In mid-July, the U.S. Department of Health and Human Services (HHS) Office of Civil Rights (OCR) released long-awaited Health Insurance Portability and Accountability Act (HIPAA) guidance on ransomware. The guidance addresses healthcare sector ransomware prevention, recovery, and breach notification processes.
The HHS Office of the National Coordinator for Health IT (ONC) and Assistant Secretary for Preparedness and Response (ASPR) released two funding opportunity announcements last week specific to the establishment of an Information Sharing and Analysis Organization (ISAO). The ISAO would be a single entity charged with IT security education, outreach, warnings and threat information dissemination across the healthcare/public health domain.
The American College of Radiology responded July 22 to a Request for Information (RFI) from the White House Office of Science and Technology Policy (OSTP) on “Artificial Intelligence.” RFI comments will inform the deliberations and future recommendations of the National Science and Technology Council Subcommittee on Machine Learning and AI. The subcommittee was recently created to explore the potential application of this technology to enhance federal government services in a variety of fields, including health care.
The ACR’s comment submission focused on the safety, efficiency, and effectiveness of AI, including: standardized data sets for training and testing, measurement of effectiveness and outcomes, validation and certification of algorithms, clarification of patient consent issues/appropriate methods, and more. The ACR encouraged federal support and partnership with professional associations and other stakeholders to address these issues.
The ACR Commission on Informatics-Clinical Data Science Committee and staff from the Research, MIS, and Government Relations teams informed the comment development efforts.
The Centers for Medicare and Medicaid Services (CMS) will publish its Hospital Outpatient Prospective Payment System (HOPPS) proposed rule for calendar year (CY) 2017 on July 14, 2016. In the meantime, the unpublished version is available to download as a PDF file from the online Federal Register public inspection desk.
The HOPPS proposed rule included several proposals for the Medicare EHR Incentive Program (or “Meaningful Use”), most of which focus on the hospital/CAH version of the program. These include various favorable tweaks to the thresholds of MU objectives/measures, as well as elimination of the CDS and CPOE objectives (functionality certified to the CDS and CPOE health IT certification criteria would still be required of “certified EHR technology” as before).
CMS proposed several revisions applicable to the physician version of the program as well….
The most important proposed change is a 90-day EHR reporting period in CY 2016 (instead of the full CY) and corresponding reduction in the eCQM reporting timeframe. If finalized, this would be the third year in a row CMS has moved to a 90-day reporting period for the EHR Incentive Program.
CMS also proposed a new significant hardship exception category to allow physicians participating in the Advancing Care Information (ACI) measures of the Merit-based Incentive Payment System (MIPS) in CY 2017, who did not participate in previous years of MU, to avoid MU penalties in CY 2018 by applying for a hardship exception by October 1, 2017. This is limited to first year participants because prior MUsers would already avoid the 2018 payment adjustments by virtue of their 2016 MU participation. In other words, this proposed hardship exception allows ACI participation in CY 2017 to substitute for first-year MU participation in order to avoid the CY 2018 MU penalties. The existing MU significant hardship exception options would remain the same for avoiding 2018 penalties, so nearly all ACR members would not need/use the proposed new option.
CMS also proposed a clarification to resolve a previous misunderstanding regarding numerator actions outside of reporting periods. Specifically, CMS clarified that unless otherwise specified, actions included in the numerators of measures must occur within the reporting period if that period is a full CY; or if it is less than a full CY, within the CY in which the reporting period occurs. The misunderstanding was apparently caused by misleading wording in a CMS FAQ.
Looking ahead beyond this HOPPS proposed rule, CMS is expected to publicly release the CY 2017 Medicare Physician Fee Schedule proposed rule in the near future—perhaps as early as this afternoon (July 7).
Update: CMS’ Medicare Physician Fee Schedule proposed rule was indeed released today and is scheduled for formal publication in the Federal Register on July 15, 2016.
The White House Office of Science and Technology Policy (OSTP) is requesting feedback from public stakeholders on the broad topic of “Artificial Intelligence (AI).” The OSTP’s formal Request for Information (RFI), published in the Federal Register on June 27, solicits comments (limited to 2,000 words) on the current and future needs for AI across all sectors. Responses are specifically requested on the following eleven AI topics:
- The legal and governance implications of AI;
- the use of AI for public good;
- the safety and control issues for AI;
- the social and economic implications of AI;
- the most pressing, fundamental questions in AI research, common to most or all scientific fields;
- the most important research gaps in AI that must be addressed to advance this field and benefit the public;
- the scientific and technical training that will be needed to take advantage of harnessing the potential of AI technology, and the challenges faced by institutions of higher education in retaining faculty and responding to explosive growth in student enrollment in AI-related courses and courses of study;
- the specific steps that could be taken by the federal government, research institutes, universities, and philanthropies to encourage multi-disciplinary AI research;
- specific training data sets that can accelerate the development of AI and its application;
- the role that “market shaping” approaches such as incentive prizes and Advanced Market Commitments can play in accelerating the development of applications of AI to address societal needs, such as accelerated training for low and moderate income workers (see https://www.usaid.gov/cii/market-shaping-primer); and
- any additional information related to AI research or policymaking, not requested above, that you believe OSTP should consider.
