CMS Pharmacy Update y p Eastern Medicaid Pharmacy Eastern - PowerPoint PPT Presentation

CMS Pharmacy Update y p Eastern Medicaid Pharmacy Eastern Medicaid Pharmacy Administrators Association (EMPAA) Conference Conference November 7-10, 2010 , Nemacolin Woods Resort and SPA Farmington, Pennsylvania Joseph L Fine R Ph MPA Joseph L. Fine, R.Ph, MPA Technical Director, Pharmacy Division Center for Medicaid, CHIP, Survey & Certification and State Operations Centers for Medicare & Medicaid Services 1

CMS Pharmacy Update y p Affordable Care Act (ACA) Medicare Part D E-Prescribing Retail Price Survey Retail Price Survey DUR APIs Li-Net 2

Affordable Care Act (ACA) Affordable Care Act (ACA) 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” 3

Affordable Care Act (ACA) ( ) Signed into law March 23 2010 Signed into law March 23, 2010 Aff Affected Medicaid pharmacy rebate t d M di id h b t program for States, manufacturers and CMS d CMS 4

Medicaid Drug Provisions in Medicaid Drug Provisions in ACA 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 5

Medicaid Drug Provisions in Medicaid Drug Provisions in ACA 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 6

Medicaid Drug Provisions in ACA M di id D P i i i ACA Rebate percentage for noninnovator multiple source drugs is increased to multiple source drugs is increased to 13 percent of AMP (Section 2501(b)) Effective January 1, 2010 7

Medicaid Drug Provisions in ACA Medicaid Drug Provisions in ACA Recapture Rebate amounts attributable to the increase in the rebate percentages increase in the rebate percentages will be deemed an overpayment and disallowed on a quarterly basis disallowed on a quarterly basis (Section 2501(a)) Effective January 1, 2010 8

Medicaid Drug Provisions in ACA M di id D P i i i ACA 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 9

Medicaid Drug Provisions in ACA M di id D P i i i ACA States are required to include information on drugs paid for by Medicaid MCOs when requesting quarterly rebates from manufacturers (Section 2501(c)) Eff Effective March 23, 2010 ti M h 23 2010 10

Medicaid Drug Provisions in ACA M di id D P i i i ACA 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 11

Medicaid Drug Provisions in ACA M di id D P i i i ACA Discounts provided by manufacturers under the Medicare coverage gap discount program under section 1860D-14A are exempt from Medicaid best price (Section 3301(d) of Subtitle D) Effective July 1, 2010 12

Medicaid Drug Provisions in ACA M di id D P i i i ACA Maximum rebate amount for single and innovator multiple source drugs is 100 percent of AMP (Section 2501(e)) Eff Effective January 1, 2010 ti J 1 2010 13

Medicaid Drug Provisions in Medicaid Drug Provisions in ACA The rebate for new formulations, such as an extended release formulation, of a single source or an innovator multiple i l i t lti l source drug shall be the greater of the rebate for such drug or the product of the rebate for such drug or the product of the AMP of such drug, the highest additional rebate for any strength of the original single y g g g source or innovator multiple source drug, and the total units of such drug paid for under the State plan in the rebate period. (Section 1206(a) of HCERA. Eff 01/01/10 14

Medicaid Drug Provisions in ACA M di id D P i i i ACA Federal upper limit (FUL) for multiple source drugs is no less than 175 percent of the weighted average of AMPs in a FUL group (Section 2503(a)) Eff Effective October 1, 2010 ti O t b 1 2010 15

Medicaid Drug Provisions in ACA M di id D P i i i ACA Definition of AMP is revised to focus on sales to wholesalers and retail community pharmacies that purchase drugs directly from manufacturers (Section 2503(a)) Eff Effective October 1, 2010 ti O t b 1 2010 16

Section 202 of H.R. 1586-6 The Education Jobs and Medicaid Assistance Act Amendment to 2503(a)(2)(B): Amendment to 2503(a)(2)(B): Effective as if included in the enactment of Public Law 111-148 of Public Law 111 148 … is amended by is amended by adding: “unless the drug is an inhalation, infusion , instilled, implanted, or injectable drug that is not generally dispensed through a retail community pharmacy; and”. it h d” Known as the five “I’s” 17

