By KIP SULLIVAN

The notion that hospital readmission rates are a “quality” measure reached the status of conventional wisdom by the late 2000s. In their 2007 and 2008 reports to Congress, the Medicare Payment Advisory Commission (MedPAC) recommended that Congress authorize a program that would punish hospitals for “excess readmissions” of Medicare fee-for-service (FFS) enrollees. In 2010, Congress accepted MedPAC’s recommendation and, in Section 3025 of the Affordable Care Act (ACA) (p. 328), ordered the Centers for Medicare and Medicaid Services (CMS) to start the Hospital Readmissions Reduction Program (HRRP). Section 3025 instructed CMS to target heart failure (HF) and other diseases MedPAC listed in their 2007 report. [1] State Medicaid programs and the insurance industry followed suit.

Today, twelve years after MedPAC recommended the HRRP and seven years after CMS implemented it, it is still not clear how hospitals are supposed to reduce the readmissions targeted by the HRRP, which are all unplanned readmissions that follow discharges within 30 days of patients diagnosed with HF and five other conditions. It is not even clear that hospitals have reduced return visits to hospitals within 30 days of discharge. The ten highly respected organizations that participated in CMS’s first “accountable care organization” (ACO) demonstration, the Physician Group Practice (PGP) Demonstration (which ran from 2005 to 2010), were unable to reduce readmissions (see Table 9.3 p. 147 of the final evaluation) The research consistently shows, however, that at some point in the 2000s many hospitals began to cut 30-day readmissions of Medicare FFS patients. But research also suggests that this decline in readmissions was achieved in part by diverting patients to emergency rooms and observation units, and that the rising rate of ER visits and observation stays may be putting sicker patients at risk [2] Responses like this to incentives imposed by regulators, employers, etc. are often called “unintended consequences” and “gaming.”

To determine whether hospitals are gaming the HRRP, it would help to know, first of all, whether it’s possible for hospitals to reduce readmissions, as the HRRP defines them, without gaming. If there are few or no proven methods of reducing readmissions by improving quality of care (as opposed to gaming), it is reasonable to assume the HRRP has induced gaming. If, on the other hand, (a) proven interventions exist that reduce readmissions as the HRRP defines them, and (b) those interventions cost less than, or no more than, the savings hospitals would reap from the intervention (in the form of avoided penalties or shared savings), then we should expect much less gaming. (As long as risk-adjustment of readmission rates remains crude, we cannot expect gaming to disappear completely even if both conditions are met.)

Numerous analysts assert that the first condition – proven methods to reduce HRRP readmissions exist – has not been met. For example, in an article posted in 2019, the Agency for Healthcare Research and Quality (AHRQ) stated “no consensus exists” on how hospitals are supposed to reduce readmissions. But proponents of the HRRP have long asserted just the opposite – that research documenting the existence of numerous proven interventions exists. MedPAC, the nation’s most influential proponent of this claim, made this argument in that 2007 report to Congress that so impressed the authors of the ACA. In Chapter 5 of that report, MedPAC stated, “Research shows that specific hospital-based initiatives to improve communication with beneficiaries and their other caregivers, coordinate care after discharge, and improve the quality of care during the initial admission can avert many readmissions.” (p. 103)

Other individuals and organizations that were influential in the promotion of the HRRP made the same argument. Horowitz and her colleagues at the Yale New Haven Health Services Corporation (hereafter the “Yale group”), who were hired by CMS to develop the HRRP measure of “excess readmissions,” made this argument in their 2011 report to CMS. They claimed “randomized controlled trials” have demonstrated hospitals “can directly reduce readmission rates” and, for that reason, 30-day all-cause readmission rates should be considered a “quality measure.” (p. 8) [3] The mainstream and health policy media have also repeated this claim. For example, a 2011 article posted on Becker’s Hospital Review’s website, which focused on the HRRP, was entitled, “Ten proven ways to reduce hospital readmissions.” A 2018 article in NEJM Catalyst asserts, “[W]hile it may seem that hospitals have little control over what happens once a patient leaves the facility, there are strategies hospitals can deploy to reduce unnecessary bounce-backs….”

