Professionalism and Caring for Medicaid Patients — The 5% Commitment?

By Lawrence P. Casalino, M.D., Ph.D.
The New England Journal of Medicine, November 7, 2013 Medicaid is an important federal–state partnership that provides health insurance for more than one fifth of the U.S. population — 73 million low-income people in 2012. The Affordable Care Act will expand Medicaid coverage to millions more. But 30% of office-based physicians do not accept new Medicaid patients, and in some specialties, the rate of nonacceptance is much higher — for example, 40% in orthopedics, 44% in general internal medicine, 45% in dermatology, and 56% in psychiatry. Physicians practicing in higher-income areas are less likely to accept new Medicaid patients. Physicians who do accept new Medicaid patients may use various techniques to severely limit their number — for example, one study of 289 pediatric specialty clinics showed that in the 34% of these clinics that accepted new Medicaid patients, the average waiting time for an appointment was 22 days longer for children on Medicaid than for privately insured children. Physicians have good reasons for not accepting Medicaid patients, as I learned from direct experience as a member of a nine-physician primary care practice in California. We accepted Medicaid patients, but it was difficult. Medicaid’s payment rate was very low — we lost money on each Medicaid visit. When referrals were necessary, we often had to personally ask specialists to accept our patient. Administratively, it was not simple to obtain payment from Medicaid for our services, in part because some patients frequently moved between eligibility and ineligibility for the program. In addition, it was time-consuming for our physicians and staff to deal with the Medicaid pharmaceutical formulary and to obtain prior authorization for Medicaid patients to see specialists and obtain imaging studies. There are additional reasons — beyond low payment rates, administrative complexity, and problems obtaining specialist care — why physicians may be reluctant to see Medicaid patients. Medicaid patients often have complicated behavioral health, transportation, and social service needs that require physician and staff time. Nevertheless, there is a fundamental reason why physicians should strongly consider providing care for at least a reasonable number of Medicaid patients. It is a core professional principle that physicians should put the patient’s interest first; refusing to care for vulnerable, socioeconomically disadvantaged Medicaid patients seems incompatible with this principle. Many medical schools ask their students to accept the World Health Organization’s Declaration of Geneva (a modified version of the Hippocratic Oath), which states in part that “I will not permit considerations of age, disease or disability, creed, ethnic origin, gender, nationality, political affiliation, race, sexual orientation, social standing or any other factor to intervene between my duty and my patient.” Physicians who are reluctant to provide care for Medicaid patients can argue, with justice, that policymakers are trying to make medicine as market-driven as possible, that physicians are increasingly expected to respond to market incentives and market constraints, and that no business in other sectors of the economy is asked to provide a service that loses money year after year. Many physicians, however, earn very high incomes, and some of the highest-paid specialties are the least willing to care for Medicaid patients. Would it be reasonable to ask all physicians to commit to providing care for enough Medicaid enrollees so that at least 5% of each physician’s practice consisted of Medicaid patients (assuming sufficient demand)? We live in an era in which, for better or for worse, market-based solutions are dominant and policymakers tend to view physicians as self-interested actors. Little or no attention is paid to physician professionalism or to the possible effects of policies on professionalism. Policies that are based on this view may be justifiable if many physicians are indeed seeking to maximize their incomes and refusing to accept even a slight reduction in income as the price for helping to provide care to the most vulnerable patients in our society. A 5%-commitment campaign would be a meaningful, highly visible demonstration of physician professionalism — of putting patients first. http://www.nejm.org/doi/full/10.1056/NEJMp1310974

Comment:

