There is broad agreement that the U.S. healthcare system must focus on improving overall care quality and cost efficiency. The pressures imposed on the system by the Affordable Care Act make this need abundantly clear. The Healthcare Leadership Council (HLC) is offering ways to transform healthcare by proposing six reforms developed by senior leaders from all sectors, engaged patient groups and key industry voices. The action areas include health information interoperability; changes to federal anti-kickback and physician self-referral (Stark) laws; health information flow improvements focused on patient privacy laws and regulations; FDA (Food and Drug Administration) reforms; comprehensive care planning; and medication therapy management.
The report effectively launches a constructive dialog, and some of their key points generated a few recommendations of my own:
- Health information interoperability: Using a patient-centered approach to interoperability could cut right to the heart of the matter, avoiding years of incremental wrangling. In the absence of a national single payer-provider framework, we must allow innovative firms to solve this problem. The only way it can be successful is with robust interoperability. We cannot have hundreds of different patient-centered medical records competing with each other. Making the patient the center of focus may finally expose the overt data blocking that still exists in the marketplace today. Profit should no longer be achievable by being a gatekeeper on data that belongs to individuals; the bar should be raised to create innovative workflows and value from this data. Furthermore, it is wonderful to see the report highlight the benefit of having open, publicly-available APIs and focus on creating value in a ‘technology neutral’ way. Policy should avoid trying to script what data points constitute interoperability. Instead, insist upon open APIs that allow bidirectional sharing of all data. By promoting and rewarding standards that allow unlimited sharing of all data, innovation will flourish.
- Changes to federal anti-kickback and physician self-referral (Stark) laws: Analogous to HIPAA misunderstandings, innovation has often been stifled out of unnecessary deference to ‘potential Stark law violations.’ However, many of those innovative ideas would have been in the best interest of patients and not in violation of any laws. We absolutely need to re-think how physicians, payers and health systems can collaborate for the benefit of patients given shared-risk business models like Accountable Care Organizations (ACOs). As mentioned in the report, waivers are a great place to start and, ultimately, more comprehensive legislation overhaul will be needed. That said, extreme caution should be used in the case of EMR vendors providing functionality to physician practices to ‘help them integrate’ to surrounding health systems, unless those EMR vendors can offer completely open bi-directional APIs without technical, political or financial barriers to interoperability.
- Health information flow improvements focused on patient privacy laws and regulations: I contend that the patient-centered approach is the only approach. So much has been wasted in a misguided attempt to apply the letter of the HIPAA law to situations that HIPAA was never intended to cover. Millions of hours of wasted productivity resulted from a paternal approach to protecting patient data. As mentioned above, the time is now for individuals to exert complete ownership and access to their data and have real-time, plain-English ways of sharing it with whomever they want. Imagine a world where individuals can in real-time choose to “hit the record button” on their medical data – and then opt in and out to subscribing their data to various services that can benefit them or society at large. The pendulum must shift somewhat from protectionism to empowerment.
- Food and Drug Administration (FDA) reforms: This point is very timely given the recent non-binding guidelines released for medical device manufacturers. While it is hard to criticize anyone for suggesting methodologies of protecting patient safety, it is very interesting that this kind of regulation is coming from the FDA now. There is the potential to shift an incredible burden to innovative firms – forcing them to think through every conceivable catastrophic scenario that could occur if the data they produce is shared in the wrong way. It is very similar to both Stark and HIPAA in that the intent may be noble, but the execution could stifle innovation and create inefficiency. The timing of this release is also concerning, given we are really starting to see some hope on the horizon for interoperability. This could very easily be used as a means of promoting fear and uncertainty – essentially creating another form of data blocking in addition to technical, political, and financial – namely, ‘safety’ blocking. What the recent guidelines fail to address is the patient care quality and safety hazards of data being trapped in EMR silos. In other words, how devices transmit data safely to EMRs is not necessarily the most pressing problem – it is the lack of access to the data once in the EMR that is far more concerning.
There is a gap between the innovations being developed in healthcare, and the ability to actually deliver those improved products and practices to patients. The HLC proposal is an outstanding jumping-off point to drive health system transformation and spur a movement toward value and innovation.