Presentation on theme: "Part B vs. Part D Drug Coverage Issues"— Presentation transcript:
1Part B vs. Part D Drug Coverage Issues Health Care Compliance Association2nd Medicare ConferenceBabette Edgar, Pharm.D., MBA, Senior Vice President, Strategic Business Solutions Sept. 11, 2006
2Agenda Introduction and overview Part B vs. Part D coverage issues Considerations for Part B vs. Part D "crossover" drugsInfusion drugs and injectablesDiscussion
3Foreseeing the Future of Medicare Part D and Part B
4Part D vs. Part B Legislative, legislative, legislative! Will remain confusing until MMA opened up- not until after electionsDrugs covered under Part B before MMA remain Part B!Plan need to do due diligence in order to be compliant with regulations and guidelines
5What 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 FDAA biological product dispensed only by a prescription, licensed under the Public Health Service Act (PHSA), and produced at establishment licensed under PHSAMedical supplies associated with the injection of insulin (e.g., syringes, needles, alcohol swabs, gauze)A vaccine licensed under the PHSA
7What 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 SystemUse of a drug for “off-label” indications not reflected in any of the 3 compendia would not meet the definition of a Part D drugPlans should deny payment** For oncology medications and Part B coverage, peer-reviewed literature can also be used if drug is not contraindicated in above compendiaReference: Social Security Act Section 1927(k)(6)
8Part D Excluded DrugsPart D excludes coverage for drugs, classes or uses of drugs that are already excluded or restricted under MedicaidAgents used for anorexia, weight loss, or weight gainAgents used to promote fertilityAgents used for cosmetic purposes or hair growthAgents used for the symptomatic relief of cough and coldsPrescription vitamins and mineral products (except prenatal vitamins and fluoride preparations)Nonprescription drugsDrugs for which the manufacturer requires that associated tests or monitoring services be purchased exclusively from the manufacturer or its designeeBarbituratesBenzodiazepines10. Agents used for sexual or erectile dysfunction (1/1/07)Exception: Prescription smoking cessation agentsDoes not meet definition of a Part D drugPDPs 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 programStates may cover through Medicaid2006 state Medicaid coverage mostly mirrors the 2005 coverageSome states have said they will be dropping coverageLong-term care facilities will probably have to purchase most items for floor stockReference: Medicare Part B versus Part D Coverage Issues.CMS, July 27, 2005.
9Part D Excluded Drugs – Non-Prescription Drugs Not considered as Part D drugsCannot be included in supplemental benefitsPlans can provide them as part of plan utilization (step-therapy) programs at no cost to enrolleesE.g., H2-blockers, proton pump inhibitorsAs of 1/1/07, incorporation into step therapy not required for coverageCost of drugs included in plans’ admin costsStates: Possible coverage through Medicaid2006 state Medicaid coverage mostly mirrors the 2005 coverageLong-term care facilities - floor stock consideration
10Plan 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 drugsTo facilitate, but not replace, a Part D plan’s existing processes for determining Part D coveragePlans 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.
11Plan Due Diligence in PA of B vs. D Coverage Determination QuestionIf 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.
12Plan Due Diligence in PA of B vs. D Coverage Determination AnswerPlans 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 formsIf indication on prescription adequate to make coverage determination, no need for additional information from physicianReference: Clarification of Plan Due Diligence in Prior Authorization of Part B vs. Part D Coverage Determinations. CMS, March 24, 2006.
13Plan 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 coverageSame as how a plan requires contracted pharmacies to report the information provided on the prescription to determine Part B vs. Part D coverageE.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 physicianIs 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 transplantReference: Clarification of Plan Due Diligence in Prior Authorization of Part B vs. Part D Coverage Determinations. CMS, March 24, 2006.
14Plan 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 DPlan ultimately responsible for determining Part D coverageCMS 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 determinationReference: Clarification of Plan Due Diligence in Prior Authorization of Part B vs. Part D Coverage Determinations. CMS, March 24, 2006.
