AlignMap

In one of those instances of serendipity about which one hears so much, the AMA and I have each been independently engaged in changing the current perspective and policies on management of non-compliant patients.

Our proposals, it turns out, are not identical.

The result of my efforts today can be found in the preceding post, Beyond Patient Compliance: Patients Who Lie, in which I hold that

optimal treatment is most efficaciously pursued by aligning the doctor, the patient, and other stakeholders to maximize mutual trust, a strategy which takes priority over the percentage of prescribed pills taken by the patient.

The AMA Resolution

After hitting the “publish” button for that post, I checked  the patient compliance news alerts I  follow, only to discover that the American Medical Association House Of Delegates was considering Resolution 710, “Identifying Abusive, Hostile or Non-Compliant Patients,” which comes up for a vote tomorrow (June 16, 2009). The text of the resolution, taken from http://www.ama-assn.org/ama1/pub/upload/mm/475/refcomg.pdf, follows:

Resolution: 710 (A-09)
Introduced by: Michigan Delegation
Subject: Identifying Abusive, Hostile or Non-Compliant Patients
Referred to: Reference Committee G, (J. Leonard Lichtenfeld, MD, Chair)

_____________________________________

Whereas, Many patients are becoming more abusive and hostile toward physicians for many reasons not limited to the economy, increasing co-pays and deductibles, unreasonable expectations and demands, a lack of instantaneous cure, arrogance and/or the belief that they “own” their physicians; and

Whereas, There are decreasing numbers of physicians both in primary care and specialties especially in terms of access; and

Whereas, Increasing noncompliance with treatment can reflect negatively on physicians during black box audits by insurance companies and oversight governmental agencies; and

Whereas, Abusive, hostile, and noncompliant patients result in increasing office resources, adding to office overhead and added stress on all of the office personnel, which can lead to potential ill health; and

Whereas, The stress of dealing with ungrateful patients is adding to the stress of physicians leading to decreased physician satisfaction; and

Whereas, Any complaint to any oversight investigative regulatory body leads to uncompensated expenditure of time, resources, and monies to defend physicians or the “guilty until proven innocent” principal; and

Whereas, Physicians need to own the data to simplify patient collection and identification to defend themselves as well as alert outside investigating agencies to the potential nature of the patient’s records; therefore be it

RESOLVED: That our American Medical Association ask its CPT Editorial Panel to investigate for data collection and report back at Annual 2010 meeting: 1) developing a modifier for the E&M codes to identify non-compliant patients and/or 2) develop an add-on code to E&M codes to identify non-compliant patients. (Directive to Take Action)

Fiscal Note: Staff cost estimated at less than $500 to implement.
Received: 05/06/09

The Implications

I have little to say about the AMA’s Resolution, which seems all too straightforward. From others, however, there has been an  (understandably)  vehement  response to the AMA resolution.  Googling “AMA non-compliant patients” displays a  batch of these venomous criticisms of arrogant doctors.

I, of course, believe my ideas on non-compliance are far superior to  those implicit in this Resolution the AMA is considering. I’ll be publishing further posts in the near future outlining this  new vision that goes beyond Patient Compliance.

Meanwhile, I’m desperately hoping that there is an explanation for the AMA even considering a resolution that threatens, by its very language, to alienate doctors and patients, exacerbating rather than alleviating non-compliance.

From Nov. 3, 2008 American Medical News - By Doug Trapp

American Medical News Critiques West Virginia Medicaid Incentive Program

The graphic above is the heading for an American Medical News¹  story about the West Virginia Medicaid patient incentive plan.  The basics of the West Virginia plan and my perspective on it was discussed in this blog two years ago at West Virginia Medicaid Compliance Contracts – The Plan, The NEJM Perspective, & The Rest Of The Story.

See if you can guess AMA’s perspective from the clues in the headline:

When incentives lack appeal:
Medicaid reform meets confusion, skepticism

That’s right – in formal terms, this means  “Incentives used in the West Virginia Medicaid reform plan to encourage certain behaviors in patients lack appeal, thus causing confusion and skepticism.”

In less formal terms, it means “The West Virginia Medicaid reform plan stinks.”

Now, try the subheading:

West Virginia is one of the first states to offer inducements
for patients who pledge to follow physicians’ orders,
but most of those eligible aren’t taking the bait.

Let me suggest that the key words are “… most of those eligible aren’t taking the bait,” a figure of speech that leads me to suspect that it required the totality of the author’s self-discipline to forgo his impulse to add “Thank God” at the end. After all, I’ve never read a story in which good things happened to anyone who does “take the bait.”

At the risk of provoking the AMA to reconsider its position, I agree with their point that the bureaucratic implementation of the incentive plan is – hmmmm, let’s call it suboptimal. In fact, I am probably more critical of the plan’s structure than is the AMA. More about this a little later.

