PhRMA Code Eliminates Free Trinkets, Still Allows ‘Modest’ Meals

Byline to Mary Ellen Schneider, Elsevier Global Medical News
 
Disclaimer: Article courtesy of Elsevier Global Medical News, the news partner for AMDA’s Caring for the Ages.

The free pens and mugs adorned with the names of commonly prescribed drugs will soon be a thing of the past, thanks to a new set of voluntary guidelines from the Pharmaceutical Research and Manufac­turers of America that will go into effect this coming January. Among the changes outlined in the new guidelines is a prohibition on even “modest” gifts to physicians if they lack educational value. For example, pens and mugs given ­ out by pharmaceutical representatives are no longer acceptable under PhRMA’s new code of conduct. However, gifts valued at $100 or less that are used primarily for patient or health care professional education, such as an anatomical model, are still allowed on an occasional basis. The guidelines also prohibit sales rep­resentatives and their immediate man­agers from taking physicians out for din­ner, even if they have an educational presentation to make. However, they can still provide “modest” meals, such as piz­za, in the office or at facility if they stay to provide their educational session there. The voluntary guidelines also pro­hibit companies from providing any type of entertainment or recreational items such as tickets, sports equipment, or trips.

In terms of continuing medical educa­tion (CME), the guidelines call on pharmaceutical ­companies to separate their CME grant-making functions from their sales and marketing activities. Subsidies to attend CME meetings should not be giv­en directly to physicians, according to the guidelines. Instead, any funds should be given directly to the CME provider who can use the money to reduce fees for all at­tendees. Companies are also not allowed to provide meals directly at CME events.


Note from AMDA:  It is recommended that you contact each company directly to see whether they are using the guidelines and if so, how they are being interpreted by their company.  The guidelines are voluntary, but many companies will be adhering to them.

The Grant Pie is Shrinking, But You Can Still Get a Piece

The rules for obtaining funding from the pharmaceutical industry for state chapter meetings and other initiatives seem to change constantly. This presents a challenge for chapters seeking grants. However, opportunities still exist for those that are organized, informed, patient, and efficient.

Valerie Okrund, MA, CCMEP, AMDA’s Director of Education, suggests the following:

  • Follow the online application process for the CME offices maintained by most large pharmaceutical firms. “Most have a detailed CME-grant process, and there is a link to this on the company Web sites,” she says. Key words to look for on the site to locate the pertinent page include “education grant,” “therapeutic areas,” and “grant opportunities.” Try to locate contact information by searching for “grant office,”  “education office,” or “grant contacts.”
  • Do your homework. “Take a look at therapeutic areas of potential funders and educate yourself about these. Then consider how you can implement these areas into your meetings and how education on these topics will benefit your members,” she notes.
  • Follow the specific company’s application process closely. “Be prepared to submit detailed needs assessment data—why you are planning education on this topic, how this education will benefit the audience, and so on,” she explains. “Some funders will want to know about outcome measures from education, that is, the impact of your educational initiative. Currently, ‘measuring change and physician behavior’ are huge buzzwords,” she suggests.
  • Plan initiatives, versus ad hoc projects. “Consider pitching a meeting with follow-up activity based on the meeting’s output,” she says. This follow-up might include a monograph or tool that extends the shelf-life of the educational information. “Be prepared to submit a detailed budget,” she adds.
  • Don’t try to negotiate or bend the rules to your needs or interests. “Grant offices must adhere to all regulatory guidelines. They—and you—have to be in compliance with these,” she says.
  • Do educate yourself about these regulatory guidelines. See www.accme.org or ama-assn.org (under professional resources for PRA credit rules).
  • Think outside the box. “When you’re pitching an idea for a grant proposal, think of your audience beyond geriatrics or long term care. Remember that most of your members also are primary care physicians with community practices. This broader scope will be of greater appeal to potential funders,” she suggests.
  • Don’t wait until the last minute to submit your application. It can take an average of between 45 and 90 days to get an application approved. “Don’t miss deadlines, but don’t submit an incomplete application.”
  • Consider creating an online grant database to track the processes, requirements, key therapeutic areas, and deadlines for each company. Chapters also can use this to track communications with different companies. Include key phone numbers, letters of agreement, and contact information.

    Regs Say…

     

    To help understand the rules with which pharmaceutical companies must comply, consider these guidelines form the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA):

     

    • Speaker fees must be “reasonable.” Travel and accommodation can be provided.
    • Venues should be “conducive to the scientific or educational objectives and the purposes of the event or meeting.” These shouldn’t be “extravagant.”
    • Refreshments or meals must be incidental to the event’s main purpose. They should be “moderate and reasonable as judged by local standards.”
    • Companies are not allowed to pay for stand-alone entertainment or “other leisure or social activities.”  

-What do you find to be the most challenging aspect of obtaining funding from the pharmaceutical industry?
-What have you done to secure funding that has been most successful?
-What have you done to “think out of the box” on securing funding?
-What information or support would you find most helpful in these efforts?

