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SBAR: TKA Outpatient Guidelines for Decision-Making Initiation and Feedback Phase Title: TKA Outpatient decision making Situation: SBAR was received by Orthopedic CEC requesting official communication on recommended guidelines when admission status is being determined for Medicare patients requiring a Total Knee Arthroplasty (TKA). Background: January 2018: CMS removed TKA from the In-Patient only list. This action then allows the procedure to be done as an outpatient as well. CMS does not allow TKA to be done in an ambulatory surgical center (ASC). CMS stated they did not expect a large volume of shift, but stated they expected hospitals to develop guidelines based on evidence and patient safety. CMS clearly states the decision on admission status is a very medically complex decision and is done by the medical team. Assessment: January 2018: guidelines were developed with a formally recognized team from several ministries across Trinity – health and were communicated to CMO/CNO, care management, finance, revenue excellence and surgical services. The team facilitating the development of the guidelines, although formally sanctioned, did not have the level of engagement and infrastructure as the current Orthopedic CEC. The CEC determined that the guidelines should be reviewed/revised and recommunicated across the Trinity Enterprise. Part of the council's assessment included the analysis of greater than 15 Trinity-Health ministries admission patterns since January 2018. Wide variation was found. Recommendation: The attached guideline should be communicated, available and serve as a reference to the enterprise in particular the admitting Orthopedic Surgeon when determining admission status for a TKA. Discussion should occur in all ministries performing TKA procedures. Thorough documentation must exist on the patients' health status and co-morbidities and risk for adverse event. Documents to cascade; Final Recommendation TKA outpatient 01.03.2018 TKA documentation 08.2018 References/ Citations: 2018 OPPS Final Rule TKR TH Commentary Kort, et.al. (2017) Patient selection criteria for outpatient joint arthroplasty. Knee Surg Sports Traumatol Arthrose 25:2668-2675 AAHKS TKA IPO Position Statement

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SBAR: TKA Outpatient Guidelines for Decision-Making Initiation and Feedback Phase Title: TKA Outpatient decision making Situation: SBAR was received by Orthopedic CEC requesting official communication on recommended guidelines when admission status is being determined for Medicare patients requiring a Total Knee Arthroplasty (TKA).

Background: January 2018: CMS removed TKA from the In-Patient only list. This action then allows the procedure to be done as an outpatient as well. CMS does not allow TKA to be done in an ambulatory surgical center (ASC). CMS stated they did not expect a large volume of shift, but stated they expected hospitals to develop guidelines based on evidence and patient safety. CMS clearly states the decision on admission status is a very medically complex decision and is done by the medical team.

Assessment: January 2018: guidelines were developed with a formally recognized team from several ministries across Trinity – health and were communicated to CMO/CNO, care management, finance, revenue excellence and surgical services. The team facilitating the development of the guidelines, although formally sanctioned, did not have the level of engagement and infrastructure as the current Orthopedic CEC. The CEC determined that the guidelines should be reviewed/revised and recommunicated across the Trinity Enterprise. Part of the council's assessment included the analysis of greater than 15 Trinity-Health ministries admission patterns since January 2018. Wide variation was found.

Recommendation: • The attached guideline should be communicated, available and serve as a reference

to the enterprise in particular the admitting Orthopedic Surgeon when determining admission status for a TKA.

• Discussion should occur in all ministries performing TKA procedures. • Thorough documentation must exist on the patients' health status and co-morbidities

and risk for adverse event. • Documents to cascade;

Final Recommendation TKA outpatient 01.03.2018 TKA documentation 08.2018

References/ Citations: 2018 OPPS Final Rule TKR TH Commentary Kort, et.al. (2017) Patient selection criteria for outpatient joint arthroplasty. Knee Surg Sports Traumatol Arthrose 25:2668-2675 AAHKS TKA IPO Position Statement

Final Decision and Action Planning Phase CEC Decision for Implementation:

1. Final Decision is to communicate newly revised guidelines that should be available to all Trinity health hospitals who perform Total Knee Arthroplasty.

2. Regional ICLT to communicate the standard to their functional teams and areas. 3. CEC to review outpatient volume data in March 2019.

Teams Actions When CMO Communicate the guidelines

and educational tool to Department of Orthopedics and Surgery. Medical Records and Patient registration

By November 30, 2018

CNO Ensure Orthopedic and Joint replacement caregivers and leaders are equipped with guidelines. Care Management

By November 30, 2018

Quality Quality leaders, chart auditors and other related departments and colleagues.

