Specialty Pharmacy Trends: Payer and Industry Considerations for Specialty Pharmacies

Transcription

1 Specialty Pharmacy Trends: Payer and Industry Considerations for Specialty Pharmacies September 18, 2017 Washington, DC

2 Frier & Levitt, LLC Jonathan E. Levitt, JD Co-Founding Partner 5th Annual 5th NASP Annual Annual NASP Meeting Annual and Meeting Educational and Educational Conference Conference September September 18-20, , Washington, 2017 Washington, DC DC 2

3 Frier & Levitt, LLC Jesse C. Dresser, JD Partner 5th Annual 5th NASP Annual Annual NASP Meeting Annual and Meeting Educational and Educational Conference Conference September September 18-20, , Washington, 2017 Washington, DC DC 3

4 Specialty Pharmacy Trends: Payor and Industry Considerations for Specialty Pharmacies 5th Annual 5th NASP Annual Annual NASP Meeting Annual and Meeting Educational and Educational Conference Conference September September 18-20, , Washington, 2017 Washington, DC DC 4

5 What Are We Going to Talk About? Reimbursement Trends: Below Cost Reimbursement DIR Fees NADAC Pricing Pharma-Pharmacy Contracting Case Studies on Manufacturer-Pharmacy Relationships HUB Models Compliance Considerations PBM Participation Considerations Audits and Investigations Credentialing and Specialty Pharmacy Contracting Network Access Strategies for Growth 5

6 DIR Fees: What Are They? DIR stands for direct and indirect remuneration DIR was a term coined by the Centers for Medicare and Medicaid Services (CMS) CMS was concerned that the actual cost for a drug under a Part D Plan was being obfuscated by price concessions (e.g. manufacturer rebates) that were not captured at the point of sale PBMs have hijacked the term DIR to extract fees from Providers after the point-of-sale and after the claim has been adjudicated 6

7 DIR Fees: Flat Fee vs. Percentage Based Flat Fee Based Administrative Performance Fee $3.50 to $9.00 per claim on every claim Assessed on every claim across the board Percentage Based Network Variable Rate or Network Rebate or Performance Fee Providers are charged between 3% to 9% of cost paid on every claim based on performance criteria Performance is measured periodically and DIR fees are deducted from PBM payments months later 7

8 DIR Fees: Flat Fee vs. Percentage Based Flat Fee Based Percentage Based Impact on Pharmacy: Impact on Pharmacy: Acquisition Cost $ Acquisition Cost $5, AWP $ WAC $5, Adjudicated Rate (AWP - 15%) $ Initial Profit Above Acquisition $3.00 DIR Fee ($5.00 per claim) $(5.00) NET REIMBURSEMENT $(2.00) The pharmacy is losing $2.00 by dispensing this claim! Adjudicated Rate (WAC + 1%) $5, Initial Profit Above Acquisition $ DIR Fee (5% per claim) $(260.08) NET REIMBURSEMENT $(58.58) The pharmacy is losing $58.58 by dispensing this claim! 8

9 DIR Fees: Performance Criteria Have No Basis in Law Most Authoritative Least Authoritative Statutes enacted by Congress Regulations adopted by HHS Guidance put out by CMS PBM Contracts Nothing in the statutes, regulations or guidance justifies PBMimposed DIR Fees 9

10 DIR Fees: Continuing Developments CMS issued new guidance on DIR reporting requirements for PDPs Part D Plans and PBMs have expanded percentage-based DIR Fees DIR Existential crisis for many specialty pharmacies Industry organizations release multiple White Papers Multiple specialty pharmacies have commenced actions against PBMs and Plan Sponsors 10

11 NADAC Pricing: Medicaid Reimbursement Trends Medicaid reimbursement is set by State agencies States have the freedom to set reimbursement terms, but must adhere to Federal Guidelines Historically, reimbursement was set at Estimated Acquisition Cost (EAC) Average Wholesale Price (AWP), Average Sales Price (ASP) or Wholesale Acquisition Cost (WAC) In 2016 CMS changed its Rules to require reimburse at Actual Acquisition Cost (AAC) National Average Drug Acquisition Cost (NADAC) or other AAC surveys Why was this done? Increasing drug prices are hammering State and Federal budgets 11

