William Rogers, MD, FACEP
Medical Officer, Office of the Administrator
Director, Physicians Regulatory Issues Team
Center for Medicare and Medicaid Services
Department of Health and Human Services

November 5, 2006

Dr. Rogers: I am president of the American Association of Clinical Urologists, past president of the California Urologic Association and the California urology representative to NHIC's Medicare Carrier Advisory Committee. For the past few months, I have been receiving queries and complaints regarding requests from the Recovery Audit Contractor PRG Schultz. These were few at the beginning but have recently turned into a flood. Although I have spoken with representatives of other medical specialties in California (several of whom are fielding similar complaints), I am writing you specifically regarding those demands for records made on California's urologists.

While we understand that the demonstration project is intended as a 3 year pilot, it was initially presented to us that records under review were going to be limited to the previous 1 year. Instead, we are finding that the vast majority of requests involve services supplied 3-4 years ago. Additionally, it seems the area of focus for our specialty is limited to patients who received LHRH agonist injections or Zometa for prostate cancer. The cover letter from PRG Schultz indicates that the intent of the audit is ultimately educational resulting in "fewer hassles for physicians, providers and their staff", but the efforts so far do not appear that way. Certainly, high cost items are at risk for fraud and abuse, but the audit is stated to focus on documentation to "validate the correct service, code and units billed and reimbursed." It is not clear that substantial abuse or fraud has been demonstrated in this area and the number of requests now targeting California urologists is quickly becoming quite burdensome. Recognizing that the contractor shares in any recovered monies, it is our hope that the RAC is not attempting to capitalize on minor charting errors to our disadvantage and their financial gain.

Treatment of prostate cancer patients with LHRH agonists (Lupron, Zoladex, etc) or Zometa requires diagnostic evidence of prostate cancer. I am most familiar with the LMRPs and LCDs covering LHRH agonists since I worked very intimately with Bruce Quinn MD and his predecessors Art Lurvey MD and Gerald Rogan MD on all of them and had a large hand in actually drafting the policies. Yet we are very puzzled by what PRG Schultz hopes to gain from these reviews. Their communications include a statement indicating that the request is based on "a recent review and discovery of potential overpayment of your Medicare paid claim". This statement would certainly suggest to the recipient that someone has already made a preliminary evaluation of the claim in question and suspects an error. And yet,generally, the records in question have never been previously reviewed so that is impossible. Moreover, chart notes from the date of service in question may not contain the entire "treatment plan" relative to the claim. Therefore, the requests are very unclear about how much documentation must be submitted in order to satisfy PRG Schultz' investigation. Since the communication itself is vague about exactly what is being reviewed or what level of documentation is necessary to support the decision to treat the patient in this fashion, the doctor is left wondering what to submit (are they looking for a pathology report to document the presence of prostate cancer, a written diagnosis in the chart, blood test evidence or x-ray data to document the stage of disease, evidence that the dose billed for was ordered in writing by the doctor and provided to the patient on the date billed, that the doctor was present in the office on the date of service, that follow up evaluation was made to determine outcomes, documentation about the intent of treatment--palliative, curative, adjunctive, neo-adjunctive, etc.--, the anticipated length of treatment, warnings about side effects, reported side effects, consultation with other cancer specialists or what). No guidelines exist to help the physician respond to what appears to be a fishing expedition by this reviewer. Additionally, the cover letter indicates that records will be reviewed by "registered pharmacists, registered nurses and contract and claims reviewers" but not physicians. This makes it even more unclear to the investigated physician how to respond and what level of documentation is really needed.

The number of requests received by urologists is now mounting with little justification causing doctors to take time away from treating patients to review charts, decide how much documentation is necessary to support their claim and responding to the RAC challenge (because that is what it is). These efforts are yet another unfunded mandate and uncompensated demand on physicians' most limited resource, their time.

Almost no information or education was provided about this program before it began and little has been forthcoming in the past few months. California physicians are left wondering what they have done wrong and how to respond to this Kafka-esque investigation. Compounding the matter, most have not received a written determination about their review even months after submitting their records. Those who have receive a terse reply that the review "resulted in no findings", that "the services you submitted were reasonable and necessary" and "that the charges submitted were processed and paid correctly". What does that mean? Was there ever really a suspicion otherwise, and why.

We have spent a great deal of effort warning our California Urologic Association members about the existence of the RAC and informing them that compliance is mandatory and consistent with HIPAA regulations. However those who have been contacted to this point are becoming quite upset about the nature of the demands, the lack of guidelines, the absence of feedback, the reasons they were singled out for investigation and concerns that they may be at risk for open ended further investigations for no apparent reason. The fact that the RAC is rewarded by sharing in overpayment collections makes this program smell even worse. The bounty hunter aspect of this project is a threat and insult to our practicing physicians. Carrying out investigations without transparency and with limited rights of appeal (especially if we don't know what the reviewer is reviewing for) aggravates the situation.

I understand through Dr. Quinn and your email to him that you have "heard very little" on this subject. That may be because targeted physicians have little understanding of what they are embroiled in and even less direction about where to complain or seek help. As the ombudsman for California's urologists, I have heard a great deal and it is growing almost daily. What can the you, the PRIT or CMS do to help mitigate this growing concern?

As I receive more and more reports, I am generating a registry of PRG Schultz's activity and sharing it with my counterparts in New York and Florida. I also understand that a motion to condemn this program will be introduced at the upcoming AMA House of Delegates. Additionally, as this burdensome intrusion continues to grow, I have already brought it to the attention of MedPAC and will bring it back to CMS in Baltimore and Congress after the elections. I hope this communication will also allow you to make comments to CMS directly on our behalf emphasizing the very burdensome nature of the program. I look forward to hearing from you any information I can share with other California physicians. Finally, I appreciate any efforts you make to re-direct the RAC activities to those areas more appropriate to their Congressional mandate.

Sincerely Yours,

Jeffrey Kaufman, MD, FACS
President, AACU
Past president, California Urologic Association
Urology representative, NHIC CAC, California