PCD Systems

CMS and ISO 9001: The Impulse Toward Quality in Healthcare

Wes Chapman — Mon, 22 Apr 2013 18:44:37 +0000

By Wes Chapman, Steve Maker, and Mario Martinez

Preface

This is the first of two white papers on ISO 9001 in healthcare. This paper provides a historical perspective, an overview of the purpose and principles of ISO 9001, and a brief look at the potential of ISO 9001 to transform healthcare delivery in the U.S. now that accreditation and certification under its standards have been embraced by CMS. The second paper will take a closer look at the process required to successfully implement ISO 9001.

Background

In 2008, a revolution started in healthcare quality – ISO 9001:2008 entered the fray when the Centers for Medicare and Medicaid Services (CMS) approved Det Norske Veritas (DNV) as a deeming authority for Medicare payments. DNV was the first new deeming authority named by CMS in over 40 years, and ISO 9001 – considered the gold standard for quality improvement systems – played a key role in the decision. DNV had just completed development of a system it calls the National Integrated Accreditation of Healthcare Organizations (NIAHO), which it will use to accredit hospitals under CMS’ Conditions of Participation (CoPs). NIAHO combines the CoPs standards with the ISO 9001:2008 quality standards developed by the International Organization for Standardization (ISO). Healthcare providers must meet the CoPs quality and safety standards in order to be reimbursed for treating patients under Medicare and Medicaid; in 2008, ISO 9001 became the best system available to achieve that accreditation and maintain the standards necessary to keep it.

Quality improvement, along with cost reduction and payment reform, has been an elusive goal in the complex environment of healthcare delivery. Traditional quality tools like Lean and Six Sigma have proven difficult to adapt from their roots in straightforward process environments such as auto manufacturing. ISO 9001 provides the overarching management structure needed to incorporate these types of tools into a more encompassing quality management system suited to healthcare organizations. ISO 9001 is designed for service providers as well as manufacturers. ISO 9001 is focused on customer requirements and satisfaction, and there is certainly no industry that should be more customer-focused than healthcare. ISO 9001 is flexible, allowing each healthcare provider to develop and implement a quality management system appropriate to its structure, methods, and organizational culture. And ISO 9001 requires continuous improvement in order to remain certified, which means continuous benefit to the healthcare provider, to CMS, and to the patients.

The Deeming Authorities

Several other organizations have deeming authority from CMS (see the table, below), but one in particular – the Joint Commission (TJC, formerly JCAHO) – has handled the majority of hospital applicants in the 40 years since Medicare was created. In fact, TJC was the only deeming authority named in the initial law. Until very recently, TJC had not incorporated ISO 9001 into its accreditation process, nor had it offered ISO 9001 certification separately. DNV does offer full certification under ISO 9001 in addition to CoPs accreditation under NIAHO. By granting deeming authority to DNV, CMS (which is itself ISO 9001 certified) seems to have signaled its determination to control rising health care costs in the U.S. without reducing the quality of care. In fact, this is almost a standing order to hospitals to improve care without backsliding.

Accreditation Organizations with CMS Deeming Authority
Accreditor	Scope of Authority	# of accredited customers (CoPs)	ISO connection
The Joint Commission	Hospitals, Labs, Durable Medical Equipment, Home Health, Hospice, other	Around 5,000 hospitals and over 10,000 other institutions	Affiliated with SGS to offer the option of ISO certification to members
DNV Healthcare	Critical Access Hospitals (CAH), Acute Care Hospitals (ACH)	Around 300 hospitals (over 1200 though DNV international groups)	Requires ISO 9001 certification within two years
American Osteopathic Association (HFAP)	CAH, ACH, Ambulatory Surgical Center, Behavioral Health, Lab	Around 230 hospitals and 200 other institutions	No ISO relationship
Accreditation Commission for Health Care (ACHC)	Home Health, Hospice, Durable Medical Equipment (DMEPOS)	No hospitals, 8,700 DMEPOS, 1,400 Home Health, and 300 Hospices	ISO-certified itself but not offering ISO certification to clients

TJC has seen the writing on the wall. In 2011, it announced an agreement with the Geneva-based ISO registrar SGS Group to offer ISO 9001 certification, in addition to CoPs and the other accreditations it offers. Due to its organizational roots and long affiliation with CMS, TJC can claim over 20,000 U.S. clients, of which over half are hospitals or home care organizations, though TJC/SGS has yet to announce any ISO 9001 clients. Depending on the source, DNV is working with somewhere between 250 and 300 clients in the U.S., for both CoPs accreditation under NIAHO and ISO certification. Globally, they have certified over 1200 healthcare organizations under ISO 9001 to date.

It’s very hard to estimate how many U.S. hospitals have achieved ISO 9001 certification already. In addition to DNV’s 300 or so clients working toward that end, a few healthcare organizations have already achieved it through other means. Two of them – Physician’ Clinic of Iowa (PCI) and the Office of Medical Services (MED) of the U.S. Department of State – are well documented in the book Using ISO 9001 in Healthcare (Levett and Burney, ASQ Quality Press, 2011). As the public becomes more concerned about quality and more aware of the high standard indicated by ISO 9001, we can expect to see more and more certification logos on hospital web sites and letterhead, and with them, higher quality throughout the healthcare system.

Introducing ISO and ISO 9001

“ISO is just quality on steroids.”
(nurse in charge of the QMS in a 700-bed hospital accredited by DNV Healthcare)

ISO can refer to the International Organization for Standardization or to the standards it produces. The organization has its roots in mechanical engineering. It was founded as the International Federation of the National Standardizing Associations in 1926, disbanded in 1942, and reformed under the current name in 1946, after the dust from World War II had settled. Then and now it was an international organization made up of its member nations’ standards organizations (the U.S. representative being the American National Standards Institute, or ANSI), and its sole purpose is to develop standards for an expanding variety of industries. In addition to standards, it publishes technical reports, specifications, and related documents, most of which are developed by a network of 2,700 committees, subcommittees, and working groups.

ISO 9001 began life in 1959 in the form of a quality/inspection-based standard for the U.S. Defense Department. With much revision and expansion, it became an ISO standard in 1979. In 1987, a new revision emerged as ISO 9000, which continued to evolve, being republished in 2000 as a management system standard suitable for both manufacturing and service industries. ISO 9000 specifies the fundamentals and vocabulary underpinning ISO 9001, a quality system standard, which evolved in parallel with ISO 9000. The latest revision is ISO 9001:2008.

ISO 9001 is a respected and widely accepted framework already used to improve quality, improve value delivered to customers, and reduce costs by:

CMS, which is rated as the most effective healthcare payer in the U.S.
The American Society for Quality (ASQ)
The automotive industry, which has continually and dramatically improved quality over the past 50 years in its race with Japanese and German manufacturers
The aeronautics industry, where good quality controls have made aircraft safer and where bad quality controls produced the Dreamliner
Manufacturing in general
Franchises, which use ISO 9001 to replicate operational improvements
Multinationals, which use ISO to replicate their successes, while still allowing for flexibility across different regions
And now healthcare

What is ISO 9001?

ISO 9001 is often referred to as a quality system, but technically it is not. As stated above, it is a quality system standard. It has also been described as a meta-management system. This is a fine point to argue, but keeping it mind can help avoid confusion over what ISO 9001 offers.

ISO 9001 does not describe a specific quality tool, like Lean or Six Sigma. Instead, it specifies the types of components a quality system must have in order to improve processes and increase value. For example, one of its requirements it to create a Quality Manual, but it does not provide a rigid outline or table of contents. Instead, it states eight principles that underlie effective quality management and then defines the processes required to incorporate those principles into a quality management system. ISO 9001 leaves it up to each organization to develop the Quality Manual that is most appropriate to its own operations. It is not a how-to book; it shows you how to write your own how-to book.

The eight principles in ISO 9001 are:

Customer focus
Leadership
Involvement of people
Process approach
System approach to management
Continual improvement
Factual approach to decision making
Mutually beneficial supplier relationships

Customer Focus refers to patients, of course, but also to their families and all the other stakeholders involved in healthcare delivery. That includes outside providers to whom you refer patients, payers, vendors, and your own staff. Each of these groups has its own set of (sometimes conflicting) expectations and needs. ISO 9001 makes customer focus the first requirement under Management Responsibility:

Top management shall ensure that customer requirements are determined and are met with the aim of enhancing customer satisfaction. (Section 5.2, page 4, ISO 9001:2008(E))

Note that the standard specifies determining the customers’ requirements and also, by implication, determining if they were satisfied by the services they received. The exact methods used to discover and document this information are left to the quality team to define.

Leadership refers to a firm commitment from management to adopt the ISO 9001 standard for quality improvement. The principles and processes described provide a framework for the quality system, but the strategy, objectives, and leadership role models must come from within the organization.

Involvement of people means just that: Everyone in the organization needs to be involved in developing the quality system and making it work. This requires another commitment from management: to provide training and resources. In the complex network of processes that is healthcare delivery, it’s also important to ask and to listen to employees at every level in every department, not only because they will have information you need to know, but also so they realize the important part they play in the development, implementation, and ongoing improvement of the quality system.

The Process Approach applies to the processes of healthcare – from clinical pathways to housekeeping to buildings and grounds – and to the processes of administration and quality management. Every key process will need to be defined and managed.

A Systems Approach to Management means viewing the entire operation as a system of interrelated processes. Knowing how the processes flow and understanding how they interact to achieve specified objectives allows managers to improve effectiveness throughout the organization.

Continual Improvement is a key component in the standards. Many quality tools provide a method to improve processes, but don’t provide a system for maintaining that level of quality over time. Throughout the quality process, ISO 9001 does a very good job of asking questions and then forcing you to not only write down the answers but also follow up on delivery. This drives the process of continual improvement.

A Factual Approach to Decision Making could be stated simply as monitor, measure, and document, but ISO 9001 goes farther, to require documentation at almost every step in the quality process. At its core, a dedication to fact-based decision making means the use of impartial and auditable data. It begins with the definition of the processes in your operations and in your quality management systems, because “you can’t control a process you can’t describe.” Documentation continues throughout the implementation of your quality management system, and afterward as you monitor the daily workings of your healthcare delivery system. Documentation continues as you identify what works well and what falls short, allowing you to analyze how to adopt strengths as standard operating procedures (SOPs), and to find solutions for problems that arise in the future. Documentation still continues as you monitor the results of your solutions to guarantee they are implemented as designed and that they work.

Mutually Beneficial Supplier Relationships includes treating each other as customers, learning each other’s requirements, and verifying that both sides are satisfied with the results. In an ISO-based system, suppliers are valued partners, with the inescapable reality of shared success. Quality is not a zero sum game. ISO 9001 also requires a process in your quality system to insure that your suppliers are working at the same level of quality you are, hopefully with their own IS0 9001 certification.

Palliative Medicine and Patient Involvement: The Heart of Patient-Centric Care

Wes Chapman — Tue, 04 Dec 2012 21:50:57 +0000

By Wes Chapman, Mike Choukas, Charles Hutchinson PhD, and Steve Maker

Preface

This is the final white paper on treatment issues in a series addressing quality improvement and patient focus in healthcare, specifically in oncology treatment pathways as they evolve under pressure from the Medicare Shared Savings Program and other outcomes of the Affordable Care Act.

Background

In the previous white papers in this series, we have dealt with several key components of an effective cancer treatment plan: care plan redesign, quality improvement, payment alignment initiatives for a complete episode of care, best practice clinical pathways and quality metrics, and the use of patient-reported outcomes (PROs) to measure the patient experience during treatment. In this paper, we look at two other necessary components: palliative care and patient involvement in decision-making. These elements complete the treatment pathway and bring the focus where it belongs: on the patient. They are also inextricably linked.

In order to make rational decisions about their own healthcare, patients must be fully informed about all of the treatment options open to them. They must also be in a mental and emotional state that allows them to think clearly. The first requirement assumes a commitment from the healthcare provider (physician, nurse, administration, and staff) to be honest and realistic about the risks and outcomes associated with every treatment option. The second requirement assumes a similar commitment to palliative medicine as an equal partner to curative medicine – palliation that treats not only the body, but also the patient’s functional, mental, and emotional states. If either of these requirements isn’t met, the decision-making is not truly shared, and the treatment is not patient-centric, it reflects only the desires and priorities of the people and institutions providing care.

Unfortunately, despite great progress in recent years, many if not most patients in oncology are not benefiting from advancements in palliative care. According to a recent study from the Dartmouth Atlas of Health Care, the average number of terminally ill patients who were admitted to hospice in the last six months of life was only 45.1% (2010 data). This was the practice at 23 notable academic medical centers, including those rated by U.S. News and World Report as being among the best hospitals for clinical excellence in 2012-13. The range was 59.1% for the highest referral rate, down to 23.1% for the lowest – less than one-quarter. (What Kind of Physician Will You Be? Variation in Health Care and Its Importance for Residency Training, Anita Arora and Alicia True, Dartmouth Atlas of Health Care, 10/30/12) Palliative care is the core of hospice, and it has been a part of our language since 1525. If, indeed, it takes an average of 17 years for at least half of American patients to receive benefits from major discoveries (E.A. Balas and S.A. Boren, 2000), palliative care and its partner, shared decision-making, are lagging way behind schedule.

A Brief History of Palliative Care

Palliation has spent most of its career under a shroud of negativity. The verb “palliate” first appears in English in the mid sixteenth century with the same meaning as its Latin root: to cloak, to clothe. By 1598, it had picked up the negative figurative meanings of “to cover up an offense, make excuses for, extenuate.” The medical sense followed a similar trajectory from good to bad. In 1525, Francis Bacon wrote:

A wise physician will consider whether a disease be incurable … if he find it to be such, let him resort to palliation; and alleviate the symptoms. (Sylva, §61)

Less than twenty years later, however, the word was being used in reference to mountebanks, whose “cures break out again, being never soundly but superficially healed” (Tho. Fuller, The Cause and Cure of a Wounded Conscience). In 1714, even a recognized doctor could be insulted by the term: “He is but half a physician, he hath palliated our sores and diseases, but he hath not removed them.” (Abp. Sharp, Sermons)

By the 1930s, the dictionary meaning of medical palliation – still in third position after the now archaic “cloak” and the still pejorative “cover-up” – had moderated to the relatively neutral “mediate.” However, the physician perspective was two hundred years behind the public understanding. In the 1950s, a Boston surgeon wrote:

If there is a persistent pain which cannot be relieved by direct surgical attack on the pathological lesion itself …, relief can be obtained only by surgical interruption of sensory pathways … if surgery is withheld, the sufferer is doomed to opiate addiction, physical deterioration or even suicide. (Quoted in The Emperor of All Maladies, Siddhartha Mukherjee, M.D., Scribner, 2010)

As Dr. Mukherjee points out, the response to a failed surgery was more surgery; all other relief was to be withheld. However, a trend toward positive change had begun.

