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.

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.

There is a lot going on this time of year. Students have been back in school for almost a month. Halloween decorations are already popping up in the stores. The SEC 2018 football season “kicks off” in three days on Saturday September 1st and, wait for it, it is thirty-three days until the start of the CMS 2019 Fiscal Year on October 1st.

As for struggles with homework, what new Halloween decorations you may need and what time your team is playing, I will leave that up to you to decide. As for the new CMS Fiscal Year, this article winds down our series of articles focusing on the 2019 IPPS Final Rule. If you will, this article begins with a Meaningful Measures Initiative pre-game show, and then provides four quarters of excitement with a high level review of finalized proposals for the Hospital Inpatient Quality Reporting Program and the three programs CMS views as a collective set of hospital value-based programs (the Hospital Value Based Purchasing Program, Hospital Acquired Conditions Reduction Program, and Hospital Readmission Reduction Program). 

Meaningful Measures Initiative

CMS launched the Meaningful Measures Initiative in October 2017 to “reduce” the regulatory burden on the healthcare industry, lower health care costs, and enhance patient care.” The aim of this Initiative is to identify “the highest priority areas for quality measurement and quality improvement in order to assess the core quality of care issues that are most vital to advancing our work to improve patient outcomes.”

According to the CMS Meaningful Measures Hub this Initiative “is not intended to replace any existing programs, but will help identify and select individual measures. Meaningful Measure areas are intended to increase measure alignment across CMS programs and other public and private initiatives. Additionally, it will point to high priority areas where there may be gaps in available quality measures while helping guide CMS’s effort to develop and implement quality measures to fill those gaps.”

Hospital Inpatient Quality Reporting (IQR) Program

The Hospital IQR Program is a pay-for-reporting quality program established by the Medicare Prescription Drug, Improvement, and Modernization Act of 2003. FY 2019 Proposals for the IQR Program are a result of CMS conducting an overall review of the Program under the “Meaningful Measures Initiative.” Current IQR Program measures were evaluated in the context of measures used in the Hospital Value Based Purchasing Program, Hospital Acquired Conditions Reduction Program and the Hospital Readmissions Reduction Program.

New “Measure Removal Factor”

Currently there are seven previously adopted “Removal Factors” that are taken into consideration when making the decision to remove a measure. CMS finalized the proposal to add the following factor:

• Factor 8: The costs associated with a measure outweigh the benefit of its continued use in the program. Note: CMS has clarified that using this factor would be on a case-by-case basis and provides the example of deciding “to retain a measure that is burdensome for health care providers to report if we conclude that the benefit to beneficiaries justifies the reporting burden.”

Removal of Hospital IQR Program Measures

CMS finalized their proposal to remove a total of 39 measures from across Fiscal Years (FYs) 2020, 2021, 2022, and 2023 payment determinations, with some modifications. In general, measures proposed for removal were due to the measure being duplicative of a measure in another program (i.e. Value Based Purchasing Program) or the cost of the measure outweighing the benefit of its continued use. A table summarizing the measures finalized for removal from the IQR Program can be found on page 41575-41577 of the Federal Register/Vol 83, No. 160 / Friday, August 17, 2018 / Rules and Regulations.

Hospital Value Based Purchasing (VBP) Program

The Hospital VBP Program is a budget neutral program. This program is funded by reducing the base operating DRG payment amount for a hospital for each discharge in a fiscal year by an applicable percent to fund this program. The applicable percent for FY 2019 and subsequent years is 2.00 percent. CMS estimates the total amount available for value-based incentive payments for FY 2019 to be approximately $1.9 billion.

CMS believes as part of their “holistic quality payment program strategy” that this Program should continue to focus on measures related to:  

• Clinical Outcomes (i.e. mortality and complications),
• Patient and Caregiver Experience (i.e. HCAHPS survey),
• Healthcare costs (i.e. Medicare Spending per Beneficiary measure).

Retention and Removal of Quality Measures

CMS finalized their proposal “to revise our regulations at 42 CFR 412.164(a) to clarify that once we have complied with the statutory prerequisites for adopting a measure for the Hospital VBP Program (that is, we have selected the measure from the Hospital IQR Program measure set and included data on that measure on Hospital Compare for at least one year prior to its inclusion in a Hospital VBP Program performance period), the Hospital VBP statute does not require that the measure continue to remain in the Hospital IQR Program.”

This finalized proposal is part of CMS’ efforts to evaluate and streamline regulations and specifically “would reduce costs…by allowing us to remove duplicative measures from the Hospital IQR Program that are retained in the Hospital VBP Program.”

Program “Measure Removal Factors”

CMS finalized their proposal to adopt for the Hospital VBP Program the current Hospital IQR Program measure removal factors used to determine whether to remove a program measure. They also finalized the following two scenarios for removing a measure:

• When the costs associated with a measure outweigh the benefit of its continued use in the program (Removal Factor 8), or
• When CMS believes the continued use of a measure poses specific patient safety concerns, they can promptly remove the measure without rulemaking and notify hospitals and the public of the removal of the measure along with the reason for its removal through routine communications channels.

Measures Finalized for Removal from the VBP Program

CMS efforts to review existing VBP Program measures “to identify how to reduce costs and complexity across programs while continuing to incentivize improvement in the quality and value of care provided to patients” resulted in ten measures being proposed for removal from the VBP Program.

Many commenters did not support the proposal to remove the five Healthcare-Associated Infection (HAI) measures and Patient Safety and Adverse Events (Composite) (PSI 90) because they “believe patient safety measures should remain in all payment programs to sufficiently incentivize continued improvement on these measures and prioritize practices that ensure safe care.” CMS agreed and did not remove these six patient safety measures that are also in the Hospital-Acquired Condition Reduction program measure set due to their critical importance to quality improvement and patient safety in the hospital setting.  The following table includes the four measures finalized for removal from the VBP Program.

Additional information about the VBP Program can be found on the CMS Hospital VBP webpage. 

Hospital Acquired Conditions (HAC) Reduction Program

The HAC Reduction Program requires payments be adjusted to hospitals ranking in the worst-performing quartile with respect to the risk-adjusted HAC quality measures. This group of hospitals are subject to a 1 percent payment reduction.

This Program “focuses on patient safety measures, which address the Meaningful Measures Initiative quality priority of making care safe by reducing harm caused in the delivery of care.” Per CMS, “measures in the HAC Reduction Program, generally represent “never events” and often, if not always, assess preventable conditions. By including these measures in the Program, we seek to encourage hospitals to address the serious harm caused by these adverse events and to reduce them.”

 

CMS finalized the following policies specific to the HAC Reduction Program:

• Adopt administrative processes to receive and validate National Healthcare Safety Network (NHSN) Healthcare-Associated Infection (HAI) data that is submitted by hospitals to the Centers for Disease Control and Prevention (CDC) beginning CY 2020
• Adjust the scoring methodology by removing domains and assigning equal weighting to each measure for which a hospital has a measure score in order to improve fairness across hospital types in the Program; and
• Established the data collection period for the FY 2021 Program Year.

