DIR FEES: WHAT YOU NEED TO KNOW JULY 13, :00 10:00 AM

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DIR FEES: WHAT YOU NEED TO KNOW JULY 13, 2017 9:00 10:00 AM ACPE UAN: 0107-9999-17-078-L04-P 0.1 CEU/1.0 hr Activity Type: Knowledge-Based Learning Objectives for Pharmacists: Upon completion of this CPE activity participants should be able to: 1. Define Direct and Indirect Remuneration (DIR) fees 2. Discuss methods to prepare and accrue for DIRs fees 3. Analyze how performance improves reimbursement 4. Review the 2017 CMS Summary positon on DIR fees Speaker: Valerie C. Fortin, B.A. Valerie Fortin is the Senior Director, PBM Relations at McKesson AccessHealth. In this capacity, she is responsible for contracting with PBMs and Plans for over 5,700 independent and small to medium-sized chain pharmacies. In addition, Ms. Fortin is responsible for the MAC Success Manager Program. Ms. Fortin has been with McKesson since January, 2011. Ms. Fortin has 15+ years of pharmacy industry experience. Prior to joining McKesson, Ms. Fortin worked for Cardinal Health for 12 years. She worked in purchasing (3 years), generics (3 years), and managed care (6 years). Prior to Cardinal Health, Valerie worked for Borden selling consumable products to pharmacy chains located east of the Mississippi, including Walgreen, CVS, and Rite Aid. Ms. Fortin holds a B.A. in Biology from Wittenberg University, Springfield, OH. Speaker Disclosure: Valerie C. Fortin reports no actual or potential conflicts of interest in relation to this CPE activity. Off-label use of medications will not be discussed during this presentation.

DIR Fees: What You Need to Know Valerie Fortin, PBM Relations, Access Health Disclosure Valerie Fortin reports she is an employee of Access Health, a wholly owned subsidiary of McKesson 1

Disclaimer McKesson was not involved in preparing this presentation and does not endorse or warrant the accuracy of the content. This information contained here does not constitute legal, medical or clinical advice and as the independent owner of your business, you are solely responsible for determining whether programs and services you offer are compliant with law. Learning Objectives Upon successful completion of this activity, pharmacists should be able to: 1. Define Direct and Indirect Remuneration (DIR) fees 2. Discuss methods to prepare and accrue for DIRs fees 3. Analyze how performance improves reimbursement 4. Review the 2017 CMS Summary position on DIR fees 2

History of DIR Fees Definition and Background Definitions Term used by the Centers for Medicare and Medicaid Services (CMS) for price concessions related to the Medicare benefit Short Answer: Discounts to pharmacy reimbursement not captured at the point of sale Long Answer: Per CMS..includes discounts, chargebacks or rebates, cash discounts, free goods contingent on a purchase agreement, upfront payments, coupons, goods in kind, free or reducedprice services, grants, or other price concessions or similar benefits offered to some or all purchasers from any source, including manufacturers, pharmacies, enrollees, or any other person, that would serve to decrease the costs incurred by the Part D sponsor for the drug. Section 11. Direct and Indirect Remuneration (DIR), pg 52, https://www.cms.gov/medicare/prescription-drug-coverage/drugcoverageclaimsdata/downloads/pdeguidance.pdf. https://www.gpo.gov/fdsys/pkg/fr-2014-05-23/pdf/2014-11734.pdf 3

Background First introduced to PSAOs / independent pharmacies as part of Medicare Part D network reimbursement for the 2013 plan year DIR growth: ü Number of Medicare Plan Sponsors using DIR ü Complexity of how DIRs are calculated CMS guidance to Plan Sponsors for the 2016 plan year ü Only have a DIR if the DIR cannot be reasonably calculated at the point of sale Currently, DIR fees for the applicable plans are variable and tied to clinical and/or operational performance criteria https://www.gpo.gov/fdsys/pkg/fr-2014-05-23/pdf/2014-11734.pdf What are DIR fees DIR fees describes a number of different types of fees or charges that are collected from pharmacies participating in Medicare Part D DIR fees are collected on the remittance statements after the claim has already been adjudicated Plan Sponsors are required to submit a DIR report to CMS on an annual basis CMS uses the data in the annual DIR report along with the data from the Prescription Drug Event (PDE) to calculate the true cost of what is paid to a Medicare Part D plan by CMS for a given plan year 4