By November 30, 2018

MG PS Communicate to Orthopedic practices

By November 30, 2018

CIN/ACO Communicate to Orthopedic practices

By November 30, 2018

Submitted by: Jim Cronk, Director Ortho CEC; Mark Pinto, Medical Director Ortho CEC CEC/CLG/CSG: CEC Date October 1, 2018

RHM/Ministries data for the TKA Outpatient volume.

TKA IP OP Graphs

Created by:

Jim Cronk, R.N., M.S.A.

Director, Clinical Transformation, System Office

Reviewed by:

Orthopedic Clinical Excellence Council, Care Management, Compliance, Revenue compliance and CDI

September 2018

Total Knee Arthroplasty (TKA)Inpatient or Outpatient?

©2018 Trinity Health 1

• Effective January 1st 2018 the surgical procedure of Total Knee Arthroplasty (TKA) was removed from the CMS inpatient only list.

• Surgeons are now allowed to select, based on patient medical status and co-morbidities, whether the procedure is to be performed on an inpatient or outpatient basis. Documentation of medical status must be present.

“the decision regarding the most appropriate care setting for a given surgical procedure is a complex medical judgment made by the physician based on the beneficiary’s individual clinical needs and preferences.” 82 FR 52523

2©2018 Trinity Health

CMS allows TKA to be inpatient or outpatient

• Physicians who have patients who are optimized, have little-to-few co-morbidities and are not anticipated to be at risk, may be candidates for outpatient surgery.

• The health status of these patients should be well-documented to support the decision.

• Discharge should be anticipated prior to the second midnight or in 24-36 hours.

“We would expect that Medicare beneficiaries who are selected for outpatient TKA would be less medically complex cases with few comorbidities and would not be expected to require SNF care following surgery.” 82 FR 52524

3©2018 Trinity Health

Out-Patient status

“…we believe that the surgeons, clinical staff, and medical specialty societies who perform outpatient TKA and possess specialized clinical knowledge and experience are most suited to create such guidelines. Therefore, we do not expect to create or endorse specific guidelines or content for the establishment of providers’patientselection protocols.” 82 FR 52523

“We agree that the physician should take the beneficiaries’ need for post-surgical services into account when selecting the site of care to perform the surgery.” 82 FR 52524

4©2018 Trinity Health

CMS does not provide guidelines for patient selection

Considerations for exclusion as outpatient:• The conditions below need to be assessed carefully and if they place the patient

at increased risk for complications or adverse events during their post-surgical hospital stay then inpatient status should be considered.

- Hgb A1c > 7.5

- Solid Organ Transplant

- Chronic renal disease stage 3 or greater

- BMI greater than 40 with additional co morbidity/risks identified.

- Cardiopulmonary event in last year. (Acute MI, Stent placement, Acute CHF etc.)

- Sleep Apnea (OSA)

- Tobacco users not willing to utilize nicotine replacement therapy (patches, gum) and participate in smoking

abstinence.

- Bleeding disorders. Patients on chronic anticoagulation requiring post-surgical reimplementation of anticoagulants

such as Coumadin, Eliquis, Lovenox, heparin, Xarelto, Arixtra, Pradaxa)

5©2018 Trinity Health

Trinity Health Recommendations

Considerations for exclusion as outpatient (Cont.) :- Chronic Opioid consumption- Malnutrition: Total Lymphocytes <1,500 cells /mm. Albumin < 3.5g/dl. Transferrin level < 200mg/dl.

- ASA (anesthesia assessment score) of 4 or greater assessed by anesthesia. ASA 3 needs thorough assessment of patient's risks and comorbidities.

- Anemia. Baseline hgb. < 11

- HTN BP greater than 140/90 and on medications.

- COPD if on regularly scheduled medications and/or inhalers.

- Patients whose post-discharge needs may include skilled nursing facility placement or inpatient rehabilitation. Special consideration for those with disabilities (amputees, partial paralysis, and psychiatric illness), frail and elderly persons that have additional conditions that preclude them from caring for themselves and require skilled care in the early postoperative period that cannot be provided as an outpatient or in-home service.

- Cancer/Immunocompromised.\

- Positive MRSA screening with Vancomycin treatment.

- Patient's post-acute setting too great of distance from emergent medical care.

6©2018 Trinity Health

Trinity Health Recommendations

Consideration for Admission Status

Inpatient or outpatient?

