STATE OF WASHINGTON HEALTH CARE AUTHORITY REQUEST FOR PROPOSALS (RFP) RFP NO. 3233 NOTE: If you download this RFP from the Health Care Authority (HCA) website, you are responsible for sending your name, address, email address, and telephone number to the RFP Coordinator in order for your organization to receive any RFP amendments or bidder questions/agency answers. HCA is not responsible for any failure of your organization to send the information or for any repercussions that may result to your organization because of any such failure. PROJECT TITLE: Eliminating Hepatitis C in Washington State PROPOSAL DUE DATE: March 4, 2019 by 5:00 p.m. Pacific Time. E-mailed bids will be accepted. Faxed bids will not. ESTIMATED INITIAL TIME PERIOD FOR CONTRACT: July 1, 2019 to June 30, 2023 HCA reserves the right to extend the contract for additional two year periods up to June 30, 2031, although no such extension is guaranteed. BIDDER ELIGIBILITY: This procurement is open to those Bidders that satisfy the minimum qualifications stated herein and that are available for work in Washington State. 1.  INTRODUCTION .................................................................................................................. 4    PURPOSE AND BACKGROUND ................................................................................................ 4    RFP OBJECTIVES AND SCOPE ................................................................................................... 6    MINIMUM QUALIFICATIONS .................................................................................................. 8    FUNDING ................................................................................................................................ 8    PERIOD OF PERFORMANCE ..................................................................................................... 8    CONTRACTING WITH CURRENT OR FORMER STATE EMPLOYEES ............................................. 9    DEFINITIONS .......................................................................................................................... 9    ADA...................................................................................................................................... 10  2.  GENERAL INFORMATION FOR BIDDERS ............................................................................ 11    RFP COORDINATOR .............................................................................................................. 11    ESTIMATED SCHEDULE ......................................................................................................... 11    PRE‐PROPOSAL CONFERENCE ............................................................................................... 11    SUBMISSION OF PROPOSALS ................................................................................................ 12    PROPRIETARY INFORMATION / PUBLIC DISCLOSURE ............................................................ 12    REVISIONS TO THE RFP ......................................................................................................... 13    DIVERSE BUSINESS INCLUSION PLAN (M) .............................................................................. 13    ACCEPTANCE PERIOD ........................................................................................................... 13    COMPLAINT PROCESS ........................................................................................................... 13    RESPONSIVENESS .............................................................................................................. 14    MOST FAVORABLE TERMS & BAFO .................................................................................... 14    PROPOSED CONTRACT ...................................................................................................... 14    COSTS TO PROPOSE .......................................................................................................... 15    RECEIPT OF INSUFFICIENT NUMBER OF PROPOSALS .......................................................... 15    NO OBLIGATION TO CONTRACT ........................................................................................ 15    REJECTION OF PROPOSALS ................................................................................................ 15    COMMITMENT OF FUNDS ................................................................................................. 15    ELECTRONIC PAYMENT ..................................................................................................... 15    INSURANCE COVERAGE ..................................................................................................... 15  3.  PROPOSAL CONTENTS ...................................................................................................... 18    LETTER OF SUBMITTAL (M) ................................................................................................... 18    BONA FIDE SERVICES (MS) .................................................................................................... 19    DISTRIBUTION TO NON‐MEDICAID PROGRAMS (M) ............................................................. 22    MEDICAID DISTRIBUTION MODEL (M) .................................................................................. 23    COST PROPOSAL (MS) .......................................................................................................... 24  4.  EVALUATION AND CONTRACT AWARD ............................................................................ 24    EVALUATION PROCEDURE .................................................................................................... 24    EVALUATION WEIGHTING AND SCORING ............................................................................. 25    ORAL PRESENTATIONS MAY BE REQUIRED ........................................................................... 27    SUBSTANTIALLY EQUIVALENT SCORES .................................................................................. 27    NOTIFICATION TO BIDDERS .................................................................................................. 28    DEBRIEFING OF UNSUCCESSFUL BIDDERS ............................................................................. 28    PROTEST PROCEDURE .......................................................................................................... 28  5.  RFP EXHIBITS ................................................................................................................... 30  HCA RFP No. Page 3 of 32 1. INTRODUCTION PURPOSE AND BACKGROUND The Washington State Health Care Authority (HCA) is initiating this Request for Proposals (RFP) to solicit proposals from drug manufacturers interested in participating on a project to eliminate hepatitis C virus (HCV) in Washington through public health outreach, education, preventive services, testing, linkage to care, and the provision of direct acting antiviral drugs (DAAs). National HCV Trends According to the Centers for Disease Control and Prevention (CDC), HCV infection is the most common blood-borne condition in the U.S. HCV is unrelated to other types of viral hepatitis, such as hepatitis A and hepatitis B virus infections, and unlike those diseases, has no vaccine available to prevent infection. HCV is usually spread when blood from an infected person enters the body of someone who is not infected. Today, most people become infected with HCV by sharing needles or other equipment to prepare or inject drugs. Before 1992, HCV was also commonly spread through blood transfusions and organ transplants. After that, widespread screening of the blood supply in the U.S. virtually eliminated this source of infection. Persons born between the years 1945 and 1965 (“baby boomers”) are at higher risk for HCV. Baby boomers make up roughly one-quarter of the U.S. population but around three-quarters of chronic HCV cases. They account for at least two-thirds of HCV-associated outpatient, emergency department, and hospital visits. As young adults, baby boomers had higher risks of blood-borne exposures due to unscreened blood products, medical or dental exposures without modern infection control measures, and injection drug use when compared to previous or subsequent generations. HCV testing only became available for clotting factor products in 1987, and for blood and organs in 1992. One-time screening for HCV infection is recommended for baby boomers, who have around a 3% prevalence of HCV infection. The CDC estimates 1% of the U.S. population is infected with chronic HCV, or roughly 3.5 million individuals. Nationally, between 2010 and 2015, there was a 2.9 fold increase in new HCV cases. Only about half of those with chronic HCV are diagnosed and aware of their infections. After diagnosis of HCV, linkage to ongoing healthcare is critical so that the infected person can be evaluated by a clinician and referred as appropriate. Nationally, only about one-third of those diagnosed with HCV (32–38%) are referred to care, around one-tenth (7–11%) receive treatment, and about half of those treated (5–6%) are cured. The burden of HCV infection is much higher in the U.S. correctional population compared to the general community. Typical HCV prevalence among inmates nationally has been reported as 17% to 29%. In the past few years, new medications have become available to treat HCV, and numerous national organizations have noted that, with these treatments, HCV could be eliminated in the U.S. “Elimination” is a state where HCV is no longer a public health threat and is achieved by identifying newly infected patients, providing preventive services, and providing treatment as early as possible, which improves individual health and prevents ongoing transmission of the virus. Yet, the high cost for these drugs has stifled aggressive outreach efforts and limited the ability to eliminate this disease. HCV in Washington State Washington has experienced a 3.3 fold increase in reported HCV cases in recent years, with nearly 40,000 cases reported from 2012 through 2017. This is primarily due to the opioid epidemic and the increase in the number of individuals who inject drugs. Overall, about 65,000 Washingtonians live with chronic HCV. HCA RFP No. 3233 Page 4 of 32 In Washington, there are four state agencies that have some responsibility for paying for and/or providing health care services to the people they serve: HCA, the Department of Corrections (DOC), the Department of Social and Health Service (DSHS), and the Department of Labor and Industries (L&I). Since June 2014, these agencies have treated 10,377 individuals at a total cost of $386,637,704. This leaves about 30,000 individuals chronically infected with HCV to be treated by state programs. (Please note that this figure