In the late 1940s, the modern palliative care movement began to grow in Europe, led by Dr. Cecily Saunders, an American nurse who had retrained as a physician in England. Her experience treating cancer patients in London’s East End ghettos made her realize how the needs of patients who had not responded to treatment were being almost completely ignored, with all attention focused on those who showed the slightest sign of improvement. In a triage of the cruelest sort, incurable patients were simply abandoned to back rooms. Saunders responded by, in Mukherjee’s words, “resurrecting a counter-discipline—palliative medicine.” And she deliberately avoided the term palliative care because it was her stated opinion that care was a “soft word” that would never be respected by the medical community.

Whether or not that opinion was correct, her movement crossed the water to the U.S. in the 1960s and eventually led to the modern hospice movement. In 1970, the unabridged Random House dictionary defined palliate (now the second definition) as, “to relieve without curing; mitigate; alleviate.” We are back to the meaning of Francis Bacon, though without the wise intent he asked of his era’s physicians.

In 1974, the first hospice in the U.S. opened at Yale. In the 1980s and on, research in the form of clinical trials began to show a wide range of benefits from palliative medicine: better quality of life, better self-reported health, better physical functioning, better mental and emotional health, lower treatment costs, a chance for both patient and family to say good-bye, and a longer life. This is a key point: Patients who stop curative care and move to hospice, whether at home or in a facility, often live longer than patients who continue aggressive treatments.

The hospice movement has become widespread and the public perception has moved even farther. The 2005 edition of the New Oxford American Dictionary puts the medical definition of palliate in the first position, and it is, “make (a disease or its symptoms) less severe or unpleasant without removing the cause.” We are no longer expected merely to mitigate or even alleviate; we are to make the disease less unpleasant, to address both physical symptoms and emotions. This is a definition a patient can easily understand.

Shared Decision-Making: Tarred by the Same Brush

Clinicians have also been slow to accept the practice of shared decision-making in its complete form. As a concept, it has a shorter history than palliation, so it has had less time to penetrate the public mind, let alone the medical establishment. Admittedly, shared decision-making is not an easy practice to implement, particularly in oncology. It can be difficult to fully inform patients and their families about life-threatening illnesses and complicated treatments without overwhelming them, and even more difficult to alleviate their emotional distress when they are overwhelmed. It takes time to present the information so that it can be understood, and to give patients tools that can help them make what could well be the hardest decisions they will ever face in their lives. Shared decision-making also demands a very personal involvement by the physician:

Shared decision-making requires the physician to make recommendations with the values and outcomes as defined by the patient. (italics ours; from The Best Care for Cancer Patients, Max Vergo, M.D., Assistant Professor, Geisel School of Medicine, DHMC, Section of Palliative Care, in a 10/11/2012 presentation.)

The long history of medical practice has always placed the physician in the role of expert, director, and commander-in-chief. In that respect, shared decision-making has always faced a stubborn resistance that stems from a philosophical tenet of modern medicine: the imperative to fight disease to the death. Here again, there has been change, and it follows the same trajectory as palliative medicine. The term shared decision-making begins to appear in the literature in the mid to late 1950s, with a steady increase in references, followed by a surge in the 1990s. A major review of the subject in 1997 lists 63 citations (Shared Decision-Making in the Medical Encounter: What Does It Mean? (Or It Takes at Least Two to Tango), Cathy Charles, Amiram Gafni, and Tim Whelan; Soc. Sci. Med. Vol. 44, No. 5, pp. 681-692). Today, there is both an Informed Medical Decisions Foundation and a Foundation for Informed Medical Decision Making, and the websites of most major cancer centers have sections on patient education.

Still, less than 50% of terminally ill patients in our major teaching hospitals were referred to hospice in 2010. Somehow, that decision is not being made nearly often enough.

Extending Our Definitions

Hospice: A home providing care for the sick, especially the terminally ill.

Cecily Saunders made palliative medicine the core of hospice care. This was only right; the terminally ill deserve relief from their symptoms, and also from the fear and anguish with which our culture faces dying. We can now find hospice programs in many communities, caring for people at home and, more and more, in independent facilities or dedicated wards in hospitals and cancer centers. Hospice is the most established way to deliver palliative care in the U.S.

Unfortunately, that practice equates palliation with hospice, and limits it to just the second half of the definition. Palliative care is understood as only for the terminally ill, only in hospice, and only in the last days or week of life. This has serious negative consequences. It delays palliation too long and it reaches far too few patients who need the medical and non-medical benefits that palliation provides. It also denigrates the very concept. Palliative care may now mean “death with dignity,” but it has also come to signify that the end is at hand and all hope is lost. Physicians tend to reject it as a white flag, while the unprepared patient reacts with shock, denial, and even anger – all the usual stages of mourning, with no time left to resolve them.

Palliation has also been politicized. The term death panel was applied to palliative care teams because they would counsel dying patients about the actual risks and benefits of proposed treatments, including the option of refusing futile treatments in favor of supportive palliative care to ease their final days. Ironically, this “death panel” advice often leads to longer lives.

Any seriously ill patient can benefit from palliative care, whatever the prognosis for survival. This is particularly true in oncology, where the symptoms and treatments can be so harsh. There is an emotional component that must be addressed as well. The very word cancer has a heavy resonance. The media has bombarded us with stories of its dire treatments and outcomes, its rare miracles. We are all aware of the constant “War on Cancer,” and its ever-receding victory. And most of us know at least one family member or friend who has died of cancer. Dr. Mukherjee called it “The Emperor of Diseases” for a good reason, not least its place in the public perception. A typical patient receiving a diagnosis of cancer reacts with panic. Even the news of a good prognosis is met with underlying doubt. From day one, the cancer patient is in a mental state guaranteed to reduce the effectiveness of treatment and the patient’s quality of life.

This is why palliation must treat mental, emotional, and spiritual symptoms, along with the pain, nausea, and loss of physical function. Dr. Vergo, quoted already above, names two critical components of palliative care: realistic hope and compassionate discussion at end of life. But these are critical at any stage of treatment. Palliation has been shown to improve outcomes. It is as much a part of healing as it is of easing death for the incurable. In fact, it is not about death – it is about living well while dying.

The Parallel Palliative Treatment Path

Palliative care is specialized team-based medical care focused on providing relief from uncontrolled pain, overwhelming suffering, and the stresses that accompany serious illness. It helps patients live a meaningful life. It is appropriate at any stage of a serious illness and is provided in conjunction with disease modifying, curative, and life-prolonging therapies. (Supportive Care Innovation 2012; Vermont Assn of Hospitals and Health Systems, with the Vermont Visiting Nurse Assn.)

Once they understand what palliative medicine is, the general public accepts the concept whole-heartedly. In a 2011 poll that used the above definition, 90% of the respondents said they want access to palliative care services for themselves and their family members (2011 Public Opinion Research on Palliative Care, Center to Advance Palliative Care).

With any disease, a complete episode of treatment runs from diagnosis to end of care and encompasses all related treatments and specialists involved with the patient. In this view, palliative care is not an alternative to curative care; it is a partner, a supportive pathway running in parallel to the clinical oncology pathway. It is a clinical specialty that treats physical symptoms brought on by the illness and the treatment. It also treats symptoms in the emotional dimensions, from the shock of the diagnosis all the way through to follow-up therapy or counseling, whichever is required. In the case of an incurable disease, this would include survivorship counseling for the family.

In the case of remission, it would include survivorship counseling of a different sort for the patient facing the specter of relapse. During the course of treatment, emphasis would continually shift lanes between curative care and palliative care, depending on frequent reappraisal of the patient’s prognosis and – for want of a better word – palliative state, which includes the mental, emotional, and spiritual dimensions of a person’s functionality and sense of well-being.

Just as curative treatments require teams of specialists in chemotherapy, surgery, and radiation, supportive treatment requires a team of specialists in the tools, techniques, and treatment pathways of palliative medicine. In addition to doctors and nurses trained in treating the physical symptoms and side-effects, palliation frequently includes psychotherapists, social workers, counselors, and chaplains. In the fullest implementation, the palliative care team can include healing arts practitioners versed in massage therapy, music therapy, guided imagery, relaxation techniques, and so on.

Following the typical trend in specialization, palliation teams have been isolated in their own specialty silo, often overlooked or disregarded by the clinicians trapped in their own silos. To be fully effective, the silos must be removed. Under Accountable Care Organization and Bundled Payment models, this has begun to happen in curative treatment specialties, and it must now happen in palliative treatment. A team of French researchers found that frequent meetings between palliative care teams (PCTs) and oncology staff committed to collaborative decision-making are the most significant factors for improving end-of-life care. Weekly cross-team meetings resulted in a 50% drop in the administration of chemotherapy within the last two weeks of life, and a 70% reduction in the odds that the patient would die in an acute care setting rather than hospice or home. The researchers concluded:

This suggests that, in addition to early clinical intervention by the PCT, the quality of collaboration and the structuring of discussion may be necessary for integrating palliative care into oncology. (Effect of integrated palliative care on the quality of end-of-life care: retrospective analysis of 521 cancer patients, Colombet et al; BMJ Supportive and Palliative Care, 2012;2:239-247)

It also suggests that too many patients are still receiving futile or even harmful care.

Like any clinical practice, palliative care is growing and evolving as new research uncovers better techniques and outlines better treatment pathways. The incorporation of parallel palliative care into the overall oncology treatment plan requires a similar insistence on best practices and quality metrics to document fidelity, point out needed improvements, and inform treatment choices. Such metrics include objective assessments by members of the palliative care team, of course, but must also rely heavily on patient-reported outcomes (PROs). These self-assessment tools are the only way to measure the patient’s experience and ascertain their sense of well-being in all of the palliative dimensions.

There is another growing set of assessment tools vital for effective palliative care: prognostication tools that can accurately forecast how long a patient can be expected to live. It turns out that doctors are not very good at predicting when their patients will die. They tend to overestimate, by over 500%. (Bias and asymmetric loss in expert forecasts: A study of physician prognostic behavior with respect to patient survival, Marcus Alexander and Nicholas Christakis, Journal of Health Economics, 27 (2008) 1095–1108) It’s a complex mistake, too: they overestimate when they calculate the survival range, when they pick what they think will be the most likely point of death, and again when they tell the patient. And the better they know the patient, the more they tend to overestimate. There are serious consequences to this, because it means that futile curative care may be continued too long, and palliation may be offered – or accepted – too late.

There are a number of metrics medical teams can use to measure symptom load and overall functionality. Functionality is important; it integrates the patient’s physical, emotional, and social capabilities. And it turns out to be a better predictor of approaching death than the stage of the patient’s cancer. The graph below, from Dr. Vergo’s presentation, shows functionality measured by the Palliative Performance Scale, or PPS (the blue line). As long as functionality remains above 60%, the patient is in a reasonably good state. The falling curve between 60% and 50% predicts a faster decline and a higher probability that the patient will be too overwhelmed by symptoms to deal well with the emotional demands of dying – saying good-bye, resolving personal issues, dealing with the stress and fear. And there may not be enough time, either. When functionality drops below 10%, the probability of the patient making it to the next day drops to 34%. (Use of Palliative Performance Scale (PPS) in Prognostication, G. Michael Downing, MD, VIHA Research Rounds, Nov. 26, 2009)

Prediction tools like the PPS underscore the need to start palliative treatment as early as possible. Combined with PROs and other palliation metrics, they can also be key components in shared decision-making, by alerting the clinical treatment teams when it is time to shift lanes.

Moving Choice from Patriarch to Patient

The standard model for decision-making in medicine has been described as the Paternalistic model – the basic Father Knows Best scripted in a medical setting. The model assumes that the physician shares some information with the patient, but, as described by Emanuel and Emanuel (1992), “the physician authoritatively informs the patient when the intervention will be initiated.” Less patriarchal doctors provide selected information and “encourage the patient to consent to what the physician considers best.” The model makes an assumption that requires omniscience – that the physician always knows what is best for the patient:

The role of physician depicted in this model is guardian of the patient’s best interest. The physician does what he thinks is best for the patient, without eliciting the latter’s preferences. Patient involvement (if there is any) is limited to providing consent to the treatment advocated by the physician. (Shared Decision-Making in the Medical Encounter…, Charles et al, op cit)

This model often leads to a preference misdiagnosis, which relies on another false assumption by the physician: that he knows what the patient wants. Preference misdiagnosis has been defined clearly by Dr. Al Mulley and his colleagues:

We define a preference diagnosis as a doctor’s inference of what a patient would choose if he or she were fully informed. It is an inference because no patient – save perhaps the patient who is also a doctor and world-renowned specialist in the very disease with which he or she is afflicted – is fully informed. Preference diagnosis, like medical diagnosis, is often a best estimate based on imperfect information. (Patients’ Preferences Matter: Stop the silent misdiagnosis; Al Mulley, Chris Trimble, and Glyn Elwyn, 2012, The King’s Fund)

The authors then state what should be obvious: Patients can suffer just as much from a preference misdiagnosis as a medical misdiagnosis.

As an example, they compare the case histories of two women diagnosed with breast cancer. The first readily agrees with the doctor’s recommendation to undergo a mastectomy. Only afterward does she learn that she has been misdiagnosed and did not have breast cancer at all. The second does not want to have a mastectomy, but agrees because it is the only option described to her. Only afterward does she learn that there was another option, probably more suited to a person of her age and condition, but more preferable to her in any case. Had she been told about it, she would never have agreed to the mastectomy. In the first case, the mastectomy was completely unnecessary. In the second case, the mastectomy was an appropriate medical treatment, but was not the patient’s preference. And she regrets it for the rest of her life. Who has suffered most?

This story, and all the others like it, leads to another dangerous assumption: that full information-sharing by itself will solve the problem of preference misdiagnosis. As Mulley et al. point out, no patient is fully informed. Just as important, no patient dealing with a life-threatening illness is equipped to make such critical decisions alone. Along with good information, they need effective decision-making tools to help them weigh all of the options and outcomes. Many also need moral and emotional support to express their preference in the face of M.D.s and well-meaning family members who might not agree. Finally, many are simply overwhelmed. As Clark et al put it, they “feel extreme psychological and/or physiological vulnerability, which may make it difficult for them to participate in treatment decision-making no matter how well informed they may feel.” Someone needs to share the burden.

