Knowledge Base Category -

This is the second article in a series of 2020 IPPS Proposed Rule Articles. Last week’s article provided details of the significant proposed changes to the CC and MCC severity designations. This week we take a look at proposed payment rate changes and the wage-index adjustment proposal being touted by CMS as a key priority of “Rethinking Rural Health.”

Proposed Payment Rate Changes by the Numbers

“By law, CMS is required to update payment rates for IPPS hospitals annually, and to account for changes in the prices of goods and services used by these hospitals in treating Medicare patients, as well as for other factors. This is known as the hospital “market basket.” The IPPS pays hospitals for services provided to Medicare beneficiaries using a national base payment rate, adjusted for a number of factors that affect hospitals’ costs, including the patient’s condition and the cost of hospital labor in the hospital’s geographic area.”

• 3.2% is the projected market basket update for general acute care hospitals paid under the IPPS that successfully participate in the Hospital Inpatient Quality Reporting (IQR) Program and are meaningful electronic health record (EHR) users.
• 3.7% is the CMS estimated total increase in IPPS payments for FY 2020.
• $4.7 Billion is the increase in total Medicare spending on inpatient hospital services, including capital, projected by CMS for FY 2020.

Hospital Readmission Reduction Program (HRRP)

• 2,599 is the number of hospitals that CMS estimates will have base operating DRG payments reduced based on their hospital readmission rates.
• $550 Million the estimated amount CMS will save in FY 2020 as a result of decreased payments to the estimated 2,599 hospitals.

Hospital Inpatient Quality Report (IQR) Program

CMS estimates that proposed changes for this program will result in changes to the information collection burden compared to previously adopted requirements. Specifically, the proposal to adopt the Hybrid Hospital-Wide All-Cause Readmission (Hybrid HWR) measure. Estimated impact of this change:

• 2,211 hours in total collection burden increase, and
• $83,266 total cost increase for all participating IPPS hospitals annually.

Hospital Value-Based Purchasing (VBP) Program

This program is a budget neutral program because “by law, the amount available for value-based incentive payments under the program in a given year must be equal to the total amount of base operating MS-DRG payment amount reduction for that year.”

• $1.9 Billion is the estimated amount available for value-based incentive payments for FY 2020 discharges.

“Rethinking Rural Health:” Proposed Changes to the Inpatient Hospital Wage Index

Public Comments

In the FY 2019 IPPS Proposed Rule, CMS solicited comments, suggestions and recommendations for changes to the Medicare inpatient hospital wage index. Fast forward to the April 2019 release of the FY 2020 IPPS Proposed Rule where CMS shares that “many of the responses received…reflect a common concern that the current wage index system perpetuates and exacerbates the disparities between high and low wage index hospitals.” There was also a concern “that the calculation of the rural floor has allowed a limited number of States to manipulate the wage index system to achieve higher wages for many urban hospitals at the expense of hospitals in other states, which also contributes to wage index disparities.”

Inpatient Hospital Wage Index, What is it?

In the April 23, 2019 Press Release CMS Advances Agenda to Re-Think Rural Health and Unleash Medical Innovation, CMS notes the following about the Inpatient Hospital Wage Index:

• It specifies how inpatient payment rates are adjusted to account for local differences in wages that hospitals face in their respective labor markets,
• It is intended to measure differences in hospital wage rates across geographic regions,
• It is updated annually based on wage data reported by hospitals, and
• Hospitals located in areas with wages less than the national average receive a lower Medicare payment rate than hospitals located in areas with wages higher than the national average.

An example provided in the Press Release is that of hospital in a rural community receiving about $4000 in payment for treatment of a Medicare beneficiary with pneumonia while a hospital in a high wage area could receive nearly $6,000 for the same case due to differences in the wage index. CMS goes on to note that, “high wage index hospitals, by virtue of higher Medicare payments, can afford to pay their staff more, allowing the hospitals to continue operating as high wage index hospitals. Conversely, low wage index hospitals often cannot afford to pay wages that would allow them to climb to a higher wage index. Over time, this creates a downward spiral that increases the disparity in payments between high wage index and low wage index hospitals, and payment for rural hospitals and other low wage index hospitals decline.”

FY 2020 Inpatient Hospital Wage Index Proposals

Stopping the “Downward Spiral”

First, CMS is proposing to increase the wage index for hospitals with a wage index value below the 25th percentile wage index. For FY 2020, the 25th percentile wage index value across all hospitals is 0.8482.

