The Medical Director and Quality Requirements in the Dialysis Facility

Abstract

Four decades after the successful implementation of the ESRD program currently providing life-saving dialysis therapy to >430,000 patients, the definitions of and demands for a high-quality program have evolved and increased at the same time. Through substantial technological advances ESRD care improved, with a predominant focus on the technical aspects of care and the introduction of medications such as erythropoiesis-stimulating agents and active vitamin D for anemia and bone disease management. Despite many advances, the size of the program and the increasingly older and multimorbid patient population have contributed to continuing challenges for providing consistently high-quality care. Medicare's Final Rule of the Conditions for Coverage (April 2008) define the medical director of the dialysis center as the leader of the interdisciplinary team and the person ultimately accountable for quality, safety, and care provided in the center. Knowledge and active leadership with a hands-on approach in the quality assessment and performance improvement process (QAPI) is essential for the achievement of high-quality outcomes in dialysis centers. A collaborative approach between the dialysis provider and medical director is required to optimize outcomes and deliver evidence-based quality care. In 2011 the Centers for Medicare & Medicaid Services introduced a pay-for-performance program—the ESRD quality incentive program (QIP)— with yearly varying quality metrics that result in payment reductions in subsequent years when targets are not achieved during the performance period. Success with the QIP requires a clear understanding of the structure, metrics, and scoring methods. Information on achievement and nonachievement is publicly available, both in facilities (through the facility performance score card) and on public websites (including Medicare’s Dialysis Facility Compare). By assuming the leadership role in the quality program of dialysis facilities, the medical director is given an important opportunity to improve patients’ lives and effect true change in a patient population dealing with a very challenging chronic disease. This article in the series on the role of the medical director summarizes the medical director’s specific role in the quality improvement process in the dialysis facility and the associated requirements and programs, including QAPI and QIP.

Introduction

Air travel didn't get safer by exhorting pilots to please not crash. It got safer by designing planes and air travel systems that support pilots and others to succeed in a very, very complex environment. We can do that in healthcare, too.

–Donald Berwick on the launch of the Partnership for Patients April 12, 2011

It is not enough to do your best; you must know what to do, and then do your best.

–W. Edwards Deming

It is self-evident that both healthcare providers and patients want high-quality healthcare. Quality is a fundamental prerequisite for value in any service area and certainly is of prime importance in medicine, where often that most critical issue, life and death, is at stake. However, the common underlying tapestry in medicine is woven by every individual’s personal understanding of what quality care entails. Not surprisingly, the definition of quality, including how to measure it, varies widely.

Since the 1973 implementation of universal access to dialysis care in the United States, many advances in the delivery of ESRD care have been implemented. The initial goal of this program—to allow rehabilitation to a full and active life—has evolved over the ensuing 40-plus years and resulted in a larger than expected program that provided dialysis services to >430,000 patients in 2013 (1). What was initially a primarily home-based therapy became a large industry of center-based dialysis care for increasingly older patients with multiple comorbidities. Delivering a reliably beneficial product (i.e., high-quality care) to a small number of patients with limited evidence-based mandates required a different set-up, one that relied heavily on individuals and their good intentions. As the program grew, the tasks required to ensure quality assurance and quality control transformed.

The role of a medical director before expansion of Medicare payments for dialysis care mainly involved being the treating physician for most if not all the patients in a facility and thus primarily practicing medicine for the individual patient. After passage of the amendments to the Social Security Act in 1973, the medical director became part of a wider care team that includes nurses, social workers, and dietitians; this Act also mandated a medical director for each facility. The governing body in each facility further reinforced the team approach set forth by Medicare. The nephrologist–medical director took on a managerial role in the facilities, a role that focused on quality outcomes for all patients with ESRD.

Since the implementation of the Medicare ESRD program, rules for participation had always been clearly outlined (2). The conditions for coverage (CfC) effective October 2008, however, made the medical director the ultimate authority responsible for all aspects of quality care delivered in the facility and markedly increased the scope of responsibilities (3). The tasks can be divided into three categories—administrative, medical, and technical oversight—accounting for a managerial position that the Centers for Medicare & Medicaid Services (CMS) estimates to be the equivalent of a quarter-full-time position. The time and responsibility requirement are no small burden for a practicing nephrologist and continue to increase, with ever more challenging clinical situations and quality metrics of increasing complexity.

The CfC outlines the duties (Table 1). The primary role of the medical director with respect to quality is providing leadership for the interdisciplinary team and its role in both individualized patient care and the quality assessment and performance improvement process (QAPI).

