As we look to the year ahead, this is an important time to reflect on 2017, and the exciting developments that will make 2018 even better for connected health innovation. 2017 was a busy and successful year for the Connected Health Initiative (CHI). We worked with the Centers for Medicare and Medicaid Services (CMS) to propose incentive and reimbursement opportunities for the use of remote monitoring tools, we urged the U.S. Food and Drug Administration (FDA) to administer much-needed guidance around the use of digital health tools and software, and we advocated for congressional efforts that support innovations in digital medicine and the protection of patients’ sensitive health data. In addition to the 17 comments filed to health agencies in the United States and the European Union, more than 40 connected health-related meetings held on the Hill, and a host of briefings and coalition meetings, CHI led several successful efforts to encourage the integration of connected health technologies throughout the American healthcare ecosystem. Here are the top five highlights for 2017.
1) CMS Introduced New Incentives to Encourage Physician Review of Patient Generated Health Data
In February, CHI answered CMS’ call for new improvement activities under the Quality Payment Program (QPP) Merit-based Inventive Payment System (MIPS) by suggesting that the activity of reviewing patient generated health data (PGHD) be recognized under the program. By November, CMS heard our call, and made it official, by including our improvement activity in their final rulemaking. For background, CMS maintains a database of Improvement Activities that qualifying physicians can use to calculate their MIPS score at the end of each year. As the name suggests, the merit-based system allows participating physicians to accrue points upon completing a specific activity, and those points can result in a financial bonus if a certain threshold is met, or a financial penalty if the points are insufficient. The improvement activity from CHI enables doctors to earn the highest number of MIPS points when they bring PGHD into their practice for the purposes of beneficiary engagement.
This is a huge win for connected health innovators. As written, this new improvement activity is “technology agnostic,” enabling doctors to equally review data gathered from patients’ wearable device or connected health tool of their choice. What’s more, many Medicare doctors and hospitals rely on improvement activities to meet their MIPS requirements. For smaller practices with fewer than 15 physicians, this improvement activity allows doctors to accrue all of their MIPS points! (For larger practices, the activity can account for half of the required points!) This marks a huge step for digital medicine and the adoption of PGHD into the management and treatment of chronic conditions.
2) CMS Activated the Reimbursement Codes for Remote Monitoring Tools, Too
2017 also saw the “unbundling” of Medicare reimbursement code 99091. Though it may seem like a random group of numbers, 99091 refers to the Physician Fee Schedule code established to account for time spent reviewing patient generated health data. Since 2015, CHI has urged CMS to unbundle and activate this code. Not only did CMS agreed to unbundle the code, but they also have assigned a value for the time spent reviewing patient generated health data. Specifically, physicians may now be reimbursed when they spend a minimum of 30 minutes reviewing PGHD from a remote monitoring tool.
This is a big deal. Considering the $1.02 trillion spent by CMS on reimbursement last year, unbundling the 99091 code will allow pioneering physicians to be reimbursed for incorporating patient generated health data into their practice and treatment efforts. By acknowledging the value of patient generated health data, we remove a significant barrier to the uptake of remote monitoring and telehealth tools. In the year ahead, we look forward to working as part of the American Medical Association’s Digital Medicine Payment Advisory Group (DMPAG) to create additional reimbursement codes to allow doctors to be paid for a broad array of innovative telehealth solutions.
3) FDA Issued Long-Awaited Guidance on Clinical Support Software
In early December, the FDA released draft guidance on the regulatory treatment of clinical decision support (CDS) software and its role within the FDA risk framework. Since 2011, CHI has urged the FDA to provide greater clarity in the regulatory requirements for medical grade software. The draft guidance finally makes clear that the FDA will place their regulatory focus on the safety and effectiveness of software that independently analyzes patient data, rather than on software that facilitates physicians’ ability to use data to make treatment decisions. This nuanced guidance will help create a clearer landscape for the current and future developers of clinical decision support software.
This is important because, after years of engagement, our advocacy is beginning to pay off. Since our inception, CHI has worked with the FDA in a variety of ways, including educating staff on the potential of digital medicine for patients and physicians, providing technical overviews of CDS software, and exploring how to improve the relationship between physicians and technology. We will continue these efforts in the year ahead.
4) CHI Collaborated with Health and Human Services (HHS) to Create Opportunities for Remote Monitoring
In May, CHI sent a letter to HHS leadership outlining the ways the agency could better support the adoption of digital medicine. In particular, the letter called on HHS to use their authority to waive payment and program requirements to allow remote monitoring tools to be used in treatment.
Throughout the year, HHS used our letter to guide several internal actions related to remote monitoring. Significantly, they heeded our call to waive the telehealth restrictions within 1834(m) of the Social Security Act to allow for reimbursement of remote monitoring activities within the 2018 Physician Fee Schedule. We’re honored that HHS took our advice to create opportunities for increased use of remote monitoring tools, and we look forward to covering more ground with the agency in 2018.
5) The CHRONIC Care Act Gained Traction on the Hill
Ever since the Creating High-Quality Results and Outcomes Necessary to Improve Chronic (CHRONIC) Care Act was introduced in Congress in April, CHI has been a vocal supporter. The bill looks to improve care options for patients with chronic conditions, particularly those aged 65 and older. The bill looks to expand telehealth offerings for this community to allow patients on dialysis, at risk of stroke or on specific insurance plans to receive at-home telehealth treatment and assessment, regardless of their geographic location.
In the months following the bill’s introduction, CHI signed and sent several letters in support, and our advocacy paid dividends. With a chorus of supportive voices from throughout the connected health ecosystem, the Senate passed the CHRONIC Care Act in October. The House has also agreed to adopt the bill, and we hope they will vote on it in early 2018.
We have a lot of exciting work to continue in 2018. We will continue to work with Congress to pass legislation that removes barriers to the use of connected health solutions. In the regulatory sphere, we will maintain an open dialogue with the FDA to ensure their guidance protects the safety, effectiveness, and availability of clinical software. Specifically, we plan to submit comments on the draft CDS software guidance and participate in the Pre-Certification Pilot workshop within the FDA’s Digital Health Innovation Action plan to continue our efforts to create a supportive regulatory environment for connected health innovators. And we will continue to collaborate with CMS to develop reimbursement codes and opportunities for remote monitoring solutions while engaging with our members and connected health innovators as they create secure, interoperable, and life-saving solutions for doctors and patients across the country.