By FRED and ALMA TROTTER

As President Obama’s healthcare reform unfolds in the last years of his administration, critics and supporters alike are looking for objective data. Meaningful Use is a funding program designed to create health IT systems that, when used in combination, are capable of reporting objective data about the healthcare system as a whole. But the program is floundering. The digital systems created by Meaningful Use are mostly incompatible, and it is unclear whether they will be able to provide the needed insights to evaluate Obamacare.

Recent data releases from HHS, however, have made it possible to objectively evaluate the overall performance of Meaningful Use itself. In turn we can better evaluate whether the Meaningful Use program is providing the needed structure to Obamacare. This article seeks to make the current state of the Meaningful Use program clear. Subsequent articles will consider what the newly released data implies about Meaningful Use specifically, and about Obamacare generally.

A short history of the problem

Historically, the US medical system has been a type of “sickcare”, rather than “healthcare”. It has been reactive – treating the ailment instead of preventing it. Doctors and hospitals have typically been rewarded by volume of procedures, rather than quality of patient outcomes. Instead of patients receiving preemptive care and monitoring early on, they often receive life-impacting procedures and prescriptions later, when their health has visibly declined.

The costs of treating or surviving a condition or injury can consume a person’s time, energy, and financial resources. What’s more, a patient’s safety under a provider’s care is not assured, as preventable medical errors in the US are commonplace – causing 400,000 deaths each year, or the equivalent of two 747s crashing each day.

We know that other national healthcare systems cost less, are subject to fewer errors, and take less of a toll on the patient.  In the US, patients must also voyage through the chaos surrounding their treatment – dealing with rejected insurance claims, record-keeping, confusing follow-ups, and frequent medical errors. These tasks can be complicated and subtle enough to confuse and dishearten the patients involved. Add to that the disturbing frequency of bankruptcy due to medical expenses, and we have a fairly accurate picture of the healthcare system that Obamacare intended to fix.

The nervous system of healthcare reform

The HITECH Act was part of President Obama’s Reinvestment and Recovery Act of 2009. It requires the government to standardize health IT and gives bonus payments to Medicare and Medicaid providers who use that technology well. The funding and regulations surrounding these payments were dubbed “Meaningful Use”.

Most people think that Obamacare is just the Affordable Care Act (ACA). But the first chapter of Obamacare was the HITECH act, which was passed as part of the stimulus package at the beginning of Obama’s first term. This act funded Health IT reform in the United States, and among other things subsidized providers to install software to create and maintain electronic healthcare records for all of their patients.

It is not possible to understand whether Obamacare is successful without using data from these Health IT systems. It is not possible to ask “Is Obamacare working” without Health IT, so a more useful question is “Is Health IT reform working”. The funding for Health IT systems has been less controversial than the contents of the ACA, because Health IT reform has been a rare area of agreement in the United States political system. Both parties have been cheerleaders of improved Health IT technology.

Obama was not the first President to consider or improve the state of health IT in the United States. President Clinton enacted The Health Insurance Portability and Accountability Act (HIPAA), which included safeguards for personal health information. The specific goal for nationwide adoption of electronic medical records (EMRs) was announced by President George W Bush, who also created the Office of the National Coordinator for Health Information Technology (ONC) under Health and Human Services (HHS).

If Obama’s healthcare reform were a ship, Meaningful Use would be both its compass and its rudder. It measures the healthcare system, but can also change health reform’s direction as needed. At least, that is how the program is supposed to work.

Reason for structure

The key component of health IT is the EHR (electronic healthcare record), which stores and shares patient information in a format that is machine and human-readable. This is the record that the doctor or hospital typically maintains about patients.

Before the Meaningful Use program, there was almost no agreement on what an EHR was and how it should be used. It was clear that many people were selling “Health IT snake oil” before the Meaningful Use regulations were in place and expected the HITECH funding to be a source of income. There was also a debate about whether we should call these digital systems Electronic Medical Records (EMRs) or Electronic Health Records (EHRs).

Eventually, the term EHR was defined as a digital health IT systems capable of appropriately moving healthcare data between providers. This concept, shortened to the single word “Interoperability”, would the highest goal of digital health technology. Meaningful Use is designed from the ground up to reject the siloing and data hoarding that had been so pervasive with health IT deployments in the past. If digital health systems remain incapable of exchanging data, then Meaningful Use was a failure.