Specifically, the increase would be equal to half the difference between the otherwise applicable final wage index value for a year for that hospital and the 25th percentile wage index value for that year across all hospitals.

To better understand what the increase would be, CMS provides the following example in the Proposed Rule:

• First, assume the wage index for a geographically rural Alabama hospital is 0.6663,
• Second, note the 25th percentile wage index value for FY 2020 is 0.8482.
• Third, determine half the distance between the hospital wage index and the 25th percentile (0.8482 – 0.6663/2) = 0.0910
• Fourth, add the Rural Alabama hospital wage index with half the difference to get the new FY 2020 wage index value for the hospital (0.6663 + 0.0910) = wage index 0.7573.

This proposal would be effective for at least 4 years beginning in FY 2020.

Budget Neutrality

Second, CMS believes that “it would be appropriate to maintain budget neutrality for the low wage index policy proposed…by adjusting the wage index for high wage index hospitals.” Specifically, CMS is proposing to identify high wage index hospitals as hospitals in the highest quartile. This would be hospitals above the 75th percentile wage index across all hospitals for a fiscal year.

The methodology would be analogous to methodology used for hospitals below the 25th percentile. Following is the example provided in the Proposed Rule:

• First, assume high wage index Hospital A has a wage index value of 1.7351,
• Second, CMS notes that based on data for the proposed rule, the 75th percentile wage index value is 1.0351.
• Third, determine the distance between the hospital wage index and the 75th percentile (1.7351 – 1.0351) = 0.7000,
• Fourth, CMS would estimate the uniform multiplicative budget neutrality factor needed to reduce those distances for all high wage index hospitals so the estimated decreased payments offset the estimated increased aggregate payments to low wage index hospitals. For FY 2020 the estimated factor is 3.4 percent. Therefore, Hospital A’s wage index would be reduced by 0.0238 (Prior distance of 0.7000 x 0.034) = 0.0238.
• Fifth, the new wage index for Hospital A would be 1.7113 (that is, current value 1.7351 – wage reduction of 0.0238) = 1.7113.

To help mitigate any significant wage index decreases, CMS is “proposing to place a 5-percent cap on any decrease in a hospital’s wage index from the hospital’s final wage index in FY 2019. In other words, we are proposing that a hospital’s final wage index for FY 2020 would not be less than 95 percent of its final wage index for FY 2019.”

Rural Floor Calculation Change

Commenters to the FY 2019 Proposed Rule “indicated that another contributing systemic factor to wage index disparities is the rural floor….for discharges on or after October 1, 1997, the area wage index applicable to any hospitals that is located in an urban area of a State may not be less than the area wage index applicable to hospitals located in rural areas in that State.”

CMS is proposing to remove the urban to rural reclassifications from the calculation of the rural floor beginning in FY 2020. You can read a detailed discussion about this on pages 19396 – 19398 of the FY 2020 IPPS Proposed Rule in the Federal Register.

April 29, 2019 CMS.Gov Newsroom Article: “What they are Saying / CMS Advances Agenda to Re-Think Rural Health and Unleash Medical Innovation”

Less than a week after the FY 2020 IPPS Proposed Rule was released, CMS posted a CMS.Gov Newsroom Article with reaction from key healthcare stakeholders to the Proposed Rule. Since I live in Alabama and work for a company located in Birmingham, I wanted to share what Alabama leaders are saying about “Rethinking Rural Health.”

Executive Vice President and Chief Policy Officer Danne Howard
Alabama Hospital Association

“We could not be more grateful to CMS Administrator Seema Verma and her staff for listening to our concerns and taking action,” Howard said.  “Alabama has been penalized for decades by this flawed formula, which has resulted in some states being paid three times as much as Alabama’s hospitals for the exact same procedure.  Alabama’s entire congressional delegation worked tirelessly in a non-partisan manner to make this happen, and we specifically would like to acknowledge Sens. Richard Shelby and Doug Jones and Rep. Bradley Byrne for leading the charge.”

Sen. Richard Shelby (R-Ala)

“The Medicare Wage Index has negatively affected Alabama hospitals for over 20 years,” said. [sic], who wrote a letter last month signed by the state’s congressional delegation to Center for Medicare and Medicaid Services Administrator Seema Verma requesting a change to the index. After two decades of working to address a problem that significantly contributes to heightened hospital closures throughout our state, I am glad to see Administrator Verma and CMS taking steps to solve this dire issue. I look forward to continuing my work with the agency to make sure that this sort of careless imbalance is eliminated moving forward.”

