GOLD COAST SURGICAL ANTI-CORRUPTION POLICIES
Brief Summary of Anti-Corruption Policy of GCSI
GCSI may occasionally provide modest, appropriate educational items to Health Care Professionals that benefit patients or serve a genuine educational function for Health care professionals. To the extent that they are or may be logically considered to be inducements to do business with GSCI or rewards for doing business with GSCI, GCSI may not provide monetary or non-monetary gifts to Health Care Professionals. This means that a GCSI may not provide Health Care Professionals with items that the Health Care Professional (or his or her family members, office staff, or friends) can use for non-educational or non-patient-related purposes (for example, office supplies, scrubs, a tablet, Smart Phone, laptop, or other mobile device that is not a medical device that is sold, recommended, inventoried or serviced by GCSI.)
General Principles
GCSI may support patients in obtaining access to a Medical Technology by providing Health Care Professionals with timely and complete coverage, reimbursement, and health economics information. GCSI may not, however, interfere with a Health Care Professional's independent clinical decision making or provide treatment, reimbursement and health economics
As Medical Technologies have become increasingly complex, so have payor coverage and reimbursement policies. Patient access to necessary Medical Technology and equipment depends on Health Care Professionals and/or patients having timely and complete coverage, reimbursement, and health economic information. To promote patient access to Medical Technologies:
GCSI may provide this information regarding its Medical Technologies if it is accurate and objective.
GCSI may collaborate with Health Care Professionals, patients, and organizations representing their interests in order to achieve government and commercial payor coverage decisions, guidelines, policies, and adequate reimbursement levels that allow patients to access its Medical Technologies.
Permissible activities of GCSI pertaining to the provision of coverage, reimbursement, and health economic information may include, but are not limited to:
Identifying the clinical value of the Company's Medical Technologies and the services and procedures in which they are used
Working with Health Care Professionals, their professional organizations, patients and patient groups to conduct joint advocacy on coverage, reimbursement, and health economics issues
Providing supporting Health Care Professionals and their professional organizations in developing materials and otherwise providing direct or indirect input into payor coverage and reimbursement policies
Promoting accurate Medicare and other payor claims by providing accurate and objective information and materials to Health Care Professionals regarding the GCSI Medical Technologies, including identifying coverage, codes, and billing options that may apply to those Medical Technologies or the services and procedures in which they are used
Providing accurate information about the efficient use of the GCSI Medical Technologies, including where and how they can be used within the continuum of care
Providing information related to the Company's Medical Technologies regarding available reimbursement and associated costs
Providing information relating to changes in coverage or reimbursement amounts, methodologies and policies and the effects of such changes to help a Health Care Professional in the decision to utilize GCSI Medical Technologies
Providing accurate and objective information designed to offer technical or other support intended to aid in the appropriate and efficient use or installation of GCSI Medical Technologies
Facilitating patient access to the GCSI Medical Technologies by providing Health Care Professionals with assistance in obtaining patient coverage decisions from payors, including providing information on payor policies and training on procedures for obtaining prior authorization, providing sample letters and information on medical necessity and appeals of denied claims
Pursuant to the request of a Health Care Professional to facilitate patient access to the GCSI Medical Technology, and subject to appropriate privacy safeguards, the Company may assist the patient by facilitating the preparation and submission of requests for coverage determinations, prior authorizations, pre-certifications and appeals of denied claims, relating to a GCSI own Medical Technology; however, such assistance may not be provided as an unlawful inducement.
GCSI and its employees, officers and agents may not interfere with a Health Care Professional's independent clinical decision making or provide coverage, reimbursement, and health economics support as an unlawful inducement. For example, a GCSI will not provide free services that eliminate an overhead or other expense that a Health Care Professional would otherwise have incurred as part of its business operations. Further, a Company will not suggest mechanisms for billing for services that are not medically necessary, or for engaging in fraudulent practices to achieve inappropriate payment.
GCSI may provide reasonable quantities of products to Health Care Professionals at no charge to permit Health Care Professionals to evaluate and assess whether to purchase the product.
GCSI may also provide Health Care Professionals with non-sterile demonstration units to use in educating patients about the product and its use.
GCSI products that may be provided to Health Care Professionals for evaluation include single use (for example, samples of consumable or disposable products) and multiple use products (sometimes referred to as capital equipment).
GCSI products provided for evaluation are typically expected to be used in patient care.
GCSI should provide Health Care Professionals with appropriate documentation to allow the Health Care Professional to address any reimbursement reporting obligations, including providing information on the no-charge status of these products.
Regarding Single Use/Consumables/Disposables. The number of single use products provided at no charge should not exceed the amount reasonably necessary for the adequate evaluation of the products under the circumstances.
Multiple Use/Capital Equipment. Multiple use products provided without transfer of title for evaluation purposes should be furnished only for a period of time that is reasonable under the circumstances to allow an adequate evaluation and consistent with any applicable transparency reporting requirements. Regarding this, GCSI employees must consider whether federal or state law (for example, the U.S. Physician Payments Sunshine Act) requires reporting the value of evaluation products provided to Health Care Professionals.
GCSI employees must maintain accurate documentation, record keeping, and asset tracking requirements, including any obligations pertaining to activities that fall within the scope of this Anti- Corruption Policy.
