21st Century Cures and the Road Ahead

John D. Halamka, MDI’ve been writing fewer posts recently because the trajectory forward for healthcare and healthcare IT seems to be evolving very rapidly.   In just the past week, we’ve had: 

• The American Hospital Association letter suggesting that 21,000 pages of regulations be rolled back including Meaningful Use Stage Three concepts and quality measurement in many care settings.
• The passage of the 21st Century Cures bill and its many IT related mandates
• The nomination of Tom Price for HHS Secretary  and Seema Verma for CMS administrator

As I’ve written about previously, I believe that value-based purchasing and the move to reimbursement based on quality measurement will still continue.    QPP , IPPS  and OPPS  will rollout as scheduled.

What can we expected from 21st Century Cures?   Here’s an IT centric evaluation:

The HIT Policy Committee and HIT Standards Committee will be consolidated into the HIT Advisory Committee.  Thus, we’ve gone from HITSP in the Bush administration to HITSC in the Obama Administration to HITAC in the Trump administration.

• Sec. 4001. Assisting Doctors and Hospital in Improving Quality of Care for Patients -  ONC shall encourage, keep or recognize voluntary certification of health information technology for use in medical specialties and sites of service for which no such technology is available or where more advancement is needed. Requires the Secretary of HHS to submit a report to the HIT Advisory Committee on the attestation statistics for the Medicare and Medicaid EHR Meaningful Use Incentive programs to assist in standards adoption.
• Sec. 4002. Transparent Reporting on Usability, Security, and Functionality.  One year after the enactment of Cures, the Secretary through rule making, shall require that a health information technology developer or entity does not take any action that constitutes information blocking, does not prohibit or restrict communications, has published application programming interfaces (API), has successfully tested the real world use of the technology for interoperability, has provided the Secretary with certain performance attestations, and has submitted reporting criteria.  The Secretary may encourage compliance with the conditions of certification and take action to discourage noncompliance, as appropriate.  Eligible professionals maybe exempt from the application of the payment adjustment if the Secretary determines that compliance with meaningful EHR use is not possible because the certified EHR technology used by a professional has been decertified. This may also applicable to MIPS eligible professionals.
• Sec. 3009A. Electronic Health Record Reporting Program. No later than 1 year after the enactment of Cures, the Secretary must convene relevant stakeholders for the purpose of developing a wide range of reporting criteria including interoperability, security, and certification testing.  Relevant stakeholders include health care providers, including primary care and specialty care health professionals; hospitals and hospital systems; health information technology developers; patients, consumers, and their advocates; data sharing networks, such as health information exchanges; authorized certification bodies and testing laboratories; security experts; relevant manufacturers of medical devices; experts in health information technology market economics; public and private entities engaged in the evaluation of HIT performance; quality organizations; experts in human factors engineering and the measurement of user-centered design; and other entities the Secretary determines appropriate. The Secretary shall award grants, contracts or agreements to independent entities to collect the information required to be reported. Includes the authorization of $15 million to support the ONC’s certification process.
• Sec. 4003. Interoperability. Includes new language instructing the ONC, NIST, and other relevant agencies within the Department of HHS to convene “public-private and public-public partnerships to build consensus and develop or support a trusted exchange framework, including a common agreement among health information networks nationally.” Includes rules of construction language and states that the trusted exchange framework and common agreement shall “take into account existing trusted exchange frameworks and agreements used by health information networks to avoid the disruption of existing exchanges between participants of health information networks.” Defines interoperability as HIT that:

“Enables the secure exchange of electronic health information with, and use of electronic health information from, other health information technology without special effort on the part of the user”

“Allows for complete access, exchange, and use of all electronically accessible health information for authorized use under applicable State or Federal law”

“Does not constitute information blocking”

ONC shall publish the trusted exchange framework and common agreement developed one year after the convening of stakeholders. ONC must publish a list of health information networks that have adopted the common agreement and are capable of trusted exchange no later than 2 years after the convening of stakeholders and annually thereafter. Federal agencies contracting or entering into agreements with health information exchange networks may require that each network adopts the trusted exchange framework and common agreement:

• Sec. 3003. Setting Priorities for Standards Adoption. The HIT Advisory Committee will identify priority uses for HIT focusing on priorities arising from the implementation of the incentive programs for the meaningful use of certified EHR technology, MIPS, Alternative Payment Models, the Hospital Value-Based Purchasing Program, and any other payment programs. Committee will also identify priorities related to a number of different issues including public health, privacy and security of electronic health information, and individual access. Committee will also identify existing standards and implementation specifications that support the use and exchange of electronic health information.
• Sec. 3022. Information Blocking. Defines information blocking  as a practice that “is likely to interfere with, prevent, or materially discourage access, exchange, or use of electronic health information; and if conducted by a health information technology developer, exchange, or network, such developer, exchange, or network knows, or should know, that such practice is likely to interfere with, prevent, or materially discourage the access, exchange, or use of electronic health information; or if conducted by a health care provider, such provider knows that such practice is unreasonable and is likely to interfere with, prevent, or materially discourage the access, exchange, or use of electronic health information.”   The Secretary, through rule making, may also identify reasonable and necessary activities that do not constitute information blocking.  The HHS Office of the Inspector General may investigate claims of information blocking or false attestations and may issue penalties up to $1 million per violation.
• Sec. 4005. Leveraging Electronic Health Records to Improve Patient Care.  Requires that electronic health records be able to transmit data to and from registries, such as clinician-led clinical data registries. Adds that health information technology developers shall be treated as patient safety organizations for the purposes of reporting and conducting patient safety activities concerning improving clinical care.
• Sec. 4006. Empowering Patients and Improving Patient Access to Their Electronic Health Information. The ONC shall promote policies that ensure that a patient’s electronic health information is accessible to the patient and/or designees to facilitate communication with other health care providers and other individuals, including researchers, consistent with such patient’s consent.  Lays out an educational effort for health care providers and patients on allowable sharing of patient health information.
• Sec. 4007. GAO Study on Patient Matching.  Requires the GAO to conduct a study on the policies and activities of the ONC and must specifically focus on efforts related to patient matching.
• Sec. 4008. GAO Study on Patient Access to Health Information.  Requires the GAO to conduct a study to review patient access to their own protected health information, including barriers to access and complications providers experience in providing access to patients.
• Additional Changes. The new version does not contain the three-star rating system that was part of Senator Bill Cassidy’s TRUST-IT Act and included in a previous version of Cures.

There is good and bad in the IT provisions of Cures.  

I’ve written in the past that interoperability really means getting the information necessary for coordination of care to those who need it without too much difficulty. You could read the Cures language as making available every data element for every purpose to every stakeholder with no effort. That is just not realistic.

I recently spoke with the CEO of a leading EHR company who noted that he has committed 600 person years of resources to support the healthcare regulations already issued in the past 10 months. Asking the EHR vendors to do something vague like support all registries and provide for “complete access, exchange, and use of all electronically accessible health information for authorized use under applicable State or Federal law” is like boiling the ocean with a lighter. Although I applaud the GAO report on patient matching (and I support a voluntary national healthcare identifier),  I cannot support legislation that co-opts the agenda of developers to the point they cannot meet customer needs because they are too busy creating functionality mandated by Congress.

Over the next 4 years, you’ll find me serving the Governor of Massachusetts, the New England region, and multiple international governments. I remain optimistic that the private sector will be allowed to innovate in response to demands from clinicians. I will do my best to serve all stakeholders, working hard at every level of government to do no harm, as mandated by the oath I took as a doctor.