is an epidemiological estimate, and that while HCA anticipates treating a roughly equal number of HCV infected persons on an annual basis over the life of the contract resulting from this RFP, treatment numbers may vary on an annual basis.) Table 1 through Table 3 summarize the total expenditures and number of individuals treated by program. Table 1. Annual HCV DAA expenditures Fiscal  Year  FY2015  FY2016  FY2017  FY2018    Medicaid  $28,121,077  $92,861,663  $127,534,556  $68,016,405          DOC  $6,069,599  $6,143,223  $9,767,666  $7,313,679  DSHS  $89,596  $269,192  $1,003,850  $633,384  UMP  $12,140,363  $9,244,209  $11,560,336  $4,318,151  L&I  $336,420  $927,842  $374,220  $173,340  DSHS  $89,596  $89,596  $91,259  $30,244  UMP  $110,367  $96,294  $66,823  $44,063  L&I  $84,105  $115,980  $124,740  $57,780  UMP  110  96  173  98  L&I  <10  <10  <10  <10  Table 2. Average Cost per individual treated Fiscal  Year  FY2015  FY2016  FY2017  FY2018  Medicaid  $43,599  $47,991  $34,394  $22,433  DOC  $94,837  $71,433  $54,265  $36,206  Table 3. Number of individuals treated Fiscal  Year  FY2015  FY2016  FY2017  FY2018  Medicaid  645  1,935  3,708  3,032  DOC  64  86  180  202  DSHS  <10  <10  11  23  On September 30, 2018, Governor Jay Inslee issued Governor’s Directive #18-13, attached as Exhibit D (the Directive), The Directive requires DOH and HCA to immediately begin working with state agencies, tribal governments, local public health officials, and other partners across the state, to develop and implement a statewide plan to eliminate HCV in Washington State by 2030. DOH was directed to lead the effort to develop an elimination plan as part of this comprehensive public health response, and to develop and implement the State HCV elimination program, called “Hep C Free WA.” In order to achieve this, DOH has convened stakeholders to develop a public health strategy to eliminate HCV (the WA Hepatitis C Elimination Coordinating Committee). It is expected that the Apparent Successful Bidder(s) will be invited to the stakeholder meetings. Stakeholders include individuals affected by HCV, local health jurisdictions, tribal governments, medical providers, and others with an interest in HCV elimination. HCA RFP No. 3233 Page 5 of 32 HCA was directed to lead, coordinate with DOH and other agencies and purchasers, and implement a comprehensive procurement strategy for the purchase of DAAs that includes provision of needed public health interventions to affordably eliminate HCV. Specifically, HCA was directed to collaborate with agencies and issue a single request for proposals for a joint, value-based purchasing agreement for DAAs from one or more pharmaceutical manufacturer(s) in January 2019. This joint purchasing agreement will aim to reduce the costs of the drugs, increase the numbers of Washingtonians treated, and incorporate key known public health strategies to address the needs described above. Furthermore, HCA was directed to collaborate with other state agencies, and possibly to engage multi-state or national organizations, to develop a strategy to assess the interest and ability of extending our purchasing and public health strategy to not only Washington’s other major purchasers of health care and commercial insurers, but also other states or purchasers (Phase II). This work may include either working to partner with a multi-state collaborative or other states individually. As part of Phase II, HCA shall work with Washington’s Health Benefit Exchange and the Office of the Insurance Commissioner to explore purchasing options for the health insurance markets. RFP OBJECTIVES AND SCOPE Pursuant to the Directive, this RFP is designed for the provision and receipt of: a. Discounted pricing for the purchase of DAAs by state agencies, including a modified “subscription model” for the Washington State Apple Health program and guaranteed net unit best price for non-Medicaid programs, b. The option to extend the discounted prices beyond the initial state agency-purchased DAAs, and c. Drug manufacturer support of the DOH-led public health outreach and education efforts through bona fide services. A key objective of this RFP is to work with a drug manufacturer to bring down the cost of medications to enable the state, and ultimately other purchasers, to eliminate Hepatitis C without exceeding current expenditures. HCA hopes that the pricing, rebate and terms associated with this procurement will create the stability that is required to ensure long-term and predictable expenditures on treating HCV, and obtain necessary resources that are critical to a successful statewide public health HCV elimination strategy. HCA intends to select a single Apparent Successful Bidder (ASB), but reserves the right to select more than one ASB. In addition, if resistance patterns emerge, or there are changes in the standard of care, HCA reserves the right to re-procure for new drugs consistent with those changes. In addition, as there are DAAs that treat specific genotypes only, and DAAs that are pangenoptypic, nothing in this RFP or any resulting contract shall prohibit HCA from purchasing other DAAs that may assist treatment for patients when medically necessary. Separate contract provisions or subagreements will be entered with the ASB(s) (i) for the Medicaid population and (ii) for the nonMedicaid population. The first phase of this initiative targets the estimated 30,000 individuals with a HCV infection who are covered by a state agency health plan: HCA (Medicaid, and Public Employees Benefits and School Employees Benefits programs (collectively, “ERB Programs”), DSHS (Eastern and Western State Hospitals), L&I, and DOC. Medicaid Program Through this procurement, HCA seeks a modified “subscription model” supplemental rebate specific to the Medicaid program. An unmodified “subscription model” is one where a drug manufacturer provides an unlimited supply of its DAA to treat infected residents of a state in exchange for a flat recurring fee. (See, Trusheim MR, Cassidy WM, Bach PB. Alternative State-Level Financing for HCA RFP No. 3233 Page 6 of 32 Hepatitis C Treatment—The “Netflix Model”. JAMA. 2018;320(19):1977–1978. doi:10.1001/jama.2018.15782.) In this RFP, HCA seeks a low guaranteed net unit price (GNUP) for DAAs with an annual maximum dollar threshold, at which point any additional purchase of DAAs will be at a minimal to no additional cost to HCA. This will allow the ASB to sustain its revenue and also ensures that HCA is able to treat as many Medicaid enrollees with HCV as possible. For example, and for illustration purposes only, a GNUP for a particular DAA might be $1 per day with a $1 million threshold. After HCA pays the total threshold, the GNUP might fall to $0.01 per day. GNUP up to and including $1 million $1.00 per day GNUP above $1 million $0.01 For the Medicaid population, HCA will give preferred status to the selected DAA(s) of the ASB(s). Consistent with the current Preferred Drug List (PDL) and existing programs, this preferred status will allow providers to prescribe the selected regimen with minimal prior authorization criteria. Also consistent with the current PDL and other HCA programs and processes, other DAAs will still be considered as non-preferred regimens, but will require prior authorization, and such authorization will only be made when (i) such alternative DAA is clinically appropriate and (ii) the preferred DAA is not clinically appropriate. Non-Medicaid Programs The non-Medicaid programs are managed by agencies that purchase DAAs directly and indirectly for individuals not enrolled in the Medicaid program. These agencies are DOC, DSHS, HCA (selfinsured options offered through the ERB Programs), and L&I. DOC and DSHS have facilities that directly purchase DAAs and distribute them to HCV-infected individuals within those facilities. The self-funded health plans administered under the ERB Programs and L&I use group programs and reimburse pharmacies for DAAs dispensed to individuals covered by their respective programs. Through this RFP, HCA seeks a single best GNUP for all non-Medicaid programs. For group programs, HCA expects that the selected ASB will make all rebates and any other price concessions that are included in a Proposal to be recovered using a state-selected administrator, who will be responsible for billing, collecting, and disbursing rebates and concessions on behalf of the state (the Rebate Administrator). Any administrative fees required by the Rebate Administrator will be clearly identified and paid for by the ASB. Bidders may also propose an alternative method for the group programs to get the GNUP at the point of service (see, Section 3.3). For facilities, HCA expects that the selected ASB will also provide for a distribution channel to deliver drugs to facilities that purchase DAAs directly. It is possible that DOC could purchase drugs on behalf of DSHS through an intragovernmental agreement and distribute to DSHS. As with the Medicaid population, non-Medicaid programs will give preferred status in a manner consistent with the existing PDL and current processes to the selected DAA(s) of the ASB(s). This preferred status will allow providers to prescribe the regimen with minimal prior authorization criteria. Non-preferred regimens will still be covered, but will require prior authorization, and such authorization will only be made when (i) such alternative DAA is clinically appropriate and (ii) the preferred DAA is not clinically appropriate. As noted above, Phase II may expand this procurement to other private or public purchasers, including other states that may wish to participate. These purchasers may include state and local government purchasers of DAAs not identified above, fully insured plans offered to government employees or retirees, and private self- or fully-insured plans. The ASB(s) will have the right of first refusal for Phase II by extending certain contract terms to cover such populations. HCA RFP No. 3233 Page 7 of 32 Bona Fide Service Plan In addition to discounted costs of DAAs, the state is requesting Bidders propose bona fide services as described in Section 3.2 of this RFP to provide in support of Hep C Free WA. These services may include the ASB(s) hiring additional staff, engaging with contractors, and/or dedicating their current staff and resources to these efforts. The programs and resources defined as bona fide services are intended to support provider education and link patients to testing and treatment. Examples of such services include support for:      Project ECHO (see, Section 3.2.5) Provider education to build the healthcare workforce capacity to test and cure HCV Increased HCV screening and linking those infected to treatment Social marketing to develop a HCV health promotion and education campaign Reporting, consultation, and support of Health Information Exchange (HIE) to track patients throughout treatment as well as providing population level outcome reporting. These bona fide services to be provided by the ASB(s) will be documented as part of the contracts between HCA and such ASB. Additional Information Bidders should note that HCA has submitted or will soon submit a portion of a contract for the Medicaid population to the Centers for Medicare and Medicaid Services (“CMS”) for its review and approval. At the time of the release of this RFP, HCA has not yet received any comment or approval from CMS. Depending on the timing of receipt of any CMS approval or comments, HCA will notify Bidders of any changes either through an amendment to this RFP; or, if received after the date Proposals are due and before a contract resulting from this RFP is fully executed, through direct communication with each Bidder. MINIMUM QUALIFICATIONS The following are the minimum qualifications for Bidders: Licensed to do business in the state of Washington, or provide a commitment that it will become licensed in Washington within 30 calendar days of being selected as the Apparent Successful Bidder. Manufactures or labels and sells an FDA-approved DAA indicated for the treatment of HCV genotype 1. FUNDING Cost of services provided under any contracts that result from this RFP will be made based on the agreed upon amounts, if any. Therefore, a maximum level of available funding is not being identified at this time. Nonetheless, any contract awarded as a result of this RFP is, and will remain throughout its term, contingent upon the availability of funding. PERIOD OF PERFORMANCE The initial period of performance of any contract resulting from this RFP is tentatively scheduled to begin on or about July 1, 2019 and terminate on June 30, 2023. HCA reserves the right to extend the contract for periods of two years through June 30, 2031, although no extensions are guaranteed. HCA RFP No. 3233 Page 8 of 32 CONTRACTING WITH CURRENT OR FORMER STATE EMPLOYEES Specific restrictions apply to contracting with current or former state employees pursuant to chapter 42.52 of the Revised Code of Washington (RCW). Bidders should familiarize themselves with the requirements prior to submitting a proposal that includes current or former state employees. DEFINITIONS Definitions for the purposes of this RFP include: Apparent Successful Bidder (ASB) – The Bidder selected as the entity to perform the anticipated services under this RFP, subject to completion of contract negotiations and execution of a written contract. Bidder – Individual or company interested in the RFP that submits a proposal in order to attain a contract with the Health Care Authority. Bona Fide Service Fee (BFSF) – A fee paid by a manufacturer to a third-party purchaser of covered outpatient drugs that represents fair market value for a bona fide, itemized service and that otherwise meets the definition of “bona fide service fee” codified at 42 C.F.R. Section 447.502. Examples include fees associated with administrative service agreements and patient care programs, such as medication compliance and patient education programs. 42 C.F.R. Section 447.502 describes the bona fides service fee as “a fee paid by a manufacturer to an entity that represents fair market value for a bona fide, itemized service actually performed on behalf of the manufacturer that the manufacturer would otherwise perform (or contract for) in the absence of the service arrangement, and that is not passed on in whole or in part to a client or customer of an entity, whether or not the entity takes title to the drug. The fee includes, but is not limited to, distribution service fees, inventory management fees, product stocking allowances, and fees associated with administrative service agreements and patient care programs (such as medication compliance programs and patient education programs).” Bona Fide Service Plan – A plan agreed upon by the parties for a manufacturer to pay Bona Fide Service Fees, or provide bona fide services, to third-party purchasers. The value of the Bona Fide Service Fees paid under the Bona Fide Service Plan will be part of the drug manufacturer proposal and will be documented in the final contract between the parties. Business Days – Monday through Friday, 8:00 a.m. to 5:00 p.m., Pacific Time, except for holidays observed by the State of Washington, unless otherwise specified in this RFP. Calendar Days – All days, including weekends and holidays. If the time when something must be performed falls on a weekend, a day observed as a holiday by the State of Washington as an employer, or a day when HCA is officially closed for other reasons, then that action is due on the next Business Day. Direct-Acting Antivirals (DAAs) – A class of medication that acts to target specific steps in the HCV viral life cycle. Elimination - A state where Hepatitis C is no longer a public health threat which improves individual health and prevents ongoing transmission of the virus. Group Program – A program that reimburses pharmacies for the cost of drugs dispensed to its members. Local Health Jurisdiction – Washington has 31 county health departments, three multi-county health districts and two city-county health departments referred to as Local Health Jurisdictions. They HCA RFP No. 3233 Page 9 of 32 are local government agencies that carry out a wide variety of programs to promote health, help prevent disease and build healthy communities. Mandatory (M) – A response to these items must be included in the Proposal in order for the Proposal to be deemed responsive to this RFP. Proposals that fail to include a response to Mandatory Scored items will be found non-responsive and will be disqualified. Mandatory Scored (MS) – A response to these items must be included in the Proposal in order for the Proposal to be deemed responsive to this RFP, and such response will be evaluated and scored by the RFP evaluation team. Proposals that fail to include a response to Mandatory Scored items will be found non-responsive and will be disqualified. Proposal – A formal offer submitted in response to this RFP. Request for Proposals (RFP) – Formal procurement document in which a service or need is identified but no specific method to achieve it has been chosen. The purpose of an RFP is to permit the bidder community to suggest various approaches to meet the need at a given price. ADA HCA complies with the Americans with Disabilities Act (ADA). Bidders may contact the RFP Coordinator to receive this RFP in Braille or on tape. HCA RFP No. 3233 Page 10 of 32 2. GENERAL INFORMATION FOR BIDDERS RFP COORDINATOR The RFP Coordinator is the sole point of contact in HCA for this procurement. All communication between the Bidder and HCA upon release of this RFP must be with the RFP Coordinator, as follows: Name E-Mail Address Vicki Sprague contracts@hca.wa.gov Mailing Address PO Box 42702 Olympia, WA 98504-2702 Phone Number 360-725-9794 Any other communication will be considered unofficial and non-binding on HCA. Bidders are to rely only on written statements issued by the RFP Coordinator. Communication directed to parties other than the RFP Coordinator may result in disqualification of the Bidder. ESTIMATED SCHEDULE Issue Request for Proposals January 22, 2019 Bidders Conference January 28, 2019 Questions from Bidders Due January 31, 2019 Answers Posted February 8, 2019 Proposals Due March 4, 2019 Evaluate Proposals March 5 – March 15, 2019 Conduct Oral Interviews with Finalists, if required Week of April 1, 2019 Announce “Apparently Successful Bidder” April 12, 2019 Hold Debriefing Conferences (if requested) Week of April 15, 2019 Begin Contract Negotiations April 29, 2019 Begin Contract Work July 1, 2019 HCA reserves the right in its sole discretion to revise the above schedule. PRE-PROPOSAL CONFERENCE A pre-proposal conference is scheduled to be held on January 28, 2019 at 11:30 a.m., Pacific Time via a web conference. The internet address to register for the web conference is: https://attendee.gotowebinar.com/register/462349433863177475. All prospective Bidders should attend; however, attendance is not mandatory. HCA will be bound only by its written answers to questions. Questions arising at the pre-proposal conference or in subsequent communication with the RFP Coordinator will be documented and answered in written form. A copy of the questions and answers will be sent to each prospective Bidder that has made the RFP Coordinator aware of its interest, and will also be posted on the Washington Electronic Business Solution (WEBS), found at https://fortress.wa.gov/ga/webs/. HCA RFP No. 3233 Page 11 of 32 Potential Bidders not registered as a vendor on WEBS should do so in order to download this RFP and any amendments. SUBMISSION OF PROPOSALS The proposal must be received by the RFP Coordinator no later than the Proposal Due deadline in Section 2.2, Estimated Schedule. Proposals must be submitted electronically as an attachment to an email to the RFP Coordinator at the email address listed in Section 2.1. Attachments to email should be in Microsoft Word or Excel formats, or PDF. Zipped files cannot be received by HCA and should not be used for submission of Proposals. The Letter of Submittal and the Certifications and Assurances form must have a scanned signature of an individual within the organization authorized to bind the Bidder to the offer. HCA does not assume responsibility for problems with Bidder’s email. If HCA email is not working, appropriate allowances will be made. Proposals may not be transmitted using facsimile transmission. Bidders should allow sufficient time to ensure timely receipt of the proposal by the RFP Coordinator. Late proposals may not be accepted and may be disqualified from further consideration. All proposals and any accompanying documentation become the property of HCA and will not be returned. PROPRIETARY INFORMATION / PUBLIC DISCLOSURE Proposals submitted in response to this RFP will become the property of HCA. All proposals received will be considered public records under chapter 42.56 of the RCW. However, proposals will remain confidential until the Apparent Successful Bidder(s) are announced; thereafter, the proposals will be subject to disclosure under chapter 42.56 RCW. Any information in the proposal that the Bidder desires to claim as proprietary and exempt from disclosure under chapter 42.56 RCW, or other state or federal law that provides for the nondisclosure of a document, must be clearly designated. The information must be clearly identified and the particular exemption from disclosure upon which the Bidder is making the claim must be cited as part of Bidder’s Letter of Submittal (see, Section 3.1). Each page containing the information claimed to be exempt from disclosure must be clearly identified by the words “Proprietary Information” or similar printed on the lower