CMS and ONC Release Two Health IT Interoperability Proposed Rules; Seek to Eliminate Data Blocking and Increase Patient Access to Electronic Health Information; ASCRS Provides Comments
In February 2019, the Centers for Medicare and Medicaid Services (CMS) and the Office of the National Coordinator for Health Information Technology (ONC) released two proposed rules that seek to increase patient access to electronic health information (EHI) and reduce data blocking by EHR vendors and healthcare providers. The two rules are separate since the CMS rule focuses on providers and payers under its programs, and the ONC rule focuses on the certification and use of health IT products. Some provisions of these proposed rules would implement provisions of the 21st Century Cures Act.
CMS Proposed Rule
CMS’ proposed rule focuses on potential strategies to improve patient access to EHI. Specifically, CMS proposes to:
- Require Medicare Advantage (MA) organizations, state Medicaid and CHIP fee-for-service (FFS) programs, Medicaid managed care programs, and qualified health provider (QHP) issuers to implement, test, and monitor application programming interfaces (APIs) based on new standards to make health information available to patients.
- Require the above payers to support electronic exchange of data for transitions of care as patients move between these plan types.
- Require MA, Medicaid, and CHIP organizations to make their provider networks available to enrollees and prospective enrollees through API technology to ensure accurate and up-to-date network information.
- Require payers in CMS programs to participate in a trusted exchange network, which would allow them to join any health information network they choose and be able to participate in nationwide exchange of data.
- Make publicly available a list of clinicians, hospitals, and other healthcare providers that participate in data blocking. Providers that answer “no” to any of the data blocking attestation statements for the MIPS Promoting Interoperability (PI) category or the hospital-based PI category will be listed.
- Create a centralized directory of provider electronic addresses for data exchange. CMS proposes to publicly list any provider that does not add digital contact information to the National Plan and Provider Enumeration System (NPPS) by mid-year 2020.
CMS also included two requests for information (RFI) in the proposed rule. One seeks comment on how to advance interoperability through the design and testing of alternative payment models, and the other is seeking strategies to increase the use of health IT in certain healthcare settings, such as post-acute and long-term care, behavioral health, and for dually-eligible beneficiaries. CMS also released a fact sheet on this proposed rule.
ONC Proposed Rule
The proposals included in the ONC rule also seek to increase patient access to EHI and reduce data blocking. Specifically, ONC proposes to:
- Require that patients' EHI be available to them at no cost. In addition, ONC proposes to promote policies that would ensure a patient’s EHI is accessible to that patient, and the patient’s designees, in a manner that facilitates communication with the patient’s healthcare providers and other individuals, including researchers, consistent with such patient’s consent.
- Implement Conditions and Maintenance of Certification for health IT vendors.
- Define activities that do not constitute data blocking, such as if the health information is not secure or the provider believes it to be inaccurate.
- Modify the definition of interoperability to be consistent with the 21st Century Cures Act, which includes: the electronic exchange of EHI without special effort on the part of the user; complete access, exchange, and use of all electronically accessible health information for authorized use under applicable state or federal law; and does not constitute data blocking.
- Encourage the healthcare industry to adopt standardized APIs, which would allow individuals to securely and easily access structured EHI using new and innovative applications for smartphones and other mobile devices.
The ONC proposed rule also includes an RFI on how a standards-based API might support improved information exchange between a healthcare provider and a registry in support of public health reporting, quality reporting, and care quality improvement. ONC released several fact sheets on this proposed rule.
We applaud the administration’s efforts to improve the flow of electronic health information and give patients access to their health data. Despite this, we caution the administration about placing too much emphasis on the ability of patients to make more cost-effective decisions about their healthcare with this information.
While the administration envisions patients becoming savvier consumers of healthcare, ASCRS notes in our response to the CMS proposed rule, which covers Medicare Advantage (MA), Medicaid and federal exchange plans, that ophthalmologists tend to treat a more elderly cohort of beneficiaries who may not want, or have the ability, to access their electronic health information. Furthermore, we note that most small ophthalmic practices are not able to negotiate rates with MA plans and may not be permitted to participate in some plans seeking to narrow their networks, which means that most beneficiaries will not have many options for choosing their physicians. Finally, we recommend that CMS also require MA plans provide their beneficiaries with additional information on quality and outcomes, rather than encourage them to seek care just based on price, and to provide additional information to the patient on step therapy and prior authorization used by the plan, which may limit access and impact the quality of care.
In response to the ONC proposed rule, which covers health IT systems such as EHR, ASCRS supports ONC’s proposal to require that EHR systems provide a function to download a patient’s complete medical record, or all the records in a practice, to facilitate the interoperability of electronic health information and make it easier for physician practices to migrate data if they switch EHR systems. While we are encouraged that ONC takes steps in the proposed rule to prevent EHR vendors from blocking the flow of data, we continue to caution that vendors will look for ways to circumvent the requirements to keep or grow their market share. Specifically, we support the proposal to require EHR vendors to make data available through open applications programming interfaces (APIs) but note that this is currently required as part of the Promoting Interoperability category of MIPS, and practices report that vendors routinely take steps, such as charging additional fees or not allowing bi-directional flow of information, that can make it difficult for physicians to use the tools effectively.
CMS and ONC propose for the provisions in the rules to begin taking effect in 2020, but it is unclear when a final rule will be released. We will keep you updated.