Part B vs. Part D Drug Coverage Issues

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? (§ ) 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 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 Does not meet definition of a Part D drug PDPs can provide but cannot charge for OTCs, i.e., cannot be considered plan’s “supplemental benefits” Some PDPs providing selected OTCs at no charge as part of a Step Therapy program States may cover through Medicaid 2006 state Medicaid coverage mostly mirrors the 2005 coverage Some states have said they will be dropping coverage Long-term care facilities will probably have to purchase most items for floor stock 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 Plans need to educate physicians on what drugs they need to do this for and what the rules are. Reference: Clarification of Plan Due Diligence in Prior Authorization of Part B vs. Part D Coverage Determinations. CMS, March 24, 2006.

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.

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 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 Is it OK for a pharmacist to ask the patient what is it being used for if not indicated on the prescription? YES…most pharmacists that do a good job know their patients and who has had a transplant Reference: Clarification of Plan Due Diligence in Prior Authorization of Part B vs. Part D Coverage Determinations. CMS, March 24, 2006.

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 Outpatient drugs covered under Parts A or B will not be paid for under Part D, even though a deductible may apply E.g., a beneficiary without Part B coverage will have to pay out-of-pocket for a Part B-covered drug such as a flu shot or hepatitis B vaccine Medicare Advantage (MA) plans must use fee-for-service coverage rules to determine whether to pay for a drug under Part A/B medical benefits or Part D prescription drug benefits E.g., if an injectable drug can be covered under Part A/B or Part D, an MA plan cannot automatically deny coverage under its medical (Part A/B) benefits – it must use due diligence to determine how the drug should be paid – under which component of the program. 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 Coverage determination factors include, but are not limited to: Indication(s) of use Who administers the drug How the drug is administered Plus: Amount of drug administered Site of service Medical necessity

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 Part D claims coverage appropriateness -- only if “crossover” drugs do not meet Part B coverage criteria and are either on a Part D plan’s formulary or otherwise approved for coverage through the plan’s exceptions and/or appeals process

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 Drugs that are provided as part of a Part A-covered inpatient hospital or SNF stay are generally bundled in the Part A payment to the facility However, in rare cases, drugs may be billed separately under Part A, such as: Clotting factors during a covered inpatient hospital stay Certain high-cost chemotherapy drugs and preventive injections such as influenza vaccinations during covered SNF stays

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 covers certain drugs that are required for a Part B-covered DME to perform its function at a patient’s home Examples of such DME include nebulizers, external or implantable infusion pumps Major categories include: Inhalation drugs administered using a nebulizer, (e.g., albuterol sulfate, ipratropium bromide) Drugs for which administration with an infusion pump is medically necessary and covered by Medicare, (e.g., some chemotherapy agents) For inhalation drugs, other forms of inhalation, are not covered under Part B, but would be considered for coverage under Part D, e.g., inhalation via a metered-dose inhaler or handheld nebulizer,

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 Additional considerations: No time limit or expiration of coverage If Medicare did not cover the transplant or if use of the immunosuppressive drug is not transplant-related, coverage will be considered under Part D

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 covers clotting factors for hemophiliacs who fulfill specific criteria – those who are competent to use such factors to control bleeding without medical supervision at home 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 If above drugs are used for different medically accepted indications (i.e., those indications included in USP-DI®, AHFS-DI, or DRUGDEX® as FDA-approved or off-label), coverage will be considered under Part D

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 For granisetron and dolasetron, coverage is limited to the loading dose plus 24 hours of therapy for each episode of chemotherapy 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” for Part B coverage. Otherwise, the drug would be considered under Part D coverage. For Part D coverage considerations, If these drugs are used for different medically accepted indications, coverage will be considered under Part D KX modifier – indicator for billing purposes that a med is being used in conjunction with chemoRx – B cvg

