Friday, December 27, 2013

The Government's Response: Notes, Part 2, "Unnecessary Treatment"

     The government says I provided medical services that "weren't reasonable or necessary."  It gives some examples in its Complaint, but it cites patients using their initials--and five or more years later, I don't recognize them without their charts.  Besides, the services it mentions were so basic to my medical practice--EKGs, ultrasounds, x-rays, labs, smoking cessation counseling--that it would be like telling an ophthalmologist a cataract surgery done 6 years ago on patient "M.S." "wasn't necessary."
     The tests available in my clinics were essential for making accurate diagnoses--they weren't arcane or extravagant tools.   As for tobacco counseling, almost half our patients were smokers or ex-smokers with lung or heart disease directly related to tobacco use, so they would have received tobacco counseling (not a covered service until March 2005, and therefore not billed until after that date).
     Patients received other kinds of counseling as well, for cholesterol, weight loss, and nutrition.  Medicare notified doctors that it would start covering these services before the smoking codes were approved.  My prosecutor seems to think this was "unnecessary," too.
     The government capitalizes on particularly bad wording in the False Claims Act (FCA) to make its argument:   it's a violation of the FCA to provide unnecessary treatment.
     What's unnecessary?  How does the prosecutor know?  Is he guessing?
     There have been many government cases against doctors for "unnecessary treatment"--it's a popular charge.  The unnecessary treatment cases usually get settled out of court, and the Department of Justice (DOJ) publicizes them widely, because they represent big coups.  They're too expensive to defend, and the cards are stacked against doctors.  I know, because dozens of lawyers have told me that's why it's hard to defend my case.  The FCA is a nasty piece of legislation when it comes to medicine.
     I've provided links for two DOJ cases involving a cardiology procedure called stent placement.  In both, the cardiologists were accused of doing "unnecessary" stent placements.  But almost all cardiologists do stent placements.  So which ones are "necessary"?  The answer is:  almost none.  I don't know the details of these two cases and I'm willing to acknowledge that the doctors and hospitals may have "knowingly and recklessly" performed and billed for "unnecessary services."  But I do know that, based on current data about stent placements (which is that 95% of them aren't necessary), the feds could just as well be prosecuting all of this country's cardiologists.
     Here are the cases:
        Michigan cardiologist settlement
        Tennessee cardiologist settlement
     Both are qui tam cases, which pay out not less than 15% and not more than 25% of the settlement to the whistleblower.  Because the FCA statutes were stacked against these cardiologists, as they're stacked against me, the docs didn't have a chance.  Of course the docs settled.
     Here's a question for the government:  when is a coronary stent "necessary"?  How does it know?  How does it decide which cardiologists to prosecute?
     In 2007 the COURAGE (Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation) trial results came as a huge surprise to everyone.  They said that stents were no better than no stents when it comes to treating coronary artery disease, in all but a handful of heart patients. What COURAGE demonstrated was that stents were "unnecessary," and medical management worked better for preventing future heart attacks.
     What's "medical management"?  It's what I did every day in my clinics;  it's what family doctors do all the time;  it's getting patients to exercise, lower their cholesterol, take four medicines (beta- blockers, ACE-inhibitors, statins and aspirin), quit smoking and keep their weight down.  It takes more time than stents, but it's better, and a lot cheaper.
     Millions of stents are placed in patients' coronary arteries every year, in spite of the 2007 data, which has been corroborated by other studies.  Drug-eleuting stent procedures cost $30,000 to $60,000.  Most cardiologists ignored the COURAGE results when they came out, and at least two-thirds of the stents placed today are probably "unnecessary."  See for yourself in two overviews of this problem--the raw data and studies are available if you want them.

