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Policies to Prevent Pharmaceutical Waste: Initial Prescription Limitations and Pro-rating Co-pays Product Stewardship Institute, Inc. May 17, 2012 Upcoming Webinars Unused Medications: Just How Much Are We Throwing Away? Wednesday, May 23 - 1:00-2:00 PM EST Policies to Prevent Pharmaceutical Waste: Looking at Sample Waste

Monday , June 4th 1-2 PM EST For more information and access to the recordings, please see the Product Stewardship Institute website at: www.productstewardship.us/networkingcalls 2 Who is the Product Stewardship Institute? Global Product Stewardship Council

PSI represented on Board of Directors Non-profit founded in 2000 Memberships 47 States 200+ Local governments Partnerships (75+) Companies Organizations Universities Non-US Governments Board of Directors: 7 states, 4 local agencies

Advisory Council: Multistakeholder (14 members) 3 How to Participate Today You can connect to the Audio portion using VoIP or your telephone. To ask a question

(verbally) via phone or VOIP please use the hand-raising function. To type in a question, use the Question tab. Technical Difficulties? Dial 800.263.6317 4

For the Audience: 2 ways to ask questions Spoken: Use the hand-raising function on your control panel so we can unmute you. Speak through a microphone on your computer OR Be dialed-in through a telephone (and enter your Audio PIN) Written: Write your question in the Question box at any time. Please tell us to whom you are addressing your question.

5 Overview of Todays Webinar Examining policies to reduce the amount of waste pharmaceuticals generated each year One large source of unused pharmaceuticals: initial prescriptions 6 Expert Panelists

Jennifer Palow, Acting MIHMS Project Manager, Director of Operations, Office of MaineCare Services Lisa Vanston Thorpe, Esq., U.S. Dept. of Health and Human Services, Centers for Medicare and Medicaid Services Medicare Drug Benefit and Part C & D Data Group Division of Drug Plan Policy and Quality 7 MaineCare Policies to Prevent Pharmaceutical Waste Jennifer Palow

Pharmacy Director Curbing waste Controlling cost Pharmacies in Maine were once allowed to give an early refill for prescriptions at their discretion. We found that pharmacies used this to bypass some PA requirements. In 2005, the Maine pharmacy program eliminated this override process.

In 2006 the Department added policy that discontinued advanced refills for vacationers and denied request to replace lost medications. In the summer of 2009, MaineCare introduced a fifteen day initial prescription supply limit. MaineCare staff and associates began developing the program for various medications that have been identified with high side effect profiles, high discontinuation rates, or frequent dose adjustments to ensure cost effectiveness without wasting or discarding of used medications. In the first year the Department saw a savings of

nearly $500,000. The department periodically reviews the list of drugs in the 15 day initial script program. We are careful not to add medications that would cost the Department to dispense twice. Challenges during implementation included the additional work for providers. We allowed the provider to write one script for the full month and the pharmacy to only dispense for 15 days at a time. Additional

challenges included making sure this program remained cost effective and actually produced savings. The drug classes included are typically those that would have side effects, a high discontinuation rate or dose changes. The list of drugs can be found on the website www.mainecarepdl.org The most recent change in policy for waste control is reducing mail order from refill tolerance allowed

at 85% to anything prescribed over 60 days to be a 90% RTA. During an audit in 2010 the Department found that mail order patients receiving 90 day fills were receiving an extra month of drugs annually. State wide efforts to clean up wasted medications include take back days, drop off sites at participating pharmacies and police stations and

in some areas the TRIAD will pick up unused medications. Questions? Product Stewardship Webinar: Policies to Prevent Pharmaceutical Waste: Initial Prescription Limitations and Pro-rating Co-pays" Thursday, May 17, 2012 2:00 PM - 3:00 PM EDT

INFORMATION NOT RELEASABLE TO THE PUBLIC UNLESS AUTHORIZED BY LAW: This information has not been publicly disclosed and may be privileged and confidential. It is for internal government use only and must not be disseminated, distributed, or copied to persons not authorized to receive the information. Unauthorized disclosure may result in prosecution to the full extent of the law. 21 Daily Cost-Sharing Rate Requirement on Medicare Part D Sponsors Lisa V. Thorpe Division of Drug Plan Policy & Quality CMS

