Measuring Quality In Wound Care

  It is estimated that 2% of the US population has a chronic wound and a conservative estimation of the cost of caring for these wounds exceeds $50 billion dollars per year. The current reimbursement model of outpatient care has continued to reward both physicians and hospitals for performing high cost, advanced therapeutics without a feedback mechanism for quality. Although the debate regarding how to measure “quality of care” may seem recent, these ideas actually date back to the early 1900s with the work of Dr. Ernest Codman. He developed the Minimum Standard for Hospitals to help eliminate substandard care. The Health Care Financing Administration (HCFA, renamed the Centers for Medicare & Medicaid Services) first attempted to measure and publicly report hospital outcomes in 1986 but it withdrew its “mortality measures” because of widespread criticism. In 1999, The Joint Commission (TJC) began to develop a set of core measures for hospitals. The core measures were formally adopted by an act of Congress in 2003 as the basis for a reimbursement incentive for voluntary performance reporting among hospitals. In the century since Codman’s initial work, debate has continued to rage regarding exactly what represents a measure of “quality” for healthcare providers. It was for this purpose that The National Quality Forum (NQF) was created.

QUALITY MEASURES AND THE NQF

  The NQF is a not-for-profit membership organization, the mission of which is to improve the quality of American healthcare by setting national priorities for performance improvement and endorsing national consensus standards for measuring and publicly reporting on performance. Although the NQF has hundreds of members (physician specialty groups, nursing organizations, insurance companies, hospitals, healthcare agencies, etc.), in 2007, the Association for the Advancement of Wound Care (AAWC) became the first member group specifically focused on the area of wound care. A 23-member Board of Directors representing healthcare consumers, purchasers, providers, health plans, and experts in health services research governs the NQF. The Board includes representatives from two federal agencies, the Center for Medicaid and Medicare Services (CMS) and the Agency for Health Care Research and Quality (AHRQ). There are some current NQF standards, which are relevant to wound care. Most of these standards were created for use by nursing homes. For example, the “Pressure Ulcer Framework Committee” developed a framework for measuring quality for prevention and management of pressure ulcers at both the facility and practitioner levels across the continuum of healthcare. This was funded by AHRQ.   There is a circular logic, which presents a challenge to the adoption of more wound care related quality measures. The NQF priorities are set, for the most part, by CMS, so the NQF will not initiate a project unless CMS first recognizes that work is needed in this area to establish quality measures. CMS on the other hand, will not adopt measures as part of its “pay for performance program” (see below) unless the measures are endorsed by the NQF. So, it is nearly impossible to get a quality measure adopted by CMS unless the NQF endorses it, and the NQF will not put resources into developing a measure unless CMS instructs them to do it.

PAY FOR PERFORMANCE: PQRI BECOMES PQRS

  In 2006 President Bush signed the Tax Relief and Health Care Act (TRHCA), which authorized CMS to establish and implement a physician quality reporting system. In response to the mandate, CMS created the Physician Quality Reporting Initiative (PQRI), known as “Pay for Performance” (P4P). To develop and implement these initiatives, CMS collaborated with a wide range of other public agencies and private organizations who have a common goal of improving quality and avoiding unnecessary health care costs, including the NQF, TJC, the AHRQ, the National Committee for Quality Assurance (NCQA), and the American Medical Association (AMA).   Under PQRI, Physician Quality Reporting Initiative has been voluntary. The Medicare Improvements for Patients and Providers Act (MIPAA) of 2008 authorized a 2% bonus for those who successfully reported quality measures, and this was increased to 4% in 2011 (2% for PQRI plus 2% for electronic prescribing). In 2011, there were 173 measures applicable to primary and specialty physicians. Remember that CMS defines “performance” as, “the right care, to the right patient, at the right time.” Most of the measures are designed to evaluate whether the clinician provides the right care, not whether the outcome is good. For example, a measure to assess counseling for smoking cessation measures only whether patients who smoke are counseled to stop smoking, not whether they actually stop. And the incentive money is awarded merely for reporting on applicable measures, regardless of whether or not the measure was met. To be eligible for the bonus, measures must be reported in at least 80% of encounters where a measure applies.   There are a variety of ways to report. Physicians can report using their “claims” (by filling out a paper charge document to track these interventions such as smoking cessation counseling). This method has not been very successful because it is complex and requires a lot of work to be done by hand. So, in April 2008, CMS expanded the data collection process from the laborious “claims based” reporting process to include reporting data via Qualified Patient Registries. In the interest of full disclosure, I am the Chief Medical Officer of one of the few national “Registries” which reports data to CMS on behalf of physicians.   Participating in PQRI has been challenging for wound care clinicians because there is only ONE measure directly applicable to wound care, specifically: the percentage of patients with venous ulcers who were prescribed [any type of] compression once in the year during which they were treated. Since it is necessary to successfully report at least 3 measures to get bonus money, wound care physicians have to select some other measures to report, which are not directly applicable to wound care (eg, screening for fall risk, tobacco cessation counseling, diabetic blood pressure control, etc.). The job of a registry is complex and not worth detailing here. Providers on whom data is successfully submitted to CMS receive their bonus check from CMS payable to the taxpayer associated with the TIN and mailed to that address. The PQRI process is transitioning to “PQRS,” the Physician Quality Reporting SYSTEM. This process is also voluntary. However, the “bonus money” phase is about to end. There will be penalties associated with failure to report certain measures, but those measures come from a different program, the “meaningful use” of an electronic health record (see below).

