CASE 0:15-cv DWF-TNL Document 17 Filed 02/05/16 Page 1 of 30 IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF MINNESOTA

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1 CASE 0:15-cv DWF-TNL Document 17 Filed 02/05/16 Page 1 of 30 IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF MINNESOTA PRIME THERAPEUTICS LLC, v. Plaintiff, CVS PHARMACY, INC., CASE NO. 15-CV DWF-TNL Defendant. DEFENDANT CVS PHARMACY INC. S ANSWER AND COUNTERCLAIMS TO PLAINTIFF S COMPLAINT JURY TRIAL DEMANDED Defendant CVS Pharmacy, Inc. ( CVS ), by and through undersigned counsel, answers Plaintiff Prime Therapeutics LLC s ( Prime ) Complaint as follows: NATURE OF ACTION 1. CVS admits that there exists a Pharmacy Participation Agreement between Prime Therapeutics LLC and CVS Pharmacy, Inc., effective October 15, 2007 (the 2007 PPA ). CVS denies the remainder of the allegations in Paragraph 1 of the Complaint. 2. CVS admits that in or about July 2015, Prime adjusted the Maximum Allowable Cost ( MAC ) of many, if not all, multiple source generic prescription drugs, thereby substantially decreasing the reimbursements CVS would receive for dispensing such drugs. CVS denies that such adjustment was pursuant to the 2007 PPA. 3. CVS denies the allegations of Paragraph 3 of the Complaint. 4. CVS admits that it has informed Prime that its conduct in adjusting MAC pricing

2 CASE 0:15-cv DWF-TNL Document 17 Filed 02/05/16 Page 2 of 30 was contrary to the terms of the 2007 PPA and state and federal laws and that CVS is entitled to damages and other remedies as a result of such conduct. CVS further admits that, by letter dated October 19, 2015, CVS reiterated, as it had been trying to discuss with Prime for the prior two months, that the unilateral pricing changes implemented by Prime beginning on or about July 1, 2015 were unacceptable and directly led to financial harm to CVS. CVS further admits that it told Prime in that letter that it would not enter go forward discussions with Prime until appropriate remedies for Prime s pricing changes occurred, such remedies defined as [i]mmediate adjustment of Generic reimbursement to our historic norms and [f]inancial compensation in the amount of $19,040,460 reflecting the damages done to CVS. 5. CVS denies that Plaintiff is entitled to any of the relief requested in Paragraph 5 of the Complaint. PARTIES 6. CVS lacks knowledge or information sufficient to admit or deny the allegations contained in Paragraph 6 of the Complaint, and, on that basis, denies them. CVS further lacks knowledge or information sufficient to admit or deny the allegations contained in Paragraphs 6(a), (b), (c), (d), (e), (f), (g), (h) and (i) of the Complaint, and, on that basis, denies them. The last sentence of Paragraph 6 of the Complaint is a legal conclusion to which no response is required. To the extent that a further response is required, CVS lacks knowledge or information sufficient to admit or deny the allegations contained in the last sentence of Paragraph 6 of the Complaint, and, on that basis, denies them. 7. CVS admits the allegations of the first sentence of Paragraph 7 of the Complaint. The allegations of the second sentence of Paragraph 7 are a legal conclusion to which no response is required. To the extent that a further response is required, CVS admits the 2

3 CASE 0:15-cv DWF-TNL Document 17 Filed 02/05/16 Page 3 of 30 allegations of the second sentence of Paragraph 7 of the Complaint. JURISDICTION AND VENUE 8. The first sentence of Paragraph 8 of the Complaint is a legal conclusion to which no response is required. To the extent that a further response is required, CVS does not contest that this Court has diversity jurisdiction. On information and belief, CVS admits the allegations contained in the second sentence of Paragraph 8 of the Complaint. CVS admits the allegations of the last sentence of Paragraph 8 of the Complaint. 9. Paragraph 9 of the Complaint asserts a legal conclusion to which no response is required. To the extent that a further response is required, CVS does not contest venue in this Court. To the extent that any further response is required, CVS admits that the 2007 PPA contains a provision designating Minnesota as governing law, except where federal common law applies, admits that it conducts business and operates retail pharmacies in Minnesota, and otherwise denies the remainder of the allegations contained in Paragraph 9 of the Complaint. BACKGROUND ON PHARMACEUTICAL PRICING 10. CVS admits that the acquisition price for pharmaceuticals is subject to change. CVS further admits that movement in MAC reimbursement for multiple source generic drugs is supposed to move in concert with the market for drugs. CVS denies that the changes to MAC effected by Prime in 2015 corresponded to changes in the market for those drugs. 11. The allegations in Paragraph 11 of the Complaint are vague and ambiguous, and CVS therefore lacks knowledge or information sufficient to admit or deny the allegations contained in Paragraph 11, and, on that basis, denies them. To the extent that Paragraph 11 alleges that it is appropriate or consistent with industry standard for Prime to adjust MAC reimbursement for multiple source generic drugs based on factors unrelated to changes in the 3

4 CASE 0:15-cv DWF-TNL Document 17 Filed 02/05/16 Page 4 of 30 market for those drugs, CVS denies that allegation. THE AGREEMENT 12. CVS admits that the 2007 PPA sets forth some of the terms and conditions under which CVS provides prescription drug services to patients in connection with Prime s administration of prescription drug benefits in Prime s pharmacy networks. To the extent that Paragraph 12 alleges that the 2007 PPA is the sole source of such terms and conditions, CVS denies the allegation. 13. Paragraph 13 of the Complaint purports to characterize the 2007 PPA, which document speaks for itself. To the extent any further response is required, CVS denies the allegations contained in Paragraph 13 of the Complaint to the extent they are inconsistent with the 2007 PPA and/or other relevant materials, including but not limited to Exhibits to the 2007 PPA or the Provider Manual incorporated by reference into the 2007 PPA. 14. Paragraph 14 of the Complaint purports to characterize the 2007 PPA, which document speaks for itself. To the extent any further response is required, CVS denies the allegations contained in Paragraph 14 of the Complaint to the extent they are inconsistent with the 2007 PPA and/or other relevant materials, including but not limited to Exhibits to the 2007 PPA or the Provider Manual incorporated by reference into the 2007 PPA. HISTORY OF THE DISPUTE 15. CVS admits that in or about July 2015, Prime adjusted the MAC of many, if not all, multiple source generic prescription drugs, thereby decreasing the reimbursements CVS would receive for dispensing such drugs. 16. CVS admits that beginning by August 2015, it raised concerns with Prime regarding Prime s generic drug reimbursements to CVS. 4

