Federal and state lawmakers and regulators are pushing to keep up with the legal framework of using adopting digital health as part of care coordination and the move to value-based payment in health care. Such efforts are resulting in coverage of telehealth and virtual care services.
Over the last year, Health and Human Services (HHS) has been focusing on “identifying regulatory requirements or prohibitions that may act as barriers to coordinated care, assessing whether those regulatory provisions are unnecessary obstacles to coordinated care, and issuing guidance or revising regulations to address such obstacles and, as appropriate, encouraging and incentivizing coordinated care.”
There have been a series of requests for information (RFI) from CMS, the HHS of Inspector General (OIG) and the Office for Civil Rights (OCR) soliciting comments and feedback on multiple areas of federal law. CMS issued an RFI for potential changes in the Stark law, the federal physician self-referral law, with a goal of reducing regulatory burden and dismantling barriers to value based care transformation while also taking care to protect the integrity of the Medicare Program. OIG issued an RFI on the anti-kickback statute (AKS) and civil monetary penalties (CMP) looking into the impact on coordinated care or value-based care and financial arrangements implicated by the AKS. OCR solicited comments on whether HIPAA Rules should be modified to better facilitate the health care industry’s transformation to value-based health care and the coordination of care.
Why have government agencies done this? Value-based payment models and the digital health tools that they use may implicate all three federal laws: Stark, AKS and CMP. It is important for the government to seek feedback on whether the laws may be a barrier to coordinated care structures. For example, health systems across the United States and providers may subsidize the use of electronic health records (EHR), telehealth programs and/or cybersecurity technologies by community providers. Healthcare is moving more and more towards digital health, and laws and regulations need to keep up with the fast-moving modalities that are available to payors, providers and patients without stifling innovation.
In November 2018, CMS issued a final rule updating the Medicare Physician Fee Schedule (PFS Final Rule) to implement recent telehealth-related legislative reforms passed by the Bipartisan Budget Act of 2018 (BBA). Not all services are available in every hospital to treat the symptoms of every patient. The services of digital health become life-saving to individuals who do not have access to certain specialist because of their location. Beginning this year, 2019, patients presenting with stroke symptoms at hospitals or in mobile stroke units may receive telehealth consultation with a neurologist for treatment. Moreover, patients with End Stage Renal Disease (ESRD) who receive home dialysis may choose to receive clinical assessments via telehealth with certain requirements. This is truly great news because both telehealth stroke and ESRD assessment provisions eliminate restrictions in the patients’ geographic location. There are specific requirements on definitions of an originating site and distant site (where the provider is located versus where a patient is located). CMS also made changes to the list of telehealth services eligible for reimbursement to include codes related to certain preventative services. There is more exciting expansion of telehealth services coming from government agencies and URAC is in a perfect position to help patients in ensuring safe quality of care through URAC accreditation.