By Don McCanne, M.D. The expansion of Medicaid for low-income patients is one of the more troublesome features of the Affordable Care Act. Because of low payment rates, many physicians, especially high-income specialists, already refuse to accept Medicaid patients. Increasing the burden on those physicians who do accept Medicaid is apt to result in a pushback wherein access may be further impaired. What can be done? Lawrence Cassalino has provided us with an excellent description of the dilemma, but I’m afraid that his 5% solution – physicians devoting 5% of their practices to Medicaid – will fail since it depends on physician professionalism, of putting patients first. After a career of trying to obtain specialized care for Medicaid patients, it was quite clear that that level of professionalism was not ubiquitous in my community, and I doubt that it is in most other communities. Relying on the pure goodness of physicians will not work because there are not enough so oriented to meet the need. One important measure in ACA is the expansion of funding for federally qualified health centers. These centers improve access for vulnerable populations, though they still have difficulties obtaining adequate support of specialists. Today, the government announced a $150 million grant to assist these community health centers. $150 million? Unless the government becomes serious about community center funding, and unless something is done to attract specialists to support these centers, we cannot expect them to fill the void either. There is a clear solution. We could establish a single payer national health program in which everyone has the same coverage and access to care. That may or may not renew the commitment of today’s physicians to professionalism, but at least it would create the appearance that patients would be placed first. For individuals considering a future career in medicine, professionalism would be a given.

Geraldo Rivera
November 1, 2013 “You know, it’s great that people get health care. I want everyone to have health care. I want single payer. I want Medicare for everybody. I want it to be like Sweden. I want it to be like the United Kingdom or Canada. I want everyone to have health care. This program (Obamacare), though, is deeply flawed, and I think part of the problem is we let the insurance industry write the legislation, and when the insurance industry, like they did for the prescription plan, Part B (D), when they write the legislation, they stack the deck so they’re the beneficiaries. Geraldo Rivera Radio, 11/1/2013 – at the 48:55 mark: http://www.wabcradio.com/common/page.php?pt=Geraldo+Podcasts&id=512&is_corp=0

Comment:

By Don McCanne, M.D. Geraldo Rivera was quite sincere when, on his radio show, he discussed briefly the serious flaws of Obamacare and then explicitly supported single payer – Medicare for everybody. This is from a Republican who also has a show (“Geraldo-at-Large”) on the Fox News Channel. Recently, much of the media attention on single payer has been coming from conservatives who seem to be threatening us with the prospect of single payer as an inevitable outcome of expanded coverage through the Affordable Care Act. They may be correct, but not for the reasons they imply. Rather than ACA being a step closer to single payer, it moves in the direction of expansion of enrollment in private plans, whereas single payer would essentially eliminate private plans. The real reason that ACA moves us closer to single payer is that the plans are further limiting our choices of physicians and hospitals, and they are shifting an unbearable amount of the costs to patients. Once a critical threshold of patients experience these abuses, the public will demand that everyone be covered with a public program like Medicare. During our PNHP meeting in Boston last weekend, Fox News broadcast an attack on single pager (likely only coincidental that it was during our meeting). It represents what seems to be an orchestrated attempt to discredit single payer before it gains further traction. If you watch the 7 minute video at the following link, you may find disconcerting the fact that media professionals apparently believe that the intellect of the average American is so low that they would be swayed by their framing.  Anyway, I report, you decide: http://www.youtube.com/watch?v=AS_eKBjW5QM On a more positive note, there are many Republicans, such as Geraldo Rivera, who do understand and support the single payer model. We need to expand our message beyond the progressive community by increasing our efforts to communicate with Republicans and with the business community. Tomorrow, November 7, Geraldo Rivera is going to have as a guest on his program, PNHP co-founder David Himmelstein: WABC at 10:00 AM Eastern (Click on “Listen Live” or listen later to the podcast): http://www.wabcradio.com/common/page.php?pt=Geraldo+Podcasts&id=512&is_corp=0

Coverage When It Counts

How much protection does health insurance offer and how can consumers know?

