Description
STATEMENT OF WORK VA INTEGRATED SERVICE NETWORK (VISN) 12 PHARMACY FIRST FILL PRESCRIPTION SERVICES PURPOSE: The Contractor shall provide pharmacy benefit management and prescription fill and dispensing services to Veteran beneficiaries of the Department of Veterans Affairs (VA) for Veteran Integrated Service Network (VISN) 12 locations including Community-Based Outpatient Clinics (CBOCs). The Contractor s pharmacies and/or the Contractor s affiliated partner pharmacies shall fill and dispense original prescriptions written by VA practitioners. The Contractor shall make arrangements with pharmacies that are located within a ten (10) mile radius of the VISN 12 facilities listed in Table A below. The objective is to identify vendors that can fulfill the VA s need for first-fill pharmacy prescription claims processing services. The Contractor, in conjunction with its affiliated/partner pharmacy network, shall fill new and emergent prescriptions (not to exceed 14 days worth), dispense prescriptions and provide appropriate medication counseling and information, report all known adverse events to the VA, and provide reports to the VA containing patient information, drug name, dosage and other relevant information. Background: The existing contract is expiring on 07/31/2023 and we now need a VISN 12-wide new contract to provide short supplies of immediately needed medications provided to Veterans through retail pharmacies for our VISN12 Licensed Independent Practitioners (LIPs). These CBOCs do not have patient volumes sufficiently large enough to warrant the establishment of in-house pharmacies. The VA uses Consolidated Mail Outpatient Pharmacies (CMOPs) to fill and mail recurring prescriptions to patients. However, when patients receive new or emergency prescriptions from care providers at their local CBOC, the CMOPs cannot fill and mail these prescriptions within the time required for treatment to begin. The cost-effective solution the VA has pursued to address the issue of CBOC first fill and emergent prescriptions, is the acquisition of Contractor provided first fill pharmacy prescription claims processing services. PERIOD OF PERFORMANCE: This contract shall be effective for a period of six months, from 08/01/2023 to 01/31/2024. SCOPE OF SERVICES: It is difficult to estimate the exact (volume) number of prescriptions filled and dispensing services accurately because this depends on the number of patients, nature of their disease and diagnoses. Therefore, to further clarify this should be an Indefinite Delivery Indefinite Quantity (IDIQ) contract. The challenge to estimate the exact (volume) number of prescription fills monthly can vary based simply on the number of veteran patients, covid-19 pandemic outcomes etc. REQUIRED TASKS: First time or emergency prescription medication fills, and dispensing services shall include but not be limited to the following: Only new prescriptions shall be filled (except for the exceptions listed below). A new prescription is defined as a written prescription for a drug product and strength that has not been previously dispensed to the Veteran beneficiary in the previous 12 months. A repeat order for the same drug product within 12 months, even if transmitted as a new prescription order, is not considered a new prescription. Exceptions may be made for second courses of antibiotic therapy and other rare situations approved by Chief of Pharmacy Service or their designee. In rare instances where refills may be necessary, there must be a pre-authorization by the Chief of Pharmacy Service at the CBOC s responsible parent VA Medical Center and so noted on the invoice. Controlled Substance prescribing should remain within VA and from one provider and one pharmacy whenever possible. However, if a controlled substance is needed from a contract pharmacy in an emergency situation, the VA provider must follow all Federal, State, and VA laws, directives, and guidelines for prescribing the medication. This includes, but is not limited to, things like appropriate documentation in the patient s chart, PDMPs (if required), etc. Controlled Substance is defined in 21 U.S.C 802(6) as a drug or other substance, or immediate precursor, included in the Schedule I, II, III, IV, or V of 21 U.S.C. 812. 