©2018 Trinity Health 7

• If the physician expects his/her patient’s stay to span less than two midnights and there is no known anticipated risks, the patient should be considered for an outpatient TKA.

• If the patient’s anticipated hospital stay is less than two midnights but the patient is at “high risk for an adverse event” and/or “required increased monitoring due to comorbidities”, inpatient admission can be evaluated by exception. - This is paid under Medicare Part A.

8©2018 Trinity Health

Two Midnight Rule CMS - 2013

Patient A Patient has a BMI greater than 40, and insulin-dependent diabetes might demonstrate a “risk of complications.” Escalating blood sugars, nausea and vomiting begin, which can lead to complications.

- Blood sugars ordered every two hours requiring the patient to receive added insulin dosages twice within the first 12 hours, and antiemetics four times in 24 hours.

- As the patient enters into the 24th hour of their stay, blood sugars are higher than normal, but controlled, VSS, Afebrile, tolerating diet every six hours. Demonstrates understanding of ongoing glucose monitoring and has home support.

- May be discharged prior to second midnight but remain inpatient admission.

Documentation of the above must be present

9©2018 Trinity Health

Example of patient with risk factors that support consideration for inpatient.

• Is this patient’s in-hospital recovery expected to extend to post-operative day two?- If yes, admit as inpatient and document why you

think this patient requires an inpatient admission.• If patient looks great on post-op day one and you

discharge, be sure to document that the patient “did better than expected.” - Documentation should include the patient’s earlier

than expected recovery and their related pre-operative needs. Be Specific.

10©2018 Trinity Health

Indication for Inpatient Status

• Is the patient’s arthritis or other co-morbidities such that you anticipate the surgery to be technically challenging? (osteoporotic bone, extensive vascular calcifications, severe deformity, obesity etc.)- If yes, consider admit to inpatient pre-op

• Document anticipated challenges in detail• Continue documenting progress on daily basis

11©2018 Trinity Health

Indication for Inpatient Status cont.

©2018 Trinity Health 12

Supporting Documentation for Trinity Health Recommendations

• Documentation of Medical Necessity should be found in office notes and should be placed in Hospital EMR and include:- Radiologic findings- Pain assessment- Prior non-operative treatments including duration

response and failed response- Medications/Therapies tried and duration- Baseline mobility- Effects on ADLs

13©2018 Trinity Health

Documentation to support TKA procedure supported by Trinity Health Clinical Pathway

• Poorly controlled = HbA1c > 7.5%• Consider Admit to Inpatient due to increased risk of

postoperative hyperglycemia and wound infection.• Document in admission notes and address daily.

• https://www.ncbi.nlm.nih.gov/pubmed/28735804

14©2018 Trinity Health

Diabetes indications for inpatient status

• Consider admission to inpatient due to increased risk:- Anesthesia- Post-op monitoring for fluid balance- Development of acute kidney injury

• Must be documented along with ongoing progression

RAC Universit01/2018

15©2018 Trinity Health

Chronic Kidney Disease indications for inpatient status

• Coronary Artery Disease:- If documented coronary artery disease on medications,

consider admit to inpatient due to:• Increased risk of surgery• Need for close post-operative monitoring

• Hypertension:- If hypertension with BP over 140/90* on medications

(uncontrolled), consider admit to inpatient due to:• Increased risk of surgery • Increased risk of bleeding• Need for close post-operative monitoring

RAC University 01/2018

16©2018 Trinity Health

CAD/HTN indications for inpatient status

• It is Trinity Health's recommendation that all patients be screened carefully and the physician provide clear documentation of patient needs,risks, and health status

• This documentation must be provided throughout the course of the patient’s stay

• Patient safety and care quality are most important consideration

• When in doubt, on inpatient vs outpatient, please utilize your physician advisor

17©2018 Trinity Health

Trinity Health recommends careful screening of all patients with clear physician documentation

Sponsored by Catholic Health Ministries | 20555 Victor Parkway • Livonia, MI 48152 • 734-343-1000 • trinity-health.org

January 3, 2018

Trinity Health Colleagues

Guidelines for Patient Selection for Total Knee Arthroplasty(TKA) In outpatient setting

January 2018/Revised September 2018

Purpose: To provide recommendations that should be considered when scheduling patients for TKA as an outpatient. Outpatient defined as in a hospital outpatient surgery area. Free standing Ambulatory Service Centers (ASC) are not hospital outpatient department.

