Share. For compliance professionals in the pharmaceutical industry, it brings to bear critical questions about whether paid speaker programs are worth the risk, especially since numerous companies in the last few years have paid hundreds of millions of dollars to resolve enforcement actions related to speaker programs. These revisions largely incorporate HHS-OIG's Special Fraud Alert for Speaker Programs as issued in November 2020. Ask the Ethicist, an ethics case study about physician-industry relations and the revised PhRMA Code on Interactions with Health Care Professionals. The PhRMA Code was initially published in 2002 and updated in 2009 and 2019. . A critical part of that process is clinical research, the study of a pharmaceutical product in humans. The focus on speaker programs isn't going away. The PhRMA Code also updated its section 2 to provide guidance on meals other than those served in speaker programs. Speaker Programs: Will the Recent Revisions on the PhRMA Code on Interactions with Health Care Professionals Change Physician Marketing by Pharmaceutical Companies? PhRMA, the pharmaceutical manufacturer trade association, announced on Fri. August 6 that it has revised its longstanding Code on Interactions with Health Care Professionals.. OIG has since issued a Compliance Program Guidance for Pharmaceutical Manufacturers, 3 which reinforces the PhRMA Code and provides additional guidance on compliance and practices that the government believes present risks. The updated code "states that pharmaceutical companies should not pay for or provide alcohol in connection with speaker programs. Special Fraud Alert: Speaker Programs November 16, 2020 I. In August 2021, the Pharmaceutical Research and Manufacturers of America (PhRMA) announced an updated and enhanced PhRMA Code on Interactions with Healthcare Professionals (PhRMA Code).1 The revisions apply to the PhRMA Code's principles applicable to company-sponsored speaker programs. AdvaMed Code of Ethics on Interactions with Healthcare Professionals. Accordingly, a manufacturing conducting a Speaker Program would need to assess in each case whether the combination of the content being presented and the specific responsibilities of the non-HCP would make for a true . Issues with Speaker Programs. The new code is to take effect on Jan. 1, 2022. USA September 15 2021. not appropriate," unless the attendee has a bona fide educational need to receive the information presented at the speaker program. PhRMA Principles for Payment and Delivery System Reforms. III. The updated language says: "Incidental meals can be provided only where there is a reasonable expectation, and reasonable steps are taken to confirm, that each attendee has a substantive interaction or discussion with the . Lastly, the panelist address the recent revisions to the PhRMA Code . PhRMA's revised "Code on Interactions with Health Care Professionals," last updated in 2019, follows a Nov. 16, 2020, "special fraud alert" from the Department of Health and Human Services Office of Inspector General that discusses the "inherent fraud and abuse risks" associated with speaker programs. In short, these guidelines outline Updated 2021 PhRMA Code Echoes HHS OIG Guidance on Speaker Programs. Building on this fundamental principle, the PhRMA Code now reiterates that the purpose of a speaker program should be to present substantive educational information designed to help address a bona fide educational need among attendees, taking into account recent substantive changes in relevant information (e.g., new medical or scientific information or a new FDA-approved indication for the product) or the importance of the availability of such educational programming. Speaker Programs (Section 7) The revised PhRMA Code includes significant updates related to speaker program meals and speaker selection. Although the revised PhRMA Code does not directly address all of the concerns articulated by OIG, it reflects a direct response to several key concerns that are likely to affect important aspects of how speaker programs will be run. August 19, 2021. The PhRMA Code is a voluntary code for pharmaceutical companies, but its standards are considered to be best practices and are commonly adhered to by pharmaceutical and medical device companies. Speaker Programs - PhRMA significantly expanded Section 7, . 11 Moreover, invitations to speaker programs should be limited to those who have a demonstrated need for the information presented at the program. 