Sen. Doug Jones (D-Ala)

“The decision by CMS to propose a new reimbursement formula is welcome news and a great first step for the health care providers across our state who have struggled for years with an inexplicably low reimbursement rate,” the senator said. “These hospitals provide care to all Alabamians, regardless of their insurance status, and they have to absorb the costs when that care isn’t reimbursed. That puts the entire system on slippery financial footing and can hurt the broader community if a hospital is forced to close its doors.”

CMS is accepting comments to the Proposed Rule no later than 5 p.m. EDT on June 24, 2019.

Resources:

CMS 2020 IPPS Proposed Rule Home Page: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/FY2020-IPPS-Proposed-Rule-Home-Page.html

CMS Fact Sheet Announcing Release of 2020 Proposed Rule: https://www.cms.gov/newsroom/fact-sheets/fiscal-year-fy-2020-medicare-hospital-inpatient-prospective-payment-system-ipps-and-long-term-acute

CMS April 23, 2019 Press Release: CMS Advances Agenda to Re-think Rural Health and Unleash Medical Innovation: https://www.cms.gov/newsroom/press-releases/cms-advances-agenda-re-think-rural-health-and-unleash-medical-innovation

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

The kicker to the saying that “time flies when you’re having fun,” is that time also flies when you are not. However, I have been extremely fortunate over the past 10 years to actually enjoy my job. Last October marked my 10-year anniversary as an employee of Medical Management Plus, Inc. (MMP). Yes, it is nerdy that I actually enjoy reading Medicare regulations, but I do. I enjoy even more writing articles, such as this one, which I hope share Medicare and related guidance in an easy-to-read and understandable format and help our readers do their own challenging healthcare jobs better. The rapid passing of time is relevant because the very first article I wrote at MMP over ten years ago was about the 2008 AHIMA (American Health Information Management Association) article, “Managing an Effective Query Process.”

In February of this year, the Association of Clinical Documentation Improvement Specialists (ACDIS) and the American Health Information Management Association (AHIMA) jointly produced “Guidelines for Achieving a Compliant Query Practice (2019 Update).”  This Practice Brief is the recommended industry standard for provider queries and describes best practices for coding and clinical documentation improvement (CDI) professionals performing query functions. It supersedes the 2016 and all prior versions.

Coders and CDI professionals should carefully review and follow the practices described in this Brief, but other healthcare team members also need to be aware of this guidance. For example, case management, quality management professionals, and infection control clinicians educate physicians to document a certain way. Since these interactions could ultimately affect coding, these healthcare professionals need to be aware of and comply with query compliance standards. Other healthcare professionals, such as compliance, revenue cycle, patient financial services, physician groups, facility leaders, and any who work with documentation and coding also need to be familiar with this guidance. The Brief also points out that it serves as a resource for external reviewers, such as the Office of Inspector General (OIG), government contractors, payor review agencies, and others.

According to the Brief, a query is a communication tool “used to clarify documentation in the health record for documentation integrity and accurate code assignment.” In addition to ensuring a medical record that accurately reflects patient complexity and the facts of the encounter, an effective query process ensures appropriate reimbursement and accurate risk-adjustment and quality of care statistics derived from claims data.

The Practice Brief states, “The objective of a query is to ensure the reported diagnoses and procedures derived from the health record documentation accurately reflect the patient’s episode of care.” Among other functions, some of the main uses of queries are to:

• Determine if a clinical condition is present when supported by clinical indicators within the record,
• Clarify conflicting documentation,
• Add specificity in certain situations,
• Establish “cause and effect” relationships, and
• Clarify when a documented diagnosis does not appear to be clinically supported.

I am not going to list all of the requirements of a compliant query and encourage those affected to read the entire Practice Brief for all the guidance provided. Here are some of the main points from the Brief that caught my attention.

Leading Queries

Bearing in mind that my background is compliance, I will start with the rule that queries should not be leading – they should not “lead” the physician or other practitioner to the preferred answer or to a specific diagnosis or procedure. Multiple choice queries are acceptable, but be sure to include options that allow the provider to explain other clinical options or to reply that the answer may be clinically undetermined. In the words of the Brief, “the choices provided as part of the query must reflect reasonable conclusions specific to the clinical scenario of the individual patient.”

Impact on Reimbursement

At one time, reimbursement seemed to be the major driver of the query process. This should not be – querying is about obtaining accurate documentation and coding, which often can affect a facility’s payment. However, keep your focus on accuracy and completeness and never include the impact on reimbursement or on quality measures in the query. It is best not to even discuss the effects of querying on reimbursement or quality measures with your physicians or others. If your records are accurate and complete, your facility will receive the appropriate reimbursement and accurate quality measures.