The Criticisms

The  article’s  basic argument is presented in the excerpts that follow:²

The program, which began almost a year ago in most parts of the state, is a novel attempt to use incentives to boost enrollees’ personal responsibility and ownership over their health care. Eligible enrollees who agree to a wellness plan, follow other physician directions, and show up on time for medical appointments can receive free additional benefits, such as help with quitting smoking and membership in Weight Watchers. Those who don’t take the option are relegated to a basic plan with somewhat fewer benefits than their existing plan.

Enrollment in the enhanced plan so far has been low. About one-third of West Virginia’s Medicaid beneficiaries — who numbered 392,000 in 2007 — are eligible for Mountain Health Choices based on their relative good health. But only about 15,500, or 12%, of those eligible had signed up as of Sept. 30, according to state counts. Another 3% had begun the enrollment process.

Why hasn’t the program been more popular?

Some patients simply might not know about or understand the program. Others might not read well enough to grasp the details. But even for those who want to pick the enhanced option, it’s not always simple.

For starters, Medicaid enrollees are instructed to call their primary care physician. “Many don’t have a primary care provider,” said Renate Pore, president of the patient advocacy group West Virginians for Affordable Health Care. “They don’t know who they’re supposed to call.”

Some eligible enrollees might not see a need for extra benefits, said Sarah Chouinard, MD, medical director of Primary Care Systems Inc., a health center in Clay, W.Va. For example, a 30-year-old woman with seasonal allergies might think she just needs her allergy prescription and annual Pap smear, not a wellness plan and extra hospital coverage.

The requirement that patients commit to regular office visits could pose a barrier for those with limited transportation options, said Rodney Fink, DO, director of clinical service for Access Health, a group of six health centers in southern West Virginia, including the Beckley facility where Dr. Bennett works.

Some observers say the state needs to do a better job of selling beneficiaries on the extra benefits. Dr. Fink said doctors also need to do a better job of focusing their patients’ attention on it.

… The Deficit Reduction Act of 2005 gives states authority to offer varying benefit levels to Medicaid enrollees. A few states, including Idaho and Kentucky, responded by offering incentives to beneficiaries who adopt healthier behaviors. Other states, such as Florida and Wisconsin, set up similar programs under waivers from the Centers for Medicare & Medicaid Services. The Deficit Reduction Act of 2005 lets states offer varying benefit levels to Medicaid enrollees.

But West Virginia took the concept one step further by limiting benefits for Medicaid recipients who do not promise to follow a wellness plan and listen to doctors’ orders. The state is now on the line to prove the tactic will work.

The ultimate goal of Mountain Health Choices is to forge relationships between patients and physicians that lead to healthier lifestyles and better preventive care, said Shannon Landrum, spokeswoman for the West Virginia Bureau for Medical Services in Charleston. …

Parents must agree to pick a medical home for their child, bring the child on time for a minimum number of office visits, and ensure that immunizations are up to date and prescriptions are followed. The agreement is similar for adults, with the addition of required screenings, such as colonoscopies, glucose levels and mammograms.

Some points of contention

The West Virginia program is more controversial than other states’ because it automatically bounces nonparticipating beneficiaries — possibly without their knowledge — into the basic plan. Once there they encounter more restrictions than in traditional Medicaid, such as caps on prescriptions and mental health services.

For example, children in the basic plan are limited to four prescriptions per month, even though a child with asthma and attention deficit disorder could easily hit that limit, said Fernando Indacochea, MD, president of the West Virginia Chapter of the American Academy of Pediatrics. Landrum, however, said a state review of data from three pilot counties prior to implementation showed that children on Medicaid average fewer than one prescription a month.

And while individual mental health therapy is covered under the basic plan, crisis intervention is not, said Bob Hansen, executive director of Prestera Center, a mental health and addictions treatment agency in Huntington.

Georgetown University’s Center for Children and Families on Aug. 9 issued a paper criticizing the state for automatically limiting kids’ benefits via the basic plan. If the program aims to encourage healthy behaviors among Medicaid enrollees, said Joan Alker, the deputy executive director of the center, “I don’t think there’s any evidence that they’re achieving that.”

West Virginia already has learned some lessons that could be applied by other states considering incentives for patient compliance.

Dr. Fink said programs such as Mountain Health Choices won’t work unless staff at clinics and health centers proactively advise patients about their health care options. He added that physicians should form a second line of support and also gauge their patients’ awareness.

Landrum said it can be difficult to engage Medicaid enrollees as they gain or lose program eligibility. About 40% of Medicaid beneficiaries in West Virginia don’t renew their benefits from one year to the next. States that want to change Medicaid from a program that simply pays claims into one that promotes health improvement and wellness need to be patient and look for ways to measure success in the long term, Landrum said.
Hope for the future

To improve physician awareness, the state could notify doctors of their Medicaid patients’ deadlines for choosing a new plan, said Violet Burdette, CEO of Northern Greenbriar Health Clinic in Williamsburg. Eligible beneficiaries receive a Mountain Health Choices enrollment packet 60 days before their Medicaid benefits are changed. They have 90 days to respond.

Burdette also said enrollees might be more engaged if they had to choose either the basic or enhanced plan instead of being channeled into the less generous plan by default. Landrum said only two Medicaid beneficiaries have actively declined the enhanced plan.