Additional information about this program can be found on the CMS HAC Reduction Program webpage.  

Hospital Readmissions Reduction Program (HRRP)

The HRRP “focuses on care coordination measures, which address the quality priority of promoting effective communication and care coordination within the Meaningful Measures Initiative.”

A hospital can be penalized by up to 3 percent for excess hospital readmissions in the following six clinical conditions:

• Acute Myocardial Infarction (AMI),
• Heart Failure (HF),
• Pneumonia (PN),
• Total Hip Arthroplasty/Total Knee Arthroplasty (THA/TKA),
• Chronic Obstructive Pulmonary Disease (COPD); and
• Coronary Artery Bypass Graft (CABG) Surgery.

Applicable Periods for FY 2019, FY 2020, and FY 2021

The HRRP Applicable Period is defined “as the 3-year period from which data are collected in order to calculate excess readmissions ratios and payment adjustment factors for the fiscal year, which includes aggregate payments for excess readmissions and aggregate payments for all discharges used in the calculation of the payment adjustment.” The following table outlines the Finalized “Applicable Periods” for FY 2019, FY 2020, and FY 2021.

The FY 2019 readmissions payment adjustment factors were not available at the time the Final Rule was released. CMS notes that after hospitals have been given time to review their hospital-specific data, they  will post Table 15 (via the Internet on the CMS website) to display the final FY 2019 readmissions payment adjustment factors that will be applicable for discharges occurring on or after October 1, 2018. CMS expects this table to be posted in the fall of this year.

Additional information about this program can be found on the CMS HRRP webpage.

While admittedly not as exciting as a football game in the deep South, for hospitals this information is definitely part of the play book for what is to come in the 2019 IPPS Fiscal Year. 

“Progress is impossible without change, and those who cannot change their minds cannot change anything.”
- George Bernard Shaw

This week’s article in our 2019 IPPS Final Rule series highlights finalized changes to MS-DRG Classifications, the complication or comorbidity (CC) list and the major complication or comorbidity (MCC) list. At least annually, DRG classifications and relative weights are adjusted to reflect changes in treatment patterns, technology, and other factors that may change the relative use of hospital resources.

Pre-MDC

Heart Transplant or Implant of Heart Assist Program

In the FY 2018 IPPS Final Rule, CMS stated their intent to review the ICD-10 logic for Pre-MDC MS-DRGs 001 and 002 (Heart Transplant or Implant of Heart Assist System with and without MCC, respectively), as well as MS-DRG 215 (Other Heart Assist System Implant) and MS-DRGs 268 and 269 (Aortic and Heart Assist Procedures Except Pulsation Balloon with and without MCC, respectively) where procedures involving heart assist devices are currently assigned.

MS-DRGs 001 and 002 (Heart Transplant or Implant of Heart Assist System with and without MCC, respectively)

Currently data shows differences in the average length of stay and average costs for cases in Pre-MDC MS-DRGs 001 and 002 according to the type of procedure, type of device, and the approach utilized. Commenters agreed with CMS that available claims data doesn’t reflect recent advice published in Coding Clinic for ICD-10-CM/PCS regarding the coding of procedures involving external heart assist devices or recent changes to ICD-10-PCS codes for these procedures. At this time CMS is maintaining the current structure of Pre-MDC MS-DRGs 001 and 002 for FY 2019 and plans to continue to analyze claims data for consideration of future modifications.

MS-DRG 215 (Other Heart Assist System Implant)

CMS stated in the FY 2018 IPPS Final Rule that they are aware of Coding Clinic advice clarifying coding and reporting for certain external heart assist devices due to the technology being approved for new indications and current claims data does not reflect the updated guidance. They also noted recent updates to descriptions of the codes for heart assist devices in the past year and provide the example qualifier “intraoperative” being added effective October 1, 2017 (FY 2018). For these reasons CMS finalized their proposal to not to make any modification to MS-DRG 215 for FY 2019.

Percutaneous ECMO: New Codes

There was a request for CMS to review claims data for procedures involving Extracorporeal Membrane Oxygenation (ECMO) in combination with the insertion of a percutaneous short-term external heart assist device to determine if the current MS-DRG assignment is appropriate. CMS indicated that “Our clinical advisors agree that until there is a way to specifically identify percutaneous ECMO in the claims data to enable further analysis, a proposal at this time is not warranted.”

It just so happens that the FY 2019 ICD-10-PCS procedure code files include new ICD-10-PCS procedure codes identifying percutaneous ECMO procedures. Additionally, the current code for ECMO procedures (ICD-10-PCS code 5A15223) has been revised. New codes effective October 1, 2018 include:  

CMS notes the new codes were not finalized at the time of the Proposed Rule. Consistent with CMS’s annual process of assigning new procedure codes to MDCs and MS-DRGs, and designating a procedure as an O.R. or non-O.R. procedure, CMS reviewed the predecessor procedure code assignments. “The predecessor procedure code (ICD-10-PCS code 5A15223) for the new percutaneous ECMO procedure codes describes an open approach which requires an incision along the sternum (sternotomy) and is performed for open heart surgery. It is considered extremely invasive and carries significant risks for complications, including bleeding, infection and vessel injury.”

“Percutaneous (peripheral) ECMO does not require a sternotomy and can be performed in the intensive care unit or at the bedside.” The new procedure codes for percutaneous ECMO procedures have been designated as non-O.R. procedures that will affect the MS-DRG assignment for specific medical MS-DRGs. Effective October 1, 2018, MS-DRGs for which the percutaneous ECMO procedure will affect MS-DRG assignment are in the following table, along with the revised MS-DRG titles.

Note: “In cases where a percutaneous external heart assist device is utilized, in combination with a percutaneous ECMO procedure, effective October 1, 2018, the ICD-10 MS-DRG Version 36 GROUPER logic results in a case assignment to MS-DRG 215 because the percutaneous external heart assist device procedure is designated as an O.R. procedure and assigned to MS-DRG 215.”

 

Brachytherapy

Commenter Request: “We received a request to create a new Pre-MDC MS–DRG for all procedures involving the CivaSheet® technology, an implantable, planar brachytherapy source designed to enable delivery of radiation to the site of the cancer tumor excision or debulking, while protecting neighboring tissue…Currently, procedures involving the CivaSheet® technology are reported using ICD–10–PCS Section D—Radiation Therapy codes, with the root operation ‘‘Brachytherapy.’’ These codes are non-O.R. codes and group to the MS–DRG to which the principal diagnosis is assigned.”

CMS Response: Claims analysis only identified 4 cases. CMS maintained their proposal to not create a new Pre-MDC MS-DRG for procedures involving the CivaSheet® technology for FY 2019.

