Over time, the app maturity model will see apps progress from being recommended on an ad hoc basis by individual physicians, to systematic use in healthcare, and ultimately to an end goal of being a fully integrated component of healthcare management. There are four key steps to move through on this process: recognition by payers and providers of the role that apps can play in healthcare; security and privacy guidelines and assurances being put in place between providers, patients and app developers; systematic curation and evaluation of apps that can provide both physicians and patients with useful summarized content about apps that can aid decision-making regarding their appropriate use; and integration of apps with other aspects of patient care. Underpinning all of this will be the generation of credible evidence of value derived from the use of apps that will demonstrate the nature and magnitude of behavioral changes or improved health outcomes.
We are nowhere near this endpoint -- integration of the use of health apps into health care management -- right now, due to a number of factors.
The new darling of the online educational community is Massively Open Online Courses (MOOCs). The example which figures most prominently in the popular imagination is the Khan Academy, though its founder says otherwise, noting that MOOCs are merely online transplantations of traditional courses, while Khan Academy offers something different.
Others would take issue with his conclusion, or characterization. A "connectivist" MOOC is based on four principles:
Aggregation. The whole point of a connectivist MOOC is to provide a starting point for a massive amount of content to be produced in different places online, which is later aggregated as a newsletter or a web page accessible to participants on a regular basis. This is in contrast to traditional courses, where the content is prepared ahead of time.
Remixing, that is, associating materials created within the course with each other and with materials elsewhere.
Re-purposing of aggregated and remixed materials to suit the goals of each participant.
Feeding forward, sharing of re-purposed ideas and content with other participants and the rest of the world.
Sounds great, but is it working? Can it work? A piece in the current issue of The Washington Monthly took a look and concluded:
Given the current 90 percent dropout rate in most MOOCs, an 8-point gap in completion rates between traditional and online courses offered by community colleges, the 6.5 percent graduation rate even at the respected Western Governors University, and the ambiguity of many other higher education reform ideas, there’s good reason to think that an unbound future might not be so great.
The best American innovations in education were the Land-Grant College Act of 1862, which helped create a system of public universities, and the GI Bill of 1944, which ensured that an entire generation had the money to attend college. This widespread access to the college experience enabled people from working-class backgrounds to advance en masse into professional jobs that required reasoning and logic and extensive knowledge of the world. The question is whether or not we will continue this trend or simply give up and say that a few online classes and specialized training are good enough for the majority of Americans.
In other words: Democratization of higher education - good; MOOCs - not so much.
Why is this relevant to you, gentle reader?
The question is whether the promise of MOOCs, or their inability to deliver, will characterize MOOM -- Eric Topol's neologism, "Massively Open Online Medicine," used in his HIMSS 2013 keynote.
In health care, a perfect implementation of big data and data analytics, combined with open access for clinicians and patients, would yield a success in MOOM along the lines of a connectivist MOOC.
We are not there yet, but Topol (who, by the way, has joined me and a growing number of others as a member of The Walking Gallery, dedicated to the very relevant themes of patient empowerment and data liberation ... see his jacket, Bursting from Within and mine, Friendship Pins) continues to call for a move to population health practiced based on individualized information, which would tend to rely on a population of quantified self adherents and e-patients. Unfortunately, at present these are vanguard groups, the minority blazing the way for the majority. There are numerous initiatives afoot seeking to leverage big data, analytics and the health care system to provide population health (a more traditional example: the Accountable Care Organization). Indeed, the future probably holds an even more radical shift away from the health care delivery system as we know it today (Topol spreads the meme of 80% of physicians not being needed in the future) with home-based and wearable sensors replacing much of the current way of practicing diagnostic medicine.
Given the FDA's recent smoke signals about mHealth guidance being issued in the near future, perhaps that future is in fact inching closer, but it seems to me that it will take some time before the democratization of medicine, or health care, or health can truly take hold. The current health care data privacy and security rules -- like so many regulatory constructs -- are designed to fight the last war, not for the current field of maneuver. Technology, delivery systems and rules all need to change before real improvement can bloom. Just as in the case of education there remains a high value in traditional higher education that has not yet been replicated in the MOOCs, MOOM has not yet delivered on its promise.
Here's hoping we don't have to wait as long as the time between the land grant college act and the GI Bill.
The latest news story to examine the issue of patient access to implantable cardiac defibrillator data (a variation on the theme of “gimme my damn data”) is an in-depth, Page One Wall Street Journal story featuring Society for Participatory Medicine members Amanda Hubbard and Hugo Campos. They have garnered attention in the past – one example is another piece on Hugo on the NPR Shots blog about six months back. The question posed by these individuals is simple — May I have access to the data collected and/or generated by the medical device implanted in my body? — but the responses to the question have been anything but. It is important to note that not every patient in Amanda’s or Hugo’s shoes would want the data in as detailed a format as they are seeking to obtain, and we should not impose the values of a data-hungry Quantified Self devotee on every similarly-situated patient. Different strokes for different folks.