An analogy: Off-label prescribing

It is true that numerous studies exist demonstrating that hospitals can reduce readmissions of carefully selected groups of patients, such as patients who speak English, have phones, live near the hospital, are not demented, and consent to the intervention. With the possible exception of HF patients, however, it is not true that numerous studies exist demonstrating how hospitals are supposed to reduce readmissions as the HRRP defines them. The HRRP defines the pool of applicable patients very broadly. With one exception (patients who leave the hospital against medical advice), the HRRP does not permit hospitals to exclude patients who might be harder or more expensive to work with. And with the exception of planned visits (for surgery or chemotherapy, for example), the HRRP counts all admissions within 30 days after discharge as readmissions even if they are not related to the cause of the original admission. (Although MedPAC recommended, and the ACA required, CMS to punish only readmissions “related” to the condition for which the patient had been previously hospitalized, CMS has, with the exception of the exclusion of planned admissions, ignored that requirement.)

And yet, as I will discuss in future installments of this three-part series, it was on the basis of a handful of studies of carefully selected patients that MedPAC, the authors of the ACA, the Yale group, and others endorsed the notion that hospitals should be punished for all-cause readmissions for virtually all patients diagnosed with one of a half-dozen diseases.

To illustrate the inappropriateness of this behavior, it might help to compare it to off-label prescribing of drugs. The AHRQ defines “off-label prescribing” as “when a physician gives you a drug that the US Food and Drug Administration (FDA) has approved to treat a condition different than your condition.” The FDA authorizes the sale of drugs only after the drugs have been shown, by rigorously conducted trials, to work for particular diseases and/or types of patients (for example, adults, not children). Prescribing an FDA-approved drug for a disease or category of patient that was not the subject of the drug company’s research can sometimes lead to useful knowledge about the drug, but it can also create adverse outcomes. Because of the risk of adverse outcomes, drug companies are not allowed to promote a drug for off-label purposes.

In the remainder of this article, I will discuss three examples of studies which demonstrated methods of reducing readmissions for a carefully selected pool of patients, but which did not demonstrate that the interventions could reduce readmissions for the much more broadly defined pool of patients to which the HRRP applies. As you read these examples, and other examples in later installments in this series, please ask yourself this question: “If drug companies are not allowed to promote drugs for purposes for which the drugs have not been tested, why do we tolerate the promotion of health policies for purposes for which they have not been tested?”

Three illustrations of the “off label” problem

As I noted above, the AHRQ stated in a 2019 article that “no consensus exists” on how hospitals are supposed to reduce readmissions. The agency then cited two “notable” studies that reported on interventions that reduced readmissions: The Care Transitions Intervention developed by Coleman et al., and the Project RED trial conducted by Jack et al. Both of these studies are frequently cited by proponents of the HRRP and in literature reviews. The AHRQ later cited a Danish study conducted by Ravn-Neilsen et al. which also reported on an intervention that reduced readmissions.

The authors of all three of these studies imposed severe limits on the patients who could participate, limits hospitals are not allowed to impose under the HRRP.

The study by Coleman et al. (which was also cited by MedPAC and the Yale group) employed the following exclusion criteria: The participants had to be over 65,  be admitted for a non-psychiatric condition, could not be in a nursing home, could not be enrolled in another research study, had to live “in a pre-defined geographic radius of the hospital” to make a home visit “feasible”, “have a working telephone,” “be English-speaking,” “show no documentation of dementia,” not be discharged to a hospice, and provide consent. These requirements led to the exclusion of 1,146 patients out of the initially screened 1,905 patients who were diagnosed with one of the eleven diseases that were the subject of the study. Here is how those 1,146 patients – 60 percent of those screened – were excluded:

• 584 lived too far away;
• 237 refused to give their consent to participate;
• 181 lived in a long-term care institution;
• 53 were enrolled in another research study;
• 53 “planned for hospice admission”;
• 27 had dementia and no willing caregiver;
• 8 did not speak English; and
• 3 had no phone (see figure p. 1825).

Jack et. al. applied equally severe limitations. According to the methods section of their article: “Patients had to [be over 18 and] have a telephone, be able to comprehend study details and the consent process in English, and have plans to be discharged to a US community. We did not enroll patients if they were admitted from a skilled nursing facility or other hospital, transferred to a different hospital service before enrollment, admitted for a planned hospitalization, were on hospital precautions or suicide watch, or were deaf or blind.”

Ravn-Neilsen et al. also imposed substantial limitations on their participants: Patients had to be over 18, speak Danish, receive five or more drugs on a daily basis, not be terminally ill, suicidal, in custody, nor “under isolation precautions, or have aphasia or severe dementia.” 