The policy makers behind the Meaningful Use program had to ensure that the funding would actually serve to improve the care of patients. The term “Meaningful Use” highlights precisely what the Obama administration was most concerned to avoid, “meaningless use”.

For instance, the traditional paper and fax system is still preferred by many doctors. They could buy whatever EHR ended up meeting government standards, receive a payment, but never actually use the EHR they purchased. While the EHR collected virtual dust, the EHR vendor would still get paid (indirectly) by the government.

Even a physician using 90% of their EHR functions could be unaware of, or ambivalent toward some feature the government believes crucial for care quality improvement.

Issues such as these encouraged the creation of detailed and challenging objectives for providers and EHRs. EHR vendors had to meet strict standards for their products. In turn, healthcare providers had to prove that they used those EHRs extensively. While some aspects of Meaningful Use are optional, there is a core list of features that are required of every provider receiving Meaningful Use payments.

Meaningful Use basics

Health and Human Services (HHS) is responsible for implementing most of Obamacare. For the HITECH Meaningful Use program, two HHS sub-agencies were delegated to split the work: ONC and CMS.

The Office of the National Coordinator for Health IT (ONC) was designated as regulator of the standards and testing for an EHR to become certified EHR technology (CHERT). Of course healthcare providers were free to purchase any health IT solutions they liked, but only by using CEHRT would they receive a subsidy from the government for their purchase. CEHRT software was designed to give a provider everything they need to attest in either the Medicare or Medicaid EHR Incentive Program.

Centers for Medicare and Medicaid (CMS), is charged with creating objectives for providers, and measuring their performance in the Medicare attestation process (state agencies assess for the Medicaid program). Objectives vary for eligible professionals and hospitals, and include things like drug allergy checks, recording vitals, and electronic prescribing.

Both the requirements for EHR Vendors and the requirements for healthcare providers were initially grouped into three stages, which increased in health IT complexity, clinical integration, and quality metrics. As the stages got harder and more time passed, the incentive funds would wane and eventually turn into negative adjustments on regular Medicare payments.

Responses to Meaningful Use

Since the beginning of the program, CMS and ONC have been criticized by both vendors and providers in their execution of this program. Vendor associations like Healthcare Information and Management Systems Society (HIMSS), and provider organizations like the American Medical Association (AMA), have been united in their protest of various requirements, almost invariably wanting to lower the Meaningful Use bar. Almost no feedback coming from vendor and provider groups requested that CMS or ONC make Meaningful Use more stringent. Of course, such associations do not represent all providers and vendors, some of whom have requested higher standards for Meaningful Use.

ONC and CMS had to weigh this kind of feedback with the responses from patients, providers, and others with front line EHR experience – those who wanted strong assurances that new digital systems would not fail them in the way that previous generations of Health IT systems had.

Even as the HITECH was being authored, regulators recognized that there would be components of the healthcare industry that would want to progress quickly and achieve the most difficult goals for Health IT, and there would be others that would prefer a more minimalist approach.

The HITECH Act specifically instructs CMS and ONC to make Meaningful Use more challenging over time, and since HITECH was passed the government has already spent $28 billion on health IT reform. During the entire Meaningful Use program ONC and CMS have been under fire from all sides, but with very different messages: “Make Meaningful Use easier”, but also “Make more progress”. In order to determine what to do, CMS and ONC must assess vast amounts of qualitative data as well as subjective industry and public feedback.

Meaningful Use Stages and CHERT Editions

As we seek to evaluate whether or not HHS has been successful pacing Meaningful Use and balancing the interests of the parties impacted by digital health technology, we will need to get specific about requirements for how certified EHRs (CEHRT) and Meaningful Use line up. Essentially, we need to precisely parse what the doctors and hospitals were supposed to do, and what the EHR vendor community was supposed to accomplish.

The first two stages of Meaningful Use have been defined, and the third (and final) is currently undergoing rulemaking. Generally a “stage” refers to a different pile of funding and a substantial increase in complexity of the requirements.

The Definition of Meaningful Use is what determines the objectives in each of the three stages. The definition dictates what providers must accomplish, and it is intended to pair with a particular generation of CEHRT. CMS has regularly changed the Definition to adapt to the needs and requests of providers, vendors, and patients. These alterations result in different “versions” of the each Meaningful Use stage, labeled by the definition year. So the next version of Stage 1 will be “Stage 1- 2015 Meaningful Use Definition”. There are also Stage 1- 2011, 2013, and 2014 Definitions.

