April 2, File Code: CMS-2345-P RIN 0938-AQ1. Dear Administrator Tavenner:

Transcription

1 Ms. Marilyn B. Tavenner Acting Administratr Centers fr Medicare & Medicaid Services Department f Health and Human Services Attn: P.O. Bx 8016 Baltimre, MD Re: Medicaid Prgram; Cvered Outpatient Drugs; Prpsed Rule t Revise Requirements Pertaining t Medicaid Reimbursement fr Cvered Outpatient Drugs t Implement the Affrdable Care Act; 77 Fed. Reg (February 2, 2012) File Cde: RIN 0938-AQ1 Dear Administratr Tavenner: On February 2, 2012, the Centers fr Medicare & Medicaid Services (CMS) published a prpsed rule in the Federal Register which wuld revise requirements pertaining t Medicaid reimbursement fr cvered utpatient drugs t implement prvisins f the Patient Prtectin and Affrdable Care Act f 2010 as amended by the Health Care and Educatin Recnciliatin Act f 2010 (the Prpsed Rule ). The Prpsed Rule wuld als revise ther requirements related t cvered utpatient drugs, including key aspects f Medicaid cverage, payment, and the drug rebate prgram. The Fd Marketing Institute (FMI) cnducts prgrams in public affairs, fd safety, research, educatin and industry relatins n behalf f its nearly 1,250 fd retail and whlesale member cmpanies in the United States and arund the wrld. FMI s U.S. members perate mre than 25,000 retail fd stres and almst 22,000 pharmacies with a cmbined annual sales vlume f nearly $650 billin. FMI s retail membership is cmpsed f large multi-stre chains, reginal firms and independent peratrs. Its internatinal membership includes 126 cmpanies frm mre than 65 cuntries. FMI s nearly 330 assciate members include the supplier partners f its retail and whlesale members. FMI submits the fllwing cmments n the Prpsed Rule:

2 FMI Cmments Page 2 f 5 Sectin Definitins Actual Acquisitin Cst: FMI is cncerned that the mve t require states t use actual acquisitin cst (AAC) fr brand name drugs withut a requirement that dispensing fees be increased will negatively impact patient access t cmmunity pharmacy services. We believe that the definitin shuld be amended t require that the wrd currently be included in the definitin between prices and paid. States have an bligatin t pay pharmacies based n current prices paid, nt utdated prices. Multiple Surce Drug: A drug can be cnsidered a multiple surce drug if it is sld r marketed in any state in the United States during the rebate perid. Fr the purpses f determining Federal upper limit (FULs), it shuld be the mst immediate mnthly rebate perid. Hwever, a drug shuld nly be cnsidered a multiple surce drug fr the purpses f determining whether there are three surces f supply when such drugs are natinally available. A simple listing f the drug in the FDA Orange Bk des nt mean it is natinally available t all pharmacies. A drug shuld be cnsidered natinally available when it is generally and widely available fr purchase by all pharmacies in the United States, such as when it is available in purchase fr sufficient quantities by supermarket pharmacies frm the natinal whlesalers. Prfessinal Dispensing Fee The Prpsed Rule makes n changes t the definitin f dispensing fee ( ) but prpses t rename the term prfessinal dispensing fee. We supprt this change. We applaud the agency s statement in the preamble t the Prpsed Rule that One cmpnent f the reimbursement frmula shuld nt be revised withut apprpriately evaluating the ther part. While state and federal plicymakers have fcused effrts n reimbursing pharmacies at the cst f drug prduct, there has been cmparatively little discussin n the imprtance f reimbursing pharmacies accurately fr the cst t dispense. As discussed abve, numerus studies have shwn that state Medicaid dispensing fees have been belw the cst f dispensing. That is ne f the reasns we remain deeply cncerned with current attempts by states t further decrease pharmacy dispensing fees. Rather than asking states t recnsider dispensing fees, we urge CMS t require states t reevaluate dispensing fees t assure that they adequately cver csts and t include specific factrs n assessing dispensing fees in this rulemaking. Elements that make up the cst t dispense prescriptin medicatins include, but are nt limited t: Prescriptin Department Payrll /Persnnel Expenses Prescriptin Department (Direct Csts):