Implications

According to the AHRQ, the Coleman, Jack, and Ravn-Neilsen studies are high-quality studies that demonstrate that hospitals can reduce readmissions. Here is how the AHRQ described the Coleman and Jack studies: “These studies … successfully reduced readmissions and emergency department visits after discharge.” That statement is literally true. But it is extremely misleading to assert or imply that these studies are examples of how hospitals can reduce readmissions under the HRRP. Hospitals to which the HRRP applies are not allowed to pick and choose their patients as the investigators in the Coleman, Jack and Ravn-Neilsen trials did. It would have taken just a single sentence for the AHRQ to state that fact.

My purpose in pointing out the dearth, possibly the complete absence, of research showing hospitals how to reduce HRRP-defined readmissions is not to suggest that hospitals are not trying to reduce readmissions. The evidence indicates they are trying, and many are spending lots of money in the process. My purpose, rather, is to document an explanation for why some, perhaps many, hospitals might feel compelled to game the HRRP.

Nor is it my purpose to suggest that there is nothing society can do to reduce readmissions. The three studies I discussed above prove there is much that can be done to reduce readmissions. I do mean to suggest the HRRP is very poorly designed to achieve that end.

In Parts 2 and 3 of this series I will review the studies used by MedPAC and the Yale group to justify their support for the program. We will see that the evidence they relied on to justify their support was woefully insufficient.

[1] Section 3025’s description of the seven conditions endorsed by MedPAC’s 2007 report is somewhat cryptic. It reads: “Beginning with fiscal year 2015, the Secretary shall, to the extent practicable, expand the applicable conditions beyond the 3 conditions for which measures have been endorsed as described in subparagraph (A)(ii)(I) as of the date of the enactment of this subsection to the additional 4 conditions that have been identified by the Medicare Payment Advisory Commission in its report to Congress in June 2007 and to other conditions and procedures as determined appropriate by the Secretary.” The reference to three previously “endorsed” conditions apparently refers to heart failure, AMI, and pneumonia, readmission conditions CMS adopted in 2009 for its Hospital Compare report. Section 3025 also left it up to the Secretary to determine the length of time after discharge – 30 days, 60 days, etc. – within which readmissions will be measured.

[2] Although readmissions within 30 days have declined somewhat over the last decade for both Medicare enrollees and the privately insured, visits to hospital emergency rooms and observation stays have risen rapidly. Figure 1-8 of MedPAC’s June 2018 Report to Congress shows unplanned readmissions of Medicare FFS enrollees fell by 19 percent between 2008 and 2016 while ER use rose 33 percent and observation stays rose 71 percent. Sabbatini and Wright found that 30-day readmission rates as traditionally defined fell 19 percent among the privately insured between 2007 and 2015, but readmission rates fell only 1 percent over that period if (a) we count observation stays as an admission and (b) we count return visits within 30 days after discharge from an observation stay as a readmission. Wadhera et al. reported that 30-day readmissions among Medicare FFS enrollees as traditionally defined fell between 2012 and 2015, but that readmissions following ER visits and observations stays rose faster than readmissions fell, and the net result was an increase in total 30-day “revisits.” By my calculation, one-third of the “revisits” reported by Wadhera et al. were revisits after ER visits and observations stays.

Studies suggesting that the HRRP has increased mortality among heart failure patients also constitute evidence suggesting gaming.

[3] Here is a longer version of the Yale group’s declaration that research has clearly characterized methods by which hospitals can reduce readmission rates:

“Furthermore, randomized controlled trials have shown that improvement in the following areas can directly reduce readmission rates: quality of care during the initial admission; improvement in communication with patients, their caregivers and their clinicians; patient education; pre-discharge assessment; and coordination of care after discharge. [Sixteen endnotes followed.] Evidence that hospitals have been able to reduce readmission rates through these quality of-care initiatives illustrates the degree to which hospital practices can affect readmission rates…. Given that studies have shown readmissions within 30-days to be related to quality of care, and that interventions have been able to reduce 30-day readmission rates, it is reasonable to consider an all-condition 30-day readmission rate as a quality measure.” [p. 8]

[4] Although MedPAC laid out their rationale for the HRRP in their 2007 report, they did not formally recommend the HRRP to Congress in that report. They did that in their June 2008 report.

Kip Sullivan is a member of the advisory board of Health Care for All Minnesota, and a member of the Minnesota chapter of Physicians for a National Health Program.