CMS: Electronic Medical Records Meaningful Use Round 2

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Health and Human Services (HHS) Secretary Kathleen Sebelius announced the next steps for providers who are using electronic health record (EHR) technology and receiving incentive payments from Medicare and Medicaid.  These proposed rules, from the Centers for Medicaid & Medicaid Services (CMS) and the Office of the National Coordinator for Health Information Technology (ONC), will govern stage 2 of the Medicare and Medicaid Electronic Health Record Incentive Programs.

“We know that broader adoption of electronic health records can save our health care system money, save time for doctors and hospitals, and save lives,” said Secretary Sebelius.  “We have seen great success and momentum as we’ve taken the first steps toward adoption of this critical technology.  As we move into the next stage, we are encouraging even more providers to participate and support more coordinated, patient-centered care.”

Under the Health Information Technology for Economic and Clinical Health (HITECH) Act, part of the American Recovery and Reinvestment Act of 2009, eligible health care professionals and hospitals can qualify for Medicare and Medicaid incentive payments when they adopt certified EHR technology and use it in a meaningful way. What is considered “meaningful use” is evolving in three stages:

  • Stage 1 (which began in 2011 and remains the starting point for all providers): “meaningful use” consists of transferring data to EHRs and being able to share information, including electronic copies and visit summaries for patients.
  • Stage 2 (to be implemented in 2014 under the proposed rule): “meaningful use” includes new standards such as online access for patients to their health information, and electronic health information exchange between providers.
  • Stage 3 (expected to be implemented in 2016): “meaningful use” includes demonstrating that the quality of health care has been improved.

CMS’ proposed rule (455 pages) specifies the stage 2 criteria that eligible providers must meet in order to qualify for Medicare and/or Medicaid EHR incentive payments. It also specifies Medicare payment adjustments that, beginning in 2015, providers will face if they fail to demonstrate meaningful use of certified EHR technology and fail to meet other program participation requirements. 

In a November 2011 “We Can’t Wait” announcement, the Department outlined plans to provide an additional year for providers who attested to meaningful use in 2011.   Under the proposed rule, stage 1 has been extended an additional year, allowing providers to attest to stage 2 in 2014, instead of in 2013.

The proposed rule (184 pages) announced by ONC identifies standards and criteria for the certification of EHR technology, so eligible professionals and hospitals can be sure that the systems they adopt are capable of performing the required functions to demonstrate either stage of meaningful use that would be in effect starting in 2014.  ONC provided a fact sheet summary of the rule.  ONC also provided a link to a recent presentation discussing these recent changes.

“Through the Medicare and Medicaid EHR Incentive Programs, we’ve seen incredible progress as over 43,000 providers have received $3.1 billion to help make the transition to electronic health records,” said CMS Acting Administrator Marilyn Tavenner. “There is great momentum as the number of providers adopting this technology grows every month.  Today’s announcement will help ensure broad participation and success of the program, as we move toward full adoption of this money-saving and life-saving technology.”

“The proposed rules for stage 2 for meaningful use and updated certification criteria largely reflect the recommendations from the Health IT Policy and Standards Committees, the federal advisory committees that operate through a transparent process with broad public input from all key stakeholders. Their recommendations emphasized the desire to increase health information exchange, increase patient and family engagement, and better align reporting requirements with other HHS programs,” said Farzad Mostashari, MD, ScM, National Coordinator for Health Information Technology.

“The proposed rules announced today will continue down the path stage 1 established by focusing on value-added ways in which EHR systems can help providers deliver care which is more coordinated, safer, patient-centered, and efficient.”

The number of hospitals using EHRs has more than doubled in the last two years from 16 to 35 percent between 2009 and 2011.  Eighty-five percent of hospitals now report that by 2015 they intend to take advantage of the incentive payments.

Stage 2 Criteria for Meaningful Use 

In the proposed rule, CMS proposes to specify Stage 2 criteria that eligible providers (EPs), eligible hospitals, and CAHs must meet in order to qualify for an incentive payment, as well as introduce changes to the program timeline and detail payment adjustments.  These proposed criteria were substantially adopted from the recommendations of the Health IT Policy Committee (HITPC), a Federal Advisory Committee that obtains industry and provider input regarding the Medicare and Medicaid EHR Incentive Programs, as well as through consideration of current program data for the Medicare and Medicaid EHR Incentive Programs. 

The proposed Stage 2 criteria for meaningful use focus on increasing the electronic capturing of health information in a structured format, as well as increasing the exchange of clinically relevant information between providers of care at care transitions.

