Knowledge Base Category -

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 

It is important to maintain balance in life, for example, people need to balance their job responsibilities with their family and personal lives. In healthcare, it is important to balance the risks of new innovations against their efficacy and safety. Medicare has detailed processes for evaluating and approving coverage of new items and services through the National Coverage Determination (NCD) process. A final NCD describes the covered indications and any contraindications for a particular item or service. Even using the NCD process, Medicare sometimes determines there is not yet enough evidence available to make a coverage decision. In these situations, Medicare must balance offering the new technology to those in need, while being careful not to cover services that may not be effective or safe enough for the benefits to outweigh the risks. They have another process for these scenarios – coverage with evidence development (CED).

According to a Medicare document, “Coverage with Evidence Development (CED) allows coverage of certain items or services where additional data gathered in the context of clinical care would further clarify the impact of these items and services on the health of Medicare beneficiaries. Medicare coverage may be extended to patients enrolled in a clinical research study. CED allows Medicare to provide coverage for an item or service because it is provided within a research setting where there are added safety, patient protections, monitoring, and clinical expertise. CED projects provide the necessary new evidence to influence clinical practice and help Medicare beneficiaries and providers make more informed diagnostic and therapeutic decisions.”

In mid-February, CMS released one final and one proposed decision memo allowing coverage with evidence development for two services.

Vagus Nerve Stimulation (VNS) for Treatment Resistant Depression (TRD):

The final decision memo allows coverage of “FDA approved vagus nerve stimulation (VNS) devices for treatment resistant depression (TRD) through Coverage with Evidence Development (CED) when offered in a CMS approved, double-blind, randomized, placebo-controlled trial with a follow-up duration of at least one year with the possibility of extending the study to a prospective longitudinal study when the CMS approved, double-blind, randomized placebo-controlled trial has completed enrollment, and there are positive interim findings.” The studies must be approved by CMS and must address whether VNS improves health outcomes for TRD patients compared to a control group. The policy delineates specific research questions, patient criteria and contraindications for trial participation.

Chimeric Antigen Receptor (CAR) T-cell Therapy:

CMS proposes to cover autologous treatment with T-cells expressing at least one chimeric antigen receptor (CAR) through coverage with evidence development (CED)

• when prescribed by the treating oncologist,
• performed in a hospital,
• for patients who have relapsed or refractory cancer and have not currently been experiencing any comorbidity that would otherwise preclude patient benefit, and
• when certain hospital and treatment criteria are met.

CAR T-cell therapy is a new form of cancer therapy that uses a patient’s own immune system to fight the disease. It is the first FDA-approved gene therapy. According to the CMS announcement, “The proposed National Coverage Determination would require Medicare to cover the therapy nationwide when it is offered in a CMS-approved registry or clinical study, in which patients are monitored for at least two years post-treatment. Evidence from the registries and studies would help CMS identify the types of patients that benefit from CAR T-cell therapy, informing a future decision by the agency regarding the types of cases in which Medicare would cover the treatment with no registry or trial requirement.”

Both of these decision memos will improve access to treatment options and maintain patient safety while deepening CMS’s understanding of how patients in Medicare respond. This will allow CMS to ensure that it is paying for treatments in which the benefits outweigh the risks.

Coverage updates over the last month from local Medicare Administrative Contractors are listed below. Notice that 9 of the 12 MACs have released a coverage article on Coding and Billing for Implantable Automatic Defibrillators (ICDs). 

MEDICARE TRANSMITTALS – RECURRING UPDATES

April 2019 Quarterly 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/MM11151.pdf

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

NCD coding changes as the result of newly available codes, coding revisions to NCDs released separately, or coding feedback received.

https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/downloads/MM11134.pdf

Healthcare Provider Taxonomy Codes (HPTCs) April 2019 Code Set Update

https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/downloads/MM11121.pdf

OTHER MEDICARE TRANSMITTALS

Processing Veterans Administration (VA) Inpatient Claims Exempt from Present on Admission (POA) Reporting

The HAC-POA payment provision required by the Deficit Reduction Act of 2005 (DRA) applies only to Inpatient Prospective Payment System (IPPS) hospitals. Therefore, VA hospitals are exempt from reporting POA and End of POA Indicators.