Summary:

Effective January 2018 TKA for Medicare recipients may be provided in the outpatient setting when a patient is deemed medically appropriate and without added safety risk. This procedure may remain inpatient when patients are medically inappropriate for outpatient or are at high risk for adverse event.

The intent of the CMS rule was to allow this procedure to be done in an outpatient setting when deemed appropriate by the medical team. No criteria or guidelines have been provided by CMS, but rather a directive that the decisions are considered medically complex and are to be based on clinical evidence and the patients risk for an adverse event. The intent is clear that the decision is in the judgement of the physician and his/her medical team. Conversation with CMS thus far has suggested the population for outpatient TKA will be minimal to moderate. The rule does not mandate outpatient. There is a two year period that exists that CMS has commented will be a learning and improvement period.

Consideration should also be given to the previously established guidance from CMS regarding the two midnight rule for inpatient admission. If the planned stay is for same day or next day discharge, these patients should be considered for outpatient status. A patient being considered for outpatient TKA needs careful review and assessment to ensure optimal patient recovery and outcome. Patients at higher risk for an adverse event or with significant medical comorbidities should be considered for inpatient admission. It is important when making decision for admission status that the comorbidities and risks for adverse events be documented clearly in the medical record, and addressed in ongoing progress notes. The plan of care must include documentation that supports the medical necessity of an inpatient stay and required hospital level of care. Patients

Sponsored by Catholic Health Ministries | 20555 Victor Parkway • Livonia, MI 48152 • 734-343-1000 • trinity-health.org

who are made inpatient and progress faster in their recovery can be paid under Medicare part A if the medical care when all signs, symptoms, and diagnoses including the ongoing need for monitoring, interventions and treatments are adequately documented.

After conducting a review of literature and best practice standards, recommendations have been provided by Trinity Health Orthopedic Clinical Excellence Council to assist providers, when determining the patient's status and care setting, outpatient vs inpatient. When a surgical patient has any or multiple of the following conditions, careful consideration must be given.

Considerations for exclusion as outpatient:

The conditions below need to be assessed carefully and if they place the patient at increased risk for complications or adverse events during their post-surgical hospital stay then inpatient status should be considered.

Hgb A1c > 7.5 Solid Organ Transplant Chronic Renal disease stage 3 or greater. BMI greater than 40 with additional co morbidity/risks identified. Cardiopulmonary event in last year. (Acute MI, Stent placement, Acute CHF etc.) Sleep Apnea (OSA) Tobacco users not willing to utilize nicotine replacement therapy (patches, gum) and

participate in smoking abstinence. Bleeding disorders. Patients on chronic anticoagulation requiring post-surgical

reimplementation of anticoagulants such as Coumadin, Eliquis, Lovenox, heparin, Xarelto, Arixtra, Pradaxa)

Patients whose post-discharge needs may include skilled nursing facility placement or inpatient rehabilitation. Special consideration for those with disabilities (amputees, partial paralysis, and psychiatric illness), frail and elderly persons that have additional conditions that preclude them from caring for themselves and require skilled care in the early postoperative period that cannot be provided as an outpatient or in-home service.

Chronic Opioid consumption Malnutrition: Total Lymphocytes <1,500 cells /mm. Albumin < 3.5g/dl. Transferrin level <

200mg/dl. ASA of 4 or greater assessed by anesthesia. ASA 3 needs thorough assessment of patient's

risks and comorbidities. Anemia. Baseline hgb. < 11 HTN BP greater than 140/90 and on medications. COPD if on regularly scheduled medications and/or inhalers. Cancer/Immunocompromised. Positive MRSA screening with Vancomycin treatment. Patient's post-acute setting too great of distance from emergent medical care.

Revision 09/2018 Orthopedic Clinical Excellence Council.

AAHKS Position Statement: Removal of TKA from Inpatient Only List Total Knee Arthroplasty Should be Considered, by Default, an Inpatient Procedure for

Medicare Beneficiaries, Absent Evidence to the Contrary

From: Mark I. Froimson, MD, MBA, President, American Association of Hip and Knee Surgeons Date: February 21, 2018 RE: TKA removal from IPO list For: Information and Guidance to Members

During the American Association of Hip and Knee Surgeons (AAHKS) Legislative Retreat in Washington, D.C., from February 8-10, 2018 AAHKS leadership gathered and met with nearly 30 congressional offices. Among the issues discussed, consensus emerged that the current confusion surrounding the removal of total knee arthroplasty (TKA) from the inpatient only list compelled AAHKS to provide this position statement to assist providers and patients navigate this transition.

