When Well-Meaning Health Policy Goes Awry

Maurie Markman, MD

Those responsible for developing and implementing governmental health policy have an extremely difficult job. Not only do they have to attempt to satisfy often highly unrealistic expectations of legislators for overall goals and timelines, but they also are frequently asked to accomplish a task with woefully inadequate funding. Political grandstanding, as recently witnessed with the substantial delay in the appointment of a first-class FDA leader, is becoming routine rather than the exception in what should be nonpartisan public policy designed to maximize a variety of health-related societal outcomes.

Unfortunately, even in the absence of such political and financial issues, the complexity of healthcare is so great that any objectively well-considered public policy initiative runs the risk of completely unpredicted and unintended consequences that may result in measurably negative results or outcomes.

Consider, for example, a recent report that documented a rather striking change in the prioritization status of patients evaluated in liver transplant centers before and following the decision by the federal government to mandate public reporting of outcomes as a requirement for participation (Conditions of Participation [COP]) in the Centers for Medicare and Medicaid Services (CMS) program.¹

Although the intent of the policy was both clear and surely appropriate, this report revealed that one result was that the sickest patients, including those who might experience the greatest benefit from a liver transplant, were less likely to be included in the prioritization pathway by many transplant centers. In fact, “delisting abruptly increased by 16% at the time of COP implementation,” researchers reported.¹

It is not difficult to understand that a reduction in the number of individuals with the greatest risk of death could make a center’s score appear better. And, although certainly not the intent of the regulatory policy, it appears that its implementation may have resulted in a concerning unintended consequence.

A second equally distressing relationship between a governmental policy and a serious unintended consequence apparently relates to the increasingly widely recognized national epidemic of narcotic abuse.² There has been an important governmental effort to publicly report patient-generated data related to their inpatient hospital experience that may have inadvertently worsened the nation’s opioid problem.³

Examples From Oncology Practice

One critical item in the publicly reported data is how well “pain” has been managed posthospital discharge. A potentially serious unintended consequence of such a strategy is that unnecessary short-term narcotic analgesia prescribed at discharge to improve patient-reported pain relief may have resulted in later opioid abuse or addiction.There are other examples of policies developed with excellent intentions that have had challenging consequences within the oncology sphere. As anyone who watches television knows, direct-to-consumer pharmaceutical marketing is not a new governmental policy but its prominence as a strategy to promote specific anticancer therapy appears to have grown substantially.⁴

Although strong arguments including fundamental constitutional claims can be advanced to support the argument that regulatory agency—approved antineoplastic drugs should be treated no differently from any other product as far as appropriate free-market advertising is concerned, the complexity of providing meaningful discussions of the limitations of efficacy and risks of serious toxicity in a 30- or 60-second verbal/visual media placement is far more than a little problematic.

And, add to this problem the fact that, with the current federal physician payment system (CMS’ relative value units) the time available for clinicians to fully discuss complex cancer care is very limited and inadequately reimbursed.⁵

Imagine for a moment a newly diagnosed or even relatively heavily pretreated patient with metastatic lung cancer and several routinely observed comorbidities such as cardiac dysfunction or diabetes inquiring about one of the new class of “wonder drugs” that “unleash an individual’s immune system to combat the cancer” that she/ he has just seen advertised on television. Does anyone really believe oncologists have sufficient time or are appropriately compensated to engage in an essential conversation with such patients and their families?

Another example of the impact of public policy in oncology is provided by a recent study detailing the objectivity of reports of dense breast tissue observed during mammographic imaging.⁶ Legislation currently exists in a number of states that specifically focuses on mammography reports and the requirement to note the presence of this radiographic finding. The apparent intent is for clinicians to subsequently discuss the potential need for additional screening procedures.

But just how objective is the current ability of radiologists to diagnose dense breast tissue so that an individual woman can be assured the stated presence or absence of this finding is accurate?

Based on this report, the answer is not encouraging. In an examination of more than 200,000 mammograms read by radiologists who had interpreted at least 500 screening mammograms from 2011 to 2013, the range of this finding varied rather substantially (6.3% to 84.5%) by radiologist. And, perhaps even more disconcerting, with consecutive procedures read by different radiologists, 17.2% had different conclusions regarding the presence or absence of dense breast tissue.

So the question to be asked is whether the public is really achieving the benefit from this well-intended but unfortunately inadequately considered policy.

Maurie Markman, MD, editor-in-chief, is president of Medi- cine & Science at Cancer Treatment Centers of America, and clinical professor of Medicine, Drexel University College of Medicine. maurie.markman@ctca-hope.com.

References

1. Dolgin NH, Movahedi B, Martins PNA, et al. Decade-long trends in liver transplant waitlist removal due to illness severity: the impact of Centers for Medicare and Medicaid Services policy. J Am Coll Surg. 2016;222(6):1054-1065. doi:10.1016/j.jamcollsurg.2016.03.021.
2. Williams AR, Bisaga A. From AIDS to opioids—how to combat an epidemic. N Engl J Med. 2016; 375(9):813-815. doi:10.1056/NE- JMp1604223.
3. Jena AB, Goldman D, Karaca-Mandic P. Hospital prescribing of opioids to Medicare beneficiaries. JAMA Intern Med. 2016;176(7):990- 997. doi:10.1001/jamainternmed.2016.2737.
4. Schnipper LE, Abel GA. Direct-to-consumer drug advertising in oncology is not beneficial to patients or public health [published online August 11, 2016]. JAMA Oncol. doi:10.1001/jamaoncol.2016.2463.
5. Byyny RL. Time matters in caring for patients: twenty minutes isn’t enough. Pharos Alpha Omega Alpha Honor Med Soc. 2016 Spring;79(2):2-8.
6. Sprague BL, Conant EF, Onega T, et al; PROSPR Consortium. Variation in mammographic breast density assessments among radiologists in clinical practice: a multicenter observational study. Ann Intern Med. 2016; 165(7):457-464. doi:10.7326/M15-2934.