Overview on IVIG Access Issues

1
Overview on IVIG Access Issues
Michelle Vogel, MPA Partner Washington Strategic
Consulting March 31, 2007
2
IVIG Access

• Lets take a quick test

• How many are comfortable dealing with their
  Health Insurance/Medicare on IVIG access problems
  or coverage determinations???

3
Are These Terms Confusing?

• On-label
• Off-label
• Experimental
• Medical Necessity
• Local Coverage Determinations
• Individual Coverage Determinations
• National Coverage Determinations
• EOBs

• Medicare Part B vs. Part D
• Deductibles
• Copays
• Medigap policies
• Secondary health policies
• Annual Caps
• Lifetime Caps
• Case Managers
• Appeals Process

4
How Does Medicare/Health Insurance Make You Feel?
5
What are the Current Threats to Quality Health
Care for Patients relying on IVIG therapy?

• Denial of coverage
• Exceeding lifetime caps
• Prior authorization causing treatment delays
• IVIG not covered
• IVIG considered off-label or experimental
• Reimbursement is not adequate to cover IVIG
• No provider sites available to administer IVIG
• Reduction in IVIG dosage or frequency of
  infusions.

6
Channel Conflict
Reimbursement
Supply
Demand
Complex problem consisting of channel conflicts,
underestimation of demand, increased utilization,
and the MMA.
7
Channel Conflict

• Industry
• Consolidation
• Changes in business practice
• US Plasma into other global markets (UK,
  Developing markets)
• Market correction
• Reduction in inventory
• Distribution
• Encumbered/unencumbered product
• Secondary or grey market
• Medicare Modernization Act
• January 2005 Medicare Part B
• January 2006 OPPS
• Part B vs. Part D for Home Care

8
Medicare Reform

• In 2003, Congress passed the Medicare
  Modernization Act (MMA), which included the
  following changes that affected our community.
• Inclusion of a home infusion benefit for PIDD.
• Exemption of IVIG from the competitive
  acquisition program (CAP)
• Changed the reimbursement formula for IVIG from
  average wholesale price (AWP) to average sales
  price (ASP)
• Changed the reimbursement for the administration
  of IVIG.

9
Medicare Reform Implemented

• In 2005, the Centers for Medicare and Medicaid
  Services (CMS) implemented the new reimbursement
  formula for physicians offices, infusion centers
  and home care.
• In 2006, CMS implemented the new reimbursement
  formula for hospital outpatient setting.

10
Summary of reimbursement changes to date

• Jan 05 New ASP formula for non-hospital
  settings, 30 cut
• Jan 06 Hospital rates cut by 40 to match
  physician office
• Hospital added 75 preadmininistration fee
• Physicians office added 69 preadministration
  fee
• Jan 07 Preadministration fee was renewed in the
  hospital and physicians office for another year
• Non PID patients now fall under Part D in the
  home care setting - reimbursement more favorable
• there is a worsening crisis in the availability
  of and access to IVIG products that is affecting
  and placing patients lives at risk ACBSA May
  05

11
IVIG Coverage in the Home Care Setting Part B
vs. Part D

• Under Medicare, patients who would like to
  receive their IVIG in the home care setting will
  fall under 2 categories Part B or Part D
• Part B for PIDD patients only
• Part D for non-PIDD patients only, such as
  autoimmune disorders and neuropathies (i.e.,
  CIDP, myositis, myasthenia gravis)
• Part B and Part D cover the drug only and not the
  nursing services and the durable medical
  equipment.
• Patients are encouraged to have supplemental
  insurance.
• Reimbursement under Part D is more favorable,
  therefore patients with conditions other than
  PIDD are generally finding the home care setting
  a viable site of care.

12
Impact of reimbursement cuts

• During 2005 the majority of Medicare patients
  transferred to hospitals.
• Hospitals became overburdened and not able to
  service all patients
• Many admitted, Not receiving the most appropriate
  brand
• Many on waiting lists, denied access, or treated
  with prophylactic antibiotics
• In 2006 physicians and hospitals can no longer
  afford to treat patients.
• Cannot purchase IVIG at Medicares rates (losing
  money on each patient)
• Many outpatient hospital infusion suites have
  been shut down, more to follow
• Some Medicare patients not able to receive
  therapy in any setting
• In 2007, where are the patients and what is their
  quality of life?????

13
Private Insurance

• If I am not a Medicare patient should I be
  concerned about the current IVIG reimbursement
  crisis?
• YES!!!
• We have received reports that private health
  insurance policies are dropping their
  reimbursement rates of IVIG to match Medicare.
  Some of these companies include
• Aetna
• Humana
• Blue Cross/Blue Shield
• United Health Care
• CIGNA

14
Impact of reimbursement cuts

• In 2007, patients are reporting problems in
  finding any site of care to treat with IVIG.
• Local Coverage Determinations are being
  implemented across the country for all disease
  states.
• 8 patient deaths have been reported due to
  inability to access IVIG therapy or lack of
  continuity of care.
• CA, FL, OH and TX.
• CIDP, CLL, MG, PM, PIDD, and Stiff Person
  Syndrome.

