Hyperbaric Medicine Quality Reporting: Building an Ark to Ensure Survival

Will wound care providers get on board with HBOT quality reporting before the flood waters get too high? That remains to be seen. 

There is good news and bad news when it comes to the field of hyperbaric medicine. First, the good news: the prior authorization pilot program¹ for hyperbaric oxygen therapy (HBOT) has ended and is now in an evaluation stage. The bad news: the reasoning behind any potential decision to expand/not expand the program does not change the fact that the program actually worked. HBOT claims have dropped to 2012 levels. Furthermore, several Medicare Administrative Contractors have begun an even more stringent program known as the Targeted Probe and Educate (TPE) process, which has Orwellian overtones.² Hyperbaric medicine practitioners are under unprecedented scrutiny to demonstrate their compliance with Medicare coverage policy and adherence to clinical practice guidelines. The best way to do this is through a clinical data registry, an entity designed by the Centers for Medicare & Medicaid Services (CMS) to help engage practitioners in quality reporting. The Hyperbaric Oxygen Therapy Registry (HBOTR) can save practitioners who are subject to the Merit-Based Incentive Payment System (MIPS) from experiencing financial penalties, and may even provide them with bonus money. In fact, widespread voluntary registry reporting might save the field of hyperbaric medicine. This article will discuss how professionals in the field of chronic wound care can help this cause. 

HYPERBARIC MEDICINE LIFEBOAT

Improperly billed HBOT services have been the target of governmental investigation since the Office of Inspector General (OIG) report in 2000 on the use and appropriateness of HBOT.³ Unfortunately, the hyperbaric community continues to send CMS the message that it still doesn’t have its act together. Continued coverage of HBOT for diabetic foot ulcers (DFUs) was undermined when a 2013 study concluded that HBOT was not effective in the treatment of DFUs.⁴ Yet, 60% of the DFUs in this study did not meet Medicare’s criteria for HBOT because they had only Wagner Grade II ulcers, nor was it possible to determine whether the requisite arterial assessment and offloading had been performed.⁵ This is an example of the way in which lack of compliance with clinical guidelines and inadequate documentation systems threaten the future of this field. 

Cardiology is an example of a specialty that has leveraged Medicare reporting requirements into a national benchmarking program that elevates practice standards and generates a vast data repository for clinical research.⁶ It’s true that from an organizational standpoint, the field of cardiology has many advantages over hyperbaric medicine, but one might not think that having mandatory registry reporting as a condition of payment for certain procedures would be one of them. However, mandated provider participation standardizes quality reporting and ensures the success of a registry. A successful registry with standardized reporting methods attracts industry financial support (because companies need data, too), which defrays the huge costs associated with measure development, programming, calculating, and transmitting quality data to CMS, not to mention the storing, protecting, and analyzing of data for research. Mandatory quality reporting for stroke centers, trauma centers, and other safety initiatives engages institutional partners, producing data that can be used to improve contracted payment rates.⁷ The publications from these well-funded registries have been used successfully by societies, such as the American College of Cardiology, to lobby government agencies for millions of dollars in research funding. Cardiologists who are committed to transparent reporting standards have also identified areas in which patient outcomes are suboptimal, which has enabled manufacturers to develop (and justify the cost of) drugs and devices to improve them. This entire virtuous cycle began with mandatory quality reporting requirements for certain high-dollar interventions, such as implanted defibrillators. 

In contrast, devoid of any national reporting standards, wound care clinics report “fantasy” healing rates,⁸ sending the clear message that the proliferation of advanced therapeutics such as cellular products is entirely unnecessary, since healing rates are already better than 90%.⁹ For decades, wound centers have swept the outcome data of the sickest patients under the carpet, so the value proposition for treatments such as HBOT, which is always the treatment of last resort, was never developed. The fragmented hyperbaric medicine industry, being unwilling to support basic initiatives (eg, national benchmarking), is certainly unwilling to promote demanding initiatives such as quality reporting. Unfortunately, without the tools necessary to optimize the utilization of hyperbaric services, payers are left with only blunt instruments (eg, eliminating covered indications and setting arbitrary limits on services). The result is a reduction in the effectiveness of HBOT, creating such serious damage to the industry that eventually it will no longer be possible to keep failing programs open. 