12 NADAC Pricing: How Is NADAC Calculated? 50-State monthly observations from independent and chain retail community pharmacies Not including specialty pharmacies, based on NCPDP designation NADAC requires at least five observations of pharmacies actual acquisition costs Voluntary participation of survey requests for acquisition cost 340B drugs should be excluded NADAC pricing is published online by CMS Includes many HIV drugs (i.e., Ziagen, Atripla, Combivir), anti-inflammatory drugs (i.e., Humira and Enbrel), and multiple sclerosis drugs (i.e., Avonex, Copaxone, Betaseron) 12

13 NADAC Pricing: What Can Done? Federal regulations Require that Medicaid must: Provide such methods and procedures relating to the utilization of, and the payment for, care services available under the plan as may be necessary to safeguard against unnecessary utilization of such care and services and to assure that payments are consistent with efficiency, economy, and quality of care and are sufficient to enlist enough providers so that care and services are available under the plan at least to the extent that such care and services are available to the general population in the geographic area At least two ways to challenge unreasonable reimbursement in violation of this regulation in court based on commentary by the United States Supreme Court 1. Administrative Procedure Act Claim that Argues HHS/CMS Failed to Act by Not Enforcing Regulations 2. Petition HHS/CMS to amend its rule and disallow NADAC pricing for specialty pharmacy. If the Petition is Denied, seek judicial review of the agency s denial. 3. Arbitration/Litigation: Federal law is incorporated into PBM Manuals and Providers have rights. 13

14 Pharma-Pharmacy Relationships Along with a third pharmacy, settled with Department of Justice for a combined total of $465 million for kickback allegations Was terminated by OptumRx, CVS Caremark, and Express Scripts stemming from its alleged captive relationships with manufacturers Announced in their K a subpoena from the U.S. Attorney's Office for the Southern District of New York investigating its patient assistance programs and relationships with specialty pharmacies Philidor Rx was terminated by all major PBMs over its relationship with Valeant, and both companies, along with key executives, have faced investigation or prosecution over the arrangement 14

15 Pharma-Pharmacy Relationships: Different Types Direct Purchasing Contracts Service Agreements Data Sharing and Reporting Arrangements Hub Models Copayment Assistance Programs 15

16 Pharma-Pharmacy Relationships: Regulatory Risks Valeant hires sales reps to call on physicians and market Valeant products VALEANT MARKETING REP Sales reps urge physicians to write for Valeant products and to direct prescriptions to Philidor 2 1 Physicians write prescriptions for Valeant products and refer them to Philidor PHYSICIAN And Valeant funds the copay coupon Philidor applies the copay coupon and collects patient data Pharmacy then remits the net payment received from the PBM, less a $100 dispensing fee Valeant has option to Pharmacy purchase purchases PBM remits the Philidor product and directly 5 payment to the Philidor from transfers Valeantthe 10 keeps it on their pharmacy Rx to a contracted books pharmacy And pharmacy pays Philidor a $10 processing fee Patient pays the balance of the copay to Philidor, which Philidor keeps along with the funds received from Valeant PBM 7 6 Pharmacy submits a claim to the patient s PBM NETWORK PHARMACY And also provide the patient with a copayment coupon issued by Valeant 3 PATIENT 16

17 Pharma-Pharmacy Relationships: Regulatory Risks Where are the concerns? VALEANT MARKETING REP 1 Anti-Kickback Violations Price Manipulation Captive Pharmacy 8 11 Valeant has option to purchase Philidor and keeps it on their books Patient 5Steerage Fee 10Splitting Board of 7 Pharmacy PBM Captive Pharmacy 6 PBM Contracts Mandatory Generics 2 3 PHYSICIAN Patient Steerage 8 Copay Waivers HIPAA Breaches 9 Prior Authorization 4 10 NETWORK PHARMACY 3 PATIENT 17

