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Part II | MedPAC’s Proposed “Reforms” Should Be Tested Before They’re Implemented: CMS’s Hospital Readmissions Reduction Program Is Exhibit A

By KIP SULLIVAN JD 

The Hospital Readmissions Reduction Program (HRRP), one of numerous pay-for-performance (P4P) schemes authorized by the Affordable Care Act, was sprung on the Medicare fee-for-service population on October 1, 2012 without being pre-tested and with no other evidence indicating what it is hospitals are supposed to do to reduce readmissions. Research on the impact of the HRRP conducted since 2012 is limited even at this late date [1], but the research suggests the HRRP has harmed patients, especially those with congestive heart failure (CHF) (CHF, heart attack, and pneumonia were the first three conditions covered by the HRRP). The Medicare Payment Advisory Commission (MedPAC) disagrees. MedPAC would have us believe the HRRP has done what MedPAC hoped it would do when they recommended it in their June 2007 report to Congress (see discussion of that report in Part I of this two-part series). In Chapter 1 of their June 2018 report to Congress, MedPAC claimed the HRRP has reduced 30-day readmissions of targeted patients without raising the mortality rate.

MedPAC is almost certainly wrong about that. What is indisputable is that MedPAC’s defense of the HRRP in that report was inexcusably sloppy and, therefore, not credible. To illustrate what is wrong with the MedPAC study, I will compare it with an excellent study published by Ankur Gupta et al. in JAMA Cardiology in November 2017. Like MedPAC, Gupta et al. reported that 30-day CHF readmission rates dropped after the HRRP went into effect. Unlike MedPAC, Gupta et al. reported an increase in mortality rates among CHF patients. [2]

We will see that the study by Gupta et al. is more credible than MedPAC’s for several reasons, the most important of which are: (1) Gupta et al. separated in-patient from post-discharge mortality, while MedPAC collapsed those two measures into one, thus disguising any increase in mortality during the 30 days after discharge; (2) Gupta et al.’s method of controlling for differences in patient health was superior to MedPAC’s because they used medical records data plus claims data, while MedPAC used only claims data.

I will discuss as well research demonstrating that readmission rates have not fallen when the increase in observation stays and readmissions following observations stays are taken into account, and that some hospitals are more willing to substitute observation stays for admissions than others and thereby escape the HRRP penalties.

All this research taken together indicates the HRRP has given CHF patients the worst of all worlds: No reduction in readmissions but an increase in mortality, and possibly higher out-of-pocket costs for those who should have been admitted but were assigned to observation status instead.

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MedPAC’s Proposed “Reforms” Should Be Tested Before They’re Implemented: CMS’s Hospital Readmissions Reduction Program Is Exhibit A

By KIP SULLIVAN JD 

Egged on by the Medicare Payment Advisory Commission (MedPAC), Congress has imposed multiple pay-for-performance (P4P) schemes on the fee-for-service Medicare program. MedPAC recommended most of these schemes between 2003 and 2008, and Congress subsequently imposed them on Medicare, primarily via the Affordable Care Act (ACA) of 2010 and the Medicare Access and CHIP Reauthorization Act (MACRA) of 2015.

MedPAC’s five-year P4P binge began with the endorsement of the general concept of P4P at all levels – hospital, clinic, and individual physician – in a series of reports to Congress in 2003, 2004, and 2005. This was followed by endorsements of vaguely described iterations of P4P, notably the “accountable care organization” in 2006 [1], punishment of hospitals for “excess” readmissions in 2007 [2], the “medical home” in 2008 and the “bundled payment” in 2008. None of these proposals were backed up by anything resembling evidence.

Congress endorsed all these schemes without asking for evidence or further details. Congress dealt with the vagueness of, and lack of evidence supporting, MedPAC’s proposals simply by ordering CMS to figure out how to make them work. CMS staff added a few more details to these proposals in the regulations they drafted, but the details were petty and arbitrarily adopted (how many primary doctors had to be in an ACO, how many patients had to sit on the advisory committee of a “patient-centered medical home,” how many days had to expire between a discharge and an admission to constitute a “readmission,” etc.).