21 CFR 1308.11-1308.15 provides a listing of each drug, substance, or immediate precursor for each schedule. Prescriptions filled by the Contractor s pharmacies and/or the Contractor s affiliated partner pharmacies shall be in written form and in accordance with VA policy and procedures as well as applicable state and federal regulations. Only prescriptions from VA authorized practitioners shall be filled under this contract. Prescriptions shall be written on VA prescription Form 10-2577F (see Form 10-2577F Sample) or locally developed prescription blanks and shall be hand carried by the beneficiary, faxed from a VA clinic practitioner, given verbally by VA clinic practitioner, or stamped with the words Authorized VA First-Time or Emergent Prescription . Prescriptions from non-VA authorized practitioners shall not be filled under this contract. Unless otherwise pre-authorized, prescription fills shall be limited to a maximum of a fourteen (14) day supply. Prescriptions shall be filled for legend drugs listed in the Department of Veterans Affairs Formulary of Drugs Department of Veterans Affairs Formulary can be found at: http://www.pbm.va.gov/nationalformulary.asp. . Prescriptions filled under this contract shall be, to the extent permitted by law, the least expensive drug product the pharmacy has in stock. Generic drugs shall be dispensed whenever possible. A product is not considered a generic equivalent unless the strength, quantity and dosage are the same as the brand name. The generic name must be displayed on all labels for all medication. VA Standardization List The Drug Standardization List is a list of pharmaceutical products for which substitution is not permitted under normal circumstances. The intent is to provide Veterans with a consistent and reliable product for drugs where interchange may compromise therapeutic response or patient safety. Products are added to this list by vote of the VISN Pharmacist Executives and the Medical Advisory Panel. Decisions are based on reviews of therapeutic equivalency and/or patient safety data. The Contractor must comply with the below VA Standardization List. Substitution is allowed in rare circumstances when the Drug Standardization item is on back order or the patient is intolerant to the formulary product. VA practitioners should be alerted when it is necessary to dispense alternative products. VA Standardization List: Attachment 1. Amiodarone: (Upsher-Smith brand Pacerone). Patients receiving a generic amiodarone will be switched to the Pacerone product. Bioequivalence cannot be guaranteed when switching from one generic to another; therefore, additional monitoring may be required. Budesonide ER Capsules* (Golden State Medical Supply/Mylan) applies to Crohn s indication Carbamazepine tabs (Golden State Medical Supply/Taro) *,** applies to epilepsy indication Clozapine (Mylan). Clozaril may be continued on existing patients. There is no mandatory conversion. Cyclosporine (Gengraf) applies to transplant indication Dofetilide (AvKare/Sigmapharm)*, ** Lamotrigine* , ** (Cadista/Avkare) all strengths except chewable, XL and ODT applies to epilepsy indication Levetiracetam*,** (Acetris/Aurobindo) applies to epilepsy indication Levothyroxine (Synthroid) Mesalamine ER/CR capsules (Pentasa) has different gastrointestinal release characteristics from other mesalamine products, and therefore shouldn t be substituted in patients with Crohn s disease. Mycophenolate Mofetil* , ** (Golden State Medical Supply/Mylan) applies to transplant indication Mycophenolic Acid Tablets*,** (Golden State Medical Supply/Apotex) applies to transplant indication Phenytoin (Mylan) extended release capsules 100mg Prenatal Tab (Major includes only the following two NDCs: 00904-5313-46 and 00904-5313-60) Tacrolimus*,** (Golden State Medical Supply/Mylan) applies to transplant indication Topiramate* (Golden State Medical Supply/Invagen) applies to epilepsy indication Warfarin* (Exelan/Invagen) Zonisamide*,** (Golden State Medical Supply/Sun/Caraco) applies to epilepsy indication *Indicates national contract **Providers will have the ability to continue to prescribe the branded product; however, when Providers determine a generic is clinically appropriate the awarded product shall be the mandatory source. Pharmacy Chief or Designee will have full authority to edit the following with the Contractor: Formulary local sites may further restrict the first fill formulary to whatever urgent and emergent medications they deem necessary. Further, Pharmacy Chief or Designee may approve one time use of non-formulary fills if needed. When restricting the formulary in this fashion, the Pharmacy Chief may choose to allow blanket overrides of non-formulary products if under a select dollar amount to reduce unnecessary override requests. For example, the restricted formulary + any medication with a cost of less than $10 will be approved automatically. This is determined per facility, by the Pharmacy Chief. Providers local sites may add and remove VA providers who have access to the first fill contract at their discretion. Contract Pharmacy Although typically pharmacies will be located within 10 miles of a CBOC location, local sites may extend this