New Medicare Policy for TKA In November 2017, the Center for Medicare and Medicaid Services (CMS) finalized the 2018 Medicare Outpatient Prospective Payment System1 rule that removed total knee arthroplasty procedures from the Medicare inpatient-only (IPO) list of procedures. This action has already had significant and unexpected consequences.

The final rule was a response to emerging evidence in non-Medicare patients that there appears to be a healthy cohort suitable for TKA in an outpatient setting; it was also a concession to the expressed interest on the part of some orthopedic surgeons of extending this option to Medicare beneficiaries. Historically, the Medicare program covered knee replacement surgery only if it was performed on an inpatient basis. Through the final rule, CMS took a measured step towards allowing Medicare coverage for outpatient TKA surgeries by only allowing the procedure in outpatient facilities associated with a hospital. CMS did not allow the procedure to be moved to the free standing ambulatory surgery setting, indicating a desire to move slowly, presumably to ensure safety during this proposed transition. The final rule was clear in stating CMS’s expectation was that the great majority of TKAs would continue to be provided in an inpatient setting.

Wide Confusion Over New Policy at the Provider Level Unfortunately, the unintended consequence of this change has been an unprecedented amount of confusion on the part of a variety of stakeholders regarding how to interpret this new rule. Hospitals, surgeons, and payers are interpreting the rule from different perspectives and as such are each coming to very different conclusions. Further, there is no observed consistency in interpretation among hospitals and surgeons, yielding uncertainty about the freedom they have to prescribe the most clinically appropriate location for a patient’s surgery. Of additional concern is the fact that many are reporting that Medicare Advantage plans are directing their networks to drive the majority of TKAs to outpatient status, despite clear evidence that that was not CMS’s intent. This may be creating unsafe conditions for patients. As such, AAHKS offers this guidance to its members.

1 82 Fed. Reg. 52,356 (Nov. 13, 2017).

Interplay Between TKA and the “2 Midnight Rule” The definition of outpatient procedure in Medicare parlance is not what many, including most beneficiaries, would understand it to be. For several years, CMS has utilized a rule called the “Two-Midnight Rule” to define outpatient status for all procedures not on the IPO list. CMS made TKA subject to the “Two-Midnight Rule” in conjunction with the decision to move TKA off the IPO list. According to the “Two-Midnight Rule,” a hospital admission should be expected to span at least two midnights in order to be covered as an inpatient procedure. If it can be reliably expected that the patient will not require at least two midnights in the hospital, the “Two-Midnight Rule” suggests that the patient is considered an outpatient and is therefore subject to outpatient payment policies. Under prior guidance related to the “Two-Midnight Rule;” however, CMS also states that Medicare may treat some admissions spanning less than two midnights as inpatient procedures if the patient record contains documentation of medical need. Application of this guidance to TKA runs counter to CMS’s stated intent. CMS did not intend that each inpatient TKA, the current care standard, required such documentation of medical need. Rather, they expected, as stated clearly in the rule, that the vast majority of TKAs would remain inpatient. When a standard status is expected by the overwhelming majority, the burden of proof should fall on the exception, not the standard.

This has been a source of great confusion for physicians and hospitals. Prior experience with this rule has made many hospital reimbursement/compliance directors concerned that incorrect application of this rule may subject the hospitals and providers to financial penalties. The result is that many hospital leadership teams have been very conservative in their interpretation and have directed their physicians to err on the side of outpatient designation – absent a clear standard.

This regulatory shift is now impacting thousands of orthopaedic surgeons who heretofore had considered this major surgical procedure for elderly patients an obvious inpatient procedure performed in hospital operating rooms, requiring significant resources. They now find that they are getting calls from C-suite and Utilization Review teams to avoid inpatient designation and face pressure to move the vast majority of TKAs to an outpatient designation. Patients also face changes in what many had assumed were inpatient procedures and which may lead to confusion over cost sharing obligations. This has been an overnight and baseless paradigm shift that requires examination and clarification.

Trend of TKA Clinical Advances Since the inception of TKA, there have been many millions of patients who have been admitted to hospitals for their post-surgical care. These patients traditionally stayed for 3-5 days and were often discharged to an inpatient rehabilitation or skilled nursing setting. Until quite recently, the percent of patients that were institutionalized for over ten days, in hospital and in post-acute care, approached 50%. Patients who were more robust, had few medical comorbidities, and/or who had reliable social support were more likely to be discharged to home with home care.

