Meals

Federal Laws, Implementing Regulations, and Government-Issued Guidance

Various federal laws and implementing regulations may be implicated in connection with providing anything of value to healthcare professionals ("HCPs"), under laws designed to prevent fraud, waste, and abuse ("FW&A") in government healthcare programs. Enforcement action and settlement history provide insight on the federal government’s perspective on these matters.  The federal government also issues guidance that may provide insight on the way it views transfers of value to HCPs. In addition to federal laws, individual U.S. states have also passed similar laws governing manufacturers’ interactions with HCPs designed to prevent fraud, waste, and abuse. Many of these laws exist independently and are not preempted by federal law.

Federal Anti-Kickback Statute (42 U.S.C. § 1320a-7b(b)):

Prohibits the offering, payment, solicitation or receipt of remuneration (including any kickback, bribe or rebate), directly or indirectly, overtly or covertly, in cash or in kind, for: (a) the referral of patients, or arranging for the referral of patients, to receive items or services for which payment may be made, in whole or in part, under a federal health care program and any state health care program, or (b) the purchase, lease, order or arranging for the purchase, lease or order of any good, facility, service or item for which payment may be made under a federal health care program and any state health care program. For purposes of the AKS, “remuneration” includes the transfer of anything of value, directly or indirectly.

U.S. courts have held that if even one purpose of an arrangement is to induce or reward referrals of items or services payable by a federal or state health care program, the statute is violated, unless a safe harbor is met. Statute provides specific safe harbor exceptions to the statute.

Because the AKS is drafted broadly and ascribes criminal liability to parties on both sides of an impermissible kickback arrangement, there are statutory and regulatory safe harbors that, if satisfied in their entirety, will immunize the parties from liability. These safe harbors remove certain arrangements that meet all the enumerated safe harbor criteria from the definition of “remuneration” under the statute, thereby relieving the parties of any civil or criminal prosecution under the AKS. However, arrangements that fail to qualify for safe harbor protection do not necessarily violate the AKS (i.e., they are not per se illegal). Rather, such arrangements require a fact-specific analysis to determine whether an AKS violation has occurred.

Physician Payment Sunshine Act (42 U.S.C. § 1320a-7h) and Implementing Regulations (42 C.F.R. Part 403, Subpart I):

Requires applicable manufacturers to track and to submit to the Centers for Medicare and Medicaid Services (CMS) information regarding payments made to certain US HCPs. Does not establish appropriate amounts to be spent on HCPs related to accommodations, travel, or meals; rather, addresses tracking and transparency obligations. Applicable manufacturers should refer to CMS guidance and data collection resources for current reporting thresholds and requirements.

False Claims Act and Civil Monetary Penalties Law:

These laws may also be relevant to manufacturers’ interactions with HCPs, particularly where conduct may involve false or fraudulent claims, improper remuneration, or other conduct resulting in fraud, waste, or abuse in federal healthcare programs.

State Laws & Implementing Regulations

FW&A Laws Including Any Payor Statutes:

Nearly all states have adopted FW&A laws that are generally analogous to the federal laws, but which in some cases apply more broadly than the federal laws (e.g., regardless of payor).

Marketing and Gift Laws: 

State marketing and gift laws should be considered. There is no single US federal gift ban applicable to all HCP interactions, but a number of states have relevant laws in place, the most restrictive of which ban gifts to HCPs licensed in that state.

Other Points to Consider (Not Addressed in this Survey): In some cases even cities (for example, the City of Chicago) may issue requirements governing marketing to HCPs;[9] and there may be other state laws applicable more broadly to gifts or other items of value (including hospitality) to state employees, with whom the life sciences industry may interact (for example, Louisiana). Further, healthcare professionals are governed by state professional licensure and related ethical requirements, the specifics of which may vary from state-to-state, and in addition the American Medical Association ("AMA") Code of Medical Ethics provides guidance regarding industry-provided gifts and subsidies for physicians. Further, healthcare institutions may have their own internal policies that prohibit or limit the receipt of hospitality. 

Industry-issued guidance is also relevant to interactions between life sciences companies and HCPs. While industry codes are generally voluntary unless incorporated into applicable state law or company policy, they are widely used as benchmarks for ethical interactions with HCPs.

