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In 1991, a group of leaders representing the alternate site infusion came together to form the National Home Infusion Association, a collaborative effort to allow the industry and its members to work collaboratively toward the improvement of care to patients, and the growth and success of the industry. 

Since the founding of NHIA in 1991, the association has been dedicated to representing and advancing the interests of organizations that provide infusion and specialized pharmacy products and services to the entire spectrum of home-based patients.  NHIA members have maintained a steadfast commitment to providing patients with safe, high-quality care and distinguished themselves by operating with the highest standards of ethical behavior. 

Yet, America’s health care system is at a crossroads.  Providers must face the challenges of a changing health care landscape.  At a time when sensational headlines on fraud and abuse abound, the alternate site infusion industry must differentiate itself by reaffirming its commitment to providing patients with the highest level of safe and quality care.  Greater complexity in regulatory requirements and the administration’s zero tolerance for unethical behavior are all solid reasons to set the definitive bar for ethical business standards among NHIA members. 

The newly created NHIA Standards for Ethical Practice serves as the industry’s proclamation of the virtue of its principles and actions and reaffirms its commitment to operating with integrity and the highest regard for the quality of patient care. 

NHIA members’ collective endorsement of the NHIA Standards for Ethical Practice is a healthy collaboration that benefits each and every association member.  By attesting to accept the general tenets of the NHIA Standards for Ethical Practice, NHIA members are reinforcing their leadership in committing to use the standards as a framework for ethical business decision making within the context of their daily operations and typical interactions with various constituents. 

Frequently Asked Questions

The Standards apply to all National Home Infusion Association (NHIA) Members.  The primary emphasis of the Standards is on provider Members who directly serve patients, interact with referral sources and bill payers.

The U.S. Congress and Department of Health and Human Services (HHS) are committed to enhancing the government’s efforts to identify and eliminate waste, fraud, abuse and errors associated with government payers such as Medicare, Medicaid and TRICARE.  In recent years, health care legislation has included increasingly more stringent requirements to ensure that services are provided legally, ethically and in compliance with all applicable laws, rules and regulations.  For example, the health reform package which was passed into law in March 2010 includes several new reforms and government investments designed to further identify and eradicate fraud, waste and abuse.  In addition, an increasing number of states have passed “payer-blind” legislation which adopts the same kinds of provisions as federal legislation and which applies to services provided to patients covered by non-government payers.

NHIA and its Members are committed to promoting compliance with applicable rules, laws and regulations.  The publication of this document serves multiple roles.  It provides guidance to NHIA Members although they should consult with their own legal counsel on specific details and their application to the Member’s business operations.  It also demonstrates that the Association and its Members will commitment to Congress and regulatory agencies operate in an ethical, legal, patient-centric manner.  Adoption of these standards by NHIA and its members will promote trust in the Association and in its Members’ services.

The Standards are intended to serve as umbrella guidance to Members and affiliates to enable you to develop your own internal policies and procedures which are customized to your organization.  They are, however, grounded in existing laws, rules, regulations or public guidance pertaining to our industry.  The government expects providers of all sizes, legal structures, numbers of employees, locations in the country, etc. to comply. NHIA expects you to embrace the direction we are taking to further clarify our position regarding a zero tolerance for fraud and abuse.

Beginning in 2011, NHIA shall release to, educate on and welcome feedback from Members on the NHIA Standards for Ethical Practice.  It is NHIA’s expectation that Members will use the standards as a framework for ethical business decision making within the context of their daily operations and typical interactions with various constituents.  Beginning with membership renewals for 2012, NHIA expects to ask Members to acknowledge receipt of the NHIA Standards for Ethical Practice and attest to accepting the general tenets of the document.

No.  Participation and adoption is important.  However, auditing its Members is well beyond the scope of activities for the Association.

No. NHIA and its Members must continue to adhere to all applicable federal and state antitrust laws and regulations. This includes large group meetings, advisory boards and other situations involving several competitors.  No provision in the Standards document shall be interpreted as a recommendation or suggestion that it is permissible for a group of competitors to participate in any antitrust activities of any kind, including price fixing, refusing to negotiate, etc.

NHIA is committed to promoting Members’ compliance with all state and/or federal laws and regulations that prohibit the offer or solicit unlawful inducements of referrals for patients whose insurance is funded by government health care programs.  Included in this prohibition are physician self-referrals.

Members who incorporate the Standards into their business operations have a responsibility to communicate the principles to their employees, subcontractors and manufacturers/suppliers with the expectation that they will embrace the tenets of the document. This does not mean that NHIA members need to distribute a copy or conduct training on this document or their own compliance policies and procedures.  Rather, via various communication methods, the Association recommends that you educate your constituents about your own – and our industry’s – commitment to compliance on a frequent basis.

