In response to two aligned regulations on interoperability and patient access that were proposed by separate federal agencies in February, the College of Healthcare Information Management Executives (CHIME) is recommending that the government provide additional time to allow for providers to implement key provisions of the rules.
CHIME, a trade group comprised of CIOs, CMIOs and many other senior health IT executives, recently made public its 44-page letter to the Office of the National Coordinator for Health IT (ONC) and the Centers for Medicare & Medicaid Services (CMS). The two proposals released in February—about 1,200 pages combined—look to further advance the nation’s healthcare interoperability progress. They represent great significance for health IT stakeholders, who will now be more under the microscope than ever before as it relates to their efforts in making sure that health information is seamlessly moving—while not restricting such efforts.
The original deadline for stakeholders to get their comments to ONC and CMS was May 3, but last month the agencies extended the comment period by a month. In its comments, the Ann Arbor, Mich.-based CHIME wrote that while it supports the overall intent of the rules, “given the magnitude of changes encompassed in these rules, CMS and ONC should publish interim final rules rather than final rules to allow additional opportunity for stakeholder comments.”
CHIME also urged the government to provide additional time that is sequenced from the date the rule is finalized to allow stakeholders and affected entities to work toward compliance. Specifically, ONC should offer at least three years for providers to absorb the changes associated with changes to certified technology, while CMS should allow at least three years for providers to make the admission, discharge and transition (ADT) changes, according to the trade group.
For context, in its rule, ONC proposed to allow two years for providers to implement their certified technology changes. But CHIME argued that “the proposed 24-month timeline does not take into account the time providers need to get into the queue to receive the new software, train on the new system, or adapt workflows -- the latter two pieces which have historically been critically necessary. Furthermore, rushing deployments and installations can present threats to patient safety.”
To this end, CHIME also recommended that rather than update the 2015 Edition certification criteria, a new edition should be created. “Our recommendation is consistent with the HITAC’s Conditions and Maintenance of Certification Requirements Task Force, which found, ‘There are broad-sweeping changes to the 2015 Edition as a result of this proposed rule. By not updating to a new Edition, users of the CHPL [Certified Health Product List] would be confused about which version of 2015 Edition is being referenced.’”
Regarding the CMS timeline, the federal agency, using what its Administrator Seema Verma called “the strongest lever we have,” is proposing to make it a condition of participation in Medicare that all Medicare-participating hospitals, psychiatric hospitals, and CAHs [critical access hospitals] to send electronic notifications when a patient is admitted, discharged or transferred.
But CHIME is urging CMS to provide a voluntary, phase-in period of no less than three years, as a flexible phase-in period “is essential for accommodating the complexity of issues individual providers will need to work through,” the organization wrote. It noted that currently, there is no criterion under the ONC Health IT Certification Program that certifies health IT to create and send electronic patient event notifications, while it disagreed with CMS’ assumption that certified EHRs can handle ADTs just because they are able to handle other HL7 functionalities like immunization registries and lab results.
CHIME also pointed out that while CMS wants to mandate that clinicians send alerts to patients’ primary care providers when they are admitted to the hospital, many patients do not have a primary care provider. CHIME further stated that its members worry about patient matching and safety issues, namely that “CMS is requesting that providers only send a few pieces of data, which we feel is insufficient to match patients.”
For patient discharges, CHIME is worried that the proposed rule introduces a new mechanism for sending notifications that is separate from the existing CCDA (Consolidated Clinical Document Architecture)-based document exchange through Direct Messages that hospitals are used to.
As such, CHIME said that CMS ought to allow more time to address these challenges before mandating these requirements; if the ADT discharge requirement is finalized as proposed, then CMS should allow providers to use CCDs, CHIME added.
Overall, the request for the feds to give stakeholders more time to implement these provisions from the date the final rule gets released is right in line with what Senate Health, Education, Labor & Pensions Committee (HELP) committee Chairman Lamar Alexander (R.-Tenn.) advised earlier this month at a Congressional hearing. Said Sen. Alexander that day, “In 2015, I urged the Obama Administration to slow down implementation of Stage 3 of the Meaningful Use program. They did not slow down, and looking back, the results would have been better if they had.”
Comments on Information Blocking
CHIME additionally made several comments related to the information blocking element of ONC’s rule, which also proposes seven exceptions to the definition of information blocking. As ONC outlined, per the 21st Century Cures Act, there are four specific healthcare “actors” regulated by the information blocking provision: providers, certified health IT developers, HIEs (health information exchanges) and HINs (health information networks).
The trade group wrote that providers should not be subjected to penalties reserved for other actors—penalties that can be as severe as $1 million fines per data blocking violation. But as CHIME contended, it’s clear that Congress set up a distinct penalty structure specifically reserved for providers. “The statute clearly articulates that providers charged with information blocking ‘shall be referred to the appropriate agency to be subject to appropriate disincentives using authorities under applicable Federal law, as the Secretary sets forth through notice and comment rulemaking,’” CHIME said.
It noted that even if a provider is acting as one of these other three types of actors, they should not be subject to the penalties reserved for developers, HIEs and HINs, as doing so introduces great risk to the healthcare system. CHIME wrote, “Congress explicitly established a separate penalty structure for providers. Even when a provider is acting in additional capacities such as self-developers or HIN, they are doing so to foster patient care and should not be subjected to fines clearly reserved for these other types of actors.”
CHIME also stated that app developers, companies managing the app ecosystem, and prescription drug monitoring programs (PDMPs), should be required to meet information blocking requirements by being included in either the HIE or HIN “actor” category.
Patient Matching RFI
As part of their rules, CMS and ONC also together requested feedback on how it can leverage its authority to improve patient identification and safety to encourage better coordination of care across different healthcare settings while advancing interoperability. The two agencies are asking for comments on how they can “continue to facilitate private sector efforts on a workable and scalable patient matching strategy.”
In response, CHIME detailed several recommendations, some of which include:
- ONC require vendors to share their patient matching rates with providers as part of their Maintenance of Certification (MOC)
- CMS should make claims data available to providers through a FHIR-based API to further patient matching
- ONC should support the standardization of some demographic data, particularly applying the U.S. Postal Service Standard to the address field
- CHIME supports CMS expanding the use of the Medicare ID number and recommend ONC add it to the USCDI