 

Laryngectomy

Pre-MDC MS-DRGs 11, 12 and 13 (Tracheostomy for Face, Mouth and Neck Diagnoses with MCC, with CC, and without CC/MCC, respectively)

Current logic for case assignment to MS-DRGs 11, 12 and 13:  

• Tracheostomies must be reported with a principal diagnosis code involving the face, mouth, or neck to satisfy the logic for assignment to Pre-MDC MS-DRGs 11, 12, or 13.
• Laryngectomies reported with any principal diagnosis code will satisfy the logic for assignment to Pre-MDC MS-DRGs 11, 12, or 13.

 

CMS finalized the following proposals specific to MS-DRGs 11, 12 and 13:

• Reorder the lists of the diagnosis and procedure codes. The list of principal diagnosis codes for face, mouth, and neck would be sequenced first, followed by the list of the tracheostomy procedure codes and, lastly, the list of laryngectomy procedure codes.
• Revise the titles of Pre-MDC MS–DRGs 11, 12, and 13 from ‘‘Tracheostomy for Face, Mouth and Neck Diagnoses with MCC, with CC and without CC/MCC, respectively’’ to ‘‘Tracheostomy for Face, Mouth and Neck Diagnoses or Laryngectomy with MCC’’, ‘‘Tracheostomy for Face, Mouth and Neck Diagnoses or Laryngectomy with CC’’, and ‘‘Tracheostomy for Face, Mouth and Neck Diagnoses or Laryngectomy without CC/MCC’’, respectively, to reflect that laryngectomy procedures may also be assigned to these MS–DRGs.

Chimeric Antigen Receptor (CAR) T-Cell Therapy

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

Two CAR T-cell therapy drugs received FDA approval in 2017 (KYMRIAH™ manufactured by Novartis Pharmaceuticals Corporation and YESCARTA™ manufactured by Kite Pharma, Inc.). Current ICD-10-PCS procedures codes involving the CAR T-cell therapy drugs includes:

• XW033C3 (Introduction of engineered autologous chimeric antigen receptor t-cell immunotherapy into peripheral vein, percutaneous approach, new technology group 3), and
• XW043C3 (Introduction of engineered autologous chimeric antigen receptor t-cell immunotherapy into central vein, percutaneous approach, new technology group 3).

Both codes became effective October 1, 2017. Procedures described by these two ICD–10–PCS procedure codes are designated as non-O.R. procedures that have no impact on MS–DRG assignment.

 

CMS notes their “clinical advisors believe that patients receiving treatment utilizing CAR T-cell therapy procedures would have similar clinical characteristics and comorbidities to those seen in cases representing patients receiving treatment for other hematologic carcinomas who are treated with autologous bone marrow transplant therapy that are currently assigned to MS–DRG 016 (Autologous Bone Marrow Transplant with CC/MCC). Therefore, CMS finalized their proposals to:

• Assign ICD-10-PCD procedure codes XW033CS and XW043C3 to Pre-MDC MS-DRG 016 for FY 2019, and
• Revise the title of MS-DRG 016 from “Autologous Bone Marrow Transplant with CC/MCC” to “Autologous Bone Marrow Transplant with CC/MCC or T-cell Immunotherapy.”

In addition to a new MS-DRG assignment and MS-DRG title revision, both manufacturers of CAR T-cell therapy submitted applications and were approved for new technology add-on payments for FY 2019.

MDC 1: Diseases and Disorders of the Nervous System

Epilepsy with Neurostimulator

In the FY 2018 IPPS/LTCH PPS Final Rule, CMS finalized their proposal “to reassign all cases reporting a principal diagnosis of epilepsy… and one of the following ICD-10-PCS code combinations, which captures cases involving neurostimulator generators inserted into the skull (including cases involving the use of the RNS© neurostimulator), to retitled MS-DRG 023 (Craniotomy with Major Device Implant or Acute Complex Central Nervous System (CNS) Principal Diagnosis (PDX) with MCC or Chemotherapy Implant or Epilepsy with Neurostimulator), even if there is no MCC reported:”

• 0NH00NZ (Insertion of neurostimulator generator into skull, open approach), in combination with 00H00MZ (Insertion of neurostimulator lead into brain, open approach);
• 0NH00NZ (Insertion of neurostimulator generator into skull, open approach), in combination with 00H03MZ (Insertion of neurostimulator lead into brain, percutaneous approach); and
• 0NH00NZ (Insertion of neurostimulator generator into skull, open approach), in combination with 00H04MZ (Insertion of neurostimulator lead into brain, percutaneous endoscopic approach).

CMS agreed with a requestor and finalized the proposal to add the following two codes representative of epilepsy diagnoses to the listing of epilepsy diagnosis codes for cases assigned to MS-DRG 023:

• G40.109 (Localization-related (focal) (partial) symptomatic epilepsy and epileptic syndromes with simple partial seizures, not intractable, without status epilepticus); and
• G40.111 (Localization-related (focal) (partial) symptomatic epilepsy and epileptic syndromes with simple partial seizures, intractable, with status epilepticus).

MDC 5: Diseases and Disorders of the Circulatory System

Pacemaker Insertions

CMS finalized all four proposals specific to pacemaker insertions:  

• First, “to recreate pairs of procedure code combinations involving both the insertion of a pacemaker device with the insertion of a pacemaker lead to act as procedure code combination pairs or ‘‘clusters’’ in the GROUPER logic that are designated as O.R. procedures outside of MDC 5 when reported together.”
• Second, “to designate all the procedure codes describing the insertion of a pacemaker device or the insertion of a pacemaker lead as non-O.R. procedures when reported as a single, individual stand-alone code based on the recommendation of our clinical advisors.”
• Third, “maintain the current GROUPER logic for MS-DRGs 258 and 259 (Cardiac Pacemaker Device Replacements with MCC and without MCC, respectively) where the listed procedure codes as shown in the ICD-10 MS-DRG Definitions Manual Version 35…describing a pacemaker insertion, continue to be designated as “non-O.R. affecting the MS-DRG” because they are reported when a pacemaker device requires replacement and have a corresponding diagnosis from MDC 5.”
• Fourth, “maintain the current GROUPER logic for MS–DRGs 260, 261, and 262 (Cardiac Pacemaker Revision Except Device Replacement with MCC, with CC, and without CC/MCC, respectively) so that cases reporting any one of the listed ICD–10–PCS procedure codes as shown in the ICD–10 MS–DRG Definitions Manual Version 35 describing procedures involving pacemakers and related procedures and associated devices will continue to be assigned to those MS–DRGs under MDC 5 because they are reported when a pacemaker device requires revision and they have a corresponding circulatory system diagnosis.

 

CMS also sought public comment on a couple of issues specific to pacemakers. First, they questioned if procedure codes currently designated as O.R. Procedure codes and are assigned to MS-DRGs 260, 261, and 262 under MDC 5 describing the removal or revision of a cardiac lead and removal or revision of a cardiac rhythm related (pacemaker) device should also be designated as non-O.R. procedure codes for FY 2019 when reported as a single, individual stand-alone code with a principal diagnosis outside of MDC 5 for consistency in the classification among these devices. CMS agreed with a commenter “that the removal or revision of a cardiac lead or pacemaker generator can be more complex and require greater resources than an initial insertion procedure.” Therefore, CMS is maintaining the O.R. designation for the codes listed in the following table.