18 Pharma-Pharmacy Relationships: Core vs. Enhanced Services Pharmacies cannot be compensated for core services that they are required to perform as a licensed pharmacy CORE ENHANCED Pharmacies may be compensated for enhanced services that go beyond core business model Calls to physicians to clarify prescription instructions Calls to physicians to educate and provide quality surveys Adverse event reporting Extensive patient follow up for quality assurance and patient compliance General patient information intake Patient information gathering and reporting for REMS Program 18

19 Pharma-Pharmacy Relationships: Fair Market Value and Commercial Reasonableness FAIR MARKET VALUE Arms-length transaction Must be not be based on the volume or value of referrals No single means of determining FMV will apply In obtaining FMV valuation, third party valuations (i.e., appraisals) may withstand more scrutiny COMMERICAL REASONABLENESS Services must not exceed those which are reasonably necessary to accomplish the commercially reasonable business purpose of the services Does the arrangement make commercial sense, even if there were no potential referrals? Establish internal processes for making and documenting reasonable, consistent, and objective determinations of commercial reasonableness of services rendered 19

20 Pharma-Pharmacy Relationships: PBM Risks Best Efforts to achieve formulary compliance PBMs have conducted analyses of percentages of non-preferred drugs or drugs from one manufacturer dispensed by a pharmacy Require pharmacies to keep a record of all original prescriptions and attempts to achieve formulary compliance Acceptance and application of copay coupons Requirement to process all claims through the system Prohibitions on submitting any data to any pharmaceutical company for the purpose of receiving any rebate, discount or the like PBMs want to retain the right to submit prescription data Terminations over mail order percentages 20

21 PBM Auditing Trends Formulary Compliance Copayment Collection Unlicensed Mailing Drug Invoice Shortage Billing Errors Prescriber Denials Off Label Dispensing Prior Authorization Patient Denials Proof of Delivery/Signature Logs 21

22 Specialty Pharmacy Credentialing and Contracting Historically three types of PBM Specialty contracting: Closed or Exclusive Specialty Networks Open Specialty Networks, but with heightened admission criteria Open Specialty Networks Historically employed closed networks After a series of rebukes by CMS, PBMs began to recognize the applicability of the Medicare Part D Any Willing Provider Law Certain PBMs began identifying pharmacies as primarily specialty or mail order pharmacies based on volume of claims submission for specialty/mailed drugs, and applying newer, lower, reimbursement rates for commercial plans Began letting specialty/mail order pharmacies into Medicare Part D (but not commercial) PBMs would route as many specialty and maintenance drugs as possible to their wholly-owned mail order/ specialty pharmacies Other PBMs have begun creating open specialty networks, but with heighted admission criteria or other superficial barriers to entry 22

23 Network Access Federal Any Willing Provider Law Federal Freedom of Patient Choice Law State Any Willing Provider and Anti-Mandatory Mail Order Laws Roughly 26 States have some form of Any Willing Provider Law 23

24 Legal Tools Available to Pharmacies Provide time limits on PBM audits as well as appeal procedures Limit number of prescriptions per audit Prohibit recoupment for clerical errors Fair Pharmacy Audit Laws Provide look back periods limiting PBM audits Prevent PBMs from unilaterally offsetting claims to recoup on audits Provide for interest and attorneys fees when there s a violation Provide certain appeal rights for audits involving Medicaid claims May limit recoupment on certain types of discrepancies (i.e., copay collection) State Medicaid Rules PHARMACY Unfair Trade Practices Laws Prompt Pay Laws Prohibit PBMs from engaging in unfair or deceptive business practices Often provide a private right of action, along with attorneys fees and punitive damages 24

