Slide 1

Report
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 Solutions
Sept. 11, 2006
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
Foreseeing the Future of
Medicare Part D and Part B
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
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
Where We Are Today
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)
Part D Excluded Drugs
•
Part D excludes coverage for drugs, classes or uses of drugs
that are already excluded or restricted under Medicaid
1.
2.
3.
4.
5.
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)
6. Nonprescription drugs
7. Drugs for which the manufacturer requires that associated tests
or monitoring services be purchased exclusively from the
manufacturer or its designee
8. Barbiturates
9. 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.
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
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 plan’s 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.
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.
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.
Plan Due Diligence in PA of B vs. D Coverage Determination
• Plan may also rely on pharmacist’s 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.
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.
PART B vs. PART D
COVERAGE ISSUES
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.
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
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
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
CONSIDERATIONS FOR
“CROSSOVER” DRUGS
Part B Coverage:
Durable 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
Part B Coverage:
Durable 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
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
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
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 physician’s service
• These drugs include:
• Busulfan
• Capecitabine
• Cyclophosphamide
• Etoposide
• Melphalan
• Methotrexate
• Temozolamide
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
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
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.
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
Part B Coverage: Influenza Vaccine
• Part B coverage - applicable state law
• Beneficiary may receive the vaccine upon request
• Influenza vaccine – no Part D coverage
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
Part B vs. Part D Coverage Issues for EPO
Source: Medicare Parts B/D Coverage Issues. CMS. April 18, 2006.
INFUSION DRUGS
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
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
Part B Infusion Drugs
• Chemotherapy Drugs
• Bleomycin
• Cladribine
• Cytarabine
• Doxorubicin (non-liposomal)
• Floxuridine
• Fluorouracil
• Vinblastine
• Vincristine
Part B Infusion Drugs
• Administration of narcotic analgesics, except meperidine,
in place of morphine for intractable cancer pain
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
Part B Infusion Drugs
• Administration of parenteral inotropic therapy
• Dobutamine
• Dopamine
• Milrinone
• For patients with CHF who meet specific criteria
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
Part B Infusion Drugs
• Administration of epoprostenol and treprostinil for the
treatment of pulmonary hypertension
• Patient must meet specific criteria
Part B Infusion Drugs
• Administration of gallium nitrate
• For the treatment of symptomatic cancer-related
hypercalcemia
Part B Infusion Drugs
• Administration of ziconotide (Prialt®)
• For the management of severe chronic pain in patients
who meet specific criteria
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
Part B Infusion Drugs
• Parenteral Nutrition is covered under the Part B prosthetic
benefit
• Beneficiaries must meet specific criteria for permanent
alimentary tract dysfunction
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
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
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
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
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 physician’s office are
considered for coverage under Part B
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
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
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
CMS Issues
• Minimal changes for 2007
• Audit
• Due diligence
• Operational policies and procedures in place
• Plans responsible for subcontractors
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
How to Contact Us
Gorman Health Group, LLC
www.gormanhealthgroup.com
2176 Wisconsin Avenue, N.W.,
Washington, D.C. 20007
Phone: 202.364.8283
Fax: 202.244.8324
[email protected]

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