NY Times: stents overused
Bloomberg report: stents lead to death

     The government could, if it wished, prosecute nearly every cardiologist in the country-- because there aren't many who don't do stents.
     Here's why cardiologists do stents:  1) patients still subscribe to the erroneous theory that coronary disease is like having blocked pipes, and stents will "open" them--so they want  stents;  2)  a stent  procedure is quicker and pays a lot more than the office visits necessary for explaining COURAGE to patients and getting them to change bad habits that contribute to heart disease;  3) in the middle of a cardiac catheterization, it's easier to justify doing something, including an unnecessary stent, than nothing.
     Why aren't government prosecutors charging every cardiologist with violations of the FCA?  Why aren't they raiding cardiology clinics, freezing money in their bank accounts, and prosecuting them all?
     The truth is, they could.  They have COURAGE to back them up.  But the government doesn't know whether procedures are "necessary" or not.  It doesn't attack physicians unless there's evidence of gross negligence--or a whisteblower to pull its chain, a whistleblower who knows how trigger-happy prosecutors are, and who is banking on a big payoff.
     If the government knows that the EKGs, labs, x-rays, ultrasounds and counseling I did in my clinics were "unnecessary" I'd like to know how.  I did many of those EKGs, echocardiograms (a heart ultrasound), stress tests, x-rays and tobacco counseling as a direct response to the 2007 COURAGE trial results--which I read when the study came out.  I did not send patients to cardiologists if the results of my own evaluations proved there was no need for catheterization or stent placement.  I did, however,  do echocardiograms, EKGs, stress tests, lab work, and x-rays.  And I did spend time getting patients to exercise, alter their diets, lose weight, change their lifestyles, take appropriate medicines, quit smoking, and stay quit.
     It is estimated that tobacco-related illness has cost the American government $500 billion in the past ten years.  If the feds want to take back money for Medicare, they should be encouraging more doctors to provide smoking cessation counseling, not apprehending them for using a code Medicare introduced to cover the cost of helping patients with tobacco-related problems.
     Instead of calculating how much money it spent on "unnecessary" EKGs, ultrasounds, x-rays, labs and tobacco counseling, why doesn't the government add up the sums it has saved on account of my patients not getting cardiac catheterizations and stents?  Why doesn't the government figure out how few emergency room visits my patients had, or calculate the savings on bronchitis, pneumonia and emphysema treatments for the ones who quit smoking?  Why should Medicare be happy to pay for cardiology visits up to $250 each, or E.R. evaluations for angina at $10,000, or cardiac catheterizations at $2,000, but questions a $23 EKG, or $20 for tobacco counseling?
     Instead of trumping up nebulous charges against me, then scurrying to find evidence to support them, why doesn't the government take a few steps back and really sort out how to reduce Medicare spending (clue:  it's not by indicting well-meaning doctors)?  Why doesn't it stop terrorizing docs who are doing their jobs?  We doctors are living a nightmare, between malpractice lawyers--who threaten to sue for "failing to diagnose" and "failing to treat"--and the feds, who hawk, "Unnecessary treatment, fraud!"  Tell me, what are we supposed to do?
    At the very least, it's about time we rewrote the False Claims Act so it doesn't gives our assistant U.S. attorneys unbounded license to attack any doctor it wants, for doing "unnecessary treatments."


  1. Did you see the Gainesville Sun article about an ophthalmologist’s troubles with the FBI and the Department of Health and Human Services? Dr. Salomon Melgen is the top biller in the nation for Lucentis. He’s been accused of improper billing based on his “multidosing” of Lucentis. Medicare said that he should only use one dose of a four-dose vial and throw the rest away. One vial costs about $2,000. He was treating four patients with one vial. The feds say he improperly billed $9 million to Medicare. Even though a vial contains four doses, Medicare says that the FDA-approved labeling for Lucentis states that physicians should use one vial of the drug for each patient and to discard the excess amount. In the end, Medicare’s cost would have been the same even if Dr. Melgen had used one vial of Lucentis to treat each patient and billed the program accordingly. Of course, this would cost Dr. Melgen his own money to buy more Lucentis vials. Do you think that burden would have a very negative impact on the patients who could benefit from a Lucentis treatment? You bet it does and all over America!