Table 1.

Condition for coverage

494.150 Condition: Responsibilities of the Medical Director
The dialysis facility must have a Medical Director to be responsible for the delivery of patient care and outcomes in the facility.	The Medical Director is accountable to the governing body for the quality of medical care provided to patients.	Medical Director responsibilities include, but are not limited to, the following: (a) Quality assessment and performance improvement program (b) Staff education, training, and performance (c) Policies and procedures

ESRD care has been paid at a composite rate composed of dialysis and some laboratory tests since 1983. In 2011, following the passage of the 2008 Medicare Improvements for Patients and Providers Act (MIPPA), a bundled payment that includes the dialysis treatment, injectable drugs, and all ESRD-related laboratory tests, was implemented. The Act allowed for the prospect of oral drugs to be included at a later time. MIPPA mandated the introduction of the ESRD quality incentive program (QIP). The intent of the program is to promote high-quality care in the outpatient dialysis facilities treating patients with ESRD. This pay-for-performance system is unique in the sense that it works through a reduced payment on the facility level, thus linking a portion of the payment directly to facility performance in specific quality metrics. The specific measures included in the QIP are modified and published annually and have increased in number, from initially 3 metrics for 2012 to 11 metrics for payment year 2016 (4). This rapid modification and increase of metrics put additional pressure on providers and facilities that have limited time available to implement the new metrics; these metrics have often been published only at the end of the year preceding the implementation year.

Nonetheless, the QIP has contributed to considerable improvement in the results achieved across the United States, including decreased percentage of catheters in place for >90 days and increased fistula penetration. Other metrics raise questions about their meaningfulness as a true quality measure likely to affect patient survival and quality of life, the primary goals of high-quality care for patients with ESRD. While the QIP may be regarded primarily as a pay-for-performance measure only for the dialysis provider, it is evident that truly life-changing quality metrics will and indeed already require the active participation of not only the medical director but all referring physicians under the medical director’s leadership. Quality measures for the practicing nephrologist may be more tangible in the care of patients with CKD rather than ESRD, resulting in similar wide-ranging reactions (5). However, no matter how one might think about the incentive program and its quality indicators, the QIP is here to stay.

With participation of all stakeholders, the ESRD community has an opportunity to advance ESRD care by working closely together.

QAPI

The QAPI is led by the medical director, with an interdisciplinary team composed of, at a minimum, a physician (typically the medical director, who has overall responsibility for the QAPI program at each facility), a registered nurse (typically the clinical manager), a Masters-prepared social worker, and a registered dietitian. This team “must have effective communications and devote sufficient time and attention to produce effective quality assessment and performance improvement activities which positively influence their patients’ outcomes” (3). The interdisciplinary team meets quarterly or monthly, depending on state law, and documents all QAPI meetings, activities, and projects.

CfC §494.110 (Condition Quality Assessment and Performance Improvement) reads as outlined in Table 2. This table also summarizes the scope and the metrics included in a standard QAPI program. Surveyors focus on these measures during state surveys.

Table 2.

§494.110 Condition: quality assessment and performance improvement process definition by conditions for coverage and metrics

The dialysis facility must develop, implement, maintain, and evaluate an effective, data-driven, quality assessment and performance improvement program with participation by the professional members of the interdisciplinary team. The program must reflect the complexity of the dialysis facility’s organization and services (including those services provided under arrangement), and must focus on indicators related to improved health outcomes and the prevention and reduction of medical errors. The dialysis facility must maintain and demonstrate evidence of its quality improvement and performance improvement program for review by CMS.

QAPI Metrics

Health outcomes and reduction of medical errors by using indicators or performance measures associated with improved health outcomes and with the identification and reduction of medical errors.

Adequacy of dialysis

Nutritional status

Mineral metabolism and renal bone disease

Anemia management

Vascular access

Medical injuries and medical errors identification

Hemodialyzer reuse program, if the facility reuses hemodialyzers

Patient satisfaction and grievances

Infection control

Analyze and document infections to identify trends, establish baseline information on infection incidence

Develop recommendations and action plans to minimize infection transmission, promote immunization

Take actions to reduce future incidents

Obtained from reference 3. CMS, Centers for Medicare & Medicaid Services; QAPI, quality assessment and performance improvement process.