The point is that if a patient wants access to this data he or she should be able to get it. What can a patient do with this data? For one thing: correlate activities with effects (one example given by Hugo is his correlation of having a drink of scotch with the onset of an arrhythmia — correlated through manual recordkeeping — which led him to give up scotch) and thereby have the ability to manage one’s condition more proactively.
Data from implantable medical devices is not covered by HIPAA until it is sent to the patient’s physician (on a periodic basis and usually in edited form — other data is typically retained by the device manufacturer) and entered into the patient’s medical record. It is, rather, governed by FDA rules, and the recent attention to this issue has prompted an FDA spokesperson to say that it would review a plan to give data directly to patients, but that data should be directed to physicians who can interpret it for patients. This is where the action will be in the future: the FDA could develop a framework to allow sharing of this data directly with patients. (The data is collected wirelessly in patients’ homes from the implantable devices.)
Not surprisingly, earlier this year, a Medtronic exec referred to the data in question here as “the currency of the future.” There is clearly a market for the secondary use of patient data — on a de-identified, or anonymized basis — for a variety of purposes, and this is the “big data” we are all hearing about so much lately. (The HIPAA enforcers at HHS recently released guidance on the de-identification of patient data for secondary use — i.e., use for research purposes.) There is value to be extracted from big data, and the question is: Who owns the value? Who owns the data? Suffering as I do from the professional disability of being a lawyer, I am reminded of Moore v. Regents of the University of California, the 1990 California Supreme Court case that found that Mr. Moore, a cancer patient who sought to share in the profits for the commercial cell line developed from cancer cells in a tumor removed from his body, had no property rights in his discarded body parts. Moore could perhaps be read to support the device manufacturers’ perspective that there is no value in the data coming from the implantable device until it is processed by the manufacturer.
Another perspective would be that each patient has a property right in the data generated by his or her body or implants. There have been a couple of discussions on e-patients.net and elsewhere about the notion of a “green button” or a “rainbow button” that would serve as a mechanism for patients to decide how to share their own data (in those cases, the discussion was focused on EHR data, but the principles ought to be the same here). If I want to share my EHR or device data with all, so that it may be aggregated with other patient data and used in research and the development of evidence-based medicine protocols, then I should be able to do so. If I want to donate that data gratis, or if I want to see a small license payment collected by an intermediary (a la the Copyright Clearance Center), if I want to permit it to be used with full identifiers, or as a de-identified record, I should be able to do that.
The quest of patients with implanted devices to gain rights to data should not have to be so quixotic. The information in question is subject to a different regulatory scheme than EHR data, but that is an accident of history, technology and politics. There is no fundamental distinction between a series of MRI images, or a blood test result, and a set of data downloaded from an implantable medical device.
It is possible that we have turned a corner on this issue. It is far from resolved, but the FDA is addressing it — or at least acknowledging it — publicly.
How close are we to resolving this issue? What obstacles do you see ahead? What other sorts of data have remained inaccessible to patients? Where is the next battlefield?
The code of conduct adopted in Massachusetts is the most restrictive set of rules in the nation, crows the Department of Public Health, and mutters the industry. The final MA pharma and medical device conflict of interest rule is posted on the DPH website, together with related comments, memos and presentations. In brief, the rule "sets
out what is and is not permissible for pharmaceutical and medical
device manufacturers with respect to providing meals, sponsoring
continuing medical education and other conferences, and otherwise
providing payments or other items of economic benefit to Massachusetts
health care practitioners." Some fear the new regulations will lead to a drop in medical conferences held in Massachusetts, further battering the local economy.
So what do they do? They implement part of the Massachusetts health reform law, part 2, so much of the commentary ought to have been (and was) directed at the legislature a while back, before it took action, and not at DPH, which is essentially just implementing the legislation. The rules build on PhRMA and AdvaMed codes of conduct, but do go a wee bit further. In DPH legalese:
Chapter 111N and 105 CMR 970.000 regulate pharmaceutical and medical device manufacturer conduct in three ways, requiring pharmaceutical and medical device manufacturers to: (1) adopt and comply with a state-authored code of conduct, (2) provide compliance information to the Department, and (3) disclose sales and marketing related payments to covered recipients. Sections 970.006-970.008 of the Department’s proposed regulations set out what is and is not permissible for pharmaceutical and medical device manufacturers with respect to providing meals, sponsoring continuing medical education and other conferences, and otherwise providing payments or other items of economic benefit to Massachusetts health care practitioners. Additionally, the Department’s proposed regulation outlines the statutory compliance directives in Section 970.005 and interprets the contours of the disclosure requirements for pharmaceutical and medical device manufacturers in Section 970.009. Finally, the Department’s proposed regulation reiterates the penalties outlined in Chapter 111N and provides procedures for enforcing the code of conduct, compliance and disclosure requirements of 105 CMR 970.000. The Department’s proposed regulations seek to address potential undue influence in interactions between pharmaceutical or medical device manufacturing companies and health care practitioners, and increase transparency with respect to such relationships without compromising Massachusetts health care consumers’ access to clinical trials and new discoveries and treatments arising from legitimate and beneficial industry interactions with health care practitioners.