INFORMATION NOT RELEASABLE TO THE PUBLIC UNLESS AUTHORIZED BY LAW: This information has not been publicly disclosed and may be privileged and confidential. It is for internal government use only and must not be disseminated, distributed, or copied to persons not authorized to receive the information. Unauthorized disclosure may result in prosecution to the full extent of the law. 22 Establishment and Application of Daily Cost-Sharing Rate CMS-4157-FC, Medicare Parts C and D Final Rule with Comment for Contract Year 2013 published on April 12, 2012. http://www.gpo.gov/fdsys/pkg/FR-2012-04-12/pdf/2012-8071.pdf

Daily Cost-Sharing Requirement (DCR) applicable for Contract Year (CY) 2014, although Part D sponsors may voluntarily implement for Contract Year 2013. DCR is found in Improving Program Efficiencies section of the Final Rule on page 22126. INFORMATION NOT RELEASABLE TO THE PUBLIC UNLESS AUTHORIZED BY LAW: This information has not been publicly disclosed and may be privileged and confidential. It is for internal government use only and must not be disseminated, distributed, or copied to persons not authorized to receive the information. Unauthorized disclosure may result in prosecution to the full extent of the law. 23

Establishment and Application of Daily Cost-Sharing Rate, Cont. Beginning January 1, 2014, Medicare Part D sponsors must apply a DCR to all prescriptions for less than a months supply (unless an exception applies due to the type of drug involved), and in the case of a monthly copayment, multiply it by the days supply actually dispensed. DCR requirement will be a feature of cost-effective utilization management and fraud, abuse and waste control programs that Part D sponsors must have in place.

INFORMATION NOT RELEASABLE TO THE PUBLIC UNLESS AUTHORIZED BY LAW: This information has not been publicly disclosed and may be privileged and confidential. It is for internal government use only and must not be disseminated, distributed, or copied to persons not authorized to receive the information. Unauthorized disclosure may result in prosecution to the full extent of the law. 24 Establishment and Application of Daily Cost-Sharing Rate Cont. Taking advantage of the DCR requirement will be voluntary for the beneficiary in consultation with the prescriber or pharmacist.

Financially incentivizes beneficiaries to ask their prescribers for less than a months supply, such as when prescribed an initial fill of a chronic medication with higher cost-sharing (e.g., a trial fill). Prescribers most likely to agree to write for trial fill when involving a drug that has significant side effects and/or is poorly tolerated. INFORMATION NOT RELEASABLE TO THE PUBLIC UNLESS AUTHORIZED BY LAW: This information has not been publicly disclosed and may be privileged and confidential. It is for internal government use only and must not be disseminated, distributed, or copied to persons not authorized to receive the information. Unauthorized disclosure may result in prosecution to the full extent of the law. 25

Establishment and Application of Daily Cost-Sharing Rate Cont. Estimate of the potential savings to the Part D program are $150 million in 2013/$1.8 billion total by 2018. Estimate takes into account additional dispensing fees, how many beneficiaries will request trial fills, average days supply and sponsor programming costs. INFORMATION NOT RELEASABLE TO THE PUBLIC UNLESS AUTHORIZED BY LAW: This information has not been publicly disclosed and may be privileged and confidential. It is for internal government use only and must not be

disseminated, distributed, or copied to persons not authorized to receive the information. Unauthorized disclosure may result in prosecution to the full extent of the law. 26 Establishment and Application of Daily Cost-Sharing Rate Cont. Additional benefits of DCR requirement will be: 1) facilitating the synchronization of prescriptions for beneficiaries, as well as 2) the reduction of unused drugs which will assist in diminishing

the environmental issues caused by the disposal of unused medications and opportunities for criminal activities and substance abuse caused by diversion of unused medications. INFORMATION NOT RELEASABLE TO THE PUBLIC UNLESS AUTHORIZED BY LAW: This information has not been publicly disclosed and may be privileged and confidential. It is for internal government use only and must not be disseminated, distributed, or copied to persons not authorized to receive the information. Unauthorized disclosure may result in prosecution to the full extent of the law. 27 Establishment and Application of Daily Cost-Sharing Rate Cont.

Comments received on proposed rule: Supportive of goal to reduce cost and waste in Part D program. Operational concerns: claim edits, duplicate prescription drug event records (PDEs), coordination of benefits (COB). Pharmacies splitting prescriptions for additional dispensing fees. Lessons to be learned from long-term care (LTC) short-cycle dispensing requirement effective January 1, 2013. INFORMATION NOT RELEASABLE TO THE PUBLIC UNLESS AUTHORIZED BY LAW: This information has not been publicly disclosed and may be privileged and confidential. It is for internal government use only and must not be disseminated, distributed, or copied to persons not authorized to receive the information. Unauthorized disclosure may result in prosecution to the full extent of the law.