By Karen Pollitz, Eliza Bangit, Jennifer Libster, Stephanie Lewis, and Nicole Johnston
Center for American Progress Action Fund, May 2009

Knowing whether insurance provides adequate coverage can be a challenge. Health insurance policies are complex products, highly variable in their design, and key information about how coverage works is not always disclosed during marketing. Further, health insurance promises protection against future, unknown events. Consumers who are healthy today can find it difficult to anticipate future medical problems and costs and harder still to evaluate how insurance might cover those needs. Using simulated claims scenarios for different types of patients we analyzed the content of coverage under a variety of health insurance policies sold to individuals and small employers in Massachusetts and California and estimated out-of-pocket costs for care that patients might face. This project estimated cost scenarios for patients with serious medical conditions: breast cancer, heart attack, and diabetes. Massachusetts is unique in requiring residents to have health insurance that meets minimum creditable coverage (MCC) standards  — a state criteria for ensuring adequate coverage. As a result of this individual mandate and minimum coverage rule, health coverage tends to be much more standardized and comprehensive in Massachusetts compared to most other states. MCC standards for 2009 include inpatient and outpatient hospital and physician care, emergency services, mental health and substance abuse treatment, and prescription drug coverage. The Commonwealth Connector (i.e., exchange) offers plans with high, medium, and low tiers of coverage — characterized as gold, silver, and bronze. Policies offered by competing insurers within each tier are supposed to be “actuarially equivalent.” Policies are said to be actuarially equivalent if, for the same population covered, they would each pay the same share of the population’s total expected medical bills. However, for any given patient, actuarially equivalent policies might offer different protection. To illustrate how coverage can vary — and how challenging it might be for consumers to appreciate the differences — we mapped the simulated claims scenarios against specific health insurance policies. Figure 2. Seemingly similar Massachusetts policies work differently Plan C – Bronze
Deductible  $2,000
Patient out-of-pocket costs
  Breast cancer  $12,907
  Heart attack  $8,400
  Diabetes management  $960 Plan G – Bronze
Deductible  $2,000
Patient out-of-pocket costs
  Breast cancer  $7,983
  Heart attack  $6,237
  Diabetes management  $4,383 Massachusetts has made great strides toward assuring that all residents will have basic health insurance protection, and the Commonwealth Connector has surpassed other states in the amount and quality of comparative health plan information provided to consumers. Yet even in that state, gaps in coverage persist and consumers may not easily appreciate what those gaps could cost if they get seriously ill. http://www.americanprogressaction.org/wp-content/uploads/issues/2009/05/pdf/CoverageWhenItCounts.pdf

Comment

By Don McCanne, M.D. These boring minutiae on benefits of two actuarially equivalent plans offered through the Massachusetts health insurance exchange seem like they would have little relevance compared to the major features of the Affordable Care Act. Quite the opposite. These numbers demonstrate that the concept of transparency in shopping for plans in the ACA exchanges is a cruel fiction. It is impossible to know what your out-of-pocket expenses will be for any given plan that you select. In ACA, just as in the Massachusetts exchange, plans in the same metal tier (bronze in the example above) must be actuarially equivalent; that is, they must pay the same average percentage of covered expenses, leaving the balance to be paid the patient. But the definition of what is covered can vary, even while maintaining actuarial equivalency. Thus, even though the plans have an annual out-of-pocket limit, that applies only to covered services, which can vary by plan. This study looked at expected expenses for three serious conditions and then calculated what each plan would cover. The out-of-pocket expenses often exceeded the plan limit because of the cost of essential services that were not covered. Think about this. When electing a plan you have to decide in advance whether or not you are going to have breast cancer or develop diabetes or have a heart attack next year. Then you have to see how much out-of-pocket expenses you will be left with after the plan makes its payments. In the case of breast cancer, even though Plans C and G are actuarilly equivalent, you would choose Plan G with out-of-pocket expenses estimated to be $7,983 since Plan C would have out-of-pocket expenses of $12,907. But wait. Suppose you are going to develop diabetes instead. Then you need to pick Plan C with out-of-pocket expenses of $960, since Plan G would entail $4,383 in expenses. Or if you are going to have a heart attack, you would save some with Plan G at $6,237 as opposed to C at $8,400. But then consider this. These numbers were not available in the plan information provided by the exchanges. They were not even available in the detailed insurance contracts that you receive after you purchase a plan. These numbers had to be calculated by policy experts who meticulously reviewed each plan. They didn’t even include costs incurred because of care unavoidably obtained out-of-network. Further, because the calculations are quite laborious, they did not provide them for the hundreds or thousands of other disorders you could develop next year. But then, really, who knows what next year holds for us? For ACA, the calculations would be even more difficult. Although there are ten categories of essential health benefits that must be included in the coverage, the insurers are allowed to vary the benefits within each of the ten categories as long as they remain actuarially equivalent. Imagine the calculating tool that would be required to compare plan coverage. It would challenge the Obamacare exchange computer systems in complexity. The bottom line? Because of private health plan chicanery, it is impossible to know what expenses you may face in the next year. But if you develop a major disorder, there is a great risk that you will have to pay more than the out-of-pocket limit that is posted on the exchange plan descriptions. For no more than our current national health expenditures, we could have had prepaid health care with first dollar coverage for everyone. We still can by enacting a single payer national health program – an expanded and improved Medicare for all. (Those attending the Boston meeting of PNHP this past weekend will recognize the numbers presented in Figure 2 above. Our thanks to Steffie Woolhandler and David Himmelstein for bringing them to our attention.)

