CMS Pharmacy Update Eastern Medicaid Pharmacy Administrators - - PowerPoint PPT Presentation
CMS Pharmacy Update Eastern Medicaid Pharmacy Administrators Association (EMPAA) Conference October 23-26, 2011 Nemacolin Woods Resort and SPA Nemacolin Woods Resort and SPA Farmington, Pennsylvania Joseph L. Fine, R.Ph, MPA Technical
Eastern Medicaid Pharmacy Administrators Association (EMPAA) Conference
October 23-26, 2011
Nemacolin Woods Resort and SPA Nemacolin Woods Resort and SPA Farmington, Pennsylvania Joseph L. Fine, R.Ph, MPA T h i l Di t Ph Di i i Technical Director, Pharmacy Division Gail E. Sexton, R.N. Policy Analyst, Pharmacy Division
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Policy Analyst, Pharmacy Division Center for Medicaid and CHIP Services Centers for Medicare & Medicaid Services
Affordable Care Act (ACA)
Pharmacy NPRM Status Rebates and Offsets Rebates and Offsets MCO Utilization Oth ACA AMP/FUL I f ti Other ACA AMP/FUL Information Draft FULs
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Other Pharmacy Topics
APIs State Plan Amendments DUR Electronic Submission RadioPharmaceuticals
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“Survey of Retail Prices: Payment and Utilization Rates and Performance Utilization Rates and Performance Rankings” Contract (Retail Price Survey) ( y)
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Affordable Care Act (ACA)
Pharmacy NPRM Status Rebates and Offsets Rebates and Offsets MCO Utilization Oth ACA AMP/FUL I f ti Other ACA AMP/FUL Information Draft FULs
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The Patient Protection and Affordable The Patient Protection and Affordable Care Act (PPACA) P.L. 111-148 and the Health Care and Education the Health Care and Education Reconciliation Act (HCERA) P.L. 111- 152 are together known as “The 152 are together known as The Affordable Care Act”
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Signed into law March 23 2010 Signed into law March 23, 2010 Aff t d M di id h b t Affected Medicaid pharmacy rebate program for States, manufacturers d CMS and CMS
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CMS h d N ti f
Proposed Rule Making (NPRM).
The NPRM currently is in the final stages
comment period.
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Minimum rebate percentage for single source and innovator multiple source source and innovator multiple source drugs increased to 23.1 percent of AMP (Section 2501(a)) AMP (Section 2501(a)) Effective January 1, 2010
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Minimum rebate percentage for single source and innovator multiple source source and innovator multiple source clotting factors and drugs approved exclusively for pediatric indications exclusively for pediatric indications increased to 17.1 percent (Section 2501(a)) 2501(a)) Effective January 1, 2010
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Rebate percentage for non-innovator multiple source drugs is increased to multiple source drugs is increased to 13 percent of AMP (Section 2501(b)) Effective January 1, 2010
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Unit Rebate Amounts (URAs), CMS was unable to provide URAs until the was unable to provide URAs until the Q1 – 2011.
manufacturers to determine their
rebate.
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th St t f CMS St t ld the States from CMS, States could then reconcile previous quarters based on their own calculations.
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increase in the rebate percentages will p g be deemed an overpayment and disallowed on a quarterly basis disallowed on a quarterly basis (Section 2501(a)).
y ,
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provided to the States provided to the States.
the States on quarterly reconciliation. q y
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Manufacturers are required to pay rebates for drugs dispensed to individuals enrolled in Medicaid MCOs, if the MCOs are responsible for coverage of drugs (Section 2501(c)) Effective March 23, 2010
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States are required to include information on drugs paid for by Medicaid MCOs when requesting quarterly rebates from manufacturers (Section 2501(c)) Eff ti M h 23 2010 Effective March 23, 2010
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Covered outpatient drugs are not subject to the rebate requirements if they are dispensed by HMOs, including Medicaid MCOs, and subject to 340B discounts (Section 2501(c)) Effective January 1, 2010
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MCO/PBMs to obtain utilization data.
Adjudication Utilization Standard a format that lends itself to MCO utilization reporting.
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MCO programs in place.
h b fit d t f MCO pharmacy benefit carved out of MCO capitation.
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All MCO States are required to bill manufacturers for rebates for MCO id l i d b it MCO paid claims and submit MCO utilization data to CMS.
To date, few States have complied with this requirement.