• The PhRMA Code is a voluntary set of guidelines adopted by the Pharmaceutical Research and Manufacturers of America (PhRMA) to govern and advocate for ethical interactions between pharmaceutical and biotechnology companies and HCPs that place the patient-provider relationship above inappropriate influence from the industry. The PhRMA Code was updated in 2021.
• The AdvaMed Code of Ethics is a voluntary set of guidelines established by the Advanced Medical Technology Association (AdvaMed) that governs and advocates for ethical interaction between medical technology companies and HCPs. The AdvaMed Code was updated in 2025.
• Healthcare professionals may also be subject to professional ethical standards, including applicable AMA ethical guidance, which may address physician relationships with industry and should be considered where relevant.

As explained, because a number of the standards cross-reference and incorporate others by reference, it is prudent to consider the landscape as a whole when approaching the US market. 

General Principle in the US: US government- and industry-issued guidance generally distinguish between two categories:

• The potential for an industry role relative to travel and hospitality expenses (payment for, or reimbursement for, such expenses) in connection with company-sponsored events, meetings, or HCP services. This may include some meetings with educational or scientific content, but the content is controlled by the company. This category may also include travel and hospitality associated with HCPs engaged to provide services for the company (e.g., consultants or clinical investigators).  This category is the focus of the US responses for this survey.
• The potential for industry financial support in connection with independent continuing medical education ("CME") or similar third-party conferences or events where the company does not control or influence content. This category is further explained in Online Conferences. Under industry codes, any financial support should be provided to conference organizers, and the conference organizers in turn should apply appropriate standards to its use.

Competent Authorities

The competent authorities responsible for enforcing US rules relevant to manufacturer interactions with HCPs include federal and state regulators and enforcement agencies. At the federal level, relevant authorities include the Department of Justice (DOJ), US Attorneys’ Offices, the Healthcare Fraud Strike Force under the Health Care Fraud Unit, the Office of Inspector General of the Department of Health and Human Services (HHS-OIG), and the Centers for Medicare and Medicaid Services (CMS).

Qui tam relators, also known as whistleblowers, may assist the government in uncovering fraud by filing lawsuits on its behalf under the False Claims Act. Enforcement priorities may also reflect a focus on waste, fraud, and abuse under applicable federal white-collar enforcement initiatives.

Certain states have incorporated the PhRMA Code, the AdvaMed Code, or both into their statutes or regulations. Examples include California, Connecticut, the District of Columbia, Massachusetts, and Nevada.

Federal Authorities

Department of Justice

Department of Health and Human Services, Office of Inspector General

Centers for Medicare and Medicaid Services 

State Authorities

Medicaid Fraud Control Units

State Attorneys General

Other State Regulatory Agencies and Boards

PhRMA Code

PhRMA does not have legal or regulatory enforcement authority, but if a company desires to be listed on the PhRMA website, it must annually certify compliance to the PhRMA Code.

In addition, some state laws incorporate adherence to the PhRMA Code as part of their requirements. 

AdvaMed Code

AdvaMed does not have legal or regulatory enforcement authority, but companies that adopt the AdvaMed Code are strongly encouraged to submit an annual certification and may display the AdvaMed Code of Ethics logo upon certification.

In addition, some state laws incorporate adherence to the AdvaMed Code as part of their requirements.

Certain states

Certain states have incorporated the HHS-OIG Compliance Program Guidance for Pharmaceutical Manufacturers into their state requirements (e.g., California).

Certain states have incorporate adherence to the PhRMA Code as part of their requirements.

Certain states have incorporated adherence to the AdvaMed Code as part of their requirements.

Event locations should be selected based on their appropriateness for the meeting to be conducted. For example, HCP speaker programs should occur in a setting where educational activities would be appropriate, such as in a restaurant’s private room where available. Meetings organized by the company should not be held in primarily entertainment venues such as golf courses, wineries, adult entertainment venues, or sports stadiums.

[[[Because “event location” and “event venue” are overlapping concepts, one tab may cross-refer to the other or the content may be consolidated to avoid duplication.]]]

Federal Law & Implementing Regulations, & Government-Issued Guidance: The laws and regulations do not specifically enumerate or define "appropriate" versus "inappropriate" venues, but enforcement action and settlement history show that selection is likely to impact the government’s perception of potential intent to induce or reward. In addition, the HHS-OIG Guidance states generally, with respect to entertainment, recreation, travel, meals, gifts, gratuities, and other business courtesies that the AKS should be considered and that "compliance with the PhRMA Code with respect to these arrangements should substantially reduce a manufacturer's risk." 68 Fed. Reg. 23,721, 23,738 (May 5, 2003). Other guidance may discuss the appropriateness or inappropriateness of venues for certain HCP interactions (e.g., OIG Special Fraud Alert on Speaker Programs provides that speaker programs held at venues that are not conducive to the exchange of educational information, such as golf courses, wineries, and sports stadiums, would be suspect). 