16Parts A/B vs. Part D Drug Coverage Part A and Part B of traditional Medicare do not cover most outpatient prescription drugsPart A provides bundled payments to hospitals and skilled nursing facilitiesPart B payments to physicians usually limited to drugs or biologicals that are usually not self-administeredOutpatient drugs covered under Parts A or B will not be paid for under Part DMedicare 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 benefitsOutpatient drugs covered under Parts A or B will not be paid for under Part D, even though a deductible may applyE.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 vaccineMedicare 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 benefitsE.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.
17Part 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” drugsCoverage determination factors include, but are not limited to:Indication(s) of useWho administers the drugHow the drug is administeredCoverage determination factors include, but are not limited to:Indication(s) of useWho administers the drugHow the drug is administeredPlus:Amount of drug administeredSite of serviceMedical necessity
18Part 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-basedPart D billing: National Drug Code (NDC)-basedPDPs and MA-PDs cannot routinelyDeny coverage under Part D for crossover medicationsRequire a Part B claim rejection before processing a Part D claimPart 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
19Additional Coverage Considerations To bill under the Part B benefit, a retail pharmacy must be an accredited Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) supplierDrugs 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 facilityHowever, in rare cases, drugs may be billed separately under Part A, such as:Clotting factors during a covered inpatient hospital stayCertain high-cost chemotherapy drugs and preventive injections such as influenza vaccinations during covered SNF stays
21Part 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 homeMajor categories include:Inhalation drugs administered using a nebulizerDrugs for which administration with an infusion pump is medically necessary and covered by MedicareFor inhalation drugs, other forms of inhalation are not covered under Part BPart B covers certain drugs that are required for a Part B-covered DME to perform its function at a patient’s homeExamples of such DME include nebulizers, external or implantable infusion pumpsMajor 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,
22Part 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 hospitalA skilled nursing facility (SNF) or a distinct part SNFA nursing home dually-certified as both a Medicare SNF and a Medicaid nursing facility (NF)A Medicaid-only NF that primarily furnishes skilled careA non-participating nursing home (i.e., neither Medicare or Medicaid) that provides primarily skilled careAn institution with a distinct part SNF and which also primarily furnishes skilled care
23Part B Coverage: Immunosuppressive Drugs Part B covers immunosuppressive therapy if beneficiary has:A Medicare-covered transplant orMedicare Secondary Payer (MSP) coverage for the transplantTransplant must be performed at a Medicare-approved facilityPlan determination of Medicare transplant coverageNo “one” database to determine thisAdditional considerations:No time limit or expiration of coverageIf Medicare did not cover the transplant or if use of the immunosuppressive drug is not transplant-related, coverage will be considered under Part D
24Part B Coverage: Hemophilia Clotting Factors Part B covers clotting factors for hemophiliacs who fulfill specific criteriaPart B coverage includes items associated with the administration of clotting factorsPart 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 homePart B coverage includes items associated with the administration of clotting factors
25Part 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 serviceThese drugs include:BusulfanCapecitabineCyclophosphamideEtoposideMelphalanMethotrexateTemozolamideIf 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
26Part 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 administrationFor granisetron and dolasetron, coverage is limited to the loading dose plus 24 hours of therapyCMS 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 prescriptionsFor granisetron and dolasetron, coverage is limited to the loading dose plus 24 hours of therapy for each episode of chemotherapyCMS 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 DKX modifier – indicator for billing purposes that a med is being used in conjunction with chemoRx – B cvg
27Part B Coverage: Emend® (Aprepitant) CMS: Aprepitant cannot function alone as a full replacement for IV anti-emetic agentsAprepitant has Part B coverage if given as part of a 3-drug regimenPart 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, streptozocinCMS has determined that aprepitant cannot function alone as a full replacement for IV anti-emetic agents for patients who are receiving highly emetogenic chemotherapyThus, 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 dexamethasonePart 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, streptozocinFor dexamethasone, J Code J8540 is used along with a KX modifier. Used to be Q0181.J code for aprepitant is J8501Granisetron is Q0166Ondansetron is Q0179Dolasetron is Q0180CMS 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
28Part B Coverage: Pneumococcal Vaccine Pneumococcal vaccine – always Part BPhysician 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 BPhysician 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.