15
Response to date

• HHS Advisory Committee on Blood Safety and
  Availability (ACBSA)
• Jan 2005
• Current reimbursement for IVIG is not adequate to
  support optimal care.
• Recommended that the Secretary take steps to
  augment reimbursement
• May 2005
• Recognized the "worsening crisis" of IVIG access
  and how this crisis places "patients' lives at
  risk.
• Recommended that the Secretary declare a public
  health emergency to enable CMS to "apply
  alternative mechanisms for determination of the
  reimbursement schedule of IVIG products.
• Sept 2005
• Increase reimbursement to current market pricing
  and true cost of administration.
• Consider declaring a public health emergency to
  enable CMS to reimburse IVIG under a different
  formula.
• Work with Congress to establish a long-term
  stable and sustainable reimbursement structure.

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Response cont.

• OIG has been requested by Congress to survey the
  industry to understand why the ASP formula
  doesnt work for IVIG.
• Manufacturers have been interviewed and report
  given to Congressional staffers.
• Distributors report is finished but has not been
  released.
• Reps. McCrery (R-LA) and Israel (D-NY) have
  initiated letter campaign twice to Secretary
  Leavitt requesting that he declare a public
  health emergency in order to give the authority
  to CMS to increase reimbursement to IVIG by using
  alternative therapies. Last campaign included 58
  Members of Congress.
• Rep. Pitts (R-PA) initiated a letter with 30
  colleagues to Secretary Leavitt requesting that
  he provide a payment adjustment to the current
  ASP formula and brand-specific reimbursement.

HHS Office of Inspector General
17
Response cont.

• HHS Assistant Secretary for Planning and
  Evaluation held an IVIG Town Hall meeting on
  September 28th and has completed a report on the
  access issues surrounding IVIG.
• The report includes Medicares claims data from
  2005 that shows that 40 of IVIG users were
  transferred out of the physician/home care
  setting under Part B and in to the hospital
  outpatient setting.
• The report has not been released.

18
Local Coverage Determinations

• Most Medicare carriers/fiscal intermediaries have
  published local coverage determinations on IVIG
  which has limited access to all patients who rely
  on IVIG.
• Patients IVIG dosing is being reduced at
  hospitals by an average 50, contrary to
  physicians orders.
• Medicare will not cover their IVIG therapy.
• Their trough levels are too high to warrant IVIG.
• Hospitals are requiring patients to sign
  documents (advance beneficiary notices or ABNs)
  indicating that they will assume financial
  responsibility for their IVIG treatments, in the
  event that Medicare refuses to cover them.
• Their IVIG treatment is being terminated
  temporarily until true medical necessity is
  determined.

19
Quotes from Medicare Beneficiaries

• Shirley Peters of Palm Beach Gardens, FL should
  not fear that her hospital will no longer be able
  to provide IVIG treatments for primary immune
  deficient patients. It is horrible to hear her
  say, What do they expect us to do? Are we
  supposed to just get sicker and sicker until we
  pass away?
• Linda Swim of Irving, Texas, No one would take
  chemotherapy away from a cancer patient, who
  calls her therapy just as crucial to survival.
  We should be able to get our treatment.
• Peggy Stadtmiller of Waterloo, IL whose son Tim
  has a primary immune deficiency disease and is on
  Medicare Disability and has not been infused in
  three months. According to Peggy, Tim is just
  one of many United States citizens who, because
  they were born with immune deficiencies, are
  having their fragile lives placed in peril
  because of a Medicare reimbursement issue. Does
  someone need to die before it gets fixed?

20
Quotes from Medicare Beneficiaries

• Angelina Michalski of Seminole, FL lost her
  husband who suffered from a neuropathy, CIDP.
  Angelina could not find a physician or hospital
  that would treat her husband with IVIG due to the
  reimbursement. According to Angelina, I had to
  fight every month to get the medicine, end
  everyone was saying they cant afford to get it
  for us. Her husband died on September 15, 2005.
  
• In May 2005, HHS Advisory Committee on Blood
  Safety and Availability heard from a patient
  named Pam Way of Texas who had lost access to
  IVIG and asked the Committee to help save her
  life. Pam was diagnosed with Polymyositis and
  CIDP. She was in a wheelchair due to the
  paralysis that had set in from lack of treatment.
  When Pam testified, she could no longer receive
  her IVIG because the physician could no longer
  afford to treat her and had transferred her to
  the local hospital. In May of 2006, we learned
  that Pam died due to lack of continuity of care.
  She spent the last months in and out of the
  hospitals intensive care unit until she died.