3 FMI Cmments Page 3 f 5 Prescriptin supplies Prfessinal liability insurance fr pharmacists Prescriptin department licenses, permits and fees Dues, subscriptins and cntinuing educatin fr the prescriptin department Delivery expenses (nly prescriptin-related) Pstage and mailing Inventry services Lst inventry Warehuse expense Bad debts fr prescriptins (including uncllected c-pays) Cmputer systems (related nly t the prescriptin department) including sftware and maintenance Prescriptin claim transmissin expenses, Switching Fees, FSA Tracking, E-prescribing charges (transactin fees, enrllment, etc.) Cmpunding equipment expenses Third party-prescriptin audit adjustments (write-ffs) Other prescriptin-department-specific csts Pharmacy-Wide Expense Items (indirect cst shared with ther departments): Building depreciatin Taxes (persnal prperty, real estate, payrll, sales etc.) Rent (building, cmputer equipment and ther equipment rent) Building and equipment maintenance and repairs Custdial services Insurance (general liability nt including prfessinal liability, prperty/casualty, wrkers cmpensatin and emplyee medical insurance, life insurance) Other emplyee benefits (pensin fund, prfit sharing and similar benefits paid by the pharmacy) Legal and prfessinal service fees (attrneys, accuntants, etc.) Bad Debts ther than third-party prescriptin audit expenses Security services Charitable cntributins Telephne/internet Utilities Other perating and ffice supplies Advertising (prmtinal and nn-prmtinal) Credit card transactin fees Central administratin expenses Sectin (a) Definitin f Retail Cmmunity Pharmacy: The statute clearly defines retail cmmunity pharmacy as an independent pharmacy, a chain pharmacy, a

4 FMI Cmments Page 4 f 5 supermarket pharmacy and a mass merchandiser that is licensed as a pharmacy by the State and that dispenses medicatins t the general public at retail prices. Mail rder, lng-term care facility pharmacies, hspital pharmacies, clinics, gvernment pharmacies and pharmacy benefit managers are nt and shuld nt be included in the definitin. Sectin Determinatin f Average Manufacturer Price (AMP): In general, we supprt the definitin f AMP as utlined in the prpsed regulatin. Hwever, we strngly bject t CMS permitting manufacturers t include within the AMP determinatin, sales t entities ther than retail cmmunity pharmacies. There is n statutry basis fr CMS t permit the inclusin f manufacturer sales t specialty pharmacies, hme infusin pharmacies and hme health prviders, r ther entities that act r cnduct business as whlesalers r cmmunity pharmacies. This is a back end way t allw ptential mail rder sales in the calculatin f AMP which is prhibited by statute. This will lwer AMPs and underpay pharmacies. Sectin Inhalatin, Infusin, Instilled, Implanted and Injectable Drugs: With regard t inhalatin, infusin, instilled, implanted and injectable drugs, we agree that a drug is nt generally sld thrugh a retail pharmacy if 90% r mre are sld t nn-retail pharmacy utlets. We als believe that CMS must prvide fr a higher multiplier than 175% f the weighted average AMP t set the FUL fr these drugs. That is because inclusin n nn-retail pharmacy sales will lwer AMPs, and a multiplier f nly 175% will nt cver retail cmmunity pharmacies acquisitin csts fr these drugs. Sectin Requirements f Manufacturers: We supprt the use f a 12-mnth rlling percentage t estimate the value f lagged price cncessins. This will smth ut fluctuatins in AMP frm mnth t mnth that can negatively impact pharmacy reimbursement. Sectin Drugs: Aggregate Upper Limits f Payments: We believe that CMS shuld allw States t use estimated acquisitin cst (EAC), as well as AAC as a benchmark fr brand name drugs. Mrever, CMS must require that states can nly use AAC if they increase their dispensing fees t mre accurately reflect pharmacies cst t dispense. Sectin Upper Limits fr Multiple Surce Drugs: Thugh the Affrdable Care Act prvides CMS with the authrity t calculate FULs at n less than 175% f AMP, we believe that CMS must prvide itself the pprtunity t use the flexibility given t it by the law t set the FUL at greater than 175% f the weighted average AMP in certain justifiable cases in rder t maintain patient access t prescriptin medicatins. We further believe that CMS shuld establish a prcess t suspend an FUL when a prduct is n lnger natinally available. If a terminated prduct reduces the number f A-rated prducts t tw, then CMS shuld immediately suspend the FUL and nt wait fr several mnths fr the prduct s AMP t be mitted frm the FUL calculatin.

5 FMI Cmments Page 5 f 5 Sectin State Plan Requirements: Findings and Assurances: We agree that states must prvide adequate data when prpsing changes t the ingredient cst reimbursement r prfessinal dispensing fee fr reimbursement. We encurage CMS t require that states demnstrate, thrugh surveys that reflect state-based data, that their ingredient csts reimbursement and dispensing fees are reflective f pharmacy csts f dispensing. The requirements fr apprval f State plan amendments regarding reimbursement changes shuld als extend t different classes f pharmacies, as different pharmacies have different csts f purchasing as well as different csts f dispensing. CMS shuld als require states t demnstrate that bth their brand name drug reimbursement as well as MAC lists fr generics are justified based n state-based data, and nt permit states t make reductins in these State maximum allwable cst lists withut justificatin t CMS. Mrever, States shuld be required t demnstrate that their MAC methdlgy is based n cmmunity pharmacies csts f purchasing prescriptin drugs, and als include a prcess by which such values are changed in a timely manner s that they are mre transparent t the pharmacy. Finally, we believe that CMS has n statutry authrity t make public individual AMPs fr brand name r multiple surce drugs. Thus, there shuld be n ability fr states t use AMPs t set Medicaid reimbursement. We appreciate yur cnsideratin f these cmments. Sincerely, Erik R. Lieberman Regulatry Cunsel