5 CASE 0:15-cv DWF-TNL Document 17 Filed 02/05/16 Page 5 of CVS admits that the parties have conducted in-person meetings, telephone conferences, and exchange of letters regarding Prime s adjustments to MAC. CVS admits that it has made a good-faith attempt to define and resolve the dispute. CVS denies that Prime has made a good-faith attempt to resolve the dispute. CVS admits that the dispute has not been resolved. 18. CVS admits that on October 19, 2015, CVS sent a letter to Prime. Paragraph 18 of the Complaint purports to characterize and quote from the October 19, 2015 letter, which document speaks for itself. To the extent any further response is required, CVS denies the allegations contained in Paragraph 18 of the Complaint to the extent they are inconsistent with the October 19, 2015 letter. 19. Paragraph 19 of the Complaint purports to characterize and quote from the October 19, 2015 letter, which document speaks for itself. To the extent any further response is required, CVS denies the allegations contained in Paragraph 19 of the Complaint to the extent they are inconsistent with the October 19, 2015 letter. 20. Paragraph 20 of the Complaint purports to characterize the October 19, 2015 letter, which document speaks for itself. To the extent any further response is required, CVS denies the allegations contained in Paragraph 20 of the Complaint to the extent they are inconsistent with the October 19, 2015 letter. 21. CVS admits that Prime sent a letter to CVS dated October 22, 2015, purportedly responding to CVS s October 19, 2015 letter. Paragraph 21 of the Complaint purports to characterize the October 22, 2015 letter, which document speaks for itself. To the extent any further response is required, CVS denies the allegations contained in Paragraph 21 of the Complaint to the extent they are inconsistent with the October 22, 2015 letter. 5

6 CASE 0:15-cv DWF-TNL Document 17 Filed 02/05/16 Page 6 of Paragraph 22 of the Complaint purports to characterize an October 22, 2015 letter, which document speaks for itself. To the extent any further response is required, CVS denies the allegations contained in Paragraph 22 of the Complaint to the extent they are inconsistent with the October 22, 2015 letter. NOTICE OF DISPUTE 23. CVS admits the allegations of Paragraph 23 of the Complaint. 24. Paragraph 24 of the Complaint purports to characterize a November 13, 2015 Notice of Dispute, which document speaks for itself. To the extent any further response is required, CVS denies the allegations contained in Paragraph 24 of the Complaint to the extent they are inconsistent with the November 13, 2015 Notice of Dispute. 25. Paragraph 25 of the Complaint purports to characterize a November 13, 2015 Notice of Dispute, which document speaks for itself. To the extent any further response is required, CVS denies the allegations contained in Paragraph 25 of the Complaint to the extent they are inconsistent with the November 13, 2015 Notice of Dispute. 26. CVS admits that Prime sent a letter dated December 2, 2015, purportedly responding to CVS s November 13, 2015 Notice of Dispute. 27. Paragraph 27 of the Complaint purports to characterize a December 2, 2015 letter, which document speaks for itself. To the extent any further response is required, CVS denies the allegations contained in Paragraph 27 of the Complaint to the extent they are inconsistent with the December 2, 2015 letter. 28. CVS admits that on December 9, 2015, CVS sent a letter to Prime. Paragraph 28 of the Complaint purports to characterize and quote from the December 9, 2015 letter, which document speaks for itself. To the extent any further response is required, CVS denies the 6

7 CASE 0:15-cv DWF-TNL Document 17 Filed 02/05/16 Page 7 of 30 allegations contained in Paragraph 28 of the Complaint to the extent they are inconsistent with the December 9, 2015 letter. 29. Paragraph 29 of the Complaint purports to characterize a December 21, 2015 letter, which document speaks for itself. To the extent any further response is required, CVS denies the allegations contained in Paragraph 29 of the Complaint to the extent they are inconsistent with the December 21, 2015 letter. 30. CVS admits that the parties have not been able to resolve the dispute. CVS denies that Prime has made a good-faith attempt to negotiate. 31. CVS admits that as of December 28, 2015, 45 days had elapsed since CVS sent a Notice of Dispute on November 13, To the extent Paragraph 31 of the Complaint purports to characterize the 2007 PPA, that document speaks for itself. To the extent any further response is required, CVS denies the allegations contained in Paragraph 31 of the Complaint to the extent they are inconsistent with the 2007 PPA. FIRST CAUSE OF ACTION FOR DECLARATORY RELIEF 32. CVS incorporates by reference its responses to the allegations set forth in Paragraphs 1-31 of the Complaint. 33. Paragraph 33 of the Complaint is a legal conclusion to which no response is required. To the extent that a further response is required, CVS does not contest this Court s authority pursuant to 28 U.S.C. 2201(a). 34. CVS denies the allegations of Paragraph 34 of the Complaint. 35. CVS denies the allegations of Paragraph 35 of the Complaint. 36. CVS denies the allegations of Paragraph 36 of the Complaint. 37. CVS admits the allegations of Paragraph 37 of the Complaint. 7