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Impact (continued)

• The cost of IVIG has risen, while reimbursement
  has been dramatically lowered by Medicare. We are
  seriously considering denial of this vital
  therapy to Medicare patients. They would be
  referred to a hospital for outpatient treatment
  and subsequently be exposed to a variety of
  pathogens while in a compromised immune state.
  Many would simply not go at all. Either way, many
  would probably succumb to pneumonia and other
  illnesses requiring lengthy hospital stays and
  extensive treatment and possible
  disability.Joan M. Nasr, RN California Allergy
  Asthma Medical Group Los Angeles, California

22
Groups working together

• Patient Organizations
• American Autoimmune Related Diseases Association
• American Partnership for Eosinophilic Disorders
• GBS/CIDP Foundation International
• International Pemphigus Society
• Myasthenia Gravis Foundation of America
• The Myositis Association
• The Neuropathy Action Foundation
• Platelet Disorder Support Association
• Stiff Person Syndrome Support Group

• Medical Societies/Providers
• American Academy of Allergy, Asthma and
  Immunology
• American Academy of Neurology
• American Association of Neuromuscular
  Electrodiagnostic Medicine
• American College of Rheumatology
• American Society of Clinical Oncology
• American Society of Hematology
• American Society of Health System Pharmacists
• Community Oncology Alliance
• National Home Infusion Association
• Public Hospital Pharmacy Coalition

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Helpful Resources for IVIG Access Problems

• If you are having trouble receiving your IVIG,
  here is some contact information that may be of
  help
• Contact your Patient Organization and ask to
  speak to Patient Services.
• Call 1-800-Medicare
• Contact your Medicare Regional Office by going to
  http//www.cms.hhs.gov/about/regions/professionals
  .asp click on your state and call or email your
  Medicare Regional Director.
• Contact your Member of Congress and share your
  story/experience.

24
Helpful Resources for IVIG Access Problems

• If you are experiencing problems obtaining IVIG,
  here are some important resources
• Advisory Committee on Blood Safety and
  Availability
• Web Posting www.hhs.gov/bloodsafety
• Report denial of treatment, delay of treatment,
  forced reduction in dosage
• Food and Drug Administration
• CBER Product Shortage Number 800-835-4709
• CBERProductshortages_at_cber.fda.gov

25
Patient Organization Contacts

• Guillain-Barré Syndrome Foundation Intl
• The Holly Building
• 104 1/2 Forrest Avenue
• Narberth, PA 19072
• 610-667-0131
• info_at_gbsfi.com
• http//www.gbsfi.com/

26
Patient Organization Contacts Cont.

• Immune Deficiency Foundation
• 40 W. Chesapeake Avenue
• Suite 308
• Towson, MD 21204
• idf_at_primaryimmune.org
• www.primaryimmune.org

27
Patient Organization Contacts Cont.

• Jeffrey Modell Foundation

747 Third Avenue New York, NY 10017 (212)
819-0200 info_at_jmfworld.org http//www.jmfworld.co
m/
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Patient Organization Contact

• Myasthenia Gravis Foundation of America
• 1821 University Ave. W.,
• Suite S256
• St. Paul, MN 55104
• Telephone [phone] or [phone]
• Fax [phone]
• Email mgfa_at_myasthenia.org

29
Patient Organization Contacts Cont.

• The Myositis Association
• 1233 20th St. NW, Suite 402
• Washington, DC 20036
• [phone]
• tma_at_myositis.org
• http//www.myositis.org

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Patient Organization Contacts Cont.

• The Neuropathy Association, Inc.
• P.O. Box 26226
• New York, NY 10117-3422
• 212-692-0662
• http//www.neuropathy.org

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Patient Organization Contacts Cont.

• The Neuropathy Action Foundation
• California Office
• 88 Townsend Street 225
• San Francisco, CA 94107
• [phone]
• Toll free [phone]
• info_at_neuropathyaction.org
• www.neuropathyaction.org

32
Patient Organization Contacts Cont.

• Platelet Disorder Support Association
• P.O. Box 61533,
• Potomac, MD 20859
• Phone 1- 87-PLATELET (877-528-3538)
• or [phone]
• Fax [phone]
• e-mail pdsa_at_pdsa.org

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To Take Action/Updates

• IG Living
• Dont forget to go to http//www.igliving.com
• Receive Updates on latest activities on Capitol
  Hill
• Take Action!!!
• To Restore access to IVIG
• To Reverse Local Coverage Determinations
• Most importantly do not forget to keep us
  informed of any problems you are having on
  reimbursement so that we can help you solve your
  problems, as well as help to develop policy
  solutions to help your fellow IVIG user.

34
Access to IVIG Must Be Restored!

• Patients have suffered too long.
• We must ensure that patients have access to all
  brands of IVIG in all sites of care and this will
  not happen until we all work together with a
  unified voice so that IVIG reimbursement is
  adequate.
• Patients lives have been put in jeopardy and we
  must make our policymakers understand that this
  is unacceptable and action must be taken
  immediately to restore access to care.
• We have 8 fatalities and thousands of patients
  suffering needlessly. We must end this crisis
  today and we can do it if we all work together.