There is a hyperbaric “lifeboat,” however; and that is for practitioners to voluntarily report relevant quality measures, including honest healing rates, through qualified clinical data registries (QCDRs). In 2008, the U.S. Wound Registry (USWR), an example of a QCDR, was among the first to be recognized by CMS. In 2014, the USWR was one of the first CMS-approved QCDRs empowered to develop specialty-specific quality measures, launching 14 in the first year. In 2015, the Undersea & Hyperbaric Medical Society (UHMS) partnered with the USWR to develop a suite of hyperbaric-specific measures. In 2017, the USWR was among the first CMS-recognized registries for quality reporting under MIPS. This year, CMS has approved 10 quality measures specific to wound care for reporting under MIPS and three for hyperbaric medicine.¹⁰ These have been developed in conjunction with the Alliance of Wound Care Stakeholders, the American Podiatric Medical Association, and the UHMS (see Table). Regrettably, since 2014, some valuable measures have been rejected by CMS due to lack of utilization, including many of the HBOT measures and wound-related quality of life. Conceptually, measuring quality of life is rather like asking for “world peace.” Everyone wants it to happen, but not as many people want to make a personal sacrifice to bring it about. Nevertheless, many wound care and hyperbaric oxygen quality measures are in their third year of reporting, so they have national benchmark rates, which greatly increases their point value under MIPS.

BUILDING A REGISTRY IS EASY, EXCEPT WHEN IT’S NOT 

In 2016, when stage II of Meaningful Use mandated participating in a “specialty registry” via direct transmission of electronic health record (EHR) data, the USWR sponsored the HBOTR (identifier at ClinicalTrials.gov is NCT02483650) so that hyperbaric practitioners could meet the requirements by transmitting continuity of care documents (CCDs). Since EHRs must be able to transmit CCDs as a condition of certification, it’s an increasingly popular method of registry enrollment because it does not require laborious secondary data entry. CMS encourages clinicians to engage with QCDRs that are able to provide national benchmarking as part of the practitioner’s MIPS-based clinical practice improvement activities (CPIAs).¹¹ Using only transmitted CCDs, dashboards can be created for activities such as debridements per patient, hyperbaric treatments per indication, comorbid conditions per patient, etc. CCD transmission can also enable the reports needed for hyperbaric facility accreditation (eg, diagnoses treated with HBOT and patient count). There are 2,100 providers who report data to the USWR by transmitting CCDs from many different EHR vendors.¹²

There is one potential barrier to registry participation through an EHR, and that is the EHR itself. Even though generating a CCD is a requirement for EHR certification, some software products are unable to do this. Sadly, the most common barrier is simply the refusal of the vendor to transmit CCDs to the registry. To combat this, Congress included language in the 21st Century Cures Act to make data blocking illegal.^13,14 The law provides a clear statutory definition of data blocking that includes such terms as “materially discouraging access,” “restricting authorized use,” “substantially increasing the complexity or burden of accessing data,” “restricting the exporting of complete information sets,” and “engaging in practices that impede the exchange and use of data.” The law tasks the inspector general with establishing a mechanism for collecting and investigating such complaints. Vendors face a penalty of up to $1 million per information-blocking episode. It will take some time, but the many hyperbaric practitioners who have wanted to participate in the registry, but have been prevented from doing so by their EHR vendor or other healthcare entity, may soon be able to participate.¹⁵

