Medicares Refusal to Continue IVIg Therapy in Patients with HIV Infection

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Medicares Refusal to Continue IVIg Therapy in
Patients with HIV Infection

• Patrick M. Nemechek, D.O.
• Nemechek Health Renewal
• October 6, 2004

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Goals for Meeting

• Review Medical Issue
• Review Past Medicare Actions
• Overview of Present Medicare Action
• Overview of Legal Options
• Organization of Grass Roots Resistance
• Development of Targeted Action Teams
• Designate Team Leaders
• Coordinate Time for Individual Team Meetings

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Dr. Patrick Nemechek

• Board-certified, Internal Medicine
• UCLA School of Medicine
• 15 years of focused HIV experience
• 26 Publications
• 44 Clinical Trials
• Nemechek Health Renewal
• 10 years in Kansas City area

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HypogammaglobulinemiaWhat does this giant word
mean?

• Dfn Low antibody levels in the blood stream.
• Common medical condition
• Acquired at birth
• Congenital or Genetic
• Acquired from non-genetic cause
• Cancer or cancer treatments
• Immune suppressing drugs
• Kidney, Intestinal or Rheumatic disorders
• Infections such as HIV.

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HypogammaglobulinemiaWhat does this giant word
mean?

• Medicare
• Does not specifically define hypogammaglobulinemia
  .
• Implies that primary immunodeficiencies are
  only from a congenital or genetic basis.
• Implies that secondary immunodeficiencies are
  from other non-genetic or congenital causes.

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What are Antibodies?

• Antibodies are
• Immune system proteins.
• Also known as immune globulin (Ig).
• 5 classes of antibodies
• G (IgG) most important class
• A (IgA)
• M (IgM)
• E (IgE)
• D (IgD)
• Used by the body along with white blood cells to
  destroy infectious organisms.

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Symptoms Associated withLow Antibody Levels

• Fever, Night Sweats and Fatigue
• Sinusitis
• Pneumonia
• Otitis Media
• Diarrhea, Bloating and Fever
• Overgrowth of bacterial in intestinal tract
• Poor absorption of nutrients and medications.

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Diagnosis of Low Antibody Levels

• Measurement of
• Antibody levels (quantitative) in the blood
  stream.
• Antibody response (qualitative) to a vaccination.
• Diagnosis is made by
• Showing low levels (quantitative) in the blood
  stream.
• Inadequate production (qualitative) of antibodies
  in response to vaccine.

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Who Needs Treatment?

• Patients with repeated bacterial infections.
• whose symptoms dont completely improve with
  standard treatment and..
• have low antibody levels (quantitative) or poor
  antibody production (qualitative).

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What is the Treatment?

• Monthly transfusions of antibodies.
• Referred to as IVIg
• Intra Venous Immune globulin.
• Antibodies come from donors and are purchased
  from pharmaceutical companies.

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How Do the Patients Improve?

• After 2-3 months of transfusions
• Energy levels improve.
• Night sweats, chills and fever resolve.
• Fewer and less severe infections.
• Fewer and shorter hospitalizations.
• Fewer bouts of diarrhea and colitis.

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Centers for Medicare Medicaid Services 7500
Security Boulevard, Baltimore MD 21244-1850
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What is Medicare?

• Financed and directed by Wash, D.C.
• Medicaid is funded by both Wash. DC and state but
  directed by the state.
• Pays for 80 of medical expense related to
  doctors, hospitals and IV medications.

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What is a Medicare Audit?

• Medicare has the right to review records
  regarding payments to physicians for services
  rendered.
• Can be issued for past or future services.
• Refunds can be demanded from physicians.
• Physicians are not able to obtain prior
  approval from Medicare.
• Medicare provides an LRMP as a guideline to
  assist physicians.

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LMRP

• Local Medical Review Policy
• State which treatments are paid for by Medicare.
• Are written by intermediary, BCBS of Kansas.
• Vary from region to region.
• Very few policies apply nationally. National
  policies are called National Coverage Decisions.

