Why I'm paranoid
A recurring nightmare
I am in a Senate hearing room, sitting alone at a long mahogany table and facing a panel of stern-faced inquisitors. There is a large gallery present, but I can’t make out any faces because of all the spotlights trained on me – more lights, it seems to me, than would be necessary for just C-SPAN. I am sweating from the heat.
I turn to my
attorney for reassurance. He
is sitting in a row of chairs behind me, fidgeting with some papers and
pointedly avoiding
eye contact. He’d
rather not be representing me, and he wants the Senators to know it.
A gavel pounds. I turn to face my accusers.
A white-haired Senator slowly pulls a microphone toward him, regards me for several moments with steely gray eyes, and says,
“Reminding
you, sir, that you are under oath –
Are you now, or have you ever been, a physician?”
I mop my brow, knowing how guilty that must make me look to the folks at home. I look for my attorney. He’s gone.
I do what I have to do.
I take the 5th.
One afternoon in June of 1994, I was summoned to a meeting by a vice president of the hospital for which I worked at the time. Meetings, especially unannounced ones, are the bane of employed physicians; but this one, I was led to understand, was mandatory.
I found the meeting room filled with high-ranking hospital administrators, hospital attorneys, and my clinical chairman. A gathering of luminaries such as these, especially on short notice, was decidedly rare. As I walked into the room all eyes were on me. I knew all these people; they’d been my friends and colleagues for years. We’d been fighting the health care wars side by side. But now they studied me as if seeing me for the first time.
“Who died?” I asked, just to break the ice.
“To be determined,” responded one of the lawyers.
They got right down to business. The federal government, in the guise of the Office of the Inspector General (OIG), had launched a major investigation of alleged improper Medicare billing practices related to the use of investigational implantable cardioverter defibrillators (ICDs) in the late 1980s. This investigation, I was told, had begun as a whistleblower law suit out on the west coast, and the feds were now expanding their inquiry. The OIG had just subpoenaed records from approximately 120 of the largest hospitals in the country that implanted ICDs. We were one of the 120.
Now I understood why I was here. As Chief of Cardiac Electrophysiology, research with the ICD was one of the major endeavors of my career.
The ICD is a device that is designed to prevent sudden death in patients whose cardiac disease makes them prone to such an event. Once implanted, the ICD recognizes lethal heart rhythm abnormalities whenever they occur, and automatically delivers a shock to the heart to restore the heart rhythm to normal, thus automatically resuscitating the patient. It is a remarkably effective device, and was obviously so from the very beginning, even during its investigational phase. Seldom, in fact, has a more dramatically effective life-saving therapy ever been devised for any illness or disease. For this reason, as long as I had access to these devices I (and most investigators), felt morally obligated to offer them to any eligible patient at high risk for sudden death, despite age or insurance status.
So now I understood why I had been summoned to the meeting. What I didn’t understand was why the feds thought we’d done anything wrong.
“I thought we’d looked into the billing for ICDs back in ’87 when I first came here,” I said. “I thought Medicare said it was okay to bill for them.” While I was an employed physician (and so the hospital did all the billing for my services), I’d had enough concern about billing Medicare for investigational devices that I’d insisted the hospital get clarification from our Medicare Intermediary (the local agent and representative of Medicare) on the matter.
One of the attorneys answered. “That’s right. The Medicare Intermediary indicated at the time that there was nothing illegal about billing them for the ICDs, but couldn’t guarantee they’d pay for them. As it turns out, they’ve paid for each one we’ve implanted, and never questioned our using them.”
“Then what’s the problem?”
“Medicare now says we’ve been violating a regulation by sending the bills,” the lawyer replied. “There’s apparently an obscure instruction in the Intermediary’s guidebook that prohibits billing for investigational devices.”
“But we got clearance from the Intermediary,” I protested.
“And that’s the defense we’ll take. But unfortunately, Medicare operates a little like the IRS. If you call the IRS with a tax question and they give you bad advice, it’s your fault if you follow that advice. The fact that the Medicare people were unaware of their own rules, and apparently told us the wrong thing, doesn't absolve us.”
“So what’s the worst case scenario?” someone asked.
We did some quick math. Over the years we’d implanted about 100 experimental ICDs at about $15,000 each. With a $10,000 fine per incident plus triple damages, we were potentially looking at having to pay the feds between five and six million dollars. And those were just the civil penalties. If the OIG decided we’d intentionally sent illegal bills, there could even be jail terms.
“Don’t worry,” a vice-president said to me sympathetically. “We’re all in this together. We’ll help you as much as we can.”
“What do you mean, you’ll help me?” I shot back. “I just work here. You do all the billing, keep what you collect, and pay me a paltry salary.”
“Like I said, we’re all in this together. But those bills do go out under your name, DrRich. As far as Medicare is concerned, they’re your bills.” As I’ve since learned, when the feds begin pointing their fickle finger, it’s customary for everybody to dive for cover.
For the next two years my life was overwhelmed by a series of complex machinations made in response to the feds’ investigation of our possible “fraudulent” submission of bills. I won’t bore you with the details – I’ll just hit the highlights.
First, my hospital threw in with two dozen other large hospitals that were also affected by the OIG’s subpoena, and together we hired a fancy inside-the-beltway law firm that specialized in health care issues. These fancy lawyers ultimately determined that the obscure regulation the OIG was invoking against us had itself been illegally promulgated, and therefore should not be enforceable. Accordingly, our hospitals sued the Secretary of Health and Human Services (HHS) in federal court to prevent her from enforcing this obscure, previously unknown, and (we held) illegal rule. “We have maybe a 50-50 chance of winning this suit,” I was told by one of our attorneys, “but it won’t be settled for years.”
While all this was going on, the subpoenaed hospitals also lobbied Congress to act on the essential unfairness of it all. “Look,” the hospitals said, “we’ve got one agency of the federal government (Medicare) coming after us for doing research that had been duly approved by another agency of the federal government, the Food and Drug Administration (FDA). We need laws to make the feds behave consistently. When the FDA approves clinical research, Medicare should reimburse for patients who avail themselves of that approved research.” Finally, in November of 1995, Congress passed just such a law. “So we’ve won!” I exulted when the hospital attorney called me with the good news. “Not exactly,” was the reply, “Congress declined to make the law retroactive. So the OIG is still coming after us for what they say we did in the 1980s.”
Then, in January of 1996, the feds launched a new attack. Senator Roth, Chair of the Senate Finance Committee, decided it would be in somebody’s best interest to have a showcase hearing, highlighting the grievous crimes against Medicare that are being promulgated by avaricious physicians and institutions like me and mine. So the Permanent Subcommittee on Investigations sent subpoenas to the CEOs of several hospitals from the OIG’s list of 120, mandating that they appear before that committee on Valentines Day (heart day - get it?) to answer questions regarding allegations of Medicare fraud in the use of the ICD. It was to be a real show –covered on C-SPAN, with major networks in attendance and lots of national publicity. The works.
Immediately, there was a mad rush to have the subpoenas quashed. All the hospitals from states whose Senators were members of the Finance Committee managed to be excused from appearing. At the end of the day, only four hospitals remained. Mine was one.
I was sure my career had ended. My family, friends, patients, referring doctors, and colleagues were about to see the CEO of my hospital appearing before a Senate Investigational Committee answering questions on the Medicare fraud that I supposedly had committed. I knew it didn’t matter that I hadn’t done anything wrong. Truth is only truth. Perception is everything.
I spent two days in Washington helping the fancy beltway lawyers prepare our CEO for his testimony. I failed miserably in my emotional pitch to be allowed to testify in his stead (the CEO had been subpoenaed, not me, and so he’d have to appear; and besides, anyone actually eager to testify before Congress must be crazy enough to get us in trouble). But at least I managed to convince the CEO that we should take a hard line with the subcommittee. After all, we had truth, righteousness, ethics, and possibly even the law on our side. We shouldn’t allow ourselves to be intimidated.
Each witness was to be permitted to read a statement into the record before the questioning began. Our attorneys had prepared a 10-page statement that was vague, wishy-washy, and as near as I could tell, didn’t deny wrongdoing as much as it promised we’d be more careful next time.
So we tore up the prepared statement and wrote a one page statement that said, in essence: 1) We implanted investigational ICDs in Medicare patients because they were at high risk of dying without them, and to withhold such life-saving devices when they were available to us would have been unethical and would have constituted malpractice. 2) Before implanting the investigational ICDs, approval for their use was obtained through the FDA. 3) Before billing for the investigational ICDs we asked for and received clearance to do so from our Medicare Intermediary. 4) The records we sent Medicare in support of our billing for these ICDs clearly indicated that the devices were investigational, and yet Medicare reimbursed us each time, over a period of several years and without questioning our actions or our bills. 5) The regulation Medicare is now invoking was unknown to us during this period of time, and also, apparently, to the Medicare Intermediary. 6) In any case, as we have asserted in federal court, that regulation was illegally promulgated, and is therefore not a legal rule. 7) Congress has agreed that regulation to have been at least an ill-advised one, as evidenced by the fact that Congress recently passed legislation that now renders that regulation illegal, whatever its previous legality. 8) If they assert that our actions constitute fraud, then the message the OIG, Medicare and the Senate subcommittee is sending to the public is that doctors and hospitals are expected to discriminate against the elderly, and will be called to task by the federal government if they refuse to do so. 9) Thank you for your attention.
The hearing was indeed quite a show. The whistleblower himself was the first witness, and he entered the chamber wearing a hood, sat behind a screen, and spoke with his voice electronically distorted. This was the first time in history, I was told, that a witness had appeared before Congress disguised in this way, except in hearings featuring Mafia turncoats, drug lords, and the like. The implication, I presume, was that I and my fellow health care providers were no less evil than other, more famous sorts of felons; and that if we learned this guy’s identity his life wouldn’t be worth a nickel.
Then it was us perpetrators’ turn to testify. The CEOs of the other three subpoenaed hospitals, after reading their relatively contrite statements into the record, were grilled mercilessly by the Senators of the subcommittee. Our CEO was the last witness. Once he read our much more straightforward and aggressive statement, the Senators seemed not to have any substantial questions for him. His testimony was over almost before it had started. Our hard line had paid off.
One more blessing occurred on the day of the hearing. Somebody apparently found some Whitewater papers that weren’t supposed to have existed, so ten minutes before the hearing, C-SPAN pulled out and went down the hall to televise the Whitewater doings. All the other media went with them. Our hearing, despite the dramatically hooded whistleblower, never made the map. The lack of national coverage (and as a result, the lack of local coverage) spared my reputation and that of my hospital.
Then finally, later in 1996, a federal judge ruled in our favor in our suit against HHS – the regulation Medicare was invoking, the judge ruled, had indeed been illegally promulgated.
So, thanks to a few smart people and a few lucky breaks the whole episode seems to have had a happy ending. Right?
I’m not complaining. It could have turned out a lot worse. And it provided me with enough amusing anecdotes to last a lifetime.
But for me, having the weight of the federal government on my shoulders for two years was a life-altering experience. As I saw it, in the service of my patients I (through my representative, the hospital) had failed to note a vague, obscure and difficult-to-interpret regulation (despite soliciting the assistance of Medicare in understanding the regulations), and as a result I had been caught up in the great Federal anti-fraud initiative.
The rightness of my actions, both morally and legally, seemed obvious to me and should have seemed obvious to the feds, too. (So my thinking went.) I had used those ICDs because I was obligated to use the tools at my disposal to help my patients in need. While the regulations had been admittedly ambiguous, they were being interpreted at the time both by my colleagues around the country, and by my own Medicare Intermediary as not prohibiting use of the ICD. Given the situation, it would have been morally, professionally, and legally reprehensible for me not to offer the ICD to those patients. I really hadn’t had any choice at all.
While I was confident I had done nothing illegal and was absolutely certain I had done nothing unethical, for two years the feds remained a constant, unrelenting and overpowering presence in my life, one that affected me profoundly. I deeply feared losing my job not to mention my entire career, my professional and personal reputation, all my worldly possessions and possibly my freedom. There were periods of weeks at a time when this issue became totally distracting, when I could think of little else. During those times I was of little use to anybody – colleagues, family or patients.
What disturbs me most of all today is whether and how much this episode has permanently changed me. At the least, it has left me with a deep and abiding fear of ever again finding myself in the feds’ gunsights. What will this fear do to my judgment when I’m faced again with a patient who needs help on one hand, and ambiguous federal regulations on the other? I frankly can’t be certain. I’ve often wondered what would I do today if I was transported back to 1988, faced with the same decision I was faced with then, but knowing what I know now. I sincerely hope I would still use ICDs in those high-risk patients. I believe I would. But having once experienced the righteous anger of the feds, I can’t be absolutely sure.
So yes, I’m a bit paranoid about health care fraud. And perhaps you should be, too.