https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/downloads/MM11053.pdf

Updates to Reflect Removal of Functional Reporting Requirements and Therapy Provisions of the Bipartisan Budget Act of 2018

Updates both the Medicare Benefit Policy Manual and Medicare Claims Processing Manual to reflect recent policy revisions including: (a) the repeal of the application of the outpatient therapy caps and the retention of the therapy cap amounts as thresholds of incurred expenses above which claims must include a modifier to confirm services are medically necessary as shown by medical record documentation; and, (b) the discontinuation of the functional reporting requirements.

https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/downloads/MM11120.pdf

Ensuring Organ Acquisition Charges Are Not Included in the Inpatient Prospective Payment System (IPPS) Payment Calculation

To prevent potential overpayments, Medicare’s Fiscal Intermediary Shared System (FISS) will deduct organ acquisition charges billed with revenue codes 081X from the total covered charges prior to sending an inpatient Type of Bill (TOB) 11X claim to the IPPS pricer for any date of service processed on or after July 1, 2019.

https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/downloads/MM11087.pdf

Revising the Remittance Advice Messaging for the 20-Hour Weekly Minimum for Partial Hospitalization Program Services

https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/downloads/MM11066.pdf

Common Working File (CWF) Provider Queries National Provider Identifier (NPI) Verification

The Common Working File (CWF) will require verification of the NPI similar to the HETS when Medicare Part A providers request Medicare beneficiary eligibility and entitlement data via the CWF provider inquiry screens.

https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/downloads/MM10983.pdf

Processing Instructions to Update the Standard Paper Remit (SPR)

Instructs MACs to update their systems to ensure that SPRs mailed after July 1, 2019, mask the Health Insurance Claim Number (HICN), so the Social Security Number (SSN) does not show.

https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/Downloads/MM11112.pdf

Implementation to Exchange the List of Electronic Medical Documentation Requests (eMDR) for Registered Providers via the Electronic Submission of Medical Documentation (esMD) System

Makes the changes required to send Additional Documentation Request (ADR) letters to participating providers via the (esMD) system. A CR to effectuate the exchange of ADR letters to registered providers via the esMD system will be released at a later date.

https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/Downloads/MM11003.pdf

Update to Mammography Editing

Modifies existing editing to ensure only revenue codes 0401, 0403, 0520, 0521, 096, 097, or 098 are billed on claims containing mammography codes 77065, 77066, or 77067.

https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/2019Downloads/R4225CP.pdf

Implementation of the Skilled Nursing Facility (SNF) Patient Driven Payment Model (PDPM)

Effectuates changes to the SNF Prospective Payment System (PPS) that were finalized in the FY 2019 SNF PPS Final Rule (83 FR 39162).

https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/downloads/MM11152.pdf

Local Coverage Determinations (LCDs) – REVISED

Multiple revisions of this transmittal that changes the LCD process.

https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/downloads/MM10901.pdf

Modification of the MCS Claims Processing System Logic for Modifier 59, XE, XS, XP, and XU Involving the National Correct Coding Initiative (NCCI) Procedure to Procedure (PTP) Column One and Column Two Codes

Medicare will allow modifiers 59, XE, XS, XP, or XU on column one and column two codes to bypass the edit.

https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/downloads/MM11168.pdf

Update to the Internet-Only-Manual (IOM) Publication (Pub.) 100-04, Chapter 32, Section 12.1

Removes diagnosis codes from and adds diagnosis codes to the list of valid diagnosis codes for Counseling to Prevent Tobacco Use.

https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/2019Downloads/R4237CP.pdf

MEDICARE COVERAGE

Update to Intensive Cardiac Rehabilitation (ICR) Programs

Effective February 9, 2018, coverage in an ICR is expanded to include stable, chronic heart failure defined as patients with left ventricular ejection fraction of 35 percent or less and New York Heart Association (NYHA) Class II to IV symptoms despite being on optimal heart failure therapy for at least 6 weeks.