Work of enrolling can fall on physicians

Some physicians are excited about West Virginia’s pilot program that offers incentives for Medicaid patients to stick with a wellness plan, even though it does cause extra work for doctors.

Sarah Chouinard, MD, medical director of a health center in Clay, about an hour from Charleston, said her facility has convinced more than a few patients to take advantage of the enhanced benefits in Mountain Health Choices. The clinic, which is in one of the three pilot counties for the program, treats about 7,200 patients, a third of whom are enrolled in Medicaid.

Dr. Chouinard said explaining the initiative to patients requires additional staff time but coordinates well with the medical home model the center offers.

Terrence Reidy, MD, was less enthusiastic. He practices at a community health center in Martinsburg, in the eastern part of West Virginia.

A state Medicaid representative visited his facility about a year ago to explain the role the center would play in promoting the expanded plan. “It seemed like our office was then expected to be the ones to get the patients to sign up,” Dr. Reidy said. The internist hasn’t been contacted by state officials since then, he said in late September.

The center treats about 2,400 Medicaid patients, two-thirds of whom are children. Only about 2% of patients have opted for the enhanced benefits. “It really has not changed our practice a bit,” Dr. Reidy said. Still, consulting even a few patients about their choices of Medicaid benefits and crafting wellness plans adds another unpaid job to his already tight schedule.

One job West Virginia physicians will not have is that of enforcer. The state will review claims records to track patient compliance with the enhanced benefits agreement.

The West Virginia Medicaid Plan As An Example Of Misalignment

If I were a hot-shot psychiatrist – and, as it turns out, I am – I would diagnose a severe case of ambivalence on the part of the creators of the West Virginia Medicaid Incentive Plan.

On one hand there are significant rewards offered to reinforce those desired patient behaviors in the form of a greatly enhanced set of benefits.

On the other hand, it’s as though the administrators fear that the incentives will prove too popular so bureaucratic hurdles (e.g., the requirement that the patient designate a primary provider and take the initiative to sign up for the program)  were created to minimize the number of patients taking advantage of the more extensive, more expensive plan.

I do not believe, however, that the increased expectations placed on the physicians as an uncompensated, de facto administrative assistant and compliance monitor is part of that ambivalence. Nope, I believe that assigning uncompensated tasks, necessary for the functioning of the plan, to physicians and ther offices is merely one more instance of habitual legislative laziness.

Otherwise, one is face with explaining why a the plan’s administrators, who apparently believe in the power of incentives, would create a program that rewards patients but not only fails to reward the clinicians for reaching the same end-points but penalizes them by requiring them to perform work without pay.

Enough of the preliminaries – my contention is that the problems in the design of the West Virginia Medicaid Incentive Plan can best be characterized as a lack of alignment.³

There are so-called pay-for-performance schemes that reward or penalize clinicians, for example, based on the extent to which they follow treatment protocols or on the percentage of their  patients that follow specific pateint protocols, such as designated disease screenings (e.g., mammography or colonoscopy) or participation in disease management programs. There are programs like the West Virginia Medicaid plan that reward or penalize patients for specified healthcare behaviors.  I know of no programs that coordinate both clinician and patient reinforcement systems.⁴

In fact, many programs seem to follow the West Virginia model by offering to reward one group (patients in West Virginia’s case) and simultaneously punishing the other (assigning time-consuming administrative tasks to clinicians without compensation). In these situations, the issue is not a lack of alignment but misalignment.

Further, we’ve only addressed aligning two healthcare stakeholders, the clinician and the patient. In many cases, for example, a patient’s outcome depends primarily on the dedication and efforts of a non-professional caregiver such as a spouse, family member, or friend.  Yet, I find no programs that provide even token rewards for this group beyond generic support groups. Other stakeholders, such as community organizations with healthcare programs, likewise must be taken into account.

And third party payers, bless their hearts, have to be in alignment with other stakeholders if ongoing healthcare efforts are to be have a chance.

And – steel yourselves – on a macro level, pharmaceutical companies and medical equipment manufacturers have to be transformed from miracle workers/sources of all evil (choose one) into participants who gain and lose in unison with other stakeholders.

OK, I only said it was easy to understand the benefits of alignment, not that it was easy to design or implement a well aligned program .

1. American Medical News is a newspaper produced by the AMA for physicians.↩
2. While I have included a large portion of the text and have tried to keep the sense of the original article intact, there is always a risk of distorting the author’s intent. Consequently, I urge viewers to read the entire piece available here: American Medical News↩
3. I use “alignment,” In the context of healthcare, to indicate the condition of the patient, the clinician, and other stakeholders sharing mutual aspirations and grasping the complementary nature of their roles such that each individual or entity involved can support the treatment decision made, even if is not the first choice of a each stakeholder.↩
4. I have purposively chosen the “I know of no programs that … ” sentence format because I continue to believe that healthcare providers and patients benefiting in concert is such an obviously beneficial idea that someone somewhere must have tried it; I just haven’t run across it yet. ↩

And Bloggers On John Edwards

Were one to draw the Venn diagram of patient compliance and presidential campaigns, one would anticipate the intersecting portion would be minuscule if it existed at all. Further restricting that intersection to an overlap patient compliance, presidential campaigns, and public controversy certainly, one would think, doom that result to the ignominy of the null set.