Even with its history of changes, Stage 1 adoption is considered by many to be a success. By 2014, two-thirds of all eligible providers had attested to it. Stage 2, however, had a rough start last year. This was partially due to implementation problems with 2014 Edition CHERTs.

Editions of CEHRTs were intended to progress whenever a new Meaningful Use stage began (2011 CHERT Edition at Stage 1’s start in 2011, and 2014 CEHRT Edition at Stage 2’s start in 2014). As the new technology became available, the older EHR technology was meant to fade out. A flexibility rule last year let certain providers who had problems using 2014 CHERT to regress to a Stage 1 attestation, though they were scheduled to be in Stage 2. These providers were also able to attest to the older, 2013 Definition of Stage 1.

Untangling the various stages of Meaningful Use standards is non-trivial, we have released infographics detailing how the program has changed for Eligible Providers and Eligible Hospitals.

Stage 2 and VDT

CEHRT challenges aside, many providers have told CMS that the current Stage 2, with its increased percentage thresholds and new objectives, is too difficult to achieve.  In response to the large volume of such opinions, CMS proposed a rule this April that would drastically change Meaningful Use for 2015-2017. It includes removing redundant and “topped out” measures, switching to one set of mandatory measures (instead of the current core and menu structure), and modifying patient engagement measures.

A cursory inspection of the proposed rule’s public comments indicates overall support from providers, and a backlash from patients. Controversy surrounds the proposal to lower the threshold for patients to view, download, or transmit their information from 5% to a single patient, and to switch the electronic messaging objective from a percentage-based measure to a yes/no for capability.

Thousands of responses were submitted by patients and organizations as part of an organized effort led by patient-advocate leaders. They stated that relaxing the objectives denies patients access their own data, and would prevent them from properly managing their own care.

Providers frequently argued that their patients are elderly or low-income and do not necessarily have a computer, know how to use email, or want to communicate digitally. They believe that the effort required to meet the objective takes away time needed to properly care for the patient.

The Meaningful Use standards that required specific interactions with patients, as well as communication with other providers, caused frustration for providers. They protested that EHR vendors blocked efforts to exchange healthcare data, and that their Meaningful Use funds might not be delivered because third parties were not willing to exchange data.

Subsequent articles, coming soon, will explore in more detail the issues surrounding Stage 2 and VDT, as well as the impact of grandfathering of Meaningful Use funding.

Exchanging healthcare information

From a policy perspective, implementing digital healthcare records nationwide, but failing to ensure that they actually exchange healthcare information, is a little like climbing Mt Everest but failing to make the summit. Simply put, it’s expensive, painful and pointless. This fact did not go unnoticed by Congress, which requested in the 2015 Omnibus Appropriations bill, that ONC use its regulatory power to enforce interoperability. Specifically:

ONC should use its authority to certify only those products that clearly meet current meaningful use program standards and that do not block health information exchange. ONC should take steps to decertify products that proactively block the sharing of information because those practices frustrate congressional intent, devalue taxpayer investments in CEHRT, and make CEHRT less valuable and more burdensome for eligible hospitals and eligible providers to use.

ONC found that healthcare providers and health IT vendors used methods such as charging unreasonable fees for information exchange, creating “non-standard” IT that made exchange difficult, or using policies that restricted individuals from accessing or transferring their data.

It is clear that at least some actors are hampering the efforts of healthcare information exchange. But even health IT backed by vendors with good intentions can still cause serious problems. EHR-born errors have started a new era of patient-safety concerns. Doctors and nurses must be cautious when entering or reading data, and vigilant as they integrate health IT in their already complicated and detailed workflow. Some doctors believe that the government is dangerously rushing EHR deployment, making them choose between protecting their patients or achieving Meaningful Use.

Up until very recently it was not possible to evaluate how CMS and ONC were collectively performing in their management of the Meaningful Use program. But newly public data submitted by providers and hospitals under the Meaningful Use program can be used to evaluate doctors. Subsequent articles will reveal how different vendors influence the performance of providers on the various clinical tasks set before them by Meaningful Use. By using provider performance to score EHR vendors, we will gain insights into how the Health IT marketplace has reacted to the Obamacare incentives, and how effective Health IT will be at measuring the overall performance of an Obamacare-based health system going forward.