8 CASE 0:15-cv DWF-TNL Document 17 Filed 02/05/16 Page 8 of CVS denies the allegations of Paragraph 38 of the Complaint. 39. CVS lacks knowledge or information sufficient to admit or deny the allegations contained in Paragraph 39 of the Complaint, and, on that basis, denies them. 40. CVS admits that on November 13, 2015, CVS sent a Notice of Dispute to Prime. Paragraph 40 of the Complaint purports to characterize the contents of the November 13, 2015 Notice of Dispute and other correspondence from CVS, which documents speak for themselves. To the extent any further response is required, CVS denies the allegations contained in Paragraph 40 of the Complaint to the extent they are inconsistent with the documents. 41. CVS denies the allegations of Paragraph 41 of the Complaint. 42. Paragraph 42 of the Complaint is a legal conclusion to which no response is required. 43. CVS denies that Plaintiff is entitled to any of the relief requested in Paragraph 43 of the Complaint. PRAYER FOR RELIEF CVS denies that Plaintiff is entitled to the relief requested in the Prayer for Relief. 8

9 CASE 0:15-cv DWF-TNL Document 17 Filed 02/05/16 Page 9 of 30 COUNTERCLAIMS Counterclaimant CVS Pharmacy, Inc. ( CVS ), by and through its attorneys, hereby asserts counterclaims against Plaintiff Prime Therapeutics LLC ( Prime ) and states as follows: I. THE PARTIES. 1. CVS is a corporation organized under the laws of Rhode Island, with its principal place of business in Woonsocket, Rhode Island, and is a citizen of Rhode Island for purposes of 28 U.S.C. 1332(a)(1). 2. Upon information and belief, Prime is a limited liability corporation organized under the laws of Delaware, with its principal place of business in Eagan, Minnesota. Upon information and belief, Prime is a citizen of Alabama, Delaware, Florida, Illinois, Kansas, Minnesota, North Carolina, North Dakota and Wyoming. II. JURISDICTION. 3. Prime has submitted to the personal jurisdiction of this Court by asserting claims against CVS. 4. This Court has jurisdiction pursuant to 28 U.S.C. 1332(a)(1), because the matter in controversy exceeds the sum or value of $75,000, exclusive of interests and costs, and is between citizens of different States. 5. Venue is proper in this Court pursuant to 28 U.S.C. 1391(b) because Prime has its principal place of business in Minnesota and the 2007 PPA contains a provision designating Minnesota as governing law. III. THE CONTRACTS BETWEEN CVS AND PRIME. 6. Prime is the pharmacy benefits manager ( PBM ) for numerous Blue Cross and Blue Shield Plans as well as other employer and union groups ( plan sponsors ). As a PBM, Prime contracts with plan sponsors to manage the pharmacy benefits for their beneficiaries. On 9

10 CASE 0:15-cv DWF-TNL Document 17 Filed 02/05/16 Page 10 of 30 information and belief, Prime currently controls the pharmacy business for over 26 million beneficiaries. 7. Part of Prime s role in managing the pharmacy benefits for these plan sponsors and their beneficiaries is to establish networks of retail pharmacies at which beneficiaries can have their prescriptions filled. To this end, Prime contracts with pharmacies, including CVS, to obtain the pharmacies participation in various networks. 8. CVS, which in 2015 operated approximately 7,800 retail pharmacies in 44 states, including Minnesota, and the District of Columbia, has played a vital role in delivering retail pharmacy products and services to the 26 million beneficiaries who depend on Prime to arrange for their retail pharmacy needs. From July to December 2015, CVS dispensed over 15 million generic prescriptions to beneficiaries in Prime networks. 9. CVS has been providing service to beneficiaries in Prime networks for almost a decade under the current contract. In 2007, Prime and CVS entered into a Pharmacy Participation Agreement, effective October 15, 2007 (the 2007 PPA ). The 2007 PPA incorporates by reference the Prime Provider Manual ( Provider Manual ). 10. Like most PBMs, Prime administers several different networks. A pharmacy network refers to Prime s agreements with a particular set of pharmacies to dispense prescription drugs pursuant to specified terms, particularly regarding reimbursement. On information and belief, plan sponsors that contract with Prime select one of the networks offered (or request that Prime develop a network customized to the plan sponsor s needs). The beneficiaries of that plan are then able to choose from among any of the retail pharmacies that participate in that network. 11. Pharmacies typically participate in some, but not all, of the networks that a PBM administers. In some cases, the PBM may intentionally structure a particular network so that it is 10

11 CASE 0:15-cv DWF-TNL Document 17 Filed 02/05/16 Page 11 of 30 limited, meaning that not all pharmacies may be contracted by the PBM to participate in that network. In other cases, a pharmacy may elect not to participate in a particular network because the pharmacy finds the contract terms for that network unacceptable. 12. Under the contract structure that exists between Prime and CVS, CVS s participation in specific networks is established by both parties executing a network-specific Exhibit B that establish the Rates and Terms applicable to that network. Since 2007, Prime and CVS have executed a number of Exhibits B to the 2007 PPA, each of which establishes the rates and terms applicable to CVS s participation in a specific network of pharmacies arranged by Prime. 13. The Exhibits B, in conjunction with the 2007 PPA and the Provider Manual, govern how much reimbursement CVS will receive for dispensing drugs to beneficiaries. IV. MAC PRICING IS SUPPOSED TO FOLLOW CHANGES IN THE GENERIC MARKET. 14. Pricing for drugs can follow various formulas. For multi-source generic drugs, one standard method of reimbursement in the industry is Maximum Allowable Cost or MAC. MAC pricing is the maximum amount that the plan sponsor or PBM will pay for a category of multi-source generic drugs. 15. Most of the Exhibit Bs that CVS has executed with Prime use MAC as one measure if not the sole measure of the rate at which CVS will be reimbursed for multi-source generic drugs dispensed to beneficiaries within the network associated with that Exhibit B. 16. Prime sets the MAC for drugs dispensed in its retail pharmacy networks. Such prices are not made public. 17. The 2007 PPA and Provider Manual establish a mechanism for setting MAC reimbursement. The 2007 PPA provides that MAC reimbursement is established and solely 11