7 Speaker Programs and Speaker Training Meetings . Pharmaceutical Research and Manufacturers of America (PhRMA) recently announced revisions to its voluntary " Code on Interactions with Health Care Professionals" (HCPs), which will take effect January 1, 2022. These programs should conform with the PhRMA code and OIG guidelines. The alert warns that pharmaceutical and medical device company speaker programs may violate the Anti-Kickback Statute. Method of Training: Online / Self-paced eLearning. This program is not an accredited CME program and is not designed to meet any training and/or educational requirements. Answer: The updated PhRMA code provides guidelines regarding appropriate interactions between health care providers and pharmaceutical and biotechnology companies, including participation in speaker programs and speaker training meetings. Additional Resources: Supplemental materials/activities. The Pharmaceutical Research and Manufacturers of America (PhRMA) issued an updated August 2021 Code on Interaction with Health Care Professionals, which takes effect January 1, 2022. As such, the PhRMA update seeks to clarify the uncertain ethical territory surrounding these speaker events. The Pharmaceutical Research and Manufacturers of America ("PhRMA") announced revisions to its Code on Interactions with Healthcare Professionals (the "PhRMA Code") this August. The Fraud Alert states that based on Open Payments data, pharmaceutical and device companies have paid nearly $2 billion to healthcare professionals for speaker-related services. Speaker Program Guidelines. According to PhRMA's Code . Credit Hours: 3 credits. Continuing our streak of bringing the most updated and valuable content . 8. While PhRMA's new language closely mirrors that of the OIG Special Fraud Alert, it did not give guidance on areas of nuance. The Revised PhRMA Code Takes Effect January 1, 2022 - On August 6, 2021, the Pharmaceutical Research and Manufacturers of America. In the November of 2020, the OIG issued a Special Fraud Alert for speaker programs in the life sciences industry. The PhRMA Code revises three principles of speaker programs sponsored by the pharmaceutical industry: PhRMA Code Revisions Tighten Rules on Speaker Programs. Address new and emerging practices for speaker program development and execution. A simple way to prohibit speaker programs while also maintaining the educational aspect of speaker programs is to limit all communications between pharmaceutical . Rob Carey | Jan 19, 2022. Those in the business of conducting or attending such events would . The Impact of New Compliance Regulations on Pharma Speaker Programs In response to HHS-OIG's November 2020 Special Fraud Alert on speaker programs, the Pharmaceutical Research and Manufacturers of America (PhRMA) has updated its Code on Interactions with Health Care Professionals, which will take effect on January 1, 2022. The webinar discussed updates to Section 7 of the PhRMA Code which covers guidelines for Speaker Programs. Regarding these programs, the updated code states that their purpose should be to "present . to speaker programs, the PhRMA Code outlines seven new applicable guidelines when a company provides an incidental meal of modest value during a speaker program. Introduction This Special Fraud Alert highlights the fraud and abuse risks associated with the offer, payment, solicitation, or receipt of remuneration relating to speaker programs by pharmaceutical and medical device companies. The PhRMA code defines speaker programs as promotional programs that involve hiring a speaker to educate health care professionals about the benefits, risks, and appropriate uses of a company's medicines [5]. . In addition, the speakers address what is currently happening with compensation arrangements in the life sciences industry and what the future of speakers programs may entail. New PhRMA Code regs clamp down on high-end venues and complimentary bar service for speaker programs. About this Course. August 19, 2021. The PhRMA Code has always recognized that speaker programs must meet a bona fide educational need, and a number of the revisions are designed to address the government's skepticism of the educational value of speaker programs. Enrollment Period: 6 months. The revised Code likely comes as no surprise in view of the 2021 PhRMA code updates that followed the Special Fraud Alert ("SFA") on speaker programs released by the Department of Health and Human Services Office of the Inspector General (the "OIG") in November 2020. Numerous investigations have involved allegations that drug and device companies organize and pay for speaker programs with the intent to induce HCPs to prescribe or The PhRMA Code has always recognized that speaker programs must meet a bona fide educational need, and a number of the revisions are designed to address the government's skepticism of the. There are still gray areas in the revised 2022 PhRMA Code about attendance at speaker programs. Without speaker programs, there would be no need to worry about a