Update on Quality Reporting & Data Registries for 2015

  Wound care providers are well aware of the efforts underway to transition the US healthcare payment system to one that is both determined by “value” and that links costs to improved patient outcomes. Few would dispute that the current volume-driven system can actually reward substandard care, particularly in the field of wound care. Currently, patients who stay in service the longest and receive the most procedures and therapeutic interventions generate the greatest revenue for wound clinics and wound care practitioners, regardless of whether outcomes are favorable. This article will provide an update on the various quality programs applicable to wound care providers, particularly since 2015 marks the year that many programs will transition from the “bonus phase” to the “penalty phase” for those who don’t report outcomes to the Centers for Medicare and Medicaid Services (CMS).

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RELATED CONTENT
Measuring Quality In Wound Care
The Changing Face of Wound Care: Measuring Quality
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Current Transition Status

  The transition to a different payment method began gradually in 2008 with Medicare’s Improvements for Patients and Providers Act, which authorized a 2% bonus of Medicare billing for qualified health providers (QHPs) who successfully reported quality measures. Bonus payments increased to a total of 4% in 2011. Initially known as the Physician Quality Reporting Initiative, the reporting program is now called the Physician Quality Reporting System (PQRS). In 2014, the bonus phase of PQRS ended. Clinicians who did not participate in PQRS in 2014 will lose 2% of their Medicare revenue in 2016. Admittedly, a relatively small percentage of physician revenue is at stake under PQRS, but that does not appear to be the case under the Affordable Care Act (ACA), otherwise known as Obamacare. With the implementation of the ACA, value-based purchasing will cause potentially substantial reductions of payment to both clinicians and hospitals tied to PQRS performance. On Jan. 27, the Obama administration announced it intends to shift 30% of payments to quality-based programs by 2016 and more than 50% by 2018. Failure to participate in PQRS in 2015 will result in a PQRS penalty of 2% in 2017 and a value modifier penalty of 2% (for groups of nine or fewer) and 4% for groups of 10 or more. Data needed to report quality measures are obtained from electronic health records (EHRs). It is now impossible for clinicians to successfully participate in quality initiatives without a certified EHR. Legislation mandating EHR standardization and utilization are specifically designed to facilitate the acquisition and transmission of quality data to the various governmental entities responsible for healthcare coverage and payment decisions, particularly CMS. In 2009, incentive programs were created to foster the adoption and Meaningful Use of EHRs. Clinicians who have not adopted a certified EHR face a potential reduction of 1% of Medicare payments in 2015. That penalty increases 1% annually to a maximum of 5% in 2019 and beyond. Electronic prescribing (eRx) is a requirement for QHPs to achieve Meaningful Use. The incentive phase of this program has now ended, and clinicians face a reduction of 2% of their 2014 Medicare payments if they are not using eRx. (For a summary of the quality programs applicable to QHPs, see the PDF “Quality Programs for QHPs.”)

  In 2015, clinicians who are not successfully reporting PQRS quality measures and who also do not meet Meaningful Use requirements for a certified EHR (and are not using eRx) will risk up to 5.5% of their Medicare payments when penalties are bundled. The extent of reductions under the ACA are not known, but since they will be linked to performance within PQRS, the long-neglected topic of wound care quality measures should be considered one of the most important issues facing healthcare.

Quality Reporting & EHRs

  When PQRS launched in 2008, quality data were submitted via claim forms. However, claims-based reporting (using paper-based documents) proved difficult and time consuming, and severely limited the types of measures that could be reported. The claims method of data submission will soon end. The lack of success with claims-based reporting lead CMS to create a mechanism for registry-based reporting in 2008. The US Wound Registry (USWR, formerly known as the Intellicure Research Consortium) was one of the original 32 registries recognized by CMS for quality reporting. In addition to submitting quality data on behalf of practitioners, as a nonprofit organization focused on quality of care for patients living with chronic wounds, the USWR began to shed light on “gaps in practice.” For example, although randomized, controlled trial data support adequate compression as the primary intervention needed to heal venous stasis ulcers, USWR data demonstrated that, even among hospital-based outpatient wound care centers, patients living with venous stasis ulcers received adequate compression at only 17% of visits. USWR data were even more disappointing regarding treatment of diabetic foot ulcers (DFUs), for which only 6% were documented to have adequate offloading. This inspired the USWR to launch a “Do the Right ThingTM” quality initiative to improve practitioner compliance with evidence-based care. The USWR also partnered with the Institute for Clinical Outcomes Research to develop the Wound Healing Index (WHI) to stratify patients by disease severity in order to provide a more fair way to report healing outcomes. The field of wound care cannot continue to report artificially inflated healing rates since this prevents us from being able to assess the value of advanced therapeutics or the effectiveness of wound care programs among the highest risk patients.