This is where the palliative care team can make a significant difference to the course of treatment. We mentioned above the findings of Colombet et al. In addition to regular, collaborative meetings, one member must play the role of counselor and advocate for the patient. This role can sometimes be played by a family member, but family members are often too emotionally involved to make a clear decision. They are dealing with the awful sight of their spouse, parent, or sibling being racked by illness and treatment; they fear losing their loved one; they have their own opinions on whether this is a war or a passage. Which of them is willing to pull the plug? They need palliative counseling as much as the patient. And what of the patient’s preference here? Do they want the family involved? If yes, which ones?

Shared decision-making, then, involves the patient, the doctor, all family members named by the patient, a full disclosure of information about the treatment options and outcomes, an accurate tool for predicting the approach of death, decision-making tools, and a counselor versed in those tools to serve as advocate for the patient.

And it requires time, often a scarce commodity in the last few days or weeks of life, particularly for patients undergoing last-minute interventions and so medicated against pain as to be semi-conscious. Shared decision-making must begin at the very moment of diagnosis, must be fully integrated into both the curative and palliative treatment pathways, and must be documented and measured as rigorously as any clinical pathways to insure fidelity and highlight areas of improvement.

What Has Taken Us So Long?

It has taken sixty years and more to reach the current state of palliative medicine and shared decision-making. Some of that lag is due to institutional inertia, that 17-year, 50%-penetration gap uncovered by Balas and Boren. Some of it is due to preconceived notions: to resistance by physicians educated in medicine as a war to be won at any cost; to the inferences of physicians who think they know what the patient wants; to the resistance of patients who equate palliation with hospice and hospice with death, and to the passive resistance of patients who do not consider themselves educated enough, smart enough, or wise enough to make their own decisions, or who are simply too exhausted by disease to do so. But there are other barriers that are equally challenging to overcome.

First, palliative treatment pathways are complex. They involve specialists in the treatment of physical symptoms and side effects, but also in non-medical fields such as psychotherapy and social work, not to mention such practices as massage therapy and guided imagery. And they are still evolving:

…here evidence-based medicine struggles to untangle which components, if any, of the complex interventions are important. (Evidence-based medicine: What is the evidence that it has made a difference?!, Henry McQuay, U of Oxford, UK; Palliative Medicine 25(5) 2011 394–397)

This is also true of metrics, including PROs and prognostics. They are out there, but few best-practice tools have been recognized. We need them, not only to document fidelity to endorsed palliative pathways, but also to provide important evidence to support best practices in the field. The public, when given the full definition of palliative medicine, fully accepts the concept, but administrators, regulators, payers, politicians, and many clinicians have yet to be convinced all this is needed or useful.

Second, there is a lack of trained personnel in all of the palliative specialties listed. This was one of three barriers named by national cancer center administrators in a survey reported in the Journal of the American Medical Association in 2010. Medical schools for doctors and nurses are struggling to restructure their curricula not only to offer palliation as a focus, but also to provide more than the usual hour or two in the general requirements.

Third, institutional budgets are not sufficient to cover the full set of requirements for effective palliative treatment plans. This was another barrier listed by cancer center executives in the JAMA 2010 survey. There are a variety of reasons for this, including all of the barriers listed above. Hospital budgets are tight and fiercely contended. Palliative medicine does not have the foothold that longevity and status provide to other specialties.

Fourth, and directly related to number three, the current reimbursement models in health care do not support effective palliative medicine. The regulations surrounding Medicare and Medicaid, set over 30 years ago in 1981, specifically limit reimbursement to non-curative end-of-life care in a hospice program. Though some private insurers will also pay for concurrent curative treatment, others will not. And not all will pay for non-medical components, such as collaborative meetings and counseling. This will not change until palliative treatment pathways have been fully endorsed as best practices, and the patient benefits and costs savings due to palliation are supported by more hard data.

The high costs of oncology care, particularly the costs of new drugs and diagnostics, contribute to the challenge. In the United States, the sales of anticancer drugs are now second only to heart disease drugs. Over two-thirds of them are new within the past decade and therefore much more expensive.

In Bending the Cost Curve in Cancer Care (Thomas J. Smith, M.D., and Bruce E. Hillner, M.D.; N Engl J Med 2011), Smith and Hillner discuss a number of changes that could be made to the practice of oncology to reduce costs, including the adoption of better and earlier palliative care. On the subject of reimbursement strategies, they suggest paying all oncologists a fixed fee per unit of cognitive care. The practice would be compensated separately for support services such as nurses, psychologists, chaplains, and so on, similar to the system used for the technical component of medical imaging. They also suggest shifting to monitored-care pathways, as proposed here.

Finally, our culture needs to get over its fear of dying. We have to get to the point where we can all talk about it with each other, and take the time to resolve our fears and regrets as the end of life approaches. This is the fear fed by death-panel rhetoric. We also need to get over our “suck it up and man it out” attitude when it comes to suffering in general. There is no reason why someone dealing with the pain, nausea, sleep deprivation, drug allergies, opportunistic infections, and myriad other side effects of chemo, surgery, and radiation should have to suck up to anything. The job of getting well is hard enough as it is.

Conclusion: Signs of Realistic Hope

Palliative care should be initiated by the primary oncology team and then augmented by collaboration with an interdisciplinary team of palliative care experts. (From the NCCN Guidelines)

Palliative care is focused on the relief of suffering, in all of its dimensions, throughout the course of a patient’s illness. (The Integration of Palliative Care into Standard Oncology Care, ASCO Provisional Opinion)

The past decade has seen palliative medicine grow from its long childhood in the arms of the hospice movement into a promising adolescence, accepted by the general public if not its clinical peers in the healthcare establishment. But even that is changing. In 2006, palliative medicine was formally recognized as a medical subspecialty. Since then, the National Cancer Center Network (NCCN), American Society of Clinical Oncologists (ASCO), Commission on Cancer of the American College of Surgeons (CoC), and the National Quality Foundation (NQF) have all endorsed some combination of policy statements, treatment guidelines, and quality metrics for palliative medicine. Significantly, all of these organizations, and more have stated clearly that palliative care should be integrated with curative care from the time of diagnosis.

ASCO and the CoC have gone so far as to set deadlines. Starting in 2015, the CoC will require providers to meet a new standard to evaluate all patients for emotional distress and refer them to palliative programs for help. ASCO has called for “…full integration of palliative care as a routine part of comprehensive cancer care in the United States” by 2020. (Ferris FD, Bruera E, Cherny N, et al. Palliative cancer care a decade later: accomplishments, the need, next steps — from the American Society of Clinical Oncology. J Clin Oncol. 2009;27(18):3052-3058)

Palliation’s partner, shared decision-making, has also been strongly endorsed. In December 2010 a Salzburg Global Seminar brought together 58 participants from 18 countries to discuss The Greatest Untapped Resource in Healthcare? Informing and Involving Patients in Decisions about Their Medical Care. They concluded that it is ethically right that patients should be involved more closely in decisions about their own medical care, it is practical (through careful presentation of information and the use of decision aids and pathways), and it brings down costs.

These endorsements are key to bringing down the barriers to adoption. They will drive new research to more firmly establish the value of palliative medicine. This, in turn, will lead the Centers for Medicare and Medicaid Services and private insurers to revise their reimbursement models. The shift from fee-for-service to pay-for-performance should support this trend. There is plenty of evidence already that palliative medicine improves patient outcomes and reduces costs, key components of the P4P model.

Some progressive healthcare providers are not waiting for the regulators and payers to catch up. They are already establishing the principles and practices of palliation in their hospitals and cancer centers. The Dartmouth-Hitchcock Medical Center (DHMC), for example, houses a palliation team that grew out of the 1998 Robert Wood Johnson-funded Project ENABLE, directed by Marie Bakitas, DNSc, ARNP, FAAN, an Associate Professor at Dartmouth’s Geisel School of Medicine, a leading researcher/clinician in palliative medicine, and an Adult Nurse Practitioner in palliative care. Now under the direction of Dr. Ira Byock – himself the author of three popular books on hospice and palliative care and a former president of the American Academy of Hospice and Palliative Medicine – the team has grown to include 17 core members from the medical specialties, plus two full-time administrative support staff, a healing arts practitioner (who is also a nurse), and three artists: a creative writer, a visual artist, and a musician. In his latest book, The best Care Possible (2012, Avery/Penguin), Dr. Byock describes it as “…team-based ‘full-dose’ palliative care.”

The DHMC is home to the Norris Cotton Cancer Center, and so the palliation team sees many oncology patients, but they serve all seriously ill patients. Patients with certain diagnoses are automatically referred to the team, and other patients are referred based on assessments of their palliative needs throughout the course of treatment. Shared decision-making is a core component of the team’s palliation treatment pathway. Often, the referral meets resistance from the patient and family. Many people still equate palliation with dying. The team respects that, and focuses on physical symptom relief mixed with suitable counseling.

The medical staff at DHMC, however, has fully accepted the palliative care team. That acceptance – in fact, the very existence of this diversified team of specialists and its highly qualified leaders – shows that, with the right blend of knowledge, credibility, and will, the changes proposed in this paper are not only possible, but well within reach, perhaps even sooner than the 2020 date proposed by ASCO.

We would like to acknowledge the help in research and editing from Dean Whitlock, writer, author, and auctioneer (deanwhitlock.com).

Cancer Business Summit: White Papers and Presentation

PCD Systems — Tue, 09 Oct 2012 19:22:11 +0000

Wes Chapman, president and CEO of PCD Partners, Inc., joins the faculty of the 2012 Cancer Business Summit on October 11–12, 2012, in Fort Worth, Texas. Chapman will serve on the panel titled “Performance Metrics in Oncology” at 10:30 a.m. on Friday, October 12, sharing insights about the crucial need for proper metrics to ensure continuous monitoring and improvement of cancer care. Download a PDF of Wes’s presentation (1.7 MB PDF): Survival Tactics in a Sea of Salty Data - Cancer Business Summit Presentation (165).

PCD Partners, Inc., is playing a key role in improving performance metrics and care delivery in oncology. Its team of quality experts, using an ISO-certified quality management system, enables oncology stakeholders to monitor and evaluate care delivery, ensuring transparency, data integrity, regulatory compliance, and continuous improvement. By tailoring information solutions to the complex needs of oncology organizations, PCD enables them to reduce costs, improve quality, and enhance patient satisfaction.

Cancer Business Summit attendees are invited to review PCD’s free white papers on the business of oncology:

Patient-Reported Outcomes: Choosing Appropriate Metrics From a Still-Evolving Toolset
Criteria for choosing Patient Reported Outcome metrics for use in oncology, plus five PROs the authors found suitable for further study.

A Taxonomy of Leading Oncology Organizations
A short catalog of the most significant organizations that serve as clearinghouses of clinical pathways and quality metrics for oncology. The article briefly describes what they specifically address, how they interact, and their different approaches to improving oncology care.

Decreasing Complexity, Improving Care Quality, and Reducing Cost in Oncology
The U.S. healthcare system is the most expensive in the world, yet it does not produce the best outcomes, either in patient expectations or in life expectancy. High costs reflect waste, inefficiency, duplication, and unnecessary services. Three underlying problems contribute to this situation.

Perverse Incentives, Clumsy Laws, and the Value/Volume & RVU Conundrum in Medical Quality
This is the second of three articles on quality issues in the delivery of clinical healthcare. It examines the alignment/quality issues and system design considerations regarding high volume procedures and high Relative Value Units.

Medical Quality Systems: The Elusive Goal of Quality in Complex Systems
The first of four articles regarding quality issues in the delivery of clinical healthcare, this article looks at the popular methods for quality improvement in healthcare, including Lean, Six Sigma, Medical Checklists, and ISO 9001, and their applications and limitations.

PCD Partners Co-Management Arrangements: A Realistic Strategy for Efficiency, Quality, and Alignment
The delivery of complex healthcare services in a hospital environment has typically involved significant misalignment between hospitals and independent physicians, in both financial and operational incentives and accountability. This inequality of the parties has hampered programs aimed at improving efficiency and lowering health care cost. The Co-Management Arrangement created a legal and operational framework to address these problems, to the benefit of both groups.

Learn more about PCD Partners, Inc., and read about our selected clients and projects.

Contact us to discuss how we can help your oncology organization, or to be put in touch with president and CEO Wes Chapman. Email moc.srentrapdcpnull@ofni or call 603-727-7300.

Patient-Reported Outcomes: Choosing Appropriate Metrics From a Still-Evolving Toolset

Wes Chapman — Sat, 29 Sep 2012 18:36:05 +0000

By Wes Chapman, Mike Choukas, Charles Hutchinson PhD, Steve Maker, and Mario Martinez

Purpose

This paper defines a set of criteria for choosing Patient Reported Outcome metrics for use in oncology, and lists five PROs the authors found suitable for further study and trial. The criteria should be useful for testing the suitability of new metrics as they become more sophisticated and more accepted in clinical care and in oncology in particular.

Background

Patient reported outcomes (PROs) are widely recognized as an important component in measuring healthcare outcomes. The National Institutes of Health (NIH), Food and Drug Administration (FDA), and Centers for Medicare and Medicaid Services (CMS), in their various programs, have all specified the use of PROs in determining effectiveness, safety, or value of a particular clinical program, pathway, medical device, or drug. This makes clear sense; the goal of healthcare is to improve the health of patients, and only the patients themselves can tell us how well they feel, before, during, and after the treatment.

As opposed to objective measures of health (blood pressure, bone density, lung capacity, etc.), which doctors or nurses can measure and report, PROs depend on answers patients provide to subjective questions about physical, mental, and emotional health: how much pain they’re feeling, how much energy, how much anxiety. In fact, there are some conditions – gastrointestinal distress, depression – where PROs are the only available measure without additional testing. PROs also examine the effects of these feelings on functional aspects of life; for example, how much their pain has affected their work, play, social life, and so on.

PROs are obtained through short surveys, either self-administered by the patient or through an interview, and usually take the form of rating scales or yes/no questions; for example:

I have pain… Not at All – A little bit – Somewhat – Quite a bit – Very much

PROs measure a patient’s sense of health and well-being, now and over time, indicating whether a particular treatment has been effective. They can also be combined with measures of service (During this hospital stay, how often did nurses explain things in a way you could understand? Never – Sometimes – Usually – Always) to measure a patient’s experience and satisfaction with the treatment they received, and they can be aggregated with other patients’ answers to provide a measure of the total process the patient went through, as well as a rating of the hospital or clinic that provided the treatment.

Cartoon by XKCD – http://xkcd.com/883/

Finally, PROs can be an important source of metrics for quality improvement at every level: the individual case, the pathway, the physician, the team, and the facility. Given this level of usefulness, we should expect to find a robust set of PROs (or metrics derived from PROs, sometimes referred to as PROMs) that physicians and clinics can choose from to suit their particular needs.

Unfortunately, this doesn’t seem to be the case.