QUALITY MEASURES SPECIFIC TO WOUND CARE

  Think of PQRS as a doctor version of “no child left behind.” Many of the quality measures are a little embarrassing when you read them. For example, oncologists get bonus money for calculating the total dose of radiation that they give a cancer patient. Clearly the first attempt to measure “quality” is extremely basic. And, I could fill pages with the challenges inherent in the reporting process. Remember that there is a “denominator” (the number of patients eligible for a measure) and the “numerator” (the patients for whom you at least considered the intervention). Then there are some “outs” (reasons you might not have done the intervention, eg, the patient refused, there was a medical reason not to do it, the supplies were not available, etc.). It is a very complex process even for reporting simple things. Add to this the complexity of gathering data. If you are still keeping your charts on paper, it will be very difficult to collect the necessary data, and even an EHR has to be specially programmed to collect the right data. That is why the first attempt at quality measures involves a very low level pass at the most basic of interventions, and is largely focused on the process of how to get data into CMS to create report cards.   When the AMA decided to look at wound care as part of their Physician Consortium for Performance Improvement (PCPI) project, they went to the American Academy of Plastic Surgery for guidance since they limit their voting members to groups with seats on the AMA House of Delegates. (“Wound care,” not being a recognized medial specialty, is hindered by not having representation in these organizations.) A multidisciplinary working group came up with 7 measures, which we discussed in the October 2011 issue of TWC. CMS announced its intention to add two of these measures to PQRS.     • Measure #1: Use of superficial swab culture technique in patients with skin ulcers (overuse measure).     • Measure #2: Use of wet to dry dressings in patients with skin ulcers (overuse measure).   These measures are “overuse” measures, meaning that the physician would “pass” the measure by NOT performing swab cultures or using wet to dry dressings. However, there was a particular problem with the way that the swab culture measure was designed in that the “denominator,” rather than being “all wounds which were cultured,” was “all chronic wounds.” The effect of this design flaw was that the measure would be passed if physicians never performed a wound culture. The Alliance of Wound Care Stakeholders sent a letter to CMS to inform them of this issue and recommend that better measures be developed than those, which came out of the AMA’s PCPI process. We don’t yet know the outcome of these comments.

THE ALLIANCE OF WOUND CARE STAKEHOLDERS SUBMITS QUALITY MEASURES TO CMS

  The Centers for Medicare & Medicaid Services (CMS) put out a call for quality measure suggestions to be considered for use in the future rule-making for the Physician Quality Reporting System with the deadline of October 7, 2011. The Alliance of Wound Care Stakeholders submitted 4 measures, which are:     1) Documenting venous compression at every visit in patients with venous stasis ulcers.     2) Documenting method of off-loading at every visit in patients with diabetic foot ulcers.     3) Prescribing a support surface for patients with stage III or IV pressure ulcers.     4) Performing vascular screening in patients with chronic leg ulcers.   In a twist of logic worthy of a Kafka novel, even though CMS issued an open “call” for measures, the measures submitted by the Alliance will not be adopted by CMS unless the NQF endorses them. However, the NQF will not endorse them unless CMS instructs them to prioritize wound care for the creation of measures. That circular logic is likely to continue to keep good wound care measures out of PQRS. However, we can increase the likelihood of these measures being adopted by testing their validity according to some very specific protocols designed by the NQF, a complex topic for another day. Only measures, which have been shown to be statistically valid, will be adopted by the NQF. Clinicians in other specialties support “measures development and testing” as part of the dues they pay to their specialty organization. It is harder for wound care professionals to do that with so many fragmented wound care societies.