The nature of the home infusion and specialty infusion pharmacy business is such that our Members interact with a number of different constituents who are the subject of general and specific laws, rules and/or regulations.  For example, physicians and hospital discharge planners may make the referral to a home infusion provider, but a patient/caregiver is the recipient of our services and a separate, third-party payer typically pays the claim we submit.  There are existing laws, rules and regulations which govern how infusion/specialty providers must operate when interacting with these audiences. Interactions with referral sources, patients, vendors and other parties should be free of the bias that results from unlawful inducements, conflicts of interest and the like.

Laws, rules and regulations exist to prevent individuals whose care is paid by a federally funded health care program from receiving or being offered gifts, including free services, if such a gift constitutes an unlawful inducement for the patient to choose or continue using a certain provider. Gifts of modest value (see Standards) are acceptable. The cumulative value of all items given in any one-year period to any one patient should not exceed $50. The value limits apply to services such as health screenings, clinical questionnaires to screen for certain conditions, or blood pressure checks.

For example, it would be acceptable for Members to give specialty advertising items to patients, such as key chains, pens and the like, as long as the $10 per item and $50 cumulative value is not exceeded in any one-year period. It is not acceptable for Members to offer discount coupons, incentives for switching from one provider to another or routine waivers of co-pays in an effort to convince the patient to choose or switch providers.  Consult with your legal counsel to develop an in-house policy if you don’t have one already.

The government defines “referral sources” as individuals and entities who may prescribe, purchase, recommend, use, or arrange for the use, purchase or rental of Members’ products and services. The term applies to both clinical and non-clinical personnel. In other words, a referral source can be a physician, nurse practitioner, another clinician, a provider or supplier, as well as clinic or physician office staff, discharge planners or hospital administrators among other entities.

Referral sources benefit from certain information and/or training on Member services when the goal is to help patients gain access to services and products which the referral source believes they need and therefore prescribe or recommend. It is to be expected that information about coverage and payment for Members’ products and services, payer documentation and billing requirements, advocacy activities and similar information will be shared with referral sources. However, laws and regulations are clear about which activities a provider may perform and which must be performed by a referral source. For example, Members may not provide “expense relief” to a hospital by performing its discharge planning functions that would otherwise be absorbed as a cost that the hospital would incur. Fax machines and other office equipment may not be provided for free to referral sources.  And it goes without saying that Members may not complete paperwork or forms that the government requires the referral source to complete, such as certificates of need or justification of medical necessity.

No. Such support would be inappropriate under current rules and laws.  Consult with your legal counsel.

Occasional hospitality in the form of “modest meals and receptions” which are “conducive to the exchange of information” is generally permitted. However, a resort location would not meet this standard. Consult with your legal counsel, because such a meeting may not meet the guidance issued by the Office of Inspector General (OIG).

Members may provide “occasional” hospitality only in the form of modest meals and receptions for referral source attendees as long as these are conducive to the exchange of information. Meals and hospitality should be incidental and conducive to the underlying business purpose. It is inappropriate to extend benefits to relatives of referral sources or others who do not have a legitimateprofessional interest in the meeting. 

In the eyes of the government and experts who interpret its regulations, “modest” means moderate or low value and “occasional” means infrequent. Meals and hospitality should be secondary to a legitimate purpose which can be documented. Members should consult with their legal counsel to develop policies that set limits on the frequency and amount of spending on hospitality provided to referral sources. Also, there are federal and/or state self referral or conflict of interest laws related to referral sources which should be incorporated into Members’ policies and procedures on the advice of legal counsel.

This is an area of increasing scrutiny by the government and also by organizations representing pharmaceutical companies, physicians and other referral sources.  Grants should be made to the conference sponsor, and that group should select and interface with the attendee about his/her program/speech. It is inappropriate for a Member to designate grant funds to be earmarked for specific referral sources. Members should not pay the registration fees or fees associated with continuing education (CE) credits of individual referral sources or other health care professionals, especially physicians in the case of Continuing Medical Education (CME) credits.

No. The ultimate selection should be made by the conference sponsor, who is entitled to incorporate input from various constituents, including Members’ recommendations.

An unlawful inducement is determined by the retail fair market value of the gift or item. Members should consider the fair market value of the gift in determining whether a gift to a referral source is within the meaning of the Standards document and related regulations.