Well, as of 2 September 2007, one would be wrong.

That day, presidential candidate, John Edwards elaborated on his healthcare plan to the folks in Tipton Iowa in a speech described in Edwards Backs Mandatory Preventive Care, the AP news story by Amy Lorentzen:

From the lighting of that fuse to explosions of outrage in the conservative blogosphere required only a few hours.

Consider, for example, a Newsalert post published at 7:52 PM the same day the speech was given:

And, just in case the reader doesn’t pick up on the subtle political connotations of “Comrade Edwards,” the post is headed by the following emblem:

How about a few other examples, just for grins?

From the post with my favorite title, Healthcare Part VIII – Drop that Twinkie or I’ll Shoot! at Angry Bear,

And from John Edwards: “you can’t choose not to go to the doctor for 20 years” posted at Althouse, come these passages:

Daystar51 goes beyond lambasting Edwards for promoting “mandatory preventive health care” to speculating on the possible origins of this notion buried in the candidate’s psyche:

An blog/article, dated September 5, 2007, in US News & World Report wields the British healthy practices incentives plan as a blunt instrument to batter the obligatory preventive care Edwards espouses:

Weird Is Relative, writing in What’s the punishment for noncompliance? Endless jury duty?, implies that the Tipton Iowa speech may be fatal to the Edwards candidacy:

It would be difficult to misunderstand the perspective of Not Larry Sabato, who exclaims in John Edwards on Health Care,

In fairness, not every blogger or commenter was bashing Edwards, but pro-Edwards postings are difficult to find. Plunderchat is a one of those few who straightforwardly support the mandatory preventive care, declaring in John Edwards Looking Good on Health Care that

Commentary

1. It turns out that the complete healthcare plan Edwards supports apparently allows folks to opt out of the program if they wish to manage their own healthcare without government mandates. This discovery disappoints me; when I read about the Tipton speech, I envisioned a post about Edwards declaring Patient Compliance “Mission Accomplished.” Then, I would go on to sardonically observe that “the answer to noncompliance was right in front of us – just issue a presidential proclamation that compliance was obligatory. And so on. If folks have the alternative of leaving the system, the obligatory preventive care lacks the extremity of arrogance that would otherwise render this notion an appealing target.

2. Few bloggers noted that we already have a batch of healthcare mandates on the books, including reporting and quarantine of various infectious diseases, undergoing certain vaccinations, obligating parents to follow doctor’s orders re their sick children, lest they be made wards of the state, and, more recently, restrictions on smoking and intake of some foods.

3. I have to wonder if Mr. Edwards and his advisers have considered the difficulty of monitoring, let alone enforcing patient compliance. While checking attendance records to determine who kept and didn’t keep a doctor’s appointment seems simple enough (although distinguishing between appointments missed because of traffic, scheduling snafus, and family emergencies from those missed through noncompliance may require compliance interrogations abetted by bright lights, good copy-bad cop tactics, and polygraphs), medication compliance, for example, is notoriously difficult to determine, and adherence to diet, exercise, and similar non-medication prescriptions is rarely even attempted. Enforcement methods, short of the Pill Police, are relatively easy to come by; e.g., dropping healthcare coverage for noncompliant patients or tying official authorizations such as driver’s licenses to certificates of healthcare compliance would be simple enough, but even a compliance-pusher like me recognizes that this would be a major shift in the patient-clinician relationship as well as in the role of government in this country.

Controlling Prescription Drug Expenditures:
A Report of Success
David P. Miller, MD; Curt D. Furberg, MD, PhD; Ronald H. Small, MBA; Franklyn M. Millman, MD; Walter T. Ambrosius, PhD; Julia S. Harshbarger, PharmD; and Christopher A. Ohl, MD
Am J Manag Care. 2007;13:473-480

Using Multiple Clinical Administrative Strategies To Control Pharmaceutical Costs

To hold the line on prescription medication costs without decreasing the necessary use of drugs ordered for treatment of chronic conditions, the health plan covering the 11,000 employees of Wake Forest University Health Sciences and North Carolina Baptist Hospital instituted four administrative level interventions, none of which resulted in higher out-of-pocket charges to individual patients, even if they were, as a result, shifted to a more expensive medication.

The four policies, their fiscal impact, and their effect on clinical utilization are summarized in this excerpt from the article:

Commentary

This article serendipitously came to my attention shortly after I published the previous entry in this blog, Another Case Of Cash For Compliance, which focused on monetary incentives and disincentives, including cost-sharing,¹ implemented to improve healthcare habits and cut costs.

The decision of this organization to eschew shifting some or all of the costs of more expensive drugs to patients to discourage their use made this article a striking counterpoint to the accounts of plans opting for cost-sharing.