geographic range as needed to accomplish the mission. Locations local sites may have contractor create new locations (and certificates) as required to provide care. Table A shows all current VA Medical Centers and CBOCs, but new locations may open and move and may require service. This includes certificates for all CBOCs and in some cases main facilities. Overrides VA Pharmacy Chief or Designee will have the authority to issue one time overrides (i.e. authorizing the contractor to pay for a medication not normally covered, or to fill for a quantity not normally covered). This is rare and will be done on a case by case basis for emergent purposes only as approved by Chief, Pharmacy or their designee. The Contractor must have a minimum of one licensed pharmacy, and/or affiliated partner pharmacy, for which pharmacy prescription services are provided within a ten (10) mile radius of each of the CBOCs listed below: Table A: Parent VA Medical Center s CBOCs and Pharmacy Service Point-Of-Contact (POC) Parent VA Medical Center CBOC Location William S. Middleton Memorial VA Hospital 2500 Overlook Terrace Madison, WI 53705 1670 South Blvd., Baraboo, WI 53913 215 Corporate Dr., Suite D, Beaver Dam, WI 53916 750 Kiwanis Dr., Suite 250, Freeport, IL 61032 1141 Black Bridge Road, Janesville, WI 53545 816 Featherstone Road, Rockford, IL 61108 1 Science Court, Madison, WI 53711 4902 Eastpark Blvd. Madison WI 53718 Parent VA Medical Center CBOC Location Tomah VA Medical Center 500 E. Veterans Street Tomah, WI 54660 8 Johnson St., Owen, WI 54460 4000 State Rd 16., La Crosse, WI 54601 515 S. 32ND Ave., Wausau, WI 54401 1105 E. Grand Ave, Rothschild, WI 54474 555 West Grand Ave. Wisconsin Rapids, WI 54495 Parent VA Medical Center CBOC Location Clement J. Zablocki VA Medical Center 5000 W. National Ave. Milwaukee, WI 53295 10 Tri-Park Way, Appleton, WI 54914 1205 North Ave., Cleveland, WI 53015 2851 University Ave., Green Bay, WI 54311 21425 Spring St., Union Grove, WI 53182 Parent VA Medical Center CBOC Location Captain James A. Lovell Federal Health Care Center 3001 Green Bay Rd. North Chicago, IL 60064 1942 Dempster, Evanston, IL 60202 8207 22nd Avenue, Kenosha, WI 53143 3715 Municipal Drive, McHenry, IL 60050 Parent VA Medical Center CBOC Location Oscar G. Johnson VA Medical Center 325 East H St. Iron Mountain, MI 49801 787 Market St. Suite 9&10, Hancock, MI 49930 629 W. Cloverland Dr. Suite #1, Ironwood, MI 49938 509 Osborn Blvd., Suite 306, Sault Ste Marie, MI 49783 1414 Fair Ave. Suite 285, Marquette, MI 49855 1110 10th Ave. Suite 101, Menominee, MI 49858 639 West Kemp St., Rhinelander, WI 54501 617 E. Lakeshore Dr., Manistique, MI 49854 2002 Minneapolis Ave, Gladstone MI 49837 Parent VA Medical Center CBOC Location Edward Hines Jr. VA Hospital 5000 S. 5th Ave. Hines, IL 60141 161 S. Lincolnway St., North Aurora, IL 60542 4885 Hoffman Blvd, Hoffman Estate, IL 60192 1210 Eagle St, Joliet, IL 60432 581 William Latham Dr., Suite 301, Bourbonnais, IL 60914 4461 N Progress Blvd., Peru, IL 61354 10201 S. Cicero Ave., Oak Lawn, IL 60453 Parent VA Medical Center CBOC Location VA Iliana Health Care System 1900 E. Main St Danville, IL 61832 792 N. Sunnyside Rd., Decatur, IL 62522 501 Lakeland Blvd., Mattoon, IL 61938 7717 N. Orange Prairie Rd., Peoria, IL 61615 5858 South 6th St., Frontage Road East, Suite A, Springfield, IL 62703 207 Hamilton Rd., Bloomington, IL 61704 Parent VA Medical Center CBOC Location Jesse Brown VA Medical Center 820 S Damen Ave Chicago, IL 60612 9301 Madison Street Crown Point, IN 46307 7731 S Halsted St Chicago, IL 60620 211 Dixie Hwy Chicago Heights, IL 60411 211 E. Ontario St., 12th Floor Chicago, IL 60611 Parent VA Medical Center CBOC Location Provider Clinical Contact Center 2500 Overlook Terrace Madison, WI 53705 Virtual will see patients at all existing VISN 12 CBOCs across all VISN 12 VAMCs. If services are needed for new CBOCs in the VISN 12 service area, these additional locations may be added to this contract by mutual agreement of the Government and Contractor. Funding will typically come from the main facility and specific contract modification is not required unless otherwise needed by Federal Law or VA policy. Pharmacies authorized to fill prescriptions under the Contractor s plan must agree to the following conditions: All information concerning VA beneficiaries shall be kept confidential and shall not be disclosed to any person, except as authorized in writing and according to all applicable laws. Representatives of the VA are authorized to visit the premises of any pharmacy filling VA prescriptions under the Contractor s plan during business hours for the purpose of auditing and evaluation, which may include the inspection of clinical records. All adverse drug