25 Geographic Strategies for Growth Single State Focus Multi-State Regional Growth Strategy All subject to one AWPL/Fair Audit Law (or lack thereof) Beholden to one (or two) large payors Risks of mailing outside home state Can cherry-pick States based on AWPL, Fair Audit Law, Prompt Pay, business volume Diversity of payors Diminished risks of mailing 25

26 Pharmacy Acquisition Considerations Stock Purchase Asset Purchase In any case, buyers should be aware of: PBM notification requirements Board of Pharmacy notification and approval requirements Proper inventory recording requirements Less interruption in PBM contracting Maintain in place key contracts with vendors and suppliers Sometimes less Board of Pharmacy paperwork involved Avoid continuing liability of old corporation Beneficial tax treatment Sometimes easier for seller to approve the sale Pharmacies should conduct a Due Diligence Checklist before selling Pharmacy contract type Outstanding PBM audits Marketing and employee contracts Pharmacy accreditation paperwork SOP Compliance 26

27 Direct Arrangements With Plan Sponsors The Pharmacy Benefits Landscape PLAN SPONSORS Employers Unions Government programs Health Insurers (or Plan Sponsors Administrative directly) contract Services with Only Group PBMs Health to administer Insurance pharmacy benefits PBM PBMs negotiate with manufacturers for rebates MANUFACTURERS Manufacturers sell drug PBMs in turn contract with a products to pharmacies network of retail and through wholesalers specialty pharmacies Patients are employees of the Plan Sponsor, who either self-funds their claims or covers health insurance premiums HEALTH INSURANCE COMPANIES PBM-OWNED PHARMACY PBMs also own mail Both order PBM-owned and specialty and independent pharmacies pharmacies provide medications to the patient PHARMACY PATIENTS 27

28 Direct Arrangements With Plan Sponsors FULLY-INSURED PLANS PPO Employer-Paid Premiums HMO Group Health PolicyIndividual Health Policy Insurance company bears actuarial, financial risk Better terms on many issues including pricing, rebates, etc. for their risk-bearing lines of business HEALTH INSURANCE COMPANY SELF-FUNDED PLANS Union Plans Insurance company bears no risk and provides Administrative Services only When contracting with PBMs Sometimes include purposely worse or submarket terms to compensate for better-thanmarket terms on the risk-bearing side PBM 28

29 Direct Arrangements With Plan Sponsors SELF FUNDED PLAN SPONSOR 1 Plan Sponsor had a contract with PBM to manage the pharmacy benefits under an ASO arrangement PBM The EOB helped reveal that the PBM was keeping over $33,000 per month in profit on this one patient! INDEPENDENT SPECIALTY PHARMACY 5 For each claim, Plan Sponsor was charged over $96,000 per 9 Instead, Plan Sponsor fill and independent pharmacy were able to agree on $79,000 per fill (67% of AWP), with the Plan Sponsor saving over $20, per PBM month offered to reimburse for one employee independent pharmacy for $63,000 per fill, below the pharmacy s acquisition cost Patient had received highpriced medication from 4 PBM-owned pharmacy, but hated the service PBM-OWNED PHARMACY 2 PBM owned its own Specialty Pharmacy and maintained an exclusive specialty network This was in addition to any profit made by the PBM s wholly-owned specialty pharmacy by dispensing the medication! Patient sought to receive his medication from an independent specialty pharmacy 6 PATIENT EMPLOYEE 3 Plan Sponsor employed a Hemophiliac requiring high-priced specialty medications for life 29

30 Direct Arrangements With Plan Sponsors SELF FUNDED PLAN SPONSOR PBM 9 Instead, Plan Sponsor and independent pharmacy were able to agree on $79,000 per fill (67% of AWP), with the Plan Sponsor saving over $20, per month for one employee INDEPENDENT SPECIALTY PHARMACY PBM-OWNED PHARMACY And patient received superior service from independent specialty pharmacy 10 PATIENT EMPLOYEE 30

31 Questions? Website: FrierLevitt.com LinkedIn: LinkedIn.com/company/Frier-Levitt-LLC 31