  The passage of the HITECH Act in 2009 changed the dynamics of quality reporting. HITECH made stimulus money available for clinicians who demonstrated Meaningful Use by a number of metrics including participation in quality reporting. HITECH also provided up to $44,000 paid out in stages to those QHPs meeting certain program requirements that are still being developed by CMS. Under Stage II of Meaningful Use, beginning in 2015 providers wishing to obtain EHR bonus money must share data with a public health agency or a specialty registry by transmitting data directly from an EHR. Medicare is also driving the PQRS program toward transmission of quality data directly from the clinician’s EHR to CMS via “eMeasures,” which obviate the need for patient data to be processed through a registry in order to be transmitted to CMS.

Losing Wound Care Quality Measures From PQRS

  Since the advent of quality initiatives, an outcome has generally been defined as “a change in a patient as a result of the care received.” This means patient outcomes should serve as validation of the effectiveness and quality of medical care. In the field of wound care, patient outcomes can be characterized by clinical endpoints (eg, amputation, wound closure), functional status (eg, ambulation), or general well-being (eg, pain, quality of life). It is also possible to measure the appropriateness of clinical interventions known to produce a desired outcome through “process measures.” Although CMS prefers measures directed at outcomes rather than processes, measuring wound care outcomes will continue to be problematic until there is national consensus on the definition of outcomes. Thus, for wound care clinicians, compliance with processes such as offloading may be easier to define than the more subjective and multifactorial endpoint of wound healing. CMS will support process measures in cases where the process is known to be causally related to the outcome and there is a demonstrated “gap in practice,” meaning clinicians do not routinely provide this treatment even though there is evidence they should.

  At the time PQRS started there were no measures relevant to wound care. However, in 2009 one measure directly relevant to wound care was added: the percentage of patients living with venous ulcers who were prescribed any type of compression one time in the calendar year during which they were seen. Most specialty societies were hard at work developing quality measures designed to reflect evidence-based clinical practice guidelines. Because wound care is not a recognized medical specialty, the development of wound care quality measures was left to other medical specialty societies or other quality organizations. In 2008, the American Medical Association Physician Consortium for Performance Improvement® (PCPI) attempted to fill the gap in wound care measures and convened a committee through the American Academy of Plastic Surgery (AAPS). A multidisciplinary working group headed by the AAPS recommended seven chronic wound care measures, one of which was DFU offloading. Only two PCPI measures were selected by CMS for inclusion in PQRS, both of them “overuse” measures: not performing a swab culture of any wound and not using saline wet-to-dry dressings. Most wound care experts would agree that these three measures (prescribing any type of compression once in a year for a venous ulcer, not using saline dressings, and not performing swab cultures) hardly represent quality wound care. It is unclear whether the lack of participation in PQRS by wound care practitioners to date is due to the poor design of the available measures or the fact that a 2% bonus was insufficient as an incentive. As a result of issues relating to measure performance, the aforementioned venous ulcer measure was retired in 2013 and the two overuse measures developed by the PCPI retired in 2014, leaving no wound care quality measures within PQRS for the 2015 reporting period.

PQRS Diabetes Measures

  There are, however, several PQRS measures (see Table 1) relevant to the management of diabetes patients, if not to DFUs. It is highly likely that a wound care clinician will check the hemoglobin A1c of a patient since control of diabetes is required prior to the use of many advanced therapeutic interventions. Assessment of body mass index is likely performed on all wound center patients. It is less likely that most wound care clinicians perform diabetic retina examinations or assess renal function. However, wound care experts may wish to report on the peripheral neuropathy assessment of patients living with diabetes as well as general foot exam findings and whether they are utilizing proper footwear. A more comprehensive diabetic foot examination measure will be discussed below.