While the results for the Wake Forest University Health Sciences and North Carolina Baptist Hospital health plan have been encouraging thus far, especially given that prescription medication costs have increased between 8% and 15% annually in this country since the year 2000, caveats are in order.

Most importantly, the study, as the authors note, only looked at one clinical parameter, the utilization of chronic medications; the effect of these interventions on other clinical outcomes (e.g., hospitalization rate) must also be determined.

Moreover, the clinical offerings and the pricing structure of the pharmaceutical industry have been and are likely to continue to be in flux (a factor also acknowledged in the article). Today’s successful price-cutting tactic can be rendered ineffective or even counterproductive by a policy shift at one of more of the medication manufacturers.

For example, pill splitting, used in this study to “yield substantial cost savings,” could be eliminated overnight by a simple change in the nonobligatory one pill, one price policy (i.e., a 25 mg dose and a 50 mg dose of a medication is typically sold for the some price, allowing a patient to split one 50 mg pill into two 25 mg doses at a saving of 50%) of many pharmaceutical producers which, as I’ve pointed out in a previous post, Intentional Noncompliance With Treatment, already consider the tactic subversive and seem well along toward the rationalization that it could be dangerous to patients.

And, of course, clinical discoveries can have analogous results, although cataclysmic changes may be less likely to occur without warning.

Nonetheless, the findings of this study support the notion that health plans willing to continually track, evaluate, and reassess pertinent changes in the clinical and business spheres of healthcare and adjust their own benefit structure accordingly can make impressive progress toward the goal of affordable healthcare.

Footnotes

1. Previous posts on cost-sharing:
   Cost-sharing and Adherence To Prescribed Medication
   Healthcare Cost-sharing And Medication Compliance
   More On Cost-sharing And Medication Compliance

   ↩

Is it acceptable for people to be paid to adhere to medication? Yes
Tom Burns. BMJ 2007;335:232, doi:10.1136/bmj.39286.399514.BE

Is it acceptable for people to be paid to adhere to medication? No
Joanne Shaw. BMJ 2007;335:233, doi:10.1136/bmj.39286.422639.BE

The Issue

A program to reinforce compliance with drug abuse treatment by awarding shopping vouchers to patients who adhere to the program was recently approved in England.

This week’s British Medical Journal includes a concise debate between two experts on this issue. While the point each makes are predictable and I suspect few readers will be swayed from their convictions held prior to perusing the article, the opposing perspectives, which are stated clearly and thoughtfully, are useful in considering the ethics and clinical pragmatics of this methodology.

Rather than rehearse the points of these two arguments, I instead suggest that viewers read the original debate by clicking on the link that follows to download the two-page PDF of the paired pro and con articles, provided by the BMJ without charge: ~Is it acceptable for people to be paid to adhere to medication?~

The QCare Gift Card

A proposal for Minnesota’s state-sponsored health plan to provide $20 gift cards as financial incentives to diabetics who control their glucose levels and smokers who quit the habit has resulted in a few news stories and some outrage from the public.¹

The plan is relatively simple. Senator Linda Berglin, who leads the health budget panel, proposes offering $1 million in incentives to patients covered by subsidized programs including the MinnesotaCare plan for the working poor, pointing out that “These quality guidelines are not reached simply by the doctor. There has to be the patient involved in it, too.”

The incentives would be part of the QCare program, which offers bonuses to health plans and providers that score well on treating costly chronic conditions like diabetes and heart disease.
The Associated Press story ends with “It was unclear Wednesday whether there would be restrictions on what gift card recipients could buy with them.”

Commentary

While the Associated Press story worked the angle of offering gift cards² for patient compliance, I submit that the core issue from the healthcare perspective is simply “Will the incentives efficaciously improve the health of the patients?”

Anyone following this blog probably knows that offering incentives for adherence, a tactic that has come and gone a few times in medicine over the past decades, is currently in ascendancy. On AlignMap.com alone, are posts about Incentives To Enhance Compliance With Addiction Treatment, Cash For Compliance & Other Ethical Dilemmas, and Shopping Discounts As Incentives For HIV Screening Compliance, among others. (Running a search for “incentives” at the site pulls up a half-dozen other posts.)

The question may well be why it isn’t more consistently popular. The fundamental paper on the topic in the medical literature is probably “Should we pay the patient? Review of financial incentives to enhance patient compliance,” by Giuffrida and Torgerson (British Medical Journal. 1997;315:703-707. 20 September), who reviewed “randomised trials with quantitative data concerning the effect of financial incentives (cash, vouchers, lottery tickets, or gifts) on compliance with medication, medical advice, or medical appointments” and found “10 of the 11 studies showed improvements in patient compliance with the use of financial incentives.”

Moreover, the improvements in compliance should save far more money than the program would cost.

I would suggest that the opposition to financial incentives has less to do with the effectiveness of that strategy than with social mores, politics, and personal philosophies.

As a political conservative, I’m not convinced that government should be micromanaging healthcare; as a pragmatist, I’m not convinced that any other currently existing agency with sufficient power to coordinate care for large populations is likely to do any better.