The second request for comment was to ask whether procedure codes describing the insertion and revision of intra-cardiac or “leadless” pacemakers should also be considered for classification into all surgical unrelated MS-DRGs outside of MDC 5 for FY 2019. CMS notes in the Final Rule that they are maintaining the O.R. designation of the procedure codes and have indicated they will continue to analyze these procedures as additional claims data become available.

 

Drug-Coated Balloons in Endovascular Procedures

In FY 2018 the new technology add-on payments for the LUTONIX® and IN.PACT™ Admiral™ drug-coated balloon (DCB) technologies were discontinued. CMS received a request to reassign cases that utilize a DCB in the performance of an endovascular procedure involving the treatment of superficial femoral arteries for peripheral arterial disease from the lower severity level MS-DRG 254 (Other Vascular Procedures without CC/MCC) and MS-DRG 253 (Other Vascular Procedures with CC) to the highest severity level MS-DRG 252 (Other Vascular Procedures with MCC). CMS data analysis results and clinical advisors do not support reassigning these cases.

MDC 6: Diseases and Disorders of the Digestive System

Benign Lipomatous Neoplasm of Kidney (D17.71)

From a commenters request and their own review, CMS identified a replication issue from ICD-9-CM to ICD-10-CM for codes D17.71 and D17.72 (benign lipomatous neoplasm of other genitourinary tract organ) and therefore finalized the reassignment of both codes. The following table highlights the current MDC and MS-DRG assignment and the new MDC and MS-DRG assignment that will be effective October 1, 2018.

The following table compares the Relative Weight (RW), Geometric Mean Length of Stay (GMLOS), Arithmetic Mean Length of Stay (AMLOS) and National Average Payment Rate for ICD-10-CM diagnosis codes D17.71 and D17.72 current MS-DRG assignment and Finalized MS-DRG assignment effective October 1, 2018. The table highlights the fact that in general the Finalized MS-DRGs assignments have a higher RW, LOS and National Payment Rate.

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Bowel Procedures

There was a request made to reassign eight procedure codes describing repositioning of the colon and takedown of end colostomy from MS-DRGs 344, 345, and 346 (Minor Small and Large Bowel Procedures with MCC, with CC, and without CC/MCC, respectively) to MS-DRGs 329, 330, and 331 (Major Small and Large Bowel Procedures with MCC, with CC, and without CC/MCC respectively). Based on data analysis CMS felt that the codes were best aligned with those in MS-DRGs 344, 345, and 346.

In their analysis of MS-DRGs 329, 330, and 331 CMS also examined a subset of cases reporting one of the following bowel procedures as the only O.R. procedure:

• 0DQK0ZZ: Repair ascending colon, open approach.
• 0DQK4ZZ: Repair ascending colon, percutaneous endoscopic approach.
• 0DQL0ZZ: Repair transverse colon, open approach.
• 0DQL4ZZ: Repair transverse colon, percutaneous endoscopic approach.
• 0DQM0ZZ: Repair descending colon, open approach.
• 0DQM4ZZ: Repair descending colon, percutaneous endoscopic approach.
• 0DQN0ZZ: Repair sigmoid colon, open approach.
• 0DQN4ZZ: Repair sigmoid colon, percutaneous endoscopic approach.
• 0DSB0ZZ: Reposition ileum, open approach.
• 0DSB4ZZ: Reposition ileum, percutaneous endoscopic approach.
• 0DSE0ZZ: Reposition large intestine, open approach.
• 0DSE4ZZ: Reposition large intestine, percutaneous endoscopic approach.

CMS noted that “this approach can be useful in determining whether resource use is truly associated with a particular procedure or whether the procedure frequently occurs in cases with other procedures with higher than average resource use.” Analysis showed that resources for these cases is more aligned with MS-DRGs 344, 345, and 346. CMS proposed to reassign the twelve codes to this group of MS-DRGs.

It was refreshing to read that commenters “noted that several questions and answers regarding these ICD-10-PCS procedure codes were published in Coding Clinic for ICD-10-CM/PCS between late 2016 and the end of 2017, and stated that because 2 full years of data were not available subsequent to publication of this advice, CMS’s analysis and proposed MS-DRG modifications may be based on unreliable data.” CMS agreed with commenters, did not finalize this proposal and plan to wait until further data is available before finalizing changes to the MS-DRG assignment for these bowel procedures.

MDC 8: Diseases and Disorders of the Musculoskeletal System and Connective Tissue

Spinal Fusion

CMS announced in the FY 2018 Final Rule their plans to review the ICD-10 logic for MS-DRGs where procedures involving spinal fusion are currently assigned. CMS did not propose any changes to the MS-DRGs involving spinal fusion for FY 2019. However, in response to a commenter’s suggestions and findings they do provide results from their data analysis.

As a background to this issue, procedure codes describing a spinal fusion with a device value “Z” represents “No Device” for the 6th character in the code. “Because a spinal fusion procedure always requires some type of device (for example, instrumentation with bone graft or bone graft alone) to facilitate the fusion of vertebral bones, these codes are considered clinically invalid.” Ninety-nine procedure codes describing a spinal fusion with a device value “Z” were proposed for deletion at the September 12, 2017 ICD-10-Coordination and Maintenance Committee meeting. Commenters supported this proposal and also supported the deletion of other procedure codes describing fusion of body sites other than the spine. A total of 213 procedure codes describing fusion of a specific body part with a device value “Z” are being deleted effective October 1, 2018 (FY 2019).

CMS data analysis found that invalid spinal fusion procedures represented approximately 12 percent of all discharges across the spinal fusion MS-DRGs from the September 2017 update of the FY 2017 MedPAR file. “Because these procedure codes describe clinically invalid procedures, we would not expect these codes to be reported on any claims data…It is unclear why providers assigned procedure codes for spinal fusion procedures with the device value ‘‘Z’’ No Device. Our analysis did not examine whether these claims were isolated to a specific provider or whether this inaccurate reporting was widespread among a number of providers.”

CMS plans to continue to monitor claims noting that due to the timing of when the procedure codes become invalid “It would be premature to propose any MS-DRG modifications for spinal fusion procedures. Possible MS-DRG modifications may include taking into account the approach that was utilized in performing the spinal fusion procedure (for example, open versus percutaneous).”