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sales to wholesalers and retail community pharmacies that purchase drugs directly pharmacies that purchase drugs directly from manufacturers (Section 2503(a))
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Amendment to 2503(a)(2)(B):
Effective as if included in the enactment of Public Law 111-148 … is amended by adding: “unless the drug is an inhalation, infusion , instilled, implanted, or injectable drug that is not generally injectable drug that is not generally dispensed through a retail community pharmacy; and”. pharmacy; and . Known as the five “I’s”
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Medicaid Program; Withdrawal of Determination of Average Determination of Average Manufacturer Price, Multiple Source Drug Definition and Upper Limits for Drug Definition, and Upper Limits for Multiple Source Drugs
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Definition of a multiple source drug is Definition of a multiple source drug is revised to clarify the drug is sold or marketed in the United States marketed in the United States (Section 2503(a)) Effective October 1, 2010
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Manufactures are required to report to CMS on a monthly basis the total units they use to calculate monthly AMPs they use to calculate monthly AMPs (Section 2503(b))
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allow CMS to disclose the weighted average AMPs and the average retail survey prices on the CMS website y p (Section 2503(a))
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q p g average of monthly AMPs on its website (Section 2503(b)) website (Section 2503(b))
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In ACA, Federal upper limit (FUL) for multiple source drugs is no less than 175 percent of the weighted average
2503(a)). Eff ti O t b 1 2010 Effective October 1, 2010
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p the FUL was released on the CMS Pharmacy website. y
calculate the FULs in accordance with ACA are based on the manufacturer ACA are based on the manufacturer reported and certified July 2011 monthly AMP and AMP unit data for monthly AMP and AMP unit data for multiple source drugs.
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f i di id l d f th for individual drugs on any of the draft FUL files.
CMS is posting the weighted average of monthly AMPs in a FUL gro p group.
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the FULs amendments "shall take ff t ith t d t h th effect … without regard to whether or not final regulations to carry out such amendments have been promulgated by such date."
Orange Book B-rated drugs.
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draft ACA FULs and the methodology used to calculate the FUL FUL.
received, but will not respond to , p individual comments.
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Following a period of releasing the FULS in draft format CMS plans to FULS in draft format, CMS plans to publish the final Affordable Care Act FULs FULs. At that time, the prior FULs calculated using the prior methodology will no longer be in effect.
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DRAFT SAMPLE - JULY 2011 - AFFORDABLE CARE AC FEDERAL UPPER LIMIT (DRAFT ACA FULs) (DRAFT ACA FULs)
Product Group Ingredient Strength Dosage Route ACA 1 ACEBUTOLOL HYDROCHLORIDE 200MG CAPSULE ORAL 0.53 2 ACEBUTOLOL HYDROCHLORIDE 400MG CAPSULE ORAL 0.59 9 ACETAMINOPHEN; BUTALBITAL; CAFFEINE 500MG;50MG;40 MG TABLET ORAL 0.14 11 ACETAMINOPHEN; CODEINE PHOSPHATE 120MG/5ML;12M G/5ML SOLUTION ORAL 0.01 13 ACETAMINOPHEN; CODEINE PHOSPHATE 300MG;15MG TABLET ORAL 0 09 13 PHOSPHATE 300MG;15MG TABLET ORAL 0.09 16 ACETAMINOPHEN; HYDROCODONE BITARTRATE 500MG;10MG TABLET ORAL 0.13 19 ACETAMINOPHEN; HYDROCODONE BITARTRATE 500MG;5MG TABLET ORAL 0 04