HBOT Quality Reporting

The registry contains 27,404 patients living with 62,843 DFUs (for an average of 2.3 DFUs per patient). In 2017, 7.3% of all DFUs were treated with HBOT (an average of 28 treatments per patient). Approximately 300 advanced practitioners report HBOT quality measure data. At 85%, the reported rate of arterial testing documented among patients living with DFUs is high. Slightly more than half (52.7%) have hemoglobin A1c recorded. Only 31% of DFUs have adequate offloading documented at each visit for the four weeks prior to starting HBOT. These data do not mean that only half the patients have their A1c checked, or that only one-third receive regular offloading; it merely indicates that documentation of these interventions is sometimes lacking. Per-visit measures such as DFU offloading set a high bar for practitioners, but surviving a hyperbaric oxygen TPE or prepayment review will necessitate religious documentation of such interventions. Quality measure performance can be used by clinicians and hospitals to identify areas where improvement is needed to protect HBOT reimbursement. Data are available on approximately 3,700 patients who have undergone HBOT and whose wounds are risk-stratified with the Wound Healing Index, allowing the creation of matched cohorts with wounds not treated with HBOT.¹⁶ Structured data are available on all comorbid diseases, medications, physical findings, interventions, procedures, and outcomes. Because this is a quality registry, it is possible to control for factors such as offloading and arterial screening. This means that the effectiveness of hyperbaric oxygen for DFUs could be properly studied in the future, should the commitment ever exist to do so. One independent institutional review board (IRB) in particular reviews data-use proposals to ensure protection of health information, since IRB oversight is a requirement for the use of patient registry data.¹⁷

THIS IS NOT A DRILL

In 2014, the payment rate for the Current Procedural Terminology hyperbaric chamber supervision code (99183) was reviewed by the American Medical Association/Specialty Society Relative Value Scale Update Committee (RUC). During its deliberations, the RUC requested data on the number of comorbid conditions present in patients undergoing HBOT. USWR data demonstrated that the average HBOT patient lives with 10 major comorbid conditions and takes 12 medications, confirming the need for a trained practitioner to be present.¹⁸ This registry project is credited with preventing a 20% decrease in the reimbursement rate of hyperbaric chamber supervision. 

Participation in the USWR’s QCDR is a way to earn a positive payment adjustment under MIPS. Practitioners can participate in CPIAs that involve national benchmarking, earn bonus points under the Quality Payment Program’s (QPP’s) advancing care information for electronically submitting data to the HBOT specialty registry, and optimize quality measure performance with “high value” quality measures. The result may be obtaining up to a 22% bonus in Medicare Part B payments. This could make a vital difference as more practitioners transition the model for outpatient wound care into the physician’s office setting. There is also a more compelling reason to participate in the HBOTR. This year, CMS begins to use “cost” as a factor in the calculation of providers’ MIPS scores. Data from a recent comprehensive analysis indicates that Medicare spends as much as $96 billion per year on the care of chronic wounds (with the majority being on outpatient treatment).¹⁹ That means the metric known as Medicare spending per beneficiary (MSPB) will be nothing short of staggering for hyperbaric and wound care practitioners. Because we truthfully heal fewer than 50% of our patients (over months, not weeks of outpatient care), we spend a lot of Medicare dollars. Medicare has developed a methodology to predict the cost of care in complex patients known as the Hierarchical Condition Category (HCC).²⁰ 

CMS generates an HCC risk score for beneficiaries based on documented comorbidities, calculates providers’ anticipated MSPB based (at least partially) on the HCC score, and then compares that to their actual Medicare spending. Providers can justify the high cost of wound care by capturing the diagnoses important to the HCC. Participation in the HBOTR can optimize the HCC in several ways, including registry-sponsored CPIAs focused on complex care coordination. 

However, practitioners will not survive the transition to the QPP on the optimizing of HCC score alone. There needs to be more engagement regarding quality measure development to help CMS understand why the price tag for wound care is so high.²¹ Industry and clinical associations have a sorry track record with this type of engagement. In 2000, the OIG concluded its report by recommending the creation of an HBOT registry. More than a decade ago, when efforts to create such a registry through the logical professional organizations failed, the USWR built a “lifeboat” for hyperbaric medicine. Although, these days, it might be better described as an ark. It remains to be seen whether providers will get on board before the flood waters get too high. 