MDC 9: Diseases and Disorders of the Skin, Subcutaneous Tissue and Breast

Cellulitis with Methicillin Resistant Staphylococcus Aureus (MRSA) Infection

A request was made to reassign ICD-10-CM diagnosis codes reported with a primary diagnosis of cellulitis and a secondary diagnosis code of B95.62 (Methicillin resistant Staphylococcus aureus infection as the cause of diseases classified elsewhere) or A49.02 (Methicillin resistant Staphylococcus aureus infection, unspecific site). Specifically reassign the codes from the current MS-DRGs 602 and 603 (Cellulitis with MCC and with MCC, respectively) in MDC 9 to MS-DRG 867 (Other infectious and Parasitic Diseases Diagnoses with MCC). Through data analysis, CMS believes these cases are more clinically aligned where they are currently assigned and finalized their proposal to maintain the current MS-DRG classification for cases reported with ICD-10-CM diagnosis codes B95.62 and A49.02 when reported as secondary diagnoses with a principal diagnosis of cellulitis.  

MDC 10: Endocrine, Nutritional and Metabolic Diseases and Disorders

Acute Intermittent Porphyria

A request was made to revise the MS-DRG classification for cases of patients diagnosed with porphyria and reported with ICD-10-CM diagnosis code E80.21 (Acute intermittent (hepatic) porphyria). “Porphyria is defined as a group of rare disorders (“porphyria’s”) that interfere with the production of hemoglobin that is needed for red blood cells.” After data analysis, CMS did not propose to revise the current MS-DRG classification. In response to comments published in the Final Rule CMS did indicate “we are sensitive to the commenters’ concerns about access to treatment for beneficiaries who have been diagnosed with this condition. Therefore, as part of our ongoing, comprehensive analysis of the MS-DRGs under ICD-10, we will continue to explore mechanisms through which to address rare diseases and low volume DRGs.”

MDC 14: Pregnancy, Childbirth and the Puerperium

In the FY 2018 proposed and final rule, CMS recognized that MS-DRG logic involving a vaginal delivery is technically complex as a result of the requirements that must be met and solicited public comments on further refinement of the following four MS-DRGs

• MS-DRG 767: Vaginal Delivery with Sterilization and/or D&C,
• MS-DRG 768: Vaginal Delivery with O.R. Procedure Except Sterilization and/or D&C,
• MS-DRG 774: Vaginal Delivery with Complicating Diagnosis, and
• MS-DRG 775: Vaginal Delivery without Complicating Diagnosis.

CMS also sought comments on further refinements to the conditions defined as a complicating diagnosis for MS-DRG 774 and MS-DRG 781 (Other Antepartum Diagnoses with Medical Complications). CMS formed an internal workgroup comprised of clinical advisors that included physicians, coding specialists, and other IPPS policy staff that assisted in the review of the GROUPER logic for a vaginal delivery and complicating diagnoses. CMS also received clinical input from 3M/Health Information Systems (HIS) staff who are responsible for updating and maintaining the GROUPER program under a contract with CMS.

CMS finalized their proposal to delete 10 MS-DRGs and create 18 new MS-DRGs based on their efforts of consolidating specific conditions and concepts into the structure of existing logic and making additional modifications, such as adding severity levels. These changes are intended to:

• Address the vaginal delivery “complicating diagnosis” logic and the antepartum diagnoses with “medical complications” logic by adding severity level MS-DRGs,
• Simplify the vaginal delivery procedure logic by eliminating the extensive diagnosis and procedure code lists for several conditions that must be met for assignment to the vaginal delivery MS-DRGs.
• Respond to issue brought to their attention through public comments.

MS-DRGs Finalized for Deletion under MDC 14:

• MS–DRG 765 (Cesarean Section with CC/MCC);
• MS–DRG 766 (Cesarean Section without CC/MCC);
• MS–DRG 767 (Vaginal Delivery with Sterilization and/or D&C);
• MS–DRG 774 (Vaginal Delivery with Complicating Diagnosis);
• MS–DRG 775 (Vaginal Delivery without Complicating Diagnosis);
• MS–DRG 777 (Ectopic Pregnancy);
• MS–DRG 778 (Threatened Abortion);
• MS–DRG 780 (False Labor);
• MS–DRG 781 (Other Antepartum Diagnoses with Medical Complications); and
• MS–DRG 782 (Other Antepartum Diagnoses without Medical Complications).

New MS-DRGs Finalized to be added under MDC 14:

• Proposed new MS–DRG 783 (Cesarean Section with Sterilization with MCC);
• Proposed new MS–DRG 784 (Cesarean Section with Sterilization with CC);
• Proposed new MS–DRG 785 (Cesarean Section with Sterilization without CC/MCC);
• Proposed new MS–DRG 786 (Cesarean Section without Sterilization with MCC);
• Proposed new MS–DRG 787 (Cesarean Section without Sterilization with CC);
• Proposed new MS–DRG 788 (Cesarean Section without Sterilization without CC/MCC);
• Proposed new MS–DRG 796 (Vaginal Delivery with Sterilization/D&C with MCC);
• Proposed new MS–DRG 797 (Vaginal Delivery with Sterilization/D&C with CC);
• Proposed new MS–DRG 798 (Vaginal Delivery with Sterilization/D&C without CC/MCC);
• Proposed new MS–DRG 805 (Vaginal Delivery without Sterilization/D&C with MCC);
• Proposed new MS–DRG 806 (Vaginal Delivery without Sterilization/D&C with CC);
• Proposed new MS–DRG 807 (Vaginal Delivery without Sterilization/D&C without CC/MCC);
• Proposed new MS–DRG 817 (Other Antepartum Diagnoses with O.R. Procedure with MCC);
• Proposed new MS–DRG 818 (Other Antepartum Diagnoses with O.R. Procedure with CC);
• Proposed new MS–DRG 819 (Other Antepartum Diagnoses with O.R. Procedure without CC/MCC);
• Proposed new MS–DRG 831 (Other Antepartum Diagnoses without O.R. Procedure with MCC);
• Proposed new MS–DRG 832 (Other Antepartum Diagnoses without O.R. Procedure with CC); and
• Proposed new MS–DRG 833 (Other Antepartum Diagnoses without O.R. Procedure without CC/MCC).
  

CMS provides diagrams illustrating how the new MS-DRG logic for MDC 14 would function. These diagrams can be found on pages 255 and 257 of the Final Rule display copy.

Dilation and Curettage Procedures

CMS finalized their proposal to reassign ICD-10-PCS procedure codes 0UDB7ZX, 0UDB7ZZ, 0UDB8ZX, and 0UDB8ZZ describing dilation and curettage (D&C) procedures from MS-DRG 767 under MDC 14 to MS-DRGs 744 and 745 under MDC 13.

The following table compares the Relative Weight (RW), Geometric Mean Length of Stay (GMLOS), Arithmetic Mean Length of Stay (AMLOS) and National Average Payment Rate for ICD-10-CM procedure codes 0UDB7ZX, 0UDB7ZZ, 0UDB8ZX, and 0UDB8ZZ current and new MS-DRG assignment effective October 1, 2018. Similar to renal dialysis, this MS-DRG reassignment highlights the fact that the presence or absence of comorbidities and complications will now impact admissions for a D&C.  