https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/downloads/MM11117.pdf

Supervised Exercise Therapy (SET) for Symptomatic Peripheral Artery Disease (PAD)—Clarification of Payment Rules and Expansion of International Classification of Diseases Tenth Edition (ICD-10) Diagnosis Codes

https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/downloads/MM11022.pdf

CMS proposes Coverage with Evidence Development for Chimeric Antigen Receptor (CAR) T-cell Therapy

https://www.cms.gov/newsroom/press-releases/cms-proposes-coverage-evidence-development-chimeric-antigen-receptor-car-t-cell-therapy

Decision Memo for Vagus Nerve Stimulation (VNS) for Treatment Resistant Depression (TRD) (CAG-00313R2)

CMS will cover FDA approved vagus nerve stimulation (VNS) devices for treatment resistant depression (TRD) through Coverage with Evidence Development (CED) when offered in a CMS approved, double-blind, randomized, placebo-controlled trial with a follow-up duration of at least one year with the possibility of extending the study to a prospective longitudinal study when the CMS approved, double-blind, randomized placebo-controlled trial has completed enrollment, and there are positive interim findings.

https://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=292&TimeFrame=7&DocType=All&bc=AgAAYAAAQAAA&

National Coverage Determination (NCD) 20.4 Implantable Cardiac Defibrillators (ICDs) – REVISED

Implementation date changed from February 26, 2019 to March 26, 2019.

https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/2019Downloads/R213NCD.pdf

MEDICARE EDUCATIONAL RESOURCES

Medicare Fast Facts

Medicare Fast Facts resources this month include:

• Medicare Hospital Claims: Avoid Coding Errors
• DME Proof of Delivery Documentation Requirements

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

New App Displays What Original Medicare Covers

Allows people with Original Medicare, caregivers and others to quickly see whether Medicare covers a specific medical item or service.

https://www.cms.gov/newsroom/press-releases/new-app-displays-what-original-medicare-covers

Emergency Triage, Treat, and Transport (ET3) Model

A voluntary, five-year payment model that will pay participating ambulance suppliers and providers to 1) transport an individual to a hospital emergency department (ED) or other destination covered under the regulations, 2) transport to an alternative destination (such as a primary care doctor’s office or an urgent care clinic), or 3) provide treatment in place with a qualified health care practitioner, either on the scene or connected using telehealth.

https://www.cms.gov/newsroom/fact-sheets/emergency-triage-treat-and-transport-et3-model

In January, the Supplemental Medical Review Contractor (SMRC) Noridian Healthcare Solutions, LLC (Noridian) finally posted current SMRC projects related to inpatient claims as depicted in the following table.

So what about Project’s 01-001, 01-002 and 01-003? Noridian notes on their website that “at CMS discretion, not all projects will be made available on this website.” Spinal Fusions have been subject to audit for several years now. This article focuses on Spinal Fusions. More specifically we will look at prior Spinal Fusion audits, the SMRCs Medical Review Announcement, why new audits may focus on DRG Validation, what other Medicare Contractors are auditing Spinal Fusions, and next steps for hospitals.

A Look Back at Spinal Fusions Audits

Cahaba, GBA

Prior to calendar year 2018 Cahaba, GBA was the Medicare Administrative Contractor (MAC) for Jurisdiction J which includes Alabama, Georgia and Tennessee. In October 2012 they posted probe review results of MS-DRG 460. Out of 306 claims submitted 172 were denied. Cahaba indicated the documentation they would expect to find would include:

• Pre-procedure radiologic findings or mention of the radiology report results in the medical record,
• Failed conservative measures/treatment prior to surgery,
• Documentation of duration of pain and/or impairment of function,
• Physical exam documenting the functional pathology, and
• Documentation of instability if applicable.

Strategic Health Solutions

Strategic Health Solutions, LLC (Strategic), the first SMRC Contractor, completed a review of Spinal Fusions in year one of their contract. Strategic noted that analysis of claims data for calendar years 2012 and 2013 indicated a significant increase in billing and payment for MS-DRGs 459 and 460 (Spinal Fusion with and without MCC respectively).  As a result of this analysis, Strategic selected a random sample of 2,000 claims representing 125 unique facilities with dates of service June 1, 2012 through May 31, 2013. The overall outcome of this audit is depicted in the following table:

‍July 2015 Medicare Quarterly Compliance Newsletter

The July 2015 edition the newsletter included findings from a Comprehensive Error Rate Testing (CERT) special study of orthopedic surgeon’s claims for fusion of the lumbar spine. This article provided examples of improper payments due to insufficient documentation. In one example the physician had submitted an operative note. It was what was not submitted that caused the improper payment. Specifically there no visit notes, consultant’s notes, lumbar spinal imaging results, documentation of prior conservative measures attempted or completed or documentation of a condition that would have made conservative treatment inappropriate.