Caroline E. Fife is chief medical officer at Intellicure Inc.; executive director of the U.S. Wound Registry; medical director of St. Luke’s Wound Clinic, The Woodlands, TX; and co-chair of the Alliance of Wound Care Stakeholders.

References

1. Medicare Prior Authorization of Non-Emergent Hyperbaric Oxygen (HBO) Therapy Model Status Update. CMS. 2016. Accessed online: www.cms.gov/research-statistics-data-and-systems/monitoring-programs/medicare-ffs-compliance-programs/prior-authorization-initiatives/downloads/hbopriorauth_statusupdate_111616.pdf
2. Gelly HB. A New Strategy For Targeted Probe and Educate Medical Review. CarolineFifeMD.com. 2017. Accessed online: https://carolinefifemd.com/2017/11/07/guest-post-by-dr-helen-gelly-a-new-strategy-for-targeted-probe-educate-medical-review
3. Brown JG. Hyperbaric Oxygen Therapy: Its Use and Its Appropriateness. OIG. 2000. Accessed online: https://oig.hhs.gov/oei/reports/oei-06-99-00090.pdf 
4. Margolis DJ, Gupta J, Hoffstad O, et al. Lack of effectiveness of hyperbaric oxygen therapy for the treatment of diabetic foot ulcer and the prevention of amputation: a cohort study. Diabetes Care. 2013;36(7):1961-6.
5. Le PN. Interpretation of the study “Lack of effectiveness of hyperbaric oxygen therapy for the treatment of diabetic foot ulcer and the prevention of amputation.” Undersea Hyperb Med. 2013;40(3):307-10.
6. About NCDR. Quality Improvement for Institutions. Accessed online: https://cvquality.acc.org/NCDR-Home/about-ncdr 
7. Quality Campaigns. Quality Improvement for Institutions. Accessed online: https://cvquality.acc.org/initiatives 
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9. Why Publicly reported “Wound Healing” Rates Are Pure Fiction … And How Truthful Reporting of Healing Rates Could Save the Field of Wound Care. CarolineFifeMD.com. 2017. Accessed online: https://carolinefifemd.com/2017/10/09/why-publicly-reported-wound-healing-rates-are-pure-fiction
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14. H.R. 34 - 21st Century Cures Act. Congress.gov. 2016. Accessed online: www.congress.gov/bill/114th-congress/house-bill/34 
15. EHR Vendor Fact Sheet. CMS. www.cms.gov/medicare/quality-payment-program/resource-library/advancing-care-information-for-vendors.pdf 
16. Horn SD, Fife CE, Smout RY, Barrett RS, Thomson B. Development of a wound healing index for patients with chronic wounds. Wound Repair Regen. 2013;21(6):823-32. 
17. Fife CE, Eckert KA. Harnessing electronic healthcare data for wound care research: standards for reporting observational registry data obtained directly from electronic health records. Wound Repair Regen. 2017;25(2):192-209.
18. Fife CE, Gelly H, Walker D, Eckert KA. Rapid analysis of hyperbaric oxygen therapy registry data for reimbursement purposes: technical communication. Undersea Hyperb Med. 2016;43(6): 633-9.
19. Nussbaum SR, Carter MJ, Fife CE, et al. An economic evaluation of the impact, cost, and medicare policy implications of chronic nonhealing wounds. Value in Health. 2018;21(1):27-32. DOI: https://doi.org/10.1016/j.jval.2017.07.007
20. Risk Adjustment. CMS. Accessed online: www.cms.gov/Medicare/Health-Plans/MedicareAdvtgSpecRateStats/Risk-Adjustors.html
21. Fife, CE. Cassandra on MIPS Year Two. CarolineFifeMD.com. Accessed online: https://carolinefifemd.com/2018/01/22/cassandra-on-mips-year-two