Tuesday will bring a study of health law at the Supreme Court, in two unrelated cases. The first hearing arises out of the opioid epidemic; it focuses on prosecution of doctors for over-prescribing pain-killing drugs. The second examines the legal duty of health insurance plans to cover treatment of patients with kidney disease.
The “live” audio (but no video) of the hearings can be heard at Quick Links on the Supreme Court’s homepage – supremecourt.gov – and c-span.org/supremecourt and C-Span Now App.
First hearing: two combined cases, Ruan v. U.S. and Kahn v.U.S. The hearing is scheduled for one hour.
Background: It is deeply set in American legal tradition that people should not be convicted of crimes unless, in some way, they intended to act illegally. That means that prosecutors must not only prove that the accused person carried out a criminal act (actus reus, in the Latin), but also that the accused person did it with a guilty state of mind (mens rea).
There are not a great many laws that involve what are called “strict liability crimes.” In those, prosecutors need only prove that the criminal conduct occurred and that the accused person did it. There is no need to prove that the accused realized the act was a crime or intended to act criminally. Examples often cited are “statutory rape” or child pornography; both are crimes involving a minor, but guilt can be found even if the accused did not know the victim was a minor.
Those are so-called “morality offenses.” Another form of strict liability crime is a “public welfare offense”; a mundane example is exceeding the speed limit. The theory behind that kind of crime is that the government is entitled to shift the civic obligation to the individual who is in the best position to avoid acting dangerously.
For years, criminal defense lawyers and legal scholars and others interested in law reform have argued that strict liability is too harsh, when an individual’s freedom is at stake. One idea that has been pressed vigorously is that there should be a “good faith” exception to strict liability.
In other words, those who make honest mistakes or operate on a mistaken assumption about the law should be able to show that they had acted in “good faith.”
The two combined cases that the Supreme Court will hear first on Tuesday involve that concept, in the context of the nation’s opioid epidemic, a multi-faceted crisis beginning in the 1990s of drug addiction, shocking death rates from overdose, pharmaceutical industry greed, shoddy medical practice, and uncertain standards of legal wrong.
According to the U.S. Center for Disease Control, 49,860 people died in America in the peak year (2017) from abuse of opioids; that was more than 70 percent of all drug overdose deaths that year. One private study recorded an average of 128 deaths a day from overdose with opioids – drugs such as fentanyl and oxycodone, often prescribed for chronic pain.
The cases before the Supreme Court focus on the meaning of a part of the Controlled Substances Act, a law passed by Congress in 1970 to create a complete new framework on how illegal drugs are classified and prosecuted.
The provision at issue makes it a federal crime for “any person knowingly or intentionally to distribute or dispense a controlled substance.” The “any person” language has some of the sweep of a strict liability crime, especially if the accused deals in large amounts of drugs; that makes it much easier to prove intent. Disputes over its interpretation have arisen because Congress wrote in an exception for doctors, to avoid treating every doctor as a criminal.
In a 1975 decision, the Supreme Court sought to narrow the scope of that language by ruling that doctors who get licensed by the federal government to dispense controlled drugs may be prosecuted only for writing prescriptions “outside the usual course of medical practice.”
During the opioid epidemic, prosecutions of doctors under that legal standard have led to broadly contradictory interpretations by the federal courts. Basically, the dispute has been over whether “usual medical practice” sets an objective standard – that is, what generally is considered proper medical practice, or a subjective one – that is, the individual doctor’s own understanding of what was proper practice (in essence, a “good faith” standard).
The cases the Court agreed to hear, and combined for Tuesday’s hearing, involve two doctors who wrote prescriptions for large volumes of opioid drugs. Given the number of charges the government filed against each of them, and the sheer volume of their opioid prescriptions after cursory or no clinical examination, it is not a surprise that they were convicted.
In one case, Dr. Xiulu Ruan had a medical practice in Mobile, Ala., specializing in pain management. He and his partner operated a medical clinic with an adjoining pharmacy that served only that clinic. Aside from being convicted of illegally dispensing opioids in huge volumes, he was also found guilty of health care fraud, illegal kickbacks and racketeering. He was sentenced to 21 years in prison. (His clinic partner, John Patrick Couch, was convicted and sentenced to 20 years. His case is awaiting the outcome of Ruan’s appeal.)
In the other case, Dr. Shakeel Kahn operated a medical practice in Arizona and, when drug stores nearby began refusing to fill his large volume of opioids, he opened a second practice in Wyoming and continued the same kind of conduct. He was convicted of a lengthy list of criminal charges, and was sentenced to 25 years in prison.
In both cases, the doctors failed to get the trial judges to instruct the jury that the “good faith” of the doctor’s belief in how his practice conformed to normal standards should lead to acquittal. When they appealed their convictions, the federal appeals courts ruled that the proper instruction to the jury was an objective one of failing to conform to usual medical practice, without regard to what they personally believed or intended. The doctors then turned to the the Supreme Court.