The terms of an evaluation of multiple use products by an GCSI client should be set in advance in writing, specifying the length of the evaluation period and addressing products that have not been returned within the evaluation period.
GCSI employees must should retain title to multiple use products during the evaluation period and should have a process in place for promptly removing multiple use products from the Health Care Professional's location at the conclusion of the evaluation period unless the Health Care Professional purchases or leases the products.
Demonstrations. GCSI demonstration products are typically unsterilized single use products or mock-ups that are used for Health Care Professional and patient awareness and education. For example, a Health Care Professional may use a demonstration product to show a patient the type of device that will be implanted in the patient.
Demonstration products typically are not intended to be used in patient care.
Consigned Products
Consigned technologies are Medical Technologies that GCSI may, subject to the provisions of this Policy, provide to a Health Care Professional for use in and storage at the Health Care Professional's patient care. Title to such technology remain with GCSI unless until such technology is sold to a Health Care Professional.
Consignment arrangements should generally be subject to an agreement that addresses the terms of consignment, for example, the number of products, any requirements to segregate consigned products from other products, and storage space rental terms (if applicable).
GCSI employees involved in the account to which a technology has been consigned, are required to implement appropriate safeguarding controls. This could include (among other measures) taking periodic inventory of consigned devices for purposes such as billing and restocking; reconciling discrepancies between the GCSI records and the number of products used or verified during inventory; and return or removal of expired product.
Technical Support
GCSI representatives play an important role in the clinical setting by providing technical support on the safe and effective use of Medical Technology. Some examples include:
GCSI representatives may need to explain how a Medical Technology's unique settings and technical controls function and may make recommendations.
GCSI representatives may assist the clinical/operating room team to ensure that the appropriate range of necessary devices and accessories are available during a procedure, especially when dealing with Medical
Regarding technical support:
GCSI representatives should enter and be present in the clinical setting only at the request of and under the supervision of a Health Care Professional.
GCSI representatives should be transparent that they are acting on behalf of the GCSI in a technical support capacity.
GCSI representatives should not interfere with a Health Care Professional's independent clinical decision-making.
GCSI representatives should comply with all applicable hospital or facility policies and requirements, including patient privacy and credentialing requirements.
GCSI technical support should not eliminate an overhead or other expense that the Health Care Professional should otherwise incur while providing patient care.
GCSI representatives may play an important role in the clinical setting by providing technical support on the safe and effective use of Medical Technology. Some examples include:
GCSI representatives may need to explain how a Medical Technology's unique settings and technical controls function and may make recommendations.
GCSI representatives may assist the clinical/operating room team to ensure that the appropriate range of necessary devices and accessories are available during a procedure, especially when dealing with Medical Technology that involves multiple devices and/or accessories.
The Policy and It’s Purpose
Gold Coast Surgical, Inc. is a provider of medical, including surgical, equipment.
The Purpose of GCSI having an anti-corruption policy (ACP) is to prevent GSCI’s employees or other representatives of GCSI from incentivizing doctors, hospitals, an others from putting their own welfare above that of their patients. Since they are not inimical to the ACP’s purpose, the ACP allows GCSI to sponsor or provide Healthcare Professionals with incidental education, allows GCSI to occasionally provide modest, appropriate educational items to Health care professionals that benefit patients or serve a genuine educational function for Health care professionals. This means that a GCSI may not provide Health care professionals with money, kickbacks, or items that the Health Care Professional (or his or her family members, office staff, or friends) can use for non-educational or non-patient-related purposes (for example, office supplies, scrubs, a tablet, Smart Phone, laptop, or other mobile device that is not sold as a part of GCSI’s regular business.
This Anti-Corruption policy is not intended to replace the U.S. Federal Anti-Kickback Statute but to incorporate it into the policies of GCSI. The federal Anti-Kickback Statute 42 U.S.C. § 1320a-7b. is a criminal statute that prohibits the exchange (or offer to exchange), of anything of value, in an effort to induce (or reward) the referral of business reimbursable by federal health care programs. That Federal Statute codifies policies referred to as Unlawful Inducements. Federal Law prohibits kick-backs, which are defines as the knowing and willful payment (or offer to pay) or receipt (or solicitation to receive) of anything of value to induce or reward referrals or the generation of business that is payable under a Federal healthcare program, such as Medicare. “Appropriately tailored” means that each GCSI implementation of an effective compliance program differs depending on a variety of factors (such as size, resources, work force, and business line, among others). Given the wide diversity within the Medical Technology industry, there is no single best compliance program. GCSI has or must develop and implement compliance controls that address the specific types of risks that apply to its operations.
Accordingly, GCSI, its officers, employees, and agents may not pay to any health care entity or professional, including but not limited to hospitals, doctors, practice managers, administrators, or any of the employees, agents, officers of said health care entities or professionals any kickback or anything of value in order to maintain or obtain the business of that health care professional or entity. This policy does not prohibit the distribution of token marketing materials such as pens, note pads, calendars, calculators or the like; which have on them the logo and/or name of GCSI. It further does not prohibit the taking of customers or potential customers to lunch or dinner in order to discuss business. It further does not prevent GCSI from holding seminars, providing lunch or dinner at such seminars, or providing no cost medical continuing education at such seminars.
If there is any doubt about whether a particular activity or item would be in conflict with this policy, a written authorization from management should first be sought and obtained