Specificity

Queries can be helpful for determining a more specific code in some situations. However, bear in mind “that code accuracy is not the same as code specificity.” Although some payors resist unspecified codes, there are times when unspecified codes are appropriate based on the clinical situation.

Clinical Indicators

When querying for documentation of medical diagnoses or conditions that are clinically evident, be sure to include clinical indicators that:

• “Are specific to the patient and episode of care
• Support why a more complete or accurate diagnosis or procedure is sought
• Support why a diagnosis requires additional clinical support to be reportable”

Clinical indicators can be such things as the physical exam and assessment, diagnostic findings, and treatments. Clinical indicators should be relevant and clearly support the clinical condition. More is not always better, as the Brief states, “The quality of clinical indicators—how well they relate to the condition being clarified—is more important than the quantity of clinical indicators.”

Patient History and Prior Encounters

Coding from prior encounters without documentation in the current record is not allowed, but generating a query based on information from a prior encounter may be acceptable, but only if the information is clinically pertinent to the current encounter. The Brief includes a list of example situations where information from a prior encounter could be used to query, such as specificity, baseline status, present on admission (POA) status, cause and effect, and etiology. The Brief cautions that “it is inappropriate to “mine” a previous encounter’s documentation to generate queries not related to the current encounter.”

Documentation and Retention of Queries

Sometimes it is easier to explain a situation to a provider in person. Verbal queries are acceptable, but the exchange, including the provider’s response, should be documented and maintained. And like written queries, conversations should not be leading. When documenting these interactions, be sure to include the same components you would include in a written query – the details of the discussion, the reason for the query, the clinical indicators, options discussed and the provider’s decision. Also, date, time, and sign your documentation.

It is recommended the query be part of the permanent medical record. Another option is to keep queries as part of the business record. They should be easily retrievable for auditing, monitoring, and compliance. Facilities should have a policy that addresses query retention and it should apply to all queries, regardless of provider response.

Clinical Validation and Escalation

Sometimes it may appear that a documented diagnosis is not clinically supported. These clinical validation queries can be more challenging than other types of queries. AHIMA has developed a separate Practice Brief to address these concerns titled “Clinical Validation: The Next Level of CDI.” AHIMA members can view this Brief in the AHIMA HIM Body of Knowledge at http://bok.ahima.org.  

Clinical validation may be a good time to involve a physician advisor or the chief medical officer. Facilities should have a documented escalation policy for certain situations, which may include clinical validation situations, failure to respond, or other issues. There should also be policies defining the role and expectations of those issuing the queries and the responders.

Again, this is a high-level overview of the Practice Brief on Compliant Queries. The Brief contains much more information, including query examples in Appendix B, which I found to be particularly enlightening. Be sure to read the entire Brief carefully – study it, discuss it with other stakeholders within your facility, and use it to develop your policies, procedures and practices. Be sure to include initial training for new employees and on-going education for all employees. Also, watch for updated guidance - I will not promise to be around in another 10 years to share the information.

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.

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. 

As you may be aware by now, on January 8, 2019 Medicare issued MLN Matters Article SE19002, “Total Knee Arthroplasty (TKA) Removal from the Medicare Inpatient-Only (IPO) List and Application of the 2-Midnight Rule,” and then after an instantaneous, critical response from the healthcare community immediately withdrew the article. On January 24, 2019, they reissued the article and again there was rapid negative critique of their scenarios. I, too, see the errors in some of their examples. In my opinion, they could write 100 examples and most would be subject to some criticism. I believe this is why they have been so hesitant to offer examples of the “case-by-case exception” for an inpatient admission when a greater-than-2-midnight stay is not expected. Hopefully CMS learns from this situation just how very hard it is to apply their rules. I maintain that even though their examples and wording are not perfect, there is something for hospitals to learn from this article.

Solid Documentation

The documentation in your medical records serves more than one function. Most importantly, medical documentation serves to communicate information about a patient’s condition and care between healthcare team members to ensure continuity of care, foster quality care, and improve efficiency of care. Medical documentation is also a legal document that serves as evidence of the care provided, especially in the case of a lawsuit. And it is the medical record that ultimately provides the justification and rationale to support payment for the medical items, tests, and services selected and provided to the patient.

Those of us that deal with Medicare are often reminded that documentation must support the medical necessity of services. It is not good when that reminder comes in the form of a claim denial following a complex medical review, such as reviews of the medical necessity of inpatient admissions. It is best to know what is expected up front so we can follow Medicare’s guidelines and make sure our documentation is thorough and solid enough to support Medicare’s requirements for payment.

