (ICDs). On November 21, 2018, CMS finally issued the transmittal updating the NCD – this transmittal indicated an effective date of February 15, 2018 and an implementation date of February 26, 2019 (for MAC local edits). On December 13, 2018, CMS revised the transmittal to emphasize that this coverage policy no longer requires trial-related coding on claims for dates of service on or after February 15, 2018.

February, November, December, February - so many dates! As often occurs with NCD updates, the question becomes when can providers change their practices and submit claims that follow the new guidelines. First let’s review a summary of the significant changes from the NCD revision.

• Adds MRI to the list of imaging studies that can evaluate left ventricular ejection fraction (LVEF);
• Requires optimal medical therapy (OMT) for at least 3 months for certain patients who have severe non-ischemic dilated cardiomyopathy;
• Requires a patient shared decision making (SDM) interaction prior to ICD implementation for certain patients;
• Removes the Class IV heart failure requirement for cardiac resynchronization therapy (CRT);
• Adds an exception for patients meeting CMS coverage requirements for cardiac pacemakers, and who meet the criteria for an ICD;
• Adds an exception for patients with an existing ICD and qualifying replacement; and
• Ends the data collection requirement.

As CMS did in the December transmittal revision, I want to emphasize this last point. Prior to the NCD changes, beneficiaries receiving an ICD for primary prevention had to be enrolled in either a clinical trial

or a qualifying data collection system (e.g. a registry). This required reporting the “Q0” modifier on the claim line item with the implantation CPT code when performed for a primary prevention diagnosis. Modifier Q0 identified patients whose data was submitted to a data collection system in accordance with the regulations. ICD procedures on claims with primary prevention diagnoses that did not contain the Q0 modifier were denied. Since the unadjusted national payment rate for these procedures is generally greater than $25,000, a missing modifier resulted in a denial with a significant financial impact on the provider.

For a more thorough discussion of the new rules, see the prior Wednesday@One article from December, 2018. Also bear in mind that this is a long and complex NCD with many detailed requirements. One of the benefits of now no-longer-required registry participation was that it compelled the provider to review and answer all of the NCD requirements for Medicare coverage. Providers still need to be diligent in ensuring their ICD implantations for Medicare patients meet the NCD requirements. A few years ago, the Department of Justice (DOJ) investigated and recovered significant overpayments from numerous providers who failed to meet the ICD NCD guidelines.

But let’s get back to the effective date issue. Medicare is a huge bureaucracy and to change rules is not simply a snap of the fingers – there are manuals to update, Medicare contractors and providers to educate, and electronic systems to tweak. This means changes are not instantaneous and take some time to fully implement.

First, a Decision Memo is not immediately binding on Medicare contractors though they are encouraged to consider it. Here is the language from the Medicare Program Integrity Manual, Chapter 13 concerning decision memos:

“Coverage Decision Memorandum- CMS prepares a decision memorandum before preparing the national coverage decision. The decision memorandum is posted on the CMS Web site, that tells interested parties that CMS has concluded its analysis, describes the clinical position, which CMS intends to implement, and provides background on how CMS reached that stance. Coverage Decision Memos are not binding on contractors or ALJs. However, in order to expend MR funds wisely, contractors should consider Coverage Decision Memo posted on the CMS Web site. The decision outlined in the Coverage Decision Memo will be implemented in a CMS-issued program instruction within 180 days of the end of the calendar quarter in which the memo was posted on the Web site.”

As we saw with the ICD NCD revision, CMS does not always meet the “180 days of the end of the calendar quarter” deadline for posting the implementation instructions. Once these instructions are posted, the effective date is generally (if not always) the date the decision memo was released, but the implementation date is sometime still in the future. This allows the Medicare Administrative Contractors (MACs) time to adjust edits and complete other tasks prior to full implementation. For example, if you look at the Business Requirements from Transmittal R211NCD, you will notice that in addition to being instructed to “cover ICDs for patients that meet the specific coverage indications and criteria described at Pub. 100-03, NCD Manual, section 20.4,” there are also instructions that MACs shall, among other things:

• work together collaboratively from a clinical aspect to ensure consistent national editing across jurisdictions,
• attend up to 4 1-hour calls to discuss feedback regarding implementation of coding for this policy and how to ensure consistent national editing across MACS, and
• implement local edits in each respective jurisdiction until such time as CMS may determine shared edits to be appropriate, which will be relayed via a subsequent CR.

This delay until full implementation also allows providers time to make any adjustments to their systems. With all of these various dates, when are providers to change their processes and when are they to start submitting claims that follow the revised guidelines?  Here are the dates for the ICD NCD revision once again and my recommendations for a timeline for provider actions:

ICD Decision Memo:  February 15, 2018

NCD Transmittal:  November 21, 2018 (revised December 13, 2018)

Effective Date NCD:  February 15, 2018

Implementation Date:  February 26, 2019

1. When a decision memo is issued, begin at that time to add any new requirements to your facility practices. For this ICD NCD, the new requirement for the shared decision making is a great example. Although this obviously could not be instituted overnight, providers need to start working to implement this as soon as possible, knowing the final NCD will have an effective date the same as the date of the decision memo release.
2. I do not recommend discontinuing any of the “old” requirements at least until the official transmittal is published since the decision memo is not officially binding.
3. For claim submission, bear in mind the MACs “old” edits will be place until they have clear directions from CMS (the NCD transmittal) and then time to modify their edits (until final implementation date). This means claims that follow the new guidelines may continue to be denied after the effective date. For example, claims without a Q0 modifier for primary prevention may continue to be denied until the edits are changed, even though we have an official new NCD and are already past the effective date of the new NCD. Provider options are:
4. Continue to follow the guidelines of the old NCD for claim submission until the implementation date,
5. Follow the new NCD guidelines, but hold your claims until the implementation date for submission, or
6. Submit your claims following the new NCD guidelines, but realize they may be denied under the old NCD requirements and you will have to appeal these claims to obtain proper payment.

I understand that decision memos often share good news for which providers have been anxiously awaiting and the tendency is to want to make the changes immediately. Practice patience! After all, you have waited this long – a few more weeks or months won’t hurt.