12 CASE 0:15-cv DWF-TNL Document 17 Filed 02/05/16 Page 12 of 30 determined by Prime and subject to review and modification by Prime in its sole discretion. In the Provider Manual, which is incorporated by reference into the 2007 PPA, Prime promises with respect to MAC reimbursement that [a]ll products are reviewed on a regular basis and will be adjusted as-needed based on market conditions. (emphasis added). 18. The Provider Manual makes reference to a MAC Appeals Process, in which Prime confirms that the relevant market conditions are those concerning acquisition cost for the drugs in question: MAC pricing is reviewed and updated every week based on market acquisition costs from Prime s wholesaler sources. 19. Prime s promise that adjustments to MAC would be made by Prime based on market conditions comports with the industry-accepted principle that MAC reimbursement for multi-source generic drugs should correspond to the market conditions relating to those drugs, and that MAC reimbursement must be adjusted frequently to track changes in those market conditions. 20. Because, however, there is imperfect information regarding market conditions for drugs, PBMs such as Prime often reserve to themselves discretion in setting MAC prices. 21. But that discretion is not unbounded. In accordance with industry standard and Minnesota law, Prime was required to exercise good faith in setting MAC reimbursement. 22. As the Provider Manual makes clear, the mutual intent of the parties was that Prime would use its discretion in setting MAC reimbursement to conform the reimbursement levels to market conditions for those drugs, not for other purposes. For example, it would violate the parties mutual understanding and intent as well as render the contract illusory if Prime were to arbitrarily set MAC reimbursement at zero or even negative values, requiring CVS to 12

13 CASE 0:15-cv DWF-TNL Document 17 Filed 02/05/16 Page 13 of 30 dispense prescription drugs to Prime beneficiaries for free or even to pay Prime, rather than vice versa. 23. CVS relies on Prime to exercise its discretion to set MAC prices in accordance with market conditions. 24. Before CVS can dispense a drug to a beneficiary, CVS must first purchase that drug itself. The price that CVS must pay upfront to acquire the drug is referred to as acquisition cost. If MAC prices are changed in ways that do not correspond to market conditions, CVS may find itself losing money based on drug cost alone that is, acquisition cost may exceed reimbursement. In addition, CVS incurs other costs and overhead in dispensing prescriptions. 25. Generics make up a significant proportion of the drugs that pharmacies such as CVS dispense, and MAC pricing is the predominant method by which such drugs are reimbursed. Thus, even seemingly small changes to MAC pricing, if made out of alignment with market conditions, can result in significant financial harm to CVS. V. IN 2015, PRIME VIOLATES ITS CONTRACTUAL OBLIGATIONS BY REDUCING MAC REIMBURSEMENT WITHOUT REGARD TO MARKET CONDITIONS. 26. As has been widely reported in the press, market prices for generic drugs increased in For example, according to a January 16, 2016 article in the Washington Post, generic drugs, which historically have tended to get cheaper over time, rose 2.93 percent [in 2015]. 27. Yet despite the fact that market prices overall were increasing for generic drugs, in July 2015 Prime reduced its MAC pricing for generic drugs across the board. 28. Prime did not provide any notice to CVS, either in advance or at the time of the adjustments. To the contrary, in May 2015 Prime had explicitly represented to CVS that it 13

14 CASE 0:15-cv DWF-TNL Document 17 Filed 02/05/16 Page 14 of 30 expected only minor changes in aggregated reimbursement rates for multi-source generic drugs subject to MAC reimbursement. 29. Instead, CVS discovered the issue when it saw a dramatic and unprecedented decline in the reimbursement that it was receiving from Prime over the next few months. 30. The financial impact to CVS of Prime s MAC adjustments for the last two quarters of 2015 was a decrease in reimbursement of approximately $50 million, and the financial impact is continuing in Prime s MAC adjustments did not follow changes to market acquisition costs from Prime s wholesaler sources. As Prime was dramatically reducing MAC reimbursement, the average cost paid by pharmacies for generic drugs (as a percentage of AWP) for which the Centers for Medicare & Medicaid Services track and report monthly Average Manufacturer Price was increasing. 32. Some of Prime s MAC adjustments resulted in MAC prices being lower than CVS s acquisition cost, causing CVS to lose money for those drugs each time they were dispensed. 33. As a member of Prime s retail network, CVS was obligated to fill all properly presented prescriptions and did not have the choice to not fill those prescriptions on which it was losing money. 34. Because the acquisition cost of multi-source generic drugs was generally increasing in the market during this period, Prime s decision to reduce MAC prices could not entirely be explained by changes in the market for those drugs. 14

15 CASE 0:15-cv DWF-TNL Document 17 Filed 02/05/16 Page 15 of On October 27, 2015, Peter Clagett, then a Senior Vice-President at Prime, confirmed during a discussion with Tom Gibbons, a Senior Vice-President at CVS, that Prime s changes to MAC price were not related to changes in the market for prescription drugs. 36. Rather, Prime s adjustments to MAC price were designed to provide Prime with a competitive advantage in bidding to plan sponsors. 37. Prime s decision to reduce MAC prices for reasons unrelated to changes in the market for multi-source generic drugs violated its contractual obligation to exercise its discretion in good faith. VI. PRIME S ACTIONS VIOLATE STATE AND FEDERAL LAW. 38. Section 2.2 of the 2007 PPA provides that Prime will comply with any and all federal, state and local laws, regulations and ordinances and, if applicable, CMS instructions. 39. By virtue of its conduct in decreasing MAC prices without regard for CVS s acquisition costs, Prime has violated Medicare Part D regulations and numerous state MAC laws. 40. Medicare Part D regulations require that MAC prices be based on the cost of the drug. Specifically, Medicare Part D regulations require that PBMs update any prescription drug pricing standard for reimbursement of network pharmacies based on the cost of a drug used by the Part D sponsor not less than once every seven days. 42 C.F.R (b)(21). The purpose of this provision is so Part D sponsors must update their prescription drug pricing standards regularly to accurately reflect the market price of acquiring the drug. 79 FR 29844, (May 23, 2014). CMS has made clear that it considers MAC such a prescription drug pricing standard based on the cost of a drug. Id. 41. The laws of numerous states in which CVS has dispensed drugs pursuant to the 2007 PPA also require that MAC pricing be tied to market or acquisition cost. For example: 15

