Dear Patients, Friends and Supporters,

Much has transpired since I wrote the above update.

Medicare went ahead and put in place some of the most restrictive guidelines for IVIG in the country that limit the use of IVIG for immune deficiencies to only individuals who were born with an antibody deficiency problem and the 2 FDA-approved indications, chronic leukemia and HIV+ children less than 13 years old.

A group of my patients who depend upon IVIG for their health, filed a formal Medicare appeal which in view of Medicare's heartless past behavior was not surprisingly denied.

The patient's appealed to an Administrative Law Judge (ALJ) to review the case.  The ALG gave a ruling in favor of Medicare without ever formally addressing the elements of the patient's legal appeal.  Simply put, the ALJ stated that Medicare officials have the right to make whatever decisions they deems are necessary to run the Medicare program, and that the burden of proof is upon the patients to prove that they have been wronged.

The ALJ failed to comment upon the salient points in the legal brief supporting the patient's claims of being target by Medicare.  The legal team supporting the patients found the formal response from the ALJ rather strange in its content and scope - it seemed a rather cursory response to what is a rather complicated issue.

The patients then decided to file a formal brief in U.S. Federal Court and received a reply last week.  Unfortunately, the Federal Judge determined Medicare is able to make whatever decisions it generally needs to run the Medicare program even if those decisions specifically target HIV patients for no other reason than to spend less money.

Just as a reminder, we have a copy of an e-mail that points to the fact that this entire Medicare witch hunt against me, my practice and the lives of my patients was driven by the concern that I might be spending too much money on my patients.

I find it interesting that Medicare never once evaluated any of the HIV- patients in my practice who also require IVIG although they stated interest was to only determine if the IVIG treatments were being used in a medically appropriate manner.  But even after 3 audits of my patient medical records over a 5-6 year period, Medicare and their outside medical experts failed to demonstrate that a single treatment of IVIG was not medically necessary.

Their repeated audits and review by outside experts only strengthens our position that the treatments are considered medically appropriate.  So failing to show the treatments were unnecessary, Medicare decided to just change the guideline we have to operate under.  They concocted a shame survey and used the purported results as a basis for the rule change.  Unfortunately, they revealed they had a draft of the new rules prior to the time they could of even of received all the survey results.  How can one develop new guidelines from a survey that hasn't even yet been concluded?

Medicare officials even tired to bolster the medical legitimacy of their position by citing a few scientific articles from the medical literature.  Unfortunately, 2 of the lead authors of Medicare's supportive documents actually submitted in writing that Medicare's position was flawed and unfounded.

So, in spite of Medicare targeting a patient population because of money concerns, their repeated outside expert reviews showing that all the IVIG treatments I gave were considered to be medically appropriate, the development the probably most restrictive IVIG guidelines in the country that were based upon a shame survey, their refusal to acknowledge the fact that the authors of Medicare's supportive research instead issued letters in support of the patient's continued use of IVIG ... the Judge ruled that Medicare has the right to make whatever rules it likes to run its program.

We cannot stand by while Medicare, a tax-payer funded health care entity is allowed to callously target innocent patients with strong-handed tactics.  We need your help in raising money to continue the legal battle in the Federal Court of Appeals.

Please contact FightbackKC, a grass-roots organization devoted to raising money for the legal fund, and make a contribution to continue our fight for medical justice in this country!

I thank you in advance for your support.

Sincerely,
Patrick Nemechek, D.O.

Dear Patients, Friends and Supporters,

(1/22/2005)

Hello, my name in Patrick Nemechek, D.O. and I'm a board-certified specialist in Internal Medicine located in Kansas City, Missouri.  I have specialized in the treatment of persons infected with HIV for approximately 15 years.  The following is a brief but thorough review of my harassment by Medicare.

I've have been the target of 2 post-payment audits by Medicare in the last 5 years for the use of immune globulin (antibody transfusions) for an antibody deficiency state known as hypogammaglobulinemia that occurs in my patients with HIV.

A post-payment audit is a laborious and expensive process in which Medicare reviews the care you have provided patients over the period of time.  If Medicare concludes you did not follow their specific guidelines for the treatment being audited, they will force you to pay back the money you were reimbursed for that treatment you provided to your patients.  It becomes even more expense if you do not agree with Medicare's conclusions and choose to file an appeal.  Unlike private insurance companies, there is no process for a physician to obtain prior approval from Medicare for a specific treatment.