PhRMA code and the inherent difficulties in using self-regulation because there would be nothing to regulate. The Fraud Alert cites the PhRMA Code on Interactions with Health Care Professionals, which states that health care professionals . . The most recent update revises the PhRMA Code's guidance on speaker programs in response to the Office of Inspector General's (OIG) Special Fraud Alert on Speaker Programs, which was issued in November 2020. A Chinese proverb says, "May you live in interesting times.". These revisions appear to be responsive to a November 16, 2020 Special Fraud Alert issued by the Office of Inspector General at the U.S. Department of Health and Human Services (OIG . The revisions, which relate to the Code's treatment of speaker programs, track concerns in a Special Fraud Alert released late last year by the US Department of Health and Human Services Office of Inspector General. The PhRMA Code was a step by industry to fill the vacuum left by the government's reticence on the issue. education: the updated phrma code reiterates that the purpose of a speaker program should be to present substantive educational information designed to help address a bona fide educational need. Accessibility: 24/7 access to all program materials. What Are the New PhRMA Code Updates? Some HCP Meetings Going Dry in 2022. Code of Ethics Compliance. education: the updated phrma code reiterates that the purpose of a speaker program should be to present substantive educational information designed to help address a bona fide educational need among attendees, taking into account recent substantive changes in relevant information or the importance of the availability of such educational … Therefore, companies must implement effective monitoring programs in order to reduce risk and potential reputational harm and promote compliance. Average Learning Time: ~. Align Speaker Programs Execution with PhRMA Code Updates and Increased OIG Scrutiny Critical content addressing marketing, operations and compliance matters for sustaining best in class speaker programs. It is essential that these interactions are ethically sound and do not stray from their primary purpose . Supporting Third-Party Educational Conferences. A mid-February virtual summit will address the PhRMA code changes that took effect on January 1, which have shifted how pharma and med-device companies can educate physicians through on-site events. a. Footnotes for this article are available at the end of this page. Codes & Guidelines. 5 . PhRMA appeared to respond to this view in its August 6, 2021, press statement, reiterating that a "fundamental principle" behind the Code's guidance on speaker programs is that it has . Section 7 of the PhRMA Code's guidance on speaker programs largely echoes a Special Fraud Alert regarding health care speaker programs which was issued by the Department of Health and Human Services' (HHS) Office of Inspector General (OIG . According to PhRMA's Code . OIG issued the Special Fraud Alert to 1) draw attention to what OIG believes are inherent fraud and . It supports PhRMA's commitment that its . As expected, the revised Code addresses some of the same key speaker . The PhRMA Code was initially published in 2002 and updated in 2009 and 2019. The "PhRMA Code" updates principles applicable to company-sponsored speaker programs. . Revisions to Section 7 of the PhRMA Code. . -. In light of the revised code's assertion that pharmaceutical companies are responsible for the active monitoring of their speaker The new code also describes the following additional amendments, summarized below: Incidental meals and modest venues. The revised PhRMA Code further limits compensation so that it "should not take into account the volume or value of past business that may have been or potential future business that could be generated for the company by the health care professional consultant. Criteria for speaker training programs: Speakers should receive "extensive training" on company's products and on FDA requirements for communications on such products. PhRMA Updates Code Principles on Company-Sponsored Speaker Programs. Speaker Programs: Updated PhRMA Code. These revisions to the PhRMA Code relate primarily to company-sponsored speaker programs, and address many of the concerns raised by the Department of Health and Human Services Office of Inspector General . For example, the Code states, "Repeat attendance at a speaker program on the same or . PhRMA updated its principles applicable to company-sponsored speaker programs and clarified other provisions of the PhRMA . Fraud and Abuse Risks of Speaker Programs . Course Objectives. "The PhRMA Code has long recognized that company-sponsored speaker programs provide important substantive educational