Getting the Word Out, FDA Partners with Medem

As we all know, the FDA is responsible for safe-guarding public health, from salmonella outbreaks to overseeing drug development/clinical trials leading to market introduction of new drugs based on efficacy and risk. Another critical function of the FDA is to keep the population informed of any unforeseen risks with a medication or medical device that may already be in the market – think Vioxx. When a risk is identified, leading to a “black box warning”, the FDA, along with the manufacturer, communicates that information through as many channels as possible including the press, payers and providers.

The weakest link in that chain of communication has been providers, which may put the physician in an embarrassing situation when a consumer/patient calls them up after reading the morning paper or getting a message from their insurer asking the physician what should they do e.g., should I keep taking the medication, am I at risk?, while the physician has no idea what the warning is about. Of course there is also, and more importantly, the scenario where neither the physician nor consumer is aware of the risk and continues prescribing and taking the medication.

Now, the FDA does notify physicians of such warnings, but these are typically delivered via “snail mail” direct from the drug manufacturer. In addition to the time delay of snail mail, oft-times such mailings are considered junk mail by admin staff and tossed or buried in all the other daily mail a physician office typically receives. The FDA also has a method to communicate such warnings electronically via MedWatch but this approach is indiscriminate. For example a pediatrician may receive not only alerts pertaining to children, but also cardiology, geriatrics, etc. Like any of us confronted with such a deluge, we quickly learn to just screen out/ignore the notices as so few pertain to us.

Getting the word out to physicians in a timely fashion is a concern of malpractice liability carriers, leading one of them to ask Medem if Medem could develop a solution to this problem. Medem was a pretty obvious choice due to their close ties with the AMA and other medical societies. Medem in turn contacted the FDA to solicit their support and involvement resulting in the creation of the Health Care Notification Network (HCNN).

Had an opportunity late last week to talk with Henry Dephillips, Medem’s CMO who filled me in on the details. Here’s the scoop:

• HCNN was built by Medem with input from FDA and liability carriers. Medem will run day-to-day operations. Similar to Medem’s iHealthRecord, HCNN governance is handled by the non-profit iHealth Alliance. iHealth Alliance was formed when the AMA, original developers of Medem, spun-out Medem as a commercial enterprise. Not exactly separation of “church and state” but it is a model they are comfortable with and may assure some physicians.
• Designed to send email notifications to physician subscribers, based on their specialty. Medem estimates that a physician will receive, on average, 20 alerts/year. No more deluge – assume physicians will love that feature.
• Currently structured to send only regulatory notifications. In no way will subscribers to the service be abused with Spam, receive commercial solicitations of any form, or have their name/contact details sold. Doubt if subscribers would accept anything less than such a policy. Keep it clean, keep it focused, keep it simple.
• Alerts will be distributed to subscribing physicians within one hour of public announcement. Operates 24/7. If physician does not open email within 72hrs, a snail mail notice is sent. Good follow-up process feature to insure notifications are delivered.  Medem will take full responsibility for the complete process on behalf of partners/sponsors of the service.
  
• HCNN is a totally opt-in service and completely free to the prescriber/subscriber. Physician must personally subscribe to the service.
• Go to market strategy is to leverage existing relationships (e.g, medical societies, payers, and liability carriers). Medem estimates the number of subscribers at roughly 550,000 prescribing physicians and another 100,000 other prescribers (nurses, physician assistants, etc.). Today, HCNN/Medem has contracts for outreach to nearly 40% of all prescribers (250,000) to encourage them to subscribe to the service. Tremendous job Medem to get to that number in just a few short months.
• While the FDA provided the regulatory changes necessary for electronic alerting to occur, as well as assisted Medem via input during development of HCNN, actual development funding came from Medem and future physician outreach/support (e.g., revenue for Medem) will come from drug companies, liability carriers, health plans and to a lesser extent, societies. Medem saw a clear problem  and took initiative/placed the bet.  Now comes the hard part, getting various stakeholders to pony-up.  But honestly, this seems like such a Win-Win-Win all around, it should not be that hard.  A bigger challenge may be in getting the physician community to sign-up in droves to create critical mass for the service.
  
• Currently, looking to drug manufacturers for funding HCNN. Have contacted all the usual suspects and are in closing talks with two pharma companies and deep discussions with several others. The pitch is for HCNN to take over the complete notification process for these companies leveraging the HCNN email-based notifications and as mentioned previously, if necessary, direct mail. Seems like a no-brainer to me, but like anything, it’s all in the details i.e., how much will this service cost us?
• Longer-term, HCNN will be extended to address medical devices and even go international. Medical devices makes sense, not convinced the international angle will fly due to regulatory complexity. One approach may be to just license the technology underpinnings and let another region/country take it from there.
• HCNN/Medem has also been approach by other federal agencies on how this service may be used for other purposes, e.g., disease outbreaks (CDC) or in response to a disaster (Homeland Security). Great idea, why just limit it to the FDA!
• Announced in March, the HCNN was operable in July, (though I have experienced a couple of glitches – page loading on main site). No notices have been sent as of today. There are currently 5 notices in the que that will be sent once a partner drug company gives the go-ahead.

So what does all this tell me about Medem?

1. Medem has some great connections within the medical establishment that it can effectively leverage.
2. Medem is first and foremost a collection of services for physicians. Not that surprising considering they were funded by the AMA. What is important here is that though they offer a PHR for consumers (iHealthRecord) and have partnered with both Google Health and Microsoft HealthVault, it seems pretty clear that they do not see this market as core to their long-term growth strategy.
3. Medem’s opportunities, which will guide strategy and subsequently development, lie in providing physicians, particularly smaller, family care and specialty practices with services delivered over the Web that assist them in better serving their customers.
4. Wherever possible, Medem will seek sponsors for those services to minimize, if not eliminate, the cost burden to physicians.

Bottomline:

Medem is taking a very practical and pragmatic approach to the simply reality that try as they might, staking their business on physician and consumer adoption of PHRs is a very risky proposition and will get only more challenging as competition heats-up. Sure, they’ll keep a stake in the PHR space, but don’t expect them to be as aggressive in promoting it in the future as there are potentially far more lucrative opportunities for them to leverage and promote.