Sunday, November 20, 2011

Thanksgiving in Health Care

Thanksgiving is almost here and between shopping for yams and turkeys and waiting for the cranberries to pop in the saucepan, there is ample time for reflection. Most folks evaluate the past year and make predictions for the next somewhere around Christmas, but since little serious business is conducted after Thanksgiving, and I’d rather leave predictions to professional gamblers, this is the week where I sift through this year’s events and try very hard to elicit personal feelings of gratitude. Since this is a health care blog, here are some health care related things I am very thankful for, and since like most social media aficionados, I too have a very short attention span, most are rather recent events.
  • First and foremost I would like to thank the Supreme Court of the United States for agreeing to hear arguments from the States, the Federal Government and small businesses backed by large businesses, on the Patient Protection and Affordable Care Act (PPACA) (a.k.a. Obamacare). Although having PPACA end up in front of the Supreme Court was a foregone conclusion since before the ink was dry on the President’s signature, and perhaps long before that, I am particularly grateful for the Supreme Court’s chosen timing for making a decision on this matter. The Court will hear arguments early in the spring of 2012, and if all goes according to plan it will either uphold or obliterate President Obama’s most important policy achievement just in time to inform my decision on who to vote for in the Presidential elections. It means a lot to me, and I am sure to many other conflicted voters, to have the advice of the wisest nine men and women in the land, and it is much more elegant and efficient to mentor us now instead of having to fix the issue after the elections take place.
  • Second, I would like to express my gratitude to Walmart who is finally volunteering to extend its unparalleled efficiencies in supply chain management to health care. Like most Americans, I have seen my health insurance premium go up by almost 20% recently and my deductible has too many zeros to fit in that little box on a standard check. It is reassuring to know that very soon Walmart will do for health care what it did for tee-shirts and accessories. Obviously, any organization that can put a plastic Luis Vuitton handbag in the hands of the humblest day laborer can surely be relied upon to bring PSA testing and chronic disease management to every hamlet and every housing project in the land. And even though I have no plans to start shopping at Walmart, particularly for health care, I am looking forward to the proven Walmart effect on prices of medical products and wages, which should make all health care, affordable for all of us.
  • On a more technical, and more work related note, I need to thank the FDA for unequivocally excluding Electronic Health Records (EHR) from its proposed regulation of mobile medical applications. The mobile health (mHealth) field is in its infancy and chock full of bright eyed and bushy tailed young entrepreneurs who can obviously benefit from FDA guidance just like their brethren in the perpetually sizzling bio-tech and device industry already do, with more innovation than any investor can handle percolating up all day every day. On the other hand, the frail and elderly EHR field, led by billion dollar technology and insurance companies, is in no position to withstand the rigors of FDA regulatory activities, which may inadvertently interfere with the massive life supporting cash infusion from government initiatives.
  • For a closely related effort, I am also grateful to the Institute of Medicine (IOM) for its recent report supporting the FDA position on EHR regulation. While acknowledging the inherent patient safety issues posed by use of EHR devices, the IOM is proposing a tangled web of voluntary and non-regulatory boards and organizations to be created for the purpose of observing and guiding EHR product use and development. The IOM does recognize that the system it proposes may very well fail to address the issue at hand, in which case it recommends that the FDA comes in to the rescue as a last resort. Hopefully by then EHR companies will have had every chance to absorb the Federal flow of cash to the industry in its entirety.
  • A few days ago we observed Veterans Day and we all expressed our heartfelt thanks for the sacrifices made by our men and women in the armed services. I would also like to thank Congress and its Super Committees for going above and beyond gratitude, and actively trying to provide our Veterans, even those who are too old, too depressed or otherwise incapacitated, with one more chance to serve our country. As we sink deeper and deeper in debt, there is a great opportunity for millions of heroes to forgo a little bit of health care services, or pay a bit more for each, so the greatest nation on earth can save a whopping $11 billion each year. Compared to putting oneself in harm’s way, this is easy stuff and while it is true that one large corporation, like GE for example, could single handedly create those savings just by paying their taxes for the year, it is much more meaningful that the glory should go to our Veterans. It is the right thing to do and I am so proud of our honorable members of Congress.
  • Finally, I would like to thank Congress one more time for perhaps the most extraordinary achievement in its history, and that is transforming pizza into a vegetable. Granted the Supreme Court of 1893 paved the way by declaring the tomato fruit to be a vegetable, but combining white flour and globs of animal fat into the texture of this new vegetable is nothing short of miraculous. Although Congress accomplished this in the context of ensuring that our children eat healthy food in school cafeterias, I am certain that many adults and most children will incorporate more of this wonderfully healthy vegetable in their diets outside of school lunch, and I for one, will try very hard to find a creative way to add this Congressional vegetable to our Thanksgiving table this year.
Now that I thanked all I could think of, and before I return to my bubbling cranberry sauce, I would like to ask for one little thing. Bypassing the Congressional middlemen, and going straight to the top, I would like to ask Hershey and Nestlé and all other multi-national decision makers, if it would be possible to make chocolate a vegetable too. Since cocoa beans grow on trees, chocolate is practically a fruit as it is, so making it a vegetable should be trivial in view of the various precedents quoted above, and it would mean so much to me and to countless other women and children trying hard to take personal responsibility for their own health and health care.
Happy Thanksgiving everybody!