29Part B Coverage: Hepatitis B Vaccine Part B coverage - high or intermediate riskPart D – consideration for coverage if low riskHigh Risk GroupsIntermediate Risk GroupsIndividuals with ESRDStaff in institutions for the mentally handicappedHemophiliacs who received Factor VIII or IX concentratesWorkers in health care professions who have frequent contact with blood or blood-derived body fluids during routine workClients of institutions for individuals for the mentally handicappedPersons who live in the same household as a hepatitis B virus (HBV) carrierHomosexual menIllicit injectable drug abusersPart B coverage applies to beneficiaries at high or intermediate risk of contracting hepatitis BPlans 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 planThe next slide delineates the high and intermediate risk groups per the current guidelines
30Part B Coverage: Influenza Vaccine Part B coverage - applicable state lawBeneficiary may receive the vaccine upon requestInfluenza vaccine – no Part D coveragePart B coverage applies when influenza vaccine is furnished in compliance with any applicable state lawBeneficiary may receive the vaccine upon request without a physician’s order and without physician supervisionInfluenza vaccine will always be considered for coverage under Part B and not covered under Part D
31Part B Coverage: Miscellaneous Vaccines Vaccines given directly related to the treatment of an injury or direct exposure to a disease or condition: Part B coverageOther miscellaneous vaccines: excluded under Part BVaccines 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 globulinOther 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
32Part B vs. Part D Coverage Issues for EPO Source: Medicare Parts B/D Coverage Issues. CMS. April 18, 2006.
34Part B Infusion DrugsLimited to drugs that require a pump for administration in the homeLimited to specific indicationsRequires a Certificate of Medical Necessity (CMN) submitted by the DMERC SupplierCovers medication, supplies, equipment and patient monitoringDrugs administered by a prolonged infusion of at least 8 hours due to proven clinical efficacy
35Part B Infusion Drugs Deferoxamine for chronic iron overload Chemotherapy for primary hepatocellular or colorectal carcinomaMorphine for cancer-related painContinuous subcutaneous insulin for diabetes mellitusDeferoxamine for chronic iron overloadChemotherapy for primary hepatocellular or colorectal carcinomaMorphine for cancer-related painContinuous subcutaneous insulin for Diabetes Mellitus
37Part B Infusion DrugsAdministration of narcotic analgesics, except meperidine, in place of morphine for intractable cancer painAdministration of narcotic analgesics, except meperidine, in place of morphine for intractable cancer pain
38Part B Infusion Drugs Administration of antifungal or antiviral drugs AcyclovirAmphotericin BFoscarnetGanciclovirLiposomal amphotericin B preparations are only covered for patients who:Have suffered significant toxicity with standard amphotericin BHave significantly impaired renal functionAdministration of antifungal or antiviral drugsAcyclovirAmphotericin B (non-liposomal…)FoscarnetGanciclovir
39Part B Infusion Drugs Administration of parenteral inotropic therapy DobutamineDopamineMilrinoneFor patients with CHF who meet specific criteriaAdministration of parenteral inotropic therapyDobutamineDopamineMilrinoneFor patients with CHF who meet specific criteria such as…
40Part B Infusion DrugsAdministration of Intravenous Immune Globulin (IVIG)Diagnosis of Primary Immune Deficiency disease onlyPart B coverage is limited to the IVIG onlyDoes not include pumps, supplies, and equipment for administrationAdministration of Subcutaneous Immune GlobulinPump, supplies and equipment are coveredAdministration of Intravenous Immune Globulin (IVIG)For patients with primary immune deficiency diseaseAdmin in the pt’s home
41Part B Infusion DrugsAdministration of epoprostenol and treprostinil for the treatment of pulmonary hypertensionPatient must meet specific criteriaAdministration of epoprostenol and treprostinilFor the treatment of pulmonary hypertension in patients who meet specific criteria
42Part B Infusion Drugs Administration of gallium nitrate For the treatment of symptomatic cancer-related hypercalcemiaAdministration of gallium nitrateFor the treatment of cancer-related hypercalcemia in patients who are symptomaticKey word here is symptomatic
43Part B Infusion Drugs Administration of ziconotide (Prialt®) For the management of severe chronic pain in patients who meet specific criteria