State Laws & Implementing Regulations:  Several state laws reflect an expectation of reasonable and appropriate event locations (for example, New Jersey in reference to venues and circumstances conducive to bona fide services; other states through incorporation of the PhRMA and/or AdvaMed Codes). 

Industry Codes of Conduct: The PhRMA Code and AdvaMed Code address restrictions regarding event venues.  For example, the PhRMA Code states that for consulting arrangements with HCPs the venue and circumstance of meetings with consultants must be conducive to the primary focus of the meeting, and resorts are specifically not appropriate venues.  The AdvaMed Code states that companies should not select a setting because of its entertainment or recreational facilities (e.g., resorts in geographic locations renowned primarily as seasonal vacation destinations).

Federal Law & Implementing Regulations, & Government-Issued Guidance: The laws and regulations do not specifically enumerate or define "appropriate" versus "inappropriate" venues, but enforcement action and settlement history show that selection is likely to impact the government’s perception of potential intent to induce or reward. In addition, the HHS-OIG Guidance states generally, with respect to entertainment, recreation, travel, meals, gifts, gratuities, and other business courtesies that the AKS should be considered and that "compliance with the PhRMA Code with respect to these arrangements should substantially reduce a manufacturer's risk." 68 Fed. Reg. 23,721, 23,738 (May 5, 2003). See below. Other guidance may discuss appropriateness or inappropriateness of venues for certain HCP interactions (e.g., OIG Special Fraud Alert on Speaker Programs provides that speaker programs held at venues that are not conducive to the exchange of educational information, such as golf courses, wineries, and sports stadiums, would be suspect). 

State Laws & Implementing Regulations:  Several state laws reflect an expectation of reasonable and appropriate event locations (for example, New Jersey in reference to venues and circumstances conducive to bona fide services; other states through incorporation of the PhRMA and/or AdvaMed Codes). 

Industry Codes of Conduct: The PhRMA Code and AdvaMed Code address restrictions regarding event venues. For example, the PhRMA Code states that for consulting arrangements with HCPs the venue and circumstance of meetings with consultants must be conducive to the primary focus of the meeting, and resorts are specifically not appropriate venues. The AdvaMed Code states that companies should not select a setting because of its entertainment or recreational facilities (e.g., resorts in geographic locations renowned primarily as seasonal vacation destinations).

HCPs who are provided accommodations should be provided lodging in hotels that are commensurate with reasonable business travel. Companies should consider aligning HCP travel rules with the company’s own internal travel policies, which reflect the company’s existing decisions around what is necessary for reasonable business travel. HCPs should not be provided lodging in luxury hotels or resorts, unless they are attending a third-party conference and the conference organizers, separately and at arm’s length from the company, decided to hold the conference at that location and therefore the accommodations would be considered reasonable for business.

Federal Law & Implementing Regulations, & Government-Issued Guidance: The laws and regulations do not specifically enumerate or define "appropriate" versus "inappropriate" accommodations, but enforcement action and settlement history show that selection is likely to impact the government's perception of potential intent to induce or reward. In addition, the HHS-OIG Guidance states generally, with respect to entertainment, recreation, travel, meals, gifts, gratuities, and other business courtesies that the AKS should be considered and that "compliance with the PhRMA Code with respect to these arrangements should substantially reduce a manufacturer’s risk." 68 Fed. Reg. 23,721, 23,738 (May 5, 2003). See below. 

State Laws & Implementing Regulations:  Some state laws incorporate adherence to the PhRMA Code and/or AdvaMed Code as part of their requirements (see below).  Some states, like New Jersey, prohibit the payment or subsidy of lodging costs for non-faculty prescribers attending an educational or promotional event. 

Industry Codes of Conduct: Industry Codes provide guidance on accommodations in certain circumstances. For example, the PhRMA Code provides that compensation for HCP lodgings for consultant arrangements and speaker programs should be reasonable and based on fair market value. The AdvaMed Code states that accommodations for HCPs to attend Company-conducted programs or meetings must be modest and reasonable under the circumstances and encourages companies to establish controls on the appropriate level of lodging accommodations.

Companies that provide HCPs with travel should allow booking of reasonable business travel arrangements. Companies should consider aligning HCP travel rules with the company’s own internal travel policies, which reflect the company’s existing decisions around what is necessary for reasonable business travel.