Part of the QAPI program is the continued performance improvement monitoring and also the expectation for prioritization of improvement activities. Over the past few years, because of a focused effort to emphasize the data-driven, target-centered quality and care delivery model, a mindset of achieving the target numbers has become increasingly prevalent in the facilities. While a desire to reach all target metrics is commendable, efforts to reach these goals need to be tempered with the larger picture in mind. The medical director’s leadership role is important in helping centers to prioritize improvement projects and in directing efforts to identify and address systemic issues. It is critical to the success of the QAPI program that true quality issues affecting many patients are differentiated from a deviation due to single-patient outliers. The focus should be on the entire group of patients, with a strategy of making changes so that most patients get better care, not just the “outliers.” The intent of quality improvement is not to solve the issue of the very sick patient who does not meet the target. The individual patient issue is addressed through direct patient care. Quality improvement instead concentrates on trends, processes, infrastructure, access, and adherence to care as the cause for not achieving quality outcomes in a group of patients (i.e., patients in a dialysis center).

A hemodialysis center with a high percentage of central venous catheters in place for >90 days thus has two issues. One concerns the “outlier” (i.e., the individual patient with a catheter in place). This is a patient issue requiring intervention by the nephrologist and care team to place a permanent access, preferably a fistula. The QAPI process looks at the cause of this issue. What needs to happen to prevent patients from having a hemodialysis catheter? What needs to be done to achieve permanent access in patients with a catheter in a timely matter? Is this a patient issue, a referral issue, or an access-to-surgery issue? Do patients understand the risk associated with a catheter?

The answers to these questions allow the facility to implement change accordingly to benefit current and future patients receiving care at the center. Thus, the QAPI process embodies one of the ways where the nephrologist as medical director moves from a patient care provider role to a population health management role with responsibility for facility patient care and outcome. Some differences in these roles affecting the nephrologist’s tasks are outlined in Table 3.

Table 3.

Nephrologist’s tasks in patient care versus role as medical director in population health management in the dialysis center

Domain	Patient Care	Population Health Management
Anemia management	Assess patient for clinical causes of anemia or hemoglobin > 12g/dl	Review, monitor and analyze target levels for hemoglobin > 12 g/dl reached in a facility
	Safety/clinical issue requiring intervention?	Protocol issue?
		Adherence to policy and procedure?
		Staff knowledge—education need?
		Safety issue?
Infection control	Treat patient with antibiotic according to clinical presentation and microbiology findings	Review, monitor, and analyze infection rate in dialysis center
	CVC requiring permanent access?	Perform route cause analysis
	Evaluate cause for infection and possible intervention to prevent recurrence	Infection surveillance
		Infection control policy and procedure
		Staff/patient and referring physicians adherence to infection control policy and procedure?
		In-service required?
Patient plan of care	Individual patient assessments and plan of care according to patient’s individual needs documented for each patient at mandated intervals	Review referring physicians’ compliance with patient care plan documentation, monthly visits and quarterly in-center visits
		Reach out to physicians who are out of compliance

CVC, central venous catheter.

Attendance at the QAPI meetings is mandated by the medical director and is critical for a successful program. Providers have supplied resources and tools, including QAPI manuals, QAPI training, fishbone (cause-and-effect) templates, and quality specialists, to help implement and maintain a QAPI culture and successful QAPI programs.

While delivering high-quality care is intrinsic to healthcare providers, the QAPI process is often not intuitive even for many well trained and dedicated professionals. A tendency to jump to solutions without asking all the right questions hinders successful execution of a quality program. It is evident that the success of the QAPI process depends on a “needs to improve—get it done” attitude of the whole team. The most common error in the QAPI process is founded on a belief that everything has already been done. Root cause analysis—which determines the most fundamental causes of an adverse event/outcome that has already occurred by systematically assessing the multiple types of possible human, process, organizational, equipment, and other failures—is a prerequisite for quality improvement. Fishbone analysis facilitates this process through its illustrative way of summarizing the causes. With a medical director leading the QAPI meeting and selecting and developing, with the interdisciplinary team, a project to execute, continued improvement is seen repeatedly. Creative, alternative venues are explored in situations where a sentiment prevailed that efforts had been exhausted. This changed approach has probably contributed to improvements in many areas of dialysis care, including adequacy and access. Through continued monitoring and tracking of the performance measures, the Plan-Do-Study-Act cycle of quality improvement is set into motion: Set a realistic goal; lay out a plan; execute it; reassess; and, depending on the outcome, modify or implement the process throughout (6) (Table 4). This approach allows the facility to correct any identified problems that threaten the health and safety of patients, as mandated by the CfC.

Table 4.