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Review of the Harassment of Dr. Nemechek and His
Patients Requiring IVIg Treatment
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Audit 1August 27, 1999

• Medicare
• Questions use of IVIg in HIV patients with
  hypogammaglobulinemia.
• Demands refund of 168,783.
• Audit results challenged in Fair Hearing
• Use of IVIG was found to be medically appropriate
  in every instance.

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Audit 2July 11, 2001

• Medicare
• Questions use of IVIg in HIV patients with
  hypogammaglobulinemia
• Patients previously reviewed in Audit 1.
• Demands refund of 167,192.
• Audit results challenged in Fair Hearing
• Use of IVIG was found to be medically appropriate
  in every instance.

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Impact of Audit 1 and 2

• Patients were forced to go w/o IVIg
• 1 patient died.
• 1 patient suffered a heart attack during both
  IVIg withdrawal periods.
• All patients had a recurrence of the fatigue,
  chills and infections that plagued them prior to
  treatment.
• All patients exposed to an increased risk of
  hospitalization and death.

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Why would Medicare audit Dr. Nemechek twice
when the 1st audit showed his use of IVIg was
appropriate in every instance?
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Medicares Reasoning

• Medicare cited the results of the first audit as
  the excuse to conduct the second audit.
• But the results of the 1st audit showed 100
  finding of medical necessity for IVIg use in HIV
  patients.
• The real reason was revealed in an internal
  Medicare memo.

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Medicare MemoPrior to Audit 1

• J1562 (code for IVIg) is aberrant over threshold
  in KC.
• our usage of this procedure code has increased
  125...

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Medicare Memo Prior to Audit 1

• Dr. Murti is in the process of rewriting the
  Immune Globulin policy
• nab that as the corrective action
• . suggest looking at least one provider
  Nemechek .

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August 10, 2004

• Medicare issues a Clarification Letter
  regarding IVIg coverage
• Excludes all persons with secondary immune
  deficiency from receiving IVIg for low antibody
  condition.
• HIV, Cancer, Medications
• No change in medical science to account for
  change to more stringent guidelines.
• Persons born with primary immune deficiency
  (genetic) still can receive treatment with IVIg.

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August 26, 2004Surprise!

• Medicare issues 3rd audit to Dr. N
• PrePayment Audit of 10 HIV patients.
• This type of audit looks at future claims
  submitted to Medicare.
• Many patients cited had already been evaluated.

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Dilemma of 3rd Audit

• Dr. Nemechek is lead to believe from the
  clarification letter that HIV patients will no
  longer qualify for reimbursement of IVIg.
• And the law says,
• If a physician
• knows a service (i.e. IVIg) is not covered by
  Medicare
• but submits a claim to Medicare for payment
• the physician could be accused Medicare fraud.

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Blatant HIV Discrimination

• My non-HIV patients with hypogammaglobulinemia
  with the exact same clinical symptoms and the
  exact same lab results are still allowed to
  received IVIg.
• However if my patients happen to be HIV and have
  hypogammaglobulinemia, they are not going to get
  it.

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Blatant HIV Discrimination

• There is no medical or scientific basis to decide
  why one group gets treatment and not another.
• So why not pick some other group?
• Theyre discriminating against a specific group
  over another.
• What about Irish patients? Females? Short
  individuals? People w/ blue eyes?

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How can we fight back?

• Political Pressure
• Federal and State Elected Officials
• Letter writing campaigns
• Press Coverage
• Public Protest
• Legal Challenges
• Raise Funds

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Progress to Date

• Legal team has drafted a lengthy legal response.
  (www.healthrenewal.org)
• Working with medical societies.
• Contacting other audited physicians.
• Contacted over 80 Congressional Representatives
  and Senators
• Senator Sam Brownback
• Representative Dennis Moore
• Representative Karen McCarthy

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Grassroots Campaign
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Why are we here?

• Chris Gordon
• Charitable Fund Raising 501c3
• Political Fund Raising - 527
• Mike Clarke
• Research and Legal Options
• Lance Kinzer
• Political and Legislative Liaison