right hand corner of the page. Marking the entire proposal exempt from disclosure or as proprietary or confidential information will not be honored. If a public records request is made for the information that the Bidder has marked as proprietary or confidential, HCA will notify the Bidder of the request and of the date that the records will be released to the requester unless the Bidder obtains a court order enjoining that disclosure. If the Bidder fails to obtain the court order enjoining disclosure, HCA will release the requested information on the date it specifies. If a Bidder obtains a court order from a court of competent jurisdiction enjoining disclosure pursuant to chapter 42.56 RCW, or other state or federal law that provides for nondisclosure, HCA will maintain the confidentiality of the Bidder’s information per the court order. A charge will be made for copying and shipping, as outlined in chapter 42.56 RCW. No fee will be charged for inspection of contract files, but 24 hours’ notice to the RFP Coordinator is required. All requests for information should be directed to the RFP Coordinator. The submission of any public records request to HCA pertaining in any way to this RFP will not affect the procurement schedule, as outlined in Section 2.2, unless HCA, in its sole discretion, determines that altering the schedule would be in HCA’s best interests. HCA RFP No. 3233 Page 12 of 32 REVISIONS TO THE RFP If HCA determines in its sole discretion that it is necessary to revise any part of this RFP, then HCA will provide amendments via email to all individuals who have made the RFP Coordinator aware of their interest. Amendments will also be published on WEBS. HCA also reserves the right to cancel or to reissue the RFP in whole or in part, prior to execution of a contract, for any reason. DIVERSE BUSINESS INCLUSION PLAN (M) Bidders are required to submit a Diverse Business Inclusion Plan with their Proposal. In accordance with legislative findings and policies set forth in chapter 39.19 RCW, the state of Washington encourages participation in all contracts by firms certified by the Office of Minority and Women’s Business Enterprises (OMWBE), set forth in RCW 43.60A.200 for firms certified by the Washington State Department of Veterans Affairs, and set forth in RCW 39.26.005 for firms that are Washington Small Businesses. Participation may be either on a direct basis or on a subcontractor basis. However, no preference on the basis of participation is included in the evaluation of Diverse Business Inclusion Plans submitted, and no minimum level of minority- and women-owned business enterprise, Washington Small Business, or Washington State certified Veteran Business participation is required as a condition for receiving an award. Any affirmative action requirements set forth in any federal governmental regulations included or referenced in the contract documents will apply. ACCEPTANCE PERIOD Proposals must provide that the offers made in such Proposal remain open for acceptance by HCA for one hundred twenty (120) Calendar Days from the Proposal due date as set forth in Section 2.2 of this RFP. COMPLAINT PROCESS Potential Bidders may only submit a complaint to HCA based on any of the following: a. The RFP unnecessarily restricts competition; b. The RFP evaluation or scoring process is unfair or unclear; or c. The RFP requirements are inadequate or insufficient to prepare a response. A complaint must be submitted to HCA prior to five (5) Business Days before the Proposal due date. The complaint must: a. Be in writing; b. Be sent to the RFP Coordinator in a timely manner; c. Clearly articulate the basis for the complaint; and d. Include a proposed remedy. The RFP Coordinator will respond to the complaint in writing. The response to the complaint and any changes to the RFP will be posted on WEBS. The Director of HCA will be notified of all complaints and will be provided a copy of HCA’s response. A Bidder cannot raise during a bid protest (see, HCA RFP No. 3233 Page 13 of 32 Section 4.7 for additional information regarding protests) any issue that the Bidder or potential Bidder raised in a complaint, or that could have been raised in a complaint. HCA’s action or inaction in response to a complaint will be final. There will be no appeal process. RESPONSIVENESS The RFP Coordinator will review all Proposals to determine compliance with administrative requirements and instructions specified in this RFP. A Bidder’s failure to comply with any part of the RFP may result in rejection of the Proposal as non-responsive. HCA reserves the right to contact a Bidder for clarification of its Proposal. HCA also reserves the right at its sole discretion to waive minor administrative irregularities. MOST FAVORABLE TERMS & BAFO HCA reserves the right to make an award without further discussion of the Proposal submitted. Therefore, the proposal should be submitted initially on the most favorable terms which the Bidder can propose. Following the evaluation of written Proposals and oral presentations (if any), HCA reserves the right to invite one or more Bidders to participate in a “Best and Final Offer” (BAFO) process in order to determine the Proposal providing the best value to HCA. The BAFO process may include the contract terms and conditions, pricing, or any other appropriate subject in Bidder’s final Proposal, as solely determined by HCA. Bidders will be responsible for their own costs and expenses related to the BAFO process. There is no guarantee that HCA will decide to use the BAFO process. The objective of the BAFO is to allow selected Bidders to refine and document changes to their Proposals for submission to HCA for final review and evaluation. However, this process may not be used to turn a non-responsive Proposal into a responsive one. Each Bidder will be provided a document identifying areas, topics, or issues HCA would like to see refined by the Bidder (each a BAFO Request). HCA reserves the right for each BAFO Request to be different for each Bidder invited to participate as each Proposal will be unique, with its own strengths and weaknesses. The BAFO Request will include additional details and instructions on the form, format, and timing for the Bidder to provide a response (BAFO Response). At the conclusion of the BAFO process, HCA will evaluate the BAFO Responses and select an ASB. This evaluation approach described is intended to identify the Proposal that offers the greatest benefit to HCA based on consideration of the total best value, which may not necessarily be the Proposal with the highest score during the written or oral evaluation, or the lowest cost. The ASB should be prepared to accept this RFP for incorporation into a contract resulting from this RFP. Such contract will incorporate some, or all, of the Bidder’s Proposal, including materials provided during any BAFO process. The Proposal will become a part of the official procurement file on this matter without obligation to HCA. PROPOSED CONTRACT HCA expects that a contract resulting from this RFP will consist of multiple parts. In addition to general terms and conditions, it is anticipated there will be multiple exhibits, attachments, or subagreements detailing rebate amounts and services for each of the populations described in this RFP. The contract will also include terms ensuring that it is “performance based” in compliance with Washington State law and executive order, including metrics or performance standards tied to agreed upon Bona Fide Services. HCA will not accept any draft contracts prepared by any Bidder. HCA RFP No. 3233 Page 14 of 32 If, after the announcement of the ASB, and after a reasonable period of time, the ASB and HCA cannot reach agreement on acceptable terms for the contract, HCA may (1) cancel the selection and award the contract to the next most qualified Bidder, or (2) not enter into any contract at all. COSTS TO PROPOSE HCA will not be liable for any costs incurred by the Bidder in preparation of a Proposal submitted in response to this RFP, in conduct of a presentation, as part of a BAFO process, or any other activities related in any way to this RFP. RECEIPT OF INSUFFICIENT NUMBER OF PROPOSALS If HCA receives only one responsive Proposal as a result of this RFP, HCA reserves the right to (1) directly negotiate and contract with the Bidder; or (2) not award any contract at all. HCA may continue to have such Bidder complete the entire RFP process. HCA is under no obligation to tell the Bidder if it is the only Bidder. NO OBLIGATION TO CONTRACT This RFP does not obligate HCA to enter into any contract for services specified herein. REJECTION OF PROPOSALS HCA reserves the right, at its sole discretion, to reject any and all proposals received without penalty and not to issue any contract as a result of this RFP. COMMITMENT OF FUNDS The Director of HCA or his/her delegate is the only individual who may legally commit HCA to the expenditures of funds for a contract resulting from this RFP. No cost chargeable to the proposed contract may be incurred before receipt of a fully executed contract. ELECTRONIC PAYMENT The State of Washington prefers to utilize electronic payment in its transactions. The ASB will be provided a form to complete with the contract to authorize such payment method. INSURANCE COVERAGE As a requirement of the resultant contract, the ASB may be required to furnish HCA with a certificate(s) of insurance executed by a duly authorized representative of each insurer, showing compliance with the insurance requirements set forth below. The ASB must, at its own expense, obtain insurance coverage which will be maintained in full force and effect during the term of the contract. The ASB must furnish evidence in the form of a Certificate of Insurance that insurance will be provided, and a copy must be forwarded to HCA within fifteen (15) Calendar Days of the contract effective date. HCA RFP No. 3233 Page 15 of 32 Liability Insurance Commercial General Liability Insurance The ASB shall maintain commercial general liability (CGL) insurance and, if necessary, commercial umbrella insurance, with a limit of not less than $1,000,000 per each occurrence. If CGL insurance contains aggregate limits, the General Aggregate limit must be at least twice the “each occurrence” limit. CGL insurance must have products-completed operations aggregate limit of at least two times the “each occurrence” limit. CGL insurance must be written on ISO occurrence from CG 00 01 (or a substitute form providing equivalent coverage). All insurance must cover liability assumed under an insured contract (including the tort liability of another assumed in a business contract), and contain separation of insureds (cross liability) condition. Additionally, the ASB is responsible for ensuring that any subcontractors provide adequate insurance coverage for the activities