The proposed Stage 2 criteria for meaningful use are based on a series of specific objectives, each of which is tied to a proposed measure that all EPs and hospitals must meet in order to demonstrate that they are meaningful users of certified EHR technology. This approach is similar to the objective and measure approach used in Stage 1. 

In their July 28, 2010, rule outlining Stage 1 criteria, CMS finalized a separate set of core objectives and menu objectives for both EPs and eligible hospitals and CAHs. In Stage 1, EPs and hospitals must meet or qualify for an exclusion to all of the core objectives and 5 out of the 10 menu measures in order to qualify for an EHR incentive payment under these Stage 1 requirements. 

In this proposed rule, CMS proposes to maintain the same core and menu structure for the program for Stage 2. We propose for Stage 2 that EPs must meet or qualify for an exclusion to 17 core objectives and 3 of 5 menu objectives. We propose that eligible hospitals and CAHs must meet or qualify for an exclusion to 16 core objectives and 2 of 4 menu objectives. 

Each objective/measure was evaluated for its applicability to all EPs and eligible hospitals. In cases where there are situations that make it impossible for an EP or eligible hospital to meet the measure, an exclusion was defined in the final rule. If an exclusion applies, then the EP or eligible hospital would not have to meet that objective/measure in order to be deemed a meaningful user. 

Nearly all of the Stage 1 core and menu objectives have been retained for Stage 2. The “exchange of key clinical information” core objective from Stage 1 was eliminated in favor of a more robust “transitions of care” core objective in Stage 2, and the “provide patients with an electronic copy of their health information” objective was eliminated because it has been replaced by an “electronic/online access” core objective. 

There are also multiple Stage 1 objectives that have been combined into more unified Stage 2 objectives, with a subsequent rise in the measure threshold that providers must achieve for each objective that has been retained from Stage 1. This eliminates unnecessary accounting and reporting burden for providers by recognizing that, for providers who have been Stage 1 meaningful users for multiple years, recording these data in structured form has become a normal part of care delivery. 

Changes to Stage 1 Criteria for Meaningful Use 

In this proposed rule, CMS proposes several changes to existing Stage 1 criteria for meaningful use. Some of these changes would be optional for use by providers in Stage 1 but would be required for use in Stage 2. Other changes would not take effect until providers have to meet the Stage 2 criteria. An overview of these proposed changes includes: 

  • Changes to the denominator of computerized provider order entry (CPOE) (Stage 1 Optional, Stage 2 Required)
  • Changes to the age limitations for vital signs (Stage 1 Optional, Stage 2 Required)
  • Elimination of the “exchange of key clinical information” core objective from Stage 1 in favor of a “transitions of care” core objective that requires electronic exchange of summary of care documents in Stage 2 (Effective Stage 2)
  • Replacing “provide patients with an electronic copy of their health information” objective with a “view online, download and transmit” core objective. (Effective Stage 2) 

Greater Applicability to Specialists 

The NPRM proposes new objectives that have greater applicability to many specialty providers. The addition of these objectives recognizes the leadership role that many specialty providers have played in the meaningful use of health IT for quality improvement purposes with respect to: 

  • Imaging results and information accessible through certified EHR technology
  • Capability to identify and report cancer cases to a State cancer registry, except where prohibited, and in accordance with applicable law and practice
  • Capability to identify and report specific cases to a specialized registry (other than a cancer registry), except where prohibited, and in accordance with applicable law and practice 

Stage 2 Reporting of Clinical Quality Measures 

Just as in Stage 1, CMS proposes that EPs, eligible hospitals, and CAHs be required to report on specified clinical quality measures (CQMs) in order to qualify for incentive payments under the Medicare and Medicaid EHR Incentive Programs. 

For EPs, CMS is proposing a set of measures that align Stage 2 CQMs with existing quality programs by aligning measures with the Physician Quality Reporting System (PQRS), Medicare Shared Savings Program, and National Council for Quality Assurance (NCQA) for medical home accreditation, as well as measures proposed under the Children’s Health Insurance Program Reauthorization Act (CHIPRA) and under section 1139A of the Social Security Act (as added by Section 2701 of the Affordable Care Act). 

For eligible hospitals and CAHs, CMS is proposing to align Stage 2 CQMs with the Inpatient Quality Reporting (IQR) and the Joint Commission’s hospital quality measures.   The proposed rule would require EPs to report 12 CQMs and eligible hospitals and CAHs to report 24 CQMs in total. CMS recognizes that for clinical quality reporting to become routine, the administrative burden of reporting must be reduced.    