Federal Law & Implementing Regulations, & Government-Issued Guidance: The laws and regulations do not specifically enumerate or define "appropriate" versus "inappropriate" air travel, but enforcement action and settlement history show that selection is likely to impact the government’s perception of potential intent to induce or reward. In addition, the HHS-OIG Guidance specifically notes that companies providing benefits, including travel, in association with information or marketing presentations could potentially implicate the AKS. The HHS-OIG Guidance states generally, with respect to entertainment, recreation, travel, meals, gifts, gratuities, and other business courtesies that the AKS should be considered and that "compliance with the PhRMA Code with respect to these arrangements should substantially reduce a manufacturer’s risk." 68 Fed. Reg. 23,721, 23,738 (May 5, 2003). See below. 

State Laws & Implementing Regulations: A number of states with laws of this type incorporate an expectation that travel expenses must be "reasonable" to be covered. 

Industry Codes of Conduct: The PhRMA Code indicates that, even in circumstances in which covering travel expenses is otherwise considered appropriate under the guidance, reimbursement should be limited to "reasonable" travel expenses. The AdvaMed Code also provides that travel costs for HCPs, where permitted, must be "modest and reasonable under the circumstances."

Federal Law & Implementing Regulations, & Government-Issued Guidance: The laws and regulations do not specifically enumerate or define "appropriate" versus "inappropriate" train transportation, but enforcement action and settlement history show that selection is likely to impact the government’s perception of potential intent to induce or reward. In addition, the HHS-OIG Guidance specifically notes that companies providing benefits, including travel, in association with information or marketing presentations could potentially implicate the AKS. The HHS-OIG Guidance states generally, with respect to entertainment, recreation, travel, meals, gifts, gratuities, and other business courtesies that the AKS should be considered and that “compliance with the PhRMA Code with respect to these arrangements should substantially reduce a manufacturer’s risk.”  68 Fed. Reg. 23,721, 23,738 (May 5, 2003).  See below. 

State Laws & Implementing Regulations: A number of states with laws of this type incorporate an expectation that travel expenses must be "reasonable" to be covered. 

Industry Codes of Conduct: The PhRMA Code indicates that, even in circumstances in which covering travel expenses is otherwise considered appropriate under the guidance, reimbursement should be limited to "reasonable" travel expenses.  The AdvaMed Code also provides that travel costs for HCPs, where permitted, must be "modest and reasonable under the circumstances."

Federal Law & Implementing Regulations, & Government-Issued Guidance: The laws and regulations do not specifically enumerate or define "appropriate" versus "inappropriate" travel considerations, but enforcement action and settlement history show that selection is likely to impact the government’s perception of potential intent to induce or reward. In addition, the HHS-OIG Guidance specifically notes that companies providing benefits, including travel, in association with information or marketing presentations could potentially implicate the AKS. The HHS-OIG Guidance states generally, with respect to entertainment, recreation, travel, meals, gifts, gratuities, and other business courtesies that the AKS should be considered and that "compliance with the PhRMA Code with respect to these arrangements should substantially reduce a manufacturer's risk." 68 Fed. Reg. 23,721, 23,738 (May 5, 2003). See below. 

State Laws & Implementing Regulations: Some states detail restrictions on payments for travel for non-faculty HCPs.  For example, New Jersey prohibits any payment or direct subsidy to a non-faculty prescriber for the costs of travel associated with attending any education event or promotional activity. 

Industry Codes of Conduct: The PhRMA Code indicates that, even in circumstances in which covering travel expenses is otherwise considered appropriate under the guidance, reimbursement should be limited to "reasonable" travel expenses.  The AdvaMed Code also provides that travel costs for HCPs, where permitted, must be "modest and reasonable under the circumstances."

HCP meetings and accompanying meals are for educational or business purposes (e.g., HCP consultant business travel). Meals are incidental to the underlying activity. Family members of an HCP should not be allowed to participate in such meals because they are not participating in the underlying activity.

Federal Law & Implementing Regulations, & Government-Issued Guidance: The laws and regulations do not specifically address this topic but given the HHS-OIG Guidance’s cross reference to the PhRMA Code, the PhRMA Code’s view should be considered (i.e., inappropriate to cover expenses for non-participating spouses or guests). 

State Laws & Implementing Regulations: Some state law restricting payments and gifts to HCPs also specifically mention family members. For example, New Jersey’s prohibitions on gifts and payments to prescribers also apply to the prescriber’s immediate family, and Massachusetts prohibits meals provided to HCP spouses or other guests. Some states more generally incorporate PhRMA Code and/or AdvaMed Code standards by reference. 