See the final reg hotlink above for the full memo, FAQs, the full text of the regs, a presentation outlining the regs and comparing them with other states' regs, etc.
There's a lot to digest here. Bottom line: Massachusetts may be in the vanguard on this front, but the industry and the rest of the nation will be following right along, as the pendulum swings to the pro-regulatory mindset. There is less and less stomach in Washington and on Main Street for anything that even smells of financial impropriety, and the national imperative to get health care costs in check will likely fuel further action on this front.
Are there cases in which the Medicare payment is appropriate? Sure, but there are many in which it is not. CMS can thinly slice payments in so many other areas, so the federales could do the same for oxygen, rather than go with a one-size-fits-all approach (XXL).
Update 12/3/07: The American Association for Homecare has posted a rebuttal to the NY Times article linked to above.
The IPPS payment reforms would restructure the inpatient diagnosis-related groups (DRGs) to account more fully for the severity of each patient’s condition. In addition, the rule includes important provisions to ensure that Medicare no longer pays for the additional costs of certain preventable conditions (including certain infections) acquired in the hospital. The rule also expands the list of publicly reported quality measures and reduces Medicare’s payment when a hospital replaces a device that is supplied to the hospital at no or reduced cost.
Highlights (quoted or adapted from the press release) include:
Payment increase. Payments to all hospitals will increase by an estimated average of 3.5 percent for FY 2008 when all provisions of the rule are taken into account, primarily as a result of the 3.3 percent market basket increase.
MS-DRGs. 745 new severity-adjusted diagnosis-related groups (Medicare Severity DRGs or MS-DRGs) to replace the current 538 DRGs. Projected aggregate spending will not change as a result of the reforms. However, payments will increase for hospitals serving more severely ill patients and decrease for those serving patients who are less severely ill. (This is intended to remove incentives for "cherry-picking.")
Outliers; capital cost reimbursement. New methodologies for calculating outlier payments and capital cost reimbursement, which are intended to be more accurate.
No pay for "never" events. The rule implements a provision of the Deficit Reduction Act of 2005 (DRA) that takes the first steps toward preventing Medicare from giving hospitals higher payment for the additional costs of treating a patient who acquires a condition (including an infection) during a hospital stay. Already the feature of many state health care programs, the DRA requires hospitals to begin reporting secondary diagnoses that are present on the admission of patients, beginning with discharges on or after October 1, 2007. Beginning in FY 2009, cases with these conditions would not be paid at a higher rate unless they were present on admission. In order to improve the reliability of care in the nation’s hospitals, the rule identifies eight conditions, including three serious preventable events (sometimes called “never events”) that meet the statutory criteria. CMS will work to add an additional 3 conditions to the list next year.
Quality measures and reporting. New quality measures that hospitals would need to report in calendar year (CY) 2008 in order to qualify for the full market basket update in FY 2009. Failure to report will result in a 2% penalty. CMS will measure 30-day mortality for Medicare patients with pneumonia and plans to adopt two measures relating to surgical care improvement in the CY 2008 outpatient prospective payment system final rule. In addition, CMS will finalize two additional surgical care improvement measures by program notice after they receive NQF endorsement.
Replacement medical device reimbursement. Payments for replaced medical devices which were recalled and replaced by manufacturers below cost will be reduced.
Specialty hospitals. In keeping with the plan contained in CMS’s August 2006 final Report to Congress on specialty hospitals, the rule creates new disclosure requirements for these hospitals. The rule requires physician-owned hospitals to disclose such ownership to patients and provide the names of the physician owners upon request. The rule also requires physician-owned hospitals to require physician owners who are members of the hospital’s medical staff to disclose their ownership to the patients they refer to the hospital. Disclosure would be required at the time of referral. In addition, the rule requires a hospital to notify all patients in writing if a doctor of medicine or doctor of osteopathy is not present in the hospital 24/7, and describe how the hospital will meet the medical needs of a patient who develops an emergency condition while no doctor is on site. CMS now has the authority to terminate a provider agreement for noncompliance with these disclosure requirements.
So by now everyone has heard/read about the end of cardiac care as we know it. Stents don't save lives. (See, e.g., the post from the WSJ Health Blog including a link to the "Courage" study released this week, and be sure to check out the comments.) Boston Scientific stock dropped. (See the post at The Health Care Blog for an in-depth look at the story.)
Folks seem to be taking issue with the claim in the study that stents don't do much for management of symptoms (pain) either. These folks are also saying that angioplasties and stents were never intended to improve anything but comfort. Remind me, when the Veep was getting a stent put in, did all the page one coverage say we're doing this procedure just to make him comfortable? I don't think so. (There's a whole other story there, I know; off-label use of the stent in his case.)
Up until now, in the public eye, angioplasties and stents have been sold as medical miracles, not as comfort care. Some would say that this revisionism on the part of the medical device manufacturers and their apologists in response to the Courage study could be read as signaling a new openness to evidence-based medicine.
Such folks may be anticipating that the industry and the specialists will change behaviors based on this one trial. Seems to me it's too soon to tell whether we can pass judgment on angioplasties and stents based on a single study.