Should all Heart Failure Patients be Admitted as Inpatients?

Who would have thought that after 10 years, there would still be so much talk about the Two-Midnight Rule? And perhaps there would not be, if the Centers for Medicare & Medicaid Services (CMS) did not finalize CMS-4201-F and make the rule applicable to Medicare Advantage (MA) plans as of January 2024 (although they technically claimed it was always applicable to MA, but for some reason felt compelled to codify it, and then gave the MA plans a six-month grace period, but that’s another story.)

The applicability of the Rule to the MA plans now means that they must allow inpatient admission for a patient with an expectation of two midnights in the hospital, along with the other provisions of the Rule. But unlike oxygen levels, sodium levels, electrocardiographic tracings, and other commonly used diagnostic testing, there is no way to objectively measure the appropriate need for two midnights of hospital care.

But CMS did assist us in making that determination when they stated in the Two-Midnight Rule that “the crux of the medical decision is the choice to keep the beneficiary at the hospital in order to receive services or reduce risk or discharge the beneficiary home because they may be safely treated through intermittent outpatient visits or some other care.” They also addressed the notion that delays in care for convenience (such as no complex diagnostic testing being available on Sundays) or personal preference (too dark to go home, need to work up every incidental finding, etc.) cannot be considered in the calculation.

Breaking this down, this means that hospital care is indicated for patients who require services that can only safely be provided in the hospital or require monitoring for adverse events in cases where their safety would be threatened if they were not monitored in the hospital. But this decision must be individualized to the patient, based on their specific circumstances.

Take, for example, dialysis. Many people receive dialysis as outpatient care, in freestanding dialysis centers, at nursing homes, or even in their home. But when dialysis is first initiated for a patient with acute manifestations of their kidney disease, no nephrologist would consider performing it at a dialysis center; in such a case, hospital care is warranted.

Every day in hospitals, imaging centers, and physician offices, MRIs and stress tests are performed on patients electively scheduled for such tests, due perhaps to a persistent headache or transient chest pain. But the patient who presents to the hospital with an acute neurologic finding or with active chest pain would never be discharged home to have that testing performed electively as outpatient. Rather, they warrant hospitalization for monitoring and testing.

Clearly, this is a patient-specific decision that requires thoughtful evaluation by the physician to determine how the patient should be treated and in what setting. But medicine changes with time. Diagnostic algorithms change as new testing is developed. Clinical trials help define the evidence-based treatment for common and not-so-common conditions. Scoring tools are developed to differentiate those at higher risk of illness or developing complications. While physician judgement has to be respected, clinical trials that accumulate data and outcomes of hundreds or thousands of patients should be given significant weight. As CMS has told us, the statement “I expect two midnights” is given no presumptive weight, and the facts of the case as documented by the totality of the medical record must portray a patient who indeed requires two necessary midnights.

Then, to make things more complex, CMS released a memorandum to MA plans answering “frequently asked questions” (FAQs) that took the discussion about the use of criteria based on the medical literature to another level. In this FAQ, CMS discussed the use of criteria for determining medical necessity for care and admission status. CMS set a new standard by requiring MA plans to make public any non-CMS-developed criteria they use for such decisions, along with supporting evidence, as specified in 42 CFR 422.101(b). The MA plan guidelines must be “based on current evidence in widely used treatment guidelines or clinical literature.”

In addition, in 42 CFR 422.101(b)(6)(i)(A), CMS specifies that “the MA organization must demonstrate that the additional criteria provide clinical benefits that are highly likely to outweigh any clinical harms, including from delayed or decreased access to items or services.” CMS is saying here that criteria can be one tool that can be used to determine medical necessity if it meets the standards outlined. But it is but a tool that must be applied rationally and with awareness of the limitations. To date, there is no tool that can encompass every single patient scenario, incorporate the guidelines, and produce an infallible determination of admission status.

On the other hand, not every physician keeps up with all the medical literature and adapts their practices accordingly. This was demonstrated after a landmark study from MD Anderson, published in 2018, demonstrating that outcomes after minimally invasive surgery for cervical cancer were poorer compared to radical abdominal surgery. Despite these findings, in 2021, an analysis of surgical techniques used for cervical cancer found little de-adoption of minimally invasive surgery in non-academic hospitals.

Now, what does this have to do with patients hospitalized with heart failure and their admission status? I must give credit to Dr. Michelle Kittleson, Professor of Medicine at Cedars-Sinai Medical Center in Los Angeles and Director of Education in Heart Failure and Transplantation (and Director of Heart Failure Research) at the Smidt Heart Institute. She authored an “In the Clinic” feature In the Annals of Internal Medicine in December 2023 titled “The Management of Heart Failure in Hospitalized Patients.” In that summary of the medical literature and guidelines, she stated, “it is critical that patients be observed for at least 24 hours after they transition to oral agents to ensure effectiveness of oral diuretic therapy, which, in turn, is associated with a lower rate of readmission.”

If one turns to the guidelines, the 2019 American College of Cardiology Expert Consensus Decision Pathway on Risk Assessment, Management, and Clinical Trajectory of Patients Hospitalized with Heart Failure states, “verifying the effectiveness of oral diuretic therapy prior to discharge, as recommended in the guidelines, generally requires at least 24 hours of observation (meaning patient monitoring and not observation as an ordered outpatient service) after discontinuation of intravenous diuretics. In a recent retrospective study, observing patients on their intended discharge diuretic regimen for ≥ 24 hours was associated with a significant reduction in 30- and 90-day HF readmissions.”

If we apply the “receive services or reduce risk” rule to this recommendation for treating heart failure, the patient will be receiving a service, oral medications, that could be safely provided outside a hospital setting. But the monitoring of the patient on oral therapy for that 24-hour period reduces the risk of a patient-oriented outcome: readmission. Put into the context of the Two-Midnight Rule and CMS guidance to MA plans, if a patient requires hospital care for an acute exacerbation of heart failure, the guidelines and medical literature support inpatient admission, because no matter how fast the patient responds to acute treatment, they will need to be transitioned to oral therapy and then will require an additional day to ensure that is effective.

Now, except for the inpatient-only list, one should be cautious when saying “never” or “always,” so there may be a small subset of patients who present with an acute heart failure exacerbation who can be treated and released within the observation timeframe – but by the time most seek emergency care, they have significant fluid overload, requiring extensive diuresis to mobilize all excess fluids and reduce not only symptoms, but also signs of congestion. And if that is the case, inpatient admission is the proper admission status.

The take-home message here is that although we all seek to streamline hospital care, ensure medical necessity for every day of hospital care, and safely reduce lengths of stay, we must be careful that our drive for efficiency does not collide with the patient-oriented outcomes that matter – or violate the rules set by CMS for the use of criteria tools.