Likewise, it is helpful when CMS shares the basis for their coverage and payment rationale, preferably in the form of guidance prior to an actual review. Hospitals have been waiting since the 2016 “case-by-case exception” for further guidance on what would justify the use of this exception. Also, hospitals have been confused by statements made in the final rule when total knee arthroplasty was removed from the inpatient-only list in 2018. TKAs are now paid by Medicare when performed as an outpatient or an inpatient, but when is inpatient admission for a TKA appropriate? Finally, CMS has issued a Special Edition MLN Matters Article SE19002 that addresses Total Knee Arthroplasty (TKA) Removal from the Medicare Inpatient-Only (IPO) List and Application of the 2-Midnight Rule. This article describes the circumstances when an inpatient admission for a TKA would be appropriate and even provides specific examples.

An inpatient admission for a TKA is appropriate when 1) there is an expectation of medically necessary hospital services spanning 2 midnights or longer or 2) there is not an expectation of a 2 midnight stay but the physician/practitioner determines other complex medical factors support an inpatient admission.

Providers should read the SE Article carefully as it provides a lengthy discussion on the topic. Here is a summary of some of that discussion. Inpatient admission for a TKA is appropriate when:

• The admitting physician/practitioner has a reasonable expectation that the patient will require medically necessary hospital services spanning 2 midnights or longer and admits the patient to the hospital based on that expectation.
• If the patient remains an inpatient receiving medically necessary hospital services for greater than 2 midnights and the patient’s medical record documents the medical necessity of a hospital level of care, this meets the 2-Midnight Presumption. Under the 2-Midnight Presumption, which helps guide contractor selection of claims for medical review, hospital claims with lengths of stay greater than 2 midnights are presumed to be reasonable and necessary for Medicare Part A payment.
• Even if the patient is discharged prior to a second midnight, as long as documentation supports that at the time the inpatient order was written, there was a reasonable expectation of medically appropriate hospital care spanning 2-Midnights, this supports the 2-Midnight Benchmark. Under the 2-Midnight Benchmark, hospital claims are generally payable when the admitting practitioner reasonably expected the beneficiary to require medically necessary hospital care spanning 2 or more midnights and this expectation is supported by the medical record documentation. The 2-Midnight Benchmark helps guide contractor reviews of short stay hospital claims for Part A payment.
• The admitting physician/practitioner does not expect the patient to need hospital care beyond a second midnight, but determines the patient requires hospital inpatient care based on complex medical factors supported in the medical record and including but not limited to:
• Patient’s history, co-morbidities, and current medical needs
• Severity of signs and/or symptoms, and
• Risk of Adverse Events

The article also emphasizes that TKAs do not always have to be performed as an outpatient and that CMS does not target TKA Short Stay inpatient claims for review.

It is also interesting to note that in the 2018 OPPS Final Rule, CMS made the following statements:

“However, we do not expect a significant volume of TKA cases currently being performed in the hospital inpatient setting to shift to the hospital outpatient setting as a result of removing this procedure from the IPO list. At this time, we expect that a significant number of Medicare beneficiaries will continue to receive treatment as an inpatient for TKA procedures.”

In a seemingly contradictory statement, SE19002 notes, “CMS has not made any pre-determinations on the number of patients receiving TKA procedures that should be treated as an inpatient or outpatient.”

Sometimes even CMS’s documentation is not solid enough to stand up to an audit.

In all the years I have been writing articles for this newsletter, I am sure that I have at least once referenced the saying, “the devil is in the details” because this saying so perfectly fits in the Medicare world. It is often all about the details. A perfect example of this is from the recent OIG report on payments for hyperbaric oxygen (HBO) therapy that did not comply with Medicare requirements. Specifically, the OIG looked at HBO therapy services paid by the Medicare Administrative Contractor (MAC), First Coast, during calendar years 2012 through 2015. The OIG selected First Coast, the MAC for Jurisdiction N, because it paid the second largest amount for HBO therapy in 2013 and 2014; the highest MAC payor, WPS, had already been audited by the OIG (OIG Review of WPS HBO Payments). The OIG found that First Coast made payments for HBO that did not comply with Medicare requirements for 110 of 115 claims – a denial rate of 92%. Based on these findings, the OIG estimates First Coast has “overpaid providers in Jurisdiction N $39.7 million during the audit period for HBO therapy that did not comply with Medicare requirements.”

