Source: http://investor.mylan.com/node/20456/html
Timestamp: 2018-05-21 22:33:44
Document Index: 581153978

Matched Legal Cases: ['§ 3730', '§ 31', '§ 1395', '§ 1320', '§ 1320', 'art 1005', '§ 1005', '§ 1005', '§ 447']

As previously disclosed, the Settlement Agreement resolves claims relating to the classification of EpiPen® Auto-Injector and EpiPen Jr® Auto-Injector (collectively, EpiPen® Auto-Injector) for purposes of the Medicaid Drug Rebate Program. The question in the underlying matter was whether the EpiPen® products were properly classified with the Centers for Medicare and Medicaid Services (CMS) as a non-innovator drug under the applicable definition in the Medicaid Rebate statute and subject to the formula that is used to calculate rebates to Medicaid for such drugs. EpiPen® Auto-Injector has been classified with CMS as a non-innovator drug since before Mylan Specialty L.P. acquired the product in 2007 based on longstanding written guidance from the federal government.
Neither the Settlement Agreement nor the CIA contains an admission or finding of wrongdoing. Mylan Specialty L.P. will reclassify EpiPen® Auto-Injector for purposes of the Medicaid Drug Rebate Program and pay the rebate applicable to innovator products effective as of April 1, 2017. As disclosed in our Quarterly Report on Form 10-Q filed on August 9, 2017, in anticipation of the Settlement Agreement being finalized, the Company has accrued the higher rebate amount since April 1, 2017.
A. Defendant Mylan Inc. is a corporation incorporated in Pennsylvania with its principal offices in Canonsburg, Pennsylvania. Mylan Inc., through its subsidiaries, manufactures, markets, and sells pharmaceuticals. Mylan Inc. acquired Dey Pharma, L.P. (Dey) as a wholly-owned subsidiary in 2007, and changed Deys name to Mylan Specialty L.P. in 2012 (collectively referred to hereafter as Mylan Specialty). Defendant Mylan Specialty L.P. is a Delaware limited partnership with its principal place of business in Morgantown, West Virginia, and is a wholly-owned subsidiary of Mylan Inc. At all relevant times, Mylan Specialty has owned the exclusive rights to sell EpiPen® and EpiPen Jr.® products, identified by National Drug Codes 49502-0500-01, 49502-0500-02, 49502-0501-01, and 49502-0501-02, (collectively, EpiPen) in the United States.
B. On July 29, 2016, sanofi-aventis US LLC (Sanofi) filed a qui tam action in the United States District Court for the District of Massachusetts captioned United States, et al. ex rel. sanofi-aventis US LLC v. Mylan Inc., et al., No. 16cv11572-ADB, pursuant to the qui tam provisions of the False Claims Act, 31 U.S.C. § 3730(b), and filed an amended qui tam complaint on August 4, 2016. On December 8, 2016, Ven-A-Care of the Florida Keys, Inc. (Ven-A-Care) filed a qui tam action in the Southern District of New York captioned United States, et al. ex rel. Ven-A-Care of the Florida Keys, Inc. v. Mylan Inc., et al., No. 16-CV-9484
(JGK), and an amended qui tam complaint on January 3, 2017. On January 19, 2017, Ven-A-Cares qui tam action was transferred to the District of Massachusetts under the same caption and later assigned Case No. 17-10140-ADB. Ven-A-Care and Sanofi are collectively referred to herein as Relators and Sanofis and Ven-A-Cares qui tam complaints are collectively referred to as the Civil Actions. Relators allege, inter alia, that Mylan misclassified EpiPen as a noninnovator multiple source drug, rather than as a single source drug, for Medicaid Drug Rebate Program purposes and underpaid rebates owed to the Medicaid Program for EpiPen as a result of this misclassification.