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19 HYDROCODONE BITARTRATE 500MG;5MG TABLET ORAL 0.04 20 ACETAMINOPHEN; HYDROCODONE BITARTRATE 500MG;7.5MG TABLET ORAL 0.07 ACETAMINOPHEN; 500MG/15ML;7 5
DRAFT SAMPLE - JULY 2011 - AFFORDABLE CARE ACT - FEDERAL UPPER LIMIT (Summary) (Summary)
Product Group Ingredient Strength Dosage Route Aberrant Code ACA FUL Weighted Average AMP ACEBUTOLOL 1 ACEBUTOLOL HYDROCHLORIDE 200MG CAPSULE ORAL 0.534196 0.305255 2 ACEBUTOLOL HYDROCHLORIDE 400MG CAPSULE ORAL 0.597436 0.341392 ACETAMINOPHEN; 4 ACETAMINOPHEN; BUTALBITAL 650MG;50MG CAPSULE ORAL 2 0.000000 0.000000 9 ACETAMINOPHEN; BUTALBITAL; CAFFEINE 500MG;50MG; 40MG TABLET ORAL 0 146865 0 083923 9 CAFFEINE 40MG TABLET ORAL 0.146865 0.083923 11 ACETAMINOPHEN; CODEINE PHOSPHATE 120MG/5ML;1 2MG/5ML SOLUTION ORAL 0.014620 0.008354 ACETAMINOPHEN;
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13 ACETAMINOPHEN; CODEINE PHOSPHATE 300MG;15MG TABLET ORAL 0.098676 0.056386 ACETAMINOPHEN; CODEINE
DRAFT SAMPLE - JULY 2011 - AFFORDABLE CARE ACT FEDERAL UPPER LIMIT (Extreme Detail) (Extreme Detail)
AM D Product Group Ingredient Stren gth Dosa ge Rou te MDR Unit Type ACA FUL Pack age Size NDC Mont hly AMP AM P Uni t Drug Cate gory Code ACEBUTOLOL 1 ACEBUTOLOL HYDROCHLORID E 200M G CAPS ULE OR AL CAP 0.5342 100.0 00 00378- 1200-01 R R N ACEBUTOLOL HYDROCHLORID 200M CAPS OR 0 5342 100 065162 1 HYDROCHLORID E 200M G CAPS ULE OR AL CAP 0.5342 100.0 00 65162- 0669-10 R R N 1 ACEBUTOLOL HYDROCHLORID E 200M G CAPS ULE OR AL CAP 0.5342 100.0 00 00904- 6173 60 R R N 1 E G ULE AL CAP 006173-60 R R N 1 ACEBUTOLOL HYDROCHLORID E 200M G CAPS ULE OR AL CAP 0.5342 50.00 50268- 0050-15 R R N ACEBUTOLOL
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1 ACEBUTOLOL HYDROCHLORID E 200M G CAPS ULE OR AL CAP 0.5342 100.0 00 67857- 0700-01 R R I ACEBUTOLOL HYDROCHLORID 400M CAPS OR 0 5974 100 000378
DRAFT SAMPLE- JULY 2011 - AFFORDABLE CARE DRAFT SAMPLE- JULY 2011 - AFFORDABLE CARE ACT - FEDERAL UPPER LIMIT
(Changes) There is no data on the Changes worksheet because this is the first month we are posting draft Affordable Care Act Federal Upper Limits. For subsequent months, this tab will include information for those FUL groups where the FUL changed from the previous month.
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DRAFT SAMPLE- JULY 2011 - AFFORDABLE CARE AC FEDERAL UPPER LIMIT (U it T I ) (Unit Type Issues)
Dru MDR Prod uct Grou Stre Dos Rout Aber rant Cod MD R Unit Typ ACA Pack age Mont hly AMP g Cate gory Cod MD R TE Units Per Packa ge M Te p Ingredient ngth age e e yp e FUL g Size NDC y AMP Unit e C g Size Da 108 AMPICILLIN SODIUM 1GM INJE CTA BLE INJE CTIO N 1 GM 0.00 000 1.00 44567
10 NR NR N AP 10.00 8/2 108 AMPICILLIN SODIUM 1GM INJE CTA BLE INJE CTIO N 1 EA 0.00 000 1.00 63323
10 R R N AP 1.000 INJE INJE 25021 108 AMPICILLIN SODIUM 1GM CTA BLE CTIO N 1 GM 0.00 000 1.00
10 R R N AP 10.00 AMPICILLIN INJE CTA INJE CTIO 0.00 1.00 00781
150.0
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108 SODIUM 1GM BLE N 1 ML 000 92 R R N AP 00 108 AMPICILLIN SODIUM 1GM INJE CTA BLE INJE CTIO N 1 ML 0.00 000 1.00 00781
92 R R N AP 150.0 00
DRAFT SAMPLE - JULY 2011 - AFFORDABLE CARE ACT - FEDERAL UPPER LIMIT (Each FUL Group) (Each FUL Group)