16 CASE 0:15-cv DWF-TNL Document 17 Filed 02/05/16 Page 16 of 30 a. North Carolina s MAC law requires that PBMs adjust the MAC price to remain consistent with changes in the national marketplace for prescription drugs. N.C. Gen. Stat A-5. b. New Mexico s MAC law requires that the PBM modify[] maximum allowable cost prices in a timely manner to remain consistent with pricing changes and product availability in the marketplace. N.M. Stat. Ann. 59A-61-4(A)(4); see also Fla. Stat c. Louisiana s MAC law requires that the PBM update its MAC list within seven days from a change... in the value of a variable involved in the methodology on which the MAC list is based. La. Rev. Stat. 22:1864(B)(2). d. Utah s MAC law mandates that the MAC be determined using comparable and current data on drug prices. Utah Code Ann. 31A (4). 42. Other states prohibit MAC pricing below acquisition cost. For example: a. North Dakota s MAC law requires PBMs to [e]nsure MAC prices are not set below sources utilized by the PBM. N.D. Century Code (2)(d). b. Arkansas, Louisiana, Tennessee and Washington specifically authorize appeals if the MAC price is less than the pharmacy s acquisition cost. Ark. Code Ann (c)(4)(A)(ii); La. Rev. Stat. 22:1865(A); Tenn. Code (b)(1); Wash. Rev. Code (3). c. Minnesota, as well as Kentucky, Maryland, Oklahoma, and Virginia, require that if a PBM denies a pharmacy s appeal of a MAC price, the PBM must identify a drug that may be purchased by the pharmacy at a price at or below the MAC set by the PBM. Minn. Stat (2)(c)(3); Ky. Rev. Stat. Ann A- 16

17 CASE 0:15-cv DWF-TNL Document 17 Filed 02/05/16 Page 17 of (1)(b)(3); Md. Code Ann. Ins (f)(4)(ii); Okla. Stat (A)(5); Va. Code. Ann :3(c)(4). VII. CVS ATTEMPTS TO RESOLVE THE DISPUTE IN In good faith, CVS attempted to resolve the MAC pricing adjustment issue with Prime throughout the fall of 2015, through in-person meetings, telephone calls, and written correspondence. CVS was clear that it believed that Prime s conduct violated the 2007 PPA and state and federal law, and provided estimates of damages upon request. 44. Contemporaneous with CVS s attempts to resolve the MAC pricing adjustment issue in fall 2015, Prime was attempting to secure CVS s participation in certain newly-created Prime networks and/or new network initiatives concerning continued participation in existing Prime networks that would be going live as of January 1, On December 16, 2015, Prime sent a letter to CVS in which Prime noted that it had sent CVS draft Exhibits for each of those networks. Prime acknowledged that the Exhibits were still under negotiation, but offered that [g]iven the network is going live next month and given our good faith efforts to execute an Exhibit for each network, Prime will include CVS as a participant in these networks as of January 1, 2016 as we finalize and execute the appropriate exhibits. 46. On December 16, 2015, CVS sent a letter response to Prime. CVS explained that the reason the agreements remained open was because of Prime s unilateral and unprecedented changes to generic reimbursement and Prime s unwillingness to remedy these changes, which CVS has been attempting to resolve with Prime since August CVS observed that [t]o date, Prime has made absolutely no attempt to remedy the ongoing underpayment for 2015 or create an appropriate reimbursement structure regarding existing Prime networks or newly 17

18 CASE 0:15-cv DWF-TNL Document 17 Filed 02/05/16 Page 18 of 30 created Prime networks. In light of the demonstrable lack of progress in resolving this dispute, your expectation that we will participate while negotiating in good faith is simply not reasonable. We need all of our issues resolved in totality. 47. On December 21, 2015, the law firm of Dykema Gossett LLP ( Dykema ) responded to CVS on behalf of Prime. In that letter, Dykema professed yet again that that Prime was negotiating in good faith, despite the fact that neither Dykema nor Prime had yet to put forward even a single proposal to address the concerns that CVS had been raising with Prime regarding MAC reimbursement for months. Regarding the networks that Prime had stated would be going live on January 1, 2016, Dykema stated that Prime will include CVS in these networks with terms and pricing as proposed in the exhibits provided to CVS in case CVS wants to process prescriptions after 1/1/ On December 22, 2015, CVS informed Dykema and Prime that Prime s offer to include CVS in those networks on the terms set forth in the draft Exhibit Bs sent by Prime was unacceptable. Given the failure of Dykema and Prime to offer any proposal to remedy the dispute, CVS offered a series of terms and conditions relating to MAC and generic reimbursement upon which CVS would accept participating in new and existing programs after January 1, In a letter dated December 25, 2015, Dykema communicated that Prime reject[ed] the proposal [CVS] set forth with regard to resolving the current dispute. But at that time, Dykema and Prime continued to refuse to offer any proposal of their own to resolve the dispute. 50. Instead, Prime filed this action for declaratory relief on December 29, 2015, 46 days after CVS sent its Notice of Dispute. 18