Non-publication of large randomized clinical trials: cross sectional analysis

By Christopher W Jones, Lara Handler, Karen E Crowell, Lukas G Keil, Mark A Weaver, Timothy F Platts-Mills
BMJ, October 29, 2013 Randomized clinical trials are a critical means of advancing medical knowledge. Clinical trials depend on the willingness of participants to expose themselves to the risks of randomization, blinding, and unproven interventions. The ethical justification for these risks is that society will eventually benefit from the knowledge gained from the trial. Because the risks involved in trial participation may be significant, and because individual trial participants often do not benefit directly from trial participation, substantial safeguards have been implemented to protect the interests of study participants both prior to and during the trial. These safeguards take multiple forms, including oversight by institutional review boards, the informed consent process, and data and safety monitoring boards. Until recently, the protection of the interests of study participants after trial completion has received significantly less emphasis. This began to change in 1997 with the signing of the Food and Drug Administration Modernization Act in the United States, which mandated that the US Department of Health and Human Services establish a registry of clinical trials, thereby providing permanent, public access to information on the conduct of both publicly and privately funded clinical trials. In 2005 the International Committee of Medical Journal Editors (ICMJE) required that prospective trials involving human participants be registered prior to the beginning of study enrollment in order to be considered for publication in member journals. This requirement was later incorporated into the ICMJE’s “uniform requirements for manuscripts submitted to biomedical journals,” along with the updated CONSORT 2010 statement for the reporting of randomized controlled trials. The prospective registration of phase II-IV clinical trials subsequently became federal law in the United States in 2007 with the passage of the Food and Drug Administration Amendments Act. This legislation also expanded the scope of ClinicalTrials.gov to include a database of trial results. Results from all registered studies may be posted to ClinicalTrials.gov, including studies completed prior to enactment of the Food and Drug Administration Amendments Act. In addition, reporting results is now mandatory for many trials. Failure to comply with this mandate can result in substantial penalties, including civil fines of up to $10 000 (£6200; €7400) per day and withholding of funds from investigators sponsored by the National Institutes of Health. The registration of clinical trials serves an important role in protecting the interests of study participants after trial completion. In addition to discouraging investigators from preferentially choosing to report statistically significant positive outcomes, trial registration can increase awareness of possible publication bias within the medical literature by allowing the public to compare the subset of trials with published results to the total number of trials that were registered and conducted. Publication bias can distort the apparent efficacy of interventions, which complicates the interpretation of the medical literature. The non-publication of trial data also violates an ethical obligation that investigators have towards study participants. When trial data remain unpublished, the societal benefit that may have motivated someone to enroll in a study remains unrealized. Systematic trial registration provides a tool that can help to assess both the magnitude and the causes of these problems. Data sources PubMed, Google Scholar, and Embase were searched to identify published manuscripts containing trial results. The final literature search occurred in November 2012. Registry entries for unpublished trials were reviewed to determine whether results for these studies were available in the ClinicalTrials.gov results database. Results Of 585 registered trials, 171 (29%) remained unpublished. These 171 unpublished trials had an estimated total enrollment of 299 763 study participants. The median time between study completion and the final literature search was 60 months for unpublished trials. Non-publication was more common among trials that received industry funding (150/468, 32%) than those that did not (21/117, 18%), P=0.003. Of the 171 unpublished trials, 133 (78%) had no results available in ClinicalTrials.gov. From the Discussion Trial investigators and sponsors have an ethical obligation to study participants to publish trial results. This principle is implicit in the US Federal Policy for the Protection of Human Subjects, also known as the “Common Rule,” which outlines the scope and responsibilities of institutional review boards for overseeing research using human participants. The Common Rule states that institutional review board approval requires demonstration that “risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result.” Similarly, the Declaration of Helsinki, which was instrumental in developing the modern system of oversight by institutional review boards, also acknowledges the importance of disseminating research results, stating “Authors have a duty to make publicly available the results of their research on human subjects and are accountable for the completeness and accuracy of their reports.” By directing institutional review boards to assess the societal importance of resulting knowledge in addition to the possible risks and harms to individual research participants, the Common Rule provides justification for institutional review board oversight of results reporting, including trial registration and publication. Because the involvement of institutional review boards with clinical trial oversight begins prior to participant enrollment, these institutions are uniquely positioned to protect the rights of study participants throughout all stages of trial conduct, from study planning to reporting results. Given the persistent problem of unpublished trial results despite continued emphasis on trial registration from governmental agencies, funding organizations, and the editorial community, increased institutional review board attention toward this issue may be needed.