Prod MD R Drug Cate MD MDR Units Per Prod uct Grou p Ingredient Stren gth Dosa ge Rout e Aberr ant Code R Unit Typ e ACA FUL Pack age Size NDC Mont hly AMP AMP Unit Cate gory Cod e MD R TE C Per Packa ge Size MDR Term Date INJE INJE 00009- 144 BACITRACIN 5000 0U CTAB LE CTIO N 7 EA 0.000 00 1.000 0233- 01 R R I AP 1.000 144 BACITRACIN 5000 0U INJE CTAB LE INJE CTIO N 7 EA 0.000 00 1 000 00009- 0233- 03 R R I AP 1 000 144 BACITRACIN 0U LE N 7 EA 00 1.00003 R R I AP 1.000 144 BACITRACIN 5000 0U INJE CTAB LE INJE CTIO N 7 EA 0.000 00 1.000 25021- 0116- 30 R R N AP 1.000 INJE INJE 25021- 144 BACITRACIN 5000 0U CTAB LE CTIO N 7 EA 0.000 00 1.000 0116- 31 R R N AP 1.000 144 BACITRACIN 5000 0U INJE CTAB LE INJE CTIO N 7 EA 0.000 00 1 000 39822- 0277- 02 R R N AP 10 000
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144 BACITRACIN 0U LE N 7 EA 00 1.00002 R R N AP 10.000 144 BACITRACIN 5000 0U INJE CTAB LE INJE CTIO N 7 EA 0.000 00 1.000 39822- 0277- 05 R R N AP 1.000 INJE INJE 39822-
DRAFT SAMPLE - JULY 2011 - AFFORDABLE CARE ACT - FEDERAL UPPER LIMIT (5I Drugs) (5I Drugs)
P d Ab MDR P k M thl Drug C t MD MDR Units P MDR Produ ct Group Ingredient Stren gth Dosag e Route Aberr ant Code MDR Unit Type ACA FUL Packa ge Size NDC Monthl y AMP AMP Unit Categ
Code MD R TEC Per Packag e Size MDR Term Date 41 ACETYLCYSTEINE 10% SOLUT ION INHALA TION, ORAL 8 ML 0.0000 4 000 00517- 7504-25 R R N AN 4 000 41 ACETYLCYSTEINE 10% ION ORAL 8 ML 4.000 7504-25 R R N AN 4.000 41 ACETYLCYSTEINE 10% SOLUT ION INHALA TION, ORAL 8 ML 0.0000 10.000 00517- 7510-03 R R N AN 10.000 SOLUT INHALA TION, 0.0000 00054- 41 ACETYLCYSTEINE 10% ION , ORAL 8 ML 10.0003027-02 R R N AN 1.000 41 ACETYLCYSTEINE 10% SOLUT ION INHALA TION, ORAL 8 ML 0.0000 30.000 00054- 3025-02 R R N AN 1.000 INHALA 41 ACETYLCYSTEINE 10% SOLUT ION TION, ORAL 8 ML 0.0000 30.000 00409- 3307-03 R R N AP 30.000 42 ACETYLCYSTEINE 20% SOLUT ION INHALA TION, ORAL 8 ML 0.0000 4.000 00074- 3308-01 NR NR N AP 4.000 06/01/ 1998 INHALA
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42 ACETYLCYSTEINE 20% SOLUT ION INHALA TION, ORAL 8 ML 0.0000 4.000 00517- 7604-25 R R N AN 4.000 42 ACETYLCYSTEINE 20% SOLUT ION INHALA TION, ORAL 8 ML 0.0000 10.000 00517- 7610-03 R R N AN 10.000
DRAFT SAMPLE - JULY 2011 - AFFORDABLE CARE ACT - FEDERAL UPPER LIMIT (Non A Rated NDCs) (Non A-Rated NDCs)
Produ ct Group Ingredient Stren gth Dosag e Route Aberr ant Code MDR Unit Type ACA FUL Packa ge Size NDC Monthl y AMP AMP Unit Drug Categ
Code MDR TEC MDR Units Per Packag e Size MDR Term Date 19 ACETAMINOPHEN; HYDROCODONE BITARTRATE 500M G;5M G TABLE T ORAL TAB 0.0403 3 100.00 00054- 4784-25 R R N NR 1.000 299 CHLORPROMAZINE HYDROCHLORIDE 10MG TABLE T ORAL 3 TAB 0.0000 100.00 00832- 0300 00 NR NR N BP 1 000 299 HYDROCHLORIDE 10MG T ORAL 3 TAB 0300-00 NR NR N BP 1.000 299 CHLORPROMAZINE HYDROCHLORIDE 10MG TABLE T ORAL 3 TAB 0.0000 1,000. 000 00832- 0300-10 NR NR N BP 1.000 299 CHLORPROMAZINE HYDROCHLORIDE 10MG TABLE T ORAL 3 TAB 0.0000 100.00 51079- 0518-01 R R N BP 1.000 299 CHLORPROMAZINE HYDROCHLORIDE 10MG TABLE T ORAL 3 TAB 0.0000 100.00 51079- 0518-20 R R N BP 1.000 299 CHLORPROMAZINE HYDROCHLORIDE 10MG TABLE T ORAL 3 TAB 0.0000 100.00 00781- 1715-01 R R N BP 100.000 CHLORPROMAZINE 100M TABLE 0 0000100 0000832
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301 CHLORPROMAZINE HYDROCHLORIDE 100M G TABLE T ORAL 3 TAB 0.0000 100.00 00832- 0303-00 NR NR N BP 1.000 301 CHLORPROMAZINE HYDROCHLORIDE 100M G TABLE T ORAL 3 TAB 0.0000 1,000. 000 00832- 0303-10 NR NR N BP 1.000 CHLORPROMAZINE 100M TABLE 0.0000100.0051079-
DRAFT SAMPLE - JULY 2011 - AFFORDABLE CARE ACT - FEDERAL UPPER LIMIT (NR AMP) (NR AMP)
D MDR U it Produ ct Group Ingredient Stren gth Dosag e Route Aberr ant Code MDR Unit Type ACA FUL Packa ge Size NDC Monthl y AMP AMP Unit Drug Categ
