Part B vs. Part D Drug Coverage Issues

1
Part B vs. Part D Drug Coverage Issues
Health Care Compliance Association 2nd Medicare
Conference
Babette Edgar, Pharm.D., MBA, Senior Vice
President, Strategic Business SolutionsSept. 11,
2006
2
Agenda

• Introduction and overview
• Part B vs. Part D coverage issues
• Considerations for Part B vs. Part D
  "crossover" drugs
• Infusion drugs and injectables
• Discussion

3

• Foreseeing the Future of
• Medicare Part D and Part B

4
Part D vs. Part B

• Legislative, legislative, legislative!
• Will remain confusing until MMA opened up- not
  until after elections
• Drugs covered under Part B before MMA remain Part
  B!
• Plan need to do due diligence in order to be
  compliant with regulations and guidelines

5
What is a Part D Drug? (423.100)

• A Part D drug includes any of the following if
  used for a medically accepted indication
• A drug dispensed only by prescription and
  approved by the FDA
• A biological product dispensed only by a
  prescription, licensed under the Public Health
  Service Act (PHSA), and produced at establishment
  licensed under PHSA
• Medical supplies associated with the injection of
  insulin (e.g., syringes, needles, alcohol swabs,
  gauze)
• A vaccine licensed under the PHSA

6
Where We Are Today
7
What is a Medically Accepted Indication?

• Any use for a covered outpatient drug which is
  approved under the Federal Food, Drug, and
  Cosmetic Act, or supported in a citation
  included, or approved for inclusion, in any of
  the compendia below
• American Hospital Formulary Service Drug Info.
  (AHFS-DI)
• United States Pharmacopeia-Drug Information
  (USP-DI)
• DRUGDEX Information System
• Use of a drug for off-label indications not
  reflected in any of the 3 compendia would not
  meet the definition of a Part D drug
• Plans should deny payment
• For oncology medications and Part B coverage,
  peer-reviewed literature can also be used if drug
  is not contraindicated in above compendia

Reference Social Security Act Section 1927(k)(6)
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Part D Excluded Drugs

• Part D excludes coverage for drugs, classes or
  uses of drugs that are already excluded or
  restricted under Medicaid
• Agents used for anorexia, weight loss, or weight
  gain
• Agents used to promote fertility
• Agents used for cosmetic purposes or hair growth
• Agents used for the symptomatic relief of cough
  and colds
• Prescription vitamins and mineral products
  (except prenatal vitamins and fluoride
  preparations)
• Nonprescription drugs
• Drugs for which the manufacturer requires that
  associated tests or monitoring services be
  purchased exclusively from the manufacturer or
  its designee
• Barbiturates
• Benzodiazepines
• 10. Agents used for sexual or erectile
  dysfunction (1/1/07)
• Exception Prescription smoking cessation agents

Reference Medicare Part B versus Part D Coverage
Issues. CMS, July 27, 2005.
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Part D Excluded Drugs Non-Prescription Drugs

• Not considered as Part D drugs
• Cannot be included in supplemental benefits
• Plans can provide them as part of plan
  utilization (step-therapy) programs at no cost to
  enrollees
• E.g., H2-blockers, proton pump inhibitors
• As of 1/1/07, incorporation into step therapy not
  required for coverage
• Cost of drugs included in plans admin costs
• States Possible coverage through Medicaid
• 2006 state Medicaid coverage mostly mirrors the
  2005 coverage
• Long-term care facilities - floor stock
  consideration

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Plan Due Diligence in PA of B vs. D Coverage
Determination

• CMS recommended that medical specialty group
  providers include additional information on
  prescriptions to help Part D plans and
  pharmacists differentiate between those drugs
  which may qualify as Part D drugs and those which
  may qualify as Part B drugs
• To facilitate, but not replace, a Part D plans
  existing processes for determining Part D coverage

Reference Clarification of Plan Due Diligence in
Prior Authorization of Part B vs. Part D Coverage
Determinations. CMS, March 24, 2006.
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Plan Due Diligence in PA of B vs. D Coverage
Determination

• Question
• If in accordance with CMS guidance a physician
  includes additional information on a prescription
  that is sufficient to determine whether the drug
  is covered, what further due diligence is
  required of the Part D plan for making a
  determination of Part D coverage?