Conclusions We observed that non-publication is common among large randomized clinical trials. Furthermore, the sponsors and investigators of these unpublished trials infrequently utilize the ClinicalTrials.gov results database. The lack of availability of results from these trials contributes to publication bias and also constitutes a failure to honor the ethical contract that is the basis for exposing study participants to the risks inherent in trial participation. Additional safeguards are needed to ensure timely public dissemination of trial data. http://www.bmj.com/content/347/bmj.f6104
NIH: ClinicalTrials.gov

Comment

By Don McCanne, M.D. Publication bias of drug and device studies has bordered on the criminal. Industry funded studies in particular were often withheld from publication if the results were not favorable for the future marketing of the product; that is, if the studies showed no benefit or, worse, if they showed that the products were harmful. Recognizing the problem, in 2005 medical journal editors began to require that studies be registered before clinical trials began or the studies would not be published in peer reviewed journals. In 2007 the federal government began to mandate the reporting of studies with the threat of civil fines for failing to comply. Many of us recognized that this failure of the private sector required government intervention, and we were relieved to finally see it. Alas, this study shows that non-compliance is still common, especially with industry funded studies. Not only does this corrupt the data bases on which our knowledge of new drugs and devices relies, it is also a failure of ethics by withholding results of human experimentation consented to by individuals who placed their health at stake to advance our understanding of the benefits and potential harms of these products. That ethical failure extends to future individuals who might be exposed to ineffective or harmful interventions merely because this adverse information was withheld from the medical community. There is an analogy with single payer. Private sector enthusiasts insist on exposing us to the waste, inefficiencies, and sometimes harm inflicted on us by the private insurance industry and its marketplace applications. The administrators of a government single payer program do not experiment with patients in order to expand the market for health care. However, they do collect generic data, rather than hiding it, to help advance our understanding of beneficial health care interventions. Whether it’s drug and device research or health care financing, we need more government involvement, not less.