The Structure of Pulmonary Hypertension Health Care Delivery: Translating Ethical Considerations into Practice

Efficacy

Although there has been no formal examination of outcome in patients managed in different types of practice, several lines of evidence exist to suggest that optimal treatment approaches and outcomes may be more likely in highly experienced centers compared to less experienced practices, including those in which patients are managed as part of a mix of patients with general medical issues, or even in general pulmonary or cardiology practices. Occasionally, when patients are referred late in the course of disease, it is apparent, in retrospect, that earlier diagnostic accuracy or therapeutic choices may not have been ideal. Consultative phone calls from primary physicians to referral centers sometimes suggest that crucial procedures or decision making is occurring without important background information or technical knowledge. Pharmaceutical representatives sporadically report that they have seen debatable approaches undertaken in some of the practices they visit. While all of these “data-acquisition” methods are fraught with potential bias, the possibility is raised as to whether directing the patient to a referral center earlier may not have been beneficial.

Though most often the pattern is one of under-diagnosis and arguably under-aggressive treatment, the reverse scenario also occurs. Patients may be treated with expensive medications laden with potential adverse effects based on dubious or incomplete evidence that an appropriate indication for therapy exists.

In the absence of a specialized center, the ability to provide concentrated follow-up is certainly compromised. Follow-up to assess whether treatment targets have been achieved is increasingly recognized as a vital determinant of outcome, and therefore is central to the efficacy of any treatment plan. Follow-up entails not only appropriately timed office visits, but also interim contacts by telephone and rapid responsiveness to new or unexpected clinical developments. This type of follow-up, if undertaken with appropriate intensity, would generally lie outside the capacity of a busy practitioner dealing with a range of other patients and clinical situations. It would also be outside the scope of practice and expertise of allied health colleagues in a general practice.

A specialized center, on the other hand, would be expected to have expert physician and nursing resources with robust training and experience who practice in an intensively focused data-driven manner, and who are readily accessible to the patient, their primary caregivers, and to others (such as emergency room staff) who may become involved with the patient at any time. This type of ongoing assessment of a treated patient is vital for making adjustments in therapy on a continuing basis, if necessary, in order to best achieve treatment targets as early as possible.

Efficiency

Consistent levels of patient demand and development of a dedicated infrastructure at a busy referral center promote efficiencies of operation that would be difficult to replicate in a general medical, cardiology, or pulmonology practice. Practice algorithms, clearly delineated responsibilities of personnel, access to related areas of expertise, and procedural standards create an environment conducive to expedient evaluation and delivery of therapy. Although there may be variability between centers, a patient referred to the Pulmonary Hypertension Center at Mayo Clinic for suspected PH generally would have a complete noninvasive and invasive evaluation and prescription for therapy within 48 hours of presentation. This includes referral to relevant related areas of expertise (such as rheumatology, adult congenital heart disease specialists, interventional radiology, medical genetics, surgery, and transplant services if appropriate) and to specialized imaging areas (CT or MR scanning), as well as comprehensive physician- and nurse-administered education and support for the patients and their families. The center is staffed by both pulmonologists and cardiologists who see 25 patients per week. In addition, a pulmonology or cardiology fellow and/or medical resident is usually in attendance.

Efficiency is an important aspect for a specialized center referral practice since patients will often have traveled out of their locality in order to be seen.

Economy

Pulmonary hypertension is expensive. Medical therapies are among the most costly for any disease, even more so when considering expected duration of treatment. From a societal standpoint, it is incumbent on the practitioner to manage costs whenever and wherever possible. The ability of specialized centers to provide efficient workups and tailor therapy to the appropriate indications contributes to economical care. From an institutional perspective, efficient care (mainly in the outpatient environment) reduces costs and diminishes risks of complications that would incur further expense. For example, at our institution we routinely initiate intravenous prostacyclin analogues in the outpatient clinic since facilities and personnel have been developed to provide adequate oversight without the need for potentially costly inpatient stays.

Should Centers of Excellence be Credentialed?

The answer to this question (and the related one about whether individual physicians should be licensed as “PH specialists”) requires resolution between 2 opposing perspectives. On the one side is the opinion that high quality specialized centers have much to offer for optimal patient care (as discussed above) and that there should be some way to identify to both referring practitioners and patients those centers which might be expected to provide them with superior care. On the other side is the concern that any method of assessing programs will not perfectly capture all the parameters that define quality, such that some programs will be erroneously included, and (perhaps more unjustly) some would be wrongly excluded from being credentialed. Additional concern is that this would simply add further regulatory hurdles to a profession that already seems burdened by excessive red tape.

Both perspectives are supported by persuasive arguments. The opinion of this author is that although the criteria may be difficult to define, there exist in theory qualities that are characteristic of centers and individuals most likely to provide efficient, accurate, effective, and innovative progress-oriented care. Though easier said than done, the medical community would be providing a service to itself, and to patients, in describing and cataloging qualities by which institutions and practitioners could be compared. At this juncture of health-delivery evolution in the US, it seems likely that increasing emphasis will be placed on the value of care delivered as a means of determining reimbursement; thus, disciplines prepared to address this will be at an advantage. Whether the appellation of “excellence” or another form of identification is less important than the fact that some distinction is used to inform the public about the quality of PH management that is being reimbursed.

Who Should Establish Criteria and Do Credentialing?

While it may be possible to agree that there are hypothetical criteria that define excellence, or at least adequacy, it is more challenging to contemplate who might be in a position to establish these criteria and then adjudicate among centers and practitioners. It seems appropriate that relevant professional associations would take on this responsibility. In the field of PH, representation from the Pulmonary Hypertension Association, American Thoracic Society, American College of Chest Physicians, American College of Cardiology, and American Heart Association might provide broad input and credibility. Of course, individual participants may bring to this effort biases which could be perceived as promoting their own interests, but this could be ameliorated to some degree by selecting individuals with diverse perspectives as well as respected clinicians, scientists, and administrators who are knowledgeable but do not have direct self-interests within the field of PH. Though arduous, such a process should not be impossible; it has already been accomplished in other subspecialty disciplines. As a first step, the process by which other clinical fields (such as interventional cardiology or electrophysiology) have achieved meaningful accreditation standards should be examined in order to replicate the results. The difficulty of this task should not be an impenetrable barrier to proceeding with this initiative.

What Criteria Should be Utilized?

If, as suggested previously, a broad-based committee (board) were to be charged with developing a process for accreditation, it would be premature and presumptuous to suggest at this juncture what the criteria should be. Nevertheless, the discussion must start somewhere and it is not unreasonable to propose the dimensions that should be considered.

At an institutional level, reasonable parameters of quality should include volume of cases, staffing levels (physician and allied health), availability of related disciplines and clinical laboratories, quality control, research involvement, and outcomes. At an individual level, parameters might include personal case volume, medical and subspecialty board certification, continuing medical education, and formal knowledge assessment (eg, “board examinations”).

Specific criteria and thresholds of acceptability would be the responsibility of the board.