The OIG Report of First Coast HBO Overpayments gives three examples of ways providers did not comply with Medicare requirements. These examples mirror issues I often see when reviewing HBO records. Also interesting is the fact that the errors are associated with the most common Medicare coverage conditions for HBO therapy. Medicare’s requirements for HBO therapy can be found in the National Coverage Determination (NCD) 20.29 for Hyperbaric Oxygen Therapy. Below is a summary of what the OIG found, along with additional information from other Medicare resources.

HBO Covered Condition – Chronic Refractory Osteomyelitis, unresponsive to conventional medical and surgical management:

The OIG example about osteomyelitis was for ‘Medicare Payment for HBO Therapy Without Failing Conventional Treatment,’ and it specifically noted “HBO therapy treatment began before the conventional

treatment had been completed.”

The First Coast HBO LCD (Local Coverage Determination) states concerning osteomyelitis, “(it) must be chronic and refractory to usual standard of care management (i.e., prolonged antibiotics therapy preferably directed by appropriate culture and sensitivity information, drainage of the abscesses, immobilization of the affected extremity, and surgical debridement with removal of infected bone). HBO for osteomyelitis that is not documented to be chronic and refractory to conventional treatment, and HBO not provided in an adjunctive fashion, is not covered.”

The medical record must also contain documentation that supports the diagnosis of chronic refractory osteomyelitis. For example, Palmetto GBA in findings and education from their reviews of HBO, requires the diagnosis be supported by imaging studies or bone description and positive cultures. When reviewing such records, I notice it is often difficult to determine how long the patient has had osteomyelitis, how the diagnosis of OM was confirmed, and exactly what treatments have been tried.

HBO Covered Condition – Preparation and preservation of compromised skin grafts (not for primary management of wounds):

In the OIG report, “there was no evidence that the beneficiary ever received a flap procedure. She had surgery that resulted in a wound that became infected and did not heal, but there was no evidence that she ever received a flap.” The OIG listed this as ‘HBO therapy That Was Not Medically Necessary.’

Additional guidance concerning HBO for skin grafts/flaps can again be found in the First Coast LCD and from Palmetto GBA education. From the FC LCD, “Preparation and preservation of compromised skin grafts utilizes HBO therapy for graft salvage in cases where hypoxia or decreased perfusion has compromised viability.” The LCD reiterates that per the NCD, coverage under this indication is “not for primary management of wounds.” The LCD also points out HBO for this indication requires the presence of a compromised skin graft, and does not include HBO treatment that is empiric treatment or prophylactic maintenance of grafts or solely for preparation of a wound bed for receiving a graft.

In a Palmetto Ask the Contractor teleconference from May 2018, Dr. Leland Garrett, Medical Director, responded to questions concerning HBO coverage and documentation requirements. Per Dr. Garrett, for Medicare coverage, skin grafts and flaps treated with HBO should not be a chronic wound that had a flap performed several months ago and has reopened as a new (non) healing wound. It is for more acute situations where the flap or graft area has dehisced or is lost partially or fully. Preservation would be to use HBO to prevent (or repair) the dehisced side, and preparation would be the use of HBO to a site where the previous graft or flap was completely lost and is being oxygenated with HBO as an attempt to promote granulation tissue for the site for a new graft or flap …”.  The physician’s documentation should include information about the original graft or flap procedure including the date of the procedure, or preferably, a copy of the operative note. The documentation should also describe what has happened to the graft/flap site since the procedure that would cause the patient to need HBO.

HBO Covered Condition – Diabetic Wounds of the Lower Extremities in patients who meet the following three criteria:

1. “Patient has type I or type II diabetes and has a lower extremity wound that is due to diabetes;
2. Patient has a wound classified as Wagner grade III or higher; and
3. Patient has failed an adequate course of standard wound therapy.

The use of HBO therapy is covered as adjunctive therapy only after there are no measurable signs of healing for at least 30 –days of treatment with standard wound therapy and must be used in addition to standard wound care. Standard wound care in patients with diabetic wounds includes: assessment of a patient’s vascular status and correction of any vascular problems in the affected limb if possible, optimization of nutritional status, optimization of glucose control, debridement by any means to remove devitalized tissue, maintenance of a clean, moist bed of granulation tissue with appropriate moist dressings, appropriate off-loading, and necessary treatment to resolve any infection that might be present. Failure to respond to standard wound care occurs when there are no measurable signs of healing for at least 30 consecutive days. Wounds must be evaluated at least every 30 days during administration of HBO therapy. Continued treatment with HBO therapy is not covered if measurable signs of healing have not been demonstrated within any 30-day period of treatment.” (NCD 20.29)