New rule, new culture

This process – invention of nebulous P4P schemes by MedPAC, unquestioning endorsement by Congress, and clumsy implementation by CMS – is not working. Every one of the proposals listed above has failed to cut costs (with the possible exception of bundled payments for hip and knee replacements) and may be doing more harm than good to patients. These proposals are failing for an obvious reason – MedPAC and Congress subscribe to the belief that health policies do not need to be tested for effectiveness and safety before they are implemented. In their view, mere opinion suffices.

This has to stop. In this two-part essay I argue for a new rule:  MedPAC shall not propose, and Congress shall not authorize, any program that has not been shown by rigorously conducted experiments to be effective at lowering cost without harming patients, improving quality, or both. This will require a culture change at MedPAC. Since its formation in 1997, MedPAC has taken the attitude that it does not have to provide any evidence for its proposals, and it does not have think through its proposals in enough detail to be tested. Over the last two decades MedPAC has demonstrated repeatedly that it believes merely opining about a poorly described solution is sufficient to discharge its obligation to Congress, taxpayers, and Medicare enrollees.
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The Usefulness and Uselessness of Electronic Medical Records

Nothing is so useless as a general maxim.

Lord MacCaulay (1800-1859), On Machiavelli (1827)

I dare say that I have worked off my fundamental formula on you that the chief end of man is to frame general propositions and that no general proposition is worth a damn.

O.W Holmes, Jr. (1809-1904), as quoted in The Practical Cogitator, 1962


The general maxim and general proposition behind the rationale of a national interoperative electronic medical record system in every physician’s office is that you can never get too much information and that government can use digital data to cut costs and improve care.

The Problem

Sounds good, doesn’t it? The problem is that so far, after nearly a decade of advancing this maxim and proposition, perhaps 80% of physicians in independent practice aren’t buying. And this, in face of the reality, that government has proposing spending $27 billion to get EHRs off the ground. And beginning this year, CMS will start offering as much as $44,000 per physician over a staggered five years if physicians make “meaningful” use of “certified” medical records. Many doctors regard such rhetoric as empty talk that will accompanied by unreasonable bureaucratic requirements, as surely as dawn following night.

Why no “buy-in” among doctors? Why have two national IT coordinators appointed by Obama, David Brailer,ND, in 2005 and David Blumenthal, MD, in 2011, resigned in frustration over the failure to persuade doctors that gathering electronic data and measuring care is a good thing? If universal EHRs are such a good thing, why have physicians and hospitals not raced to embrace EHRs?

As Steve Lohr of the New York Times, a leading thinker in health care innovation, says in yesterday’s Times (“Seeing Promise and Peril in Digital Records,”

“What is beyond doubt is that the promise of digital records will be unfulfilled if doctors refuse to adopt them, because they regard the technology as cumbersome, time consuming, and possibly dangerous.”

To date, most doctors, except for enthusiastic early adopters, IT nerds, and those in large organizations, have found EHRs “useless” in their daily work. EHRs cost excess money, show little return on investment, change the very nature of practice, slow productivity, tell no narrative tales, cause conflicts among staff and colleagues, require extensive record keeping, are subject to hacking, and, more often than not, are useless as a tool for communicating to colleagues, hospitals, and other doctors outside your practice.

When the government establishes “usability standards” that work, maybe doctors will come on board the electronic train. Until then, says Dr. Edward H. Shortliffe , a professor at the University of Texas Health Science Center in Houston, “Usability is going to be the single greatest impediment to physician acceptance. “

If EHRs are not made more useful and soon, universal digital records may turn out to be a giant boondoggle rather than a scientific bonanza.

Richard L. Reece, MD, is pathologist, editor, author, speaker, innovator, and believer in abilities of practicing doctors and their patients to control and improve their health destinies through innovation. He is author of eleven books. Dr. Reece posts frequently at his blog, Medinnovation.

HIT Trends Summary for August 2011

This is a summary of the HIT Trends report for August 2011.  You can get the current issue or subscribe here.

Incentives driving the EMR market. According to a report by Sage Healthcare, most physicians (65%) buying EMRs are doing so because of federal incentives.  The biggest obstacle is still cost with 32% of non-users saying it’s the number one issue.  This is creating a mainstream market, even in solo practices, which report over 30% EMR adoption rates in a new survey by SK&A.