28 Establishment and Application of Daily Cost-Sharing Rate Cont. CMS response to comments: Proper programming will be essential to addressing technical issues raised and lessons may be learned from implementation of new LTC dispensing requirement in CY 2013; therefore, applicability of DCR delayed for one year until CY 2014. CMS will publish guidance as needed to address technical questions.

INFORMATION NOT RELEASABLE TO THE PUBLIC UNLESS AUTHORIZED BY LAW: This information has not been publicly disclosed and may be privileged and confidential. It is for internal government use only and must not be disseminated, distributed, or copied to persons not authorized to receive the information. Unauthorized disclosure may result in prosecution to the full extent of the law. 29 Establishment and Application of Daily Cost-Sharing Rate Cont. Sponsors will be expected to implement contractual terms and auditing and other internal controls to detect and prevent fraud,

waste and abuse. Industry encouraged to develop appropriate coding so pharmacies may communicate the reason for dispensing less than a months supply. INFORMATION NOT RELEASABLE TO THE PUBLIC UNLESS AUTHORIZED BY LAW: This information has not been publicly disclosed and may be privileged and confidential. It is for internal government use only and must not be disseminated, distributed, or copied to persons not authorized to receive the information. Unauthorized disclosure may result in prosecution to the full extent of the law. 30

Establishment and Application of Daily Cost-Sharing Rate Cont.. 42 CFR 423.100 Daily cost-sharing rate means, as applicable, the established: (1) Monthly copayment under the enrollees Part D plan, divided by 30 or 31 and rounded to the nearest lower dollar amount, if any, or to another amount, but in no event to an amount which would require the enrollee to pay more for a months supply of the prescription than would otherwise be the case; or (2) Coinsurance percentage under the enrollees Part D plan. INFORMATION NOT RELEASABLE TO THE PUBLIC UNLESS AUTHORIZED BY LAW: This information has not been publicly disclosed and may be privileged and confidential. It is for internal government use only and must not be

disseminated, distributed, or copied to persons not authorized to receive the information. Unauthorized disclosure may result in prosecution to the full extent of the law. 31 Establishment and Application of Daily Cost-Sharing Rate Cont. 42 CFR 423.153 (b) Drug utilization management. A Part D sponsor must have established a reasonable and appropriate drug utilization management program that (4)(i) Establishes a daily cost-sharing rate and applies it to a prescription presented to a network pharmacy for a covered Part

D drug that is dispensed for a supply less than 30 days, and in the case of a monthly copayment, multiplies the daily cost-sharing rate by the days supply actually dispensed-- INFORMATION NOT RELEASABLE TO THE PUBLIC UNLESS AUTHORIZED BY LAW: This information has not been publicly disclosed and may be privileged and confidential. It is for internal government use only and must not be disseminated, distributed, or copied to persons not authorized to receive the information. Unauthorized disclosure may result in prosecution to the full extent of the law. 32 Establishment and Application of Daily Cost-Sharing Rate Cont.

(A) If the drug is in the form of a solid oral dose, subject to paragraph (b)(4)(i)(B) of this section and may be dispensed for a supply less than 30 days under applicable law; (B) The requirements of paragraph (b)(4)(i) of this section do not apply to either of the following: (1) Solid oral doses of antibiotics. (2) Solid oral doses that are dispensed in their original container as indicated in the Food and Drug Administration Prescribing Information or are customarily dispensed in their original packaging to assist patients with compliance. INFORMATION NOT RELEASABLE TO THE PUBLIC UNLESS AUTHORIZED BY LAW: This information has not been publicly disclosed and may be privileged and confidential. It is for internal government use only and must not be

disseminated, distributed, or copied to persons not authorized to receive the information. Unauthorized disclosure may result in prosecution to the full extent of the law. 33 Establishment and Application of Daily Cost-Sharing Rate Cont. Questions? INFORMATION NOT RELEASABLE TO THE PUBLIC UNLESS AUTHORIZED BY LAW: This information has not been publicly disclosed and may be privileged and confidential. It is for internal government use only and must not be disseminated, distributed, or copied to persons not authorized to receive the information. Unauthorized disclosure may result in prosecution to

the full extent of the law. 34 Interested in Learning More? Contacts Sierra Fletcher Director of Policy and Programs Product Stewardship Institute 617-236-4822 [email protected] 35

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