events reported to the Contractor s pharmacies by Veteran beneficiaries of the VA, shall be reported to the parent VA Medical Center s Pharmacy Service within 12 hours. Adverse drug events include, but are not limited to, the following: dispensing errors, drugs allergies, and adverse drug reactions. The adverse drug events (even zero finding) need to be included in the monthly key performance indicators report from the Contractor. Pharmaceutical care provided to Veteran beneficiaries under this contract shall meet all standards applicable to Medicaid recipients in the state where the services are being provided and standards set forth in the current Joint Commission accreditation manual for Ambulatory Care/Pharmaceutical Services. Patient waiting times for prescription dispensing shall be approximately 30 minutes, but shall not exceed two hours. All patients shall be offered counseling from a Pharmacist for each prescription filled. Counseling offered shall be consistent with the Wisconsin, Illinois and Michigan State Board of Pharmacy requirements as applicable, to ensure appropriate use and optimal outcomes from drug therapy. The counseling shall include, but not necessarily be limited to: Name, description and use of medication. Dose, dosage, form, and route. Special directions and precautions. Common side effects and action required if side effects occur. Techniques for self-monitoring drug therapy. Action to be taken if a dose is missed. Proper storage. What the patient can expect from the medication; and The balance of the patient s prescribed medication shall be mailed from the VA Pharmacy. The Contractor shall provide Registered Pharmacists who shall: Be registered in the State where service is provided; Collect, synthesize, and interpret patient prescription, and disease data; Check for factual and potential drug related problems including, but not limited to: therapeutic duplication drug-disease contraindications drug-drug interactions (including interactions with over the counter drugs) incorrect drug dosage drug-allergy interactions Identify, clarify, and resolve drug related problems with the prescription and patient; Be available to answer any drug related questions that a patient may have after the prescription is filled; Treat all patients with dignity, courtesy and respect; and Provide clinical pharmaceutical monitoring (i.e. anticoagulation) and medication management services as required and requested by the VA Great Lakes Healthcare System Critical Patient Safety Requirement for Verbal and Telephone Orders: In the event of a circumstance that requires a telephone order to be taken, the Pharmacist taking the order shall REPEAT THE ORDER (also known as Read Back) to the VA practitioner and ensure the practitioner s concurrence with the repeated order. Any and all changes or clarifications to a prescription order which require communication with the patient s practitioner shall be confirmed by REPEATING THE ORDER, the change or clarification to ensure accuracy. The REPETITION OF THE ORDER (Read Back) requirement is mandatory with no exceptions. The Contractor shall invoice the parent VA medical facility monthly for services rendered. The VA will randomly audit all invoices. Pharmacies accepting payment through the Contractor must make records available to VA auditors in a timely manner at the location where dispensed. All invoices shall reference the following information: Contract Number, Order Number and Purchase Order Number Date of invoice Invoice number Claim period the invoice relates to Rx cost per clinic location Number of Rx dispensed per clinic location Dispensing fee per Rx Total cost of invoice Patient name The last four digits of the patient s Social Security Number Prescription number Name of medication, strength, quantity, and NDC number of dispensed drug QUALIFICATIONS Personnel assigned by the Contractor to perform the services covered by this contract shall have a full and unrestricted license in a State, Territory, or Commonwealth of the United States or the District of Columbia. The qualifications of such personnel shall also be subject to review by the VA Chief of Staff and approved by the VA Facility Director. Personnel assigned by the Contractor to perform the services covered by this contract shall be proficient in written and spoken English (38 USC 7402). REPORTING REQUIREMENTS The Contractor shall provide a monthly summary for each CBOC to the CBOC s respective responsible VA Medical Center Pharmacy Service POC detailing the following information for services provided: Patient Name and Address Last four digits of the patient s Social Security Number Dispensing Pharmacy Prescription Number Date of fill Drug (generic name) Drug Strength Quantity