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On Tuesday July 13, 2010 the Centers for Medicare & Medicaid Services (CMS) and the Office of the National Coordinator for Information Technology (ONC) released the final rules on "Meaningful Use and Standards and Certification for the Electronic Health Records Incentive Program"[1] as well as "Standards and Certification for the Electronic Health Records" under the Health Information Technology for Economic and Clinical Health Act (HITECH) as included in the American Recovery and Reinvestment Act (ARRA).  As we have written previously, the effects of properly implemented health information technology (HIT) on the Nation's health care system could be tremendous.[2]  Increased care coordination, a reduction in medical errors, and elimination of waste are all potential benefits of HIT. 

In conjunction with the Meaningful Use rule, on June 24, 2010 ONC published a final rule to establish a temporary certification program to test and certify complete electronic health records (EHRs) and EHR modules.[3]  ONC still plans to publish a final certification rule to replace the temporary certification program and ensure that the definition of meaningful use does not require providers to perform functions for which standards have not been established.[4]  As of now, there are no certified EHRs in the country, but CMS estimates that there should be fully certified EHRs by the fall of this year.[5]

Background on HIT Incentive Payments

It has been widely acknowledged that health information technology could greatly reduce unnecessary health care spending and increase quality of care available to patients.  However, adoption of the technology has been slow, in large part due to high start-up costs.  In order to encourage the adoption of HIT, HITECH established a voluntary program for eligible providers to adopt health information technology, and use it in a meaningful manner, beginning in January 2011.  A Medicare provider who is able to demonstrate such meaningful use of HIT may be eligible to receive up to $44,000 over the course of the program, while a Medicaid provider may be eligible to receive up to $63,750.

While the program is voluntary, an eligible provider who is unable to demonstrate meaningful use of HIT by January 2015 will receive a negative adjustment to the applicable Medicare fee schedule.  An eligible provider under the Medicare program is defined as a non-hospital based physician or hospital that receives reimbursement under the Medicare Fee-For-Service program or that has a contractual relationship with a qualifying Medicare Advantage Organization. 

Changes from the Proposed Rule to the Final Rule 

Overall, the strength and integrity of the meaningful use criteria were maintained, but CMS and ONC made some notable changes in the final rule:

• Division of Objectives Eligible Providers Must Meet.  CMS originally proposed that an eligible provider be required to meet each of 25 proposed objectives, and associated measures, in order to qualify for the incentive payments.  Under the proposed rule, a provider missing even one of the meaningful use objectives could not qualify for any incentive payment.  The final rule divides the meaningful use objectives into two categories: the "core set" and the "menu set."[6]  To be considered a meaningful user of HIT, an eligible provider is required to accomplish all of the "core set" of objectives and a portion of the "menu set" of objectives and their associated measures.  An eligible provider may choose five "menu set" criteria to defer and still be considered a meaningful user of HIT.[7]  Eligible providers are free to determine which of the "menu set" criteria they will satisfy, although they must meet at least one of the population and public health measures.[8] 
   

• Patient Population Percentage Requirements.  Percentages of patient population required to meet a meaningful use objective in order for a provider to be deemed as having met that goal were reduced.  To meet the measures that are solely reliant on a provider's own certified EHR, such as updated problem lists, the compliance threshold is 80% for nearly all of the objectives.  Where all of the elements to meet the requirements do not rest solely in the provider's control, this threshold is lowered to 50% or less in some cases.[9]
   

• Descriptions of Eligible Providers and Incentive Payments under Medicare and Medicaid.  Eligible providers may receive incentive payments under the auspices of either Medicare or Medicaid, but may only switch programs one time after choosing which program they wish to participate in.  The proposed rule included different descriptions of eligible providers and incentive payments for the Medicare and Medicaid programs.  In the final rule, the definitions for the two programs were aligned so that providers would be better able to understand the incentives under both programs and could compare them easily to make informed decisions.[10]
  
  Note: While CMS has tried to align the incentive programs under Medicare and Medicaid, States may add additional requirements in order to demonstrate meaningful use under the Medicaid incentive program.  For Stage 1, CMS will only entertain states' requests to add additional requirements to meaningful use if the requirements are specifically intended to meet public health objectives and data registries.  Some such public health objectives specifically mentioned in the rule are: generating lists of patients by specific conditions for use in reducing disparities, submitting immunization data electronically to immunization registries, or submitting data on reportable lab results electronically.  At this time, CMS has received no state HIT plans requesting additional measures under the Medicaid incentive program. 
   

• 90-day Demonstration Period under Medicaid.  In the first payment year, eligible providers under Medicare must demonstrate meaningful use for a continuous 90-day period in order to qualify for incentive payments.  Under the Medicaid program, however, there is a provision that allows eligible providers to receive their first payment simply for adoption, implementation, or upgrade of their HIT systems.  Therefore CMS removed the 90-day demonstration period for the Medicaid program as being unnecessary.
   