Plan-do-study-act: quality improvement cycle

Project Phases	Steps
Goal: Define a specific, measurable and achievable goal	Decide what you want to change
	Set a percentage or absolute change target
	Establish a timeline for completion
	Better to start small than to over-reach
Plan	What will you do?
	Who will do it?
	When will it be done?
	What are the expectations?
	What data will be collected?
Do	Carry out the plan
	Document observations
	Collect the data
Study	Analyze the data
	Did the process work?
	Was it enough?
	Was the objective met?
	Is the new process realistic?
	Are the resources available to implement this new process?
Act	Process worked:
	Implement the plan
	Process did not work:
	Revise the plan or start over with a new plan

QIP

In accordance with section 1881(h) of the MIPPA, added on July 15, 2008, by section 153(c), CMS implemented the ESRD QIP to promote high-quality care by outpatient dialysis facilities treating patients with ESRD starting in January 2012 (7). The QIP is a first-of-its-kind program in Medicare and changes the way CMS reimburses for dialysis treatments of patients with ESRD. Payment is linked to certain performance-quality metrics as pay for performance in a “value-based purchasing” program. However, the QIP represents a withholding rather than a reward for performance payment incentive. Facilities who do not meet certain performance standards are subject to a payment reduction (withholding) of up to 2% in subsequent years, also known as payment years. An overall facility score for applicable measures will determine whether payment should decrease. The scores are publicly reported on Dialysis Facility Compare (8) and also in the Performance Score Certificate. CMS provides this certificate annually to all centers, both those with perfect scores and those with scores resulting in payment reductions. The certificate must be displayed in the facility for easy review by staff and patients.

It is obvious that a proactive involvement of the medical director is key to achieving the QIP targets. A successful medical director must fully understand the QIP, the underlying metrics, and its scoring system. The ongoing monitoring of target metrics, the reinforcement of staff and physician behavior working toward this goal, and patient engagement and education are essential. The award of certificates for perfect performance relies heavily on strong collaborative efforts between the medical director and the dialysis provider. In a world where consumers use the Internet and social media for product and service choices, it is easy to imagine that patients’ choice for their dialysis therapy will be guided by such public ratings. And we would not expect our patients to accept a lower quality rating when trusting their lives to our care.

While the format of the program does not change, the quality metrics, standards, and weighting of the results and formulas are subject to annual changes. Thus, the initial QIP, performance year of 2010 and payment year in 2012, consisted of 3 metrics, while the current QIP, based on 2014 performance for 2016 payment, encompasses 11. The measures initially comprised only clinical metrics, starting with anemia and adequacy measures. Since then a variation has been implemented with clinical metrics, commonly accounting for 75%–90% of the overall score, and reporting measures, representing 10%–25% of the overall score. The measures have evolved from laboratory results and vascular access distribution to more complex clinical events, such as infections reported via the National Healthcare Surveillance Network (9) and patient experiences captured through the In-Center Hemodialysis Consumer Assessment of Healthcare Providers and Systems (10).

The actual details of the program are complex, with several program-years potentially affecting the QIP: a payment year, the comparison period, and the performance period. The comparison period is the designated time (often a full year) during which CMS is gathering data on all dialysis facilities. The performance year follows the comparison period and requires the facility to perform at least as well as during the comparison period to avoid payment cuts. CMS assesses the facility’s performance on the basis of the comparison period and calculates a score for each measure, according to the methods detailed each year in a final rule published in the Federal Register. These changes clearly indicate CMS’s efforts to align ESRD care outcomes with the desired triple aim of healthcare initiatives to achieve improved patient outcomes and experience of care while containing costs (11).

Examples are given for the payment year of 2015 and 2016 based on the measures achieved in the performance period in 2013 and 2014, currently ongoing (Table 5). The table illustrates the complexities of controlling the details of this annually changing program. The frequent QIP changes and time frames may evoke experiences of the Ghosts of Christmases Past, Present, and Yet to Come from Charles Dickens’ A Christmas Carol. Not only is everyone required to consider and execute best practices in the present, but performances of the past and future represent continuous challenges, eventually painting the longitudinal picture of quality achievement of each facility.

Table 5.