Still in Their Adolescence

The current state of PROs is best described in an expert commentary posted May 14, 2012, on the website of the National Quality Metrics Clearinghouse (NQMC):

For more than 40 years … outcomes have had a central role in how high-quality health care is conceptualized. In an era in which individualized or personalized care, patient-centered care, patient-centered medical homes, and “patient-important” outcomes are increasingly invoked as critical aims for the U.S. health care system, using patient-reported outcomes (PROs) in quality assessment and improvement schemes seems crucial.

The significance of this view has not yet, it would seem, reached any substantial level of practical application.

—Kathleen N. Lohr, PhD

Dr. Lohr, a researcher with RTI International at Research Triangle Park in North Carolina, has worked in the field of healthcare quality metrics for over two decades. She is affiliated both with the PROMIS Health Organization (a nonprofit foundation that develops and administers PROs), and the Core Editorial Board for the National Quality Measures Clearinghouse and the National Guideline Clearinghouse. She bases her statement not only on her experience, but on the simple fact that “even though NQMC has more than 360 outcome measures (as of early 2012), the Clearinghouse has very few patient-reported outcome measures – those directly salient to and reported by patients about the end results of health care.” By her count, somewhere between 20 and 40 measures at most involve PROs. She can’t be more definite because the NQMC’s search functions don’t allow a simple means to find PROs, which is, in itself, a statement about the status of PROs.

Dr. Lohr points out that thousands of PROs exist, but few of the developers have made an effort, or succeeded, in submitting their measures to the NQMC for approval and inclusion. She analyzes why this is the case, and provides a solution that revolves around the NQMC’s requirements for inclusion. Both her suggestions and the editor’s response imply that most developers of PROs would not have any trouble getting their measures approved. Yet that hasn’t been happening. Given the requirements from NIH, FDA, and CMS, this seems remarkable.

Barriers to Endorsement

It’s significant to note that CMS has endorsed only one PRO measurement tool, the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS), which is actually far more focused on hospital services than it is on patient health and well-being. Questions on the HCAHPS range from “how often did the nurses treat you with courtesy and respect” to “how often was the area around your room quiet at night”. It does not ask if the patient is currently in pain, anxious, nauseous, able to walk or work. It does not compare the patient’s current state with their previous state, nor with their expectation of how they should feel after going through treatment. It doesn’t measure outcomes, it measures process, and a limited part of the process at that: just a few variables that are universal to every hospital experience, heavily weighted toward hospitality rather than clinical treatment.

Why is this significant? Because the HCAHPS is now a key piece in the payment formula for Medicare and Medicaid patients. Hospitals and clinics are driven to use the HCAHPS in order to be paid, not because it’s an effective tool in quality improvement. Until CMS requires other PROs for a wider range of situations and more related to the health state of the patient, there will be less incentive for the industry to start using them. But this is not the only barrier.

Most PROs Were Not Designed for Clinical Care

Many PROs, if not most, were developed for use in clinical trials, not for use in standard clinical care. Using PROs in trials can be vitally important, of course, helping to determine if new treatment pathways are beneficial from the patient’s perspective. Because these PROs have been validated in the clinical trial arena, however, some would argue that they are not reliable quality metrics for use in clinical treatment. This ignores the fact that the patient’s experience is very much the same in both settings, and the effects of the disease vary only to the extent that treatment pathways vary. In oncology, there will still be the same array of symptoms to deal with – pain, nausea, anxiety, depression, fatigue, sleeplessness, and so on – with slight variations depending on the specific cancer. And the questions you want to ask the patient about their physical, mental, and emotional state are the same.

Most PROs Are Not Disease Specific

The large majority of PROs are designed to assess the general state of a patient’s well-being. This makes sense; the health effects that PROs attempt to measure are caused by most diseases. A migraine, for example, is far more than a pain in the head. But it is true that certain diseases have a spectrum of effects that are not all covered in a general health assessment survey. Cancer and its treatment can cause pain, nausea, weakness, vertigo, confusion, weight loss, hair loss, fatigue, sleeplessness, anxiety, depression, and more. However, the extreme cases do seem to be covered. There are PROs for general cancer and some specific cancers, as well as for headaches, asthma, hepatitis, HIV, and more. And these tools can be combined with a general health PRO to generate a more compete picture of health and well-being.

Many PROs Conflate Process with Outcome

This seems to be particularly true of hospital rating tools, such as the HCAHPS and the many commercially offered tools that have the CAHPS as their core metric set. As we said above, these tools include quite a few measures of hospitality and service during treatment, rather than measures of the quality of clinical pathways and their before-and-after effects on the patient. Or they mix the measures in such a way that it is difficult to separate hospitality from treatment and process from outcome. While it is undoubtedly true that the total healthcare experience, from ease of parking to post-discharge follow-up, has an effect on the patient’s well-being and satisfaction, providers are rightfully concerned that too much emphasis can be placed on factors that are only marginally important to health outcomes.

PROs Imply Criticism of Doctors and Clinics

Healthcare providers are not always happy to see their work measured in such a personal and transparent way. As one doctor put it:

In medicine, we are used to confronting failure … What we’re not used to doing is comparing our records of success and failure with those of our peers … the truth is that we have had no reliable evidence about whether we’re as good as we think we are.

—Atul Guwande, M.D.; Better: A surgeon’s notes on performance (p.207); 2007, Picdor/Henry Holt & Company.

PROs provide that evidence, and they have special weight, because they are essentially spoken in the patient’s own words. Doctors and the facilities where they work not only cringe at the potential criticism, they worry that a poor rating will drive away business. Dr. Gawande’s book shows at least one example where that doesn’t seem to be the case, and where transparency has led to quality improvement in all of the clinics being rated, including those already at the high end of the curve. It’s important to note, though, that the PROs must be appropriate to the situation and, to state the key point of any quality metric, they must be analyzed, understood, and acted on. Doctors, nurses, and other staff must be educated about the benefits to both patient and provider that accrue from the quality improvement gains made possible with PROs; not just higher ratings, but also better treatment pathways, more patient involvement, better palliation, and better outcomes all around.

Criteria for Choosing the Right PROs

In a previous paper, we outlined a taxonomy of organizations that endorsed clinical pathways and metrics in oncology. Our selection criteria there was based on the Anna Karenina Principle, which states that the key organizations will be the only ones that meet a specific set of must-have characteristics. PROs require a less restrictive approach. The range of uses to which they are put, along with their current evolving state of development and acceptance in healthcare, is such that no one set of criteria would identify PRO instruments that fit every application. That said, we have been able to define a set of five characteristics that apply to many PROs in varying degrees. In some cases, it’s a loose fit, but the importance of each criterion to any given application can be considered when making choices.

Our five characteristics are:

1) Applicable to Oncology – The questions cover a range of negative symptoms associated with cancers, as well as measures of general health and functionality. Some PROs, such as the FACT-G, are designed specifically for oncology and rate very highly here. Others, such as the SF-36 are general health assessment tools, but do ask about pain, anxiety, and other symptoms applicable to oncology.

2) Broadly used – The PRO instruments have been used in many institutions or trials. (Since so few have been endorsed by CMS, AHRQ, or NQF, this provides a reasonable measure of acceptability and potential for endorsement.) It can be difficult to determine if a particular PRO instrument is widely used in clinical care without relying on unsupported claims made by vendors.

3) Well validated – The PRO instrument tests well for both validity (the measure is associated with what it purports to measure) and reliability (the measure is free from random error). Note that, in some cases, the only statements of validity and reliability that are easy to find come from the vendor of the instrument.

4) Easy to use – The survey is brief and easy to understand and complete by a person under the stress of treatment. The FACT-G, for example, has 28 questions, while the Symptom Impact Profile has over 100, and a long set of detailed instructions. Alternative methods of administration, such as by interview, by phone, with assistance, or via computer (tablet, online, etc.) can simplify a long instrument or complicated set of questions (e.g., if the answer is Yes, jump to question 13).

5) Clinically Useful – That is, the measure can be used to immediately adjust treatment to improve the patient’s state of health. In an Anna Karenina universe, the HCAHPS would not be welcome in the happy family of PROs.

A Selection of PROs for Oncology ACOs

Our projects require PROs suitable for use in accountable care organizations (ACOs) focused on clinical oncology. Using our five criteria, we have selected four PROs that fit the critera fairly well, and have decided to include one special case: the HCAHPS.

HCAHPS
Hospital Consumer Assessment of Healthcare Providers and Systems
This is the only PRO instrument endorsed by CMS; it is required in the Medicare Shared Savings Program. There are forty-five approved vendors/administrators, and more that are not officially approved. It scores very low on many of our criteria and would not be included if not for the CMS approval. It is self-administered only after discharge (via mail) or is taken by phone interview. http://www.hcahpsonline.org

SF-36
Short-Form-36 Health Survey
This survey is not oncology specific but has been very broadly used (with 11,000 listings in PUBMED for the search string “SF-36”). It has a fixed set of 36 questions, with shorter versions that have 12 and 8 questions (the SF-12 and SF-8), and a companion inventory that focuses on pain. It can be self-administered on paper or computer or taken via interview. The SF-36 was originally developed by the Rand Corporation, which sold the commercial rights. Rand still makes the original version available as a free, public domain instrument.
http://www.rand.org/health/surveys_tools/mos/mos_core_36item.html

FACT-G
Functional Assessment of Cancer Therapy–General
The FACT-G was developed for use during treatment rather than clinical trials. It is applicable to all cancer tumors (though only three cancers were involved in its initial development: breast, lung, and colorectal). The FACT-G is a core set of metrics, with many different add-on sets designed for negative health affects in various cancers. It is brief, self-administered on paper (computer-based versions are being developed, according to the steward organization), or taken by interview (p2p or phone).
http://www.facit.org

PROMIS
Patient Reported Outcomes Measurement Information System
PROMIS is a government program, funded by NIH, but not yet officially endorsed by CMS, AHRQ, or NQF. It is not oncology-specific, but it is very flexible; the user can select from existing core PRO sets and individual questions, as well as add questions of their own creation. It is free and hosted on the web, for use by researchers and clinicians. Users have their own secure databases, where they develop the sets they wish to use. The surveys can be self-administered on paper or online and also taken via interview (p2p or phone). Brevity and ease of use would depend on how customized you make it. It is a relatively new instrument but claims that the core set is well validated.
http://www.nihpromis.org

MDASI
M.D. Anderson Symptom Inventory
The MDASI is oncology-specific and was developed for clinical and research use, with many subsets for different cancers. It is brief and can be self-administered (paper) or taken by interview (p2p or phone). It is relatively new (2000), but appears to be well validated. It is difficult to assess how broadly it has been used. (Searching PUBMED for “MDASI” reveals only 51 articles, and there are no hard data available that indicate the breadth of use of any PRO in clinical care.) http://www.mdanderson.org/education-and-research/departments-programs-and-labs/departments-and-divisions/symptom-research/symptom-assessment-tools/m-d-anderson-symptom-inventory.html

Conclusions

Our selection criteria have given us a reasonable start; we have several useful PRO instruments to explore further. Dr. Lohr’s expert opinion is certainly true – the developers and stewards of PROs should make more effort to have them approved by NQMC and NQF, and those organizations should do more to facilitate the process. It would be a great benefit to hospitals, ACOs, and other providers to have a list of endorsed PRO metrics from which to choose. There are too many sets and too many vendors competing for the top hits on Google, and the most effective at cadging links are not necessarily the organizations most oriented to patient health and quality improvement over operations and ratings.

It is also true the CMS must make an effort to endorse and require PROs that are more focused on quality improvement in both patient health outcomes and clinical pathway processes. The financial carrot and stick that CMS provides cannot be ignored in the drive to move PROs to a more mature state of development. This is underscored by a study published on February 12, 2012 in the Archives of Internal Medicine entitled The Cost of Satisfaction: A National Study of Patient Satisfaction, Health Care Utilization, Expenditures, and Mortality. (Joshua J. Fenton, MD, MPH; Anthony F. Jerant, MD; Klea D. Bertakis, MD, MPH; Peter Franks, MD; Arch Intern Med. 2012;172(5):405-411. doi:10.1001/archinternmed.2011.1662).

Noting that “…the relationship between patient satisfaction and health care utilization, expenditures, and outcomes remains ill defined…,” the authors conducted a study of seven years’ worth of data from the national Medical Expenditure Panel Survey. What they found was that “…higher patient satisfaction was associated with less emergency department use but with greater inpatient use, higher overall health care and prescription drug expenditures, and increased mortality.” In fact, the highest patient satisfaction quartile was 26% more likely to die compared to the lowest quartile.

This bald statistic has been seized on by some bloggers as a clear sign that PROs – at least those related to patient satisfaction – do not indicate healthcare quality. That may be true, but we can’t make that claim without first trying to fully understand the results of the study – as we would with any quality metric before acting on it. There are many questions we must ask. Were the survey questions focused on hospitality and patient experience or on health status? Were the results consistent across provider? Were satisfied patients more or less involved in the decisions regarding their treatment? Are highly satisfied patients more complacent, and thus more likely to accept whatever is offered? Are they more likely to accept their fate and not struggle against their disease? The fact is that these results could indeed show that satisfaction is a powerful tool for improving healthcare quality if we can be sure we are reading them correctly. Then we can design an appropriate adjustment to our treatments so that what we now call satisfaction is no longer an indicator of increased mortality. Or we might find that we simply need a better tool for measuring satisfaction; for example, a tool that measures health states not only before, during, and after treatment, but also against the patient’s expectation of what the outcomes should be.

In Better, Dr. Gawande describes a visit between a cystic fibrosis patient and doctor, the head of the CF clinic with the best patient outcomes by far in the U.S. The patient’s scores on several important measures had dropped, and the doctor was trying to discover why. He did what doctors always do in a one-on-one clinical situation: He looked at the scores and then he started to ask questions. In this case, he listened intently and asked more questions, until he uncovered where the patient had strayed from her treatment regime. In other words, the doctor was using PROs, made up on the fly for the specific disease, patient, and treatment pathway.

The patient, a teenager going through all of the changes and rebellions that that age brings on, balked at the discipline the doctor was asking of her, and he replied, “We’ve failed … it’s important to acknowledge when we’ve failed.” With that acknowledgement – and with both of them sharing the failure – they began to work out the adjustments she needed to make to get back on track with her treatment.

A PRO survey cannot have that level of sensitivity or insight, but a well-designed survey used in the appropriate situation can reveal when a treatment pathway is failing, and a careful analysis of the results can lead to measurable quality improvement, if not perfection.

We would like to acknowledge the help in research and editing from Dean Whitlock, writer, author, and auctioneer (deanwhitlock.com).