 

 

 

 

Chapter Leader’s Experiences in Writing Resolutions for House of Delegates

Dan Haimowitz, MD, CMD, has worked on several resolutions that have passed the AMDA House of Delegates; and he knows the best way to make sure that resolutions don’t get lost in the shuffle or dismissed. He offers some tips from his extensive experience for other state chapter leaders:
• Start with an issue that you are passionate about and that is of national—not just regional—import or concern.
• Don’t assume someone else will address or has addressed the issue. (See http://www.amda.com/governance/papers.cfm for a list of resolutions that have passed the House through March 2008.)
• Always be thinking about issues that could/should be addressed in a resolution. Ask about potential issues at state chapter meetings.
• Seek input on your ideas and your drafted resolutions from leaders and experts outside of your chapter.

Dr. Haimowitz also suggested some “don’ts” that could kill a resolution before it gets started:
• The resolution addresses an issue that is not of national interest.
• The fiscal impact of the resolution makes it unfeasible.
• The resolution itself is not actionable (for example, it requires the support of a broad array of organizations or it presents an unpopular issue or point that is not supported at the state or national level).
• The resolution is too wordy and/or the action unclear. “The ‘whereas’ section paints the picture and sets the tone, but it virtually disappears after the resolution is passed; so you really have to make sure that the action—‘be it resolved’—provide a clear action,” Dr. Haimowitz said.

Dr. Haimowitz urged state chapter leaders to reach out to him or others who have worked on successful resolutions. These individuals can help chapters develop resolutions that have the best chance of passing the House of Delegates and becoming part of AMDA policy.

Do you have any questions for Dan?

Contributing to AMDA Policy Via Resolutions

“If you have evolving changes in your area that you think need national attention, this may be the place,” Leonard Hock, DO, FACOI, CMD,said of resolutions to be submitted to the AMDA House of Delegates. Dr. Hock, AMDA House of Delegates Chair, discussed the how-tos of creating and submitting a successful resolution during a recent conference call with state chapter leaders.  

There are several keys to resolution success, said Dr. Hock. These include effective formatting, without which, he stressed, a resolution cannot move forward. “Resolutions begin with background information and conclude with a specific proposal,” he noted. Background information follows the term whereas, while the proposed course of action is set forth by the term “therefore, be it resolved….” The background information provides the rationale for the course of action; the “whereas” statement should lead readers to the conclusion.

 In writing the “whereas” statements, Dr. Hock advised, begin with an introduction to the resolution’s topic. “Be factual rather than speculative. For the ‘resolved’ portion of the document, keep it short and to the point. Limit it to 2-3 statements and 2-3 lines in length. Bear in mind that it is only the resolved portion of the resolution on which action is taken, so it must be capable of standing alone,” he said.

 Dr. Hock stressed that AMDA leadership and staff will work with state chapters to make sure that resolutions are well crafted before they go to the House of Delegates. When it comes time to submit the resolution, it is essential to follow the instructions detailed on AMDA’s Web site at http://www.amda.com/governance/papers.cfm. “The rules for submission are strictly applied,” Dr. Hock emphasized.

 Dr. Hock urged state chapter officers to take the lead on developing and submitting resolutions from their states. AMDA President Charles Crecelius, MD, CMD, added, “We get excellent ideas, actions form the state chapters and it is very important for them to present their ideas, problems, concerns, issues in form of a possible resolution.”

What issue(s) are you facing that might warrant a resolution in 2009?

Sample - Talking Points on Hospice Care

Here is a sample of talking points developed for the subject of hospice care. You can use this as a guide for developing talking point son any topic.

• Family members sometimes hesitate to put their loved one in hospice care because they don’t understand the services or benefits or don’t want to admit that the person is dying. It is important to discuss your fears and concerns with your physician. He or she can help you make decisions about hospice when the time comes. The physician is an advocate for families as well as patients.
• Palliative care is part of hospice care. While pain management often is an important aspect of end-of-life care, palliative care goes much farther than that and involves management of symptoms such as nausea and vomiting, spiritual care, and comfort care such as music or pet therapy.
• A current advance directive, a document that details the patient’s preferences and wishes (such as whether or not he or she wants tube feeding or to be resuscitated), is an important way to make sure that the facility and staff understand what your loved one wants—even when he or she is too ill to speak personally. Your physician can tell you more about this document and how to complete one.
• Family support is an important part of end-of-life care and involves bereavement care and needed counseling from social workers, clergy, and support groups. It is important to discuss your feelings with your physician. He or she can help you get the services and support you need to deal with your loved one’s illness and death.
• Hospice care should involve a physician who understands the patient’s needs and feelings. This physician can help minimize negative outcomes such as weight loss, pressure sores, depression, and dehydration.
• Good communication is important in hospice and palliative care. Work with your physician to help make sure that he or she and staff know your loved one’s needs and preferences. It is important to remember that your physician is an ally in this difficult time.

