RESPIRONICS, INC. DEMONSTRATION, EVALUATION, AND SAMPLE POLICY

Transcription

1 Page 1 of 5 I. Purpose RESPIRONICS, INC. DEMONSTRATION, EVALUATION, AND SAMPLE POLICY The provision of Products to Healthcare Providers ( HCPs ) for Evaluation and Demonstration purposes can benefit patients in many ways, including but not limited to: Improving patient care; Improving patient adherence; Educating HCPs regarding the use of Products or technology; and Increasing the safe and effective use of Products. This document sets forth Respironics, Inc. s ( Company ) policy concerning the distribution of Products at no charge to facilitate HCPs or patients Evaluation or Demonstration of the use of the Product. II. Scope This Policy applies to: Company, including both its business group and U.S. and U.S. territories sales activities, and their officers, directors, and employees, and Company s consultants, contract workers, and temporary workers, who provide services to Company, which relate to government reimbursed Products or services; and The distribution and accountability of Evaluation and Demonstration units (including Product samples) and services. III. Definitions Centralized Arrangements Tracking Systems ( CATS ) SharePoint: The database that serves as the electronic repository for Company s Focus Arrangements, including signed agreements, and supporting documentation. Demonstration: An Company representative s or an HCP s use of serialized (Trunk Stock) and nonserialized product to train or educate customers, in topics such as Product use and features and general awareness about the disease that the Product is designed to treat and the treatment it provides. Evaluation or Evaluate: A customer s or clinician s, use of a Product to (a) assess the appropriate use and functionality of the Product, (b) determine whether to use, order, purchase, lease, or recommend the Product, or (c) train patients on the use of the Product or allow patients to use the Product for their own evaluation purposes. Evaluation equipment converts to sale if not within returned within evaluation period.

2 Page 2 of 5 Healthcare Professional or Provider ( HCP ) or Potential Referral Source: The term U.S. Healthcare Professional is defined very broadly to cover any person or entity that is involved in the provision of healthcare services or items to patients, and that purchases, leases or recommends, uses or arranges for the purchase or lease, of Company medical Products, services, or solutions in the U.S. Practically, this includes, among others: Clinicians, such as physicians, nurses, PhDs, technologists, pharmacists, and medical staff, such as respiratory technologists or physician assistants, as well as clinicians in training. Hospitals, medical schools affiliated with hospitals, medical group practices, medical clinics, nursing homes, sleep diagnostic clinics, surgical centers, emergency medical services and home healthcare organizations, as well as nonmedical personnel in these facilities who make purchasing decisions. Medical device distributors and dealers, including durable medical equipment ( DME ) suppliers, who sell to HCPs or bill Medicare and Medicaid for their items and services. Healthcare-related trade associations which serve HCPs or have a significant number of HCPs on its board, such as the American Sleep Association. Employees, administrators, officers, and directors of HCPs are also considered HCPs, where involved in the decision to purchase or lease Company services or Products. Product: Devices, medical supplies, equipment, software, and services provided by Company. Respironics Code of Conduct ( COC ): Consists of three distinct policies: SimplyRight, Philips General Business Principles, and Code of Conduct on Interactions with Healthcare Professionals (collectively, Code of Conduct ). Respironics Compliance Officer ( CO ): Primarily responsible for overseeing and managing the Company s Corporate Healthcare Compliance Program and related Corporate Integrity Agreement, and monitoring that the Company and its employees for compliance are complying with applicable regulatory, legal, and compliance requirements including internal policies and procedures, as well as external regulations and codes of conduct. Sample: Non-serialized product provided to a customer or patient for single use or single-patient use for Evaluation and Demonstration purposes, such as masks. Shell unit: base built products in which the interior core is removed or qualifies as non-functional, which are provided to customers for the purpose of educating patients on the use and function of the product. IV. Policy Trunk Stock: serialized equipment that resides with a rep that is not sold to or left with a customer. Company personnel may provide Products at no charge for the period of time and volume permitted Policy solely for Evaluation or Demonstration purposes pursuant to internal policies and procedures including the Sample Policy.

3 Page 3 of 5 Company personnel may not: (a) provide Products or services to HCPs for free to improperly induce the purchase of any Philips Products; (b) commit to provide Evaluation or Demonstration Products in connection with a purchase commitment, except as permitted under this Policy; (c) provide a Sample, Evaluation and Demonstration Product to an HCP for his/her personal use or for use by his/her immediate family or office staff; and Items identified for Demonstration use shall not be converted for Evaluation purposes. Company must include language reminding customer of their obligation, where appropriate, to NOT bill or seek reimbursement if patient care is predicated on the use of Evaluation Products, including Samples. A. Volume Limits Evaluation Products and Samples The number of Evaluation Products and Samples that Company may provide at no charge may not exceed the amount reasonably necessary for the adequate Evaluation of the Products under the circumstances. Separate quantity limits may apply for Products intended for HCP Evaluation and for patient Evaluation. Company will establish quantity limits, which must be approved Chief Medical Liaison, the Compliance Officer ( CO ), and Company s Legal Department. B. Duration of Use Evaluation of Products, Services and Software Non-consumable Products or software and associated services may be provided to HCPs without transfer of title for Evaluation purposes, but only for a period of time that is reasonable under the circumstances to allow an adequate Evaluation, which the Company has established to be 60 (sixty) days for Products, and 90 (ninety) days for software and services. In no circumstances should the Evaluation period exceed 90 (ninety) days without prior written approval from Company Legal Department and CO. Company must establish and maintain a process for promptly removing such Products or software or services from an HCP s location at the conclusion of the Evaluation period, unless the HCP purchases or leases the Product upon the expiration of the Evaluation Period. C. Frequency and Circumstances Evaluation Product Company has determined that the distribution of free Product for Evaluation or Demonstration purposes is permitted in the following circumstances: New Product introduction Product upgrades

4 Page 4 of 5 Clinician turnover Clinician competency gaps reestablish clinician competency after a given time since the last Product training HCP lacks familiarity with a Product and wishes to evaluate it before making a purchasing decision. Prior to providing any Product for Evaluation or Demonstration, Company must provide the customer general Product awareness training and any standard Product training applicable to the Product and an agreement that addresses the terms of the Evaluation. D. Marking of Demonstration Products and Samples Demonstration Products are typically single patient use Products or mockups of such Products that are used for HCP and patient awareness, education, and training. For example, a HCP may use a Demonstration Product to show a patient the type of device that will be used by the patient. Demonstration Products not intended for patient use must be identified by such designations as "Demo Only" "Not for Human Use," or other suitable designation on the Product, the Product packaging, or Product documentation. If a Product is given as a Sample for Evaluation Purposes, the Product must be marked as Sample Not for Resale and tracked in CATS.. E. Required Documentation IV. Appendices Company must provide documentation reflecting the provision and receipt of the no-charge Products for Evaluation or Demonstration purposes. For Evaluation products, such terms shall include, at a minimum: (i) language requiring the return of, and authorizing Company access to secure the return of, multiple-use products upon the conclusion of the Evaluation period, unless the customer otherwise elects to purchase or lease the Product; and (ii) when appropriate, language reminding customer of their obligation to NOT bill or seek reimbursement if patient care is predicated on the use of products. For Demonstration products, when appropriate, language reminding customers of their obligation to NOT bill or seek reimbursement if patient case is predicated on the use of products. Not Applicable V. References Anti-Kickback Statute, 42 U.S.C. 1320a-7b(b) Referenced Documents:

5 Page 5 of 5 Document Number Not Applicable Document Description