Federal Register: F id Friday Sept. 3, 2010 S t 3 2010 Medicaid Program; Withdrawal of Medicaid Program; Withdrawal of Determination of Average Manufacturer Price Multiple Source Manufacturer Price, Multiple Source Drug Definition, and Upper Limits for Multiple Source Drugs Multiple Source Drugs Comments Due October 4, 2010 18

Medicare Part D in ACA ‘The Discount Program’ Th The ACA established the Medicaid ACA t bli h d th M di id Coverage Gap Discount Program by adding sections 1860D-43 and ddi ti 1860D 43 d 1860d-14A of the Act. The Discount Program makes manufacturer discounts available to applicable Medicare beneficiaries receiving applicable covered Part D while in the coverage gap. 19

Medicaid Drug Provisions in ACA M di id D P i i i ACA Definition of a multiple source drug is revised to clarify the drug is sold or marketed in the United States (Section 2503(a)) Effective October 1, 2010 20

Medicaid Drug Provisions in ACA M di id D P i i i ACA Manufactures are required to report to CMS on a monthly basis the total units they use to calculate monthly AMPs (Section 2503(b)) Effective October 1, 2010 21

Medicaid Drug Provisions in ACA M di id D P i i i ACA Confidentiality provisions modified to allow CMS to disclose the weighted average AMPs and the average retail survey prices on the CMS website (Section 2503(a)) Eff Effective October 1, 2010 ti O t b 1 2010 22

Medicaid Drug Provisions in ACA M di id D P i i i ACA CMS is required to post the weighted average of monthly AMPs on its f thl AMP it website (Section 2503(b)) Effective October 1, 2010 23

Medicaid Drug Provisions in ACA M di id D P i i i ACA Definition of new term ‘retail community pharmacy’ (Section it h ’ (S ti 2503(a)) Effective October 1, 2010 24

Medicaid Drug Provisions in ACA M di id D P i i i ACA Definition of new term ‘wholesaler’ (Section 2503(a)) (S ti 2503( )) Eff Effective October 1, 2010 ti O t b 1 2010 25

Medicaid Drug Provisions in ACA Medicaid Drug Provisions in ACA State Medicaid Director (SMD) letter was State Medicaid Director (SMD) letter was issued on April 22, 2010, discussing increased rebate percentage for covered p g outpatient drugs dispensed to Medicaid patients, the extension of prescription of drug rebates to covered outpatient drugs dispensed to enrollees of Medicaid MCOs and the rebate offset associated with the and the rebate offset associated with the increase in the rebate percentages. Other SMD letters are to follow Other SMD letters are to follow. 26

Medicare Part D in ACA ‘The Discount Program’ I In general, the discount on each l th di t h applicable covered Part D drug is 50 percent of an amount equal to the t f t l t th negotiated price. The manufacturer discounts attributed to the Discount Program will be excluded from the determination of best price as defined in 42 CFR section 447.505. 27

E-Prescribing E Prescribing E-Prescribing is becoming an accepted E Prescribing is becoming an accepted vehicle for prescription processing. NCPDP has developed E-prescribing p p g standards NCPDP/CMS has developed a proposed p p p solution to address the Medicaid “brand medically necessary” requirement. 28

E-Prescribing and Medicaid E Prescribing and Medicaid Several States have been awarded transformation grants to perform e- prescribing initiatives. Requires prescriber to have software to R i ib t h ft t both inquire to the Medicaid program patient specific information, e.g., drug patient specific information e g drug history, preferred drugs, preauthorization requirements, etc. Enhanced funding is available to States for development of MMIS portal or contractor development for data exchange development for data exchange. 29

PROPOSED MEDICAID E-PRESCRIPTION PATHWAY Rx Claim MMIS POS Dispense to Patient Pharmacist E-prescription E prescription Web Portal Rx W b P t l R Rebate Hub / Surescripts Patient Inquiry Physician’s Practice Physician s Practice Physician & Patient Management Software 30