This proposed rule outlines a process by which EPs, eligible hospitals, and CAHs beyond their first year of Stage 1 participation would submit CQM data electronically, thereby reducing the associated burden of reporting on quality measures for providers.  CMS is soliciting public comment on two mechanisms of electronic CQM reporting: aggregate-level electronic reporting as a group, or through existing quality reporting systems (for Medicare providers). Within these and States’ mechanisms of reporting, CMS has proposed different approaches to CQM reporting that offer flexibility to EPs, eligible hospitals, and CAHs. 

Payment Adjustments and Exceptions 

Medicare payment adjustments are required by statute to take effect in 2015. In this NPRM, CMS proposes that any Medicare EP or hospital that demonstrates meaningful use in 2013 would avoid payment adjustment in 2015. Also, any Medicare provider that first demonstrates meaningful use in 2014 would avoid the penalty if they meet the attestation requirement by July 3, 2014 (eligible hospitals) or October 3, 2014 (EPs). 

Meaningful use attestations to State Medicaid Agencies by EPs who are eligible for either Medicare or Medicaid but opted for Medicaid, will be accepted to avoid the Medicare penalty. However, it is important to note that the receipt of Medicaid EHR Incentive Program payments for one kind of Medicaid incentive payment (the adopt, implement or upgrade, the criteria for the first year of Medicaid EHR Incentive Program payments), is not the same as meeting the meaningful use criteria. Therefore, those providers may be subject to Medicare payment adjustments if they do not otherwise demonstrate meaningful use. 

CMS is proposing exceptions to these payment adjustments. This proposed rule outlines three categories of exceptions based on: 

  • Availability of internet access or barriers to obtaining IT infrastructure;
  • A time-limited exception for newly practicing EPs who would not otherwise be able to avoid payment adjustments; and
  • Unforeseen circumstances such as natural disasters that would be handled on a case-by-case basis. 

CMS is also soliciting comment on additional criteria for exceptions. 

Discussion 

Thus far CMS has spent less than 10% or $3.1 billion of the $36.3 billion allocated for electronic health records in the stimulus package.  Thus far only 43,000 healthcare providers at a cost of $72,500 per provider have entered the meaningful use program.   This is far short of goal to have at least ½, 600,000 of the 1.2 million eligible providers participate in EHR. 

A major policy selling point for the adoption of EHR is the ability for systems to share information.  This week at a major healthcare IT conference it was regularly discussed that even providers using the same version of a EHR software package cannot share records due to customization by one or both parties.   CMS is funding information exchanges for each state but they are doing so on a pittance compared to the rest of the budget and the complexity of the task.  Unfortunately this has all the makings of a failed government program. 

The proposed rules with 443 pages for the stage 2 criteria and 184 pages for standards and criteria for certification are overwhelming for both the system developers and health care providers.  This type of consuming regulations will only work against more providers jumping in and implementing EHR systems.    It is hard to imagine how a regulation with over 600 pages will meet the Presidents executive order calling for agencies to reduce and not create burdensome regulations.  The combined total of just this section of the regulation is 1/4th in length of the entire affordable care act..

Hospitals with IT infrastructure and concern about the penalties eventually increasing to 5% of their Medicare billings will implement this rule despite its complexity. 

Several other factors are weighing in against the adoption of EHR for small practices include;

  • Small providers which account for roughly 75% of healthcare delivered in this country and many don’t believe they have the technical skills or IT infrastructure to implement EHR.  Think about a provider’s office where the providers spouse or other relative is the receptionists and also keeps the books and does the billing, this is not as uncommon as you may first think.  
  • As long as Medicare and Medicaid reimburse using the fee for service model anything that slows down throughput, seeing patients quickly will cut into their eventual reimbursement and will not be adopted with any speed.   Even with CMS penalizing the provider, it may not make economic sense for them to reduce their patient throughput to implement EHR.
  • Many of these smaller providers are also seeing other local practices bought up by local hospitals; this is also a disincentive as they may delay purchase of an EHR system knowing that they will make the transition to EHR with their new employer’s software.  As one physician shared with me there is no sense in learning two systems and it takes time to sell your practice.
  • A major obstacle to purchasing EHR has been the conversion in less than two years to ICD 10 a system of billing codes that is uniquely different and significantly more complex than the current ICD 9 system.  Now that HHS has permanently delayed its implantation, many offices may now go in and purchase a record system. 

In the end the rush to EHR is proving to be more elusive than originally projected and the calls for simplification may be coming sooner rather than later.

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