19 CASE 0:15-cv DWF-TNL Document 17 Filed 02/05/16 Page 19 of 30 VIII. PRIME DEEMS CVS AS PARTICIPATING IN ADDITIONAL NETWORKS, DESPITE THE PARTIES FAILURE TO REACH AGREEMENT ON EXHIBITS B. 51. Pursuant to the 2007 PPA, CVS s participation in specific networks is established by both parties executing a network-specific Exhibit B that establishes the Rates and Terms applicable to that network. Executed Exhibit Bs are an essential component of the contractual structure, because they contain, inter alia, the rates at which a pharmacy will be reimbursed for claims associated with that network. The 2007 PPA defines Pharmacy Payment to mean the amount payable to Pharmacy as described in the applicable Exhibit B, pharmacy reimbursement exhibit for the Prescription Drug Services renders. PPA 1.19 (emphasis added). The 2007 PPA provides that Pharmacy shall accept as payment in full for Prescription Drug Services rendered to Covered Persons such amounts as defined in the Rates and Terms, Exhibit B (s) hereunder. PPA (emphasis added). 52. If CVS and Prime do not both execute an Exhibit B in connection with a particular network administered by Prime, then there is no agreement between the parties on the fundamental issue of how reimbursement will be determined for drugs dispensed by CVS to Prime beneficiaries who are covered by that network. 53. This essential role performed by Exhibit Bs in the parties contracting framework is further reinforced by the fact that the 2007 PPA expressly enables CVS not only to terminate the 2007 PPA itself on notice to Prime, but also to terminate specific Exhibit Bs on prior written notice. PPA CVS is dependent on Prime to determine whether or not a particular Prime beneficiary is covered by a Prime network in which CVS participates. 55. Whenever a Prime beneficiary requests that CVS fill a prescription, CVS attempts to verify the beneficiary s eligibility via Prime s Point of Sale ( POS ) claims processing 19

20 CASE 0:15-cv DWF-TNL Document 17 Filed 02/05/16 Page 20 of 30 system. Prime represents that the system gives Participating Pharmacies real-time access to Covered Person eligibility.... Furthermore, Prime has agreed that [A] Covered Person s eligibility can be verified through the POS system during claim adjudication If Prime communicates to CVS that a beneficiary is eligible, several significant consequences follow. 57. First, CVS is obligated to dispense the prescription drug to that beneficiary, subject to a pharmacist s professional judgment. Thus, in most circumstances, a representation by Prime via its POS system that a beneficiary is eligible will obligate CVS to dispense the prescribed drug to that beneficiary. 58. Second, CVS is prohibited from asking the beneficiary to pay more than is due under the terms of the Agreement. Instead, CVS becomes obligated to accept as payment in full for Prescription Drug Services rendered to Covered Persons such amounts as defined in the Rates and Terms, Exhibit B(s). PPA Finally, verification of eligibility, drug coverage and other applicable edits to Pharmacy via Prime s POS system constitutes authorization for Pharmacy to service the Covered Person. Prime agrees that it shall pay Pharmacy for all claims that Pharmacy receives approval for via Prime s POS. PPA And the Pharmacy Payment that Prime thereby agrees to pay is defined as the amount payable to Pharmacy as described in the applicable Exhibit B, pharmacy reimbursement exhibit[.] PPA In short, when CVS queries Prime s POS system to ask whether a beneficiary is eligible, and Prime responds that the beneficiary is eligible and the claim is approved, Prime is representing that, among other things, the beneficiary is a member of a Prime network in which 20

21 CASE 0:15-cv DWF-TNL Document 17 Filed 02/05/16 Page 21 of 30 CVS has agreed to participate according to mutually agreed reimbursement terms, as the 2007 PPA contemplates will be set forth in a fully executed Exhibit B. 61. In late 2015, Prime sought to secure CVS s participation in the Blue Cross Blue Shield North Carolina Extended Service Network, the Mississippi Instate Network, the Narrow Extended Supply Network, and the Medtronic Network (collectively, the 2016 Networks ). 62. CVS was willing to negotiate regarding participation in the 2016 Networks in good faith, but was steadfast in its position that any agreement on a going forward basis must resolve the dispute regarding Prime s MAC pricing adjustments in 2015 and provide a defined level of generic reimbursement in the future. 63. Because Prime refused to negotiate regarding its MAC pricing adjustments in 2015 or to provide a defined level of generic reimbursement in the future, on December 22, 2015, CVS explicitly stated that [u]ntil these terms [as proposed by CVS in the same letter] are accepted and agreed to by Prime Therapeutics, Prime Therapeutics is not authorized to enroll CVS/pharmacy into the agreements documented in your letter dated December Because CVS depends on (and is contractually entitled to depend on) queries to Prime s POS system to determine whether beneficiaries belong to a network in which CVS has agreed to participate, CVS warned Prime that [a]ny return of a paid message for claims under any of these networks [for which agreements had not yet been executed]... will be deemed as acceptance of the terms contained in this document by Prime Therapeutics. 65. CVS thus put Prime on notice that CVS expected Prime s POS system to accurately report to CVS that beneficiaries were ineligible if those beneficiaries belonged to networks in which CVS had not agreed to participate. And CVS made clear to Prime that if Prime chose nevertheless to enroll CVS in the 2016 Networks, or caused its POS system to 21