arising out of subcontracts. Business Auto Policy As applicable, the ASB shall maintain business auto liability and, if necessary, commercial umbrella liability insurance with a limit not less than $1,000,000 per accident. Such insurance must cover liability arising out of “Any Auto.” Business auto coverage must be written on ISO form CA 00 01, 1990 or later edition, or substitute liability form providing equivalent coverage. Employers Liability (“Stop Gap”) Insurance In addition, the ASB shall buy employers liability insurance and, if necessary, commercial umbrella liability insurance with limits not less than $1,000,000 each accident for bodily injury by accident or $1,000,000 each employee for bodily injury by disease. Additional Provisions Above insurance policy must include the following provisions: Additional Insured The State of Washington, HCA, its elected and appointed officials, and its agents and employees must be named as an additional insured on all general liability, auto liability, cyber liability, excess, umbrella and property insurance policies. All insurance provided in compliance with this contract must be primary as to any other insurance or self-insurance programs afforded to or maintained by the state. Cancellation The State of Washington, HCA, must be provided written notice before cancellation or non-renewal of any insurance referred to therein, in accord with the following specifications. Insurers subject to Chapter 48.18 RCW (Admitted and Regulation by the Insurance Commissioner): The insurer must give the state 45 Calendar Days advance notice of cancellation or non-renewal. If cancellation is due to non-payment of premium, the state must be given ten days advance notice of cancellation. Insurers subject to Chapter 48.15 RCW (Surplus lines): The state must be given 20 Business Days advance notice of cancellation. If cancellation is due to non-payment of HCA RFP No. 3233 Page 16 of 32 premium, the state must be given ten (10) Business Says advance notice of cancellation. Identification The policy must reference the state’s contract number and HCA. Insurance Carrier Rating All insurance and bonds should be issued by companies admitted to do business within the state of Washington and have a rating of A-, Class VII or better in the most recently published edition of Best’s Reports. Any exception must be reviewed and approved by the Health Care Authority Risk Manager, or the Risk Manager for the state of Washington, before the contract is accepted or work may begin. If an insurer is not admitted, all insurance policies and procedures for issuing the insurance policies must comply with Chapters 48.15 RCW and 284-15 WAC. Excess Coverage By requiring insurance herein, the state does not represent that coverage and limits will be adequate to protect the ASB, and such coverage and limits will not limit the ASB’s liability under the indemnities and reimbursements granted to the state in the contract resulting from this RFP. Workers’ Compensation Coverage The ASB will at all times comply with all applicable workers’ compensation, occupational disease, and occupational health and safety statutes and regulations to the full extent applicable. The state will not be held responsible in any way for claims filed by the ASB or its employees for services performed under the terms of the contract resulting from this RFP. HCA RFP No. 3233 Page 17 of 32 3. PROPOSAL CONTENTS Proposals must be written in English and submitted electronically to the RFP Coordinator in the order noted below: A. Letter of Submittal, including signed Certifications and Assurances (Exhibit A to this RFP) B. Bona Fide Services C. Distribution Channels D. Cost Proposal E. Diverse Business Inclusion Plan (Exhibit B to this RFP; see, Section 2.7) Proposals must provide information in the same order as presented in this RFP with the same headings. Items marked “(M)” must be included as part of the Proposal for the Proposal to be considered responsive; however, these items are not scored. Items marked “(MS)” must be included as part of the Proposal for the Proposal to be considered responsive and are awarded points as part of the evaluation conducted by the evaluation team. This Section 3 contains information on what must be included in Proposals. Information about the evaluation of the Proposals and how the ASB will be selected is covered in Section 4. LETTER OF SUBMITTAL (M) The Letter of Submittal and the attached Certifications and Assurances form (Exhibit A to this RFP) must be signed and dated by a person authorized to legally bind the Bidder to a contractual relationship. Along with introductory remarks, the Letter of Submittal is to include the following information about the Bidder and any proposed subcontractors: Name, address, principal place of business, telephone number, and email address of legal entity or individual with whom any contract would be written. Name, address, and telephone number of each of Bidder’s principal officers (President, Vice President, Treasurer, Chairperson of the Board of Directors, etc.). Legal status of the Bidder (sole proprietorship, partnership, corporation, etc.) and the year the entity was organized to do business as the entity now substantially exists. Federal Employer Tax Identification number or Social Security number and the Washington Uniform Business Identification (UBI) number issued by the state of Washington Department of Revenue. If the Bidder does not have a UBI number, the Bidder must state that it will become licensed in Washington within thirty (30) Calendar Days of being selected as the Apparent Successful Bidder. The current U.S. Food & Drug Administration approved package insert of each DAA that Bidder is including within its Proposal. Identify any state employees or former state employees employed or on the Bidder’s governing board as of the date of the Proposal. Include their position and responsibilities within the Bidder’s organization. If, following a review of this information, it is determined by HCA that a conflict of interest exists, the Bidder may be disqualified from further consideration for the award of a contract. HCA RFP No. 3233 Page 18 of 32 In addition to indicating what the Bidders construes as the confidential or proprietary nature of information included in a Proposal, the Letter of Submittal must separately identify any information in the Proposal that the Bidder desires to claim as proprietary and exempt from disclosure under the provisions of Chapter 42.56 RCW. The page must be and the particular exemption from disclosure upon which the Bidder is making the claim must be listed. BONA FIDE SERVICES (MS) A successful elimination strategy requires those with HCV be identified, screened, and treated. DOH will lead development and implementation of these public health efforts. Currently, DOH supports and coordinates a limited number of targeted HCV screening, linkage to care, and supportive service programs, as well as strategies that strengthen health care workforce capacity. These efforts primarily focus on people who inject drugs (PWID) and other communities disproportionately impacted by HCV incidence in order to stem the tide of new infections. It is HCA’s intention to partner with one or more ASBs that will fund public health efforts related to identification and screening of those with HCV. DOH has identified several additional public health strategies, and is leading a multisector coordinating committee to advance this work. The intention is to expand upon or complement the already successful outreach strategies in place, and to leverage the unique expertise, perspective, and capabilities of a DAA manufacturer to augment those with additional services and resources in order to achieve elimination. These bona fide services will supplement the work being performed by the state. Further, DOH and HCA expect that these bona fide services may change over time. While the services proposed by Bidders will serve as the basis for HCA’s evaluation of Proposals, and the contract resulting from this RFP will incorporate those services, some services may prove more effective than others, new strategies may be identified, or the state’s needs may change over time. DOH will make recommendations regarding what is needed to implement a comprehensive public health response. DOH will develop, oversee and support implementation of Hep C Free WA as described above. DOH, in collaboration with the Hepatitis C Elimination Coordinating Committee, will be responsible to: • • • • • • Finalize the public health program designs and implementation plans Provide data collection, assessment and dissemination Engage in evidence gathering and analysis to prioritize regions, communities, and populations for services and to assess success Determine the best practices and standards for community based organizations delivering highly targeted education and screening services Disseminate best practices for replication throughout the State of Washington Develop and oversee related contracts, including quality assurance Washington views the ASB(s) as a critical partner(s) in the effort to reach HCV patients and get them into treatment. The ASB(s) will present to and be actively engaged with the WA Hepatitis C Elimination Coordination Committee as Hep C Free WA is implemented. It is expected that the supports provided by the ASB(s) will be documented as part of a Bona Fide Service Plan and included in any contracts resulting from this RFP. Bona Fide Services Description HCA is seeking Bidders to propose a Bona Fide Service Plan that will identify and screen potential patients, support the education of the provider community and help track and monitor incidence and cures. Identified in subsections 3.2.1 through 3.2.6 below are several strategies currently being considered by DOH as part of Hep C Free WA and the ideal approach to fulfill that strategy. While the HCA RFP No. 3233 Page 19 of 32 strategies listed below are ones suggested by DOH, Bidders may propose alternative or additional public health elimination strategies. Bidder may also choose to support the strategy below and propose a different approach to address it. In a maximum of 30 pages, please provide a Bona Fide Service Plan that (i) describes strategies, (ii) an approach to fulfill that strategy, and (iii) the expected outcome, for bona fide services the Bidder is proposing in support of Hep C Free WA, including, as applicable, the number and type of staff, the number and types of supplies, details on communication and outreach methods and collaterals, the project management or implementation support, and operationalization support. Also include a single, aggregate estimated fair market value for all such services. Please note that pages in excess of the 30-page limit set forth above will not be reviewed or scored, including any supplemental materials