A Taxonomy of Leading Oncology Organizations

Wes Chapman — Fri, 07 Sep 2012 18:14:05 +0000

by Wes Chapman, Steve Maker, and Mario Martinez

Purpose

This paper is a short catalog of organizations that we believe are the most significant clearinghouses of clinical pathways and quality metrics for oncology. Our goal is to provide some insight into the organizations that influence oncology clinical pathways and quality measures by briefly describing what they specifically address, how they interact with each other, and their different approaches to improving oncology care. Read the full paper below, or download a print-ready version (450K PDF): A Taxonomy of Leading Oncology Organizations (166).

Background

In the past decade, quality improvement has become a focus in health care, driven in large part by efforts at the Center for Medicare and Medicaid Services (CMS) to reduce Medicare and Medicaid payments, while simultaneously increasing the perceived value of health care services; in other words, improving patient outcomes. One component of the effort is to increase efficiency and reduce errors during treatment. Another is to document and promulgate best practices in clinical pathways by endorsing a chosen set of pathways as guidelines for approved practice. These two components are linked by quality metrics that measure how well the chosen clinical pathway has been followed and, in the fullest implementation, how well patient outcomes compare to those achieved by similar healthcare providers following the same pathways.

CMS has also announced plans to shift payments from a fee-for-service basis to a pay-for-performance basis (P4P), and has run trials to test the efficacy of the shift. In order to work, P4P requires healthcare providers to use CMS-approved clinical pathways and to document fidelity by using approved sets of quality metrics. CMS is choosing its approved pathways and metrics from a number of organizations, some of which also provide some form of certification for healthcare providers; essentially, an official stamp of approval that has the potential to raise a provider’s level of payment, not only from CMS but also from other payers.

Additionally, CMS, through its Center for Medicare & Medicaid Innovation, has begun large scale testing of Accountable Care Organizations (ACOs) and various Bundled Payment Initiatives (BPIs) targeted at specific medical procedures and conditions. In every case, the ACOs and BPIs are required to submit extensive quality reporting – on both process and outcomes. Under section 3022 of the Affordable Care Act, the Department of Health and Human Services has established the Medicare Shared Savings Program, which allows ACOs to receive up to 60% of any cost savings they achieve for Medicare beneficiaries, provided they also score well and show improvement on a specific set of 33 quality reporting and performance metrics. While the majority of the metrics are not specific to oncology, two are (screening for colorectal and breast cancers), and the current metrics set also includes patient evaluations of the performance of their physicians, including oncologists. Significantly, the program relies on at least one newly derived metric (an ACO-specific Consumer Assessment of Healthcare Providers and Systems survey), and it increases the performance requirements over the course of three reporting periods. Future iterations also call for the inclusion of more metrics focused on specialty care. In other words, the future of P4P will be more specific, more detailed, and more rigorous in its dependence on quality metrics.

Thus, it has become very important for healthcare providers to know which organizations produce and publish the approved guidelines for clinical pathways and quality metrics and which provide certification for quality in clinical practice. When P4P is finally implemented, these organizations will influence not only a provider’s revenues but also its reputation.

Making the Cut: the Anna Karenina Principle

Currently, there are hundreds of healthcare organizations developing clinical practice pathways or sets of quality measures or both. These include at least a hundred with some focus on oncology, which is our area of concern. Luckily, only a few of these organizations currently have the reach and stature to be recognized by CMS and private payers, which will make the search for accepted pathways and metrics much easier to complete. The hard step is the first one: identifying the key organizations.

We took direction from an unlikely source, Leo Tolstoy, who stated the situation this way:

Happy families are all alike; every unhappy family is unhappy in its own way.
(From Anna Karenina)

There are hundreds of individual quirks that must all be right for a family to be happy, but if any one quirk is not right, dysfunction ensues. The same principle has been broadly adopted as a statistical methodology, and applies directly in taxonomy: To be included in the happy family of a species, an organism must express every characteristic in a specific set. Restated in terms of oncology organizations, the Anna Karenina Principle tells us that the key organizations will be the only ones that meet a specific set of criteria. We define these must-have characteristics as:

Clearly focused on oncology (or with a subgroup focused on oncology)
Provides a clearinghouse of clinical pathways or quality metrics or both
Is frequently referred to or partnered with other healthcare organizations
Has clear links to/from CMS
Has a large or prestigious membership with national reach
Makes its pathways and metrics available to the public

Using these criteria, we identified eight organizations that we can label as significant clearinghouses of oncology pathways or metrics or both. Two of these are governmental organizations: CMS and the Agency for Healthcare Research and Quality (AHRQ). The other six are non-governmental organizations that mostly take the form of professional associations or networks:

American Society of Clinical Oncology (ASCO)
American Society for Radiation Oncology (ASTRO)
American College of Surgeons Commission on Cancer (ACS CoC)
Association of Community Cancer Centers (ACCC)
National Comprehensive Cancer Network (NCCN)
National Quality Forum (NQF)

Obviously, some big names in healthcare are missing. The American College of Surgeons National Surgical Quality Improvement Program (NSQIP), for example, lacks an oncology focus. The AMA has endorsed oncology quality measures produced by other organizations, but it does not provide a clearinghouse. The American Cancer Society has the oncology focus, but also does not provide a clearinghouse.

That said, none of the eight key organizations has a perfect match on every characteristic, as the following table shows. AHRQ and the NQF are definitely clearinghouses, for example, with many pathways and metrics in their databases, while ASTRO and ACCC have but a few each. Some are better known and more often referred to than others. Then there is CMS, which we have included because it is the regulating body that will ultimately identify what pathways must be followed and what metrics must be collected in order to be certified for payment under Medicare/Medicaid (followed quickly by private payers). These differences are detailed in the catalog that follows, and made more obvious in a set of contrasting tables at the end of the paper. (There is a list of acronyms there, too.)

What You’ll Find There

All of the organizations use the web to announce and distribute their sets of pathways and metrics. In some cases, the websites contain an online, searchable database, and in other cases they provide a way to download their guidelines in a large PDF document. These differences are relatively minor. There are more serious usability issues to deal with.

Despite over a decade of discussion in journals, conferences, consensus groups, press releases, blogs, and governmental pronouncements, the healthcare community has made only slow progress on developing accepted sets of clinical pathways and quality metrics. The terminology has not even had time to settle on an accepted nomenclature. “Clinical pathways,” for example, are often referred to as “clinical practices,” and also as “protocols” and “treatment plans”. The most common term you’ll see to identify a set of endorsed clinical pathways is “guidelines”. For metrics, the most common term seems to be “quality measures,” but you will also see “quality indicators,” and both appear on the AHRQ website. Drilling down through the large AHRQ database can also be tricky, requiring close attention to topic areas and search terms.

A more fundamental problem is the relative incompleteness of the guidelines and particularly the measures, and in the links between them. In the best of all possible worlds, you would be able to search on a term like “staging metrics stage IV non–small-cell lung cancer” and immediately find one or two CMS-endorsed, evidenced-based, best-practice clinical pathways that clearly define all the steps in the treatment. In addition, each pathway would automatically be linked to an endorsed set of quality measures that will not only document adherence to the pathway and help to insure the best possible outcome, but also provide data to support quality improvement.

The system is not there yet, but there are indications that it is at least heading in that direction, and not in separate winding routes mapped out by each organization. These key players have been forming partnerships, both among themselves and with other healthcare and oncology organizations, to achieve a broader consensus of approval of their guidelines and quality measures. Perhaps the best example is a pair of simultaneous initiatives, one undertaken by ASCO and NCCN, the other by the ACS CoC, to develop quality measures for breast and colorectal cancer. The CoC submitted their measures to the NQF for endorsement as part of the NQF’s Cancer Project. The NQF is now facilitating a collaboration among the three organizations to synchronize the measures and present a unified set to the public. (For details, visit this page on the NCCN website: http://www.nccn.org/professionals/quality_measures/.)

We can only hope this trend continues and accelerates.

What You’ll Find Here

For each organization, we provide the following information.

Name and relevant web addresses
Mission statement and/or goals
Membership requirements and number of members
Certifications offered
Key partnerships (regarding pathways, metrics, and accreditation)
Journals and Newsletters
Stance on patient education, palliative care, and multimodal care
Pathways/Guidelines: purpose and general description
Metrics: purpose and general description

A set of tables comparing basic data for each organization appears after the detailed descriptions.

The Family of Organizations

Center for Medicare & Medicaid Services (CMS)

http://www.cms.gov
http://www.innovations.cms.gov/

Mission Statement: CMS currently specifies reporting requirements through the Physician Quality Reporting System (PQRS), “a reporting program that uses both incentive payments and payment adjustments to promote reporting of quality information by eligible professionals. The program provides a payment to practices with professionals who satisfactorily report data on quality measures for covered physician fee schedule services furnished to Medicare part B Fee-for-Service beneficiaries. In 2015 the program will also apply a payment adjustment to eligible professionals who do not satisfactorily report data on quality measures for covered professional services.” As described in the Background section, CMS has just initiated the Medicare Shared Savings Program, which requires ACOs to report specific quality measures and eventually achieve performance standards.

Memberships: There is no membership program per se. Physicians, groups, etc. who wish to take part must register and go through several steps to confirm eligibility. Technically, every provider in the U.S. and its territories that accepts Medicare/Medicaid patients will eventually need to take part in this or an equivalent program for P4P.

Certifications offered: None. CMS provides payment incentives for physicians who are board certified and take part in a certification maintenance program, but they endorse qualified certifying entities rather provide their own certification.

Key Partnerships: CMS endorses pathways and metrics developed by a number of organizations, along with qualified entities that provide board certification in a number of clinical areas. However, they do not themselves partner with other organizations to create pathways or metrics or to certify physicians.

Journals and Newsletters: None

Stance on Patient Education/Involvement: No stated position.

Stance on Palliative Care: Endorses metrics related to pain control, palliation, and end-of-life care.

Stance on Multimodal Care: Recent Bundled Payment Initiatives show an increasing awareness of and support for multimodal care; however, current regulations and programs do not fully support it in practice.

Pathways: CMS does not publish guidelines for clinical practice. Instead, it relies primarily on the National Guidelines Clearinghouse (NGC) maintained by AHRQ (http://guidelines.gov), and on the endorsements provided by the NQF.

Metrics: Purpose: To collect quality data documenting that physicians have followed prescribed pathways and are eligible for payment under the Medicare/Medicaid system. PQRS specifies both the financial carrot and stick to encourage physicians to collect and report this data. The physicians are under no requirement to use the data for any other purpose, such as quality improvement. The Medicare Shared Payments Program for ACOs does require care providers to meet specified performance standards and show improvement. As with pathways, CMS does not publish metrics, referring users to AHRQ’s National Quality Measures Clearinghouse (NQMC: http://qualitymeasures.ahrq.gov) and the NQF.

Agency for Healthcare Research and Quality (AHRQ)

http://www.ahrq.gov
http://guidelines.gov/index.aspx
http://qualitymeasures.ahrq.gov/index.aspx

Mission Statement: “To improve the quality, safety, efficiency, and effectiveness of health care for all Americans. Information from AHRQ’s research helps people make more informed decisions and improve the quality of healthcare services.”

Memberships: No memberships; all information is free and accessible by the public. “Customers” include clinicians and other healthcare providers, consumers and patients, healthcare policy-makers at federal, state, and local levels, purchasers and payers, and other hospital officials.

Certifications offered: None

Key Partnerships: Effective Health Care Program National Partnership Network (232 partners). “These organizations have joined us in promoting patient centered outcomes research in patient and professional communities across the United States. By becoming partners, they have become part of a growing partnership network committed to improving the quality of health care through informed decision making.” http://www.ahrq.gov/clinic/partners/partners.htm

Journals and Newsletters: Two digital newsletters, free to the public, register on the site

Research Activities (email updates that summarize latest findings from AHRQ-funded studies, announce AHRQ publications, funding opportunities, events, etc.)

Inside Track (email and online, provides news and developments from AHRQ’s Effective Health Care program)

Stance on Patient Education/Involvement: Actively promotes educating patients and involving them in decision-making.

Stance on Palliative Care: No stated position. Various reports and presentations have addressed the issue, but they do not yet have categories for palliative care in their guidelines or quality measures clearinghouses. One advisory council member urged the group in 2011 to create a separate clearinghouse for end-of-life and palliative care practices.

Stance on Multimodal Care: No stated position.

Pathways: AHRQ hosts and maintains the National Guideline Clearinghouse (NGC), a database of evidence-based clinical pathway guidelines submitted by clinical research centers and professional clinical organizations. AHRQ does not create guidelines; it endorses them and makes them available to clinicians. Currently, there are 936 pathways found with the search text of “oncology or cancer”.

Purpose: “…to provide physicians and other health professionals, health care providers, health plans, integrated delivery systems, purchasers, and others an accessible mechanism for obtaining objective, detailed information on clinical practice guidelines and to further their dissemination, implementation, and use.”

http://guidelines.gov/index.aspx

Metrics: AHRQ hosts and maintains the National Quality Measures Clearinghouse (NQMC). As with the guidelines clearinghouse, AHRQ endorses metrics submitted by other organizations. AHRQ has also developed a set of metrics on its own, which are cataloged in the NQMC without any special priority or endorsement. Currently, the NQMC holds 332 measures that can be found with the search text of “oncology or cancer”. (For each clinical pathway guideline, the Guidelines Clearinghouse displays a link labeled “Related NQMC Measures”; however, it appears to return the same small set of metrics every time.)

Purpose: “Health care delivery measures are used to assess the performance of individual clinicians, clinical delivery teams, delivery organizations, or health insurance plans in the provision of care to their patients or enrollees. Population health measures are applied to groups of persons identified by geographic location, organizational affiliation or non-clinical characteristics, in order to assess public health programs, community influences on health, or population-level health characteristics that may not be directly attributable to the care delivery system.” The clearinghouse includes both types of measures, broken into these sub-groups: quality measures, related health measures, and efficiency measures. (More information on the Domain Framework and inclusion criteria will be found here:

http://qualitymeasures.ahrq.gov/about/domain-framework.aspx

American Society of Clinical Oncology (ASCO)

www.asco.org

Mission statement: ASCO is “a professional oncology society committed to conquering cancer through research, education, prevention and delivery of high-quality patient care.”

Vision statement: “All cancer patients will have lifelong access to high quality, effective, affordable and compassionate care; The most accurate cancer information will be available so that patients and physicians can make informed decisions about cancer prevention and treatment; Information we learn from every patient will be used to accelerate progress against cancer; Resources will exist to attract the best clinicians and investigators to provide optimal patient care and to conduct transformative research; ASCO will be recognized as the most trusted source of cancer information world wide.”