information about the benefits, risks, and appropriate uses of . The revised Code provides the following principles for offering incidental meals of modest value to attendees of company-sponsored speaker programs: Last month, the Pharmaceutical Research and Manufacturers of America ("PhRMA"), which has published a voluntary code of ethics (the "Code") for the pharmaceutical . The changes will go into effect on . PhRMA followed OIG's lead by supporting several of the provisions that its signatory companies, which include both PhRMA members and non-members submit annual certifications fostering . The PhRMA Code Effective January 1, 2022, PhRMA updated its principles relating to company-sponsored speaker programs and clarified other provisions of the PhRMA Code. In response to HHS-OIG's November 2020 Special Fraud Alert on speaker programs, the Pharmaceutical Research and Manufacturers of America (PhRMA) has updated its Code on Interactions with Health Care Professionals, which will take effect on January 1, 2022. I. Industry Codes of Conduct: The PhRMA Code permits modest, occasional Key takeaways from last year's Special Fraud Alert regarding speakers programs will be discussed. The new PhRMA Code speaker program provisions give guidance to companies concerning how speaker programs should be structured, with the aim of mitigating the fraud compliance risks identified in OIG's Special Fraud Alert. The PhRMA Code explicitly states that speaker programs without a meal are outside the scope of PhRMA. The latest changes to the PhRMA Code are primarily focused on speaker programs, including meals and drinks offered, the venue used, and attendance at such programs. The PhRMA Code, first published in 2002, is a voluntary code of conduct for pharmaceutical companies that establishes best practices and generally recognized industry standards for interactions between such pharmaceutical entities and health care . PhRMA's revised "Code on Interactions with Health Care Professionals," last updated in 2019, follows a Nov. 16, 2020, "special fraud alert" from the Department of Health and Human Services Office of Inspector General that discusses the "inherent fraud and abuse risks" associated with speaker programs. care programs and impose civil money penalties for conduct prohibited by the anti-kickback statute. The PhRMA Code is a voluntary code of ethics . Company-Conducted Product Training and Education. If the 2020 release of the OIG's Special Fraud Alert related to speaker programs was a figurative shot across the bow of the life sciences industry, the updated PhRMA Code, scheduled to take effect January 2022, offers steadying guidance on the details of how to conduct more compliant programs Speaker programs are a common practice in the industry and generally entail pharmaceutical and medical . The updated PhRMA Code also clarifies that high-end restaurants and other such venues are not . However, the PhRMA code "does not address attendance at a speaker program that does not include an incidental meal to the attendee." Product and Procedure Training and Educational Events are appropriate to facilitate the safe and effective use of Medical Technologies by professionals. Understanding the New Rules for Speaker Programs. Day Pitney Cybersecurity, Healthcare and Technology (C.H.A.T.) PhRMA Updates Code Principles on Company-Sponsored Speaker Programs. The PhRMA Code. This course will broaden your knowledge of AdvaMed and PhRMA Code. The Pharmaceutical Research and Manufacturers of America (PhRMA) issued an updated August 2021 Code on Interaction with Health Care Professionals, which takes effect January 1, 2022.Section 7 of the PhRMA Code's guidance on speaker programs largely echoes a Special Fraud Alert regarding health care speaker programs which was issued by the Department of Health and Human Services' (HHS . PhRMA's latest updates involve factors to consider when engaging HCPs in speaker programs. The new PhRMA Code speaker program provisions give guidance to companies concerning how speaker programs should be structured, with the aim of mitigating the fraud compliance risks identified in . . In what is likely to be the headline for this refresh of the Code, PhRMA adopts OIG's position that companies should not pay for or provide alcohol in connection with speaker programs . Share. The updated Code also clarifies that speakers who speak on a topic should generally not subsequently attend a program on the same . In this revision, PhRMA once again reiterated the purpose of speakers programs: to present substantive . Following this alert, the PhRMA Code was also revised in August 2021 to help the industry prepare well and adhere to the regulations around speaker programs.
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