My concerns about the government’s involvement in healthcare and my recognition of the gap between the lofty goals of a plan and its execution notwithstanding, I am impressed with the stated objective of Minnesota’s QCare Program: … To apply QCare standards and align payments and es for all state purchased health care.

I am, you see, big on the alignment thing.

Sources:
Gift Cards Proposed as Health Incentive

State of Minnesota: Information on Quality Care and Rewarding Excellence (QCare)

Footnotes

1. A sense of the response from at least a portion of the populace can be ascertained from scanning the comments to the news story at http://www.freerepublic.com/focus/f-news/1808798/posts↩
2. I’m not wild about gift cards myself; I can only guess that Minnesota will but them at a discount or that offering cash (my preference) would be bad politics.↩

The Issues

In a drama that one can imagine scripted by John Kani or Tony Kushner, the post-apartheid politics of South Africa, the physiological and psychological dynamics of AIDS, a life and death struggle with a potentially global impact, the clash of national and ethnic traditions, cultures, and mores, medical research, the concept of individual freedom and dignity of the individual, the reality of clinical healthcare practice in places like KwaZulu-Natal, the sovereign authority of a recognized nation Vs the needs of the world community, the role of international public opinion, the pronouncements of a self-described institution of bioethics, and the socio-economic forces associated with poverty, homosexuality, and race are joined together in agonized battle by a paper issued in a forum with the prosaic, even by bureaucratic standards, title of the “Public Library of Science Medicine.”

The Proposal

In the January 2007 (Vol. 4) issue of the Public Library of Science Medicine Journal, Drs. Jerome Amir Singh and Nesri Padayatchi of the Centre for AIDS Programme of Research in South Africa and Dr. Ross Upshur, the director of the Joint Centre for Bioethics at the University of Toronto, propose that patients with XDR-TB, a drug-resistant form of tuberculosis, who refuse treatment be involuntarily detained in hospitals or other health care facilities in South Africa.

The following excerpt from that paper accurately reflects, I believe, the authors’ thinking, but has been significantly truncated. I heartily recommend reading the original paper, which is freely available at XDR-TB in South Africa: No Time for Denial or Complacency and is just over six pages, including references.

The Public Library of Science Medicine Journal paper carefully discusses the pragmatic difficulties of treating patients in South Africa, the epidemiology that threatens populations far outside the borders of that country, the criteria for determining when the risk to public safety abrogates individual freedoms and rights, and more.

The proposal specifically recommends that South Africa end its policy stipulating that those hospitalized at state expense lose their social welfare benefits, a regulation that encourages patients to avoid hospitalization and, all too often, treatment of any sort.

The Reactions

Official reactions to the proposal range from cautious agreement to cautious opposition.

The South African Department of Health released this supportive statement from its adviser, Ronnie Green-Thompson, “The issue of holding the patient against their will is not ideal but may have to be considered in the interest of the public. Legal opinion and comment as well as . . . the opinion of human rights groups is important.”

These excerpts from South Africa may lock up “killer TB” patients, written for the Associated Press (24 January, 2007) by Maria Cheng, is representative of the latter perspective:

Commentary

While the threat to world health and the tragedy of those currently afflicted with XDR-TB are themselves compelling, even broader and more fundamental concerns are raised by this situation. The long-debated conflict between individual rights and the good of the community, the authority and responsibility of the state to protect all its citizens, personal morality and accountability, and the large scale economics of public health, among others, are unavoidably and usefully raised by a thoughtful review of this paper.

An October 11, 2006 FDA Warning Letter addressed, among other issues, the claim by Orapred that the addition of flavor enhancers improves compliance with its product. The FDA letter, excerpted below,¹ focuses on the need for evidence of such claims.

Unsubstantiated Claims

The “NEW INSTITUTIONAL 10-PACKS” link on the main product website claims that Orapred is “ENGINEERED FOR COMPLIANCE,” and the main product website contains the tagline, “Perfecting the Science of Compliance.” Similarly, the “About Orapred” page on the product website claims that Orapred “helps mask the bitter taste of prednisolone, making it easier to take without experiencing the natural gag reflex commonly induced by other liquid formulations of prednisolone.” In addition, the “NEW INSTITUTIONAL 10-PACKS” link on the main product website contains claims such as, “Designed to taste better, ease administration.”

We acknowledge that Orapred contains flavor enhancers. However, these claims misleadingly suggest that because of its formulation, patients gag less often when taking Orapred or that the taste of Orapred is superior to that of other formulations of prednisolone and thus that Orapred improves rates of compliance. FDA is not aware of any evidence to support these claims. If you have data to support these claims, please submit them to FDA for review.

Commentary

The FDA’s insistence on scientific evidence rather than the “common sense” assumption that better tasting medications will achieve higher compliance rates is laudable.

My impression is that compliance claims based on a specific quality of a medication (e.g., decreased side-effects, oral rather than parenteral administration, reduced dosing frequency) receive far more regulatory attention than claims made on behalf of non-pharmaceutical compliance enhancers such as adherence monitoring devices, medication reminders, and patient education compliance programs.

