Description
This is a Request for Information (RFI.) This is NOT a solicitation for proposals, proposal abstracts, marketing materials or quotations, but rather an exploration into the technical issues that might underpin a future solicitation to accomplish its intended goals. The purpose of this RFI is to obtain knowledge and information for project planning purposes. 1. BACKGROUND The Clinical Center (CC) of the National Institutes of Health (NIH) is the largest hospital in the world dedicated solely to clinical research. The CC complex is comprised of a 240-bed inpatient facility, outpatient clinics, and day hospitals and provides care to patients enrolled in clinical research protocols conducted by the Institutes and Centers that compose the NIH. Its patients come from around the country and the world to participate in research studies, often as a last hope for uncovering a diagnosis or providing a treatment. The portfolio of research studies conducted at the NIH CC is comprised mostly of natural history studies and clinical trials, more than 90% of which are phase I and II studies testing new drugs and treatments. Thus, the primary mission of the hospital is clinical research and the hospital's primary ‘product' is the translation of basic science findings into clinical medicine. The NIH, like the rest of the federal government, is facing continued tight budget times and, therefore, is compelled to develop and test new strategies to contain costs. The budget of the NIH CC, situated organizationally within the Department of Health and Human Services, is provided by the NIH Institutes and Centers who use this research hospital to conduct their clinical research protocols. In its 60-year history, the CC has never billed for its services- Approximately 10% of the CC's $400 million annual budget is spent on drugs. Containing costs within this component of the budget is the subject of this RFI. Studies conducted at the CC often use investigational medications; commercially available medications as part of a research question (e.g., as part of a combination regimen, or repurposing of agents for non-approved indications); commercially available medications as supportive care for the research medications; and, commercially available medications for patient conditions not related to their participation in the research study but considered essential for adherence to the clinical research protocol. In support of these protocols, the CC Pharmacy Department provides take home/mail-out orders of approximately 100,000 prescriptions annually, including investigational drugs. Protocol-related, commercially-available drugs (such as pain medications, anti-emetics, HIV antiretrovirals) as well as investigational drugs are provided to all patients, regardless of their insurance status (which is currently not known). NIH has never billed third party payers. Because the CC has never entered into electronic financial transactions with payers or providers, we were viewed as not subject to the Health Insurance Portability and Accountability Act (HIPAA). The hospital is currently subject to the Public Health Service Privacy Act of 1973 but is working towards HIPAA compliance. The CC is considering asking its patients to request payment from their insurers for outpatient pharmaceuticals that are not the focus of the investigational protocol in which they are participating. The CC is pursuing whether we can find a partner who can provide the expertise and infrastructure necessary to accomplish these tasks. We are specifically seeking a mechanism that assures that our patients (i.e., actually our partners in these clinical research studies and ‘co-producers' of our ‘product') bear no expense, as they are volunteers in these studies. The CC estimates that the partnership organization could dispense approximately 50-75% of prescribed, commercially available drugs. Attached are two workflows to demonstrate the process of filling prescriptions at the CC outpatient pharmacy. 2. PURPOSE of this RFI The purpose of the RFI is to explore the feasibility of a partnership with an entity capable of filling take-home prescriptions, including those drugs available from only specialty pharmacies. The entity will be responsible for third party insurance identification, adjudication, and billing. A guiding principle of this program is that CC patients will not incur any expense (i.e. copays or deductibles) as a result of their participation in studies conducted at NIH. SCOPE of POTENTIAL PARTNERSHIP • The NIH CC Pharmacy is seeking a partner to provide dispensing of commercially available medications, including those dispensed through specialty pharmacies for any "take home" prescriptions written for patients with prescription insurance coverage. CC patients who do not have any insurance coverage (approximately 15%, based on prior surveys) are outside of the scope of this project; their outpatient pharmaceuticals will continue to be supplied by the CC pharmacy. • The partner would determine the most efficient delivery method for the pharmaceuticals. • The partner would need to have the ability to deliver products to patients across the U.S. and seek reimbursement from a variety of payers. • The CC Pharmacy could provide the initial "starter supply" to bridge patients until the filled prescription order is received by the patient, assuming reasonable turnaround time. • The CC Pharmacy would need the partner to make real-time determinations of coverage for each pharmaceutical prescription at the time the prescription is generated, so that the CC pharmacy can fill those that will not be covered. • Because of the strict requirement of these research protocols, drug substitutions would not be permissable. • All transactions must be cost neutral to the patient. • The partner would be responsible for fulfilling all authorized refills. • A mechanism is needed to transmit clinically-relevant information about prescription filling and refilling by the partner to the CC Pharmacy. 3. INFORMATION REQUESTED • Can the potential partner provide all commercially available pharmaceutical products, including those distributed by specialty pharmacies? o For pharmaceutical products requiring pre-authorization by the payer, what process/processes might be followed for these prescriptions? o If the partner is unable to access all specialty pharmacies, how can the number of sources/shipments be minimized? o What would be required from a regulatory perspective for the partner to dispense controlled substances? o Is it feasible for the partner to fill inexpensive prescriptions not covered by the patient's insurance or for uninsured patients? • How can the payer's requirement for co-payment be managed such that filling the prescription is cost-neutral to the patient? • What mechanisms are available for the partner to receive prescription orders and patient insurance information since the CC is currently not a covered entity under HIPAA? o What physical space onsite and equipment would be needed for each of the proposed mechanisms? • What mechanism is available for weekend prescription coverage by the partner? • What would be the expected overall turn-around time (i.e., time from prescription acceptance to patient receipt of pharmaceuticals), and what are the anticipated turnaround times for the component processes involved? o Would there be any special information needed to make this determination given that our patients will be on research studies? o What kind of information is typically needed for drugs that require "prior approval"? How can this information be provided to minimize the involvement of the prescriber and the time required to obtain approval? o To what degree would a prescriber need to be involved if there are questions around a particular prescription from a payer? • What mechanisms are available for the CC Pharmacy to receive relevant clinical information about prescription fills and refills from the partnership organization and how could these data be recorded in the Clinical Center's Clinical Research Information System? • What customer support would be provided to patients? Responses to the RFI are to be submitted electronically to the Contracting Officer. Respondents are requested to provide an index which addresses the information requested. Page limit is up to 30 pages (references, workflows or charts excluded.) The CC is requesting the respondent's technical and administrative points of contact, including name, address, phone number and email address. Disclaimer and Important Notes This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed. Information provided will be used to assess tradeoffs and alternatives available for the potential requirement and may lead to the development of a solicitation. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. Any solicitation resulting from the analysis of information obtained will be announced to the public in Federal Business Opportunities in accordance with the FAR Part 5. However, responses to this notice will not be considered adequate responses to a solicitation. Confidentiality: No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).