Friday, April 22, 2016

Maryland's Tuskegee Experiment, 2016

According to the current Maryland Medical Assistance Program guidelines, Medical Assistance (Medicaid) patients with hepatitis C are denied insurance coverage for the treatment of their disease if they are early stage (stage 0 or stage 1). Only patients with stage 2 or higher, in most cases, are approved for treatment. Patients with stage 0 or stage 1 must progress to stage 2 or higher before the Maryland Medical Assistance Program will approve treatment for them.
      The demographics of hepatitis C are such that there are thousands of patients in Maryland, many of them in Baltimore, many of them African-American, who need treatment for hepatitis C. Maryland's denial of insurance coverage to a significant subset of these patients bears some similarities to the infamous Tuskegee Experiment, a research study conducted by the U.S. Public Health Service between 1932-1972, in which African-American men in Macon County, Alabama were denied treatment for syphilis, even after penicillin became available as a cure for the disease.
      There is currently a cure for hepatitis C (ledipasvir/sofosbuvir has a cure rate of greater than 95% in patients infected with genotype 1), but the state of Maryland, because of budgetary considerations, is denying treatment to the subset of patients with early-stage disease, even though their disease is easily curable. Hepatitis C, if untreated, can cause a variety of serious and potentially fatal complications, such as cirrhosis, liver failure, and liver cancer. Thus, treatment for hepatitis C can be lifesaving.
      Basically, physicians in Maryland are being told to say to some of their patients, "We can't treat you for hepatitis C, even though it's a serious illness that could cause you to have long-term health problems, including a risk of severe liver damage and liver cancer. You have to get sicker before we can treat you." This is not the way that physicians treat patients with other chronic, significant health problems.
      Of course, the denial of treatment to patients with hepatitis C is not just a problem in Maryland; in California, Washington, and Florida the denial of treatment to patients with hepatitis C by insurance companies has already become a subject of litigation. According to a study by Edlin, et al. (Hepatology, Aug. 25, 2015), there are at least 3.5 million people in the United States who are currently infected with hepatitis C. Physicians who treat hepatitis C often have to file appeals on behalf of their patients when approval of treatment is denied by public or private insurers.
      According to the 2016 guidelines provided by the American Association for the Study of Liver Disease (AASLD) and the Infectious Diseases Society of America (IDSA), "Treatment is recommended for all patients with chronic HCV (hepatitis C virus) infection, except those with short life expectancies that cannot be remediated by treating HCV, by transplantation, or by other directed therapy," and "clinicians should treat HCV-infected patients with antiviral therapy with the goal of achieving an SVR (sustained virologic response), preferably early in the course of chronic HCV infection before the development of severe liver disease and other complications" (www.hcvguidelines.org).
      Of course, there are a number of factors that have to be considered regarding the cost of treatment and the likelihood of treatment benefit. Which patients are likely to benefit the most from treatment? Certainly, the stage and activity of the disease in patients must be considered in deciding who will benefit the most. But let's look at the patient population that's currently being denied access to treatment. The impact of Maryland's budgetary constraints falls most heavily on the poor, on those who are most economically disadvantaged.
      Moreover, the denial of insurance coverage for treatment of hepatitis C by public and private insurers is presently not justified by medical or scientific opinion concerning treatment of the disease; it is based solely on cost considerations. Insurers cannot therefore rightfully claim that denial of treatment is based on considerations of medical necessity. According to the AASLD/ISDA guidelines, hepatitis C treatment is recommended for nearly all patients with the disease.
      This issue needs to be discussed further in the public sphere, and there needs to be greater public awareness that "health care rationing" has become a part of our health care system. There needs to be wider public discussion of the ethics and management of health care rationing, and there needs to be wider discussion of the measures that can be taken to utilize our health care resources more efficiently and equitably, as well as wider discussion of the steps that can be taken to control costs, increase affordability, remove barriers to access, encourage innovation, and achieve other aspects of health care system reform.

ADDENDUM:

On Friday, May 27, 2016, U.S. District Court Judge John C. Coughenour ruled that Washington State's Medicaid program must cover treatment for all patients with hepatitis C, regardless of the stage of their disease. In his ruling, Judge Coughenour said that untreated patients are likely to suffer irreparable harm, and that under Title XIX of the Social Security Act (which establishes federal guidelines for state Medicaid programs), patients cannot be denied access to medically necessary care.

No comments:

Post a Comment