Because the notion of expanding governmental oversight gives one pause, and it’s difficult to imagine another source of funding for an independent agency that would serve as a sort of Consumer’s Union for the field, perhaps the message to those of us working with patient compliance is to maintain a high index of suspicion about such claims and to straightforwardly and repeatedly raise the expectation that claims of improved compliance be clarified (e.g., terms defined) and supported by evidence.

1. The entire Warning Letter can be viewed at FDA Warning Letter To Orapred↩

Aids causes life insurers to take stock
by Mariette le Roux. Mail&Guardian Online. 28 December 2006

This newspaper article reports on South African insurance companies that offer life insurance to HIV-positive individuals at prices that are significantly more affordable than traditional costs contingent upon adherence to a treatment program.

This innovation is summarized in this excerpt:

The link to treatment compliance is clearly delineated: “Clients have to commit to treatment once their CD4 count (a measurement of the strength of the immune system) falls below 200, with the company monitoring and encouraging adherence. Defaulters have their cover slashed. ‘Unlike traditional insurance companies, your history is almost irrelevant to us. It is how you are going to behave in the future that is important. We tell you exactly what you must do to live a long life,’ said [AllLife co-founder and managing director Ross Beerman].”

Commentary

While the availability of limited amounts of life insurance is hardly a panacea, the alignment of lower premiums and adherence, based on market forces rather than charity, provides a heartening model of compliance enhancement. Following the results of this naturalistic experiment should be enlightening.

EU Urged To Vaccinate Girls Against Cervical Cancer Reuters October 5, 2006

An editorial in Lancet recommends that member states of the European Union mandate the vaccination of 11-12 year old girls against the human papillomavirus (HPV), a major cause of cervical cancer. Cervical cancer is diagnosed in 470,000 women each year and is the cause of death in 230,000.

The European Commission last week licensed the first HPV vaccine (Gardasil) for use in children aged 9–15 years and women aged 16–26 years. The vaccine has already been used in the United States in girls as young as nine and women up to the age of 26.

The Lancet editorial also noted growing support for vaccinating boys as well as girls but held off this recommendation pending more data from clinical trials.

Commentary

Compulsory vaccination is interesting arena for patient compliance. This nexus of government and medicine highlights the inherent conflict between private freedoms and the public good. Consequently, competent medical advice should be a necessary but not sufficient element in a political entity’s decision to demand any medical procedure, including preventive ones such as vaccination. Lancet’s endorsement of the cervical cancer vaccination certainly qualifies as competent medical advice. How the countries making up the European Union react to this recommendation by a medical source that is medically reputable and publicly prestigious but unendorsed by any government.

In The Trib

Yesterday’s Chicago Tribune carried at least three unrelated stories about public policies on healthcare compliance. Although none of these three are, literally, front page news, that all three happened to be featured the same day does emphasize the frequently overlooked fact that governmental or institutional enforcement of adherence is common in our society.


1. Immunization Laws
Are Lenient Laws Linked To Pertussis Outbreak? By Lindsey Tanner

This article summarizes a study pointing out that those states with more liberal immunization exemptions had about 50 percent more whooping cough cases.


2. State Restrictions On Snacks Sold At School
Tougher Junk Food Rule OKd By Crystal Yednak

New rules were approved in Illinois that prohibit the purchase of snacks with high fat, sugar or calorie content before and during the school day by students in elementary and middle school. Henceforth, juice drinks sold in schools must contain 50 percent or more juice, no sweetened or carbonated drinks can be sold, and snacks must be under 200 calories and meet specifications re fat and sugar content.


3. Government Imposed Quarantine
Halloween Guard Set For Woman With TB By Jeff Long

By judge’s order, “… a community service officer will steer trick-or-treaters away from the home of a Lake in the Hills woman who McHenry County health officials say has tuberculosis … .” There is a dispute whether the woman, a 67-year-old great-grandmother, is contagious, her doctor claiming she is not while county officials maintain that tests performed last summer indicate she is contagious. In a compromise, the woman agreed to continue taking medication that both sides agree should either “prevent her TB from becoming active or cure the disease if it is already active.” A court order prohibits contact with anyone other than family members living in the same home.

The West Virginia Medicaid Plan

West Virginia plans to require that residents of that state who are eligible for Medicaid because of low income sign the “West Virginia Medicaid Member Agreement.”¹

The agreement lists “member responsibilities and rights,” the former of which include, for example, taking medications as prescribed, appearing for appointments on time, and using the emergency room only for emergencies.

Failure to meet these terms would result in the decrease or elimination of some benefits.

According to the legislation, West Virginia will track four indicators:

• Participation in health care screenings
• Adherence to health improvement programs indicated b their health care providers
• Attendance at medical appointments
• Compliance with medication schedules

The NEJM Perspective

Source: Personal Responsibility and Physician Responsibility — West Virginia’s Medicaid Plan by Gene Bishop, M.D., and Amy C. Brodkey, M.D. NEJM Volume 355:756-758 August 24, 2006 Number 8

As Drs. Bishop and Brodkey point out, albeit in more measured terms, this scheme of contracting with patients has been justified and, I believe, pseudo-beatified, by its supporters invoking personal responsibility, an understandably popular concept.