A number of clinical advances have made the care of patients facing TKA safer and more expedient. These include, among others, better pain management, opioid sparing protocols, better blood management protocols, improved surgical techniques, improved patient preparation and selection for surgery, improved patient and family education and engagement, and better infection prevention strategies. Consequently, patients are now convalescing more quickly following TKA and are finding it easier to return to their homes more reliably. Rather than being away from home for 10-14 days, as in the recent past, many can receive resource intensive interventions that span one to three days as an inpatient and can then be ready and safe to continue their recovery in a non-clinical setting. This had been a great advance for patients and, as evidenced in the BPCI program, has saved considerable resources for CMS and the Medicare program.

Impact of an Outpatient Designation Remains Unknown Great care, however, is needed before extrapolating from these advances in inpatient-anchored, resource-intensive care, as to how to move selected patients to an outpatient setting. In fact, the Medicare rule that allows for TKA to be done as an “outpatient procedure” provides no evidence that such a transition would be safe and without adverse consequence. Although there is some evidence on

how to risk stratify non-Medicare patients for ambulatory environments, these patients are quite different from the typical Medicare patient. They are, by definition, younger, and, by design, selected based on evolving evidence that remains under study. In fact, the number of true outpatient TKA procedures remains quite small – by recent estimates, less than 5%.

Another important outcome of this rule is that the surgeon bears the responsibility for the inpatient/outpatient designation, as stated in the preamble to the rule. Less appreciated is the lack of clarity surrounding acceptable justification for inpatient admission spanning fewer than two midnights. Pressure is being placed on the surgeon to make outpatient the default designation prior to surgery, before he/she is aware of any potential adverse surgical event, the degree of blood loss, the length of the procedure, or how the patient tolerates anesthesia. As a result of the final rule, the surgeon must admit the patient to the facility in order for the procedure to be considered an inpatient procedure. Those patients for whom one midnight may be sufficient, yet are clearly not acceptable outpatient candidates, fall into a gray area forcing outpatient status. It is unclear at this time that a surgeon has reliable criteria to predict that a given, elderly patient facing the stress of the surgery is suddenly, unlike the millions who preceded him, now suitable for treatment as an outpatient.

AAHKS Guidance to Members As such, and after careful consideration of the evidence and the facts, and following a detailed conversation with the relevant CMS officials and governing agencies, AAHKS recommends to its members the following:

» Although TKA has been taken off the IPO list, it is reasonable to expect that the vast majority of patients should be treated, by default, as qualifying for inpatient designation. The physiology of patients did not change, nor did the standard of care, from December 2017 to January 2018.

This is consistent with CMS’s own statements in 2018 Medicare Outpatient Prospective Payment System Final Rule of the impact of removing TKA from the IPO list. CMS stated that “the decision regarding the most appropriate care setting for a given surgical procedure is a complex medical judgement made by the physician.”2 CMS also stated that the Medicare beneficiaries “who are able to receive this procedure safely on an outpatient basis . . . are a subset,” and that “we [CMS] do not expect a significant shift in TKA cases from the hospital inpatient setting to the hospital outpatient setting.” 3

» Therefore, all relevant parties agree that the burden of proof is on the surgeon to clearly state, not why this patient requires inpatient designation, but rather what criteria are present that suggest that inpatient resources are not expected to be utilized.

While it is possible to convert an outpatient admission to an inpatient admission, such a process takes additional surgeon time and creates an unplanned need for services and bed availability. Only when there is clarity that a patient is expected to be safely discharged within 24 hours should the surgeon designate the patient as an outpatient. A safe discharge is expected to occur when a patient has an acceptably low risk of developing life-threatening complications, including, confusion, delirium, fall, wound complication, bleeding, cardiovascular instability, urinary retention and ileus. Although current advanced care protocols have reduced the incidence of many of these adverse events, predicting which patient may experience one or more of these is generally not possible.

» Consequently, AAHKS would encourage its members to only utilize an outpatient designation for a patient when doing so does not pose the risk of making the occurrence of, or failure to detect, such an adverse event more likely.

It is expected that, at the present time, having little experience with treating TKA patients in outpatient departments, most of our members would continue to utilize the inpatient designation for the vast majority of their Medicare beneficiaries. This should remain the default designation and one that is

2 82 Fed. Reg. 52,523 (Nov. 13, 2017) 3 82 Fed. Reg. 52,524 (Nov. 13, 2017).

readily met through standard documentation whether the admission is one, two or three or more days. We believe that the intention of CMS supports an assumption of the appropriateness of an inpatient stay regardless of the expectation of a two-midnight stay.

