Summary of IPPS Proposed Rule
You can find a pretty comprehensive report on the proposed reimbursement changes for 2008. The report was written by Larry Goldberg, senior advisor for health care
legislative and regulatory matters at Grant Thornton, LLC, an accounting, tax and business advisory firm.
[Hat tip: S-DRG Report]
Pay for Performance No Guarantee
Researchers led by the Duke Clinical Research Institute looked at whether paying hospitals extra for following specific treatment guidelines
would improve patient outcomes, and you know, reduce costs. “They found no evidence that financial incentives were associated with
improved outcomes, nor that hospitals had shifted their focus from
other areas in order to concentrate on the areas being evaluated for
possible increased payments.”
hospitals participating in a large Center for Medicare & Medicaid
Services (CMS) pilot project of pay for performance, found that paying
hospitals extra money for following specific guidelines led to better
patient care and outcomes. However, that study did not include a group
of hospitals not receiving incentives as a comparison. So the Duke team
compared the CMS data with that of a registry of 105,383 patients
treated for a heart attack at 500 hospitals involved in a national
quality improvement effort.
Did the Premier study fall victim to the Hawthorne effect? Researchers also made three important points about their study relative to the Premier study.
- “On one hand, the data showed that care is improving overall in the
United States, which is obviously good. However, we did not find that
pay for performance alone will be the sole means of improving care. In
fact, it all comes down to hard work by individual caregivers and
institutions.” [Imagine that.] - It appears that a voluntary effort to 'do good and improve care' [were] equally as powerful as the incentive for additional payment.
- Heart attack mortality declined significantly over time in
pay-for-performance and non-pay-for-performance hospitals over time
with better care processes.
Two things strike me. First, there is no silver bullet to improving patient safety and outcomes. Pay for performance is a novel incentive of some value, a carrot if you will, and CMS' proposal to stop reimbursing hospitals for the cost to treat patient's that the hospital itself has injured (initially, the 13 hospital-acquired conditions) adds a stick to the government's armamentarium to improve outcomes. A carrot and a stick together is always better than just one or the other.
I'm also struck by the admirable scientific bent physicians to apply to, well everything. According to one researcher, “…what we really need a robust research base to inform the design of
the program and clearly we need to continuously monitor performance to
ensure that we are achieving our clinical goals through these efforts.” To paraphrase, if your tool for studying change is the scientific method, then everything requires a randomized controlled double blind trial. What we need to apply to our persistent patient safety and outcomes problem is some engineering - specifically safety engineering. This is not rocket science, and has been done much more successfully in aerospace for decades.
Patient Safety Culture Survey – Take It
Associate Geoff Teed of P3 pointed me to this patient safety assessment survey the other day. Very interesting.
Patient Safety Transparency Pressures Continue
Two recent stories in Modern Healthcare highlight the continued pressure providers face on patient safety and outcomes. The Hospital Quality Alliance will be publishing hospital mortality rates later this month on this Health & Human Services web site. From the story:
then known, first released death rates for hospitals based on data from
1984. At the time, the media referred to the information simply as “the
death list,” and many hospital executives contended the raw data could
mislead patients. This time around, federal officials and healthcare
quality experts are hoping the refined mortality data release will be
better received than previous efforts.
This month the CMS will post 30-day, post-admission mortality rates for
heart attack and heart failure of patients for more than 4,000
hospitals that are Medicare fee-for-service beneficiaries. Nancy
Foster, vice president for quality and patient safety at the American
Hospital Association, a member of the Hospital Quality Alliance, said
unlike most information on the Hospital Compare site, the data are
strictly for Medicare payments. The CMS said only Medicare—using its
claims database that reflects care to the Medicare fee-for-service
population—has sufficient national data to meaningfully assess outcomes
for patients who suffer from acute myocardial infarctions and heart
failure.
Also in Modern Healthcare is this story on AHRQ's publication of sample quality report cards.
The federally funded Agency for Healthcare Research and Quality has released a Health Care Report Card Compendium,
a new Web-based directory of more than 200 sample approaches to
preparing quality report cards for use by hospitals, health plans,
medical groups, solo physician practices and nursing homes.
“The demand for information about healthcare quality is rising rapidly,
and it will be increasingly important for this information to be
presented clearly and effectively,” AHRQ Director Carolyn Clancy said
in a news statement. “Report card developers can use the examples from
the Health Care Report Card Compendium to explore the scope and
information they might want to cover, as well as various approaches to
presenting their own organization's comparative data.”
You can visit the compendium page here. While everyone in health care is in it to save lives, the industry as a whole embodies certain character flaws that cause us to resist change – even when it's the right thing to do. But between withholding reimbursement for preventable adverse event and publicly available patient safety and outcomes data, those that change will thrive and those that don't will fail – and rightfully so.