22 CASE 0:15-cv DWF-TNL Document 17 Filed 02/05/16 Page 22 of 30 represent to CVS that beneficiaries of the 2016 Networks were eligible to have their prescriptions filled at CVS, then Prime would be obligated to reimburse CVS according the terms on which CVS had offered to participate in the 2016 Networks. 66. In its December 25, 2015, letter, Dykema claimed that Prime will continue to process prescription drug claims submitted to CVS pursuant to the October 15, 2007 PPA unless and until that Agreement is terminated in accordance with its terms, ignoring the fact that in the absence of a mutually agreed Exhibit B for a given network, the 2007 PPA would completely fail to establish how much Prime was required to pay CVS. 67. On December 28, 2015, CVS reiterated to Dykema and Prime what it had stated previously: Until these terms are accepted and agreed to by Prime, Prime is not authorized to enroll CVS/pharmacy into the agreements documented in your letter dated December 21, including Exhibit B-12 NC (BCBS North Carolina Instate ESN), Exhibit B-25 (Mississippi Instate); Exhibit B-12N (Narrow Extended Supply Network), Exhibit B-NJ (New Jersey Instate) and HCSC Fee Schedule for 2016 Medicare D Preferred. 68. On information and belief, Prime has represented to CVS via its POS system that Prime beneficiaries in the 2016 Networks are eligible to have their prescriptions filled at CVS after January 1, 2016, despite CVS s unambiguous directive that Prime should not include CVS in the 2016 Networks unless Prime agreed to terms designed to ensure fair reimbursement to CVS for generics going forward. 69. CVS has reasonably relied on Prime s representations to CVS via its POS system that Prime beneficiaries in the 2016 Networks are eligible to have their prescriptions filled at CVS, and has dispensed prescription drugs to those beneficiaries based upon Prime s verification that they are eligible. 22

23 CASE 0:15-cv DWF-TNL Document 17 Filed 02/05/16 Page 23 of 30 IX. FIRST COUNTERCLAIM (BREACH OF CONTRACT ALL NETWORKS) 70. CVS incorporates by reference and restates the allegations set forth in Paragraphs 1-69 above. 71. CVS and Prime are parties to a valid and existing contract, consisting of the executed PPA, all executed Rates and Terms Exhibit Bs thereto, and the Provider Manual as incorporated by reference ( the contract ). 72. CVS has fully performed all conditions precedent to its right to demand performance from Prime. 73. Prime s decision to reduce MAC reimbursement for reasons unrelated to changes in the market for multi-source generic drugs violated its express contractual promise that it would adjust MAC reimbursement as-needed based on market conditions. 74. Prime s discretion in setting MAC reimbursement is subject to the implied covenant of good faith and fair dealing. If Prime s discretion in setting MAC reimbursement were unbounded, it would render the contract illusory and would violate the plain intent of the parties. 75. Since July 2015, Prime has violated that implied covenant by exercising its discretion in setting MAC reimbursement in bad faith. Contrary to the commitment it made in the Provider Manual, Prime has adjusted MAC reimbursement based on factors unrelated to market conditions and has set MAC reimbursement levels so low that they are commercially unreasonable and/or are less than CVS s acquisition costs. 76. Furthermore, Prime s conduct has violated state and federal law as set forth in paragraphs Pursuant to Section 2.2 of the 2007 PPA, Prime is obligated to comply with any and all federal, state and local laws, regulations and ordinances and, if applicable CMS 23

24 CASE 0:15-cv DWF-TNL Document 17 Filed 02/05/16 Page 24 of 30 instructions. Prime s violations of state and federal law therefore constitute breaches of Prime s express and implied contractual duties to CVS. 77. As a result of Prime s breaches of contract, CVS has been damaged in an amount to be proven at trial. X. SECOND COUNTERCLAIM (DECLARATORY JUDGMENT THE 2016 NETWORKS) 1-69 above. 78. CVS incorporates by reference and restates the allegations set forth in Paragraphs 79. Pursuant to 28 U.S.C. 2201(a), the United States District Court for the District of Minnesota may declare the rights and other legal relations between CVS and Prime. 80. Prime and CVS have been unable to reach express agreement on rates and terms with respect to the 2016 Networks. As a result, the parties have not executed Exhibit Bs to the 2007 PPA concerning those networks. 81. Prime offered to provisionally include CVS in the 2016 Networks on the terms Prime had proposed in draft Exhibit Bs until such time as the parties reached agreement, and CVS expressly declined that offer. 82. CVS explicitly instructed Prime not to include it in the 2016 Networks unless Prime were willing to accept the terms set forth in CVS s letter of December 22, Prime nevertheless included CVS in the 2016 Networks after January 1, 2016 and verifies beneficiaries within those networks as eligible when CVS queries Prime s POS system. Yet Prime refuses to reimburse CVS according to the terms upon which CVS expressly conditioned being included in the 2016 Networks. 24

25 CASE 0:15-cv DWF-TNL Document 17 Filed 02/05/16 Page 25 of CVS therefore has an immediate need for declaratory relief to clarify the rights between the parties regarding pricing and reimbursement for generic drugs with respect to the 2016 Networks. 85. An actual controversy exists between the parties regarding pricing and reimbursement for generic drugs with respect to the 2016 Networks. 86. CVS requests, inter alia, an entry of judgment in its favor declaring: (1) no validly formed contract exists between the parties to govern rates and terms of reimbursement for drugs dispensed by CVS to Prime beneficiaries covered by the 2016 Networks; (2) that if Prime continues acting as if CVS is included in the 2016 Networks and continues verifying to CVS via the POS system that beneficiaries of those networks are eligible, then Prime must reimburse CVS according to the terms and conditions set forth in CVS s letter of December 22, 2015; and (3) that if Prime is unwilling to reimburse CVS for claims in connection with the 2016 Networks according to the terms and conditions for reimbursement set forth in CVS s letter of December 22, 2015, then Prime must remove CVS from those networks and conform its POS system to accurately communicate to CVS that beneficiaries within those networks are ineligible. XI. THIRD COUNTERCLAIM (ANTICIPATORY BREACH OF CONTRACT THE 2016 NETWORKS) 87. CVS incorporates by reference and restates the allegations set forth in Paragraphs 1-69 above. 88. Prime and CVS have been unable to reach express agreement on rates and terms with respect to the 2016 Networks. As a result, the parties have not executed Exhibit Bs to the PPA concerning those networks. 25

