From the widespread adoption of electronic health records (EHRs), to the advances (and failures) of patient data interoperability, to the launch of the health app economy through application programming interfaces (APIs), the digital health industry over the past decade has grown and evolved significantly as a direct result of government regulations. And now, as we enter 2020, there are a handful of emerging regulatory issues that have the potential to play a major role in shaping the future direction of our industry over this next decade:
Office Visit Documentation and Payment System Overhaul
Last November, the Centers for Medicare and Medicaid Services (CMS) finalized an overhaul of the coding, documentation, and payment system for Evaluation & Management (E/M) outpatient office visits. The previous system, which had been in place since the 1990s, was long bemoaned for adding excessive documentation requirements and “clicks” into the EHR workflow of physicians. The new system, which offers physicians the option to document patient visits based solely on time or medical decision making, isn’t set to take effect until 2021, establishing 2020 as a key transition year for education, training, and workflow changes. But perhaps the biggest question remains whether commercial insurers will follow Medicare’s lead in instituting this new system?
Interoperability and Patient Data Access Rules
In February 2019, CMS issued a proposed regulation that would require all health plans and states operating government programs (Medicare, Medicaid, and the individual exchange markets) to make patient claims data available to patients through APIs and third-party software applications. The rule would also require hospitals to send electronic notifications to other care team members when a patient is admitted, discharged or transferred (ADT) from a facility. Pending any changes from the proposal, this rule is scheduled to be finalized in 2020, placing accountable care organizations (ACOs) and other risk-bearing physician entities on a path to soon having mandated electronic access to insurance claims and hospital ADT data for all of their attributed patients.
Health Data Blocking Rules
Included in the bipartisan 2016 21st Century Cures Act law were provisions requiring the Office of the National Coordinator for Health Information Technology (ONC) to define and enforce a set of “information blocking” rules for the industry. In 2020, after years of delay, we may finally see those rules enforced. As soon as this month, ONC is expected to release a final rule that will describe in detail how they plan to determine whether information blocking occurs. Then, HHS will have the authority to issue civil penalties of up to $1 million to any developer, information network, information exchange, or provider found “guilty” of data blocking. Whether this approach succeeds in spurring a greater exchange of patient data or not, it will create new liability for every EHR developer, HIE, network, and provider in the country.
Price Transparency Mandates
In December, a coalition of hospital groups filed a lawsuit against CMS to challenge the legality of the agency’s rule requiring hospitals to post publicly online their payer-negotiated prices for specific services. The outcome of that lawsuit could have widespread effects, impacting not only the hospital regulation at issue, but also the Administration’s broader price transparency agenda that seeks to make all payer negotiated payment rates for all medical services public over the next several years.
2020 Election and National Healthcare Reform Efforts
Throughout last year’s Democratic Party presidential debates, healthcare was the most frequent and most controversial issue discussed by the candidates. With plans ranging from instituting a government-run single payer system to adding a public insurance “option” to Obamacare, every one of the leading candidates has called for instituting a major healthcare reform law if elected President in November. As a result, conversations about our healthcare industry are likely to be dominated by politics and uncertainty until election day.
Beyond these issues, there are other key regulations that will shape our industry in 2020, including the transition to alternative payment models and an overhaul of the Merit-based Incentive Payment System (MIPS). State level reforms will continue to play an increasingly important role in certain states, especially among certain specialties. All in all, 2020 promises to be another busy year, so stay tuned!