Wednesday, November 9, 2011

The IOM Report on Health IT Safety

A recent report from the Institute of Medicine (IOM),  “Health IT and Patient Safety: Building Safer Systems for Better Care”, introduces a new health care related term, "Health IT-assisted care", defined as "health care and services that incorporate and take advantage of health information technologies and health information exchange for the purpose of improving the processes and outcomes of health care services. Health IT–assisted care includes care supported by and involving EHRs, clinical decision support, computerized provider order entry, health information exchange, patient engagement technologies, and other health information technology used in clinical care”. And the IOM report, as its title implies, is recommending strategies to ensure that health IT-assisted care is safe for patients.

The IOM report presents a comprehensive literature review regarding the status of health IT as it pertains to patient safety from every conceivable angle, starting with the manufacturing process and drilling down into product selection, implementation processes, training, and actual use of EHRs and other health IT products. As most folks who follow the health IT industry know all too well, the report concludes that data concerning the effects of health IT on patient safety is currently scarce and inconclusive. Nevertheless, the scarcity of data and the “sparse evidence pertaining to the volume and types of patient safety risks related to health IT” did not prevent the committee from acquiring “the sense that potentially harmful situations and adverse events caused by IT were often not recognized and, even when they were recognized, usually not reported”. That maybe so and again it may be that what we see is all there is to see. Either way, “[t]he committee believes the current state of safety and health IT is not acceptable; specificactions[sic] are required to improve the safety of health IT”. To that end, the report presents 10 recommendations to the Secretary of Health and Human Services (HHS).
  1. HHS should create and publish an action plan in the next 12 months to assess the risk of health IT for patient safety and begin mitigation through education, research, standardization and the testing and accreditation of health IT products. Suggested organizations for funding and carrying out these activities are ONC, AHRQ and NLM.
  2. HHS should insure that health IT vendors freely exchange information regarding issues as they pertain to patient safety. This is where the infamous gag clauses in EHR contracts should be addressed.
  3. ONC should work with public and private sectors to make user reports of patient safety issues publicly available. NCQA and JCAHO are amongst the suggested implementers.
  4. HHS should fund the creation of a new Health IT Safety Council to evaluate criteria for measuring safety of health IT.
  5. ONC should require all health IT vendors to publicly register with the agency.
  6. HHS should define mandatory quality management processes for health IT vendors. ONC, FDA and certification bodies are suggested organizations for administering a compliance process.
  7. HHS should establish a mechanism for reporting adverse events which is mandatory for vendors and voluntary for users. Reports should be collected analyzed and acted upon.
  8. Congress should create an independent federal entity, similar to the National Transportation Safety Board (NTSB), to investigate the reports collected in item 7 above.
  9. HHS should monitor progress and if found lacking, should direct the FDA to exercise its full authority to regulate health IT. The FDA should immediately begin preparing the infrastructure for this eventuality.
  10. HHS should support cross disciplinary research of safety aspects of health IT, such as user centered design, safe implementation methods, sociotechnical systems, and effects of policy decisions on health IT.
This is a very impressive and very well-reasoned list of tactical and strategic initiatives, but it also presents some difficulties. First, reporting adverse events is a prerequisite to almost all activities recommended by the committee. It is not clear how such reporting is to be implemented when malpractice suits are a consideration. The report suggests that reports should be kept private, even anonymised, and that users should be protected from punitive actions. Does this protection extend to legal action? If the report-collection agency becomes aware that a patient died due to preventable error, should the patient’s family be notified? Should malpractice attorneys be allowed to review this public information and subpoena the identifiable data? Second, all ten recommendations made by IOM require significant funding and it is not clear where the monies should come from at the moment. The recommendation in item 9 above, that the FDA readies itself for full regulation of health IT as a contingency plan if all else fails, seems duplicative and particularly wasteful. Somehow the committee seems to believe that FDA regulation, unlike regulation by multiple disjointed organizations, would negatively affect anticipated innovation in health IT.

Speaking of the FDA, the immediate question, of course, is why do we need a 137 page report from the IOM to figure out how and who should oversee patient safety? The Food and Drug Administration (FDA) is currently overseeing patient safety issues arising from surgery-assisted care, radiology-assisted care, pharmaceutical-assisted care, implantable device-assisted care and all sorts of other types of assisted care. Most recently the FDA published its proposal to oversee mobile device-assisted care (phones, tablets and laptops). How and why is health IT-assisted care different? How is a medication dosing calculator on an iPhone different than the same calculator in an EHR? How is an iPhone connected to a blood pressure cuff different than an EHR connected to a blood pressure cuff?

To my immeasurable delight, the IOM report contains the answer in the Dissent Statement of Dr. Richard Cook. While the IOM report is recommending that health IT be regulated and monitored by a smorgasbord of existing or yet to be created organizations, none of which have the required expertise to tackle the task, and all of which will need to be heavily funded for this endeavor, with the FDA as a last resort measure, Dr. Cook proposes to allow the FDA to do its job in the first place.  Dr. Cook’s simple and straightforward recommendation is to have HHS “direct the FDA to exercise its authority to regulate health IT, including all EHRs and associated components, and health information exchanges, as Class III medical devices”. While possessing all salient characteristics of a Class III device, “health IT is on track to be a medical device used for every person in the United States” [italics in the original], which makes it both urgent and imperative to have health IT regulated and monitored properly and Dr. Cook's conclusion succinctly sums it all up: "health IT is a medical device. It should be regulated as a medical device now and should have been regulated as a medical device in the past".