Hypogammaglobulinemia is a well know immune disorder that HIV negative individuals may acquire at birth, and they are diagnosed and treated in the same fashion as I diagnose and treat my patients with HIV.  Individuals may also acquire this condition after treatment for cancers, various rheumatic diseases, kidney or gastrointestinal diseases. The diagnosis of this condition is straight forward, and the treatment with immune globulin for hypogammaglobulinemia is FDA approved.

At the conclusion of both audits, every single instance in which I used immune globulin in my patients was determined to be medically sound and in compliance with Medicare's regulations.  I was allowed to continue treating my patients, and was even given written clarification after the first audit that as long as I was using immune globulin to primarily treat the low antibody condition and not HIV per say, and that future approval and reimbursement by Medicare would not be withheld or challenged.

But now the Medicare intermediary (a private insurance company that helps Medicare pay insurance claims from physicians and hospitals) BCBS of Kansas, has concocted a modification to the rules (Exhibit 1) applying to the use of immune globulin.  This modification essentially allows for the use of immune globulin for hypogammaglobulinemia only in individuals who are felt to have acquired the antibody deficiency condition at birth (with the exception of Lymphoblastic Leukemia which has its own FDA approval) and have no explainable secondary cause.  Anyone who happens to develop this condition secondarily from another medical condition such as cancer, HIV or even medications they are forced to take, are no longer covered.

This makes as much sense as saying that if your blood sugar is too high, Medicare won't pay for insulin unless you were born with Diabetes Mellitus.  If the high blood sugar is due to a medication that you cannot stop, Medicare's logic would suggest they wouldn't pay for your insulin either.

These are not a national set of rules; these rules apply only to Kansas, Nebraska and the North Western portion of Missouri. I should add that no significant changes in medical knowledge have occurred regarding the use of immune globulin in the treatment of hypogammaglobulinemia to account for their rule change.  

In addition, 17 days after posting these 'modifications', BCBS notified me of a third audit (Exhibit 2) regarding the use of immune globulin in my patients with HIV.  Many of the patients specified in the third audit have already been evaluated in one or both of the prior audits, and were found to be receiving immune globulin appropriately in every instance.

The third prepayment audit is an effort to trick me into breaking the law.  BCBS of Kansas is essentially daring me to submit a financial claim to Medicare for reimbursement of expenses that I had been told in advance are not allowed.  When a physician knowingly submits a claim that is not allowed by Medicare regulations, he is knowingly breaking the law, and could be accused of healthcare fraud. 

Obviously, I can't file any more claims for immune globulin in patients with HIV for fear of prosecution, and because of the expense of immune globulin (approx $2000 per month) neither my patient's nor I can afford continue providing them this aspect of their health care.  I am continuing to provide all other aspects of their medical care, and have even provided the patients psychological counseling at my own expense to help them deal with the trauma associated with this careless rule change.

Because of the change, 23 healthy HIV infected patients are now forced go without a specific therapy which every single patient believes was the missing piece to the puzzle for their renewed health.  These patients are becoming very anxious and scared because during the appeal process of the prior 2 audits, I was forced to discontinue this expensive treatment until the appeal of the audit ruling found that my treatment with immune globulin was medically appropriate.

During the time without immune globulin, the patients became extremely fatigued, began developing more frequent and severe sinus infections, drenching night sweats, chronic fever and chills and weight loss.  Within 2-3 months they all had regressed to the previously ill state they were in when we had initially chosen to try treating them with immune globulin.

Interestingly, the regional Medicare office in Kansas City has been shocked at the overall treatment I have received at the hands of the BCBS of Kansas (the subcontractor who makes the regional rules for the government), and has been very vocal in their support of my position.  But BCBS of Kansas has refused to cooperate in spite of several meetings with the Kansas City Medicare officials.  It seems that the BCBS of Kansas is intent upon getting their way in spite of the dangerous consequences their actions may hold for my patients.

Unfortunately, no one within the Kansas City Medicare office is willing to give me any substantial support in writing.  They've only given me their verbal "assurance" that I can go ahead and continue to provide immune globulin to my patients without fear of retribution.  Verbal assurances don't give me any comfort when rules prohibit  billing Medicare for immune globulin in the treatment of hypogammaglobulinemia secondary to HIV infection are still in place, and the penalty for breaking them could potentially include going to jail.