referenced or linked to in the Proposal. Accordingly, all information Bidders want to be considered should be included entirely within the 30-page response. HCA anticipates that the resource requests will be brought in through a phased approach, which will be developed collaboratively with DOH and in alignment with Hep C Free WA. Bidders should recommend the ideal phasing of the services described in their proposed Bona Fide Service Plan. Bona fide services that HCA believes best align with the goals and expected outcomes of Hep C Free WA are as follows. Strategy 1: Health Care Workforce Preparation DOH and HCA seek to improve academic detailing and health care workforce preparation to educate and build provider capacity to deliver HCV screening, and linkage to care activities within health care settings. Ideally this would include support from at least one (1) full-time clinically trained practice detailer to provide face-to-face HCV-related provider education and support to increase the number of primary care providers managing HCV in their practices. The expected outcome of this strategy is face to face HCV-related provider education and support to significantly increase the number of primary care providers managing HCV in their practices. Strategy 2: Health Promotion & Education DOH and HCA seek to launch a social marketing campaign. This work would engage a social marketing firm to promote a comprehensive plan aimed at priority populations to deliver education through various media formats, with a focus on educating those at risk about the importance of screening to identify infection, and educating those with infection about the importance of obtaining treatment. Ideally this would include use of a social marketing firm to develop and place 4-5 HCV culturally appropriate campaigns promoting HCV prevention, testing, and curative treatment for PWID, and testing and curative treatment for Baby Boomers (particularly Boomers from disproportionately impacted communities, such as Native Americans and African Americans). The expected outcome is the self-identification and referral of patients through media campaigns promoting HCV prevention, testing, and curative treatment. Strategy 3: Syringe Service Programs DOH and HCA seek to modernize Syringe Service Programs (SSPs) to deliver enhanced HCV screening, linkage to care and supportive services. DOH intends to expand the total amount of SSPs with the goal of ensuring each county has a minimum of one (1) SSP site and modern clinical linkages to care activities. HCA RFP No. 3233 Page 20 of 32 Ideally, this would include support for six (6) full-time HCV Medical Case Managers (“MCMs”) providing care management, including, but not limited to HCV Ab screening, performing phlebotomy for confirmatory testing, conducting risk/need assessments, signing up clients for insurance, healthcare system navigation, linkage to care, and adherence counseling. MCMs would be stationed in DOH supported SSP sites throughout WA State. MCMs to be provided by Bidder(s) would be assigned by DOH to an SSP that meets the following criteria: a. b. c. d. Currently operating a DOH approved onsite HCV rapid screening program, Delivering services within a moderate/high burden jurisdiction, Past history of identifying cases (>15% zero-positivity rate), and The ability to scale screening services to meet population needs. Expected outcomes, based on ideal staffing and supplies is, on an annual basis, the ASB will (i) engage in 10,000 case management encounters (i.e., any documented contact with an individual client throughout their time being managed by a case manager) for people living with HCV, and (ii) provide approximately 1,500 RNA laboratory tests per year for clients that screen Ab+ through SSP settings. The number of encounters is based on Hepatitis Education Project’s HCV case management program. DOH supports the HEP’s case management program and they are able to reach ~5,000 encounters per calendar year. It’s common that clients need multiple encounters with their case manager throughout the course of receiving services. Strategy 4: Local Health Jurisdiction Enhancement DOH and HCA seek to enhance the ability of Local Health Jurisdictions (LHJs) to deliver highly targeted screening and linkage to care activities. Expansion will target LHJs located in medium and high prevalence jurisdictions. LHJs selected for MCM support represent the ten (10) most highly impacted counties within the state (selected jurisdictions represent 90% of HCV case reports from 2013 – 2017). LHJ screening sessions should include, but not limited to, risk assessment, pre-test counseling, risk reduction counseling, post-test counseling, and referral to medical care and supportive services. Ideally, this would include: a. Support for fifteen (15) full-time HCV MCMs who would be stationed in ten (10) LHJs throughout the state. MCMs will provide care management, including, but not limited to:       HCV Ab screening, performing phlebotomy for confirmatory testing, Conducting risk/need assessment, Signing up clients for insurance, Healthcare system navigation, Linkage to care, and Adherence counseling. In addition, MCMs shall provide services to hard-to-reach populations, including, but not limited to, HCV screening services, education, medication adherence services, linkage to clinical care and supportive services, and provide/exchange harm reduction supplies. b. Support for five (5) pharmacists (PharmD). Pharmacists will provide regional coverage for the selected (10) jurisdictions for the State and will cover the following counties: • • • • Region 1: Mason, Thurston, Cowlitz and Clark (1 pharmacist) Region 2: Whatcom and Snohomish (1 pharmacist) Region 3: King County and Pierce County (2 pharmacists) Region 4: Yakima, Walla Walla, and Spokane (1 pharmacist) HCA RFP No. 3233 Page 21 of 32 Pharmacists will provide direct care, including but not limited to: HCV Ab screening, perform phlebotomy for confirmatory testing, prescribe DAA treatment under collaborative practice agreements approved by the Pharmacy Quality Commission, and adherence counseling. Expected outcomes based on ideal staffing and supplies is, on an annual basis, (i) engage in 35,000 case management encounters for people living with HCV, and (ii) provide approximately 5,000 RNA laboratory tests per year for clients that screen Ab+ through SSP settings. Strategy 5: Project ECHO DOH and HCA seek to build workforce capacity via Project ECHO to support a health care workforce prepared to diagnose, care for, treat and cure persons infected with hepatitis C. (For more information, please see: https://www.uwmedicine.org/referrals/telehealth-services/provider) Ideally, this would include support of Project ECHO’s capacity for primary care provider enrollment. HCA recommends contracting with the University of Washington. Capacity should be two weekly 90minute sessions. The expected outcome is participation by 150 providers and 40 participating sites. Strategy 6: Health Information Exchange Reporting and Analytics HCA and DOC intend to build, or utilize an existing Health Information Exchange (HIE) to meet the tracking and reporting needs of Hep C Free WA. Additionally, pricing and rebate information may be tracked in the HIE for Hep C Free WA. As that system is developed, and potentially on an ongoing basis, HCA and DOH seek regular, timely reporting on the DDA treatments provided; and on non-PHI statistics on patients by patient treatment categories listed in Exhibit C, patient outcomes, and patient referral source. Also being requested is HCV Washington State population surveillance, consultation, and support as Hep C Free WA develops its data strategy.   Ideally, the bona fide services would include reporting and subject matter expertise and consultation on establishing and maintaining an HIE platform that allows all entities to input data specific to their requirements. DISTRIBUTION TO NON-MEDICAID PROGRAMS (M) In addition to the bona fide services described in Section 3.2, Bidders need to describe how they intend to meet the distribution needs of Hep C Free WA. Accordingly, Bidders must submit confirmation of its capability to support the distribution processes described below. Bidders may also submit suggested revisions or alternatives to the distribution methods described. Attached as Exhibit E to this RFP are diagrams of both the current and anticipated future distribution models for three (3) populations that will be served by Hep C Free WA. Non-Medicaid Programs – Facilities This distribution model ensures the delivery of drugs to facilities managed by DOC and DSHS. For DOC, Moda Health contracts with PeaceHealth for access to GPO prices through Premier. PeaceHealth contracts with Cardinal, a distributor, who sells the drugs directly to DOC using Premier’s GPO rates. DOC pays Cardinal the GPO prices directly. PeaceHealth negotiated additional GPO price concessions from Cardinal in exchange for agreeing to an exclusive wholesale distribution HCA RFP No. 3233 Page 22 of 32 relationship. This concession is extended to Premier affiliates, including DOC, in the form of a lower cost. DSHS currently contracts directly with PeaceHealth. Like DOC, Cardinal sells the drugs to DSHS and DSHS pays Cardinal. In its Proposal, Bidders must include a description of the following: a. Confirmation that Bidder will use existing distribution process, or b. An alternative distribution process. Non-Medicaid Programs – Group Programs (ERB Programs and L&I) Both the ERB Programs and L&I currently contract with Moda Health to access drug manufacturer rebates negotiated through MedImpact. The entirety of the rebates are passed through Moda to the programs. For the ERB Programs, MedImpact sends 100% of the rebates to Moda, who passes 100% of the rebates on to UMP. L&I sends quarterly claims to Moda. Moda passes the claims information on to Medimpact. MedImpact invoices the manufacturer for rebates. MedImpact sends 100% of the L&I rebate to Moda, Moda subtracts the administrative fee and passes the remaining rebate amount to L&I. The selected ASB(s) will make all rebates and any other price concession that are included in a Proposal to be recovered using either (i) a state-selected administrator who will be responsible for billing, collecting, and disbursing rebates and concessions on behalf of the state, or (ii) Bidders may propose an alternative method for the group programs to get the GNUP at the point of service. Any administrative fees required by the HCA administrator or Bidder’s alternative will be paid for by the drug manufacturer. HCA estimates that such administrative fee for its administrator would be approximately $25,000 per non-Medicaid program per quarter. However, the actual administrative fees will be determined at a later date and will be incorporated into the contract resulting