    Medicare is accusing him of providing treatment that is medically unnecessary for patients with leaky blood vessels that damage the area of the eye responsible for central vision. This accusation is a good example of bureaucrats taking the place of doctors. If these bureaucrats were blind and house bound, would they sing a different tune? You bet!

    He has returned millions in payments. Medicare wants more from him. He is now fighting back. His attorneys argue that he had the discretion to multidose the drug.

    The feds have found their grove. The medical professional is in a fight for survival, even if they don’t know it, yet. While physicians have toiled away, the feds have steadily conferred to come up with a system that solves their need for more money. The feds have found their cash cow in doctors, hospitals, and clinics. They have the methodology down to almost becoming entrenched in success.

    Join ranks, as there is strength in a large group with the same purpose. I get from you that doctors think that they are safe working within large groups of physicians. Do you think that this will be true ten years down the road? Physicians should feel more threatened by the possibility they could come up against a criminal probe by the federal government if compared to a malpractice complaint. Isn’t it at least as threatening as a medical malpractice lawsuit? Are there lobbyists working to represent doctors, clinics, and hospitals to the folks on Capitol Hill? Consider establishment of law firms that have knowledge, skill, and experience in defending doctors’ accused of Medicare Fraud? There doesn’t seem to be even a referral system in place to help a physician with the threat. Don’t doctors need competent advice from the initial contact with the feds? You know, when the FBI first comes sniffing around asking to see patient charts. If you are a doctor in Georgia who would that be? How about in Florida?

    1. Could you share the link to the article about Dr. Melgen? I haven't been able to find it.

  2. The field of law pertaining to protecting doctors against federal criminal and civil lawsuits has grown exponentially in the past ten years. There are ads all over the internet for law groups that "specialize" in this area of protecting doctors once they're raided or questioned. I don't know how good they are, but they grease their interactions with bewildered doctors with infusions of fear and self-congratulatory soliloquies before they ask for astounding retainers. I have had contact with many of the big and small groups who have taken up the reins to defend doctors, and why shouldn't they? It's a lucrative field--think of the local attorneyI mentioned in a blogpost last month, the one who told me he would need to see proof of my assets in advance so he knew I could pay him, if I chose to hire him, adding as a aside that the last doctor he represented went bankrupt after the case was won. The doctor wasn't found guilty, but he was left with his bankbook broke by the lawyer, his reputation ruined by the feds, his mental state in a shambles, and no one else the worse for it all, certainly not the feds (who went back to work the next day) nor the lawyer who represented him.
    As for Dr Melgen, there are many questions to be asked. Why does the pharmaceutical company put four doses of medicine in a single-use vial? They don't do this with single-dose flu serum, or Reclast, or Boniva, or Depoprovera, or any other medicine I know. I expect that, according to the feds, Dr. Melgen was free to give the other doses to other patients for free--no one would have cared. What bothers them is that Dr. Melgen billed Medicare for all four doses, and that's where the bounty-hunters are headed. The next question is: why are these medicines so costly? The answer: the government, for all its pronouncements about saving money, doesn't regulate the cost of medicines. Medicare's charges for meds are based on the manufacturer's prices, so Medicare pays top dollar for meds--why doesn't it save money for the country by telling the drug companies to charge less?
    The third question is: can Dr. Melgen go back and bill the other three patients for their treatment, since Medicare refuses to pay? No, he can't--not if he's a Medicare provider. It's illegal for him to collect from patients who want to pay cash. Doctors are strapped in many ways, and this is one. Dr. Melgen can stop being a Medicare provider, but no one can afford Lumigen, and most of the patients who need it are on over 65 and on Medicare. It's true that Dr. Melgen was making four times as much as doctors who used one vial per patient, and I don't know whether that's cause for punishment or not. I guess in the government's eyes it is, because it behooves the government for it to be. These days the justice system isn 't interested in stopping crime, it's interested in making money.