You may hear of DIR fees as: Pay to play : A fee to participate in a preferred pharmacy network. [Keep in mind, can be used for non-preferred pharmacies, too] A charge consisting of: The difference between the agreed upon reimbursement rate and another variable contractual metric. A fee based on: Compliance with contractually imposed performance metric or more often, performance offset by another fee http://www.ncpa.co/pdf/dir-one-pager-2016.pdf What DIR fees are, What they aren t DIR fees ARE: DIR fees are NOT: Regulated by CMS Applied at point of sale Assessed post-adjudication One part of reimbursement Typically used to lower cost and/or improve patients health outcomes Exclusive to any one PSAO Retained by PSAO Exclusive to preferred networks https://www.gpo.gov/fdsys/pkg/fr-2014-05-23/pdf/2014-11734.pdf 5

Calculating DIR fees Examples Example 1: DIR as a percentage of the ingredient cost Ingredient Cost Paid (AWP x%) $10 Ingredient Cost Paid (AWP x%) $10 + Dispense Fee $1 POS Reimbursement $11 X DIR % 5% DIR $0.50 POS Reimbursement ($11) DIR ($0.50) = Actual Reimbursement $10.50 6

Example 2: DIR as a flat dollar amount Ingredient Cost Paid (AWP x%) $10 + Dispense Fee $1 POS Reimbursement $11 Flat DIR Amount $2 DIR $2 POS Reimbursement ($11) DIR ($2.00) = Actual Reimbursement $9.00 13 Generic Effective Rate (GER) Generics are paid according to a Maximum Allowable Cost (MAC) Schedule. The MAC schedule varies by drug, PBM, Plan Sponsor, etc. There can be multiple MAC lists. Generic Effective Rate (GER) is the average reimbursement for all generics in terms of AWP y%. If the MAC runs at AWP x%, and the contractual GER is AWP y%, then the true-up/dir is the difference between AWP x% and AWP y% 7

Example 3: As difference between adjudicated reimbursement amount and contractual reimbursement amount (GER) Ingredient Cost Paid (AWP x%) $10 + Dispense Fee $1 POS Reimbursement $11 Contractual Ingredient Cost (AWP y%) $5 + Dispense Fee $1 Contractual Reimbursement $6 - POS Reimbursement $11 Agreed-upon Reimbursement $6 True-up/DIR $5 POS Reimbursement ($11) True-up/DIR ($5) = Actual Reimbursement $6 15 Preparing for DIR fees Calculating DIR Accruals 8

Know the Schedule; and Accrue Lump sum DIR DIR Schedule Pharmacy Accrues A Jan Feb Mar April May June July Aug Sept Oct Nov Dec Jan Feb Mar April May ü ü ü ü ü ü ü ü ü ü ü ü ü ü ü ü ü DIR collected each week DIR collected each week DIR collected each week B C D Collection weekly throughout the year no need to accrue Collection weekly throughout the year no need to accrue Collection: Every other week throughout the year no need to accrue Collection or rebate Rebate Rebate E Collection Collection Collection Collection Determine BIN/PCN Gather Information Estimate DIR fees Accrue Funds 9

Step 1: Determine BIN/PCN Determine BIN/PCN Utilize resources PSAO PBM Plan CMS (see link below) https://www.cms.gov/medicare/prescription-drug-coverage/prescriptiondrugcovgenin/pharma.html Step 2: Gather Information Run reports from your pharmacy system Data points: ingredient cost, claim count Gather Information 10

Step 3: Estimate DIR fees DIR calculators Manual tracking (see examples) Estimate DIR fees https://www.cms.gov/medicare/prescription-drug-coverage/prescriptiondrugcovgenin/pharma.html Monthly DIR Accrual Calculation: Percentage based Monthly ingredient cost paid for claims subject to DIR $20,000 x DIR percentage 5% Monthly accrual amount $1,000 11

Monthly DIR Accrual Calculation: Flat dollar based Monthly claim volume for claims subject to DIR 400 x DIR amount per claim $2.00 Monthly accrual amount $800 Add up the total monthly accruals by PBM/Plan PBM/Plan #1 $1,000 + PBM/Plan #2 $800 Monthly accrual amount $1,800 12

Step 4: Accrue funds Set aside funds each month so the money is available when DIR fees are collected Accrue/save funds https://www.cms.gov/medicare/prescription-drug-coverage/prescriptiondrugcovgenin/pharma.html Know the Schedule; and Accrue DIR Schedule Lump sum DIR Pharmacy Accrues A Jan Feb Mar April May June July Aug Sept Oct Nov Dec Jan Feb Mar April May ü ü ü ü ü ü ü ü ü ü ü ü ü ü ü ü ü DIR collected each week DIR collected each week DIR collected each week B C D Collection weekly throughout the year no need to accrue Collection weekly throughout the year no need to accrue Collection: Every other week throughout the year no need to accrue Collection or rebate Rebate Rebate E Collection Collection Collection Collection 13