Next Steps We are currently working with CMS to pursue a resolution to this issue. Potential clarifications, guidance, or exceptions may take a number of forms. There are a number of additional considerations that must be carefully worked through as we consider the impact.

One includes the financial impact on patients and our duty to inform them of such. Will they be able to afford the potential increased patient financial responsibility conferred by this policy when their payment for events around their TKA move from Part A to Part B? Why would they agree to expedited discharge with decreased utilization of resources when such “engagement” results in a financial penalty to them because of time spent under observation status?

Our outreach with CMS will also address the unintended consequence that affects many of our members participating in episode based alternative payment models (APMs) that are based arounds DRG 469/470. Removing lower resource utilizing, healthier outpatients from the denominators for cost and quality performance metrics will impact most members’ ability to achieve quality goals and target pricing.

AAHKS wants, as we expect CMS does, what is best for our patients. Surgical and medical advances will continue to make this a dynamic conversation. We simply ask that the clinical and payment consequences be thoroughly examined and that we continue to allow total knee replacement admissions to default to approved inpatient stays regardless of discharge on post-op days one or two. This will allow for time to study the outcomes of total knee arthroplasty being removed from the IPO list.

Trinity Health - Genesis SitesComparison of IP vs OP DRG 470: IP Only Rule Impact

(Partial & Total Knee Replacements)July 2016 - Dec 2017 vs Jan - Jun 2018

Prior to Rule Change (Jul 16 - Dec17) Post Rule Change (Jan - Jun 18)IP OP Tot Rule Change OP IP OP Tot ule Change OP%

St. Joseph Mercy Hospital 238 3 241 1.2% 101 3 104 2.9%Medicare - Trad 51 1 52 1.9% 23 1 24 4.2%Medicare - Adv 51 2 53 3.8% 20 1 21 4.8%Non-Medicare 136 136 0.0% 58 1 59 1.7%

St. Joseph Mercy Livingston Hospita 115 14 129 10.9% 40 2 42 4.8%Medicare - Trad 32 2 34 5.9% 13 1 14 7.1%Medicare - Adv 30 2 32 6.3% 11 11 0.0%Non-Medicare 53 10 63 15.9% 16 1 17 5.9%

Chelsea Community Hospital 177 177 0.0% 78 2 80 2.5%Medicare - Trad 40 40 0.0% 20 20 0.0%Medicare - Adv 38 38 0.0% 17 17 0.0%Non-Medicare 99 99 0.0% 41 2 43 4.7%

St. Mary Mercy Hospital 136 136 0.0% 47 47 0.0%Medicare - Trad 36 36 0.0% 14 14 0.0%Medicare - Adv 33 33 0.0% 12 12 0.0%Non-Medicare 67 67 0.0% 21 21 0.0%

St. Joseph Mercy Oakland 198 1 199 0.5% 83 2 85 2.4%Medicare - Trad 41 41 0.0% 18 1 19 5.3%Medicare - Adv 41 41 0.0% 19 19 0.0%Non-Medicare 116 1 117 0.9% 46 1 47 2.1%

Saint Agnes Medical Center 169 169 0.0% 71 11 82 13.4%Medicare - Trad 42 42 0.0% 17 10 27 37.0%Medicare - Adv 19 19 0.0% 10 10 0.0%Non-Medicare 108 108 0.0% 44 1 45 2.2%

Mercy Medical Center - Clinton 45 45 0.0% 20 7 27 25.9%Medicare - Trad 18 18 0.0% 8 5 13 38.5%Medicare - Adv 5 5 0.0% 1 1 2 50.0%Non-Medicare 22 22 0.0% 11 1 12 8.3%

Mercy Medical Center - Dubuque 144 19 163 11.7% 5 52 57 91.2%Medicare - Trad 42 9 51 17.6% 4 21 25 84.0%Medicare - Adv 14 14 0.0% 3 3 100.0%Non-Medicare 88 10 98 10.2% 1 28 29 96.6%

Saint Mary's Health Care 192 2 194 1.0% 62 7 69 10.1%Medicare - Trad 36 36 0.0% 13 1 14 7.1%Medicare - Adv 37 37 0.0% 12 1 13 7.7%Non-Medicare 119 2 121 1.7% 37 5 42 11.9%