The authors note that “[the policy’s] speedy approval by the Centers for Medicare and Medicaid Services (CMS) demonstrates the agency’s enthusiasm for such an approach” and that the head of the CMS, Mark McClellan declared that “Medicaid enrollees in West Virginia will now become part of an emerging trend in health care that empowers patients to make educated, consumer-driven decisions related to their own treatment.”

[Note: Shouldn't someone alert Dr. McClellan that the rest of us of figured out the code so we know that whenever a bureaucrat from the government or a healthcare organization says "empower the patient," that bureaucrat actually means "give the patient two poor choices instead of one mediocre one and tell him it's his responsibility to choose wisely."]

While personal responsibility is the mantra, it seems apparent, at least to me, that this program would change the dynamics of the doctor-patient relationship dramatically, shifting it from an autonomous patient negotiating his or her health care with a clinician to something that would more resemble an employee being instructed by a superior with his job on the line if the employee resists or fails to meet production goals.

Medicaid patients will assume obligations and be required to meet standards significantly beyond those demanded of other patient groups. Not only does this violate the basic principles of fairness but it also overlooks the fact that Medicaid patients are more likely at the mercies of public transportation, have fewer funds, less access to wholesome foods, less opportunity to participate in exercise programs, and, since 75% are children, have no authority to enforce their own wishes.

The authors use an all too realistic scenario of a 53 year old obese woman with diagnoses of diabetes and schizophrenia who is unable to lose weight as required and misses appointments, probably because of her psychosis. Under the new regulations, she stands to lose her health benefits, including those funding her mental health care.

While such patients are not unusual, the plan is fundamentally flawed regareless of the patient group(s) it would cover.² The fact is that roughly half all patients with any diagnosis prescribed any medication will fail to comply. Complete compliance with complex treatment programs, such as diabetic treatment, is quite rare with rates in the single digits. Further, it’s not difficult to imagine, say, a surgeon who sincerely believes that an aggressive surgical approach to a problem is a given patient’s best hope for survival while the patient is less convinced and is frankly fearful of the risk of the operation. If this patient makes a reasoned, defensible decision to forgo or defer the surgery, should he or she lose health benefits? Or, as the authors rhetorically ask, “Is it irresponsible to refuse to take a medication if it makes you ill and you cannot reach your physician to ask for advice?”

The Rest Of The Story

It is not clear, however, from the NEJM Perspective that the West Virginia plan actually offers a Basic and an Enhanced plan and that only the extra benefits (i.e., those offered in the Enhanced plan but not in the Basic plan) are contingent on fulfilling the compliance contract. Failure to sign or successfully fulfill the contract does not eliminate the patient’s benefits entirely but rather shifts him or her from the Enhanced to the Basic plan. See thumbnails marked “West Virginia Plan,” “Benefits Package – Adults,” and “Benefits Package – Children” for details.

I agree with Bishop and Broadkey that, in toto, the problems of the West Virginia plan significantly outweigh its potential benefits. The specific details of the Basic Vs Enhanced plan are problematic. Mental health services, for example, are available only through the Enhanced plan; a psychotic patient would, according to my reading of these documents, lose his psychiatric benefits if, because of his psychosis, he were unable to keep his appointments and take his medications. Moreover, implementing this idea with the population with the fewest resources to follow through on their personal health plans seems a mistake. Most importantly, however, the current West Virginia plan demands the most primitive form of compliance – obedience.

I find it difficult, in fact, to reconcile the contractual demands with these excerpts from the “Members Rights” section in the second half of the same document:

I have a right to decide things about my health care and the health care of my children.

I will not be treated differently because I am in the Medicaid Program.

My objection to the NEJM Perspective stems from my convictions that (1) reinforcing cooperation between clinicians and patients is a worthwhile strategy and (2) providing an enhanced healthcare package is itself a valid and potentially useful methodology deserving of more consideration. Denouncing the program without at least considering its potential benefits seems a case of throwing the baby out with the bathwater.

Documentation From The West Virginia Medicaid Plan

The documents below  are from the West Virginia Medicaid State Plan Amendment as approved by the Center for Medicaid and Medicare Services. (Accessed August 23, 2006, at http://www.wvdhhr.org/bms/oAdministration/bms_admin_WV_SPA06-02_20060503.pdf.)  Click on thumbnails below to enlarge to  full size for reading.

Members Agreement - Page 1

Members Agreement - Page 2

West Virginia Plan

Benefits Package – Children

Benefits Package – Adult

Footnotes

1. Idaho and Kentucky have submitted plans with similar philosophies.↩
2. On the other hand, it would be a dandy plan if all the patients were Spock clones operating on pure logic – or if the patients at least had enough sense to never be sick. Or, better yet, if there were no patients at all.↩