At this point, I feel that I've exhausted all my options available to my representatives at the regional Kansas City Medicare office, and on Friday, September 24, 2004, I delivered a demand letter to BCBS of Kansas instructing them to reverse their recent regulation change or they would face legal action (See Nemechek BCBS Demand Letter).  Reading the demand letter will help you understand how threatening the audit process can be when abused by regulators.

The 3rd audit was withdrawn only after complaining loudly to the regional Medicare officials as well as senior Medicare officials in Baltimore.  Although the audit of my practice was withdrawn, the rule change remained in place that still prevents me from providing immune globulin to my patients.

On December 1, 2004, my attorneys and I held a face-to-face meeting with the carrier's Medical Director, his staff and representatives from the Kansas City regional Medicare office.  At that meeting it became very clear that my suspicion about being targeted was reaffirmed.  The Medical Director's staff stated they were "upset" that their audits of me continued to be overturned by the appeals division of Medicare, and they admitted that they continued to audit me in spite of knowing that my medical care had been determined to be medically necessary during the prior audit appeals.

We also learned at the last minute that the carrier has already posted on their website a Proposed LCD (Local Coverage Determination) for immune globulin excluding patients with HIV from receiving immune globulin.  To their credit, the carrier offered to extend the comment period deadline an additional 30 days to allow me to prepare comments regarding the proposed LCD.  I delivered my comments to the carrier on January 10, 2005. 

The important points of my comments against the proposed changes which exclude HIV-infected adults from receiving immune globulin include:

• Scientific literature showing the benefit of immune globulin in HIV-infected adults with secondary immunodeficiency.

• Highlighting the fact that FDA-approval for the same treatment already exists for HIV-infected children less than 13 years of age.

• Demonstrating support of the general medical community for the use of immune globulin in HIV-infected adults by demonstrating that 80% of existing Medicare carrier LCD's would allow the use of immune globulin in adults with HIV infection and secondary immunodeficiency.

• Have refuted the scientific basis of BCBS's refusal to provide immune globulin to adults with HIV infection with letters from the authors of their referenced, supportive scientific papers.  The authors of both of the carrier's references disagree with the carrier's position, and conclude that immune globulin treatment in HIV-adults with secondary immunodeficiency is medically appropriate. 

Then on December 2, 2004, I received a phone call from a legislative aide to Senator Bill Frist, Senate Majority Leader and former Cardiac Transplantation Surgeon.  The aide told me Senator Bill Frist was quite upset about my harassment and wanted my problem "fixed as quickly as possible".  Senator Frist asked my problem be forwarded to Senator Grassley's staff and possibly the Finance Subcommittee on Medicare Operations and Investigations to review the issue.

I plan to be in Washington, D.C. within the next few weeks to press this issue face-to-face with our congressional representatives.  I have even arrange to have highly respected immunologists attend a possible congressional hearing on the matter if necessary.

My personal belief is that BCBS of Kansas is trying to save money by preventing the use of an expensive medication in HIV patients because the their staff has decided its use is either futile (i.e., the patients will die anyway), this specific patient group doesn't deserve it (i.e., they patient's brought it on themselves, immorality, etc.), they think science doesn't support its use, or all of the above.

This is the unfortunate beginning of a potentially long and protracted legal fight with Medicare.  I am willing to lead the way but need assistance in any form it may come.  A few simple things you can do:

• Call or write your congressional representative (See List) and demand they investigate why Medicare is targeting doctors in order to save money.  Refer them to this web site to see all the facts.

• Ask friends or relatives to get involved.  If this trend is allowed to continue, Medicare will be destroyed beyond usefulness.

• We are accepting donations to pay for the ongoing legal and lobbying effort.  Standing up against the resources of the federal government is no small task.

• Let us know if you or your physician has also been involved in a Medicare audit concerning the use of immune globulin.

Please do not let this challenge go unnoticed.  Today Medicare will save money by limiting immune globulin in persons with HIV or other secondary causes of hypogammaglobulinemia, and tomorrow who knows which treatment or what disease will be chosen for the financial chopping block?  It might affect you, your partner or spouse, your parents or grandparents.

Sincerely,

Patrick M. Nemechek, D.O.
Nemechek Health Renewal
4010 Washington, Suite 500
Kansas City, MO  64111
pnemechek@healthrenewal.org
816-756-0090 Office
816-756-0120 Fax