These plentiful NCD requirements seem to be a challenge to providers. The OIG’s 3rd and final example is ‘HBO Therapy With Insufficient Documentation.’ In this case, the medical records did not contain sufficient documentation to support that there were at least 30 days of standard wound care therapy provided prior to HBO therapy. Since the NCD provides so many details for diabetic wounds, there is not a lot to add from the First Coast LCD or Palmetto findings. I recommend making a check list for diabetic wounds from the NCD requirements looking at each requirement from two perspectives – 1) does the patient meet the criterium and 2) is there documentation to support it. For example, your checklist would be:

• Is the patient diabetic? Is there documentation of such in the medical record?
• Does the patient have a lower extremity wound due to diabetes? Is the record clear that the wound is a diabetic wound?
• Is the wound a Wagner Grade III or higher and is that clearly documented in the record? Check for consistency in the documentation of the Wagner grade in physician’s progress notes and nursing assessments.
• Has the patient been receiving conservative wound care for treatment of the wound for at least 30 days? Does the medical record describe the different types of assessments and interventions that have been done to promote wound healing?
• Has there been no measurable signs of healing for at least 30 consecutive days? For example, the wound may fail to decrease in size as one indication of lack of healing, or there may be other wound characteristics signifying lack of healing. The First Coast LCD contains this statement – “Documentation of all aspects of optimization defined by the NCD (clarified by this LCD) and the absence of improvement in the wound characteristics constitutes stalled wound healing and suggests that it may benefit from adjunctive HBOT.”

The conditions addressed above are frequent reasons for a need for HBO therapy and providers need to ensure the coverage criteria and documentation requirements are met to receive appropriate reimbursement. Also remember to include other required elements in your HBO therapy – make sure you have:

• A physician’s (or practitioner’s) order for the HBO therapy,
• The physician/NPP’s explanation of the reason for HBO therapy (diagnosis or condition warranting the HBO treatment),
• The expected benefits of HBO treatment – these are the HBO treatment goals, and
• An evaluation of the patient’s progress from HBO therapy at least every 30 days.

This sounds like a lot of documentation but it is really just the basics of what is wrong with the patient, what is being done to help the patient, what is the expected outcome, and what is the actual outcome. The difficulty is, the devil is in the details.

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.  

CMS published Transmittal 825 on September 1, 2018. The purpose of this transmittal was to instruct Contractors on which healthcare professionals should be performing medical record reviews for the purpose of making coverage determinations. Guidance in this transmittal had an effective and implementation date of October 22, 2018.

Background

The Medicare Administrative Contractor (MAC) Medical Review Program performs reviews to carry out the goal of reducing “payment error by preventing the initial payment of claims that do not comply with Medicare’s coverage, coding, payment, and billing policies.” To accomplish this goal, MACs identify noncompliance through:

• Analysis of data (e.g., profiling providers, services, or beneficiary utilization), and
• Evaluation of other information (e.g., complaints, enrollment and/or cost report data).
  

Credentials of Medical Reviewers 

This Transmittal instructs MACs, the Medical Review Accuracy Contractor (MRAC) and the Comprehensive Error Rate Testing (CERT) Contractor that record reviews for the purpose of making coverage determinations must be performed by RNs, therapists or physicians. Current Licensed Practical Nurses (LPNs) performing medical reviews can be grandfathered in and continue to perform reviews. However, Contractors are to no longer hire new LPNs to perform reviews.

Zone Program Integrity Contractor (ZPIC)/Unified Program Integrity Contractor (UPIC), Recovery Auditors (RACs) and the Supplemental Medical Review Contractor (SMRC) must ensure reviewer credentials are consistent with the requirements in their respective Statements of Work (SOWs).

Advice from Other Health Care Professionals

In addition to advising who can perform the reviews, this transmittal adds the following new guidance to Chapter 3, Section 3.3.1.1 of the Medicare Program Integrity Manual:  

• “The MACs, MRAC, and CERT, shall ensure that services reviewed by other licensed health care professionals are within their scope of practice and that their MR strategy supports the need for their specialized expertise in the adjudication of particular claim type (i.e., speech therapy claim, physical therapy).”
  

Who are Your Contractors?

For those not closely involved with Medicare Medical Reviews, you can see from this Transmittal there are a lot of Contractors requesting and reviewing records. To find out the specific Contractors that could be requesting records, you can go to the Review Contractor Directory Interactive Map on the CMS website. https://www.cms.gov/Research-Statistics-Data-and-Systems/Monitoring-Programs/Medicare-FFS-Compliance-Programs/Review-Contractor-Directory-Interactive-Map/.