‍MDC 18: Infectious and Parasitic Diseases, Systemic or Unspecified Sites

Systemic Inflammatory Response Syndrome (SIRS) of Non-Infectious Origin

ICD-10-CM codes R65.10 (Systemic Inflammatory Response Syndrome (SIRS) of non-infectious origin without acute organ dysfunction and R65.11 (Systemic Inflammatory Response Syndrome (SIRS) of non-infectious origin with acute organ dysfunction are currently assigned to the following three MS-DRGs:

• MS-DRG 870: Septicemia or Severe Sepsis with Mechanical Ventilation >96 Hours,
• MS-DRG 871: Septicemia or Severe Sepsis without Mechanical Ventilation >96 Hours with MCC, and
• MS-DRG 872: Septicemia or Severe Sepsis without Mechanical Ventilation >96 Hours without MCC.

In the Proposed Rule CMS’ Clinical Advisors noted that these two ICD-10-CM codes describe non-infectious conditions and recommended reassignment to a more clinically appropriate MS-DRG. Claims data analysis included cases in MS-DRGs 870, 871, and 872 with a principal diagnosis of R65.10 or R65.11. CMS noted the cases “appear to have been coded inaccurately according to the ICD-10-CM Official Guidelines for Coding and Reporting at Section I.C.18.g., which specifically state: “The syndrome (SIRS) can develop as a result of certain non-infectious disease processes, such as trauma, malignant neoplasm, or pancreatitis. When SIRS is documented with a non-infectious condition, and no subsequent infection is documented, the code for the underlying condition, such as an injury, should be assigned, followed by code R65.10, Systemic inflammatory response syndrome (SIRS) of noninfectious origin without acute organ dysfunction or code R65.11, Systemic inflammatory response syndrome (SIRS) of non-infectious origin with acute organ dysfunction.’’ Therefore, according to the Coding Guidelines, ICD–10–CM diagnosis codes R65.10 and R65.11 should not be reported as the principal diagnosis on an inpatient claim.” CMS finalized their proposal to reassign ICD-10-CM diagnosis codes R65.10 and R65.11 to MS-DRG 864: Fever and to revise the title of the MS-DRG to “Fever and Inflammatory Conditions.”  

The following table compares the Relative Weight (RW), Geometric Mean Length of Stay (GMLOS), Arithmetic Mean Length of Stay (AMLOS) and National Average Payment Rate for ICD-10-CM diagnosis codes R65.10 and R65.11 current and new MS-DRG assignment effective October 1, 2018. This table highlights the expectation that SIRS without infection takes fewer resources to treat and has a much shorter LOS.

MDC 14: Pregnancy, Childbirth and the Puerperium

In the FY 2018 proposed and final rule, CMS recognized that MS-DRG logic involving a vaginal delivery is technically complex as a result of the requirements that must be met and solicited public comments on further refinement of the following four MS-DRGs

• MS-DRG 767: Vaginal Delivery with Sterilization and/or D&C,
• MS-DRG 768: Vaginal Delivery with O.R. Procedure Except Sterilization and/or D&C,
• MS-DRG 774: Vaginal Delivery with Complicating Diagnosis, and
• MS-DRG 775: Vaginal Delivery without Complicating Diagnosis.

CMS also sought comments on further refinements to the conditions defined as a complicating diagnosis for MS-DRG 774 and MS-DRG 781 (Other Antepartum Diagnoses with Medical Complications). CMS formed an internal workgroup comprised of clinical advisors that included physicians, coding specialists, and other IPPS policy staff that assisted in the review of the GROUPER logic for a vaginal delivery and complicating diagnoses. CMS also received clinical input from 3M/Health Information Systems (HIS) staff who are responsible for updating and maintaining the GROUPER program under a contract with CMS.

CMS finalized their proposal to delete 10 MS-DRGs and create 18 new MS-DRGs based on their efforts of consolidating specific conditions and concepts into the structure of existing logic and making additional modifications, such as adding severity levels. These changes are intended to:

• Address the vaginal delivery “complicating diagnosis” logic and the antepartum diagnoses with “medical complications” logic by adding severity level MS-DRGs,
• Simplify the vaginal delivery procedure logic by eliminating the extensive diagnosis and procedure code lists for several conditions that must be met for assignment to the vaginal delivery MS-DRGs.
• Respond to issue brought to their attention through public comments.

MS-DRGs Finalized for Deletion under MDC 14:

• MS–DRG 765 (Cesarean Section with CC/MCC);
• MS–DRG 766 (Cesarean Section without CC/MCC);
• MS–DRG 767 (Vaginal Delivery with Sterilization and/or D&C);
• MS–DRG 774 (Vaginal Delivery with Complicating Diagnosis);
• MS–DRG 775 (Vaginal Delivery without Complicating Diagnosis);
• MS–DRG 777 (Ectopic Pregnancy);
• MS–DRG 778 (Threatened Abortion);
• MS–DRG 780 (False Labor);
• MS–DRG 781 (Other Antepartum Diagnoses with Medical Complications); and
• MS–DRG 782 (Other Antepartum Diagnoses without Medical Complications).

New MS-DRGs Finalized to be added under MDC 14:

• Proposed new MS–DRG 783 (Cesarean Section with Sterilization with MCC);
• Proposed new MS–DRG 784 (Cesarean Section with Sterilization with CC);
• Proposed new MS–DRG 785 (Cesarean Section with Sterilization without CC/MCC);
• Proposed new MS–DRG 786 (Cesarean Section without Sterilization with MCC);
• Proposed new MS–DRG 787 (Cesarean Section without Sterilization with CC);
• Proposed new MS–DRG 788 (Cesarean Section without Sterilization without CC/MCC);
• Proposed new MS–DRG 796 (Vaginal Delivery with Sterilization/D&C with MCC);
• Proposed new MS–DRG 797 (Vaginal Delivery with Sterilization/D&C with CC);
• Proposed new MS–DRG 798 (Vaginal Delivery with Sterilization/D&C without CC/MCC);
• Proposed new MS–DRG 805 (Vaginal Delivery without Sterilization/D&C with MCC);
• Proposed new MS–DRG 806 (Vaginal Delivery without Sterilization/D&C with CC);
• Proposed new MS–DRG 807 (Vaginal Delivery without Sterilization/D&C without CC/MCC);
• Proposed new MS–DRG 817 (Other Antepartum Diagnoses with O.R. Procedure with MCC);
• Proposed new MS–DRG 818 (Other Antepartum Diagnoses with O.R. Procedure with CC);
• Proposed new MS–DRG 819 (Other Antepartum Diagnoses with O.R. Procedure without CC/MCC);
• Proposed new MS–DRG 831 (Other Antepartum Diagnoses without O.R. Procedure with MCC);
• Proposed new MS–DRG 832 (Other Antepartum Diagnoses without O.R. Procedure with CC); and
• Proposed new MS–DRG 833 (Other Antepartum Diagnoses without O.R. Procedure without CC/MCC).
  