26 CASE 0:15-cv DWF-TNL Document 17 Filed 02/05/16 Page 26 of Prime offered to provisionally include CVS in the 2016 Networks on the terms Prime had proposed in draft Exhibit Bs until such time as the parties reached agreement, and CVS expressly declined that offer. 90. CVS explicitly instructed Prime not to include it in the 2016 Networks unless Prime were willing to accept the terms set forth in CVS s letter of December 22, Prime nevertheless included CVS in those networks after January 1, 2016 and verifies beneficiaries within those networks as eligible when CVS queries Prime s POS system. 92. By including CVS in the 2016 Networks and by verifying beneficiaries within those networks as eligible when CVS queries Prime s POS system, Prime accepted CVS s offer with respect to those networks. 93. For all CVS claims approved by Prime with respect to the 2016 Networks after January 1, 2016, Prime is thus contractually obligated to reimburse CVS in accordance with the terms set forth in CVS s letter of December 22, Prime has repudiated its obligation by stating that it will not reimburse CVS in accordance with the terms set forth in CVS s letter of December 22, CVS has fully performed all conditions precedent to its right to demand performance from Prime. 96. As a result of Prime s anticipatory breach, CVS has been damaged in an amount to be proven at trial. XII. FOURTH COUNTERCLAIM (QUANTUM MERUIT THE 2016 NETWORKS) 1-69 above. 97. CVS incorporates by reference and restates the allegations set forth in Paragraphs 26

27 CASE 0:15-cv DWF-TNL Document 17 Filed 02/05/16 Page 27 of This Counterclaim is pled in the alternative to the Third Counterclaim, supra, and presumes that no contract has formed between CVS and Prime concerning reimbursement with regard to the 2016 Networks. 99. Prime and CVS have been unable to reach express agreement on rates and terms with respect to the 2016 Networks. As a result, the parties have not executed Exhibit Bs to the 2007 PPA concerning those networks The parties existing contractual relationship entitles CVS to reimbursement for any claim which Prime authorizes via its POS system, and requires CVS (subject only to a pharmacist s professional judgment) to dispense prescription drugs to eligible Prime beneficiaries However, because the parties have not executed Exhibits B concerning the 2016 Networks, the parties contractual relationship is silent regarding the amounts that CVS is to receive in reimbursement for claims covered by those networks It would unjustly enrich Prime and would be contrary to equity to permit Prime to enjoy the benefit of CVS dispensing prescription drugs to beneficiaries covered by the 2016 Networks without reasonably reimbursing CVS for dispensing those drugs Prime has failed to reasonably reimburse CVS for generic prescription drugs dispensed by CVS to beneficiaries covered by the 2016 Networks As a result, CVS has been damaged in an amount to be proven at trial. XIII. FIFTH COUNTERCLAIM (BREACH OF CONTRACT THE 2016 NETWORKS) 1-69 above CVS incorporates by reference and restates the allegations set forth in Paragraphs 27

28 CASE 0:15-cv DWF-TNL Document 17 Filed 02/05/16 Page 28 of This Counterclaim is pled in the alternative to the Third Counterclaim, supra, and presumes that no contract has formed between CVS and Prime concerning reimbursement with regard to the 2016 Networks The 2007 PPA requires Prime to operate the POS system, which CVS and other participating pharmacies must use to verify eligibility and submit claims. If Prime verifies to CVS via the POS system that a beneficiary is eligible, CVS is required under the Provider Manual to provide that beneficiary with covered pharmacy products subject only to a pharmacist s professional judgment Prime is required to conduct its performance under the 2007 PPA, including its operation of the POS system and its designation to CVS of beneficiaries as eligible or not, in accordance with the implied covenant of good faith and fair dealing There was no agreement between CVS and Prime for CVS to participate in the 2016 Networks. CVS had been clear that there would be no agreement between the parties with respect to rates and terms for the 2016 Networks unless Prime agreed to the terms set forth in CVS s letter of December 22, Prime did not satisfy and had no intention of satisfying CVS s explicit conditions for participation in those networks Nevertheless, Prime intentionally enrolled CVS in the 2016 Networks Prime knew that CVS was reliant upon Prime s POS system for eligibility determinations, and that CVS would be obligated to dispense medication to any beneficiary that Prime s POS system verified as eligible Prime abused its contractual authority to operate the POS system and to designate eligibility with the intent to force CVS to participate in the 2016 Networks on terms that Prime knew CVS had not agreed to and was unwilling to accept. 28

29 CASE 0:15-cv DWF-TNL Document 17 Filed 02/05/16 Page 29 of Prime s conduct violated the implied covenant of good faith and fair dealing and thus breached the 2007 PPA As a result of that breach, CVS has been damaged in an amount to be proven at trial. PRAYER FOR RELIEF Wherefore, Counterclaim-Plaintiff CVS Pharmacy, Inc. prays for relief and judgment as follows: a. An award of compensatory damages and other damages available by law in an amount to be proved at trial, plus pre-judgment interest as permitted by law; b. Declaratory relief as set forth in Counterclaim-Plaintiff s Second Counterclaim; and c. Such other and further relief as is just and proper. DEMAND FOR JURY TRIAL CVS hereby demands a trial by jury on all issues so triable. 29

30 CASE 0:15-cv DWF-TNL Document 17 Filed 02/05/16 Page 30 of 30 Dated: February 5, 2015 Respectfully submitted, s/ Kari S. Berman Kari S. Berman (# ) Scott M. Flaherty (# ) BRIGGS AND MORGAN, P.A IDS Center 80 South 8th Street Minneapolis, MN Telephone: (612) Facsimile: (612) Enu Mainigi (pro hac vice) Holly Conley (pro hac vice) Daniel Dockery (pro hac vice) WILLIAMS & CONNOLLY LLP 725 Twelfth St. NW Washington, D.C Telephone: (202) Facsimile: (202) (202) Counsel for CVS Pharmacy, Inc. 30