Incentives may also be driving hospital implementation of computerized physician order entry (CPOE).  80% of hospitals still lack CPOE capabilities as of last year.  Meaningful use requires providers to order at least one medication for 30% of unique hospital patients.  In a new KLAS report, CPOE projects have more than doubled, being led by Cerner and Epic.

It is a likely unintended consequence that the incentives are speeding the dominance of market leaders.

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Don Berwick, Martyr for Socialized Medicine

I have a piece up at National Review in which I reflect upon Don Berwick’s controversial tenure as Administrator of the Centers for Medicare and Medicaid Services, the 800-billion-dollar federal agency that dominates the American health-care landscape. Despite White House rhetoric to the contrary, I write, Berwick “wasn’t done in by Republican intransigence. He was done in by presidential cowardice. And therein lies a microcosm of everything that’s been wrong with Obamacare.”

The thing to understand about Don Berwick is that there are really two Don Berwicks. There’s the Don Berwick who, through the Institute for Healthcare Improvement, has focused on apolitical aspects of health delivery reform. Here’s what I wrote about Berwick in April 2010:

First, the good. Berwick is a serious and credible health-care analyst. In his capacities both as a Harvard professor and as founder and CEO of a Cambridge-based think-tank called the Institute for Healthcare Improvement, he has written extensively about health-care policy in all of the leading scholarly journals. His focus, in most of these writings, is on the quality and efficiency of health care: things like avoiding medical errors and unnecessary spending. He was granted an honorary knighthood by Queen Elizabeth for his role in shaping Tony Blair’s (mostly futile) attempts to modernize Britain’s National Health Service.

While he was a big supporter of Obamacare, Sir Donald acknowledges its core failing; in an October lecture, he said, “Health-care reform without attention to the nature and nurture of health care as a system is doomed. It will at best simply feed the beast, pouring precious resources into the overdevelopment of parts and never attending to the whole — that is, care as our patients, their families, and their communities experience it.” Indeed, if you put Berwick in a room with a leading market-oriented health-care analyst, the two would find broad areas of agreement as to where our health-care system fails patients.

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As Goes the Post Office, So Too Medicare?

With the announcement that the Center for Medicare and Medicaid Services (CMS) will begin auditing 100% of expensive cardiovascular and orthopedic procedures in certain states earlier this week, we see their final transformation from the beneficient health care funding bosom for seniors to health care rationer:

The Center for Medicare and Medicaid Services will require pre-payment audits on hospital stays for cardiac care, joint replacements and spinal fusion procedures, according to the American College of Cardiology in a letter to members. Shares in both industries fell with Tenet Healthcare Corp., the Dallas- based hospital operator, plunging 11 percent to $4.18, the most among Standard & Poor’s 500 stocks. Medtronic Inc., the largest U.S. maker of heart devices, dropped 6 percent to $34.61.

The program means hospitals won’t receive payment for stays that involve cardiac care or orthopedic treatment until auditors have examined the patient records and confirmed that the care was appropriate, Jerold Saef, the reimbursement chair for the Florida chapter of the American College of Cardiology, wrote in a Nov. 21 letter to members. The review process is expected to take 30 days to 60 days, beginning January 1, Saef said.

This is not at all unexpected. In fact, in our field of cardiac electrophysiology, we have known this day would be coming; our expensive, life-saving gadgets and gizmos are easy targets upon which the government can cut its rationing teeth. And so as it will go for us at first, and then for many other areas of health care.

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Physician Payment Sunshine Act Proposed Regulations Out

CMS has published proposed rules for its implementation of the Physician Payment Sunshine Act (SUNSHINE ACT or Act), which was enacted by Congress as part of the 2010 Patient Protection and Affordable Care Act.  In short, the SUNSHINE ACT requires life science companies to report annually to CMS their conferral of anything of value, whether it be payment for services or a dinner, in connection with a particular product of the paying company.  By requiring CMS to post the information on its website, the Act seeks to ensure that interested patients become aware of physicians’ conflicts of interest that could affect their prescription of a branded drug or choice of a specific medical device.