Quality improvement program for 2015 and 2016

Payment year	2015	2016
Measure	6 clinical	8 clinical
	Hb > 12 g/dl	Hb > 12 g/dl
	VAT measure topic	VAT measure topic
	Catheter	Catheter
	Fistula	Fistula
	Kt/V	Kt/V
	HD	HD
	PD	PD
	Pediatric	Pediatric
	4 reporting	NHSN bloodstream infections in HD outpatients
	NHSN	Hypercalcemia
	ICH CAHPS	3 reporting
	Mineral metabolism	ICH CAHPS
	Anemia management	Mineral metabolism
		Anemia management
Performance period	CY 2013	CY 2014
Comparison period	CY 2011 (achievement)	CY 2012 (achievement)
	CY 2012 (improvement)	CY 2013 (improvement)
		No improvement scoring for NHSN bloodstream infections
Performance standard	National performance rate (CY 2011)	National performance rate (CY 2012)
		National performance rate (May–December 2012) for hypercalcemia
		National performance rate (CY 2014) for NHSN
Weighting	Clinical 75%, reporting 25%	Clinical 75%, reporting 25%, hypercalcemia at two thirds of each remaining clinical measure
Maximum performance score	100 points	100 points
Minimum total performance score	60 points	54 points
Payment reduction scale	0.5%–2% with a 0.5% reduction for every 10 points under the minimum total performance score

Adapted from Centers for Medicare & Medicaid Services ESRD quality improvement project summary for payment year 2012–2016. "Clinical" means that target value needs to be achieved. "Reporting" indicates that no target value was available and credit was given for reporting results only. Hb, hemoglobin; VAT, vascular access type; HD, hemodialysis; PD, peritoneal dialysis; NHSN, National Healthcare System Network (reporting of dialysis-related infection events); ICH CAHPS, In-Center Hemodialysis Consumer Assessment of Healthcare Providers and Systems; CY, Calendar Year.

However, one has to applaud some of the results emerging since the introduction of the QIP with improvements in some important areas, such as vascular access, results once thought by many to be unachievable in the United States. Thus, Medicare has introduced a transparent program suitable for tracking and positively affecting quality improvements in some domains while maintaining high marks in others, such as adequacy (12).

As nephrologists and other stakeholders discuss the ultimate definition of goals for high-quality kidney care, expressing support for many metrics and questioning others as to their importance in improving patients’ lives, the focus on more clinical measures guided by clinicians is a good step forward. Advancing quality care to improve patient survival, reduce hospitalizations, and improve our patients’ experience with their care are unanimously agreed-upon goals.

Kidney Care Partners, a coalition of patient advocates, dialysis professionals, care providers, and manufacturers, has collaborated since its foundation in 2003 to improve quality of care for patients with CKD. The Kidney Care Partners Strategic Blueprint for Advancing Kidney Care Quality, released in March 2014, outlines the essential areas for improvements and touches on wide-reaching domains ranging from care coordination and disease management to patient engagement, education, and infrastructure changes (13). This will be a roadmap for many coming years, with great potential to affect the way we deliver dialysis care at a time when the discussion about quality care has been reframed (14). Nephrologists are taking the lead in promoting and implementing innovative models of care addressing the primary concerns in ESRD care, including fluid control, longer dialysis times, incorporation of underlying comorbid conditions into the dialysis prescription, infection control, coordinated care approaches, increased penetration of home dialysis, and better education for our patients (15–17).

These are truly exciting times for nephrologists—and an opportunity for medical directors to show and live true leadership.

Conclusion (Tip of the Month for Medical Directors)

It cannot be overstated how this is a time of opportunity for all clinicians, medical directors especially, to wield their clinical expertise, intuition, and aspiration to live the core mission of being a physician to affect patient’s lives by preventing further adverse events, alleviating suffering, and delivering truly patient-centered care.

Responsibilities and tasks for the medical director of a dialysis center have increased both in number and complexity over the past few years. A leadership position is a privilege requiring hard work and dedication. The stresses of daily routine, the increasing requirement for documentation with ever-changing demands, pay-for-performance programs, and the looming beginnings of healthcare reform may often mitigate the initial motivation to choose this profession.

However, the leadership role of the medical director in a dialysis center opens an incredible opportunity to improve not only individual patient care but also the experience of all patients cared for in a center. Using intuition and the application of knowledge and guidance to all staff and patients, the medical director makes a difference in patients’ lives not through direct patient care but through population health management for all patients at the center.

One might argue that the medical director sets the tone and culture of a dialysis center as the leader who will determine whether quality improvement processes are an integral part of caring for patients or yet another task to check off on an overwhelming list of things to do.

When compassion and love are ingredients of the quality program—or any aspect of healthcare—they may prove not just to require more time and energy. They may also in return give back and both fill the buckets of those who rely on us and miraculously add quality to the physician’s life as well (18).