Saint Alphonsus Regional Medical Ce 289 18 307 5.9% 101 18 119 15.1%Medicare - Trad 48 4 52 7.7% 23 5 28 17.9%Medicare - Adv 41 4 45 8.9% 17 5 22 22.7%Non-Medicare 200 10 210 4.8% 61 8 69 11.6%

St Alphonsus Medical Center - Nampa 142 1 143 0.7% 27 38 65 58.5%Medicare - Trad 34 34 0.0% 7 12 19 63.2%Medicare - Adv 35 35 0.0% 10 16 26 61.5%Non-Medicare 73 1 74 1.4% 10 10 20 50.0%

St Alphonsus Medical Center - Ontari 106 4 110 3.6% 36 36 0.0%Medicare - Trad 34 1 35 2.9% 11 11 0.0%Medicare - Adv 17 17 0.0% 10 10 0.0%Non-Medicare 55 3 58 5.2% 15 15 0.0%

St Alphonsus Medical Center - Baker 37 37 0.0% 15 15 0.0%Medicare - Trad 16 16 0.0% 7 7 0.0%Medicare - Adv 1 1 0.0% #DIV/0!Non-Medicare 20 20 0.0% 8 8 0.0%

St. Joseph RMC, SB Campus 225 18 243 7.4% 86 35 121 28.9%Medicare - Trad 38 7 45 15.6% 12 12 24 50.0%Medicare - Adv 36 3 39 7.7% 12 8 20 40.0%Non-Medicare 151 8 159 5.0% 62 15 77 19.5%

St. Joseph RMC, Ply Campus 56 56 0.0% 17 17 0.0%Medicare - Trad 25 25 0.0% 7 7 0.0%Medicare - Adv 13 13 0.0% 5 5 0.0%Non-Medicare 18 18 0.0% 5 5 0.0%

Mercy Medical Center - North Iowa 138 2 140 1.4% 49 49 0.0%Medicare - Trad 37 37 0.0% 13 13 0.0%Medicare - Adv 12 12 0.0% 4 4 0.0%Non-Medicare 89 2 91 2.2% 32 32 0.0%

Holy Cross Germantown Hospital 75 2 77 2.6% 22 8 30 26.7%Medicare - Trad 22 1 23 4.3% 10 7 17 41.2%Medicare - Adv 6 6 0.0% 1 1 0.0%Non-Medicare 47 1 48 2.1% 11 1 12 8.3%

Holy Cross Hospital 145 1 146 0.7% 42 17 59 28.8%Medicare - Trad 41 1 42 2.4% 11 16 27 59.3%Medicare - Adv 6 6 0.0% 4 4 0.0%Non-Medicare 98 98 0.0% 27 1 28 3.6%

Mercy Health Muskegon 219 219 0.0% 49 62 111 55.9%Medicare - Trad 44 44 0.0% 14 16 30 53.3%Medicare - Adv 44 44 0.0% 13 12 25 48.0%Non-Medicare 131 131 0.0% 22 34 56 60.7%

Mount Carmel St. Ann's 151 4 155 2.6% 49 13 62 21.0%Medicare - Trad 37 37 0.0% 12 2 14 14.3%Medicare - Adv 37 37 0.0% 12 6 18 33.3%Non-Medicare 77 4 81 4.9% 25 5 30 16.7%

Mount Carmel East 180 3 183 1.6% 54 13 67 19.4%Medicare - Trad 39 39 0.0% 15 4 19 21.1%Medicare - Adv 40 40 0.0% 15 5 20 25.0%Non-Medicare 101 3 104 2.9% 24 4 28 14.3%

Mount Carmel West 169 6 175 3.4% 44 19 63 30.2%Medicare - Trad 37 1 38 2.6% 11 1 12 8.3%Medicare - Adv 36 36 0.0% 12 3 15 20.0%Non-Medicare 96 5 101 5.0% 21 15 36 41.7%

Mount Carmel New Albany 285 40 325 12.3% 62 67 129 51.9%Medicare - Trad 48 8 56 14.3% 15 12 27 44.4%Medicare - Adv 42 10 52 19.2% 15 12 27 44.4%Non-Medicare 195 22 217 10.1% 32 43 75 57.3%

Mercy Medical Center - Sioux City 53 53 0.0% 31 31 0.0%Medicare - Trad 27 27 0.0% 10 10 0.0%Medicare - Adv 5 5 0.0% 6 6 0.0%Non-Medicare 21 21 0.0% 15 15 0.0%

Grand Total 3684 138 3822 3.6% 1191 376 1567 24.0%