12. The Settlement Amount shall not be decreased as a result of the denial of claims for payment now being withheld from payment by any Medicare contractor (e.g., Medicare Administrative Contractor, fiscal intermediary, carrier), Medicaid, or any State payer, related to the Covered Conduct; and Mylan agrees not to resubmit to any Medicare contractor, Medicaid, or any State payer any previously denied claims related to the Covered Conduct, agrees not to appeal any such denials of claims, and agrees to withdraw any such pending appeals.
a. Unallowable Costs Defined: All costs (as defined in the Federal Acquisition Regulation, 48 C.F.R. § 31.20547; and in Titles XVIII and XIX of the Social Security Act, 42 U.S.C. §§ 1395-1395kkk-1 and 1396-1396w-5; and the regulations and official program directives promulgated thereunder) incurred by or on behalf of Mylan, its present or former officers, directors, employees, shareholders, and agents in connection with:
b. Future Treatment of Unallowable Costs: Unallowable Costs shall be separately determined and accounted for by Mylan, and Mylan shall not charge such Unallowable Costs directly or indirectly to any contracts with the United States or any State Medicaid program, or seek payment for such Unallowable Costs through any cost report, cost statement, information statement, or payment request submitted by Mylan or any of its subsidiaries or affiliates to the Medicare, Medicaid, TRICARE, or FEHBP Programs.
c. Treatment of Unallowable Costs Previously Submitted for Payment: Mylan further agrees that, within 90 days of the Effective Date of this Agreement, it shall identify to applicable Medicare and TRICARE fiscal intermediaries, carriers, and/or contractors,
22. For the avoidance of doubt, and notwithstanding anything to the contrary herein, Mylan and Sanofi agree that neither this Agreement nor any release contained in this Agreement shall apply in any way to bar any claims or other relief by Sanofi against Mylan pending in Sanofi-Aventis U.S. LLC v. Mylan Inc. and Mylan Specialty, L.P., 17-cv-02763 (D.N.J.) (and as transferred for pretrial purposes: Sanofi-Aventis U.S. LLC v. Mylan Inc., et al., No. 17-CV-02452-DDC-TJJ (D. Kan.)) or In re EpiPen (Epinephrine Injection, USP) Marketing, Sales Practices and Antitrust Litigation, 17-md-02785-DDC-TJJ/MDL 2785 (D. Kan.), or any compulsory counterclaims by Mylan against Sanofi arising out of such claims.
A. Compliance Responsibilities of Certain Mylan Employees and the Board of Directors.
1. Compliance Officer. To the extent not already accomplished, within 90 days after the Effective Date, Mylan shall appoint a Compliance Officer and shall maintain a Compliance Officer for the term of the CIA. The Compliance Officer shall be an employee and a member of senior management of Mylan Inc., shall report directly to the Chief Executive Officer of Mylan Inc. and shall not be, or be subordinate to, the General Counsel or Chief Financial Officer or have any responsibilities that involve acting in any capacity as legal counsel or supervising legal counsel functions for Mylan. The Compliance Officer shall be responsible for, without limitation:
2. Compliance Committee. To the extent not already accomplished, within 90 days after the Effective Date, Mylan shall appoint a Compliance Committee. The Compliance Committee shall, at a minimum, include the Compliance Officer and other members of senior management necessary to meet the requirements of this CIA (e.g., members of senior management with responsibility for relevant departments, such as government pricing and contracting, human resources, audit, and operations). The Compliance Officer shall chair the Compliance Committee and the Compliance Committee shall support the Compliance Officer in fulfilling his/her responsibilities (e.g., shall assist in the analysis of Mylans risk areas and shall oversee monitoring of compliance-related audits and compliance investigations). The Compliance Committee shall meet at least quarterly. The minutes of the Compliance Committee meetings shall be made available to OIG upon request.
3. Board of Directors Compliance Obligations. The Board (or a committee of the Board) shall be responsible for the review and oversight of matters related to compliance with Federal health care program requirements and the obligations of this CIA. The Board must include independent (i.e., non-executive) members.
4. Management Accountability and Certifications. In addition to the responsibilities set forth in this CIA for all Covered Persons, certain Mylan employees (Certifying Employees) are specifically expected to monitor and oversee activities within their areas of authority and shall annually certify that the applicable Mylan business unit is compliant with applicable Federal health care program requirements with the obligations of this CIA. These Certifying Employees shall include, at a minimum, the following: (1) Chief Financial Officer; (2) Head of Commercial Finance  North America; (3) Head of Government Reporting; (4) Head of Finance, Global Integrated Services  North America; and (5) Director, Accounts Receivable.