Memberships: Full member, Member in training, Allied Physician/doctoral scientist, Affiliated health professionals, Internal corresponding, Student/non-oncology resident (dues vary by category). Full members are licensed physicians or other health professionals at the doctoral level of a nation who devote a majority of their professional activity to cancer patient care and/or research. Number of members: 30,000 individual members from every oncology subspecialty.

Certifications offered: Quality Oncology Practice Initiative (QOPI) Certification Program

http://qopi.asco.org/certification

Key Partnerships:

NCCN
NQF
ACS CoC
ASTRO
AMA
PCPI
ONS (Oncology Nursing Society)

Journals and Newsletters:

Journal of Clinical Oncology: Three times monthly (36 times a year); on the 1st, 10th, and 20th each month. Circulation: 23,809 (16,190 domestic, 7619 international; 20,653 member, 3,156 non-member)

Journal of Oncology Practices: Bi-monthly (6 times/year in odd-numbered months). Circulation: 16,883 (16,165 domestic, 718 international; 16,656 member, 227 non-member)

Stance on Patient Education/Involvement: Part of their vision statement.

Stance on Palliative Care: No stated position, but has metrics for palliative and end-of-life care

Stance on Multimodal Care: No stated position

Pathways: Purpose: ASCO maintains a list of clinical pathway guidelines that “…address specific clinical situations (disease-oriented) or use of approved medical products, procedures, or tests (modality-oriented) … Topics for guidelines are selected on the basis of significant clinical or economic importance; presence of variations in patterns of, or access to, care; availability of suitable data; and ethical considerations.” Currently, there are 37 guidelines, sorted into these categories:

Assays and Predictive Markers
Breast Cancer
Gastrointestinal Cancer
Genitourinary Cancer
Head and Neck Cancer
Hematologic Malignancies
Lung Cancer
Melanoma
Supportive Care and Quality of Life
Survivorship
Treatment-Related Issues

A full list of guidelines is available here: http://www.asco.org/ASCOv2/Practice+%26+Guidelines/Guidelines/Clinical+Practice+Guidelines

Metrics: Purpose: To aid oncology practices in quality self-assessment.

Core oncology metrics (required for QOPI certification):

Documentation of care
Chemotherapy planning, administration, and treatment summary
Pain assessment and control
Smoking cessation
Psychosocial support

Disease-Specific Modules:

Breast (as applicable to practice)
Colorectal (as applicable to practice)
Non-Hodgkin’s Lymphoma (as applicable to practice)

Domain-Specific Modules:

Symptom/Toxicity Management
Care at the End of Life

(Download this document to see the full list of certification metrics: http://qopi.asco.org/Documents/QOPICertificationMeasuresasof3.2012_000.pdf)

American Society for Radiation Oncology (ASTRO)

http://www.astro.org

Mission statement: Dedicated to improving patient care through education, clinical practice, advancement of science, and advocacy.

Memberships: Active members must be physicians certified in radiation oncology or therapeutic radiology, or a radiation physicist certified in radiological physics or therapeutic radiological physics, or a radiation or cancer biologist with a PhD who dedicates significant time to radiation oncology or sciences. Other types of membership include affiliate, international, corporate, etc. Number of members: More than 10,000.

Certifications offered: Accreditation offered jointly with American College of Radiologists (ACR)

Key Partnerships:

AMA
ASCO
Physician Consortium for Performance Improvement (PCPI)
American Association of Physicists in Medicine (AAPM)
Affiliates: Association of Residents in Radiation Oncology (ARRO), Society of Chairmen of Academic Radiation Oncology Programs (SCAROP), ASTRO Radiation Oncology Nurses (ARON), and Association for Directors of Radiation Oncology Programs (ADROP).

Journals and Newsletters:

Red Journal: Published online 15 times per year; Monthly unique visitors: 15,681; Email distribution: 10,823

Practical Radiation Oncology (PRO): Published quarterly; Circulation: 6,705

ASTROgram: weekly e-mail to members

ASTROnews: quarterly emagazine

Stance on Patient Education and Involvement: No formal statement; however the ARON affiliate section of the web site has patient education resources, and they maintain a separate patient website, www.RTAnswers.org, “…a resource for patients and caregivers to find detailed information about radiation therapy; what to expect before, during and after treatment; questions for patients to ask about radiation safety and a dictionary to help patients with terms they will hear.”

Stance on Palliative care: No stated policy, but two of their five guidelines are related to palliative treatment.

Stance on Multimodal Care: Participates in two multidisciplinary symposiums

Pathways: Their website has separate sections on Guidelines and Best Practices; both appear to be in their infancy. The guidelines section currently has 5 guidelines (Breast Cancer, Palliation (2), Thoracic Malignancies, and Brain Tumor). The best practices page has a stated purpose but no content. (Development is scheduled to start some time in 2012.)

https://www.astro.org/Clinical-Practice/Guidelines/Index.aspx
https://www.astro.org/Clinical-Practice/Best-Practices/Index.aspx

Metrics: Actively promotes use of CMS’ PQRS measures. In addition, ASTRO partnered with the AMA, ASCO, and PCPI on 10 quality measures that are included in the AHRQ’s National Quality Metrics Clearinghouse.

American College of Surgeons, Commission on Cancer (ACS CoC)

www.facs.org
http://www.facs.org/cancer/

Mission statement: “The American College of Surgeons is dedicated to improving the care of the surgical patient and to safeguarding standards of care in an optimal and ethical practice environment.”

“The Commission on Cancer (CoC) is a consortium of professional organizations dedicated to improving survival and quality of life for cancer patients through standard-setting, prevention, research, education, and the monitoring of comprehensive quality care.”

Memberships: CoC membership is composed of 100 individuals who are either surgeons representing the American College of Surgeons or representatives from the 49 national, professional organizations or member organizations affiliated with the CoC. Applicants must demonstrate involvement in one or more of the following areas within the field of oncology: Cancer registration and/or surveillance, Cancer patient care services, Patient advocacy (oncology-focused across all cancers), Cancer control & prevention efforts, Professional education in oncology, and Oncology research. In addition, the CoC’s Cancer Liaison Program is a network of 1,500 Cancer Liaison Physicians serving CoC-accredited cancer programs.

Certifications offered: Yes. “The CoC Accreditation Program encourages hospitals, treatment centers, and other facilities to improve their quality of patient care through various cancer-related programs. These programs focus on prevention, early diagnosis, pretreatment evaluation, staging, optimal treatment, rehabilitation, surveillance for recurrent disease, support services, and end-of-life care.”

Key Partnerships:

Alliance for Clinical Trials in Oncology (ACTO)
ASCO
NCCN
NQF

Journals and Newsletters:

CoC Flash: Published monthly online and via email (by free subscription)

Stance on Patient Education/Involvement: No stated position; however, they provide some informational resources for patients.

Stance on Palliative care: Standards in their accreditation program focus on palliative and end-of-life care.

Stance on Multimodal Care: Standards in their accreditation program focus on encouraging multimodal care. In their own words, “Recognizing that cancer is a complex group of diseases, the CoC Cancer Program Standards promote consultation among surgeons, medical and radiation oncologists, diagnostic radiologists, pathologists, and other cancer specialists. This multidisciplinary cooperation results in improved patient care.”

Pathways: “The Commission on Cancer does not endorse any specific guideline, but has elected to make guidelines from various national organizations available through this Web site for informational purposes only. Inclusion on this Web site does not constitute a guarantee or endorsement of these guidelines by the Commission on Cancer or the American College of Surgeons.”

http://www.facs.org/cancer/coc/cocpracguide.html#

That said, the standards that the CoC sets for accreditation include both pathways and related metrics (see below). Finally, the CoC maintains a Best Practices Repository that contains “Tools and best practice resources designed to help cancer programs meet the CoC Cancer Program Standards” in order to become accredited or maintain accreditation.

http://www.facs.org/cancer/coc/bestpractices.html

Metrics: The primary set of metrics is part of the extensive requirements for accreditation (core metrics). They are described in detail on pages 63-92 in this document:

http://www.facs.org/cancer/coc/cocprogramstandards2012.pdf

The CoC developed a separate small set of metrics – the Quality of Care Measures – that focuses on breast and colorectal cancer. These standards parallel a set developed jointly by ASCO and NCCN. Facilitated by the NQF, the three organizations have agreed to synchronized their developed measures to ensure that a unified set are put forth to the public.

Association of Community Cancer Centers (ACCC)

www.accc-cancer.org

Mission statement: “The ACCC is a national multidisciplinary organization that promotes the entire continuum of quality cancer care for our patients and our communities.” Its core purpose is “to be the leading education and advocacy organization for the cancer team.”

Memberships: There is an application process, but the organization is open to almost anyone involved in the broad area of cancer research, diagnosis, treatment, care, administration, and support. There are 17,000 individual members, 28 chapters, and 700 cancer programs affiliated with the ACCC.

Certifications offered: No

Key Partnerships:

CoC
National Cancer Advisory Board (NCAB)

Journals and Newsletters:

Oncology Issues magazine: Published bimonthly by subscription; circulation: 16,881

ACCConnect: Bi-weekly newsletter distributed to members via email and available on the website.

Stance on Patient Education/Involvement: No stated policy. They have a publication called the “Patient Assistance Guide” that focuses on supplementary services and reimbursement resources.

Stance on Palliative care: Their cancer program guidelines discuss palliative care “…to assist patients in achieving maximum comfort and relief of suffering at the end of life.”

Stance on Multimodal Care: Their cancer program guidelines emphasize the “multidisciplinary Team.”

Pathways: None. The ACCC publishes a set of Cancer Program Guidelines that are structural rather than clinical: “The Association of Community Cancer Centers Cancer Program Guidelines have been established to assist cancer programs that want to develop and/or maintain a comprehensive interdisciplinary program that meets the needs of cancer patients and their families. These guidelines were developed to reflect the optimal components for a cancer program. The guidelines are not intended to act as an accrediting or credentialing mechanism and are not a list of standards, such as those published by the American College of Surgeons Commission on Cancer. The guidelines should not be a surrogate for independent medical judgment; they serve only as the term implies: as guidelines to help programs meet the optimal attributes.”

Metrics: None. The final section of their cancer program guidelines names Quality Improvement as a requirement for a successful program and describes what a QI system should look like in the broadest terms. No actual metrics are included.

National Comprehensive Cancer Network (NCCN)

www.nccn.org

Mission Statement: “Dedicated to improving the quality and effectiveness of care provided to patients with cancer.” Develops resources to present information to those who deliver health care. They help promote continuous quality improvement through the creation of clinical practice guidelines. NCCN’s primary goal is to “…improve the quality, effectiveness, and efficiency of oncology practices so patients can live better lives.”

Memberships: All member institutions are major cancer centers; there are currently 21 members. Member institutions pay dues that support the development of their guidelines, which are available to the public for free.

Certifications offered: No

Key Partnerships:

ASCO
NQF
ACS CoC
ASTRO
NCCN Health IT Licensees: 13
NCCN website supporters: 5

Journals and Newsletters:

NCCN Flash Updates™ – a timely notification of changes and updates to the NCCN guidelines
eBulletin newsletter: Every other Monday; Circulation 75,000-plus, including 26,000-plus physicians (for all registered U.S. users on nccn.org)
Journal of the National Comprehensive Cancer Network (JNCCN): Monthly, by subscription; Circulation 23,143 (21,00-plus physicians, physician assistants, and nurse practitioners)

Stance on Patient Education/Involvement: Has guidelines created specifically for patients, with a separate web site aimed specifically at patients, families, and caregivers. (www.nccn.com)

Stance on Palliative care: Has guidelines specific to palliative care.

Stance on Multimodal Care: According to the website, NCCN member institutions pioneered the multidisciplinary teams approach.

Pathways: Purpose: To show consensus from leading cancer treatment institutions on how to treat specific kinds of cancer. Metrics and pathways are categorized based on level of evidence and degree of consensus. The guidelines are free, but visitors to the website must register in order to view or download them. The guidelines are sorted into these categories:

Treatment of cancer by site (48 diagnostic areas in 6 procedural areas)
Detection, prevention, and risk reduction
Supportive care (includes palliative care)
Age-related recommendations (adolescent/young adult and senior)
Guidelines for patients

Metrics: Purpose: The same as for Pathways. NCCN partnered with ASCO to develop quality metrics for breast and colorectal cancer, and the two are now working with the ACS CoC and NQF to bring their separate guidelines in these areas into sync. Details are given on this web page: http://www.nccn.org/about/news/newsinfo.asp?NewsID=79.

National Quality Forum (NQF)

www.qualityforum.org

Mission statement: “The National Quality Forum is a nonprofit organization that operates under a three-part mission to improve the quality of American healthcare:

Building consensus on national priorities and goals for performance improvement and working in partnership to achieve them

Endorsing national consensus standards for measuring and publicly reporting on performance

Promoting the attainment of national goals through education and outreach programs”

Memberships: Membership is open to healthcare organizations with an interest in quality improvement. Individuals in the field who are not currently employed by such an organization may apply as individuals. The membership includes consumer organizations, public and private purchasers, physicians, nurses, hospitals, accrediting and certifying bodies, supporting industries, and healthcare research and quality improvement organizations. Current number of member organizations is 370.

Certifications offered: None

Key Partnerships:

The National Priorities Partnership (NPP) – “…offers consultative support to the Department of Health and Human Services on setting national priorities and goals for the HHS National Quality Strategy.” (Currently 51 members)
The Measure Applications Partnership (MAP) – “…provides multi-stakeholder input to HHS on the selection of performance measures for public reporting and payment reform programs.” (Approx. 110 members)
Dept. of Health and Human Services (HHS)
AHRQ
ACS CoC
ASCO
NCCN

Journals and Newsletters: None

Stance on Patient Education/Involvement: The website has topic section focusing on Patient and Family Engagement, and they have announced the recent endorsement of 45 practices to guide healthcare systems in providing culturally competent care; however, there are no clearly identifiable standards related to patient education.

Stance on Palliative care: Endorses measures that deal with palliative care. Members have access to a “National Framework and Preferred Practices for Palliative and Hospice Care Quality.”

Stance on Multimodal Care: Have standards regarding different types of treatment, including surgery, chemotherapy, and hormonal therapy.

Pathways: Currently none, although the introduction to their performance standards includes this statement: “NQF also endorses other types of consensus standards, including preferred practices and measurement frameworks. Information about these other types of standards will be added in the coming months.”

Metrics: NQF endorses quality measures submitted by other organizations, which it makes publicly available in an online database called the National Voluntary Consensus Standards for Quality of Cancer Care. Stated purpose: “…to facilitate the comparison of cancer care providers for the purpose of accountability, quality improvement and surveillance and can be used by consumers, providers, federal and private purchasers and researchers.”