Each Member should consult with legal counsel to determine whether such gifts to a referral source, or to a referral source’s family, are consistent with the spirit of the laws and regulations on the books, and the Standards document.  In general, gifts should be related to business interactions between Members and referral sources.

No.  The Standards are intended to provide a framework for ethical business decision making within the context of our Members’ daily operations and typical interactions with various constituents.  They are not intended to be, nor should they be, construed as legal advice. All Members are urged to consult with personal counsel to ensure that their policies, procedures and interactions with referral sources, patients and other constituents comply with all current laws and regulations. Aside from consulting with their own attorneys, Members are urged to monitor guidance issued by the HHS Office of Inspector General and other regulatory bodies.

No.  The NHIA staff is not in a legal advisory role to Members.  Members should address any questions about specific practices to their own attorneys and in-house compliance officers or regulatory compliance experts.

The Standards apply to all National Home Infusion Association (NHIA) Members.  The primary emphasis of the Standards is on provider Members who directly serve patients, interact with referral sources and bill payers.

The U.S. Congress and Department of Health and Human Services (HHS) are committed to enhancing the government’s efforts to identify and eliminate waste, fraud, abuse and errors associated with government payers such as Medicare, Medicaid and TRICARE.  In recent years, health care legislation has included increasingly more stringent requirements to ensure that services are provided legally, ethically and in compliance with all applicable laws, rules and regulations.  For example, the health reform package which was passed into law in March 2010 includes several new reforms and government investments designed to further identify and eradicate fraud, waste and abuse.  In addition, an increasing number of states have passed “payer-blind” legislation which adopts the same kinds of provisions as federal legislation and which applies to services provided to patients covered by non-government payers.

NHIA and its Members are committed to promoting compliance with applicable rules, laws and regulations.  The publication of this document serves multiple roles.  It provides guidance to NHIA Members although they should consult with their own legal counsel on specific details and their application to the Member’s business operations.  It also demonstrates that the Association and its Members will commitment to Congress and regulatory agencies operate in an ethical, legal, patient-centric manner.  Adoption of these standards by NHIA and its members will promote trust in the Association and in its Members’ services.

The Standards are intended to serve as umbrella guidance to Members and affiliates to enable you to develop your own internal policies and procedures which are customized to your organization.  They are, however, grounded in existing laws, rules, regulations or public guidance pertaining to our industry.  The government expects providers of all sizes, legal structures, numbers of employees, locations in the country, etc. to comply. NHIA expects you to embrace the direction we are taking to further clarify our position regarding a zero tolerance for fraud and abuse.

Beginning in 2011, NHIA shall release to, educate on and welcome feedback from Members on the NHIA Standards for Ethical Practice.  It is NHIA’s expectation that Members will use the standards as a framework for ethical business decision making within the context of their daily operations and typical interactions with various constituents.  Beginning with membership renewals for 2012, NHIA expects to ask Members to acknowledge receipt of the NHIA Standards for Ethical Practice and attest to accepting the general tenets of the document.

No.  Participation and adoption is important.  However, auditing its Members is well beyond the scope of activities for the Association.

No. NHIA and its Members must continue to adhere to all applicable federal and state antitrust laws and regulations. This includes large group meetings, advisory boards and other situations involving several competitors.  No provision in the Standards document shall be interpreted as a recommendation or suggestion that it is permissible for a group of competitors to participate in any antitrust activities of any kind, including price fixing, refusing to negotiate, etc.

NHIA is committed to promoting Members’ compliance with all state and/or federal laws and regulations that prohibit the offer or solicit unlawful inducements of referrals for patients whose insurance is funded by government health care programs.  Included in this prohibition are physician self-referrals.

Members who incorporate the Standards into their business operations have a responsibility to communicate the principles to their employees, subcontractors and manufacturers/suppliers with the expectation that they will embrace the tenets of the document. This does not mean that NHIA members need to distribute a copy or conduct training on this document or their own compliance policies and procedures.  Rather, via various communication methods, the Association recommends that you educate your constituents about your own – and our industry’s – commitment to compliance on a frequent basis.

The nature of the home infusion and specialty infusion pharmacy business is such that our Members interact with a number of different constituents who are the subject of general and specific laws, rules and/or regulations.  For example, physicians and hospital discharge planners may make the referral to a home infusion provider, but a patient/caregiver is the recipient of our services and a separate, third-party payer typically pays the claim we submit.  There are existing laws, rules and regulations which govern how infusion/specialty providers must operate when interacting with these audiences. Interactions with referral sources, patients, vendors and other parties should be free of the bias that results from unlawful inducements, conflicts of interest and the like.