Reference Clarification of Plan Due Diligence in
Prior Authorization of Part B vs. Part D Coverage
Determinations. CMS, March 24, 2006.
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Plan Due Diligence in PA of B vs. D Coverage
Determination

• Answer
• Plans may rely on physician information included
  with script, such as
• Diagnosis information (e.g., to determine if
  prescription is related to a Medicare covered
  transplant)
• Location of administration (e.g., to determine if
  prescription is being dispensed to beneficiary in
  a nursing home)
• Same as when plans rely on physician information
  documented on prior authorization forms
• If indication on prescription adequate to make
  coverage determination, no need for additional
  information from physician

Reference Clarification of Plan Due Diligence in
Prior Authorization of Part B vs. Part D Coverage
Determinations. CMS, March 24, 2006.
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Plan Due Diligence in PA of B vs. D Coverage
Determination

• Plan may also rely on pharmacists report of
  appropriate information to determine Part D
  coverage
• Same as how a plan requires contracted pharmacies
  to report the information provided on the
  prescription to determine Part B vs. Part D
  coverage
• E.g., if prednisone is prescribed for a condition
  other than immunosuppression secondary to a
  Medicare-covered transplant, and this is
  indicated on the prescription, a plan may
  authorize the pharmacy to dispense the drug under
  Part D without further contacting the prescribing
  physician

Reference Clarification of Plan Due Diligence in
Prior Authorization of Part B vs. Part D Coverage
Determinations. CMS, March 24, 2006.
14
Plan Due Diligence in PA of B vs. D Coverage
Determination

• Does not imply that plan may not impose PA or
  other steps to ensure appropriate coverage under
  Part D
• Plan ultimately responsible for determining Part
  D coverage
• CMS expects plan to have met appropriate due
  diligence standards without further contacting a
  physician if necessary and sufficient information
  is provided on the script and contracted pharmacy
  able to communicate this information to the plan
  to make the coverage determination

Reference Clarification of Plan Due Diligence in
Prior Authorization of Part B vs. Part D Coverage
Determinations. CMS, March 24, 2006.
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• PART B vs. PART D
• COVERAGE ISSUES

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Parts A/B vs. Part D Drug Coverage

• Part A and Part B of traditional Medicare do not
  cover most outpatient prescription drugs
• Part A provides bundled payments to hospitals and
  skilled nursing facilities
• Part B payments to physicians usually limited to
  drugs or biologicals that are usually not
  self-administered
• Outpatient drugs covered under Parts A or B will
  not be paid for under Part D
• Medicare Advantage (MA) plans must use coverage
  rules to determine whether to pay for a drug
  under Part A/B medical benefits or Part D
  prescription drug benefits

Reference Medicare Part B versus Part D Coverage
Issues. CMS, July 27, 2005.
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Part B vs. Part D Crossover Drugs

• Certain drugs or uses of drugs may be covered
  either under Part B or Part D, also known as
  crossover drugs
• Coverage determination factors include, but are
  not limited to
• Indication(s) of use
• Who administers the drug
• How the drug is administered

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Part B vs. Part D Crossover Drugs

• MA-PDs can only bill Part B or Part D each time a
  crossover drug is dispensed
• Part B billing J code-based
• Part D billing National Drug Code (NDC)-based
• PDPs and MA-PDs cannot routinely
• Deny coverage under Part D for crossover
  medications
• Require a Part B claim rejection before
  processing a Part D claim

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Additional Coverage Considerations

• To bill under the Part B benefit, a retail
  pharmacy must be an accredited Durable Medical
  Equipment, Prosthetics, Orthotics, and Supplies
  (DMEPOS) supplier

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• CONSIDERATIONS FOR CROSSOVER DRUGS

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Part B CoverageDurable Medical Equipment (DME)
Supply Drugs

• Part B covers certain drugs that are required for
  a Part B-covered DME to perform its function at
  home
• Major categories include
• Inhalation drugs administered using a nebulizer
• Drugs for which administration with an infusion
  pump is medically necessary and covered by
  Medicare
• For inhalation drugs, other forms of inhalation
  are not covered under Part B

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Part B CoverageDurable Medical Equipment (DME)
Supply Drugs

• The following facilities are not considered a
  home under the Medicare DME benefit and will not
  meet Part B coverage requirements
• A hospital
• A skilled nursing facility (SNF) or a distinct
  part SNF
• A nursing home dually-certified as both a
  Medicare SNF and a Medicaid nursing facility (NF)
• A Medicaid-only NF that primarily furnishes
  skilled care
• A non-participating nursing home (i.e., neither
  Medicare or Medicaid) that provides primarily
  skilled care
• An institution with a distinct part SNF and which
  also primarily furnishes skilled care

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Part B Coverage Immunosuppressive Drugs

• Part B covers immunosuppressive therapy if
  beneficiary has
• A Medicare-covered transplant or
• Medicare Secondary Payer (MSP) coverage for the
  transplant
• Transplant must be performed at a
  Medicare-approved facility
• Plan determination of Medicare transplant
  coverage
• No one database to determine this

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Part B Coverage Hemophilia Clotting Factors

• Part B covers clotting factors for hemophiliacs
  who fulfill specific criteria
• Part B coverage includes items associated with
  the administration of clotting factors