Code MDR TEC Units Per Packag e Size MDR Term Date ACETAMINOPHEN; 300M G;30M TABLE 0 0000100 0064720 09/25/ 14 ACETAMINOPHEN; CODEINE PHOSPHATE G;30M G TABLE T ORAL 9 TAB 0.0000 100.00 64720- 0304-10 NR NR N AA 100.000 09/25/ 2007 14 ACETAMINOPHEN; CODEINE PHOSPHATE 300M G;30M G TABLE T ORAL 9 TAB 0.0000 1,000. 000 64720- 0304-11 NR NR N AA 1,000.0 00 07/31/ 2010 300M 15 ACETAMINOPHEN; CODEINE PHOSPHATE 300M G;60M G TABLE T ORAL 9 TAB 0.0000 100.00 63304- 0561-01 NR NR N AB 1.000 12/31/ 2010 15 ACETAMINOPHEN; CODEINE PHOSPHATE 300M G;60M G TABLE T ORAL 9 TAB 0.0000 100.00 64720- 0305 10 NR NR N AA 100 000 07/31/ 2010 15 CODEINE PHOSPHATE G T ORAL 9 TAB 00305-10 NR NR N AA 100.000 2010 15 ACETAMINOPHEN; CODEINE PHOSPHATE 300M G;60M G TABLE T ORAL 9 TAB 0.0000 500.00 64720- 0305-50 NR NR N AA 500.000 06/30/ 2010 69 AMANTADINE HYDROCHLORIDE 100M G CAPS ULE ORAL 9 CAP 0.0000 100.00 00832- 1015 00 NR NR N AB 1 000
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69 HYDROCHLORIDE G ULE ORAL 9 CAP 01015-00 NR NR N AB 1.000 69 AMANTADINE HYDROCHLORIDE 100M G CAPS ULE ORAL 9 CAP 0.0000 500.00 00832- 1015-50 NR NR N AB 1.000 81 AMIODARONE HYDROCHLORIDE 200M G TABLE T ORAL 9 TAB 0.0000 100.00 00245- 0147-01 NR NR N AB 1.000 AMIODARONE 200M TABLE 0 0000500 0000245
DRAFT SAMPLE - JULY 2011 - AFFORDABLE CARE ACT - FEDERAL UPPER LIMIT (S Drugs) (S Drugs)
MDR Produ ct Group Ingredient Stren gth Dosag e Route Aberr ant Code MDR Unit Type ACA FUL Packa ge Size NDC Monthl y AMP AMP Unit Drug Categ
Code MDR TEC MDR Units Per Packag e Size MDR Term Date BETAMETHASONE CREA TOPIC 0.5878 00085- 157 BETAMETHASONE DIPROPIONATE 0.05% CREA M TOPIC AL GM 0.5878 5 15.000 00085 0517-01 R R S NR 15.000 157 BETAMETHASONE DIPROPIONATE 0.05% CREA M TOPIC AL GM 0.5878 5 50.000 00085- 0517-04 R R S NR 50.000 158 BETAMETHASONE DIPROPIONATE 0 05% LOTIO N TOPIC AL ML 0.5821 8 30 000 00085- 0962-01 R R S NR 30 000 158 DIPROPIONATE 0.05% N AL ML 8 30.0000962 01 R R S NR 30.000 158 BETAMETHASONE DIPROPIONATE 0.05% LOTIO N TOPIC AL ML 0.5821 8 60.000 00085- 0962-02 R R S NR 60.000 159 BETAMETHASONE DIPROPIONATE 0.05% OINT MENT TOPIC AL GM 1.3950 9 15.000 00085- 0575-02 R R S NR 15.000 BETAMETHASONE OINT TOPIC 1 3950 00085 159 BETAMETHASONE DIPROPIONATE 0.05% OINT MENT TOPIC AL GM 1.3950 9 50.000 00085- 0575-05 R R S NR 50.000 191 BUPRENORPHINE HYDROCHLORIDE 0.3MG /ML INJEC TABLE INJEC TION 5 ML 0.0000 1.000 12496- 0757-01 NR NR S NR 1.000
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237 CARBIDOPA; LEVODOPA 10MG; 100M G TABLE T ORAL 9 TAB 0.0000 100.00 00006- 3915-68 R R S NR 1.000 CARBIDOPA; 25MG; 100M TABLE 0 1851100 0000006-
DRAFT SAMPLE - JULY 2011 - AFFORDABLE CARE ACT - FEDERAL UPPER LIMIT (Bioequivalent Groups) (Bioequivalent Groups)
Product Group Ingredient Strength Dosage Route FDA TEC 390 CYCLOSPORINE 100MG CAPSULE ORAL AB2 TABLET, EXTENDED 1135 NIFEDIPINE 90MG EXTENDED RELEASE ORAL AB2 1747 FLUOXETINE HYDROCHLORIDE 10MG CAPSULE ORAL AB1 1749 FLUOXETINE HYDROCHLORIDE 20MG CAPSULE ORAL AB1 1766 LEVOTHYROXINE SODIUM 0.137MG **See Current Annual Edition 1.8 Description of Special Situations Levothyroxine Sodium TABLET ORAL AB1 1766 LEVOTHYROXINE SODIUM Sodium TABLET ORAL AB1 1965 METFORMIN HYDROCHLORIDE 500MG TABLET, EXTENDED RELEASE ORAL AB1 TABLET
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1965 METFORMIN HYDROCHLORIDE 500MG TABLET, EXTENDED RELEASE ORAL AB2 TABLET, EXTENDED
DRAFT SAMPLE - JULY 2011 - AFFORDABLE CARE ACT - FEDERAL UPPER LIMIT (Aberrant Codes) (Aberrant Codes)