Laws, rules and regulations exist to prevent individuals whose care is paid by a federally funded health care program from receiving or being offered gifts, including free services, if such a gift constitutes an unlawful inducement for the patient to choose or continue using a certain provider. Gifts of modest value (see Standards) are acceptable. The cumulative value of all items given in any one-year period to any one patient should not exceed $50. The value limits apply to services such as health screenings, clinical questionnaires to screen for certain conditions, or blood pressure checks.

For example, it would be acceptable for Members to give specialty advertising items to patients, such as key chains, pens and the like, as long as the $10 per item and $50 cumulative value is not exceeded in any one-year period. It is not acceptable for Members to offer discount coupons, incentives for switching from one provider to another or routine waivers of co-pays in an effort to convince the patient to choose or switch providers.  Consult with your legal counsel to develop an in-house policy if you don’t have one already.

The government defines “referral sources” as individuals and entities who may prescribe, purchase, recommend, use, or arrange for the use, purchase or rental of Members’ products and services. The term applies to both clinical and non-clinical personnel. In other words, a referral source can be a physician, nurse practitioner, another clinician, a provider or supplier, as well as clinic or physician office staff, discharge planners or hospital administrators among other entities.

Referral sources benefit from certain information and/or training on Member services when the goal is to help patients gain access to services and products which the referral source believes they need and therefore prescribe or recommend. It is to be expected that information about coverage and payment for Members’ products and services, payer documentation and billing requirements, advocacy activities and similar information will be shared with referral sources. However, laws and regulations are clear about which activities a provider may perform and which must be performed by a referral source. For example, Members may not provide “expense relief” to a hospital by performing its discharge planning functions that would otherwise be absorbed as a cost that the hospital would incur. Fax machines and other office equipment may not be provided for free to referral sources.  And it goes without saying that Members may not complete paperwork or forms that the government requires the referral source to complete, such as certificates of need or justification of medical necessity.

No. Such support would be inappropriate under current rules and laws.  Consult with your legal counsel.

Occasional hospitality in the form of “modest meals and receptions” which are “conducive to the exchange of information” is generally permitted. However, a resort location would not meet this standard. Consult with your legal counsel, because such a meeting may not meet the guidance issued by the Office of Inspector General (OIG).

Members may provide “occasional” hospitality only in the form of modest meals and receptions for referral source attendees as long as these are conducive to the exchange of information. Meals and hospitality should be incidental and conducive to the underlying business purpose. It is inappropriate to extend benefits to relatives of referral sources or others who do not have a legitimateprofessional interest in the meeting. 

In the eyes of the government and experts who interpret its regulations, “modest” means moderate or low value and “occasional” means infrequent. Meals and hospitality should be secondary to a legitimate purpose which can be documented. Members should consult with their legal counsel to develop policies that set limits on the frequency and amount of spending on hospitality provided to referral sources. Also, there are federal and/or state self referral or conflict of interest laws related to referral sources which should be incorporated into Members’ policies and procedures on the advice of legal counsel.

This is an area of increasing scrutiny by the government and also by organizations representing pharmaceutical companies, physicians and other referral sources.  Grants should be made to the conference sponsor, and that group should select and interface with the attendee about his/her program/speech. It is inappropriate for a Member to designate grant funds to be earmarked for specific referral sources. Members should not pay the registration fees or fees associated with continuing education (CE) credits of individual referral sources or other health care professionals, especially physicians in the case of Continuing Medical Education (CME) credits.

No. The ultimate selection should be made by the conference sponsor, who is entitled to incorporate input from various constituents, including Members’ recommendations.

An unlawful inducement is determined by the retail fair market value of the gift or item. Members should consider the fair market value of the gift in determining whether a gift to a referral source is within the meaning of the Standards document and related regulations.

Each Member should consult with legal counsel to determine whether such gifts to a referral source, or to a referral source’s family, are consistent with the spirit of the laws and regulations on the books, and the Standards document.  In general, gifts should be related to business interactions between Members and referral sources.

No.  The Standards are intended to provide a framework for ethical business decision making within the context of our Members’ daily operations and typical interactions with various constituents.  They are not intended to be, nor should they be, construed as legal advice. All Members are urged to consult with personal counsel to ensure that their policies, procedures and interactions with referral sources, patients and other constituents comply with all current laws and regulations. Aside from consulting with their own attorneys, Members are urged to monitor guidance issued by the HHS Office of Inspector General and other regulatory bodies.

No.  The NHIA staff is not in a legal advisory role to Members.  Members should address any questions about specific practices to their own attorneys and in-house compliance officers or regulatory compliance experts.