Total Knee Arthroplasties

Confusing Mixed Signals: Expected When Dating, Not Expected in the Federal Register

Assume we set out to play a game of soccer on an open field. Suppose instead of having visible field markings with sidelines, goals, penalty boxes, and so on, we leave the field unmarked. I suspect we would have some major disputes on our hands. Imagine if a soccer club association advised, “when determining if a ball is out of bounds, we recommend you consult others tied more closely to the game.+ Ask the players on the two teams; ask the crowd; ask the goalies to suggest where they feel the sidelines should be. Then have each stakeholder make their case to the referee for each play.” The result would probably be a very confusing game and a lot of frustrated people. Some shell-shocked players would likely keep the ball in the utmost center portion of the field to avoid penalties. The scenario above is very close to the situation created when ‘total knee replacement’ was removed from the ‘inpatient only’ list by CMS. Instead of simply removing the procedure from the ‘inpatient only’ list, CMS provided well over 5,000 words of guidance and comments. I am fairly certain most would agree that 5,000 words is a lot of information. By comparison, the Gettysburg Address contains 272 words, the Declaration of Independence has 1458 words, and the original US Constitution has 4,543 words. Our Founding Fathers were able to articulate how to organize our country’s governance with fewer words than it took to inform physicians that a single procedure would be removed from the ‘inpatient only’ list. The CMS regulations on the removal of TKA from the inpatient only list felt a bit like reading a book report that needed to be 5,000 words long written the night before the due date.

A Uniform Understanding

One would hope 5,000 words would be enough to create a uniform understanding of which patients were appropriate for outpatient procedures and which were appropriate for an inpatient knee replacement. Instead, this is the guidance provided: “While we continue to expect providers who perform outpatient TKA on Medicare beneficiaries to use comprehensive patient selection criteria to identify appropriate candidates for the procedure, 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’ patient selection protocols.” Two orthopedic societies, which I suspect have specialized clinical knowledge and experience with TKA, did just that. They suggest every patient should be considered appropriate to place in inpatient status and rather, we should have to prove that patients are appropriate for outpatient services. In an open door forum, CMS said, and I paraphrase, “Well, maybe not those specialty societies.” Studies cited by guidelines such as MCG would suggest that most Medicare beneficiaries would be excluded from research protocols evaluating outpatient total knee replacements. In one study the age range of patients was 42-64 (1). Another cited instructional course lecture stated, “The authors …. recommend surgeons start with healthier, motivated patients and focus on total hip replacements and unicompartmental knee replacements in the learning curve phase of the transition to outpatient total joint arthroplasty.” (2) In that same open door forum, CMS made it clear, consistent with prior policy, that they will not endorse any specific guidelines. The 5,000 words did include CMS’ great expectations: “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… we expect a significant number of Medicare beneficiaries will continue to receive treatment as an inpatient for TKA procedures.”  The word ‘significant’ used in the guidance is fairly non-specific and offers little direction. Is 1% as significant as 99%?  CMS also suggested guidance regarding factors to consider when evaluating a patient for inpatient status. “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.” “…the patient’s anticipated need for postoperative skilled nursing care, and other factors.

The Two-Midnight Rule

Further CMS related that the ‘Two-Midnight Rule’ should be applied to these cases, that is, if the patient is expected to stay in the hospital for two midnights, then the case is appropriate for payment under the inpatient prospective payment system or IPPS schedule. An obvious concern, particularly in high-performing surgery centers doing a high volume of joint replacement surgeries, is that many patients do not require a two-midnight stay. For these cases CMS provides the following guidance: “For stays for which the physician expects the patient to need less than two midnights of hospital care, an inpatient admission is payable under Medicare Part A on a case-by-case basis if the documentation in the medical record supports the admitting physician’s determination that the patient requires inpatient hospital care. This documentation and the physician’s admission decision are subject to medical review.”  Is this guidance an extension of the ‘short-stay,’ case-by-case exception that CMS put into effect January 1, 2016, which reads: “Part A payment is appropriate on a case-by-case basis where the medical record supports the admitting physician’s determination that the patient requires inpatient care, despite the lack of two-midnight expectation. The QIOs will consider complex medical factors such as history and comorbidities, the severity of signs and symptoms, current medical needs, and the risk of an adverse event to determine whether the medical record supports the need for inpatient hospital care. These cases will be approved by the QIOs when the other requirements are met.” It is fairly easy to see how this exception may apply to a patient who has a life-threatening medical emergency such as a myocardial infarction treated with a stent and released the next day. Guidance from the Quality Improvement Organizations (QIOs) has largely centered on these emergent cases. Applying this exception to patients who are undergoing an elective procedure presents challenges. The lack of clear guidance for what scenario will constitute an ‘inpatient status’ rather than ‘outpatient status’ has created confusion, leading to a more conservative approach, creating risk for patients who may be moved to an outpatient status inappropriately. Would uncontrolled diabetes be enough to place a patient in inpatient status even if they were not expected to stay beyond two midnights in the hospital? How about well-controlled hypertension in an otherwise healthy 80-year-old? What about a 68-year-old patient with mild COPD who uses short-acting bronchodilators at home and get dyspnea when climbing stairs? Many hospitals are reluctant to use the ‘short stay exception’ for acute care cases, let alone for patients undergoing elective surgery. If we are left with only the Two-Midnight Rule to guide inpatient status vs. outpatient status, we might be adversely affecting higher performing surgeons and hospital’s surgical services. If I am a surgeon working at a hospital who sends patients home the day following surgery most of the time, the majority of my patients risk falling into outpatient status. The impact of this is significant for hospitals. For patients this can result in:

• Potentially higher out-of-pocket expenses,
• Potentially losing a midnight stay that could contribute to a skilled nursing facility stay, if they have complications later in their hospitalization

Will more savvy patients factor this in when selecting a surgeon or place where they will have their surgery? In general, we want to be sure we are aligning incentives with improved performance. Using this example, the change in status might do just the opposite. High-performing hospitals and surgery centers often take on additional costs in preparing patients so they can safely transition to their next site of care in a single day. In this scenario, we may see additional therapy resources, more frequent checks on the patient, more judicious pain assessments and counseling, more time on patient education and expectation management. This change may result in a disproportionate reduction in revenue. Furthermore, in the situation where there is a bundled payment care improvement program in place at a high-performing hospital that consistently discharges patients at the day following surgery, that group of patients will fall out of the MS-DRG 470 and results in a bundle with sicker, more complex patients. Even if there is an adjustment to the bundle reimbursement or other reconciliation, a hospital that can safely discharge a greater share of patients before a second midnight may still incur disproportionately higher than average costs within the bundle.

What do we need?

We need clarity from CMS or the Quality Improvement Organizations (QIOs) on what is allowed for short stay case-by-case exceptions to the Two-Midnight Rule.  Otherwise, we are working in the dark and risking assignment of an inappropriate status which will have ‘significant’ – to borrow the word – impact on both patient’s due rights under Medicare Part A and the reimbursement to hospitals, particularly those providing excellent quality outcomes and exceptionally efficient care. If we cannot have that, then I would like to suggest that they replace the 5,000 words of guidance with “use the Two-Midnight Rule.” Resources:

1. Berger RA, Cross MB, Sanders S. Outpatient hip and knee replacement: the experience from the first 15 years. Instructional Course Lectures 2016;65:547-51.
2. Instr Course Lect.2016;65:547-51.

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