The NQF’s partnerships with HHS make it a key player in healthcare quality improvement. The National Quality Measures Clearinghouse maintained by AHRQ has a navigation link specifically for NQF endorsed measures. (Currently, AHRQ shows 444 NQF endorsed measures, while a search on the NQF site shows 734.)

Comparative Tables

These three tables provide a quick comparison among the members of our taxonomy. The data points are all taken from the preceding descriptions of the organizations.

Conclusion

The eight chosen organizations that meet the requirements of our taxonomy show an encouraging similarity of purpose: All of them agree that the use of evidence- or consensus-based pathways and metrics will lead to better patient care and outcomes. It is also encouraging that, with two organizations focused on medical oncology, one on surgical oncology, and one on radiation oncology, all of them endorse the concept of multimodal treatment plans. Most of them also make a clear statement in support of patient education and involvement, and some provide extensive patient resources. This is strong evidence for positive trends toward quality improvement in treatment and also toward more patient-centric care.

Our taxonomy also reveals a pyramidal hierarchy in the development and endorsement of pathway and metrics that puts the largest payer for healthcare in the world – CMS – in a key role in selecting pathways and metrics that correspond to payment:

As the regulating body, CMS specifies that treatment must meet certain standards, to ensure meeting payment requirements. CMS chooses which quality measurement tools will be used to demonstrate that the standards are being met, drawing from the endorsed catalogs maintained by AHRQ and NQF. These two clearinghouses, in turn, choose the best practices submitted by the research centers and clinics that make up the broad base of the pyramid.

The organizations at the base are labeled “stewards” of the pathways and metrics that they develop; by implication, they will watch over their products and update or retire them as new evidence comes to light. The remaining five organizations in our taxonomy – ASCO, ACCC, ACS CoC, ASTRO, and NCCN – form an upper tier among the stewards for oncology pathways and metrics. They endorse metrics submitted by their members and by affiliated organizations of smaller reach and output.

As a final note, it is striking that, of the thousands of pathways, metrics, and patient educational materials developed at the level of the steward organizations, CMS has reduced the number actually utilized to determine and/or influence payment to a few dozen. For metrics and pathways to have a broad-based impact, this number will have to increase dramatically, and pathways will have to become much more broadly utilized to influence payment.

Much has been made of patient reported outcomes (PROs), but there has been very little systematic analysis of who promulgates PROs, what they are used for, and how they might be organized into a rational taxonomy. Stay tuned for the next paper, which will look at these issues.

We would like to acknowledge the help in research and editing from Dean Whitlock, writer, author, and auctioneer (deanwhitlock.com).

Healthcare Organization and Program Acronyms

Bloomberg Highlights Vermont Cancer Pilot; PCD Partners Plays Key HIT Role

PCD Systems — Fri, 24 Aug 2012 18:04:26 +0000

BloombergBusinessweek recently published a story about the Vermont Green Mountain Care Board’s new oncology pilot project, an initiative that aims to provide better communication and coordination of care among cancer care providers.

PCD Partners has been retained to support this project with both healthcare IT consulting and implementation of its proprietary cloud-based ISO-style Quality Management System (QMS). The QMS will give all program participants a transparent view into process and outcomes data, helping to ensure care coordination and adherence to best practices.

PCD is pleased to be playing a key role in the early phase of development of such critical healthcare business solutions. Because of its scalable design, the Vermont initiative could also become a model for further state and federal oncology programs, and ultimately make an impact on the quality and cost of national healthcare.

Read the full story: http://www.businessweek.com/ap/2012-06-26/vt-dot-health-care-changes-arrive-in-st-dot-johnsbury

PCD Partners to provide healthcare IT support for cancer care pilot project

Wes Chapman — Thu, 05 Jul 2012 19:57:06 +0000

The Green Mountain Care Board recently approved a cancer care pilot project in the St. Johnsbury area designed to improve quality, enhance patient satisfaction, and reduce costs. PCD Partners has been retained to provide consulting and to deploy a cloud-based, proprietary ISO-style Quality Management System to support this important initiative. PCD’s process and outcomes data will demonstrate best practice adherence among the participating healthcare providers, and aid the players in designing optimal payment reform that aligns incentives between patients, providers, and payors.

Wes Chapman, President and CEO of PCD Partners, said, “PCD is pleased to be part of this oncology based reform initiative that will rationalize healthcare operations and improve quality of care for Vermont cancer patients,” adding, “Since the program is designed to be scalable to other state and federal initiatives, the project is also capable of significant impact on the quality and cost of healthcare nationally.”

Read the full press release below.

St. Johnsbury cancer care program approved as first Green Mountain Care Board payment and delivery system pilot

June 25, 2012 – Montpelier, VT –The Green Mountain Care Board (GMCB) last week approved a health care delivery system and payment reform pilot for cancer care in the St. Johnsbury area. The goals of this three-year pilot are to improve the quality of care for cancer patients residing in the St. Johnsbury area, improve patient experience and satisfaction, reduce avoidable use of services, and reduce growth in overall expenditures related to this care.

The pilot has received funding from Blue Cross and Blue Shield of Vermont, the Division of Vermont Health Access (which oversees Vermont’s Medicaid, Vermont Health Access Plan, and Catamount Health programs), the GMCB, and Northeastern Vermont Regional Hospital (NVRH). The GMCB will seek participation from the federal government through the Medicare program after the pilot is fully developed.

The pilot is a collaboration among the three organizations that treat most of the cancer patients in the St. Johnsbury area: Northern Counties Health Care, Northeastern Vermont Regional Hospital, and Dartmouth-Hitchcock Medical Center’s Norris Cotton Cancer Center, which has a cancer center in St. Johnsbury. The organizations aim to improve the quality of cancer care for an estimated 270 patients during the trial period. Patient participation in the pilot project will be entirely voluntary.

The pilot builds on the framework established by Vermont’s Blueprint for Health, which seeks to create a “medical home” for each Vermonter in his or her primary care physician’s office. Through their involvement in the Blueprint for Health, the primary care practices participating in the pilot have created “Community Health Teams” of health professionals who will coordinate and monitor the care of patients in the pilot. This pilot will test the hypothesis that the quality of care for patients with cancer can be improved through the integration of primary care, cancer care, and palliative care, and that the cost of care can be moderated at the same time.

“This is a perfect example of how we can improve patient experience—reducing the number of trips they make to the doctor, improving communication between their doctors and, most importantly, improving communication with patients about what they want and need,” said Allan Ramsay, M.D., a member of the GMCB who has been involved in the development of the pilot project. “This kind of quality improvement inevitably reduces waste and results in better service for the patient.”

“Doctors want to provide the best care for their patients,” said Anya Rader Wallack, Chair of the GMCB. “But too often we don’t pay them for critical services like care management.”

The pilot anticipates that commercial payers and Medicaid will pay providers an additional monthly fee for collaborating to create and monitor “care plans” for each patient. This close communication between providers involved in the care of these patients is intended to reduce avoidable office visits, tests and procedures and increase adherence to clinical standards and protocols of care. There will also be closer monitoring of prescriptions and other treatments to assure high quality care.

“We appreciate that the health care community in St. Johnsbury is stepping forward to test a truly collaborative system designed to wrap around each individual patient in the way we expect care to work in small Vermont communities,“ said Wallack.

“We believe that we can provide our community better cancer care and reduce costs if we find ways to work more closely together,” said Paul Bengtson, CEO of Northeastern Vermont Regional Hospital. “This makes sense for our patients.”

About the Green Mountain Care Board (GMBC): Vermont’s Health Reform law, Act 48, charges the GMCB with controlling the rate of growth in health care costs and improving the health of Vermonters. The GMCB approves hospital budgets, major health care capital investments, health insurer rates increases, all-payer rates for all providers, and minimum health benefit requirements.

For more information, contact Anya Rader Wallack at (802) 828-2160.

Decreasing Complexity, Improving Care Quality, and Reducing Cost in Oncology

Wes Chapman — Thu, 05 Jul 2012 14:39:29 +0000

Introduction

The U.S. healthcare system is the most expensive in the world, yet comparisons with other industrialized countries show that it does not produce the best outcomes, either in patient expectations or in life expectancy. While the high costs do reflect the frequent use of advanced medical technologies, they also indicate the presence of waste, inefficiency, duplication, and unnecessary services. This is even more the case in the Medicare/ Medicaid system, which is plagued by a high incidence of fraud. Three underlying problems contribute to this situation:

The Fee-For-Service payment system (FFS), which has resulted in healthcare billing procedures that account for as much as 15% of total healthcare system costs.
The division of healthcare into primary care and specialty care, which has led to the creation of treatment and billing silos. This division negatively impacts the patient experience as well as the quality and cost of care.
Medical treatment and medical fees that are not tied to outcomes – that is, the quality of treatment as experienced by the patient has little bearing on the bill – which provides no incentive for improvement.

Recently, the Centers for Medicare & Medicaid Services (CMS) have instituted a Bundled Payment initiative (BPI) that offers a direct opportunity to address these problems. As proposed, however, the BPI is flawed as a tool for oncology applications, primarily due to its focus on the Diagnosis-Related Groups (the DRGs) as a basis for specifying incidents of care, and therefore costs. With several adjustments, however, bundled payments, coupled with new patient centric care plans can provide an effective solution that will reduce complexity, waste, inefficiency, and costs, while at the same time improving objective care delivery, clinical outcomes, and the oncology patient experience.

The Core Problem Areas

Fee for Service

The Fee-For-Service payment model that currently predominates in health care has led to a treatment-centric practice rather than a patient-centric practice. As long as they can document that a given service was performed, hospitals and physicians get paid. The results of the service are not part of the calculation. This encourages physicians to prescribe more procedures, including many that are unnecessary or of limited value to either doctor or patient. The result is an increase in waste and expense, with no increase in benefit to the patient.

Fee-for-Service has also led to the development of extremely complex billing and bill-tracking systems that are expensive to operate and are open to both error and fraud. At the core for oncology, the fundamental problem is that oncology is a complex disease, requiring the effective interaction of numerous specialists who operate in a system that normally does not provide any method for integrated care planning and/or delivery. The result in most cases is uncoordinated and unplanned care. Worse still, there is virtually no method to integrate either patient preferences or documented evidence-based best practices into the system. The result: high costs, poor outcomes, disenfranchised patients, and operational chaos.

Treatment and Billing Silos

The division of healthcare into primary care and specialty care has led to the creation of treatment and billing silos. This has serious impacts on the patient experience, the quality of care, and the cost of care. Consider the case of patient Jill, who is diagnosed with metastatic colon cancer. Jill will need care from a large group of specialists – including medical oncology, radiation oncology and surgical oncology – in addition to a huge variety of diagnostic labs and diagnostic imaging. In most cases, these specialists operate on a referral basis, with limited information exchange and no planning. There is absolutely no way to ensure that Jill’s desires for quality of life are respected across all of the provider groups.

The Patient Experience

Patients with acute medical needs, like Jill, become physically and professionally separated from their primary care physician (PCP) and the local clinic or hospital that serves as their “medical home.” They’re forced to travel varying distances and deal with serious medical conditions without the personal connection and advice that would help them make the most informed and appropriate treatment decisions. While the specialist may have a highly experienced team, they won’t know Jill’s medical background or her level of knowledge and comfort. Jill probably won’t know what questions to ask nor understand who or when to ask. She won’t know when things are going right or wrong. The reverse occurs when Jill returns to her medical home for post-treatment care. The personnel there won’t know exactly how she was treated or the best way to deal with the specific complications or comorbidities that could arise from her treatment.

In the case of oncology, patients are often faced with very difficult choices and very poor prognoses from the initial diagnosis. Ensuring that patients understand the reality that they face and the actual choices available to them is currently impossible in most clinical care settings. Assuming that the patient chooses extensive treatment, there is typically nobody in the system actually responsible for that patient’s overall care and comfort.

Quality of Care

The value of specialization is usually an increase in quality of outcomes, because specialists get lots of practice. The literature is very clear that, more than any other single factor, experience – of both the provider and the medical center – determines the success or failure of a medical procedure. Birkmeyer et al. concluded, in a 2003 paper in the New England Journal of Medicine, “For many procedures, the observed associations between hospital volume and operative mortality are largely mediated by surgeon volume. Patients can often improve their chances of survival substantially, even at high-volume hospitals, by selecting surgeons who perform the operations frequently.” (N Engl J Med 2003;349:2117-27) These findings have been replicated many times.

In the case of people like Jill, however, the requirements for multi-specialty care swamp the patient’s ability to understand care interactions and effectively self-direct care. The result puts the patient in the center of potentially conflicting specialists, with no information or support, in a period when they are physically weakened and emotionally highly stressed. It hardly seems fair – and it is a recipe for chaos and wild cost overruns.

Cost of Care

Specialists, having no working relationship with the PCP or the medical home, often duplicate many of the diagnostic tests, which wastes time and increases costs. The reverse occurs when Jill returns home for post-procedural care. Her PCP may well ask for tests that have already been done or that are not needed. Meanwhile, both the medical home and the specialty acute care hospital deal with fees and billing in isolation, following the wasteful FFS model.

Treatment and Fees Disconnected from Outcomes

The quality of treatment as experienced by the patient has little bearing on the bill. In fact, the quality of the medical outcome is seldom related to the bill. Barring a malpractice suit, there are no warranties on healthcare. Key to this is the fact that there is no clear definition of quality that satisfies all the affected parties. Patients have no idea what the rational expectations for service outcomes are. Nobody wants to get sick, old, or die, and we have developed the ethos that modern healthcare can fix all of that. It cannot – not at any price.

CMS has dodged the question of defining quality of outcome, relying instead on “process metrics” as a surrogate for real specifications. There is some sense to this, for it relies on a definition of quality that integrates the system producing a product or service with its value to the customer: Quality is the ability to deliver, through a consistent and efficient system, a product or service that meets or exceeds a customer’s rational value expectations. This captures both the necessity of price considerations and the operational characteristics of the system involved, tying both to the customer’s (i.e., patient’s) expectations.

Now add to this the fact that the current billing and payment systems merely seek proof that a particular service was performed, not that it was needed or was performed well, and you can see that there is an institutionalized financial disincentive to clearly define quality. The result has been to institutionalize waste, inefficiency, and the increased costs that result.

Movement Toward a Solution

Best Practices and Process Metrics

Over the past two decades, medical specialty organizations have developed catalogs of evidence-based best practices, clearly defining the appropriate procedures required to deliver each. The best practices are linked to specific medical conditions through the standard diagnostic codes (ICD 9/10). At the same time, the Agency for Healthcare Research & Quality (AHRQ) has developed an extensive list of process metrics for healthcare, inspiring many medical specialty organizations to do the same.