For many years, many people (providers, patients, and even Medicare contractors and reviewers) believed that one basis for Medicare coverage of therapy services was an expectation of improvement in the patient’s function. In 2013, a court case settlement known as the Jimmo Settlement Agreement clarified that “the Medicare program covers skilled nursing care and skilled therapy services under Medicare’s skilled nursing facility, home health, and outpatient therapy benefits when a beneficiary needs skilled care in order to maintain function or to prevent or slow decline or deterioration (provided all other coverage criteria are met).” However, this was taking a while to sink in so the case went back to court in 2017 and the court again confirmed there is no improvement standard for therapy services. The 2017 decision resulted in a CMS webpage dedicated to Jimmo including a corrective statement disavowing the improvement standard and further clarification with a listing of frequently asked questions (FAQs) and other resources. There were also national calls and training for contractors making coverage decisions.

It is interesting and amusing to note that all the Medicare “clarifications” insist this is not a policy change, but is consistent with Medicare’s longstanding policy. They do admit however, “the Jimmo Settlement Agreement may reflect a change in practice for those providers, adjudicators, and contractors who may have erroneously believed that the Medicare program covers nursing and therapy services under these benefits only when a beneficiary is expected to improve.”

Section 220 (Coverage of Outpatient Rehabilitative Therapy Services) of Chapter 15 of the Medicare Benefit Policy manual was revised in response to the Jimmo settlement and includes this statement, “Skilled therapy services may be necessary to improve a patient’s current condition, to maintain the patient’s current condition, or to prevent or slow further deterioration of the patient’s condition.” The manual now specifically includes separate sections for Rehabilitative Services and Maintenance Programs. Rehabilitative therapy addresses recovery or improvement in function with restoration to a previous level of health and well-being when possible. Maintenance programs are to maintain functional status or to prevent or slow further deterioration in function. The key to coverage for both types of services is that they must require the specialized skill, knowledge and judgment of a qualified therapist and meet all other Medicare therapy coverage requirements.

Last month, Noridian JE published a new coverage article for Maintenance Programs effective August 31, 2018 that is again a clarification regarding outpatient therapy services and maintenance programs. The article states, “Maintenance programs are developed to:

1. Maximize the patient's rehabilitation potential;
2. Assure patient safety;
3. Train the patient, family member and/or unskilled staff in home maintenance activities;
4. Prevent further decline in the patient's condition.”

The article also makes it clear that once services in a maintenance program can be safely and effectively furnished by non-skilled personnel without the supervision of a qualified professional, the need for coverage of skilled therapy is over. At that point, the patient should be discharged from therapy.

The Jimmo FAQs discuss that specific documentation is not an element of coverage, but documentation is the means to support that skilled services were indeed necessary. The Noridian article requires clear documentation of:

• Focus on establishing or revising an individualized maintenance program,
• The change in the patient’s status/condition that justifies skilled intervention, and
• Services requiring a skilled level of care.

Documentation should include specific goals for the patient that make it clear what benefit to the patient is expected from the therapy, especially since it is not an improvement in function. Documentation should explain why a therapist is needed – this may relate to specifics of the patient’s condition or patient safety that could not be addressed by non-skilled personnel. When documenting, therapists should think about the story they want to tell about their patient’s limitations, that patient’s need for their specific skills, and the benefit those skills will bring to the patient.

My elderly father was a perfect candidate for this type of therapy services. He has multiple conditions that limit his mobility and function for which a maintenance exercise program would benefit him. Because of his conditions, the skills of a therapist were required to establish a program and to initially ensure proper performance of the program. Once the program was established and taught, my dad and his caregiver were able to continue the program safely and effectively without the supervision of the therapist. I did not see the home health therapist’s documentation, but hopefully it explained the goals were to establish a home exercise program to prevent or slow further decline in function and mobility. The skills of a therapist were required because of multiple conditions affecting strength, function, and cognition; a high fall risk; and the need for specific strengthening exercises performed properly. Patient would be discharged once he could safely and properly perform the program alone or with non-skilled assistance.

To clarify (yet again), therapy services can be covered by Medicare even if there is no expectation of improvement in the patient’s function. The services must require the skills of a therapist to safely and effectively develop and/or perform the maintenance program. Once the patient or non-skilled personnel can perform the maintenance program, the services are no longer covered.