Aberrant Codes: Aberrant Codes: 0 = all criteria in place to establish a FUL 1 = Inconsistent Unit Type – all labelers within the FUL group are not reporting i th it t using the same unit type. 2 = < 3 NDC9s –less than three suppliers of the drug for this FUL group 3 = <3 TEC As – FDA has rated less than three therapeutically equivalent (TE) formulations for this FUL drug group 4 = <3AMPs >0 less than three distinct monthly average manufacturer prices (AMP) have been reported 4 = <3AMPs >0- less than three distinct monthly average manufacturer prices (AMP) have been reported and certified by the labeler at the NDC-9 level for this FUL group 5 = <3AMP units > 0 –less than three distinct monthly AMP units have been reported and certified by the labeler at the NDC-9 level for this FUL group 6 = <3NDC-9s, with TEC A and AMP > 0 and AMP units > 0 – less than three distinct, FDA rated TE products with monthly AMP and AMP units have been reported and certified by the labeler at the NDC-9 level for this FUL group
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7 = Unit Type “EA” – certain products correctly reported and certified as EACH currently excluded from a FUL calculation 8 = Route Exceptions – products that are generally considered to be “5-I” currently excluded from a FUL calculation (inhalation infusion instilled implanted or injectable drug)
DRAFT SAMPLE - JULY 2011 - AFFORDABLE CARE ACT
(Groups with No NDCs) ( p )
Product Group Ingredient Strength Dosage Route 12 ACETAMINOPHEN; CODEINE PHOSPHATE 120MG/5ML;12MG /5ML SUSPENSION ORAL 29 ACETAMINOPHEN; PROPOXYPHENE HYDROCHLORIDE 650MG;65MG TABLET ORAL ACETAMINOPHEN; 30 PROPOXYPHENE NAPSYLATE 325MG;50MG TABLET ORAL 31 ACETAMINOPHEN; PROPOXYPHENE NAPSYLATE 650MG;100MG TABLET ORAL 39 ACETOHEXAMIDE 250MG TABLET ORAL 40 ACETOHEXAMIDE 500MG TABLET ORAL AEROSOL,
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50 ALBUTEROL 0.09MG METERED INHALATION 57 ALCOHOL; DEXTROSE 5ML/100ML;5GM/1 00ML INJECTABLE INJECTION 78 AMINOPHYLLINE 105MG/5ML SOLUTION ORAL
DRAFT SAMPLE - JULY 2011 - AFFORDABLE CARE ACT - FEDERAL UPPER LIMIT (U t h d P i S ) (Unmatched Price Summary)
Ingredient Strength Dosage Route THEOPHYLLINE 400 MG CAP ER 24H ORAL SENNOSIDES 8.6 MG TABLET ORAL DOBUTAMINE HCL/D5W 500MG/250 IV SOLN INTRAVEN DOBUTAMINE HCL/D5W 1000MG/250 IV SOLN INTRAVEN ISOSORBIDE DINITRATE 40 MG TABLET ORAL DILTIAZEM HYDROCHLORIDE 90 MG CAP ER 12H ORAL
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DILTIAZEM HYDROCHLORIDE 90 MG CAP ER 12H ORAL DILTIAZEM HYDROCHLORIDE 60 MG CAP ER 12H ORAL GUAIFENESIN 100 MG/5ML SYRUP ORAL
DRAFT SAMPLE - JULY 2011 AFFORDABLE CARE ACT - FEDERAL UPPER LIMIT (Unmatched Price Detail) (Unmatched Price Detail)
Package Size NDC Monthly AMP AMP Units Drug Category MDR TEC Size NDC Monthly AMP AMP Units Category MDR TEC 1.0 00002-8031- 01 R R S AP 00003-1482- 30.0 20 NR NR I AT 60.0 00003-1482- 30 NR NR I AT 60.0 00003-6335- 17 R R I AB 60.0 00003-6336- 17 R R I AB 60.0 17 R R I AB 60.0 00003-6337- 17 R R I AB 00006-0717-
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100.0 28 R R S NR 30.0 00006-0717- 31 R R S NR
Other Pharmacy Topics
APIs State Plan Amendments DUR Electronic Submission RadioPharmaceuticals
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What is a drug? What is a drug? Section 201 (21 USC 321) Definition; under (g)(1) the term ‘drug’ means … (B) articles (g)( ) g ( ) intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man … and (C) … (other than food) (D) … a food or dietary supplement for which a claim is made is not a for which a claim … is made … is not a drug solely because the labeling contains such a claim
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such a claim …
An API is a bulk drug substance An API is a bulk drug substance, which is defined by FDA as any substance that is represented for use substance that is represented for use in a drug and that, when used in a manufacturing processing or manufacturing, processing, or packaging of a drug, becomes an active ingredient of the drug product active ingredient of the drug product 21 CFR section 207.3(a)(4).