• Computerized Physician Order Entry (CPOE).  CMS saw CPOE as a particularly essential meaningful use objective related to reducing medical errors and improving healthcare quality, and so retained it as a core objective despite intense opposition.  In the final rule, CMS clarified that any licensed healthcare professional can enter an order using CPOE. While CMS' initial objective was to require prescription, laboratory, and diagnostic imaging orders to be captured using CPOE, the final rule adopts an incremental approach by only requiring medication orders in stage 1.[11]  CPOE use satisfies the e-prescribing objective as well as drug contraindication and drug allergy checks in CPOE.  The patient population threshold for the CPOE objective was lowered from more than 80% to "more than 40%."
   

• Advanced Directives.  In the proposed rule, CMS discussed including Advanced Directives in the EHRs but did not make reporting of Advanced Directives a requirement for demonstrating meaningful use.  There was concern about potential conflicts with existing state laws, and confusion over what the measures for the objective should be and which populations this objective would apply to.  In the final rule, CMS required the indication of the existence of an advance directive in EHRs by eligible hospitals for patients age 65 and older who have been admitted to the hospital as an inpatient.[12]  According to the final rule, CMS feels that the patients in this age range will receive the most benefit from eligible hospitals knowing whether or not an advance directive is in place so that their wishes may be carried out.  Since this measure is not included in the current standards of practice, this objective was placed in the "menu set" of objectives which may be deferred and given a lower threshold of 50%.
   

• Electronic Submission of Claims Data. In an effort to improve EHRs, enhance patient privacy and security, and increase efficiency, CMS included in the proposed rule a requirement for meaningful use that claims data be submitted electronically to public and private payers.  This requirement was removed from the final rule. While CMS still considers administrative simplification to be an important long-term policy goal, it determined that in some instances, checking eligibility and submitting claim data for 80% of patients would simply not be possible.  CMS referred to comments that checking eligibility and submitting claims is not relevant to the Medicare Advantage program because virtually all patients are members of the same insurance plan.[13]
   

• Patient Reminders. CMS had proposed a measure to issue reminders to patients ages 50 and over for preventive and follow-up care.  In response to comments, CMS revised the age limits to patients ages 65 years or older and less than 5 years of age.  Additionally for this goal, CMS lowered the percentage of patient population needed to demonstrate meaningful use to only 20% of patients. Patients will have a choice of internet-based or non-internet based delivery of reminders.[14]
   

• Time Limit for Providing Health Information. In order to meet the patient engagement objective and to take advantage of the full benefits that EHRs have over paper records, CMS proposed that at least 80% of all patients requesting their health information must be provided an electronic copy within 48 hours.  The final rule extends the time period to three business days to reflect comments that some practices do not operate on a regular schedule.  Business days have been defined as Monday through Friday, excluding federal or state holidays on which the staff of the provider is unavailable.[15]  Additionally, the threshold was reduced to 50% of patients receiving access to their medical record within three business days rather than the original goal of 80% or more.
   

• Access to New Information.  In the proposed rule, access to new information in a patient's medical record was to be made available to the patient within 96 hours of its becoming available to the eligible provider.  This timeline was extended to four business days.[16]
   

• Percentage of Patients Receiving Discharge Instructions. In order to provide better care and to better involve patients and their families in the provision of care, CMS proposed that at least 80% of patients receive their discharge instructions from an eligible hospital upon request.  This threshold was deemed to be too high and was lowered to 50% of patients. 

Concerns

In its comments to CMS on the proposed regulations, the Center for Medicare Advocacy stressed the importance of Advanced Directives being included in the EHR.  We are therefore concerned that the final rule only requires the information to be collected when a patient is admitted as an inpatient to an eligible hospital.

Over the last two years, the Center has seen a marked increase in the number of patients in hospitals who are called outpatients (receiving observation services under Medicare Part B), rather than inpatients under Medicare Part A.  Some hospitalized patients have been outpatients for as long as 13 days, despite provisions in the Medicare Manuals limiting observation services to, at most, 24-48 hours.[17]  CMS recently sent a letter to several hospital associations asking why the use of observation services lasting more than two days doubled between 2006 and 2008.[18]  Additionally, with a new provision of the Affordable Care Act which penalizes hospitals that re-admit too many patients[19], there is a new disincentive to admit patients to inpatient status.  An unintended consequence of this provision may be even greater use of observation services by hospitals.  Advocates should be concerned that their clients may not receive the full benefits of meaningful use of HIT if their clients have been placed in observation. 

There is also concern that patients are still responsible for much of their own care coordination.  While there has been a focus on patient access to information in the stage 1 meaningful use criteria, there has been virtually no attention on ensuring that all of a patient's healthcare providers have all of the same information and can share it with each other at will.  Given that more than 20% of the Medicare population is suffering from five or more chronic conditions, care coordination among all of the healthcare providers is critical and should not be left to the patient to figure out.[20]

Conclusion

In the final rules establishing meaningful use standards, CMS and ONC tried to strike an appropriate balance that will allow for increased adoption of HIT and its meaningful use.  Both the functional and quality measures retained in the final rule go a long way to improving patient care and decreasing costs and waste in the system.  While there is room for improvement and clarification in Stages 2 and 3, the Stage 1 meaningful use criteria move us one step closer to a fully integrated e-health system.