CMS stated “it is important to note that supplier prepared statements and physician attestations that conservative treatment measures were completed do not by themselves provide sufficient documentation of medical necessity, even if signed by the ordering physician. For example, a claim was scored an insufficient documentation error when a physician dictated the following generalized statement as part of an operative note without providing any supporting documentation, “the patient failed conservative measures and has met all of the Medicare requirements.”

Palmetto GBA Jurisdiction M Review

In 2015 and 2016 Palmetto conducted pre-payment service specific targeted medical reviews on MS-DRG 460. By the eighth quarter of targeted medical review this review had been discontinued in North Carolina, Virginia and West Virginia based on “acceptable Edit Effectiveness results.” In February 2017 they posted results for South Carolina’s eighth quarter of targeted medical reviews for claims processed October 1, 2016 through December 2016. Twenty three of forty three claims were completely or partially denied which represented $560,903.53 dollars denied and a charge denial rate of 50.8%. Examples of “granular detail” of reasons for denial included the following:

• No documentation of conservative measures/treatments failed or no documentation of neurological impairment-spinal stenosis.
• No documentation of pain impacting the functional ability of beneficiary despite conservative treatment.
• No X-ray, CT or MRI results submitted that support advanced degenerative changes, mechanical instability, and deformity of the lumbar spins or neural compression that would require this type of procedure.

For those closely involved with documentation requirements for total hip and knee procedures, the expected documentation requirements by Cahaba, the CERT and Palmetto should hopefully sound vaguely familiar.

Noridian Medical Review Announcement

Noridian’s Medical Review announcement notes this is a post-payment review of claims for Part A services billed on dates of service from January 1, 2017, through December 31, 2017. They note that prior review activities have focused on MS-DRGs 459 and 460 (Spinal Fusion except cervical with and without MCC respectively) and “further medical review activities were anticipated.”

Documentation Requirements

Specific documentation requirements being requested in the Additional Documentation Request (ADR) is in line with prior Spinal Fusion audits and includes the following:

1. Office notes/hospital record, including history and physical by the attending/treating surgeon
2. Documentation of the history and duration of unsuccessful conservative therapy (non-surgical medical management as applicable)
3. Records sufficient to document failed non-surgical medical management to include, but not limited to the following:
4. Documentation to support activity modifications and exercises or explanation why these could not be completed
5. Documentation and clinical notes to support supervised skilled physical therapy (PT) and/or occupational therapy (OT) for support of activities of daily living (ADLs) diminished despite completing a plan of care or explanation why these could not be completed
6. Documentation to support the trial of anti-inflammatory medications, oral or injection therapy as appropriate, and analgesics, or explanation why these could not be used
7. Interpretation and reports for X-rays, MRI’s, CT’s, etc.
8. Medical clearance reports (as applicable)
9. Complete operative report(s)

The review announcement also includes references and resources including two Local Coverage Determinations (LCDs) for Spinal Fusion.

• The first LCD is L33382 Lumbar Spinal Fusion for Instability and Degenerative Disc Conditions. This is First Coast Service Options, Inc. LCD. They are the MAC for Jurisdiction N which includes Florida.

• The second LCD is L35942 Surgery: Fusion for Degenerative Joint Disease of the Lumbar Spine. This was a Cahaba GBA LCD for Alabama, Georgia and Tennessee that was active during the date range of claims being reviewed.

Spinal Fusion and MS-DRG Validation Reviews

In addition to medical necessity audits, changes in the FY 2019 IPPS Final Rule could well prompt Spinal Fusion MS-DRG validation reviews. Spinal Fusion procedures require some type of device to facilitate fusion of the vertebral bones (i.e. instrumentation with bone graft or bone graft alone.) When an ICD-10-PCS code includes a device value of “Z” this means that “No Device” was used in the procedure. CMS identified ICD-10-PCS codes describing spinal fusion with a device value of “Z” meaning they were clinically invalid codes for Spinal Fusions.