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Part B Coverage Oral Anti-Cancer Drugs

• Part B covers oral anti-cancer drugs if they
  contain the same active ingredients and are used
  for the same indications as Part B-covered
  chemotherapy drugs furnished incident to a
  physicians service
• These drugs include
• Busulfan
• Capecitabine
• Cyclophosphamide
• Etoposide
• Melphalan
• Methotrexate
• Temozolamide

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Part B Coverage Oral Anti-Emetic Drugs Used
With IV Chemotherapy

• Covered under Part B if used as a full
  therapeutic replacement for an intravenous (IV)
  anti-emetic drug within 48 hours of IV
  chemotherapy administration
• For granisetron and dolasetron, coverage is
  limited to the loading dose plus 24 hours of
  therapy
• CMS requires physicians to indicate on
  prescription that oral anti-emetic is being used
  as a full therapeutic replacement for an IV
  anti-emetic drug as part of a cancer
  chemotherapeutic regimen
• Part D coverage considerations-split
  prescriptions

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Part B Coverage Emend (Aprepitant)

• CMS Aprepitant cannot function alone as a full
  replacement for IV anti-emetic agents
• Aprepitant has Part B coverage if given as part
  of a 3-drug regimen
• Part B coverage for the oral anti-emetic 3-drug
  regimen applies only to patients receiving one or
  more of the following anti-cancer drugs
• Carmustine, cisplatin, cyclophosphamide,
  dacarbazine, doxorubicin, epirubicin, lomustine,
  mechlorethamine, streptozocin

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Part B Coverage Pneumococcal Vaccine

• Pneumococcal vaccine always Part B
• Physician order is not required per Medicare
  Benefit Policy Manual
• In CMS 7/27/05 guidance on Medicare Part B
  vs. Part D Drug Coverage Issues, it was stated
  that a physician order is required for
  pneumococcal vaccine.

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Part B Coverage Hepatitis B Vaccine

• Part B coverage - high or intermediate risk
• Part D consideration for coverage if low risk

High Risk Groups Intermediate Risk Groups
Individuals with ESRD Staff in institutions for the mentally handicapped
Hemophiliacs who received Factor VIII or IX concentrates Workers in health care professions who have frequent contact with blood or blood-derived body fluids during routine work
Clients of institutions for individuals for the mentally handicapped
Persons who live in the same household as a hepatitis B virus (HBV) carrier
Homosexual men
Illicit injectable drug abusers
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Part B Coverage Influenza Vaccine

• Part B coverage - applicable state law
• Beneficiary may receive the vaccine upon request
• Influenza vaccine no Part D coverage

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Part B Coverage Miscellaneous Vaccines

• Vaccines given directly related to the treatment
  of an injury or direct exposure to a disease or
  condition Part B coverage
• Other miscellaneous vaccines excluded under Part
  B

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Part B vs. Part D Coverage Issues for EPO
Source Medicare Parts B/D Coverage Issues. CMS.
April 18, 2006.
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• INFUSION DRUGS

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Part B Infusion Drugs

• Limited to drugs that require a pump for
  administration in the home
• Limited to specific indications
• Requires a Certificate of Medical Necessity (CMN)
  submitted by the DMERC Supplier
• Covers medication, supplies, equipment and
  patient monitoring
• Drugs administered by a prolonged infusion of at
  least 8 hours due to proven clinical efficacy

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Part B Infusion Drugs

• Deferoxamine for chronic iron overload
• Chemotherapy for primary hepatocellular or
  colorectal carcinoma
• Morphine for cancer-related pain
• Continuous subcutaneous insulin for diabetes
  mellitus

36
Part B Infusion Drugs

• Chemotherapy Drugs
• Bleomycin
• Cladribine
• Cytarabine
• Doxorubicin (non-liposomal)
• Floxuridine
• Fluorouracil
• Vinblastine
• Vincristine

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Part B Infusion Drugs

• Administration of narcotic analgesics, except
  meperidine, in place of morphine for intractable
  cancer pain

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Part B Infusion Drugs

• Administration of antifungal or antiviral drugs
• Acyclovir
• Amphotericin B
• Foscarnet
• Ganciclovir
• Liposomal amphotericin B preparations are only
  covered for patients who
• Have suffered significant toxicity with standard
  amphotericin B
• Have significantly impaired renal function

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Part B Infusion Drugs

• Administration of parenteral inotropic therapy
• Dobutamine
• Dopamine
• Milrinone
• For patients with CHF who meet specific criteria

40
Part B Infusion Drugs

• Administration of Intravenous Immune Globulin
  (IVIG)
• Diagnosis of Primary Immune Deficiency disease
  only
• Part B coverage is limited to the IVIG only
• Does not include pumps, supplies, and equipment
  for administration
• Administration of Subcutaneous Immune Globulin
• Diagnosis of Primary Immune Deficiency disease
  only
• Pump, supplies and equipment are covered