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APIs may be included in APIs may be included in extemporaneously compounded prescriptions and may serve as the prescriptions and may serve as the active drug component in a compound formulation. co pou d o u at o FDA regulations at 21 CFR part 207 require that all API manufacturers require that all API manufacturers register with the FDA.
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caused concern regarding coverage of these products under State plans, as to whether they should be placed y elsewhere in the State Plan (e.g. Home Health DME) Health, DME)
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State Release #158, issued 7/13/11, stated that products may be covered as prescribed drugs when included in an extemporaneously compounded prescription and billed through the pharmacy point of sale system and can be attributed to prescription drugs
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New electronic submission process h b d l d has been developed. Documentation
Public notice (if required) Current and new SPA pages Answers to funding questions Supportive rationale for changes 90 day clock
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Section 1927(g) of the Social Security Act Section 1927(g) of the Social Security Act and CFR 456.700 requires States to implement DUR programs. Changes have been made to the annual report and reviewer instructions. An electronic submission process has been developed and in place since June 2011. CMS is planning to post on the CMS website DUR summaries and States’ best ti practices.
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RadioPharmaceuticals are considered covered out-patient drugs.
manufacturers have had difficulty in manufacturers have had difficulty in determining the required rebates
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drug product that is ultimately administered drug product that is ultimately administered to the patient requires the use of a “Technetium-99 Generator” which, when a Technetium 99 Generator which, when a sterile saline solution is passed through it, creates the radioactive isotope that is creates the radioactive isotope that is combined with the “Lyophilized Vial” (a.k.a. “cold kit,”) to create the end drug product. cold kit, ) to create the end drug product. Both the generator and cold kit have NDCs, but the end drug product does not. NDCs, but the end drug product does not.
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CMS is planning on working with the RadioPharmaceutical manufacturers to l th i d t th M di id place their products on the Medicaid Drug Rebate file.
CMS will advise States regarding provider billing instructions.
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“Survey of Retail Prices: Payment and Utilization Rates and Performance Utilization Rates and Performance Rankings” Contract (Retail Price Survey) ( y)
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Myers & Stauffer, LC was awarded the Retail Price Survey contract on July 1, 2011. The contract consists of two parts, Part I and Part II. Will provide States with a valid array p y
ingredient costs paid by retail i h i h
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community pharmacies to those prices available to the consumer.
National average prices on a monthly National average prices on a monthly basis for each of the following:
Cash customers 3rd party payers Medicaid programs p g
Also provides States information p when a new single source drug is available.
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States must report annually: p y Payment rates for outpatient y p drugs; Dispensing fees; Utilization rates for non- innovator multiple source drugs.