CMS provides diagrams illustrating how the new MS-DRG logic for MDC 14 would function. These diagrams can be found on pages 255 and 257 of the Final Rule display copy.

Dilation and Curettage Procedures

CMS finalized their proposal to reassign ICD-10-PCS procedure codes 0UDB7ZX, 0UDB7ZZ, 0UDB8ZX, and 0UDB8ZZ describing dilation and curettage (D&C) procedures from MS-DRG 767 under MDC 14 to MS-DRGs 744 and 745 under MDC 13.

The following table compares the Relative Weight (RW), Geometric Mean Length of Stay (GMLOS), Arithmetic Mean Length of Stay (AMLOS) and National Average Payment Rate for ICD-10-CM diagnosis codes 0UDB7ZX, 0UDB7ZZ, 0UDB8ZX, and 0UDB8ZZ current and new MS-DRG assignment effective October 1, 2018. Similar to renal dialysis, this MS-DRG reassignment highlights the fact that the presence or absence of comorbidities and complications will now impact admissions for a D&C.  

‍MDC 18: Infectious and Parasitic Diseases, Systematic of Unspecified Sites

Systemic Inflammatory Response Syndrome (SIRS) of Non-Infectious Origin

ICD-10-CM codes R65.10 (Systemic Inflammatory Response Syndrome (SIRS) of non-infectious origin without acute organ dysfunction and R65.11 (Systemic Inflammatory Response Syndrome (SIRS) of non-infectious origin with acute organ dysfunction are currently assigned to the following three MS-DRGs:

• MS-DRG 870: Septicemia or Severe Sepsis with Mechanical Ventilation >96 Hours,
• MS-DRG 871: Septicemia or Severe Sepsis without Mechanical Ventilation >96 Hours with MCC, and
• MS-DRG 872: Septicemia or Severe Sepsis without Mechanical Ventilation >96 Hours without MCC.

In the Proposed Rule CMS’ Clinical Advisors noted that these two ICD-10-CM codes describe non-infectious conditions and recommended reassignment to a more clinically appropriate MS-DRG. Claims data analysis included cases in MS-DRGs 870, 871, and 872 with a principal diagnosis of R65.10 or R65.11. CMS noted the cases “appear to have been coded inaccurately according to the ICD-10-CM Official Guidelines for Coding and Reporting at Section I.C.18.g., which specifically state: “The syndrome (SIRS) can develop as a result of certain non-infectious disease processes, such as trauma, malignant neoplasm, or pancreatitis. When SIRS is documented with a non-infectious condition, and no subsequent infection is documented, the code for the underlying condition, such as an injury, should be assigned, followed by code R65.10, Systemic inflammatory response syndrome (SIRS) of noninfectious origin without acute organ dysfunction or code R65.11, Systemic inflammatory response syndrome (SIRS) of non-infectious origin with acute organ dysfunction.’’ Therefore, according to the Coding Guidelines, ICD–10–CM diagnosis codes R65.10 and R65.11 should not be reported as the principal diagnosis on an inpatient claim.” CMS finalized their proposal to reassign ICD-10-CM diagnosis codes R65.10 and R65.11 to MS-DRG 864: Fever and to revise the title of the MS-DRG to “Fever and Inflammatory Conditions.”  

The following table compares the Relative Weight (RW), Geometric Mean Length of Stay (GMLOS), Arithmetic Mean Length of Stay (AMLOS) and National Average Payment Rate for ICD-10-CM diagnosis codes R65.10 and R65.11 current and new MS-DRG assignment effective October 1, 2018. This table highlights the expectation that SIRS without infection takes fewer resources to treat and has a much shorter LOS.

‍Severity Level Changes

Complications and comorbidities (CCs) are conditions that, when present, lead to increased resource utilization. Major Complications and comorbidities (MCCs) reflect the highest level of severity. Both CCs and MCCs have the potential to impact MS-DRG assignment.

Here a few key changes made to MCC and CC ICD-10-CM diagnosis codes lists effective October 1, 2018:

• B20 (Human immunodeficiency virus [HIV] disease) has been reassigned from an MCC to a CC.  
• G93.40 (Encephalopathy, unspecified) has been reassigned from an MCC to a CC.
• J80 (Acute Respiratory Distress Syndrome) has been reassigned from a CC to an MCC.

The following table contains a group of ICD-10-CM codes discussed at the March 6, 2018 – March 7, 2018 ICD-10-CM/PCS Coordination and Maintenance Committee meeting that were not finalized in time to include in the proposed rule but will be added to the CC List effective October 1, 2018.

A complete list of the MCC and CC changes can be found in Final Rule tables 6I.1, 6I2, 6J.1 and 6J.2.

MMP has combined these lists into one pdf document so you can quickly see what has changed from MCC to CC, what has changed due to further specificity of a code or what is new. Click here to download this combined list

This week MMP continues our series of articles focusing on the 2019 IPPS/LTCH Final Rule. In a related CMS Fact Sheet, they note that this Final Rule further advances “the agency’s priority of creating a patient-centered healthcare system by achieving greater price transparency, interoperability, and significant burden reduction so that hospitals can operate with better flexibility and patients have what they need to be active healthcare consumers.”

Last week’s article focused on the change to the admission order requirement. CMS put the admission order change into the “variety of changes” that will result in “Burden Reduction” for hospitals. This week’s article focuses on the finalized payment rate changes for acute care hospitals, “transparency” through online posting of standard charges, and “Burden Reduction” through revisions to the Physician Certification requirement.

Payment Rate Changes for IPPS Participating Acute Care Hospitals

“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.”

“The increase in operating payment rates 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 is approximately 1.85 percent.” This first table details Payments Rates Finalized for FY 2016 through FY 2018 compared to the Finalized Rate 1.85 percent change for FY 2019.

Table 1: Operating Payment Rate Compare: Hospital Inpatient Quality Reporting & Meaningful EHR Users

This next table details the Market Basket and “other factors” accounted for in the payment rate updates. Keep in mind that this percentage is for Hospitals that successfully participate in the Hospital Inpatient Quality Reporting (IQR) and are Meaningful EHR users.

Table 2: Elements Used to Compute Operating Payment Rates

“CMS projects that the rate increase, together with other changes to IPPS payment policies, will increase Medicare spending on inpatient hospital services in FY 2019 by approximately $4.8 billion, including an increase in new technology add-on payments of $0.2 billion.” The projected increase in Medicare spending doubles the expected increase of $2.4 billion in FY 2018.

 

Transparency: Requirements for Hospitals to Make Public a List of Their Standard Charges via the Internet

Public Health Services Act

Section 2718 of the Public Health Services Act focuses on bringing down the cost of health care coverage. More specifically, Section 2718(e) is sub-titled Standard Hospital Charges and provides the following requirement:

“(e) Standard Hospital Charges – Each hospital operating within the United States shall for each year establish (and update) and make public (in accordance with guidelines developed by the Secretary) a list of the hospital’s standard charges for items and services provided by the hospital, including for diagnosis-related groups established under section 1886(d)(4) of the Social Security Act.”

