The Countdown Is On: Cannot Miss 2019 Deadlines for Health Tech & HITECH
In early 2009, President Obama signed the American Recovery and Reinvestment Act (ARRA), an economic stimulus package that, in part, allocated billions of dollars to the health sector. And specifically within the ARRA, the Health Information Technology for Economic and Clinical Health Act (HITECH) aimed to “promote the adoption and meaningful use of health information technology.” But 10 years and $36 billion later, many in the health ecosystem see little progress in the meaningful use of health IT. However, as HITECH moves into its second decade (and 2019 draws to a close) there are some major milestones that can – and will – impact those in digital health. For those working to make evidence-based, tech-enabled care synonymous with health care, you have less than 30 days to influence the future.
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Sparked by a recent twitter thread from Lucia Savage, Chief Privacy and Regulatory Officer at Omada Health and a former HHS official, some of the biggest players in the health tech space weighed in on upcoming deadlines and opportunities for input, as well as the key policymakers, agencies, and committees that we should be paying attention to. Moreover, as experts in the thread point out, the final month of 2019 is an opportunity for those in the digital space to let policymakers and legislators know what barriers are still preventing effective use of health technologies, as well as what best practices, real-world lessons, and unintended consequences have been gleaned from previous experiences.
If you’re looking to have an impact in digital health, and potentially reap some of the rewards of the decade old stimulus package, here is your year-end calendar of policies and guidances open for public comment:
December 16th is the deadline to submit feedback for the second iteration of the 21st Century Cures Act, also known as Cures 2.0, in which Representatives Diana DeGette and Fred Upton have put a significant focus on digital health. They ask for real-world evidence (even releasing a framework and guidance on how to submit) to tackle the issues around harnessing and utilizing data.
Topics of interest also include the significant issue of reimbursement for digital health and technologies that impacts caregivers. According to the request for information (RFI) “Cures has been and forever will be a process of health care reform predicated on input from stakeholders and collaboration as we move them through the legislative process.” Reps DeGett and Upton have requested that input be mailed to email@example.com.
December 20th is the RFI deadline for providing feedback to HHS and Secretary Azar on how “HHS could catalyze the scaling and deployment of effective prevention strategies into today’s social and economic environment.” Particularly, as we rethink preventative care through tech and data, HHS needs to better understand 1) barriers to effective chronic disease prevention in the U.S.; 2) highlights of effective chronic disease prevention strategies and; 3) the potential of scientific and technological advancements, innovative partnerships, and human-centered design to create and scale new models of chronic disease prevention.
If you’re looking to have influence with the Office of the Chief Technology Officer, this RFI allows you to directly provide input. Further, there are opportunities to supply evidence from the work you are doing. Learn more here.
Medicare Proposed Rules
December 31st (5:00pm EST) has two major deadlines pertaining to HHS proposed rules, one within the Office of Inspector General (OIG) and one within the Centers for Medicare and Medicaid Services (CMS). In tandem, these proposed rules aim to advance value-based care. The OIG proposed rule has multiple parts of interest – primarily the addition of safe harbor for donations of cybersecurity technology and amend existing safe harbors for many parts of EHR contracts. The proposed rule would also add a new safe harbor related to the Budget Act of 2018 as it pertains to “beneficiary incentives under the Medicare Shared Savings Program and a new CMP exception for certain telehealth technologies offered to patients receiving in-home dialysis, also pursuant to the Budget Act of 2018.”
Of great interest for those in health tech is the OIG proposal to categorically exclude “things” that are required to register as DMEPOS (durable medical equipment, prosthetics, orthopedics and supplies) from being in the approved “value-based arrangements.”
The proposed rule at CMS also relates to value-based care, but more specifically to fraud, abuse, and physician self-referral, otherwise known as Stark Law. It would also create “a new exception for donations of cybersecurity technology and related services; and amend the existing exception for electronic health records (EHR) items and services.” All of which can have a great impact on the ability of physicians and innovators to collaborate, as well as get reimbursed, for utilizing new technologies.
To many, it seems obvious why commenting on proposed rules and requests for information is important. But for others, it can feel like a waste of time and energy to send in documents that policymakers may or may not use. But at the end of the day, the regulations that policymakers enact will have an impact on all health technology businesses. And without the voices of those in the industry, providing evidence-based data and citing real-world experiences, legislators are missing key pieces of information.
Remember, in the digital health space your voice matters. Provide helpful, relevant evidence and data. Tell true stories and give anecdotes with nuance and context. Explain how unintended consequences have or can play out. And never hesitate to link to verified information to help legislators and policymakers find more information.