Additionally, the RFI formally notified the public of OSTP’s establishment of the National Science and Technology Council (NSTC) Subcommittee on “Machine Learning and AI” to examine the state of things and develop a report to coordinate the Administration’s efforts. This subcommittee was informally announced via White House press release in early May, and has since held a series of four broad workshops on AI. The NSTC is a Cabinet-level council and its subcommittees are interagency bodies not subject to public transparency requirements that govern normal federal advisory committees, so this RFI may serve as the only formal opportunity for members of the public to chime in prior to future publication of the report.
The ultimate goal is that the work of the NSTC Subcommittee on Machine Learning and AI could lead to increased use of these technologies to improve the delivery of government services. Despite the inherently inward focus on government, the subcommittee’s report could also potentially influence agencies that regulate and/or fund the private sector, thereby having some impact downstream on the private sector itself.
The Office of the National Coordinator for Health IT (ONC) held a joint meeting of its Health IT Policy Committee and Health IT Standards Committee on June 23 in Washington, DC. The committees approved final comments addressing the Centers for Medicare and Medicaid Services’ proposed rule to implement the Quality Payment Program (i.e., Alternative Payment Models [APMs] and Merit-based Incentive Payment System [MIPS]). The approved comments included the following recommendations:
MIPS: Advancing Care Information (ACI, formerly “Meaningful Use”)
- Shorten the performance period to 6 months
- Reduce the number of objectives/measures
- Reweight ACI to the other MIPS categories until 2019 for physicians not previously in the EHR Incentive Program
- Award bonus points for marked improvement in high-priority areas
MIPS: Clinical Practice Improvement Activities (CPIA)
- Additional integration of health IT
- Use CPIA as a “test bed” for practicing APM activities
- Enable more of a buffer between MIPS (automatic success) and Advanced-APM participation for QPs
- Additional information about new models with Advanced-APM status
The ONC’s Chief Privacy Officer, Interoperability Experience Task Force, and Interoperability Standards Advisory Task Force also provided updates on their respective activities. The committees will jointly convene their next business meeting via webcast on July 27.
Last week, the American College of Radiology (ACR) and thirty other national specialty societies co-signed a letter by the American Medical Association (AMA) responding to the HHS Office of the National Coordinator for Health IT’s (ONC) April 2016 Request for Information (RFI) on “assessing interoperability for Medicare Access and CHIP Reauthorization Act of 2015 (MACRA).” The letter encouraged ONC to measure interoperability with respect to usefulness, accuracy, timeliness, cost-effectiveness, specialty-specific use cases, etc., rather than volume. The expectation is if ONC focused on interoperability/exchange issues and capabilities that matter to physicians and patients in the real world, vendors would be incented to take a more holistic view of data-sharing, and get out of the rut of developing to the minimum health IT certification criteria requirements.
A provision of MACRA mandated ONC to determine whether EHR technology is successfully enabling widespread health information exchange by the end of 2018. ONC’s RFI asked respondents about considerations for nationwide interoperability metrics to make this determination. Many physician stakeholder groups were concerned that ONC’s RFI focused on a Meaningful Use-style approach of tallying the number of summary of care records sent to exchange partners in order to determine “widespread interoperability.”
The HHS Office of the National Coordinator for Health IT (ONC) held its annual meeting in Washington, DC on May 31 to June 2. The emphasis of this year’s conference was on ONC’s efforts as a grantor and convener, rather than the office’s primary role as a regulator and policymaker.
Centers for Medicare and Medicaid Services (CMS) representatives participated in a couple sessions, but the payor’s presence was noticeably dialed back from that of previous years. With only one dedicated breakout session on CMS’ Alternative Payment Models (APMs) and Merit-based Incentive Payment System (MIPS) proposed rule, and a few indirectly related breakout sessions, the hottest healthcare policy topic in years was severely underrepresented. The few sessions that were directly or indirectly related to MACRA implementation were packed with attendees.
Dr. Karen DeSalvo (National Coordinator for Health IT, ONC) used the plenary session to announce a new certified health IT product transparency tool. The general idea is to empower purchasers of certified health IT with plain language information about a product’s certification status and pricing, per the 2015 Edition certification requirements and the March 2, 2016 proposed rule on enhanced certification program oversight/transparency. The new tool shows if a vendor has “attested” to make future efforts to provide more information to prospective customers per 45 CFR 170.523(k)(2), and provides links (if available) to vendors’ public disclosure pages. Most of these links simply go to vendors’ certification criteria coverage information, and a few go to completely barren placeholder pages. Some vendors provide “price transparency disclosure” information regarding fee timetables, but these often do not list the associated dollar amounts. Only one or two of the vendor resources I found thus far list fee totals in their current price disclosures. So, the transparency tool is severely limited for now but will hopefully improve.
The third and final day of the conference (tomorrow, June 2) will focus on patient/consumer access to data. Dr. DeSalvo will provide closing remarks around 1:30PM Eastern. Interested individuals can view the main plenary portions of the event online.