Reporting Via Qualified Registry

  Recognizing a looming need for PQRS, the USWR submitted wound care quality measures to CMS during open calls in 2009 and 2011. Suggested measures included DFU offloading at each visit and venous leg ulcer (VLU) compression at each visit. “Per visit” measures had been impossibly burdensome using claims-based reporting methods, but the HITECH Act had resulted in dramatic improvements in EHR data reporting capabilities, enabling more precise measure development. The suggested VLU measure was actually a more detailed version of the venous ulcer measure retired from PQRS and the DFU measure was a more detailed version of the PCPI offloading measure. Unfortunately, CMS did not include either suggested measures into PQRS, presumably because they were not endorsed by the National Quality Forum (NQF). It may be worth noting that the NQF had not endorsed any of the three wound care measures previously available in PQRS, nor were those measures likely to have achieved NQF endorsement given the flaws in their design and the rigorous evidentiary standards of the NQF. Since it appeared CMS was going to require NQF endorsement for any future wound care measures, the USWR approached the NQF with its measures. Unfortunately, the NQF was unable to consider them for review because “wound care” did not fit within any NQF-specific quality topics. There being no logical avenue for wound care measures to be reviewed by the NQF, by 2014 there was no logical pathway by which new wound care quality measures could enter PQRS. The battle for wound care quality measures appeared lost until the American Taxpayer Relief Act was passed by Congress on Jan. 1, 2013. Section 601(b) of this legislation outlined a new process through which physicians would be able to satisfy federal quality reporting requirements under PQRS by participating in a qualified clinical data registry (QCDR) beginning in 2014. The critical factor of importance to the wound care industry was that a QCDR could develop its own evidence-based quality measures. A QCDR had to possess benchmarking capacity, allowing it to measure the quality of care that clinicians provide in comparison to other clinicians. At least one measure had to be outcome-based and it had to be able to stratify patients by severity or risk, a difficult task already accomplished by the USWR with the WHI. CMS agreed to allow the Alliance of Wound Care Stakeholders, as an umbrella organization for many professional societies, to act as a de facto specialty society for the field of wound care. As a result of USWR published data that demonstrated gaps in wound care practice, such as offloading, CMS agreed that process measures were needed in wound care. The Alliance and its member organizations worked diligently with the USWR to craft a suite of 12 quality measures, all of which were accepted by CMS in 2014 when the USWR was recognized by CMS as a QCDR. The American Podiatric Medical Society provided to the USWR a carefully designed, comprehensive diabetic foot examination measure and partnered with the USWR to develop a vascular screening measure for patients living with lower extremity ulcers. Table 2 shows an abbreviated list of the 12 wound care measures in the USWR, specifications for which can be viewed at www.uswoundregistry.com/specifications.aspx.

  A clinician using any certified EHR can report wound care quality measures to CMS through the USWR by providing these specifications to their EHR vendor. Some measures can be reported from the Continuity of Care Document, which all certified EHRs must be able to transmit. In 2014, eligible professionals who satisfactorily reported data on nine wound care quality measures through the USWR received an incentive equal to 0.5% of their total Medicare Part B allowed charges — the last opportunity for bonus money (and avoided the 2% payment penalty in 2016). Failure to participate at all in PQRS in 2014 will result in a 2% loss of Medicare revenue in 2016. Transmission of data to the USWR can also be used to meet the registry-reporting menu set objective for Stage II Meaningful Use. Although the shift from the current outpatient payment model will be painful, data from well-designed quality measures that are transmitted to the USWR represent a golden opportunity for the wound care industry. Providers can publicly demonstrate their clinical excellence using the USWR’s QCDR measures. Thanks to the WHI, it’s possible to predict the statistical likelihood that a wound will heal based on patient and wound factors. Actual wound outcomes can then be reported in comparison to predicted likelihood. For example, it is now possible for clinicians to report that in the category of wounds with a 25% or less likelihood of healing, the clinician actually healed 50% of wounds. Using this method, clinicians caring for the sickest patients are not penalized for “poorer” outcomes. In fact, using risk stratification, it is possible for clinicians who achieve unusually good outcomes in the toughest patients to demonstrate their effectiveness. This is also the way that the value of advanced therapeutics can be assessed in real-world practice.