Dispensed NDC (National Data Code) Prescription Cost Dispensing fee Prescriber Name Name of approving official (clinic contact at VA Medical Center) if prescription was an approved exception to the VA VISN 12 emergent formulary drug list. Cumulative quarterly reports shall also be provided to the Contracting Officer s Representative (COR), and the Contracting Officer (CO). Quarterly reports shall include, in addition to the reports listed above, a controlled substance use report, and a non-formulary report. The CO requires a quarterly report comparing the dollar amount of drugs dispensed under the contract compared to Average Wholesale Price (AWP). In addition, the Contractor shall provide trended dispensing information for the areas mentioned above, as requested by the VA Medical Center Pharmacy Service. All Contractor reports and non-verbal communications shall be submitted to the VA via secure, encrypted email. The contractor shall obtain VA PKI partner certificates from each CBOC s parent VA Medical Center to allow this encrypted exchange. QUALITY ASSURANCE The Contractor shall provide, for quality control and performance improvement purposes, the following information: All medication errors and medication related incidents shall be recorded, investigated and reported to the parent VA Medical Center by the Contractor on a quarterly basis. Medication errors or events that result in required hospitalization, clinical intervention or significant negative sequela shall be reported to the parent VA Medical Center immediately. Customer complaints, suggestions, and compliments shall be recorded and reported to the parent VA Medical Center on a quarterly basis (or more frequently if a significant problem occurs). STATUTORY REQUIREMENTS Services required under this contract shall be performed in accordance with the following: Wisconsin, Indiana, Illinois or Michigan State Board of Pharmacy; Pharmacy Law (as applicable) Code of Federal regulations, Title 21 United States Code, Title 21 RADIUS REQUIREMENT: The Contractor shall provide Pharmacy locations within a ten (10) mile radius of each VA Facility indicated in Table A above. The Contractor shall provide the name, address, and phone number of each pharmacy and the parent VA Medical Center shall approve the use of each facility. Google Maps shall be used to determine if a Pharmacy location is within the required ten (10) mile radius, should a dispute in regard to a Pharmacy s location occur. CONFIDENTIALITY AND SECURITY: The Contractor shall ensure the confidentiality and security of all patient information and shall be held liable in the event of breach of confidentiality. The Contractor shall comply with the provisions of the Privacy Act of 1974 (5 USA 522a), Confidentiality of Drug Abuse, Alcohol Abuse, Sickle Cell Anemia and HIV/AIDs Treatment Records (38 USC 7332) and Confidentiality of Medical Quality Assurance Records (38 USC 5705). The Contractor shall comply with all laws and regulations pertaining to confidentiality and security statutes. The Contractor shall be HIPAA (Health Insurance Portability and Accountability Act) compliant. Failure to comply with statutes regarding confidentiality and security of patient health information and/or individually identifiable information may result in financial sanctions. ISSUANCE OF PRESCRIPTION FILL AND DISPENSING REQUESTS: Only prescription orders from VA authorized practitioners through authorized local pharmacies are eligible for reimbursement under this contract. The Contractor and its pharmacies or its affiliated/partner pharmacies shall not require the patient to provide more information than the patient s name, last four digits of the patient s Social Security Number, and the patient s date of birth. THE CONTRACTOR, ITS PHARMACIES, OR ITS AFFLIATED/PARTNER PHARMACIES SHALL NOT REQUIRE THE PATIENT TO PROVIDE THE PATIENT S FULL SOCIAL SECURITY NUMBER. CONTRACTING OFFICER S REPRESENTATIVE (COR): The COR is responsible for facilitating communication between the Contractor and the Contracting Officer and for monitoring Contractor performance. The COR does not have the authority to change the terms and conditions of the contract. ADDITIONAL REQUIREMENTS: The services specified herein may be changed by written bi-lateral modification to this contract if agreed upon by both the Government and Contractor. In this instance, the VA Contracting Officer shall prepare the modification. The services to be performed by the Contractor shall be performed in accordance with VA policies and procedures and the regulations of the medical staff by laws of the VA facility. The parties agree that the Contractor, its employees, agents, and subcontractors shall not be considered VA employees for any purpose.