So you want to build the next best app-based telehealth solution? Great, the world needs you! But working through Washington DC’s never-ending lists of legislation and regulations to identify which will maximize return on your efforts is like unlocking a code. Incorporating national and state regulatory requirements into your prototype design can be the linchpin to the successful expansion of your company. Lucky for you, we’ve got the key! In today’s installment, we’re going to lay out some key regulations that touch the telehealth sector that you should definitely keep your eye on:
THE NAME: HR 6- SUPPORT for Patients and Communities Act
THE BASICS: Passed on June 22nd this year, HR 6 was mainly focused on addressing the opioid crisis, but has two key provisions that affect telehealth. First, it expands access to telehealth service for Medicare recipients living with an opioid disorder. The previous regulation for reimbursement restricts telemedicine usage to rural patients and also limits which services they can use. These requirements can now be waived by the Secretary of HHS. HR 6 also establishes a requirement for electronic opioid prescriptions. Overprescribing, fraud, and abuse are some of the root causes of the opioid crisis, and all could be greatly reduced by electronic prescribing. This will also provide better data and traceability of the crisis which could be leveraged by hospitals, drug companies, insurance companies, and health tech companies to fight the epidemic.
THE TAKEAWAY: Momentum behind solving the opioid crisis will push further reimbursement of telemedicine and eventually adoption by a larger swath of the market. Considering how your solution can be leveraged to address opioid abuse issues may open up partnerships with upcoming federal or state pilot funding for you.
THE NAME: MACRA
THE BASICS: MACRA stands for Medicare Access and CHIP Reauthorization Act of 2015, and is also often called the Permanent Doc Fix. What it did was create a new payment framework for Medicare based on quality rather than volume of service. This is huge for telehealth platforms, because their improved access to care alongside higher patient engagement and compliance certainly improve value of care practitioners are able to provide. MACRA also specifically mentioned telehealth services as being applicable for satisfaction of MIPS (Merit-Based Incentive Payment System) requirements.
THE TAKEAWAY: Telehealth solutions have the opportunity to not only maintain quality of care but also improve both outcomes and volume through data driven care and tech efficiencies. Can your product allow providers to offer enhanced quality in their care with decreased in-person “encounters?” (See how Babyscripts is accomplishing this in our previous blog.)
THE NAME: HIPAA
THE BASICS: Passed in 1995, this law regulates how protected health information (PHI) can be stored and transferred electronically. HIPAA law applies to any health care provider (HCP), their vendors/suppliers, and business associates who have access to PHI. The guidelines and standards establish privacy and security procedures for handling PHI which, if not followed, can result in financial and criminal penalties for the responsible entities. Telehealth solutions must be built with HIPAA compliance in mind, since any use of PHI opens up users and companies to HIPAA liability. Physicians must enter into business associate agreements with technology providers to remain compliant, and must subject vendors to the same HIPAA standards.
THE TAKEAWAY: From inception, all tech solutions should keep HIPAA privacy and security standards at the forefront of development. Failure to do so could result not only in lost business, but also financial or criminal penalties.
THE NAME: “Meaningful Use”
THE BASICS: Though not an acronym, the phrase “Meaningful Use” has a very specific definition when used in reference to electronic health records (EHR) and telehealth. Meaningful Use defines the minimum standards for EHR and data exchange between patients, HCPs, and insurers. Providers must comply with the standards in order to receive funding from Medicare/Medicaid through their EHR incentive program. As we’ve said before, improved patient portals and remote records access for higher patient engagement is critical for health tech products. Hospitals will need to improve their metrics to show compliance with Meaningful Use, and will be looking for products that meet these requirements.
THE TAKEAWAY: MU patient engagement requirements are an opportunity for app developers to create improved graphical user interfaces (GUI) to allow patients to review their health data. Intuitive GUIs and built-in metrics for telehealth solutions will be the keys for hospitals and providers to better engage with their patients and use these telehealth solutions to meet MU requirements.
THE NAME: FCC
THE BASICS: Shorthand for Federal Communications Commission, it’s the FCC’s job to regulate interstate communications by radio, television, wire, satellite, and cable. In 1996, congress passed the Telecommunications Act, directing the FCC to promote the deployment of advanced telecommunications capabilities nationwide, especially so that rural health care providers have access to affordable and reliable services for telemedicine. As we covered in part 2, the best telemedicine solutions still need reliable broadband internet. The FCC has some initiatives to assist rural HCPs with discounts and improved access to high-speed internet. Most importantly, the FCC recently announced intentions to release around $100 million in funding to promote connected health through solutions such as telehealth.
THE TAKEAWAY: Timing is everything. Follow the FCC’s connected health funding announcements for pilot funding opportunities. How can you offer— on its own or in partnership with other businesses— a full end-to-end solution for improving health outcomes in a remote environment? Remember that remote describes care delivered via technology-based modalities regardless of the distance over which it is delivered.
THE NAME: 21st Century Cures Act
THE BASICS: This act was passed in December 2016 and intended to prevent information blocking, which includes practices that “interfere with, prevent, or materially discourage access, exchange, or use of electronic health information.” These rules are intended to speed up the drug, device, and medical technology (including telehealth products) approval process so patients have access to treatments sooner. The main reason to be interested in this regulation is that it promotes interoperability for electronic health information and seeks to penalize entities which inhibit interoperability of health data to which they may have access. The final definitions for information blocking are due out in September 2018, which we will cover as they are released.
THE TAKEAWAY: Currently viewed mostly as a fringe capability, telehealth should and is moving toward mainstream health care. This act solidifies working definitions of interoperability and information blocking, which are central to advancing the adoption and proliferation of telehealth. Great telehealth solutions are designed to collect, store and exchange data seamlessly with other healthcare technologies, especially EHRs. New health data standards like FHIR have huge potential and deserve your attention.
It’s a lot, we know! But armed with information about current and upcoming regulations your tech will be more resilient to potential liabilities at launch and beyond.