from this RFP. MEDICAID DISTRIBUTION MODEL (M) Medicaid: Apple Health Coverage for all DAAs within the Apple Health program is through the fee-for-service plan. Apple Health currently participates in the TOP$ program through Magellan for negotiated supplemental rebates. The contracted retail pharmacies buy the drugs from a wholesaler. The Apple Health members receive their drugs from the contracted retail pharmacies. Apple Health reimburses the contracted retail pharmacies for drugs dispensed to Apple Health members. Apple Health then invoices the manufacturers, who pay the federal and supplemental rebates directly to Apple Health. HCA expects that the selected ASB(s) will make all rebates and any other price concession that are included in a Proposal for Medicaid programs to be recovered using HCA staff and systems, who will be responsible for billing, collecting and disbursing rebates and concessions on behalf of the state. After selecting an ASB(s), HCA will contract directly with that HCV drug manufacturer for supplemental and value-based rebates. The drug distribution process will remain the same. HCA RFP No. 3233 Page 23 of 32 COST PROPOSAL (MS) The evaluation process is designed to award this procurement not necessarily to the Bidder of least cost, but rather to the Bidder whose proposal best meets the requirements of this RFP. However, Bidders are encouraged to submit proposals which are consistent with state government efforts to conserve state resources. Bidders are asked to provide a detailed cost proposal using the form provided as Exhibit C, Cost Proposal. In the Cost Proposal, populations historically treated by HCA and DOC are divided into four (4) categories for each HCV genotype. Those categories are based on (1) whether the patient was treatment naïve or treatment experienced, and (2) whether or not the patient was or was not diagnosed with cirrhosis. The Cost Proposal Form has two (2) primary parts: one tab for treatment of the Medicaid population, and one for the treatment of the non-Medicaid population. Instructions for completion of the form are included on the first tab of the worksheet. Included in each cost table is an estimated number of patients categorized in one of four (4) ways for each HCV genotype. Again, these categories are based on (1) whether the patient was treatment naïve or treatment experienced, and (2) whether or not the patient was or was not diagnosed with cirrhosis. These “Patient Counts” are based on estimates of the remaining undiagnosed HCV patients expected to be treated over the initial 4-year period. For the purposes of determining a total cost for each Bidder, HCA will calculate an aggregate cost for the 4-year period using the following formula: Patient Count x % Patient Type Treated x Average Cost/Day x Treatment Duration = Type Cost After the Type Cost for each category of patient for each genotype is determined, HCA will then sum all of the Type Costs to determine Bidder’s total costs for each of the Medicaid and non-Medicaid populations. Each of these totals are scored independently as described in Section 4.2.2, below. Also included in the Cost Proposal Form for the Medicaid population is the annual maximum amount HCA would have to pay for the treatment of that population. Under this modified “subscription model,” HCA will agree to pay the GNUP for all DAAs purchased to treat Medicaid patients up to the agreed upon Subscription Max. For any purchase of DAAs in excess of that amount, the GNUP would be reduced to $0.01. 4. EVALUATION AND CONTRACT AWARD EVALUATION PROCEDURE Responsive Proposals will be evaluated strictly in accordance with the requirements stated in this RFP and any amendments issued. The evaluation of proposals will be accomplished by an evaluation team, to be designated by HCA, which will determine the ranking of the proposals. Evaluations will only be based upon information provided in the Bidder’s Proposal. All proposals received by the stated deadline, Section 2.2, Estimated Schedule of Procurement Activities, will be reviewed by the RFP Coordinator to ensure that the Proposals contain all of the required information requested in the RFP. Only responsive Proposals that meet the requirements will be evaluated by the evaluation team. Any Bidder who does not meet the stated qualifications or any Proposal that does not contain all of the required information will be rejected as non-responsive. The RFP Coordinator may, at his or her sole discretion, contact the Bidder for clarification of any portion of the Bidder’s Proposal. Bidders should take every precaution to ensure that all answers are clear, complete, and directly address the specific requirement. HCA RFP No. 3233 Page 24 of 32 Responsive Proposals will be reviewed and scored by an evaluation team using a weighted scoring system, Section 4.2, Evaluation Weighting and Scoring. Proposals will be evaluated strictly in accordance with the requirements set forth in this RFP and any amendments issued. HCA, at its sole discretion, may elect to select the top-scoring firms as finalists for an oral presentation. EVALUATION WEIGHTING AND SCORING Evaluation of Proposals Proposals that have passed the initial screening described above will be evaluated and scored by the evaluation team, and may include evaluators from outside HCA. Evaluators are under no obligation to create written notes or explanation of their scores during Proposal evaluation. Any award will be made to the lowest responsive and responsible Bidder whose Proposal, in the sole opinion of HCA, offers the greatest benefit to HCA. The decision will be based on consideration of the total best value, including, but not limited to, the responsiveness of the Proposal to the requirements as set forth in this RFP, the competence and responsibility of the Bidder, quality of service, breadth and depth of offering, the strength and form of contractual commitments made by the Bidder to HCA, and total cost. HCA reserves the right to make the award to the Bidder(s) whose Proposal is deemed to be in the best interest of HCA and the State of Washington. Hence, HCA may choose to not award to the highest scoring or lowest-cost Proposal. Written Proposals Evaluation teams will be formed to evaluate the written Proposals. Evaluation team members will individually review each Proposal before meeting with the rest of their evaluation team to discuss the Proposals. HCA may bring in subject matter experts with specific, relevant backgrounds to assist in evaluating portions of the written Proposals, in determining how well each Proposal responds to the RFP requirements, and how the Proposal and Bidder meet the needs of HCA. Evaluation team members will take into account their own expertise and any input from experts to individually evaluate and score the Proposals. It is important that each Proposal be concise, clear, and complete. HCA may elect to award a contract at the end of the evaluation process for the written Proposals. However, the HCA reserves the right to advance Bidders to the oral presentation phase. The scores assigned by individual team members will be used in calculating the total number of points awarded to each Bidder. For bona fide services, the points awarded to a Bidder will be calculated by averaging the scores assigned by individual evaluation team members, and multiplying that average by the weight listed below. Scores used by individual team members (0 – 10) and a brief statement about the general characteristics of a Proposal earning each of those individual scores is provided in the table below. Score Description 9 – 10 Far Exceeds Requirements 6–8 Exceeds Requirements 5 Meets Requirements HCA RFP No. 3233 Discussion Bidder has provided an innovative, detailed, efficient approach or established, by presentation of material, far superior capability in this area. Bidder has demonstrated an aboveaverage capability, approach, or solution and has provided a complete description of the capability, approach, or solution. Bidder has an acceptable capability of solution to meet this criterion and has described its approach in sufficient detail to Page 25 of 32 be considered “as substantially meeting the requirements”. 3–4 Below Requirements 1–2 Substantially Below Requirements 0 No value Bidder has established some capability to perform the requirement but descriptions regarding their approach are not sufficient to demonstrate the Proposer will be fully able to meet the requirements. Bidder has not established the capability to perform the requirement, has marginally described its approach, or has simply restated the requirement. Bidder has omitted any discussion of this requirement or the information provided is of no value. As indicated in the table below, Bidder’s Proposal with regard to bona fide services and each of the strategies listed in Section 3.2 will be evaluated and scored as a whole. Points will be awarded based on the Bidder’s demonstrated understanding of patient outreach, the quality and comprehensiveness of services to identify and engage those with HCV, the quality and comprehensiveness of any provider training proposed by Bidder, the quality and comprehensiveness of proposed use of media proposed by the vendor, and the alignment of Bidder’s proposed services to those outlined in Section 3.2 as part of Hep C Free WA. BONA FIDE SERVICES Section Weight Modernizing Syringe Service Programs (SSPs) Enhance Local Health Jurisdictions Academic Detailing and Health Care Workforce Preparation 140 Project ECHO Health Promotion and Education Health Information Exchange Platform Other Bona Fide Services Maximum Points 1,400 The Cost Proposal will be scored by summing all of the total costs calculated as described in Section 3.5. The lowest total cost will receive all of the points listed in the table below for each year and cost category. Point totals for the remaining Bidders will be calculated by dividing the lowest total cost by the Bidder’s total cost, and then multiplying the result by the number of points listed for each year and cost category. Year 1 (2019 – 2020) 2 (2020 – 2021) 3 (2021 – 2022) 4 (2022 – 2023) DAA – NonMedicaid 350 350 350 350 DAA – Medicaid 70 70 70 70 Subscription Max 700 700 700 700 For example, if there are two bidders and they have proposed the total costs for each population and the Subscription Max listed in the following table: HCA RFP No. 3233 Page 26 of 32 Year DAA – NonMedicaid $50 $48 $46 $45 1 2 3 4 Bidder 1 DAA – Medicaid $45 $42 $40 $38 Subscription Max $10,000 $10,000 $10,000 $10,000 DAA – NonMedicaid $55 $52 $46 $42 Bidder 2 DAA – Medicaid $50 $45 $40 $36 Subscription Max $12,000 $11,000 $10,000 $9,000 Bidder 2 DAA – Medicaid Subscription Max The following scores would be assigned: Year 1 2 3 4 TOTAL COST TOTAL DAA – NonMedicaid 350 350 350 326.7 1,376.7 Bidder 1 DAA – Medicaid 70 70 70 66.3 276.3 4,383 