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Based on 50 most widely prescribed singe source drugs prescribed singe source drugs. CMS ti l t il l CMS compares national retail sales price to prices for these drugs for each State each State. CMS k St t d b it CMS ranks States and submits a full report to Congress.
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A template has been developed and A template has been developed and cleared by the Paper Work Reduction Act (PRA) for State data survey Act (PRA) for State data survey usage. An all-State call will occur later this t t i St t i t ti f quarter to review State instructions for Part I completion.
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AWP is no longer being published by AWP is no longer being published by First Data Bank (FDB), effective September 29, 2011. p This change was announced by FDB This change was announced by FDB in September, 2009. 44 States currently have a contract with FDB for DUR and/or AWP
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with FDB for DUR and/or AWP information.
As a result of FDB’s announcement in 2009, Medicaid State pharmacy administrators prepared a white paper entitled “Post AWP Pharmacy Pricing and Reimbursement”, which was reviewed by NASMD reviewed by NASMD. NASMD d CMS i i NASMD requested CMS to assist in providing a national benchmark of pharmacy acquisition costs pharmacy acquisition costs.
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fi d ll lifi d d t find a well-qualified vendor to survey ingredient costs paid by retail community pharmacies.
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The vendor was required to: The vendor was required to:
Possess a thorough knowledge of retail Possess a thorough knowledge of retail pharmacy drug purchasing and the factors that affect those purchasing costs Possess the ability to obtain net drug costs i i d ff i i b i d
performing on a sample basis that will be valid nationwide audits of retail pharmacy
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p y purchases
The vendor was required to: The vendor was required to:
Be able to maintain separate files of prices Be able to maintain separate files of prices
pharmacies and specialty pharmacies Be able to look at geographic variation in pricing if any to provide reliable pricing, if any, to provide reliable nationwide data
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The vendor was required to: The vendor was required to:
Be able to support and maintain files of Be able to support and maintain files of current drug ingredient cost prices on an
Be able to provide updated pricing information on very tight time schedules information on very tight time schedules
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CMS plans to provide the States a file
community pharmacies on the CMS website. CMS is including Stakeholders in the CMS is including Stakeholders in the development to ensure transparency throughout the process.
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g
On A g st 4 2011 CMS held a
Stakeholders’ Meeting.
teleconference or in-person attendance.
States, manufacturers, wholesalers, pharmaceutical industries, and other interested parties.
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The meeting objectives:
re-evaluate and modify methodology re evaluate and modify methodology as appropriate.
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Th lti ti l d The resulting national average drug acquisition cost will be termed:
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A C t th t t il h Average Cost that retail pharmacy pay to acquire drugs.
M&S will evaluate geographic, chain and independent, rural and urban cost ariations variations.
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assist State Medicaid pharmacy assist State Medicaid pharmacy programs in evaluating their existing i b t th d l reimbursement methodology.
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Sampling process: Sampling process:
pharmacies in all States (excludes pharmacies in all States (excludes closed-door pharmacies) will be evaluated separately.
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S l Sample process: Invoice purchase records for most
recent 30-day period.
pharmacy location will not be surveyed more than once every two y y years.
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A separate special purpose survey: ill b f d l ll
reviewing discounts, rebates, h b k f d t i ll t chargebacks, free goods, typically not included on invoices or correlated to i di id l d d t individual drug products. ill tili ll l i
Th d t d fi di l t d ill
determine next steps.
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P bli h d fil Published file:
NADAC per drug group name
P t d th CMS b it
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Data collection process: El t i h d d
acceptable.
from wholesalers.
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Brand drugs: Brand drugs:
groups will have a margin of error of groups will have a margin of error of <5% of the mean unit cost at a confidence level of 95% confidence level of 95%.
p g approximately1%.
80% of payor total spend.
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Generic Drugs: g
groups will have a margin of error <10% groups will have a margin of error 10%
level of 95%. level of 95%.
error is 5%. G i d t i ll t f
20%-40% of payor total spend.
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exclusively controlled by the U.S. y y Government.
disclosing “confidential” information to disclosing confidential information to any parties other than the U.S. G t Government.
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from private parties, the information can be designated as being “confidential” if it is the kind of information that would customarily not be released to the public by the person from whom it was obtained.
p y be published.
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produced monthly pricing changes produced monthly, pricing changes that warrant immediate updates will b d d i th th ff be processed during the month, off- cycle.
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Every year there are new Every year there are new challenges to Medicaid and Pharmacy. Pharmacy. It is CMS’ intent to continue to work It is CMS’ intent to continue to work collaboratively with States in addressing the issues necessary to addressing the issues necessary to serve the beneficiaries who need pharmacy services
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pharmacy services.
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