  3. My apologies, I should have anticipated that you would want to read the article. The article was titled “Despite federal probe, eye doctor’s patients see him as a ‘godsend’” appeared in the Gainesville Sun on Tuesday, December 31, 2013. But, I found it online here: federal-probe-patients.html

    It is logical on Dr. Melgen’s part to utlilize all four doses. It is no wonder why Dr. Melgen is the top biller in the nation for Lucentis. If Medicare is only paying $2,000 for an individual treatment and the medicine alone costs $2,000 per treatment, then, it would stand to reason that Dr. Melgen is one of few doctors offering the treatment to Medicare patients. It is ludicrous to throw away $1,500 worth of medicine in a free market society. Thus, our marketplace must be regulated by a government that intervenes in the setting of prices.

    Section 1311(h)(1)(b) of Obamacare reads:
    “Beginning on January 1, 2015, a qualified health plan may contract with … a health care provider only if such provider implements such mechanisms to improve health care quality as the Secretary may by regulation require.

    In other words, insurance companies will be banned from doing business with doctors who do not comply with the regulations established by the health secretary. Offending doctors, clinics, and hospitals will be shutdown.

    Right now in America where our quality of health care is concerned, we have a government that not only intervenes in the setting of prices but also intervenes by the setting of regulation.

    God help us.

    1. The government's regulation has kept many patients from being able to receive medicines like Reclast and Lucentis. Doctors won't give these valuable medicines if they are required to lose money every time they do so. This is one reason most family doctors don't give immunizations to children and adults, instead sending them to the health department. But when patients leave the doctor's office it's less likely they'll go somewhere else for treatment that should have been given in that office. Kids get immunizations only because the school system requires them for matriculation. But adults routinely miss important shots and other preventive treatments. Medicare then pays for the consequences: hospitalization for pneumonia or influenza that could have been prevented by a pneumovax or flu shot; hip surgery for fractures that could have been prevented with yearly Reclast, etc. Who's looking at the big picture? Not the DOJ, which sees medicine as a cash cow.

  4. I worked with Dr. Colasante, as one of her two Nurses (with Degrees) husband Steve was her other Nurse. I worked for Dr.C from 2002 until 2005, when I then retired. My husband continued working for her, then even worked for her at her Gainesville office.

    Dr. C is one of the best doctors I have ever worked for. I worked with quite a few Physicians in Michigan who were either blatentely incompetent or were rude to their patients and staff. Some of them had a "God" complex even. Dr. C is a real person. Her patients love her so much that some of the would come up to the Facility just to visit her and our staff.

    Dr. Colasante was also a very thorough Doctor. I have personally watched her save lives by performing some of those so-called "Unneccessary tests" right in her office. Her office was almost a miniature Emergency Room. We did lots of testing and treatments that most other doctors' office's do not do. We could give I.V. treatments and medications, perform EKG's and stress tests. We tested for STD's, UTI's and even Allergies. We were a full-service doctors' office.

    Dr. C has a huge heart too. Not only does she care for her staff and patients...she cares for them enough to give them special treatment. She makes house calls when her patients aren't able to come in to the office. This, in an era that no doctor does house calls anymore. We had elderly patients that we did "Home visits" on either every day or once a week, depending on their needs...Her patients absolutely loved her and fully trusted and believed in her ability as a Doctor to keep them healthy. Some would come from hundreds of miles away just to see her.

    It was a sad day for everyone when Dr. C closed her doors. Never will there be a more caring, brilliant doctor again as was Dr. C. She will be missed...

    I'm so sorry to see you have to go through this Ona. You are the last Doctor I would have thought they would do this to. I don't understand how they can call those test "unnecessary". Those tests saved lives! Do they even get that?

    Prayers go out to you. all if you need Steve or I for anything. Good Luck with this.

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