CMS analyzed the FY 2017 MedPAR File and found that “invalid spinal fusion procedures represented approximately 12% of all discharges across the spinal fusion MS-DRGs.” They also found this group of claims to have a longer length of stay and higher average costs as reflected in the following summary table for spinal fusion procedures provided by CMS in the FY 2019 IPPS Final Rule.   

As a result of their review, CMS deleted 99 spinal fusion ICD-10-PCS procedure codes with a device value of “Z” effective October 1, 2018. CMS plans to continue to collaborate with the American Hospital Association (AHA) through Coding Clinic and provide further education on spinal fusion procedures and proper reporting of procedure codes.

Who else is Reviewing Spinal Fusion MS-DRGs?

CGS Administrators, LLC (CGS)

CGS, the Jurisdiction J MAC for Kentucky and Ohio, currently has edits in place to review Spinal Fusion MS-DRGs 456-460 as part of their Targeted Probe & Educate Process.

Recovery Auditors

All of the Recovery Auditors have received approval to perform complex inpatient hospital MS-DRG Coding Validation reviews.  With the issues noted by CMS in the FY 2019 IPSP Final Rule there is a high possibility that they may include spinal fusions in their list of audits.

Moving Forward

Noridian Resource

While Noridian as the SMRC Contractor is conducting post-payment reviews of Spinal Fusions (MS-DRGs 459 and 460), Noridian is also the MAC for Jurisdictions J-E (California, Hawaii, Nevada, American Samoa, Guan, Northern Mariana Islands) and J-F (Alaska, Arizona, Idaho, Montana, North Dakota, Oregon, South Dakota, Utah, Washington and Wyoming).

Noridian has a Local Coverage Article titled Spinal Fusion Services: Documentation Requirements for both MACs. (J-E Article A53972 and J-F Article A53975). The articles indicate that the “Noridian Medical Review team and CERT contractor has identified multiple errors regarding documentation to support the medical necessity of spinal fusion procedures. This article clarifies medical necessity and documentation requirements regarding spinal fusion procedures.”

CMS Resource

In 2016 CMS created a Provider Compliance Video containing pointers to help provide proper documentation when billing for Lumbar Spinal Fusion. You can find a link to this YouTube video on the CMS website.

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. There are a few key questions that you should answer.  

• Do your surgeons know what documentation elements are required?
• Does your staff responding to ADRs know what information needs to be sent to an auditor?
• Have you performed an internal audit of Spinal Fusion records to make sure expected documentation is in the record?

If you can’t answer yes to these three questions, now is the time to make sure you can. 

It is no secret that physical activity and exercise are good for you. For most healthy adults, the Department of Health and Human Services recommends at least 150 minutes of moderate aerobic activity or 75 minutes of vigorous aerobic activity a week, or a combination of the two. Medicare patients with certain conditions can participate in structured exercise programs as a benefit through Medicare. For example, there are cardiac and pulmonary rehabilitation programs for patients who meet certain cardiac and obstructive pulmonary criteria and in 2017 Medicare approved supervised exercise therapy for patients with symptomatic peripheral artery disease.

On February 1, 2019, CMS issued a new transmittal that clarified the payment rules and expanded the list of covered diagnosis codes for supervised exercise therapy (SET). Here are some things providers need to know about SET:

