Thursday, September 10, 2015

Patient Engagement is a Wellspring of New Trends...from Venture Capital to FDA to CMS.

This blog often starts off with trends in the lab industry but includes a wide range of healthcare topics as well, reflecting the range of health policy consulting work I do.

On the laboratory side, there are many efforts to seek "closer engagement with patients," ranging from Theranos to Labcorp (from here to here).

However, the concept of patient engagement is high in other areas as well.  For background, see Marc Boutin's excellent open access article on Patient Engagement at American Journal of Managed Care earlier in 2015 (here).  Boutin is CEO of the National Health Council.  The Food and Drug Law Institute is offering a webinar on Patient Engagement and the FDA, on September 30, 2015, here.  (The webinar features Pat Furlong of the Parent Project Muscular Dystrophy, Janet Woodcock of the FDA, and is moderated by my colleague Debra Lappin of FaegreBD Consulting).

Is patient engagement always important?  My new health employer health plan begs me to use an extensive patient engagement website, although in fact I really just want to know that my physician and our pediatrician are in-network and if my drug copays are $30 or less.  The health plan wants to "engage" me more than I want. But let's look at some other trends and examples.

Recent FDASIA funding the FDA requires the FDA to interact more extensively with public/patient opinion.  This has been well covered in many sources (e.g. here) and I'll focus on patient/payer engagement below.

Historical Examples: Medicare's Diabetes Self-Management Training Benefit
For many years, CMS has had a classic bricks-and-mortar benefit for diabetic self-management courses (here).  This benefit, which stems from the Balanced Budget Act of 1997, almost 20 years ago (here), would now fall under the rubric of patient engagement.

Fee for Service Medicare and Patient Engagement 2017-2020
Important newer trends are recent legislation under which physician will be incented, among other things, to offer programs that demonstrably raise patient engagement of Medicare patients.   (This is the MIPS physician reward system that will replace or consolidate PQRS and other metrics, a system created by the SGR repeal of April 2015 and to-be-implemented by CMS by 2020).  (And disclaimer: I am currently helping clients adapt to the potential of these changes).

Omada Health
Omada Health, in San Francisco, is successfully rolling out highly interactive but virtual programs for diabetes prevention programs for patients at risk, and expanding its offerings as it continues to develop data on their clinical outcomes and effectiveness.  (Here, here).   This also falls under the exploding area of digital health (here).

See also Willowglade Technologies (here).  And companies as big as IBM and J&J are looking at this space (here; subscription).

GetWellNetwork and Skylight Healthcare
Bethesda meets San Diego in the newly announced union of two companies leading in the field of Interactive Patient Care (TM).  At the bottom of this blog, I will quote there press release in full; at Yahoo Finance here.

FDA and Patient Engagement

On its blog, FDAVoice, on September 18, 2015, the FDA announced its "First Ever Patient Engagement Advisory Committee" (here).  The FDA writes,

This body will provide advice to the FDA Commissioner on a range of complex issues relating to medical devices, the regulation of devices, and their use by patients. It will give FDA the opportunity to obtain expertise on various patient-related topics, with the goal of improving communication of benefits and risks and increasing integration of patient perspectives into the regulatory process. Some questions that the PEAC may discuss include where and how best to engage patients across the device development and assessment lifecycle as well as how FDA and sponsors should communicate patient preference information to patients. The PEAC represents a new and exciting opportunity to foster patient partnerships with FDA....
Along with the announcement of the advisory committee, FDA noted it had published a draft guidance on incorporating patient preferences in PMAs, HDEs, and device labeling in May 2015 (here).

The FDA webpage for the Patient Engagement Committee is here.  The commitee's charter is here. According to one trade website, the formation of the committee is favorable to the dHealth/mHealth industry (here).

The FDA requests public comment on potential topics as well as nominations for committee members.  See several related Federal Register notices on the FDA website for the committee (go to left hand column, here).  For example, nominations are requested by October 21, topics by November 20.


Postscript.  In the essay above, I listed both Omada (pre diabetes health improvement and thus diabetes prevention) and GetWellNetwork (patient engagement for oncology) as being related in the patient engagement space.   I was asked to expand on this - the Venn diagram I perceive would be something like this:

Different = Pre Diabetes Wellness Improvement vs Oncology Post Hospital Care
Same = Virtual and Digital State of Art approaches to Patient Engagement and Education
Same = Interest in real impact on outcomes measures and real world impact on patient care


GetWellNetwork Acquires Skylight Healthcare Systems
Combined Company Delivers Interactive Patient Care 
to Over 80,000 Hospital Beds and Clinics in U.S. and Middle East

September 9, 2015 9:00 AM

BETHESDA, MD GetWellNetwork®, Inc. and Skylight® Healthcare Systems, Inc., ranked #1 and #2 respectively for the past five years by KLAS, have joined forces to create the leading Interactive Patient Care™ (IPC) company in the United States.

As the early pioneers in IPC, each company brings more than 15 years of patient and family engagement experience to the newly formed entity. The company plans to leverage this expertise to accelerate product development and expand its renowned clinical transformation services to continue driving better patient outcomes and inspire individuals to improve their own health.

"The combination of the industry's most experienced IPC providers will have a profound impact on the health care landscape," said Michael O'Neil, GetWellNetwork's founder and chief executive officer. "Effective patient engagement -- the kind of engagement that actually leads to better outcomes -- is a science that requires years of expertise to cultivate. Skylight's employees and clients share that vision with us. We are thrilled to welcome them to the GetWellNetwork team."

"Coming together with GetWellNetwork will serve to strengthen our relentless commitment to enhancing the patient experience at every point along their journey of care," commented Tom Klopack, Skylight's chief executive officer. "Our commitment to our customers and product innovation has enabled us to build a thriving and dynamic client community of progressive health care thought leaders. Going forward, our larger integrated community will have even more impact on the industry. We will all benefit from new levels of clinical collaboration, technology integration, and the growing commitment to transform and improve care quality and outcomes."

Patient engagement has become a central focus as American consumers take a more active role in their health, and the health care industry adopts a value-based delivery model. Research confirms that IPC effectively improves patient engagement and helps providers achieve the Triple Aim of better care and better outcomes at lower cost.

Financial details of the transaction, which closed on September 1, 2015, were not disclosed. Michael O'Neil will remain as chief executive officer of the combined company, which will continue to be headquartered in Bethesda, Md. The San Diego office will become a full-service, West Coast innovation hub for GetWellNetwork.

About GetWellNetwork

GetWellNetwork®, Inc. provides patient engagement solutions that help health care providers engage, educate and empower patients along the care continuum. Our patient-centered platform, delivered across multiple technology platforms including mobile devices, computers and televisions, enables providers to implement a revolutionary care delivery model called Interactive Patient Care™ to improve performance and patient outcomes. The company further extends the value of existing IT investments by integrating seamlessly with electronic medical record and patient portal applications.

GetWellNetwork is recognized by KLAS® as the leader in the Interactive Patient Systems category. Learn more at

About Skylight Healthcare Systems

Skylight® Healthcare Systems, Inc. provides a technology platform, Skylight Interactive®, which engages and empowers both patients and providers while addressing a hospital's needs in clinical efficiency, information technology integration and patient experience. Skylight Interactive uses common technologies including televisions, computers, and mobile devices to seamlessly connect with patients across the continuum -- pre-admission, inpatient, and post-discharge. The platform addresses patient and family needs in health education and care services, eases communication with clinicians and enables better outcome tracking. By engaging patients throughout the continuum of care, Skylight Interactive® effectively bridges care transitions, empowers healing and optimizes outcomes.