The SUNSHINE ACT represents another example of the transparency movement, which has had varying degrees of success in either changing the behavior of the parties subject to disclosure, and/or enabling consumers to make better decisions based upon their access to the disclosed information.  It is likely that the SUNSHINE ACT will impact physicians and manufacturers’ behavior more than it will enlighten consumers about conflicts of interest.  Some physicians will simply conclude that accepting certain gifts or benefits from pharmaceutical or medical device companies isn’t worth having their names on the CMS website.  Some companies have already discovered that they haven’t necessarily reaped the value of the costs of gifting many physicians, or that the cost of recording certain activities simply isn’t worth the return on investment.  Unquestionably, certain transactions will continue to be valuable to both physician and company, and will continue.

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EHR and Practical, Tactical Outcomes

I hope people are watching the news around the Meaningful Use attestation data released by CMS recently, because it is so instructive as to the difference between where we are in health care and where the deliverers of keynotes THINK we are. Since last September, we’ve been publishing our Meaningful Use (MU) dashboard data and as of this week for example, we know that 83% of our Medicare MU doctors have attested to the measures.

But our constraints as a marketplace are at the practical, tactical level. According to our analysis, some 48% of what doctors order does NOT turn into a documented update to the chart within 60 days of that order. And we all know the average EHR makes docs go slower—causing employment by hospitals in large numbers—at large losses to the hospital. And NOW, based on the CMS data, it looks like a large percentage of docs are on track to miss a bloody lay-up of a bonus from the federal government! Do you guys really think we are going to build integrated ACOs that drive down hospitalization?

Pass it on—we are further behind than we think we are, and we need to hold ourselves accountable for PRACTICAL, TACTICAL outcomes before we even talk about grand outcomes like “total quality.” So what do we do? So glad you asked. I hazard three guesses, and you guys can throw in more… or challenge mine.

1. Make a market for health information exchange. Today, HIE is universally used as a NOUN. It’s a thing you buy from Aetna or Lockheed Martin or IBM. In every other information supply chain I know of, people who WANT info PAY others to give that info to them. They pay only when the info is delivered in usable form. This is, of course, not allowed in health care, but it can be. We should get behind legislation that allows for the most rudimentary mechanism for exchange in the history of man.

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Separating Professional and Hospital Records

As Patient Centered Medical Homes and Accountable Care Organizations form, the lines between professional and hospital practice become increasingly murky.

CMS has long required that hospital and professional records be separable, so that in the case of audits or subpoenas, it is clear who recorded what.

Today, the BIDMC ACO continues to expand into the community, adding owned hospitals, affiliated hospitals, owned practices, and affiliated practices.

Our strategy to date has been to use our home-built inpatient and ambulatory systems at the academic medical center, Meditech in the community hospitals, and eClinicalWorks in private ambulatory practices which are part of our ACO.

We share data among these applications via private and public HIE transactions – viewing, pushing, and pulling.

The challenge with emerging ACOs is that professionals are likely to work in a variety of locations, each of which may have different IT systems and each of which serves as a separate steward of the medical record from a CMS point of view.

Our clinicians are asking the interesting question – can I use a single EHR for all patients I see regardless of the location I see them?

Our legal experts are studying this question.

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Meaningful Use — A Pinch of 3 and a Dash of 4

While most folks are busy trying to keep up with Meaningful Use Stage 1, and Meaningful Use Stage 2 only recently emerged from the customary rulemaking process, those who plan for distant futures are providing us a glimpse of what is being considered for Meaningful Use Stage 3 and here and there a hint at the possibility of a never before mentioned Stage 4 and beyond. Since Stage 2 is still somewhat theoretical, there is little value to enumerating the proposed measures of Stage 3, which is not due to take effect until 2016, but it may prove instructive to take a general look at the overall direction that seems to be favored by policy makers for future design and use of EHR technologies. To that end, several new proposed measures seem most enlightening.

The New US Census Bureau

Stage 1 of Meaningful Use added language, race and ethnicity to the customary demographic information collected from patients, such as name, address, date of birth, gender, etc. Stage 2 proposes to add language, race and ethnicity to clinical summaries provided to patients or sent to other providers of care. So the patient header of a Stage 2 clinical summary might look something like this:

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