Conclusion

  Clinicians wishing to take advantage of the remaining bonus (0.5% of Medicare billing) within PQRS in 2014 will need to successfully report on nine measures in three “domains” of care. This may be difficult for most wound care clinicians using only the measures available in PQRS. There are, however, currently 12 wound care-specific quality measures within the USWR’s QCDR. Clinicians can satisfy the requirements of PQRS by selecting measures to report from among those available within the QCDR in addition to any measures within regular PQRS for which they might have data (eg, medication reconciliation or hemoglobin A1c). The QCDR process is a lifeline for the wound care industry since the two remaining wound care specific quality measures in the PQRS system retired in 2014. NQF endorsement has been a barrier to obtaining new wound care measures within PQRS because the NQF process is cost prohibitive, not structured to facilitate review of measures outside of specific topics, and NQF endorsement is usually not given to measures with GRADE (Grading of Recommendations Assessment, Development, and Evaluation) scale evidence ratings less than “strong.”

  The QCDR process allows wound care organizations to develop their own measures and allows clinicians to receive PQRS credit for submitting data on those measures while providing data that can be used for measure validation. It is hoped that data from the QCDR process can be used to obtain NQF endorsement since the measures will have undergone real world testing. More wound care measures are needed in order to reflect the broad scope of practice among clinicians practicing in the diverse fields of wound care, venous and lymphatic disease management, podiatry, and hyperbaric medicine. Many societies have partnered with industry to defray the cost of measure development. Thankfully, this is beginning to happen in wound care.

  Nestle® has sponsored the development of a nutritional screening quality measure for patients living with wounds and ulcers that was submitted to CMS by the USWR’s QCDR. Several new hyperbaric oxygen therapy quality measures will also be available in 2015 through the USWR developed by the Undersea and Hyperbaric Medical Society. Stakeholders in the wound care industry need a collaborative approach to the development and testing of a suite of quality measures so that wound care will not be left behind in the transition to a value-based healthcare system.

Resources

1. US Department of Health & Human Services. The Affordable Care Act. 2010. Accessed online: www.healthcare.gov/law/full/index.html.

2. Centers for Medicare & Medicaid Services. 2013 Physician Quality Reporting System. 2013. Accessed online: www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/PQRS/MeasuresCodes.html.

3. American Society of Plastic Surgeons, Physician Consortium for Performance Improvement, and National Committee for Quality Assurance. 2008. Chronic Wound Care Physician Performance Measurement Set. American Medical Association and National Committee for Quality Assurance. Accessed online: www.ama-assn.org/resources/doc/pcpi/wound-care-worksheets.pdf.

4. Fife CE, et al. Electronic health records, registries, and quality measures: What? Why? How? Adv Wound Care. 2013;2(10): 598-604.

5. CMS. Qualified Registries for the 2012 Physician Quality Reporting System and Electronic Prescribing Incentive Programs. 2012. Accessed online: www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/PQRS/downloads/2012_Qualified_Registries_Posting_Phase1.pdf.

6. Fife CE, Carter MJ, Walker D. Why is it so hard to do the right thing in wound care? Wound Rep Regen. 2010; 18:154–8.

7. Fife CE, Carter MJ, Walker D, Thomson B, Eckert KA. Diabetic foot ulcer offloading: The gap between evidence and practice. Data from the US Wound Registry. Adv Skin & Wound Care. 2014; 27(7): 310-316.

8. Horn SD, Fife CE, Smout RJ, Barrett RS, Thomson B. Development of a wound healing index for patients with chronic wounds. Wound Rep Regen. 2013; 21: 823–32.

9. Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule, Clinical Laboratory Fee Schedule & Other Revisions to Part B for CY 2014; A Rule by the Centers for Medicare & Medicaid Services on 12/10/2013. Accessed online: www.federalregister.gov/articles/2013/12/10/2013-28696/medicare-program-revisions-to-payment-policies-under-the-physician-fee-schedule-clinical-laboratory.

10. National Qualify Forum. 2012. Measure Evaluation Criteria. The National Quality Forum. Accessed online: www.qualityforum.org/docs/measure_evaluation_criteria.aspx.