The U.S. Senate Committee on Health, Education, Labor and Pensions (HELP) is preparing to markup health IT/interoperability legislation on February 9 based on their recent discussion draft. The draft bill incorporated language from the Transparent Ratings on Usability and Security to Transform Information Technology (TRUST IT) Act, including the information blocking prohibitions supported by the American College of Radiology (ACR). The ACR submitted comments on January 29.
The committee’s discussion draft revised TRUST IT’s definition of “information blocking” to create two distinct categories based on entity type – one for developers/vendors/HIE networks, and one for providers (e.g., hospitals and health systems). Developers would be held accountable for essentially the same behaviors covered by the earlier TRUST IT Act (including blocking via ignorance/disregard), and providers would be held accountable for only “knowingly and unreasonably restricting” information exchange. HHS, through rulemaking, would identify reasonable and necessary actions by developers that are not information blocking, as well as a set of specified actions that are information blocking by providers.
The draft legislation also mandates different penalties based on entity type. Developers/vendors/exchange networks that engage in information blocking would receive civil monetary penalties in an amount determined to be a sufficient deterrent by HHS. Providers would be subject to a “sufficient deterrent”—but not specifically fines—under HHS’ existing authority. A “sufficient deterrent” could potentially mean consideration and penalization through the existing incentive programs for information-blocking actions, or it could mean something else within HHS’ current authority.
ACR’s comments to the committee reaffirmed the College’s support for the earlier TRUST IT version of the information blocking prohibition, which held hospitals and health systems accountable for blocking resulting from ignorance and reckless disregard, and penalized such entities for each blocking infraction by up to $10,000. That said, the committee’s legislation will be viewed as the evolved state of play moving forward, and reverting to the TRUST IT language is exceedingly unlikely. While the details of the TRUST IT Act language are preferable, ACR is generally supportive of the committee’s efforts to address information blocking in some manner, and will continue to work with policymakers to proliferate interoperability and exchange.
The recent comments of Andy Slavitt (Acting Administrator, Centers for Medicare and Medicaid Services [CMS]) at the J.P. Morgan Annual Health Care Conference created waves around the Internet, in large part because of the oversimplified, click-bait headlines: MU will be over in 2016!!! The agency quickly had to post clarification tweets as well as a full transcript of Slavitt’s presentation on its website – which is not the standard operating procedure for presentations given at conferences, by the way.
With the clarification, Slavitt’s real message was basically this: Meaningful Use (MU), as it has existed, will no longer exist in the Merit-based Incentive Payment System era. In fact, Slavitt pointed out in his presentation that all three incentive programs (MU, PQRS, and VBM) will be “sunset” and “aligned together in a new single program.” Importantly, official agency announcements will be coming over the next several months, presumably including the MIPS/APMs proposed rule itself which was already planned for March-April-ish 2016.
MIPS and its repackaging of the financial components of the three current quality incentive programs is obviously old news. So, what else did Slavitt mean for MU’s future?
This is just a guess, but his statements could indicate a radical simplification of MU requirements heading into the MIPS era. Stage 3 was the previous plan, but maybe the agency plans to revert back to the basics of the statute – before the federal advisory committees to ONC and the agencies helped turn MU regulatory implementation into a complicated tapestry of unnecessary objectives and data capture exercises. After all, “MU,” and however that concept is defined in the future, still needs to be 25% of a physician’s composite score under MIPS.
Slavitt’s full statement includes a glimpse at what the “MU” 25% of the composite score could mean in the MIPS era:
“Let me dive a little deeper on the technology component. Now that we effectively have technology into virtually every place care is provided, we are now in the process of ending Meaningful Use and moving to a new regime culminating with the MACRA implementation.
The Meaningful Use program as it has existed, will now be effectively over and replaced with something better. Since late last year we have been working side by side with physician organizations across many communities — including with great advocacy from the AMA — and have listened to the needs and concerns of many. We will be putting out the details on this next stage over the next few months, but I will give you [the] themes guiding our implementation.
For one, the focus will move away from rewarding providers for the use of technology and towards the outcome they achieve with their patients.
Second, providers will be able to customize their goals so tech companies can build around the individual practice needs, not the needs of the government. Technology must be user-centered and support physicians, not distract them.
Third, one way to aid this is by leveling the technology playing field for start-ups and new entrants. We are requiring open APIs in order to the physician desktop can be opened up and move away from the lock that early EHR decisions placed on physician organizations so that allow apps, analytic tools, and connected technologies to get data in and out of an EHR securely.
And finally, we are deadly serious about interoperability. We will begin initiatives in collaboration with physicians and consumers toward pointing technology to fill critical use cases like closing referral loops and engaging a patient in their care. And technology companies that look for ways to practice “data blocking” in opposition to new regulations will find that it won’t be tolerated.”
Each of the themes Slavitt listed were clearly based on the original HITECH statutory definition of MU, paraphrased as follows:
1) certified EHR technology is used in a meaningful manner (eRx is the only example used by Congress);
2) information exchange (connected and able to exchange health information for quality and care coordination); and,
3) reporting on clinical quality measures (CQMs).
Reverting to the original Congressional intent via a radical simplification of “MU” would be welcomed by physician participants dreading the expected regulatory challenges of MIPS participation. MU will be a supporting character – not the star of the show – during the MIPS era, so it makes sense to streamline the MU definition into something more manageable and, frankly, less extensive.
How the changes will be implemented in regulation will hopefully be answered by the future CMS announcements—will there be a separate standalone rulemaking to replace Stage 3, or will these changes be handled within the MIPS rulemaking itself? Slavitt’s comments suggest the changes have not yet been drafted internally, which could mean the upcoming APMs/MIPS proposed rule will either be delayed beyond the March-April-ish timeframe, or that a separate proposed rule will be needed to reform the MU piece of the MIPS puzzle. Stay tuned…
On December 22, the HHS Office of the National Coordinator for Health IT (ONC) released its expanded 2016 Interoperability Standards Advisory – a policy document showing the status of select interoperability standards and implementation specifications for specific health IT needs. The 2016 ISA adds/expands several imaging items beyond the 2015 iteration. Comments will soon be accepted by ONC to inform the draft 2017 ISA.
CMS and ONC RFI on CQM Reporting Certification for Health IT Modules
On December 31, the Centers for Medicare and Medicaid Services (CMS) published a Request for Information (RFI) on “certification frequency and requirements for the reporting of quality measures under CMS programs.” Public comments will be accepted until February 1.
The purpose of the RFI is to solicit input on potential health IT certification changes for products that enable quality measure (CQM) reporting for the Medicare/Medicaid EHR Incentive Program and other quality incentive programs. CMS and ONC are exploring the possibility of requiring vendors to recertify products’ CQM reporting capabilities on a regular basis. The agencies may also expand the minimum number of CQMs that certified health IT modules must report. The options are: 1) requiring CQM reporting modules to enable reporting all CQMs for the eligible professional or eligible hospital audiences; 2) gradually increasing the required minimum number of CQMs that products must report (until all-encompassing); or 3) requiring a larger or more specialty-targeted subset of CQMs that must be reported.
Stage 3 MU (Un)Popularity
As of this writing, CMS has officially received 683 public comments addressing the Stage 3 Meaningful Use final rule. When combined with the proposed rule, that puts the tally at 1,744 formal public comments on just CMS’ Stage 3 MU regulations. (This is not counting comments submitted on the accompanying ONC rulemaking, earlier advisory committee RFIs, advocacy letters sent to the agencies, or comments on the recent APMs/MIPs RFI…)
On December 15, the American College of Radiology (ACR) submitted comments to the Centers for Medicare and Medicaid Services (CMS) regarding the Stage 3 EHR Incentive Program (Meaningful Use) final rule. ACR’s comments reiterated its prior recommendations to the agency on the Alternative Payment Models/Merit-based Incentive Payment System (MIPS) Request for Information from October as well as the Stage 3 MU Notice of Proposed Rulemaking from last March.
For the MU performance category in MIPS (worth 25 percent of the composite score), ACR recommended that “non-patient-facing professionals” be able to choose from three potential options: 1) Stage 3 MU as is, 2) exclusion and recalculation of the MIPS composite score using the remaining categories, or, 3) active engagement with relevant clinical data registries. Additionally, ACR recommended simplification and various other changes to the MU paradigm in the MIPS era (2019 and beyond) so that Stage 3 MU would not be an all-or-nothing, pass-or-fail chunk of the composite score.
ACR also focused on the clinical information incorporation and reconciliation measures of the “health information exchange (HIE)” objective—perhaps the most challenging and resource-intensive requirements of future Stage 3 MU compliance for diagnostic radiologist participants. Specifically, the College recommended that referrals for imaging services not be included in the “transitions of care/first time encounters with new patients” denominator for the second and third measures of the Stage 3 HIE objective. Several reasons were provided for this recommendation: 1) referring providers still rarely send C-CDA documents alongside imaging orders, so radiologists’ requests for the missing summary of care records (and, to a lesser degree, HIE network queries) as called for by MU requirements (prior to being able to exclude those referrals from the denominator) would be commonplace and time/resource-intensive; 2) physicians may not always have a clinical need for their referred patients’ medications, medication allergies, or problem list data (the minimum data from C-CDA documents that need to be incorporated and reconciled by ToC/referral recipients); and 3) radiologists should have the option to securely obtain, incorporate, and reconcile any clinically relevant patient data from referring providers—not be forced to double back and request C-CDA documents prior to excluding referrals from the denominator of measures 2 and 3 of the HIE objective, or to incorporate/reconcile potentially unhelpful data from any (rare) received summary of care records.
For questions regarding ACR’s comments or MU in general, please contact Michael Peters, ACR Director of Regulatory and Legislative Affairs, at email@example.com or 202-223-1670.
The American Medical Association (AMA) recently opened a physician survey to assist the HHS Office of the National Coordinator for HIT (ONC) with gathering information pertaining to Summary of Care documents exchanged as part of the Medicare/Medicaid EHR Incentive Program (Meaningful Use).
Interested American College of Radiology (ACR) members are encouraged to complete the survey to inform ONC of the data sets that are important to be provided by referring physicians, and the EHR functionality that is most desirable for incorporating and reconciling any data elements of interest from received SoCs.
Representative Tom Price (R-GA-6) recently introduced H.R. 3940, the Meaningful Use (MU) Hardship Relief Act of 2015, to authorize a blanket significant hardship exception from EHR Incentive Program penalties for CY 2015 reporting periods. The bill would address obvious concerns that CMS published the final rule to modify MU in 2015 around mid-October, weeks after the last possible start date for a 90-day CY 2015 reporting period.
As written, the legislation would prevent CMS from penalizing providers for failing to meet MU in CY 2015. Presumably, this blanket hardship exception would thus negate all MU penalties for everyone in CY 2017, as that would be the applicable payment adjustment year. The bill’s language does not explicitly address the issue of would-be-rookie participants who could have avoided payment adjustments in CY 2016 as well by beginning the program in CY 2015.
The blanket exception is not “free,” as it would still count toward an individual’s cap of five total years of awarded hardship exceptions.
Diagnostic radiologists, interventional radiologists, and nuclear medicine physicians already automatically avoid MU penalties via a different hardship exception option, so this bill would primarily benefit ACR’s radiation oncologist members as well as non-radiologists.
In 2013, the American College of Radiology (ACR) Council passed a resolution directing the College to make interoperability and information-sharing an advocacy priority. That same year, ACR provided input into an Office of the National Coordinator for Health IT (ONC) request for information about health information exchange and interoperability, and successfully worked with the Centers for Medicare and Medicaid Services (CMS) and the HHS Office of Inspector General (IOG) to strengthen regulatory requirements around the previously lax “interoperability” prerequisites in the EHR exception and safe harbor from self-referral and anti-kickback requirements.
This week, ACR continued its efforts to proliferate interoperability and exchange by officially supporting S. 2141, the Transparent Ratings on Usability and Security to Transform Information Technology (TRUST IT) Act of 2015, sponsored by U.S. Senators Bill Cassidy, MD (R-LA) and Sheldon Whitehouse (D-RI). This bipartisan legislation would expand HHS OIG’s authority to investigate and penalize “information blocking” beyond EHR donations under the EHR exception/safe harbor to include any information blocking related to certified health IT. If a hospital/provider, vendor, or system were reported for information blocking, HHS OIG would be empowered to investigate and assess a civil monetary penalty of up to $10,000 per act.
The legislation defines “information blocking” as follows:
The term ‘information blocking’ means, with respect to the development, configuration, implementation, and use of qualified electronic health records and other health information technology, business, technical, and organizational practices that—
“(A) except as required by law, prevent or materially discourage the access, exchange, or use of electronic health information; and
“(B) the person knows or should know (as defined in section 1128A(i)(7) of the Social Security Act [SSA]) are likely to interfere with the access, exchange, or use of electronic health information.
“Should know” in the current section 1128(i)(7) of the SSA means:
The term “should know” means that a person, with respect to information—
(A) acts in deliberate ignorance of the truth or falsity of the information; or
(B) acts in reckless disregard of the truth or falsity of the information, and no proof of specific intent to defraud is required
Beyond empowering HHS OIG to investigate and penalize information blocking, the legislation would also improve physician and consumer protections by implementing a development council-administered, three star ratings scale for certified health IT products in the areas of usability, interoperability, and security. The HHS and the development council would work with specialty physicians, among other stakeholders, to develop reporting criteria to guide the ratings.
The TRUST IT Act arose out of a series of several Senate Health, Education, Labor and Pensions Committee hearings on interoperability issues and barriers throughout 2015. Senators Cassidy and Whitehouse both serve on the committee. ACR is now urging Congress to include TRUST IT Act in the upcoming Senate companion to H.R. 6, the 21st Century Cures Act.
If members have questions about the TRUST IT Act or ACR’s support for this bill, please contact Michael Peters, ACR Director of Regulatory and Legislative Affairs, at firstname.lastname@example.org.