MEANINGFUL USE AND THE $44,000 PER CLINICIAN UP FOR GRABS

  Among the many provisions included in the February 2010 “stimulus bill” signed by President Obama was a piece of legislation known as HITECH, or the Health Information Technology for Economic and Clinical Health Act. This mandate was funded with more than $20 billion dollars to incentivize clinicians and hospitals to adopt health information technology (HIT). The Medicare EHR Incentive Program pays up to a $44,000 bonus to each eligible provider (EP) who adopts and “meaningfully uses” an electronic medical record. EPs must license a product, which is certified by the Office of the National Coordinator for Health IT (ONC). Then the EP must meet the requirements for Stage 1 of Meaningful Use (2011 and 2012). Meaningful use includes both a core set and a menu set of objectives that are specific to eligible professionals. To qualify for an incentive payment you must meet 20 of these 25 objectives. There are 15 required core objectives (see call out box on page 15).   Take note of objective #11, “implement one specialty specific clinical decision support rule with the ability to track compliance with that rule.” A wound care specific EHR can track compliance with any wound care specific quality measure. Examples might include the % of venous ulcer patients put in compression, the % of patients with diabetic foot ulcers placed in off-loading, or the % of patients with chronic leg ulcers who undergo vascular screening. This one of the many ways that having an EHR “purpose built” for wound care is an advantage, and a way in which wound care clinicians can harness the HITECH requirements to improve quality reporting in wound care even in the absence of good national guidelines.   In addition to the core measures, EPs also must also select 3 additional Clinical Quality Measures (CQMs) from a set of 38. Three of these are somewhat relevant to wound care (NQF 0056 Diabetes: Foot Exam, NQF 0059 Diabetes Control: Hemoglobin A1c >9.0%, NQF 0575 Diabetes Control: Hemoglobin A1c how well you are able to use your electronic health record. It is hoped that one of the dividends of properly using an EHR will be an improvement in quality of care. In order to be eligible for the $44,000 (paid out in increments) EPs must register with CMS and then report these measures to CMS. CMS encourages providers to register for the Medicare and/or Medicaid EHR Incentive Program(s) as soon as possible to avoid payment delays (see resources for instructions).   Physicians who report their data are to be compensated by taking away money from the physicians who don’t report, beginning in 2015. In 2015, non-reporting physicians will lose 1% of their Medicare revenue, in 2016, they will see a 2% deduction, and in 2017, a 3% deduction.

WHAT IS THE BOTTOM LINE?

  If wound care clinicians are not going to lose Medicare dollars by 2015, they need to participate in quality reporting. This means that they need to get a certified EHR and use it in a meaningful way. The addition of wound care quality measures to PQRS would make quality reporting more relevant. To get the “Alliance measures” adopted, political pressure will need to be brought to bear on CMS to request that the NQF consider new quality measures in wound care. The suggested measures will have to undergo the prescribed measures testing, and that will require funding. In the meantime, wound care clinicians can ensure that there is a wound care specific CQM among their 15 required core objectives for meaningful use, and can also report on the diabetic foot assessment and the hemoglobin A1C as their “menu” options.   While these rules seem arcane and frustrating, we don’t have the option of “sitting this one out.” Although wound care is at a tactical disadvantage in not having a specialty society to represent it, we can begin to work through the process of deciding upon what we think quality measures ought to BE, and then figure out how to get the government to support these measures.   As an industry, we probably need to mirror other specialties and move toward “process measures” which better evaluate whether we are “doing the right things” (like compression and off-loading) rather than attempting to track “healing rates” which are hard to define and dependent on the co-morbid conditions of the patient. Furthermore, the HITECH Act and the financial penalties for NOT reporting quality measures make it mandatory to have an EHR, and preferably one, which can calculate your meaningful use “scorecard.”   Dr. Fife received her BS and MD degrees from Texas A&M University College of Medicine (AOA). After a residency in Family Medicine at the University of Texas, Southwestern in Dallas she completed a two-year Fellowship in Undersea and Hyperbaric Medicine at Duke University and then joined the faculty of the University of Texas Health Science Center, Houston where she is a Professor of Medicine in the Division of Cardiology. She is subspecialty Board Certified in Undersea and Hyperbaric Medicine through the American Board of Preventive Medicine and has been a Certified Wound Specialist since 1998, previously serving on the Boards of the American Academy of Wound Management and the Association for the Advancement of Wound Care. She initiated the Memorial Hermann Center for Wound Healing in 1990, affiliated with the University of Texas, Houston, and the Memorial Hermann Center for Lymphedema Therapy in 1998. She is a past President of the Undersea and Hyperbaric Medical Society. Dr. Fife is co-editor of the books Wound Care Practice, and, Women and Pressure: Diving and Flying, both published by Best Publishing. Dr. Fife is also the Chief Medical Officer of “Intellicure,” a Texas based software company which, since 2000 has provided a specialty specific electronic medical record system to wound and hyperbaric centers across the U.S. She is the Director of Clinical Research for the U.S. Wound Registry; responsible for performing the largest outcome studies in the wound care industry.

Resources:

CMS Registration Resources for the EHR Incentive Programs:     • Step–by–step registration guides, available on CMS’ Registration page: https://www.cms.gov/EHRIncentivePrograms/20_RegistrationandAttestation.asp#TopOfPage     • A number of FAQs about registration on the EHR Incentive Programs website: https://questions.cms.hhs.gov/app/answers/list/p/21,26,1139,1149     • Webinars on YouTube to help guide providers through the registration process: https://www.youtube.com/user/MSHHSgov#p/u/3/kL-d7zj44Fs