(August 29, 2014) The American Cancer Society has estimated that 43.92% of all males and 38.00% of all females in the United States will develop cancer at some point during their lifetime. While a number of clinical advances have been made over the last 25 years, chemotherapy remains one of the predominant tools used to fight cancer in many of its various forms. Depending on the type of cancer at issue, chemotherapy can be used as a primary or as an adjuvant therapy. While a number of drugs have been developed to address several of the adverse side effects normally associated with chemotherapy, this therapeutic approach is often still devastating on patients. How would you feel if you learned that your oncologist has put you or a loved one through an intensive course of chemotherapy, when it was not needed? According to federal investigators that is exactly what happened to the patients of one oncologist in Detroit, Michigan.
I. Background of this Oncology Fraud Case:
In August 2013, the government first alleged that a noted Michigan oncologist routinely prescribed chemotherapy and other drastic medical interventions for patients who were either healthy or ill but in need of alternate treatments. According to federal prosecutors, the oncologist
"submitted fraudulent claims to Medicare for medically unnecessary services, including chemotherapy treatments, positron emission tomograph (PET) scans, and a variety of cancer and hematology treatments for patients who did not need them".
The government further alleged that the doctor engaged in this improper conduct to increase his own income. Records reflect that the doctor billed Medicare for approximately $150 million in services between August 2010 and July 2013.
II. Nature of the Allegations:
Essentially, the government has alleged that the defendant ordered chemotherapy for patients whose cancer was in remission. The defendant is also alleged to have ordered chemotherapy for all of the terminal patients under the physician’s care, even if the treatment would not improve or extend their lives. Further, the oncologist sometimes issued patients life-long prescriptions of drug treatment for low platelet conditions, without informing patients that surgery was a treatment alternative to years of drug therapy. Ultimately, it appears that the government believes that the defendant improperly ordered chemotherapy for monetary gain, rather than because the treatment regimen was medically necessary.
III. Origin of this Oncology Fraud Case:
While the August 2013 U.S. Attorney’s Office Press Release did not discuss how these concerns were first brought to the government’s attention, a segment by ABC News reported that the case was the result of complaints brought by an oncology nurse who worked with the defendant in 2010. According to the government, the Oncology fraud scheme put $35 million in the oncologist’s pocket.
IV. Current Status of this Oncology Fraud Case:
In May 2014, the defendant’s legal counsel moved for a change of venue, in an effort to have the trial transferred to another judicial district. The defendant’s motion was denied in June 2014 and the trial was originally scheduled to begin on August 12, 2014. It has been reset to begin in mid-October 2014. The defendant could face 10 years in prison and a $250,000 fine if convicted.
V. Why Should Our Oncology Practice Be Concerned About this Case?
Readers may ask, “Why is this case relevant to me – I am an honest provider?” Frankly, all oncologists should take note of this case. Issues of medical necessity can be extremely difficult to parse out, especially in cases where a patient is suffering from a potentially deadly illness. As earlier discussed, chemotherapy is used for a wide variety of purposes. Depending on the type of cancer involved, it may be administered as a patient’s primary treatment regimen. Other cancers may utilize radiation therapy as the primary treatment regimen yet still use chemotherapy as an adjuvant remedy. Finally, chemotherapy may be prescribed and used as a palliative measure in cases where a patient has already been diagnosed as terminal. The point is this – the utilization of chemotherapy as a course of treatment may be reasonable and appropriate, despite the fact that the clinical profile of one patient may be very different from that of another. Moreover, two independent, competent oncologists may have divergent views on whether chemotherapy is warranted in a particular case. Despite arguments to the contrary, medicine is also an “art,” not merely a “science.”
VI. Steps You Can Take to Reduce Risk:
It is essential that oncologists participating in Medicare review both their operational and documentation practices to ensure that entities processing and examining their patient treatment records can readily ascertain why certain care and treatment decisions were made. Several essential considerations to be taken into account include:
Coverage and Payment Requirements Medicare Administrative Contractors (MACs) working for the Centers for Medicare and Medicaid Services (CMS) are responsible for developing and administering coverage and payment guidance which delineates when it is appropriate to utilize one or more treatment options when caring for a cancer patient. MACs often publish guidance which specifies whether it is appropriate to administer a particular type of chemotherapy when treating a patient suffering from a particular type of cancer. Often, this information is set out in Local Coverage Determination (LCD) guidance maintained by the MAC. It is not uncommon to find that an LCD specifies the type of chemotherapy that is appropriate, and the frequency it may be used, when prescribing it to fight a particular type of cancer. Unfortunately, you may find that the government seems to sometimes confuse "coverage" with "medical necessity". In other words, the government may allege that an order for chemotherapy was not medically necessary, when in fact, what the government is really saying is that the Medicare program does not cover the use of a certain type of chemotherapy when addressing a certain type of cancer.
Community Standard of Care Notably, the issue of whether or not a physician has acted reasonably in the medical decision-making process can vary from one region to another. As one source has noted, a physician is expected to provide care at:
"the level at which an ordinary, prudent professional with the same training and experience in good standing in a same or similar community would practice under the same or similar circumstances".
The standard of care one would expect from a physician when treating a cancer patient may vary from one locale to another. For example, the standard would likely be higher in a large metropolitan area where clinical research on oncology issues is being conducted and state-of-the-art remedies are being applied than it would be in a small town in Texas or Alaska, where an oncologist is unlikely to be involved in oncology research studies and has fewer opportunities to further develop their treatment skills.
Patient and Family Wishes At the end of the day, every cancer patient must decide whether or not they intend to receive chemotherapy. We are aware of instances where an individual diagnosed with a treatable cancer chooses not to undergo such a regimen, despite the fact that such a decision may hasten their demise. Alternatively, a critical patient may actively seek to receive chemotherapy, even though it may not be recommended for individuals who has been diagnosed as terminal.
Although this case is a dramatic example of what can happen when an oncologist is alleged to have bilked Medicare, it provides a stark example of a situation where the defendant should have previously identified that their chemotherapy practices were different from those of their peer.
In light of the risks presented, we strongly recommend that oncology practices develop, implement and follow the rules and regulations set out in an effective Compliance Plan. Through the use of a GAP analysis, oncologists can identify potential documentation, medical necessity, coding and billing deficiencies in their practice. Once identified, these deficiencies can be carefully assessed so remedial action may be taken to address any overpayments or other improper claims practices that have been identified to avoid any possible Oncology fraud. When conducting a GAP analysis, we strongly recommend that you engage experienced legal counsel to assist you with this process.