Federal health officials are pulling an array of levers that fall under the core aim to improve interoperability and patient access to data.
The two proposed rules—one from CMS (the Centers for Medicare & Medicaid Services) and one from ONC (the Office of the National Coordinator for Health IT) are separate, but at the same aligned as the two agencies within HHS (the Department of Health & Human Services) look to further advance the nation’s healthcare interoperability progress. The two rules 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 ONC rule, titled “21st Century Cures Act: Interoperability, Information Blocking, and the ONC Health IT," is 724 pages in length, and according to federal health IT officials, is designed to increase innovation and competition by giving patients and their healthcare providers secure access to health information and new tools, allowing for more choice in care and treatment. It calls on the healthcare industry to adopt standardized application programming interfaces (APIs), which will help allow individuals to securely and easily access structured electronic health information (EHI) using smartphone applications, officials attested.
In the ONC proposed rule, a provision also exists requiring that patients can electronically access all of their digital health data (structured and/or unstructured) at no cost. What’s more, the rule implements the information blocking provisions of the 2016 Cures Act, which defined information blocking as interfering with, preventing, or materially discouraging access, exchange, or use of electronic health information.
The new ONC rule proposes seven exceptions to the definition of information blocking. As it outlines, 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 seven proposed exceptions include:
1. Preventing harm;
2. Promoting the privacy of EHI;
3. Promoting the security of EHI;
4. Recovering the costs reasonably incurred;
5. Responding to requests that are infeasible;
6. Licensing of interoperability elements on reasonable and non-discriminatory terms; and
Maintaining and improving health IT performance
ONC fact sheet on the seven exceptions (further details) Additionally teeth are provided for violations by ONC’s Office of Technology, noting that the first three actors listed—developers, HIEs and HINs—are subject to up to a $1 million fine per information blocking violation, if they are found to be bad actors. Providers are not subjected to a monetary fine, Posnack noted, adding that exceptions will be reviewed by ONC and the OIG (Office of Inspector General).
Some of the standards will be changed, ONC is calling for the removal of the CCDS (Common Clinical Data Set) definition and its references from the 2015 Edition and replacing it with the USCDI standard. “This will increase the minimum baseline of data classes that must be commonly available for interoperable exchange,”
CMS Rule Focuses on Patient Access
CMS’ rule, “Interoperability and Patient Access Proposed Rule,” while separate from ONC’s, is quite aligned with it in several ways—such as requiring FHIR for APIs. Building on the Blue Button 2.0 API that allows Medicare beneficiaries to electronically access their health data through an app, CMS is now proposing to require Medicare Advantage (MA) organizations, state Medicaid and CHIP fee-for-service (FFS) programs, Medicaid managed care plans, CHIP managed care entities, and QHP (qualified health plan) issuers in FFEs (federally-facilitated exchanges) to implement, test, and monitor an openly-published FHIR-based APIs to make patient claims and other health information available to patients through third-party applications and developers.
CMS is also proposing to require MA organizations, Medicaid managed care plans, CHIP managed care entities, and QHP issuers in the FFEs to support the electronic exchange of data for transitions of care as patients move between these plan types. This data includes information about diagnoses, procedures, tests, and providers seen and provide insights into a beneficiary’s health and healthcare utilization.
In yet another push on health plans, CMS is proposing that payers in CMS programs be able to participate in a trusted exchange network that would allow them to join any health information network they choose and be able to participate in the nationwide exchange of data. "We propose requiring MA organizations (including MA-PD plans), Medicaid managed care plans, CHIP managed care entities, and QHP issuers in the FFEs to participate in trust networks to improve interoperability," CMS said.
“We have proposed that by 2020, all health plans doing business in Medicare, Medicaid, and through the federal health insurance exchanges, allow their patients to obtain their data through an API. This will allow patients to be true partners in their healthcare,” said CMS Administrator Seema Verma
And in regard to information blocking, CMS said it would make public the names of clinicians and hospitals that submitted "no" to three attestation statements committing them to data sharing. “Making this information publicly available may motivate clinicians, hospitals, and CAHs to refrain from information blocking,” CMS said.
“We’re also putting an end to information blocking,” Verma boldly stated on the press call. “The days of holding patients’ data hostage are over. We propose to publicly identify hospitals, doctors, and others who engage in information blocking. Simply put, we’re exposing the bad actors who keep their patients from their data.”
These Orwellian tactics are not voluntary, and CMS intends to enforce this rule using 'shame' and negative publicity. It also assumes that these measures improve the quality of care without any prior studies or documentation for this extension of interoperability. (show me the references)
Massive Rule Drops at HIMSS19: CMS, ONC Propose New Regulations to Transform the Future of Interoperability and Patient Access | Healthcare Innovation:
No comments:
Post a Comment