Industry Codes of Conduct: The PhRMA Code states it is not appropriate for companies to pay for travel and lodging for non-faculty HCPs (e.g., it would not be appropriate to pay for the cost of an HCP’s spouse). The AdvaMed Code also states that companies may not pay for or otherwise subsidize travel or lodging for spouses or guests of HCPs.

For online meetings, companies should consider procedures to verify that the meeting occurred and that the relevant HCP participation took place. COVID-era guidance should be removed where no longer current. Meal-related rules should not be repeated in this section unless specifically relevant to the online meeting format.

General Principle in the US: US government- and industry-issued guidance generally distinguish between two categories:

1. The potential for an industry role relative to travel and hospitality expenses (payment for, or reimbursement for, such expenses) in connection with company-sponsored events, meetings, or HCP services.  This may include some meetings with educational or scientific content, but the content is controlled by the company.  This category may also include travel and hospitality associated with HCP’s engaged to provide services for the company (e.g., consultants or clinical investigators).  This category is the focus of the US responses provided above for this survey.  Relative to this category and with consideration of online formats, note:
   • Federal Guidance: In general, in light of significant restrictions on travel due to the COVID-19 pandemic, industry-sponsored or funded travel and hospitality is likely to be subject to a higher degree of scrutiny under the relevant standards (e.g., bona fide need, reasonableness). In one specific example, under the OIG Special Fraud Alert on Speaker Programs, industry can anticipate a higher degree of scrutiny of the justification for in-person events when it is possible to provide information virtually.
   • State Laws and Implementing Regulations: Some states specifically address the provision of honoraria for company-sponsored events.  For example, Maine limits the aggregate value of all cash and gifts received by an HCP for a particular speaking engagement to an annual limit of $500 in retail value. 
   • Industry Codes of Conduct: The PhRMA Code already addressed an expectation that if meals are provided there must be a reasonable expectation that the HCP will remain present throughout the event. Supplementing this, PhRMA’s Statement on Application of PhRMA Code Section 2 During Emergency Periods addresses the provision of meals in conjunction with virtual information presentations to HCPs during the COVID-19 pandemic. PhRMA states that meals should only be provided if there is a reasonable expectation that the HCP will remain present (e.g., virtually “present” over video or audio conferencing) throughout the event, and any meals offered in connection with informational presentation made by field sales representatives or their immediate managers should continue to be limited to in-office or in-hospital settings. 
2. The potential for industry financial support in connection with independent continuing medical education ("CME") or similar third-party conferences or events where the company does not control or influence content. (Note: If a company has engaged an HCP to present on behalf of the company at an event, this should be treated as a consulting arrangement, subject to considerations under category (1) above.)
   • The PhRMA Code states: "Since the giving of any subsidy directly to a health care professional by a company may be viewed as an inappropriate cash gift," any financial support should be given to the CME provider or conference’s sponsor, which, in turn, can use the money to reduce the overall  registration fee for all attendees.
   • The AdvaMed Code states that companies cannot provide direct contributions to individual HCPs or pay directly for individual HCPs registration fees. Educational grants provided by companies directly to third party program organizers can be used by these organizers to allow HCPs-in-training (for example, medical and nursing students, residents, etc.) to attend the program, provided that the Company does not select or control the selection of the specific HCPs-in-training who will benefit.
   • Some states (e.g., Massachusetts) specifically prohibit the reimbursement of costs for health care providers to participate in any CME event or third-party scientific or educational conferences, while others incorporate PhRMA Code and/or AdvaMed Code standards by reference.
   • The Accreditation Council for Continuing Medical Education ("ACCME") Standards for Continuing Medical Education sets forth standards regarding industry support of CME.  For example, the ACCME states that industry grants may not be used for travel, lodging, honoraria, or personal expenses for non-teacher or non-author participants of a CME activity.  The CME provider may use commercial support to pay for travel, lodging, honoraria, or personal expenses for bona fide employees and volunteers of the provider, joint providers or educational partners.
   • Given that in the US, industry should not generally be providing funds or reimbursement directly to HCPs in connection with attendance at, or travel to and from, independent third-party events, this topic is not further covered in the US survey responses. 

Refer to the General Principle in the US describing the distinction between company-sponsored and independent third-party events.

With respect to company-sponsored events, PhRMA's Statement on Application of PhRMA Code Section 2 During Emergency Periods addresses the provision of meals in conjunction with virtual presentations to HCPs during the COVID-19 pandemic.  Meals may only be provided if there is a reasonable expectation that the HCP will remain present throughout the event, and meals should continue to be limited to in-office or in-hospital settings.