Focus on Performance Variable DIR fees* *reduced for top performers Performance based incentives Leverage Tools DIR Management Using Performance to Reduce DIR fees 14

DIR Criteria Varies by Plan Sponsor Ensure you know what each plan requires in order to minimize DIR fees, which ultimately maximizes your overall reimbursement. Some plans measure at the individual pharmacy level; other plans measure at the PSAO/network level. If you are directly contracted with a PBM or Plan that has a DIR, refer to your contract for specific details. A plan may have one or more of the common clinical and operational criteria listed below. Gap in care (Statin) HTN (RAS) Adherence Cholesterol Adherence Diabetes Adherence High Risk Medication CMR Completion Rate Formulary Compliance Generic Dispensing Rate (GDR) % of 90 Day Fills ü ü ü ü ü ü ü ü ü Focus on Performance How you can improve clinical performance 1 2 3 4 5 Determine plan-specific expectations Leverage EQuIPP Consider medication adherence solutions Complete assigned MTM cases Have effective conversations 15

Q: Do DIR fees apply to claims for dual eligible members? Q: Do DIR fees apply to claims for dual eligible members? A: If a dual eligible member is enrolled in a plan that has a DIR as a component of reimbursement, then a DIR fee would apply and be collected from the pharmacy based on that plan s performance criteria. 16

Q: Do dual eligible members pay the same copay regardless of the pharmacy being preferred or nonpreferred? Q: Do dual eligible members pay the same copay regardless of the pharmacy being preferred or nonpreferred? A: Yes, and No. If the preferred cost sharing copay for a plan is greater than the dual eligible member s LIS copay, then the dual eligible member pays the same LIS copay regardless of the pharmacy. However, if the plan s preferred cost sharing copay is less than the dual eligible member s LIS copay, the dual eligible member benefits from the lower preferred cost sharing copay. 17

Q: Do commercial plans charge DIR fees? Q: Do commercial plans charge DIR fees? A: Right now, no. However, what happens in Medicare tends to flow into commercial and managed Medicaid. 18

Q: If DIR goes away, or becomes disallowed by CMS, does that mean my reimbursement will be higher? Q: If DIR goes away, or becomes disallowed by CMS, does that mean my reimbursement will be higher? A: No, the reimbursement would likely be the same whether there is a DIR or not. Let s look at an example to illustrate this scenario. 19

Total Reimbursement With DIR Without DIR Ingredient Cost $14 $6.50 + dispensing fee $1 $0.50 - DIR $8 NO DIR FEES Total Reimbursement $7 $7 Q: Do DIRs apply for preferred pharmacies only? 20

Q: Do DIRs apply for preferred pharmacies only? A: No, for some plans, DIRs also apply for non-preferred pharmacies. Additionally, there are some plans where there are no preferred pharmacies, and a DIR applies to all pharmacies. Q: Do DIR fees apply to 340B claims? 21

Q: Do DIR fees apply to 340B claims? A: The short answer is, yes, a DIR fee would apply to 340B claims if that claim is reimbursed under a contract that has a DIR. A pharmacy would need to work with their contracted covered entity to make adjustments to account for the DIR fee. Q: Do DIR fees apply to Long Term Care claims? 22

Q: Do DIR fees apply to Long Term Care claims? A: If a pharmacy is being reimbursed for a LTC claim based on a Long Term Care contract, a DIR fee would not apply. Keep in mind, LTC is defined by CMS, and is generally a skilled nursing facility; and it is not assisted living or a group home. Q: I paid my taxes, and then at a later date DIR fees were collected for the tax year in which I already filed. What should I do? 23

Q: I paid my taxes, and then at a later date DIR fees were collected for the tax year in which I already filed. What should I do? A: A pharmacy could overpay on taxes if the DIR fees are not properly accounted. It is important to seek advice from a tax advisor regarding your pharmacy s DIR fees. Q: What is the best way to minimize DIR? A: Make sure you understand the measurement criteria for the plans most important to your business. The higher the performance, the lower the DIR amount, and ultimately the higher your overall reimbursement. 24

Advocate What you can do: Encourage CMS to finalize Proposed Guidance on DIR and Pharmacy Price Concessions Urge Congress to Enact H.R. 1038/S. 413, the Improving Transparency and Accuracy in Medicare Part D Spending Act Submit concerns to CMS Write a letter to the editor of your local newspaper http://www.ncpanet.org/advocacy/dir-fees Questions? Valerie Fortin, PBM Relations, Access Health 25