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 CMS has determined that aprepitant cannot function alone as a full replacement for IV anti-emetic agents for patients who are receiving highly emetogenic chemotherapy Thus, aprepitant is covered under Part B only if given as part of a 3-drug regimen and in conjunction with a 5-HT3 antagonist and dexamethasone 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 For dexamethasone, J Code J8540 is used along with a KX modifier. Used to be Q0181. J code for aprepitant is J8501 Granisetron is Q0166 Ondansetron is Q0179 Dolasetron is Q0180 CMS has defined the patient population for whom the use of the oral 3-drug combination is reasonable and necessary as only those patients who are receiving 1 or more of those drugs listed

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. Pneumococcal vaccine is always covered under Part B Physician order is not required per Medicare Benefit Policy Manual*, which slightly differs from the 7/27/05 guidance from CMS * 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 applies to beneficiaries at high or intermediate risk of contracting hepatitis B Plans may establish medical necessity criteria for the vaccine coverage as part of their PA programs for Part D such that only low risk individuals who meet the plan’s criteria would be eligible for vaccine coverage under that Part D plan The next slide delineates the high and intermediate risk groups per the current guidelines

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 applies when influenza vaccine is furnished in compliance with any applicable state law Beneficiary may receive the vaccine upon request without a physician’s order and without physician supervision Influenza vaccine will always be considered for coverage under Part B and not covered under Part D

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 Vaccines given directly related to the treatment of an injury or direct exposure to a disease or condition are always covered under Part B, e.g., antirabies treatment, tetanus antitoxin or booster vaccine, botulin antitoxin, antivenin sera, or immune globulin Other miscellaneous prophylactic vaccines are excluded under Part B and coverage will be considered under Part D, e.g., typhoid vaccine administered prior to potential exposure to typhoid/typhus bacteria if it is determined to be medically necessary

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 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 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 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 Administration of antifungal or antiviral drugs Acyclovir Amphotericin B (non-liposomal…) Foscarnet Ganciclovir

Part B Infusion Drugs Administration of parenteral inotropic therapy
Dobutamine Dopamine Milrinone For patients with CHF who meet specific criteria Administration of parenteral inotropic therapy Dobutamine Dopamine Milrinone For patients with CHF who meet specific criteria such as…

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 Pump, supplies and equipment are covered Administration of Intravenous Immune Globulin (IVIG) For patients with primary immune deficiency disease Admin in the pt’s home

Part B Infusion Drugs Administration of epoprostenol and treprostinil for the treatment of pulmonary hypertension Patient must meet specific criteria Administration of epoprostenol and treprostinil For the treatment of pulmonary hypertension in patients who meet specific criteria

Part B Infusion Drugs Administration of gallium nitrate
For the treatment of symptomatic cancer-related hypercalcemia Administration of gallium nitrate For the treatment of cancer-related hypercalcemia in patients who are symptomatic Key word here is symptomatic

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 Administration of parenteral nutrition (TPN) Specific criteria include: Sole source of nutrition Specific diagnosis to include a non-functioning GI tract Use TPN for a minimum of 90 days

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 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 if drugs supplied from physician’s office

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 Method of administration in the home determines B versus D coverage consideration 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 – covered under Part D IV drip – covered under Part D Subcutaneous – covered under Part D Self-administered – covered under Part D

Reimbursement for Part B vs. Part D
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 Intravenous Medications/TPN – Additional Considerations A number of professional organizations 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 the rationale for covering infusion therapy under Medicare Part B (for consistency) 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

Gorman Health Group, LLC
How to Contact Us Gorman Health Group, LLC 2176 Wisconsin Avenue, N.W., Washington, D.C Phone: Fax:

Part B vs. Part D Drug Coverage Issues

Similar presentations

Presentation on theme: "Part B vs. Part D Drug Coverage Issues"— Presentation transcript:

Similar presentations

About project

Feedback

Log in

Auth with social network:

Part B vs. Part D Drug Coverage Issues

Similar presentations

Presentation on theme: "Part B vs. Part D Drug Coverage Issues"— Presentation transcript:

Similar presentations

About project

Feedback