Bed Sore Treatment Device Gains Momentum
Israeli company Life Wave appears to be gaining momentum in the market with their medical device for treating bed sores (pictured right). According to Globes online, the company has signed two new European distributors. Bed sores are one of the 13 preventable hospital-acquired conditions that for which CMS will stop paying hospitals to treat in 2008 (more here).
Each distributor will have exclusive marketing rights in their countries for LifeWave’s BST and disposable electrodes.
The
company said that with these two new deals, it now has exclusive
marketing agreements with five distributors in five European countries.
Since hospitals will be on the hook for any costs related to treating preventable bed sores, any device that proves cost effective in treating bed sores should do quite well in the U.S.
At right is the Life Wave device and disposable electrodes.
Welch Allyn Launches Clinical Notification System
At the AACN/NTI, Welch Allyn launched the alarm notification system that was shown for the first time at HIMSS in New Orleans. Alarm notification has been a persistent patient safety issue of such magnitude that the Joint Commission added it to their National Patient Safety Goals in 2003 and 2004.
Conventional alarm notification can be local, i.e., the alarm is annunciated at the device; alarms can be conveyed to a central station; and sometimes includes message panels, lights and annunciators distributed throughout the unit. Of course, all the flashing lights, alarms and blinking message panels contribut to alarm fatigue – a major factor in adverse events and failure to rescue.
The optimal solution for safe and effective alarm notification is to deliver the alarm directly to the responsible caregiver, where ever they are on the unit. The first vendor with this kind of alarm notification was Baxter with their Colleague “smart” pump – they use a Symbol PDA that receives alarms based on nurse to patient assignments. Welch Allyn is the first patient monitoring vendor with such a solution.
The AcuityLink clinical notification system provides alarm notification and escalation for life critical alarms, as well as near real time surveillance of moving waveforms from one to several patients. The system is designed to be safe and effective in a wireless environment where caregivers go in and out of wireless coverage and may leave the unit to transport a patient or take a break. The system has pre market approval via a 510(k) for alarm notification. In recognition that caregivers can't carry a PDA dedicated to each of the medical device vendors on their unit, AcuityLink does not preclude customers from loading and running third party software on the PDA. (In contrast, the Baxter PDA is “locked” and must be dedicated to running Baxter's application.)
Here's a link to an “editorially massaged” version of the press release, and an apparently unmodified press release. I looked for a copy of the press release and product information on the Welch Allyn sites (corporate and monitoring) and couldn't find a thing. Perhaps someone can send me a link once something is up.
Pictured right is the AcuityLink PDA (really a HandHeld Products 7900) showing a snippet of ECG waveform that accompanies each alarm – this provides the caregiver an opportunity to determine if the alarm is a false positive (a frequent occurrence that results from patient movement) or an actual alarm. Shot at HIMSS 2007.
UPDATE: If you're interested in alarm notification, alarm fatigue and the future direction of medical device alarms, check out this article I wrote for Patient Safety & Quality Healthcare magazine, called Trends in Point-of-Care Alarm Notification.
Commenter Dave Hoglund mentions the Philips-Cisco-Emergin integration that provided alarm notification with a sample waveform on a Cisco wireless VoIP phone (using Emergin middleware) . This was shown a couple years ago at HIMSS in Dallas and made it's way into a Cisco brochure.
First off, alarm notification is unambiguously a “medical device” as defined by law and thus requires pre market approval by the FDA. Secondary alarm notification is a term of art created by vendors who sell alarm notification without pre market approval – the continued existence of this class of product is a consequence of the FDAs decision to look the other way if the alarm is simply a text alarm and does not include waveforms. I think the FDAs position is pretty smart – “secondary” alarm notification does provide some benefit, and the public's interest is probably not best served by yanking all those products from the market. At the same time, regulated alarm notification systems with proven safety and effectiveness (a consequence of pre market approval) better serves the public interest, so vendors are being pushed in that direction. To effect this push the FDA has been rapping knuckles when secondary alarm notification systems include waveforms. Alarm notification for many types of alarms are of limited utility without presenting a waveform with the alarm to filter out false/positive alarms; the market wants waveforms.
In the Philips-Cisco-Emergin example that Dave mentions, Philips was in the best position to 1) know that a 510(k) was required, and 2) to actually get pre market approval for the alarm notification feature. It certainly does not make sense for Cisco to get a 510(k) on their wireless VoIP phone as a medical device. As an event management middleware vendor targeting hospitals, a case could be made for Emergin to get a 510(k) – many events that occur at the point of care could theoretically fall under the legal definition of a medical device – but this is not necessary either.
There is a savvy product strategy in all of this somewhere – actually more than one.