• On May 25, 2017, CMS issued a National Coverage Determination (NCD) to cover SET for Medicare beneficiaries with Intermittent Claudication (IC) for the treatment of symptomatic peripheral artery disease (PAD).
• Claudication is pain in the thigh, calf, or buttocks that occurs when walking. Intermittent claudication (IC) is the most common symptom experienced by people with PAD.
• SET involves the use of intermittent walking exercise, which alternates periods of walking to moderate-to-maximum claudication, with rest. SET has been recommended as the initial treatment for patients suffering from IC.
• SET consist of sessions lasting 30-60 minutes comprising a therapeutic exercise-training program for PAD in patients with claudication.
• It must be performed in an outpatient hospital setting or a physician’ s office.
• It must be delivered by qualified auxiliary personnel trained in exercise therapy for PAD and under the supervision of a physician or non-physician practitioner (PA, NP, or CNS).
• Medicare covers up to 36 sessions over a 12-week period with the option, at the discretion of the Medicare Administrative Contractor (MAC), to cover an additional 36 sessions (up to 72 sessions) over an extended period of time. Providers should append the KX modifier to sessions beyond the initial 36 to attest documentation is on file verifying that further treatment is medically necessary and meets the policy requirements.
• Patients must have a face-to-face visit with the physician responsible for PAD treatment to obtain the referral for SET. At this visit, the patient must receive information regarding cardiovascular disease and PAD risk factor reduction, which could include education, counseling, behavioral interventions, and outcome assessments. Be sure there is documentation of this visit in your SET records to support coverage.
• SET is non-covered for beneficiaries with absolute contraindications to exercise as determined by their primary attending physician.
• SET is reported with CPT code 93668 and an appropriate diagnosis code is required for coverage. Please see the ICD-10 diagnosis code table in the transmittal for covered diagnoses.

People should start their own exercise regimen while they are healthy and before health conditions qualify them for one of Medicare’s exercise programs. An ounce of prevention is worth a pound of cure.

MEDICARE TRANSMITTALS – RECURRING UPDATES

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

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

https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/downloads/MM11099.pdf

Clinical Laboratory Fee Schedule – Medicare Travel Allowance Fees for Collection of Specimens

Revises travel allowances payment amounts when billed on a per mileage basis using HCPCS code P9603 and when billed on a flat rate basis using HCPCS code P9604 for Calendar Year (CY) 2019.

https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/downloads/MM11146.pdf

Quarterly Update to the National Correct Coding Initiative (NCCI) Procedure-to-Procedure (PTP) Edits, Version 25.1 Effective April 1, 2019

https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/downloads/MM11126.pdf

Calendar Year (CY) 2019 Annual Update for Clinical Laboratory Fee Schedule and Laboratory Services Subject to Reasonable Charge Payment

Provides instructions for the Calendar Year (CY) 2019 Clinical Laboratory Fee Schedule (CLFS), mapping for new codes for clinical laboratory tests, and updates for laboratory costs subject to the reasonable charge payment.

https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/Downloads/MM11076.pdf

OTHER MEDICARE TRANSMITTALS

Medicare Claims Processing Manual Chapter 23 - Fee Schedule Administration and

Coding Requirements

Updates manual concerning National Correct Coding Initiative (NCCI) procedure-to-procedure (PTP) edits, medically unlikely edits (MUEs), and modifiers -59 and -91 usage.

https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/2018Downloads/R4188CP.pdf

Local Coverage Determinations (LCDs) – REVISED

Added language to show that MACs have the discretion to host multi-jurisdictional CACs.

https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/downloads/MM10901.pdf

New Waived Tests

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/MM11080.pdf

Medicare Claims Processing Manual, Chapter 30 Revisions

Chapter revised to provide improved formatting and readability – current policy is not changing.

https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/downloads/MM10848.pdf

New Electronic System for Provider Reimbursement Review Board Appeals

https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/Downloads/SE19004.pdf

MEDICARE SPECIAL EDITION ARTICLES

Total Knee Arthroplasty (TKA) Removal from the Medicare Inpatient-Only (IPO) List and Application of the 2-Midnight Rule - Reissued

Addresses TKA procedures and application of the 2-Midnight Rule now that this procedure has been removed from Medicare’s inpatient-only (IPO) list.

https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/downloads/SE19002.pdf

MEDICARE EDUCATIONAL RESOURCES

Appropriate Use Criteria for Advanced Diagnostic Imaging MLN Fact Sheet

https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/Downloads/AUCDiagnosticImaging-909377.pdf

ICD-10-CM, ICD10-PCS, CPT, and HCPCS Code Sets MLN Fact Sheet

https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/Downloads/ICD9-10CM-ICD10PCS-CPT-HCPCS-Code-Sets-Educational-Tool-ICN900943.pdf

Medicare Fast Facts

Medicare Fast Facts resources this month include:

• Proper Coding for Specimen Validity Testing Billed in Combination with Urine Drug Testing
• Proper Use of the KX Modifier for Part B Immunosuppressive Drug Claims

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

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

RAC ADR limits for facilities updated December 21, 2018

https://www.cms.gov/Research-Statistics-Data-and-Systems/Monitoring-Programs/Medicare-FFS-Compliance-Programs/Recovery-Audit-Program/Downloads/ADR-Limits-Institutional-Provider-Facilities-May-2016-revised-12-21-18508ao.pdf

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.