This combination of best practices related to clearly defined diagnostic codes and to process metrics provides a way to move from Fee-For-Service to a pricing model that fits the disease. Instead of a grab-bag of procedures, the physician and patient can choose from several appropriate treatment plans that are clearly defined best practices. The process metrics provide clear documentation that the chosen treatment plan was followed and therefore payment is due. We move from profit-centric to patient-centric treatment, while still providing appropriate payment levels.

The Oncology Specific Bundled Payment

The BPI, launched by the CMS in August of 2011, provides a second component necessary to move away from the FFS model. Though it is flawed, it points the way. Under the BPI, the medical silos are broken open. Treatment plans can span a complete episode of treatment, from diagnosis through specialty treatment to rehabilitation and, if necessary, palliative care. With adjustments to the BPI, the patient’s PCP and medical home can become a part of the treatment plan, through co-management agreements with the ACH that provides the specialty care. Note that the patient, supported by the PCP, becomes an active, informed participant in the treatment decision-making process.

As we described above, every stage of the treatment plan can now be based on clearly defined best practices. A refined payment bundle aligns with both the best practice treatment plan and the co-management agreement, spanning locations as well as medical specialties and procedures. The payment bundle specifies the total to be paid for the entire treatment plan, and the various participants each receive their appropriate portions as specified in their co-management agreement. The payor processes one item, the bundle; the payee deals with sharing it out.

The Combined Effect

Process metrics, which can now be applied to every part of the treatment plan, indicate that it was not only completed, but was completed properly, which will be a key requirement for payment. In addition, the process metrics also allow for continuous quality improvement.

While still complex, the medical treatment process for each episode is now more defined and therefore more easily measured. Continual measurement paired with regular re-evaluation allows patient and provider to decide if the expected outcomes are being achieved. If not, the treatment plan can be adjusted to achieve the most appropriate outcomes, again using best practices, and adjusting the payment bundle to reflect the change in treatment. In this way, the best practices can also be adjusted and improved.

Process metrics and continual quality improvement have the combined effect of improving efficiency, reducing errors, and reducing waste – all of which will reduce costs – while also improving medical outcomes and patient satisfaction. The simplified billing and payment systems associated with defined best-practice treatment plans and bundled payments should also reduce error and inefficiency, which will not only reduce costs but also greatly reduce the opportunities for fraud.

Require: A Patient-centric Care Plan with Timely Information and Process Control to Improve Care Quality

Central to success in this problem are: 1) the ability of different care providers to form a defined team to design and implement a patient-oriented care plan, based in documented best practices, with documented patient involvement and education; 2) the ability to share information regarding the patient and the execution of the plan across diverse EMR’s and related systems in different venues; 3) the ability to track the execution of the care plan by all participants – including the patient – and provide documented adherence or rationale for variance from the plan; 4) the ability to update and adjust the care plan based on outcomes – i.e., the ability to reset as needed; and 5) the requirement that all providers respect the life choices and treatment requirements of the patient.

This is hard, but it can be done, and no realistic bundle in oncology can be put in place until it is.

Charting the Waters – Oncology Bundled Payments

PCD Partners is currently managing a pilot project designed to test the solutions outlined in this white paper. The Care Enhancement Pilot Project (CEPP) is focused on a patient population of geographically isolated adults and seniors with cancer in Vermont and New Hampshire. This is an underserved rural population whose medical homes are small critical access hospitals (CAHs), federally qualified health centers (FQHCs), and similar clinics, but who need oncology care from a specialty center that is not local.

This population was chosen not only for its level of need, but also because their diagnoses allow us to define oncological treatment plans that span the total episode of care, cross venue and cross specialty, with corresponding payment bundles accepted by the state agencies involved in distributing payments. These plans can involve a mix of diagnosis and screening, chemotherapy, radiation therapy, surgery, post-operative care, inpatient, and outpatient care, rehabilitation, palliative care, and hospice care. In each case, the PCP at the medical home is able to oversee the entire episode of care, simplifying the process and creating continuity, which will lead to improved patient convenience and satisfaction.

The model utilized by the CEPP is expected to: 1) improve patient education and experience, 2) improve clinical outcomes through the use of and adherence to clinical practice guidelines, 3) improve objective care delivery through utilization of process metrics, and 4) reduce costs. This will be achieved through the following program goals:

1) The implementation of clinical pathways and protocols that extend across multiple venues. Treatment is provided between Northeastern Vermont Regional Hospital (NVRH) in St. Johnsbury, Vermont and affiliated FQHCs from Northern Counties Health Care, the Norris Cotton Cancer Center (NCCC) at the Dartmouth-Hitchcock Medical Center (DHMC) in Lebanon, New Hampshire, and the NCCC facility in St. Johnsbury, VT. The CEPP builds upon an existing program – the Vermont Payment Reform Oncology Pilot Project – which is jointly sponsored and funded by the State of Vermont, VT BC/BS, DHMC, and NVRH.

2) Control and improve care delivery through integrated adherence to patient-oriented protocols. All care will be delivered according to approved clinical pathways vetted and approved by the patient, the primary care physician, the palliative care team, and the key oncologist participants. The implementation of data collection and an ISO-style quality management system provide a mechanism for continuous improvement.

3) The implementation of novel cost bundles to reduce overall cost of care. In this pilot program, the focus on cross-venue payment bundles that encompass an entire episode of care, from diagnosis through rehabilitation/palliative care; the use of ICD 9/10 based coding for bundle determination; and protocol-based care and shared decision making among PCPs, oncologists, and palliative care teams establishes a unique and innovative alternative to FFS billing used in the past.

Conclusion

Already, the Care Enhancement Pilot Program indicates that the model described here can work. Adjustments can be made to the BPI, all stakeholders can be educated and involved, and care can be taken to implement an appropriate, functional quality improvement system. These changes can be extended throughout the U.S., in all healthcare organizations, for all patients and services, including Medicare/Medicaid cases, as long as the following required components of the model are implemented:

1) Implementation of clinical pathways and protocols that extend across multiple venues and specialties.

2) Integrated adherence to patient-oriented protocols, with the patient fully informed and included in all treatment decisions.

3) Implementation of clearly defined cost bundles based on best practices and ICD 9 codes and spanning an entire episode of care, across venues and specialties.

4) Inclusion of all stakeholders (including payers) in defining the bundles.

5) Implementation of an ISO-style QMS, using process metrics and patient feedback to document proper adherence to the treatment plan, which will trigger payment and allow continuous improvement.

6) Education of healthcare providers so they clearly understand the goals of the bundled care initiative and the connections between the process data they are collecting and the resulting improvements in quality and patient satisfaction.

When these requirements are met, we can expect to achieve our goals to:

improve patient education and experience
improve clinical outcomes
improve objective care delivery
reduce complexity, waste, inefficiency, and the opportunity for fraud
significantly reduce costs

What can this mean in dollar terms? On a national scale, we estimate that there are savings of 10% of total system costs just related to billing. While this may differ from place-to-place, the noted investment bank, Cain Brothers, estimates that 15% of total medical costs related to the simple act of billing and collection. The movement to bundles dramatically simplifies this problem, and should easily reduce costs by 10%.

Secondly, we estimate that reduction of unnecessary testing and repeated services due to the complex referral patterns in oncology can reduce total costs by 5-10%. Finally, the movement to protocol based drug regimens and related clinical pathways has been shown to reduce costs by up to 15% in drug cost alone. In total, this amounts to 35% of total costs, or over $35 Billion dollars annually nationwide. This figure does not consider the additional savings that may be forthcoming from patient preference for palliative/supportive care, instead of the more difficult and painful alternatives.

Chapman to Address Performance Metrics in Oncology at the 2012 Cancer Business Summit

Mario Martinez — Tue, 22 May 2012 21:28:45 +0000

Lebanon, NH – M. Weston Chapman, president and CEO of PCD Partners, Inc., will join the faculty of the 2012 Cancer Business Summit on October 11–12, 2012, in Fort Worth, Texas.

Chapman will serve on the panel titled “Performance Metrics in Oncology” at 10:30 a.m. on Friday, October 12, sharing insights about the crucial need for proper metrics to ensure continuous monitoring and improvement of cancer care. Joining Chapman on the panel will be Deborah Hood, VP of the National Oncology Service Line at Catholic Health Initiatives, and Bruce Pyenson, FSA, MAAA, principal and consulting actuary at healthcare consulting firm Milliman.

PCD Partners, Inc., is playing a key role in improving performance metrics and care delivery in oncology. Its team of quality experts, using an ISO-certified quality management system, enables oncology stakeholders to monitor and evaluate care delivery, ensuring transparency, data integrity, regulatory compliance, and continuous improvement. By tailoring information solutions to the complex needs of healthcare and health management organizations, PCD enables them to reduce costs, improve quality, and enhance patient satisfaction.

Learn more about PCD Partners, Inc., and read about PCD’s selected clients and projects.

Contact: moc.srentrapdcpnull@ofni or 603-727-7300.

Chaos Theory in Financial Markets: Chaos, the Perfect Storm, and the Sub-Prime Fiasco

Wes Chapman — Tue, 17 Apr 2012 12:11:13 +0000

Capitalism at a Cross Roads

Considerations of Persistent Disequilibria and Positive Feedback: Finding the Butterfly

PREFACE

The twin marvels of truly awful weather and systemic market meltdowns have a lot in common. First they feed on persistent disequilibria in their respective systems – weather systems feed on temperature and pressure differentials which can only be resolved through long time frames for adjustment or short term violence – storms. Similarly, economic and financial disequilibrium tend to be founded on regulatory or information impediments, leading to persistent positive feedback loops – first running markets up, and then, inevitably, leading to collapse.

Awful weather – a self-feeding phenomena

Really chaotic behavior in weather systems and financial markets requires that several positive feedback phenomena – think low interest rates, rising housing prices, systematic mispricing of securities, failed regulation, and systemic level fraud – are required to produce a real financial apocalypse. What makes the process interesting is that these factors may exist in the system functioning perfectly for decades, and only when combined a special brew a la the Three Witches of Macbeth do we get the resultant fiasco.

There has been a steady stream of metaphorical comparisons of Sebastian Junger’s book, The Perfect Storm, with the Great Recession in general, and the meltdown in sub-prime mortgages in particular. It is worth taking a look at what actually made the Perfect Storm unique, and what comparisons are meaningful to the sub-prime meltdown vis-à-vis complexity theory.

If they merge – you get the perfect storm

The Great Recession is a rolling disaster that the world economy seemingly stumbled into in the spring of 2008 led by a housing collapse which began in the sub-prime mortgage market. This rolling economic Verdun was born many years before in a series of ill-conceived and poorly understood policy initiatives championed by consumer advocates and industry groups alike. These reforms – generally characterized as deregulation – were targeted at the seemingly laudable targets of risk mitigation and fairness, and categorically achieved just the opposite. In this paper I take a look at the human faces behind the fiasco, it takes clever and dedicated people to create a mess this big.

A result of negative feedback

Each of these examples is a terrific case study of chaos theory at work. In chaos theory, a small action/change in a complex/dynamic system can have enormously disproportionate impact in the future. The classic example is posited by Lorenzo in his 1972 paper, Predictability: Does the Flap of a Butterfly’s Wings in Brazil set off a Tornado in Texas? What is most important to remember here is that chaos theory is very sensitive to initial conditions, and unpredictable beyond very short periods of time. For those making economic policy this requires a constant vigilance for the undesirable unintended consequences of policy changes – clearly the butterfly did not intend the tornado.

It is to the quest of finding Lorenzo’s butterfly that I dedicate this series of articles.

PCD Systems

CMS and ISO 9001: The Impulse Toward Quality in Healthcare

Preface

Background

The Deeming Authorities

Accreditation Organizations with CMS Deeming Authority

Accreditor

Scope of Authority

# of accredited customers (CoPs)

ISO connection

Introducing ISO and ISO 9001

What is ISO 9001?

Palliative Medicine and Patient Involvement: The Heart of Patient-Centric Care

By Wes Chapman, Mike Choukas, Charles Hutchinson PhD, and Steve Maker

Preface

Background

A Brief History of Palliative Care

Shared Decision-Making: Tarred by the Same Brush

Extending Our Definitions

The Parallel Palliative Treatment Path

Moving Choice from Patriarch to Patient

What Has Taken Us So Long?

Conclusion: Signs of Realistic Hope

Cancer Business Summit: White Papers and Presentation

Patient-Reported Outcomes: Choosing Appropriate Metrics From a Still-Evolving Toolset

By Wes Chapman, Mike Choukas, Charles Hutchinson PhD, Steve Maker, and Mario Martinez

Purpose

Background

Still in Their Adolescence

Barriers to Endorsement

Most PROs Were Not Designed for Clinical Care

Most PROs Are Not Disease Specific

Many PROs Conflate Process with Outcome

PROs Imply Criticism of Doctors and Clinics

Criteria for Choosing the Right PROs

A Selection of PROs for Oncology ACOs

Conclusions

A Taxonomy of Leading Oncology Organizations

by Wes Chapman, Steve Maker, and Mario Martinez

Purpose

Background

Making the Cut: the Anna Karenina Principle

What You’ll Find There

What You’ll Find Here

The Family of Organizations

Center for Medicare & Medicaid Services (CMS)

Agency for Healthcare Research and Quality (AHRQ)

American Society of Clinical Oncology (ASCO)

American Society for Radiation Oncology (ASTRO)

American College of Surgeons, Commission on Cancer (ACS CoC)

Association of Community Cancer Centers (ACCC)

National Comprehensive Cancer Network (NCCN)

National Quality Forum (NQF)

Comparative Tables

Conclusion

Next

Healthcare Organization and Program Acronyms

Bloomberg Highlights Vermont Cancer Pilot; PCD Partners Plays Key HIT Role

PCD Partners to provide healthcare IT support for cancer care pilot project

St. Johnsbury cancer care program approved as first Green Mountain Care Board payment and delivery system pilot

Decreasing Complexity, Improving Care Quality, and Reducing Cost in Oncology

Introduction

The Core Problem Areas

Fee for Service

Treatment and Billing Silos

The Patient Experience

Quality of Care

Cost of Care

Treatment and Fees Disconnected from Outcomes

Movement Toward a Solution

Best Practices and Process Metrics

The Oncology Specific Bundled Payment

The Combined Effect

Require: A Patient-centric Care Plan with Timely Information and Process Control to Improve Care Quality

Charting the Waters – Oncology Bundled Payments

Conclusion

Chapman to Address Performance Metrics in Oncology at the 2012 Cancer Business Summit

Chaos Theory in Financial Markets: Chaos, the Perfect Storm, and the Sub-Prime Fiasco

Capitalism at a Cross Roads

Considerations of Persistent Disequilibria and Positive Feedback: Finding the Butterfly