B. Written Standards.
C. Training and Education.
1. Training Plan. Within 90 days after the Effective Date, Mylan shall develop a written plan (Training Plan) that outlines the steps Mylan will take to ensure that: (a) all Covered Persons receive adequate training regarding Mylans CIA requirements and Compliance Program and the applicable Federal health care program requirements, including the requirements of the Anti-Kickback Statute, and (b) all Relevant Covered Persons receive adequate training regarding: (i) Mylans systems and processes relating to Government Pricing Functions; (ii) all applicable Federal health care program requirements relating to Government Pricing Functions; and (iii) Mylans systems for gathering relevant data and calculating, verifying, and reporting information to CMS and/or the State Medicaid Programs for purposes of the Medicaid Drug Rebate Program, the Medicare Program, or any other Federal or state government price reporting requirement.
2. Board Member Training. Within 90 days after the Effective Date, each member of the Mylan Board of Directors shall receive at least two hours of training. This training shall address the corporate governance responsibilities of board members and the responsibilities of board members with respect to review and oversight of the Compliance Program. Specifically, the training shall address the unique responsibilities of health care industry Board members, including the risks, oversight areas, and strategic
3. Training Records. Mylan shall make available to OIG, upon request, training materials and records verifying that Covered Persons, Relevant Covered Persons, and Board members have timely received the training required under this section.
a. Engagement of Independent Review Organization. Within 90 days after the Effective Date, Mylan shall engage an entity (or entities), such as an accounting, auditing, or consulting firm (hereinafter Independent Review Organization or IRO), to perform the reviews identified in this Section III.D. The applicable requirements relating to the IRO are outlined in Appendix A to this CIA, which is incorporated by reference.
b. Retention of Records. The IRO and Mylan shall retain and make available to OIG, upon request, all work papers, supporting documentation, correspondence, and draft reports (those exchanged between the IRO and Mylan) related to the Government Pricing Function Review.
2. Government Pricing Functions Review. The IRO shall assess Mylans systems, processes, policies, and procedures relating to Mylans Government Pricing Functions (Government Pricing Functions Review) and shall prepare a Government Pricing Functions Review Report, as outlined in Appendix B to this CIA, which is incorporated by reference.
3. Additional Items Review. In addition to the Government Pricing Functions Review, OIG may, in its discretion, require a review by the IRO of up to three additional areas or practices of Mylan identified by OIG relating to Government Pricing
4. Independence and Objectivity Certification. The IRO shall include in its report(s) to Mylan a certification that the IRO has: (a) evaluated its professional independence and objectivity with respect to the reviews required under this Section III.D; and (b) concluded that it is, in fact, independent and objective in accordance with the requirements specified in Appendix A. The IROs certification shall include a summary of all current and prior engagements between Mylan and the IRO.
E. Risk Assessment and Internal Review Process.
F. Disclosure Program.
To the extent not already accomplished, within 90 days after the Effective Date, Mylan shall establish a Disclosure Program that includes a mechanism (e.g., a toll free compliance telephone line) to enable individuals to disclose to the Compliance Officer or some other person who is not in the disclosing individuals chain of command any identified issues or questions associated with Mylans policies, conduct, practices, or procedures with respect to a Federal health care program requirement believed by the individual to be a potential violation of criminal, civil, or administrative law. Mylan shall appropriately publicize the existence of the Disclosure Program and the disclosure mechanism (e.g., via periodic e-mails to employees, or by posting the information in prominent common areas).
G. Ineligible Persons.
1. Definitions. For purposes of this CIA:
2. Screening Requirements. Mylan shall ensure that all prospective and current Covered Persons are not Ineligible Persons by implementing the following screening requirements.
3. Removal Requirement. If Mylan has actual notice that a Covered Person has become an Ineligible Person, Mylan shall remove such Covered Person from responsibility for, or involvement with, Mylans business operations related to the Federal health care program(s) from which such Covered Person has been excluded and shall remove such Covered Person from any position for which the Covered Persons compensation is paid in whole or part, directly or indirectly, by any Federal health care program(s) from which the Covered Person has been excluded, at least until such time as the Covered Person is reinstated into participation in such Federal health care program(s).
4. Pending Charges and Proposed Exclusions. If Mylan has actual notice that a Covered Person is charged with a criminal offense that falls within the scope of 42 U.S.C. §§ 1320a-7(a), 1320a-7(b)(1)-(3), or is proposed for exclusion during the Covered Persons employment or contract term, Mylan shall take all appropriate actions to ensure that the responsibilities of that Covered Person have not and shall not adversely affect the quality of care rendered to any beneficiary, or the accuracy of any claims submitted to any Federal health care program.
H. Notification of Government Investigation or Legal Proceeding.
I. Reportable Events.
1. Definition of Reportable Event. For purposes of this CIA, a Reportable Event means anything that involves:
2. Reporting of Reportable Events. If Mylan determines (after a reasonable opportunity to conduct an appropriate review or investigation of the allegations) through any means that there is a Reportable Event, Mylan shall notify OIG, in writing, within 30 days after making the determination that the Reportable Event exists.
3. Reportable Events under Section III.I.1.a and III.I.1.b. For Reportable Events under Section III.I.1.a and b, the report to OIG shall include:
4. Reportable Events under Section III.I.1.b. For Reportable Events under Section III.I.1.b, the report to OIG shall include:
5. Reportable Events under Section III.I.1.c. For Reportable Events under Section III.I.1.c, the report to OIG shall include documentation of the bankruptcy filing and a description of any Federal health care program authorities implicated.
A. Implementation Report.
C. Certifications.
1. Certifying Employees. In each Annual Report, Mylan shall include the certifications of Certifying Employees as required by Section III.A.4;
2. Compliance Officer and Chief Executive Officer. In the Implementation Report and each Annual Report, Mylan shall include the following
3. Medicaid Drug Rebate Certification. In the Implementation Report and each Annual Report, the Chief Financial Officer must provide the Medicaid Drug Rebate certification set forth in Appendix C.
D. Designation of Information.
A. Stipulated Penalties for Failure to Comply with Certain Obligations. As a contractual remedy, Mylan and OIG hereby agree that failure to comply with certain obligations as set forth in this CIA may lead to the imposition of the following monetary penalties (hereinafter referred to as Stipulated Penalties) in accordance with the following provisions.
B. Timely Written Requests for Extensions. Mylan may, in advance of the due date, submit a timely written request for an extension of time to perform any act or file any notification or report required by this CIA. Notwithstanding any other provision in this Section, if OIG grants the timely written request with respect to an act, notification, or report, Stipulated Penalties for failure to perform the act or file the notification or report shall not begin to accrue until one day after Mylan fails to meet the revised deadline set by OIG. Notwithstanding any other provision in this Section, if OIG denies such a timely written request, Stipulated Penalties for failure to perform the act or file the notification or report shall not begin to accrue until three days after Mylan receives OIGs written denial of such request or the original due date, whichever is later. A timely written request is defined as a request in writing received by OIG at least five days prior to the date by which any act is due to be performed or any notification or report is due to be filed.
C. Payment of Stipulated Penalties.
1. Demand Letter. Upon a finding that Mylan has failed to comply with any of the obligations described in Section X.A and after determining that Stipulated Penalties are appropriate, OIG shall notify Mylan of: (a) Mylans failure to comply; and (b) OIGs exercise of its contractual right to demand payment of the Stipulated Penalties (this notification is referred to as the Demand Letter).
2. Response to Demand Letter. Within 10 days after the receipt of the Demand Letter, Mylan shall either: (a) cure the breach to OIGs satisfaction and pay the applicable Stipulated Penalties or (b) request a hearing before an HHS administrative law judge (ALJ) to dispute OIGs determination of noncompliance, pursuant to the agreed upon provisions set forth below in Section X.E. In the event Mylan elects to request an ALJ hearing, the Stipulated Penalties shall continue to accrue until Mylan cures, to OIGs satisfaction, the alleged breach in dispute. Failure to respond to the Demand Letter in one of these two manners within the allowed time period shall be considered a material breach of this CIA and shall be grounds for exclusion under Section X.D.
3. Form of Payment. Payment of the Stipulated Penalties shall be made by electronic funds transfer to an account specified by OIG in the Demand Letter.
4. Independence from Material Breach Determination. Except as set forth in Section X.D.1.c, these provisions for payment of Stipulated Penalties shall not affect or otherwise set a standard for OIGs decision that Mylan has materially breached this CIA, which decision shall be made at OIGs discretion and shall be governed by the provisions in Section X.D, below.
D. Exclusion for Material Breach of this CIA.
1. Definition of Material Breach. A material breach of this CIA means:
2. Notice of Material Breach and Intent to Exclude. The parties agree that a material breach of this CIA by Mylan constitutes an independent basis for Mylans exclusion from participation in the Federal health care programs. The length of the exclusion shall be in OIGs discretion, but not more than five years per material breach. Upon a determination by OIG that Mylan has materially breached this CIA and that exclusion is the appropriate remedy, OIG shall notify Mylan of: (a) Mylans material breach; and (b) OIGs intent to exercise its contractual right to impose exclusion (this notification is hereinafter referred to as the Notice of Material Breach and Intent to Exclude).
3. Opportunity to Cure. Mylan shall have 30 days from the date of receipt of the Notice of Material Breach and Intent to Exclude to demonstrate to OIGs satisfaction that:
1. Review Rights. Upon OIGs delivery to Mylan of its Demand Letter or of its Exclusion Letter, and as an agreed-upon contractual remedy for the resolution of disputes arising under this CIA, Mylan shall be afforded certain review rights comparable to the ones that are provided in 42 U.S.C. § 1320a-7(f) and 42 C.F.R. Part 1005 as if they applied to the Stipulated Penalties or exclusion sought pursuant to this CIA. Specifically, OIGs determination to demand payment of Stipulated Penalties or to seek exclusion shall be subject to review by an HHS ALJ and, in the event of an appeal, the HHS Departmental Appeals Board (DAB), in a manner consistent with the provisions in 42 C.F.R. § 1005.2-1005.21. Notwithstanding the language in 42 C.F.R. § 1005.2(c), the request for a hearing involving Stipulated Penalties shall be made within 10 days after receipt of the Demand Letter and the request for a hearing involving exclusion shall be made within 25 days after receipt of the Exclusion Letter. The procedures relating to the filing of a request for a hearing can be found at http://www.hhs.gov/dab/divisions/civil/procedures/divisionprocedures.html.
2. Stipulated Penalties Review. Notwithstanding any provision of Title 42 of the United States Code or Title 42 of the Code of Federal Regulations, the only issues in a proceeding for Stipulated Penalties under this CIA shall be: (a) whether
3. Exclusion Review. Notwithstanding any provision of Title 42 of the United States Code or Title 42 of the Code of Federal Regulations, the only issues in a proceeding for exclusion based on a material breach of this CIA shall be whether Mylan was in material breach of this CIA and, if so, whether:
4. Finality of Decision. The review by an ALJ or DAB provided for above shall not be considered to be an appeal right arising under any statutes or regulations. Consequently, the parties to this CIA agree that the DABs decision (or the ALJs decision if not appealed) shall be considered final for all purposes under this CIA.
OF THE DEPARTMENT OF HEALTH AND-HUMAN SERVICES
1. Mylan and IRO. If Mylan terminates its IRO or if the IRO withdraws from the engagement during the term of the CIA, Mylan must submit a notice explaining its reasons for termination or the reason for withdrawal to OIG no later than 30 days after termination or withdrawal. Mylan must engage a new IRO in accordance with Paragraph A of this Appendix and within 60 days of termination or withdrawal of the IRO.
2. OIG Removal of IRO. In the event OIG has reason to believe the IRO does not possess the qualifications described in Paragraph B, is not independent and objective as set forth in Paragraph D, or has failed to carry out its responsibilities as described in Paragraph C, OIG shall notify Mylan in writing regarding OIGs basis for
2. The systems, processes, policies and practices used to determine which Mylan customers and classes of trade are included or excluded for purposes of calculating Average Manufacturer Price (AMP)1 and Best Price;
3. The systems, processes, policies and practices used to determine whether and which particular transactions (e.g., sales, prices, discounts, rebates) are included in or excluded from AMP and Best Price calculations;
8. A review of any Mylan inquiries to or communication with CMS regarding: (a) AMP calculations and reporting requirements pursuant to the Medicaid Drug Rebate Program, including requests for interpretation and guidance; (b) the classification of a drug as a Single Source Drug, Innovator Multiple Source Drug, or Non-Innovator Multiple Source Drug; (c) Best Price determinations and reporting requirements pursuant to the Medicaid Drug Rebate Program, including requests for interpretation and guidance; (d) Additional Rebate Amounts; and (e) any reporting obligations under the Medicaid Drug Rebate Program, including reporting of any product information (e.g., NDC information or baseline information about a product); and a review of any responses from CMS to any such inquiries or communications;
1 For purposes of this Appendix B, references to AMP includes AMP for 5i drugs (i.e., inhalation, infusion, instilled, implanted, and injectable drugs) as referenced in 42 C.F.R. § 447.507.
1. AMP Transactions Review.
2. Best Price Transactions Review. For each Reporting Period, the IRO shall perform a review to test whether Mylan determined and reported Best Price for Government Reimbursed Products in accordance with Medicaid Drug Rebate Program Requirements. The Best Price Transactions Review shall consist of two parts:
a. Part One of the Best Price Transactions Review.
(2) For each of the large and small Selected Customers, the IROs review shall cover the 20 NDCs (at the NDC-9 level) for which Mylan paid the largest amount (i.e., total dollars) of Medicaid rebates during the Reporting Period and 5 randomly selected other NDCs (collectively, the Selected BP NDCs). However, for purposes of determining the Selected BP NDCs, if Mylan paid less than $20,000 in Medicaid rebates during the Reporting Period for any randomly selected NDC, the IRO will replace that NDC with a randomly selected NDC for which Mylan paid at least $20,000 in Medicaid rebates for the Reporting Period.
b. Part Two of the Best Price Transactions Review.
(1) For all of its Single Source Drugs and Innovator Multiple Source Drugs that are Government Reimbursed Products, Mylan shall provide the IRO with a listing of the 37 Medicaid rebate eligible NDCs (at the NDC-9 level) for which Mylan paid the largest amount (i.e., total dollars) of Medicaid rebates during the Reporting Period or 25% of the number of NDCs for such products, whichever is a larger number.
3. Additional Rebate Review.
4. AMP Transactions Review Report. For each Reporting Period, the IRO shall prepare a report based on its AMP Transactions Review. The report shall include the following information:
5. Best Price Transactions Review Report. For each Reporting Period, the IRO shall prepare a report based on its Best Price Transactions Review. The report shall include the following information:
6. Additional Rebate Review Report. For each Reporting Period, the IRO shall prepare a report based on its Additional Rebate Review. The report shall include the following information:
E. Product Classification Review.
1. At the end of the first Reporting Period, Mylan shall provide to the IRO a list of all its Medicaid-rebate eligible drugs (Mylan Medicaid Rebate Eligible Drugs). The list shall identify both the drug name and the drug classification (i.e., Single Source Drug, Innovator Multiple Source Drug, or Non-Innovator Multiple Source Drug) for purposes of the Medicaid Drug Rebate Program, along with any additional information that the IRO determines is necessary in order to evaluate the drugs product classification. The IRO shall review the product classification for each Mylan Medicaid Rebate Eligible Drug and identify any Mylan Medicaid Rebate Eligible Drug that the IRO determines is incorrectly classified. The IRO shall provide Mylan with a report (Product Classification Review Report) that identifies any Mylan Medicaid Rebate Eligible Drug that the IRO determined was incorrectly classified by Mylan, along with an explanation of the basis for the IROs determination.
F. Review of Additional Items. As set forth in Section III.D of the CIA, for each Reporting Period, OIG at its discretion may identify up to three additional items for the IRO to review (hereafter Additional Items). No later than 90 days prior to the end of the applicable Reporting Period, OIG shall notify Mylan of the nature and scope of the IRO review to be conducted for each of the Additional Items. Prior to undertaking the review of the Additional Items, the IRO and/or Mylan shall submit an audit work plan to OIG for approval and the IRO shall conduct the review of the Additional Items based on a work plan approved by OIG. The IRO shall include information about its review of each Additional Item in the Transactions Review Report (including a description of the review conducted for each Additional Item; the IROs findings based on its review for each Additional Item; and the IROs recommendations for any changes in Mylans systems, processes, policies, and procedures based on its review of each Additional Item).
G. OIG Review of Proposed Work Plan. At least 60 days prior to the end of each Reporting Period, the IRO shall submit to OIG a work plan outlining the methodology for each element of the AMP Transactions Review, the Best Price Transactions Review, the Additional Rebate Review, and the Product Classification Review described above. OIG
The settlement resolves claims relating to the classification of EpiPen® Auto-Injector and EpiPen Jr® Auto-Injector for purposes of the Medicaid Drug Rebate Program. The question in the underlying matter was whether the EpiPen products were properly classified with the Centers for Medicare and Medicaid Services (CMS) as a non-innovator drug under the applicable definition in the Medicaid Rebate statute and subject to the formula that is used to calculate rebates to Medicaid for such drugs. EpiPen Auto-Injector has been classified with CMS as a non-innovator drug since before Mylan acquired the product in 2007 based on longstanding written guidance from the federal government.