According to the Payment Accuracy.gov website “The Improper Payments and Elimination and Recovery Act of 2010 defines an “improper payment” as any payment that should not have been made or that was made in an incorrect amount under statutory, contractual, administrative, or other legally applicable requirements.”

The Comprehensive Error Rate Testing (CERT) Program calculates improper payment rates for the Medicare Fee-for-Service program. This article focuses on the CERT Program and Review Process and findings from the 2018 CERT Report.

CERT Program & Review Process

Medical Record Request

For each reporting period, the CERT Program selects a stratified random sample of approximately 50,000 claims submitted to Part A/B Medicare Administrative Contractors (MACs) and Durable Medical Equipment MACs (DMACs). This sample include claims that were paid or denied by the MAC.

When the CERT requests medical records from a provider if no documentation is received within 75 days of the initial request, the claim is classified as a “no documentation” claim and counted as an error. However, the CERT will still review documentation received after 75 days as long as it’s before the end of the report period deadline.

Review of Claims

Medical review professionals perform complex medical reviews to determine whether a claim was paid properly under Medicare coverage, coding and billing rules. Claim reviewers includes nurses, medical doctors and certified coders. This group of Medical review professionals assign improper payment error categories.

Improper Payment Error Categories, Definitions, and Examples

In a CMS Introduction to CERT download on the CMS CERT webpage, the following examples are provided specific to each improper payment category.

‍Calculation of the Improper Payment Rate.

CMS calculates a national improper payment rate and contractor specific and service specific improper rates from this stratified random sample of claims. As noted on the CMS CERT webpage, “The improper payment rate calculated from this sample is considered to reflect all claims processed by the Medicare FFS program during the report period.”

CMS notes “that the improper payment rate is not a “fraud rate,” but is a measurement of payments that did not meet Medicare requirements. The CERT program cannot label a claim fraudulent.”

2018 CERT Report by the Numbers:

Annually, the Department of Health and Human Services (HHS) publishes the improper payment rate in the Agency Financial Report. CMS later publishes more detailed improper payment rate information in the form of the annual Medicare FFS Improper Payments Report and Appendices.  CMS published the

2018 Medicare Fee-for-Service Supplemental Improper Payment Data Report on November 30, 2018. This report includes a review of claims submitted from July 1, 2016 through June 30, 2017.  

Overall

Overall Percent Accuracy Rate – 91.9% - Improper Payment Rate $357.7B

Percent Improper Payment Rate – 8.1% - Improper Payment Rate $31.6B

Common Causes of Improper Payments

Below is a table comparing the common causes of improper payments are broken out by the type of error. It appears that providers are doing better at submitting medical records. However, Medical Necessity errors are on the rise.

‍“0 or 1 Day” LOS Claims Continued Outlier

The CERT Program has reported Projected Improper Payments by Length of Stay (LOS) since the 2014 Report. While the Improper Payment Rate has dropped for “0 or 1 day” LOS claims, this group of claims continues to have the highest improper payment rate.

‍Compliance with Short Stays

Have you tracked your short stay volume overall, by MS-DRG or Physician over time? Do you know if your hospital is an outlier? Where can you look to find these answers?   

PEPPER

One resource available to hospitals is the Short-Term Acute Care PEPPER (Program for Evaluating Payment Patterns Electronic Report). The PEPPER is made available to hospitals on a quarterly basis and compares your hospital to your state, MAC Jurisdiction and the nation. One-day Stays for Medical and Surgical MS-DRGs are two of the “Target Areas” at risk for improper payments included in this report.