44Part B Infusion Drugs Administration of parenteral nutrition Regulated by the FDA as a drugIncludes total parenteral nutrition (TPN) and its componentsAmino AcidsDextroseLipidsStandard TPN additivesAdministration of parenteral nutrition (TPN)Specific criteria include:Sole source of nutritionSpecific diagnosis to include a non-functioning GI tractUse TPN for a minimum of 90 days
45Part B Infusion DrugsParenteral Nutrition is covered under the Part B prosthetic benefitBeneficiaries must meet specific criteria for permanent alimentary tract dysfunction
46Part B Coverage: Parenteral Nutrition Specific criteria include:Sole source of nutritionSpecific diagnosis to include a non-functioning GI tractUse of TPN for a minimum of 90 daysIncluded in coverage:IV vitaminsTrace elements/mineralsHeparin and saline flushSupplies and equipment for administration
47Part 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 disorderA temporary defect in gastric emptying such as a metabolic or electrolyte disorderA psychological disorder impairing food intake such as depressionA metabolic disorder inducing anorexia such as cancerA physical disorder impairing food intake such as the dyspnea of severe pulmonary or cardiac diseaseA side effect of a medicationRenal failure and/or dialysis
48Part D Coverage: Parenteral Nutrition For all Part D plans, CMS will reimburse the Part D drug components in a parenteral nutrition solutionMultivitamin and trace mineral/elements additives:May be added to the solution per standard of practiceThese components do NOT meet the definition of a Part D drug and may NOT be billed under Part DSupplies and equipment for TPN administration are NOT covered under Part D
49Overview of Medicare Part D Infusion Drugs Medicare Part D covers infusion therapies that do not fulfill Part B criteriaCovers the medication onlyPatient financially responsible for supplies and equipmentNo coverage for monitoring or education of therapyNo coverage of heparin and saline for IV line maintenance
50Part B Infusion DrugsPlace of service helps determine Part B versus Part D coverageInfusion by pump, IV push, IV drip or injectable medications administered in a physician’s office are considered for coverage under Part BPlace of service helps determine Part B versus Part D coverageInfusion 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
51Part B vs. Part D Infusion Drugs Method of administration in the home determines B vs. D coverageIV pump – covered under Part B for specific drugs and if certain criteria are metIf criteria not fulfilled, coverage considered under Part DIV push – Part DIV drip – Part DSubcutaneous – Part DSelf-administered – Part DMethod of administration in the home determines B versus D coverage considerationIV Pump – covered under Part B for specific drugs and if certain criteria are metIf criteria not fulfilled, coverage considered under Part DIV Push – covered under Part DIV drip – covered under Part DSubcutaneous – covered under Part DSelf-administered – covered under Part D
52Reimbursement for Part B vs. Part D Patient must meet very specific criteriaReimbursement includes the medication, supplies, equipment, and professional servicesPart DReimbursement for the medication onlyNo provision for supplies, equipment, or professional services
53Additional Considerations Intravenous Medications/TPN – Additional ConsiderationsA number of professional organizations are working to address gaps in care for this issueAmerican 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 DVariations in coverage from each PDP in 2006Intravenous Medications/TPN – Additional ConsiderationsA number of professional organizations working to address gaps in care for this issueAmerican 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 DVariations in coverage from each PDP in 2006
54CMS Issues Minimal changes for 2007 Audit Due diligence Operational policies and procedures in placePlans responsible for subcontractors
55ConclusionPlans must exercise due diligence in determining appropriate Part B vs. Part D drug coveragePlans must have appropriate operational policies and procedures in placePlans must have reliable information source that is updated frequently relating to Part B vs. Part D drugs and coverage determinationsAccurate 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
56Gorman Health Group, LLC How to Contact UsGorman Health Group, LLC2176 Wisconsin Avenue, N.W.,Washington, D.CPhone:Fax: