Healthcare Technology Featured Article

November 24, 2015

Four Sets of Federal Guidance You Should Know if You're in Health IT

The federal government just released a flurry of guidance that will significantly affect the development, use and adoption of health information technology (health IT) for the next decade or so. The Centers for Medicare and Medicaid Services (CMS) issued a long-awaited final regulation with comment period for meaningful use (MU) stages 2 and 3. The Office of the National Coordinator for Health Information Technology (ONC) released a companion regulation that finalizes new certification criteria, standards and implementation specifications for electronic health record (EHR) technology. ONC topped it all off by introducing its 2015 Interoperability Roadmap, Connecting Health and Care for the Nation: A Shared Nationwide Interoperability Roadmap. Here are some initial thoughts.

Meaningful use regulations for stages 2 and 3. Most of what is contained in the MU final rule was hinted at or offered in previous guidance. CMS restructured the objectives and measures of the EHR incentive programs in 2015 through 2017 to align with stage 3 and modified “patient action” measures in stage 2 objectives. The goal clearly was to consolidate and simplify in response to stakeholder requests.  For the MU2 program in 2015 through 2017, major provisions include nearly halving objectives for eligible professionals, hospitals and critical access hospitals. Clinical quality measures (CQM) reporting remains as previously finalized. For MU3, more than 60 percent of the proposed measures require interoperability, up from 33 percent in stage 2. There is new emphasis on the required use of application program interfaces (APIs), which is one way the government is striving to address the perceived need for EHR interoperability. There also is more emphasis on public health reporting and cyber security.  

Changes related to electronic prescribing (ePrescribing) include:

  • The eligible hospital electronic prescribing objective — covering prescriptions at discharge — changed from a menu objective to a required objective for stage 2 from 2015 through 2017.  Some exclusions would be available. 
  • Under stage 3, more than 10 percent of hospital discharge medication orders for permissible prescriptions (for new, changed, and refilled prescriptions) are to be queried for drug formulary and transmitted electronically using certified electronic health record technologies (CEHRT). There are exclusions.
  • The inclusion of controlled substances is still optional, which represents no change from stage 2.  However, there is a wording and definitional change for stage 3. Now controlled substances are to be included automatically in the category of “permissible prescriptions,” providing they meet various criteria under federal and state laws. The use of permissible prescriptions counts toward the denominator that is used to determine compliance with the objective.

                                                                                                                                                                                                                                                                                                                                        MACRA. One of the biggest issues in the regulation is the impact of landmark Medicare reform legislation, the Medicare Access and CHIP Reauthorization Act of 2015 or MACRA. MACRA sunsets MU as we know it at the end of 2018 and rolls it up with the Physician Quality Reporting System (PQRS) and Value-Based Payment Modifier (VBPM) into one big reporting system at the beginning of 2019. The result: MU will be transformed from a stand-alone program to a component of a larger reporting system called the Merit-Based Incentive Payment Systems program (MIPS), which will affect everyone for the next 10 to 12 years. most likely will tie MU to physician reimbursement. That is because MACRA originated as legislation to “fix” Medicare physician payment mechanisms and the other two programs in MIPS are tied to physician payment.  It appears the goal is to link MU functionality and physician payment, which is the only thing that makes policy sense in creating a gigantic new reporting system. Stakeholders can see glimpses of this already as stage 3 CQM reporting is to be aligned with the CMS quality reporting programs. Will a program such as MIPS be an improvement in the sense that having the three major programs under one roof will make things easier to coordinate or will MIPS be too unwieldy? CMS has asked for comments about MACRA coordination with MU3, so it will be interesting to see what stakeholders think and how CMS reacts.

Impact on providers. Despite major pushback from physician organizations and Congressional concerns, MU stage 3 is set to be optional in 2017 and start on January 1, 2018. Providers have said it before and they’ll say it again: this is too much, too soon. There is a lot of merit in that concern. Although the vast majority of providers are now using EHRs, more than 60 percent - of hospitals and about 90 percent - of physicians have yet to attest to MU stage 2.  

There is a silver lining for providers. According to the government, the MU3 final rule adopts flexible reporting periods that are aligned with other programs, ostensibly reducing burden on providers. For example, MU3 will move from fiscal year to calendar year reporting for all providers beginning with 2015 reporting. Reporting periods also will change, with a 90-day reporting period in 2015 for all providers, for new participants in 2016 and 2017, and for any provider moving to stage 3 in 2017. However, providers are left with barely 90 days to attest for the 2014 reporting period, which doubtless will lead to confusion and consternation.

In the end, all this might be too much for many providers. They face a lack of readiness for stage 2, the end of the MU incentive money, and the perceived moving target of MU3 requirements. Plus, the full details of MU stage 2 have just been finalized, leaving providers scrambling to comply. All this is likely to convince more providers to abandon MU in the near term, take any payment reductions that result and hope things will get better in 2019, when MACRA provisions kick in.

Moreover, MU3 may not even make it to the next administration in its current iteration — if providers have anything to say about it. The American Medical Association and 110 medical societies sent letters on November 2 to Congress urging relief from MU stage 3 — or at least a "refocus" — due to its “less achievable and more disruptive” requirements and negative consequences. The unhappiness of these provider groups carries a lot of weight on the Hill. Provider groups can be powerful allies or enemies to those seeking election or reelection during this cycle.

Impact on vendors. Vendors remain skeptical about what the future holds for MU because it’s unclear to those outside the Beltway whether the “final” rule for MU stage 3 is, well, final. That is because it includes a 60-day comment period, suggesting that there may be additional modifications or delays down the line. As mentioned previously, modifications for MU stage 2 were also recently released, further lending credence to the perception that nothing is final and everything related to MU is a moving target. This is likely to have two effects.

Large- and top medium-size EHR vendors will continue to build to the new MU3 requirements. Their business models have dealt almost exclusively with meeting MU requirements over the past few years, so they know the drill and how to do it profitably. There are some vendors who are unlikely to start building to MU3 requirements in the face of the uncertainty surrounding its requirements. They may determine that they will have time to let the dust settle and start worrying about the stage 3 requirements in a few years. There definitely is time. MU3 is optional in 2017 and will begin in earnest on January 1, 2018. Some vendors are taking advantage of the breaks in the MU timeline to beef up their analytics offerings — for the business side of physician practices as well as the clinical side.

From a practical point of view, vendors are likely to use this point in time to decide whether they want to stay in the MU-certified world, ignore it and tread water for a few years until the regulatory dust has settled, or go out of business. Time will tell.

Certification rule. There certainly will be a lot of work to go around to sync up with the new certification criteria. From a certification perspective, EHR vendors are faced with a slew of new certification, standards and technology requirements, such as new criteria for Application Access, Common Clinical Data Set Summary Record, Data Segmentation for Privacy, and Care Plan certification.

All of these certification changes have implications as to whether vendors will create certified products. It is clear that providers must use certified health IT in order to meet evolving payment and quality criteria. However, certification remains a significant cost of doing business for EHR vendors. The costs and benefits of certification are something that vendors will have to weigh as MU fades from relevance in favor of MIPS.

A silver lining for providers and vendors is that compliance with the 2015 edition is voluntary. In addition, EHR developers that have certified EHR technology to the 2014 edition would not need to recertify to the 2015 edition. Likewise, providers eligible to participate in MU would not need to upgrade to 2015 edition criteria to have systems that meet the definition of certified EHRs. This is good news all around, as it affords providers the ability to adopt new features and vendors an opportunity to innovate.

In a press release, ONC noted that this is the first time it is proposing certification criteria separate from MU regulations, again setting the stage to move to MACRA requirements. This also signals ONC’s new regulatory approach, which will be marked by more incremental and frequent rule making and a focus on improved standards. This clearly is in response to the MACRA requirements, which folds MU into a new payment program and eliminates it as a stand-alone entity that was closely tied with certification. According to ONC, this incremental approach will allow the agency to update certification criteria more frequently to reference improved standards and allow for “regulatory clarity” (whatever that is) through more frequent solicitation of comments on potential proposals.

The incremental approach, unfortunately, does not accommodate the reality of software development and version control. While incremental and frequent changes to requirements enable ONC to be more responsive to stakeholder feedback, this tactic will be challenging for vendors. Software vendors plan months in advance for feature changes, and practices are loath to implement software upgrades and associated new functionality and updated work flows more than once or twice a year. Frequent changes to the requirements necessitate rework by software developers and create havoc with providers trying to meet MU requirements.

ONC’s Interoperability Roadmap. The Roadmap is a thoughtful, 150-plus page document addressing everything from governance, standards and certification to privacy and security.

The Roadmap has lofty goals for interoperability. It envisions that medical providers and patients will receive, transmit and utilize priority data by the end of 2017 in an effort to improve health outcomes. Private and public stakeholders will work to expand the number of interoperable IT system users and data sources between 2018 and 2020. By 2021, stakeholders will start to collaborate in order to achieve health IT interoperability across the country as well as deploy a learning health system by 2024.

Those goals will be achieved by following three critical pathways to achieving interoperability: using consensus-based standards, enabling the shift in payment policies from fee-for-service to value-based models, and aligning federal and state privacy and security requirements that enable interoperability. As with its predecessors, it adopts an optimistic and somewhat aggressive timeline and set of activities. 

The Roadmap lacks the force of regulation and is strictly a guidance document. That said, while ONC is a forceful policy organization, it is not apparent how the Roadmap will affect future adoption and use of EHRs and health IT. It clearly is poised to align with various government programs and emerging legislation, such as H.R. 6, the 21st Century Cures Act. This House bill contains provisions concerning interoperability that are likely to be supported by the Senate. Because this bipartisan legislation has legs, many observers believe it will end up on the President’s desk, where he will sign it.

It will be interesting to see how this work product will be viewed and addressed (or not) by the policymakers in the next administration. Whether it stays in the hands of the same party or shifts to the other, don't hard code the word "interoperability.” A new buzzword is sure to come down the pike. Anybody remember the Nationwide Information Superhighway?  

Edited by Maurice Nagle
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