The PEPPER provides the following suggested interventions for high One-day Stays Hospitals:  

“This could indicate that there are unnecessary admissions related to inappropriate use of admission screening criteria or outpatient observation. A sample of same- and/or one-day stay cases should be reviewed to determine if inpatient admission was necessary or if care could have been provided more efficiently on an outpatient basis (e.g., outpatient observation). Hospitals may generate data profiles to identify same- and/or one-day stays sorted by DRG, physician or admission source to assist in identification of any patterns related to same- and/or one-day stays. Hospitals may also wish to identify whether patients admitted for same- and/or one- day stays were treated in outpatient, outpatient observation or the emergency department for one or more nights prior to the inpatient admission. Hospitals should not review same- and/or one- day stays that are associated with procedures designated by CMS as “inpatient only.”

RealTime Medicare Data

Another source that can help assist you is our sister company, RealTime Medicare Data (RTMD). RTMD collects over 800 million Medicare Fee-for-Service paid claims annually from 23 states and the District of Columbia, and allows for searching of over 7 billion historical claims. In response to the “Two-Midnight” Policy, RTMD has available in their suite of Inpatient Hospital reports a One Day Stay Report. To give you a true picture of your “at risk” volume, this report excludes claims with a discharge status for Expired (20), left against medical advice (07), hospice (50 & 51) and /or were transferred to another Acute care facility (02). This report enables a hospital to view one day stay paid claims data by DRG and Physician to direct where audits should be focused. For further information on all that RTMD has to offer you can visit their website at www.rtmd.org.

To learn more about the CERT visit AdvanceMed’s CERT Provider Documentation Information website at https://certprovider.admedcorp.com/Home/About.

It’s hard to believe that Thanksgiving is almost two weeks ago now and there are only nineteen shopping days left until Christmas. CMS provided what one could potentially call a gift depending on your point of view when they finally published Change Request (CR) 10865 on November 21st related to the ICD Final Decision Memo published early this year.  

Background

CMS posted a Final Decision Memo on February 15, 2018 for the National Coverage Determination (NCD) for Implantable Automatic Defibrillators (20.4). The Decision Memo finalized what CMS described as “minimal changes” to the ICD NCD from the 2005 reconsideration.

Decision Memo: Summary of the Changes

Patient Criteria

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

Additional Patient Criteria

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

Exceptions to Waiting Periods

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

November 21, 2018: CMS Releases Change Request (CR) 10865

Chapter 13, section 13.1.1 of the Medicare Program Integrity Manual indicates “the decision outlined in the Coverage Decision Memo will be implemented in a CMS- issued program guidance instruction within 180 days of the end of the calendar quarter in which the memo was posted on the Web site.” The end of September came and went with no program guidance.

CMS finally published CR 10865 on November 21, 2018. This CR includes updates made to the Medicare National Coverage Determinations Manual, Chapter 1, Part 1 for NCD 20.4 Implantable Cardioverter Defibrillators (ICDs).

It is important to note that “a subsequent CR will be released at a later date that contains a Pub.100-04 Claims Processing Manual update with accompanying instructions. Until that time, the Medicare Administrative Contractors (MACs) shall be responsible for implementing NCD 20.4.”

Shared Decision Making, a Deeper Dive

A significant portion of the February Decision Memo was dedicated to detailing public comments received and CMS responses. The following table highlights comments and responses specific to the new SDM criteria.   

In addition to the example SDM tool for ICDs, CMS made note of a website for patients with heart failure designed to lead them through information on ICDs to increase knowledge of their medical condition, the risks and benefits of available treatments and to empower the patient to become more involved in the decision-making process. https://patientdecisionaid.org/icd/.

Considerations Moving Forward

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

Questions to Consider:

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

Optimal Medical Therapy, a Deeper Dive

Patients who have severe non-ischemic dilated cardiomyopathy but no personal history of sustained ventricular tachyarrhythmia or cardiac arrest due to ventricular fibrillation must have been on optimal medical therapy (OMT) for at least 3 months prior to ICD placement. The following table highlights comments and responses specific to the new OMT criteria. 

‍Questions to Consider:

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

CR Implementation Date: February 26, 2019

It is up to you to decide if the 2019 implementation date is an early gift from CMS or a potential lump of coal for those that have not begun to prepare for the changes. Either way, MMP will be on the lookout for the subsequent Change Request specific to the Medicare Claims Processing Manual and accompanying instructions and encourages key stakeholders to put processes in place now to meet the new NCD requirements.