Subscription Max 700 700 700 630 2,730 DAA – NonMedicaid 318.2 323.1 350 350 1,341.3 63 65.3 70 70 268.3 4,229.3 583.3 636.4 700 700 2,619.7 The following table shows the total points available for both the non-cost and cost elements of Proposals: RFP Element Bona Fide Services DAA – Non-Medicaid (Years 1 – 4) DAA – Medicaid (Years 1 – 4) Subscription Max (Years 1 – 4) TOTAL Oral Presentation (if any) TOTAL Total Available Points 1,400 1,400 280 2,800 5,880 1,000 6,880 HCA reserves the right to award the contract to the Bidder whose proposal is deemed to be in the best interest of HCA and the State of Washington. ORAL PRESENTATIONS MAY BE REQUIRED HCA may, after evaluating the written proposals, elect to schedule oral presentations for one (1) or more Bidders. Should oral presentations be scheduled, HCA will contact the top-scoring firm(s) from the written evaluation to schedule a date, time, and location. Commitments made by the Bidder at the oral interview, if any, will be considered binding. The scores from the written evaluation and the oral presentation combined together will determine the Bidders with the highest scores. SUBSTANTIALLY EQUIVALENT SCORES Substantially equivalent scores are scores separated by two percent or less in total points. If multiple Proposals receive a Substantially Equivalent Score, HCA may leave the matter as scored, or select HCA RFP No. 3233 Page 27 of 32 as the ASB the one Proposal that is deemed by HCA, in its sole discretion, to be in HCA’s best interest relative to the overall purpose and objective as stated in Sections 1.1 and 1.2 of this RFP. If applicable, HCA’s best interest will be determined by HCA managers and executive officers, who have sole discretion over this determination. The basis for such determination will be communicated in writing to all Bidders with equivalent scores. NOTIFICATION TO BIDDERS HCA will notify the ASB(s) of their selection in writing upon completion of the evaluation process. Bidders whose proposals were not selected for further negotiation or award will be notified separately by email. DEBRIEFING OF UNSUCCESSFUL BIDDERS Any Bidder who has submitted a Proposal and been notified it was not selected as an ASB may request a debriefing. The request for a debriefing conference must be received in writing (email is acceptable) by the RFP Coordinator no later than 5:00 p.m., Pacific Time, within three (3) Business Days after the Unsuccessful Bidder Notification is emailed to the Bidder. The debriefing will be held within three (3) Business Days of the request, or as schedules allow. Discussion at the debriefing conference will be limited to the following:  Evaluation and scoring of the Bidder’s Proposal;  Critique of the Proposal based on the evaluation; and  Review of the Bidder’s final score in comparison with other final scores without identifying the other Bidders. Topics a Bidder could have raised as part of the complaint process (Section 2.9) cannot be discussed as part of the debriefing conference, even if the Bidder did not submit a complaint. Comparisons between proposals, or evaluations of the other proposals, will not be allowed. Debriefing conferences may be conducted in person or on the telephone and will be scheduled for a maximum of thirty (30) minutes. PROTEST PROCEDURE A bid protest may be made only by Bidders who submitted a response to this RFP and who have participated in a debriefing conference. Upon completing the debriefing conference, the Bidder is allowed five (5) Business Days to file a protest with the RFP Coordinator. Protests must be received by the RFP Coordinator no later than 4:30 p.m., Pacific Time, in Olympia, Washington on the fifth Business Day following the debriefing. Protests may be submitted by email or by mail. The Bidder is solely responsible for ensuring the RFP Coordinator receives the protest, and the Bidder must maintain proof of delivery of the protest. Bidders protesting this RFP must follow the procedures described below. Protests that do not follow these procedures will not be considered. This protest procedure constitutes the sole administrative remedy available to Bidders under this RFP. All protests must be in writing, addressed to the RFP Coordinator, and signed by the protesting party or an authorized agent. The protest must state (1) the RFP number, (2) the grounds for the protest HCA RFP No. 3233 Page 28 of 32 with specific facts, (3) complete statements of the action(s) being protested, and (4) the relief or corrective action being requested. Only protests alleging an issue of fact concerning the following subjects will be considered: a. A matter of bias, discrimination, or conflict of interest on the part of an evaluator; b. Errors in computing the score; or c. Non-compliance with procedures described in the RFP or HCA requirements. Protests based on anything other than those items listed above will not be considered. Protests will be rejected as without merit to the extent they address issues such as: 1) an evaluator’s professional judgment on the quality of a Proposal; or 2) HCA’s assessment of its own needs or requirements. Upon receipt of a protest, HCA will undertake a protest review. The HCA Director, or an HCA employee delegated by the HCA Director who was not involved in the RFP, will consider the record and all available facts. If the HCA Director delegates the protest review to an HCA employee, the Director nonetheless reserves the right to make the final agency decision on the protest. The HCA Director or his or her designee will have the right to seek additional information from sources he or she deems appropriate in order to fully consider the protest. If HCA determines in its sole discretion that a protest from one Bidder may affect the interests of another Bidder, then HCA may invite such Bidder to submit its views and any relevant information on the protest to the RFP Coordinator. In such a situation, the protest materials submitted by each Bidder will be made available to all other Bidders upon request. The final determination of the protest will: a. Find the protest lacking in merit and uphold HCA’s action; or b. Find only technical or harmless errors in HCA’s acquisition process and determine HCA to be in substantial compliance and reject the protest; or c. Find merit in the protest and provide options to the HCA Director, which may include: (i) Correct the errors and re-evaluate all Proposals; or (ii) Issue a new solicitation document and begin a new process; or (iii) Make other findings and determine other courses of action as appropriate. If the protest is not successful, HCA will enter into a contract with the ASB(s), assuming the parties reach agreement on the contract’s terms. HCA RFP No. 3233 Page 29 of 32 5. RFP EXHIBITS Exhibit A Certifications and Assurances Exhibit B Diverse Business Inclusion Plan Exhibit C Cost Proposal Exhibit D Governor’s Directive 18-13 Exhibit E Distribution Models HCA RFP No. 3233 Page 30 of 32 EXHIBIT A CERTIFICATIONS AND ASSURANCES I/we make the following certifications and assurances as a required element of the proposal to which it is attached, understanding that the truthfulness of the facts affirmed here and the continuing compliance with these requirements are conditions precedent to the award or continuation of the related contract: 1. I/we declare that all answers and statements made in the proposal are true and correct. 2. The prices and/or cost data have been determined independently, without consultation, communication, or agreement with others for the purpose of restricting competition. However, I/we may freely join with other persons or organizations for the purpose of presenting a single proposal. 3. The attached proposal is a firm offer for a period of 120 days from the due date for receipt of proposals, and it may be accepted by HCA without further negotiation (except where obviously required by lack of certainty in key terms) at any time within such period. 4. In preparing this proposal, I/we have not been assisted by any current or former employee of the State of Washington whose duties relate (or did relate) to this proposal or prospective contract, and who was assisting in other than his or her official, public capacity. If there are exceptions to these assurances, I/we have described them in full detail on a separate page attached to this document. 5. I/we understand that HCA will not reimburse me/us for any costs incurred in the preparation of this proposal. All proposals become the property of HCA, and I/we claim no proprietary right to the ideas, writings, items, or samples, unless so stated in this proposal. 6. Unless otherwise required by law, the prices and/or cost data which have been submitted have not been knowingly disclosed by the Bidder and will not knowingly be disclosed by him/her prior to opening, directly or indirectly, to any other Bidder or to any competitor. 7. I/we agree that submission of the attached proposal constitutes acceptance of the solicitation contents. If there are any exceptions to these terms, I/we have described those exceptions in detail on a page attached to this document. 8. No attempt has been made or will be made by the Bidder to induce any other person or firm to submit or not to submit a proposal for the purpose of restricting competition. 9. I/we grant HCA the right to contact references and other, who may have pertinent information regarding the ability of the Bidder and the lead staff person to perform the services contemplated by this RFP. 10. If any staff member(s) who will perform work on this contract has retired from the State of Washington under the provisions of the 2008 Early Retirement Factors legislation, his/her name(s) is noted on a separately attached page. On behalf of the Bidder submitting this proposal, my name below attests to the accuracy of the above statement. If electronic, also include: We are submitting a scanned signature of this form with our proposal. Signature of Bidder Printed Name Title HCA RFP No. 3233 Date Page 31 of 32 Exhibit B DIVERSE BUSINESS INCLUSION PLAN Do you anticipate using, or is your firm, a State Certified Minority Business? Y/N Do you anticipate using, or is your firm, a State Certified Women’s Business? Y/N Do you anticipate using, or is your firm, a State Certified Veteran Business? Y/N Do you anticipate using, or is your firm, a Washington State Small Business? Y/N If you answered No to all of the questions above, please explain: ____________________________________________________________________________ Please list the approximate percentage of work to be accomplished by each group: Minority __% Women __% Veteran __% Small Business __% Please identify the person in your organization to manage your Diverse Inclusion Plan responsibility. Name: __________________ Phone: __________________ E-Mail: __________________ HCA RFP No. 3233 Page 32 of 32