The questions before the Court: May a doctor be prosecuted and found guilty of illegally dispensing drugs if the doctor personally believed in “good faith” that his or her practice in writing prescriptions was proper professionally? How should judges instruct juries about guilt in such cases?
Significance: A nation that has grown deeply worried over a public health emergency faces a heavy task in finding the combination of responses that will provide some relief, even if not capable of ending the emergency altogether. That has been the story in America of the abuse of synthetic opioids, especially fentanyl.
The bluntest instrument the government can use in such an emergency is criminal prosecution of doctors. Guilt or innocence are stark alternatives, especially when used against members of a learned profession guided by both science and the art of healing. To a considerable degree, such cases represent a failure of the Hippocratic oath (“First, do no harm”) upon which patients necessarily rely and upon which the profession’s reputation is grounded.
It may be that enforcement of professional ethical standards will be a more effective response. Criminal trials for misconduct by doctors (or the civil law alternative of malpractice trials) can become mere debating contests, with each side summoning its own experts to try to persuade a jury of untrained citizens on what is appropriate professional conduct.
In the context of the opioid epidemic, there is another factor at work in these prosecutions: the deep anxiety of patients whose pain is so severe as to be at least disabling and at times intolerable. In these two Supreme Court cases, patient advocates and professors of health law have filed briefs urging caution in defining criminal standards lest they stifle the healing arts.
These cases illustrate that, while the law is often more at home with precision than it is with nuance, the task before the Court actually turns upon the elusive phenomenon, “justice.”
Second hearing: Marietta Memorial Hospital v. Davita Inc. Scheduled for 70 minutes, the hearing is expected to begin at about 11:30 a.m., after the opioid cases hearing finishes.
Background: Few issues in health law are more complex that the calculation of reimbursement for the costs of medical treatment. The complexity grows when a federal program of medical benefits, like Medicare, is involved.
This case involves the way Medicare law treats coverage of treatment for patients suffering from “end-stage renal disease” – a condition in which the kidneys have stopped functioning, and the patient’s life then depends upon dialysis treatment, a kidney transplant or both.
In 1980, Congress had grown concerned about preserving the funds available for Medicare, the program of federal benefits for health care for the aged. It passed the Medicare Secondary Payer Act, with the aim of having Medicare become only the backup source of funds for health care, with the primary obligation being taken over by private group health insurance plans, such as those many employers provide for their workers.
This case turns on a special Medicare provision: individuals diagnosed with end-stage kidney disease are eligible for Medicare benefits, no matter their age. A part of the 1980 law specifies that group health plans, in providing coverage for dialysis treatments, may not consider the amount to pay based on the fact that a patient is or will become Medicare-eligible.
In this case, the Marietta Memorial Hospital in Marietta, GA, has a group health plan for its employees. For participants in the plan who obtain dialysis treatments on an out-patient basis, the plan provides a uniform rate of coverage regardless of the medical reason for that procedure and without regard to the stage of the disease for kidney patients.
That approach brought a lawsuit by DaVita, Inc., the nation’s largest provider of dialysis treatments, against the hospital and its plan on behalf of a patient getting the treatment, claiming that the uniform payment scheme discriminated against the patient. After the treatment began, the patient became eligible for Medicare under its end-stage coverage, left the plan and began receiving Medicare coverage.
The lawsuit argued that the hospital was keeping its payments for dialysis so low as to force patients to leave the group plan and switch to Medicare coverage. A federal appeals court ruled for DaVita, finding that Marietta Memorial was discriminating against patients with end-stage renal disease, in violation of the 1980 law. Because the federal appeals courts are split on that legal question, the hospital appealed to the Supreme Court. The federal government supports the hospital’s challenge.
The question before the Court: Is it illegal, under federal Medicare law, for a group health plan to provide uniform coverage of all forms of dialysis treatment without regard to the impact on patients with end-stage kidney disease?
Significance: There are times when a case comes before the federal court that is so specific in its legal terms, with only a narrow range of options open to the Justices, that such a case seems significant only to itself. This case appears to be one of those – tightly focused on the specific wording of a complex federal statute.
Of course, it is highly important for those 786,000 Americans who have end-stage kidney disease, and face difficult choices on how to pay for those expensive treatments. As expected, advocates for kidney patients are taking part in the case to try to assure the best financial outcome available.
If there is wider impact, it might lead the Court to provide new guidance on how a federal law dealing with federal benefits can be challenged as a form of unequal treatment. Federal law generally does not assure equal access to medical care, because there is no guaranteed right to it. There are, though, wide economic disparities in access.
Tomorrow, the Supreme Court concludes the hearings in the current sitting, with a case on whether U.S. Border Patrol agents can be sued for violating constitutional rights.