41
Part B Infusion Drugs

• Administration of epoprostenol and treprostinil
  for the treatment of pulmonary hypertension
• Patient must meet specific criteria

42
Part B Infusion Drugs

• Administration of gallium nitrate
• For the treatment of symptomatic cancer-related
  hypercalcemia

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Part B Infusion Drugs

• Administration of ziconotide (Prialt)
• For the management of severe chronic pain in
  patients who meet specific criteria

44
Part B Infusion Drugs

• Administration of parenteral nutrition
• Regulated by the FDA as a drug
• Includes total parenteral nutrition (TPN) and its
  components
• Amino Acids
• Dextrose
• Lipids
• Standard TPN additives

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Part B Infusion Drugs

• Parenteral Nutrition is covered under the Part B
  prosthetic benefit
• Beneficiaries must meet specific criteria for
  permanent alimentary tract dysfunction

46
Part B Coverage Parenteral Nutrition

• Specific criteria include
• Sole source of nutrition
• Specific diagnosis to include a non-functioning
  GI tract
• Use of TPN for a minimum of 90 days
• Included in coverage
• IV vitamins
• Trace elements/minerals
• Heparin and saline flush
• Supplies and equipment for administration

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Part D Coverage Parenteral Nutrition

• Parenteral nutrition is covered under Part D (not
  Part B) if patient has a functioning GI tract
  whose need for parenteral nutrition is due to
• A swallowing disorder
• A temporary defect in gastric emptying such as a
  metabolic or electrolyte disorder
• A psychological disorder impairing food intake
  such as depression
• A metabolic disorder inducing anorexia such as
  cancer
• A physical disorder impairing food intake such as
  the dyspnea of severe pulmonary or cardiac
  disease
• A side effect of a medication
• Renal failure and/or dialysis

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Part D Coverage Parenteral Nutrition

• For all Part D plans, CMS will reimburse the Part
  D drug components in a parenteral nutrition
  solution
• Multivitamin and trace mineral/elements
  additives
• May be added to the solution per standard of
  practice
• These components do NOT meet the definition of a
  Part D drug and may NOT be billed under Part D
• Supplies and equipment for TPN administration are
  NOT covered under Part D

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Overview of Medicare Part D Infusion Drugs

• Medicare Part D covers infusion therapies that do
  not fulfill Part B criteria
• Covers the medication only
• Patient financially responsible for supplies and
  equipment
• No coverage for monitoring or education of
  therapy
• No coverage of heparin and saline for IV line
  maintenance

50
Part B Infusion Drugs

• Place of service helps determine Part B versus
  Part D coverage
• Infusion by pump, IV push, IV drip or injectable
  medications administered in a physicians office
  are considered for coverage under Part B

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Part B vs. Part D Infusion Drugs

• Method of administration in the home determines B
  vs. D coverage
• IV pump covered under Part B for specific drugs
  and if certain criteria are met
• If criteria not fulfilled, coverage considered
  under Part D
• IV push Part D
• IV drip Part D
• Subcutaneous Part D
• Self-administered Part D

52
Reimbursement for Part B vs. Part D

• Part B
• Patient must meet very specific criteria
• Reimbursement includes the medication, supplies,
  equipment, and professional services
• Part D
• Reimbursement for the medication only
• No provision for supplies, equipment, or
  professional services

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Additional Considerations

• Intravenous Medications/TPN Additional
  Considerations
• A number of professional organizations are
  working to address gaps in care for this issue
• American Society of Consultant Pharmacists (ASCP)
• Hospice Association of America (HAA)
• National Home Infusion Association (NHIA)
• Discussion regarding covering infusion therapy
  under Medicare Part B vs. Part D
• Variations in coverage from each PDP in 2006

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CMS Issues

• Minimal changes for 2007
• Audit
• Due diligence
• Operational policies and procedures in place
• Plans responsible for subcontractors

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Conclusion

• Plans must exercise due diligence in determining
  appropriate Part B vs. Part D drug coverage
• Plans must have appropriate operational policies
  and procedures in place
• Plans must have reliable information source that
  is updated frequently relating to Part B vs. Part
  D drugs and coverage determinations
• Accurate and expedient Part B vs. Part D coverage
  delineation is important to ensure beneficiaries
  have timely access to medications they need while
  paying the appropriate cost share

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How to Contact Us

• Gorman Health Group, LLC
• www.gormanhealthgroup.com
• 2176 Wisconsin Avenue, N.W.,
• Washington, D.C. 20007
• Phone [phone]
• Fax [phone]
• Bedgar_at_gormanhealthgroup.com