2015 IPPS/LTCH Final Rule

In the FY 2015 IPPS/LTCH Final Rule (79 FR 50146), CMS reminded hospitals of their obligation to comply with provision 2718(e) of the Public Health Service Act and provided guidelines for its implementation.  

Guidelines

• Hospitals either make public a list of their standard charges (whether that be the chargemaster itself or in another form of their choice), OR
• Have a policy for allowing the public to view a list of those charges in response to an inquiry.

MedPAC suggested that hospitals be required to post the list on the internet. While CMS agreed posting a list on the internet would be one approach to satisfy the guidelines, they believed hospitals were in the best position to determine the manner and method to make the list public and did not make this a requirement.

CMS did encourage hospitals to undertake efforts to do the following:

• Engage in consumer friendly communication of their charges to help patients understand what their potential financial liability might be for services they obtain at the hospital, and
• Enable patients to compare charges for similar services across hospitals.

The expectation was that hospitals would update the information at least annually, or more often as appropriate, to reflect current charges. CMS ended this section of the 2015 Final Rule by stating “We are confident that hospital compliance with this statutory transparency requirement will improve the public accessibility of charge information. As hospitals continue to make data publicly available in compliance with section 2718(e) of the Public Health Service Act, we also will continue to review and post relevant charge data in a consumer friendly way, as we previously have done by posting on the CMS Web site the following hospital and physician charge information: May and June 2013 hospital charge data releases; 2013 physician data requests for information; and the April 2014 physician data releases and data provided on geographic variation in payments and payments per beneficiary.”

CMS maintains a Medicare Provider Utilization and Payment Data webpage on the CMS.gov website. Here you will find data across several settings (i.e., Hospital Inpatient and Outpatient, Home Health, Skilled Nursing Facilities and Physician Data).

2019 IPPS/LTCH Proposed Rule

In the 2019 IPPS/LTCH Proposed Rule CMS shared their concern “that challenges continue to exist for patients due to insufficient price transparency.” Specific challenges cited include:

• Patients being surprised by out-of-network bills for physicians, such as anesthesiologists and radiologist, who provide services at in-network hospitals.
• Patient being surprised by facility fees and physician fees for emergency department visits.

Another concern was “that chargemaster data are not helpful to patients for determining what they are likely to pay for a particular service or hospital stay. In order to promote greater price transparency for patients…we are considering ways to improve the accessibility and usability of the charge information that hospitals are required to disclose under section 2718(e) of the Public Health Service Act.”

As a first step, CMS acted upon MedPAC’s prior suggestion and effective January 1, 2019, hospitals will be required “to make available a list of their current standard charges via the Internet in a machine readable format and to update this information at least annually, or more often as appropriate. This could be in the form of the chargemaster itself or another form of the hospital’s choice, as long as the information is in machine readable format.”

2019 IPPS/LTCH Final Rule: Comments and CMS Responses

Comment: Some supported the update to the guidelines and indicated many hospitals already make their standard charges available voluntarily or under applicable State law.

CMS Response: CMS agreed many hospitals already make information available, “for example, the 2014 American Hospital Association State Transparency Survey data indicated that 35 States required hospitals to release information on some charges and 7 States relied on voluntary disclosure of charge data.”

Side note, in July 2014, the American Hospital Association released a Toolkit for Hospitals regarding Achieving Price Transparency for Consumers.

Comment: Commenters suggested that payers are a better source of information about the cost of care and should be the primary source of information for out of pocket costs and that CMS should require that insurance companies provide cost calculators or other tools to patients to calculate costs specific to their situation. This comment ended by noting that many uninsured patients receive free or discounted care through the hospital’s charity care policies.

CMS Response: With respect to the commenters who indicated that, for insured patients, payers are a better source of information about the cost of care and should be the primary source of information for out-of-pocket costs for patients, we note that nothing in our guidelines precludes hospitals and payers from working together to provide information on out-of-pocket costs for patients and to improve price transparency for patients. We also recognize that sometimes uninsured patients receive free or discounted care through a hospital’s charity care policies and again commend hospitals for those policies. Nothing in our guidelines precludes a hospital from providing charity care to uninsured patients.

CMS finalized their proposed update to the guidelines that effective January 1, 2019 hospitals will be required “to make available a list of their current standard charges via the Internet in a machine readable format and to update this information at least annually, or more often as appropriate.”

 

Burden Reduction: Physician Certification Changes

In a related article about the 2019 IPPS Final Rule, MMP reported that the proposed and finalized revision to the hospital inpatient admission orders documentation requirements did not include changes to the Physician Certification requirements. Specifically, CMS notes in the Final Rule that Physician certification of inpatient services continues to be a requirement for cases that are 20 inpatient days or more (long-stay cases), for outlier cases of hospitals other than inpatient psychiatric facilities, and for cases of Critical Access Hospitals as per the CY 2015 OPPS/AC final rule (79 FR 66997), and 42 CFR part 312, subpart F, 42 CFR 424.13, and 42 CFR 424.15.

Towards the end of the display copy of the Final Rule, page 2142, CMS discusses the revisions made to the Physician Certification and Recertification of Claims. Medicare regulations at 42 CFR 424.11 implements §1814(a) and 1835(a)(2) of the Act, specifying “the requirements for physician statements that certify and periodically recertify as to the medical necessity of certain types of covered services provided to Medicare beneficiaries.”

• §424.11 (c) “specifies that when supporting information for the required physician statement is available elsewhere in the records (for example, in the physician’s progress notes), the information need not be repeated in the statement itself. The last sentence of §424.11(c) further provides that it will suffice for the statement to indicate where the information is to be found.”

CMS notes as part of their initiative “to identify Medicare regulations that are unnecessary, obsolete, or excessively burdensome on health care providers and suppliers…we have been made aware that the provisions of §424.11(c)” which state that it will suffice for the statement to indicate where the information is to be found may be resulting in unnecessary denials of Medicare claims.”  

At the end of the day, “the medical record must contain adequate documentation of the relevant criteria for which the physician is providing certification and recertification” even when the exact location of this information is not noted on the Physician Certification. CMS notes “the precise location is becoming increasingly obsolete with the growing utilization of electronic health records (EHRs)—which, by their nature are readily searchable.”

CMS finalized their proposal to delete the last sentence of §421.11(c) and relocate the second sentence of §421.11(c) to the end of the immediately preceding paragraph (b).

Resources:

CMS 2019 IPPS/LTCH Final Rule Home Page: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/FY2019-IPPS-Final-Rule-Home-Page.html

CMS Fact Sheet Announcing Release of 2019 IPPS/LTCH Final Rule: https://www.cms.gov/Newsroom/MediaReleaseDatabase/Fact-sheets/2018-Fact-sheets-items/2018-08-02.html