Supporting Points:

• Approximately 1.3 million patients received hospice services in 2006, a 162% increase in 10 years.1
• Approximately 870,000 patients died while in hospice care, while 220,000 were discharged live. About 36% of all deaths in the U.S. in 2006 involved patients in hospice care.1
• The average length of stay in hospice care is 59 days.1
• Most hospice programs are operated out of the home or a setting such as a nursing facility.
• Non-cancer diagnoses are the most common reasons for admission to hospice. Heart disease is the most common diagnosis.1
• Patients with dementia, including Alzheimer’s disease, account for approximately 10% of hospice admissions.1
• Four out of five hospice patients are 65 years of age or older, and one-third are 85 years old or older.1
• There are more than 4,500 hospice programs in the U.S. today.1
• In 2007, a study demonstrated that hospice services save money for Medicare and bring quality care to patients.2
• On average, about two family members per hospice death receive bereavement support from the hospice; this commonly involves seven contacts—such as follow-up phone calls, visits, and mailings—during the year after their loved one passes.1

1. NHPCO web site: www.nhpco.org/files/public/Statistics_Research/NHPCO_facts-and-figures_Nov2007.pdf
2. Taylor DH Jr et al. What length of hospice use maximizes reduction in medical expenditures near death in the US Medicare program? Soc Sci Med 2007 Oct;65(7):1466-78.

The Media Wants An Interview - Help!

It’s Friday afternoon. You’re ready to leave your office when your assistant says a reporter from a national magazine is on the phone for you. What do you do?

If you ask your assistant to tell the reporter you’ve already left for the day and to take a message (that you know you won’t return), you’re making a mistake. As intimidating, upsetting, or inconvenient an interview may be, it also can do much to promote your facility and your profession in a positive way.

There are tips for handling press inquiries that are win-win for both you and the reporter. Follow these and you can take that next call with confidence:

• Find out specifically what the reporter wants. What is the subject of the article or segment? Who else is being interviewed? What is the purpose of the article or segment?
• Don’t agree to an impromptu interview. Find out the reporter’s deadline and agree on a time for her or her to call back. Even if the deadline is in an hour, ask for 10 minutes to pull your thoughts together. If possible, have the reporter send you questions in advance.
• Don’t agree to talk about topics you feel ill equipped to address. If possible, refer the reporter to a colleague or other individual who has expertise on the topic. Decline such interviews politely, and tell the reporter what topics you would be willing to discuss.
• Prepare notes (including talking points—see below) for the conversation.
• If you work for a facility with a community/media relations staff member, have this individual present during the interview.
• If the interview involves your chapter, discuss it with your executive director or board prior to the conversation. If possible, have another chapter leader present during the interview.
• Most publications will not let you review the article before it goes to press. If you are concerned that a reporter has misunderstood something you’ve said, ask him or her to repeat it back to you.
• If you have real concerns that a reporter is determined to produce a negative story or that he or she misunderstands what you are saying, it is okay to terminate the interview and request that your comments not be used. Do this firmly but politely.

Boost Confidence with Talking Points

AMDA has produced talking points on a variety of popular and important topics that you can use during your conversations with reporters. These talking points offer facts and figures, consensus opinions, and key details about issues such as assisted living, the role of the medical director, end-of-life issues, consumer health education, and other issues.

Prior to an interview, read through the talking points and determine which you want to emphasize. Keep them handy during the conversation and refer to them when necessary.

The preceding article is a sample of talking points on hospice care. You can use it as a guide for developing talking point on any topic.

Do you have any suggestions for working with the media? What has your own experience been with interviewing?

Keep the Chapter Momentum Going - Perry Kemp (GMDA Executive Director)

Georgia Medical Directors Association Executive Director Perry Kemp, PharmD, offers these tips for maintaining chapter momentum and member involvement:

  • Have someone who by job description is responsible for making sure assignments are done, goals are met, and timelines followed.
  • Rotate board terms so that you always have experienced and new members serving together. This helps keep enthusiasm and ideas fresh.
  • Never waste your members’ time. Know what they want and need from you and give this to them consistently.
  • The key word in educational programming is “practicality.” Include take-home points in educational programs that physicians can implement successfully into their practices when they return home.
  • Keep it simple. Don’t be so ambitious about member services that everyone is exhausted and/or program quality suffers. Commit to only the number and size of programs you can comfortably and effectively provide.
  • Keep lists of all facilities and medical directors in the state. Send mailings to these individuals, even if they aren’t members.

Do you have additional tips to share?

 

Strengthening Your State Chapter - Interviews with Drs. Gilson and Goldberg

In many ways, state chapters are living, breathing organisms. Without care and feeding, they suffer and get weak. However, caring physicians with determination and enthusiasm can strengthen their chapters. Currently, two chapters in the process of revitalization have lessons to share about breathing new life into their organizations.

 

In Oregon, Ron Gilson, MD, CMD, says, “The main issue is how to get more people involved in our chapter. We’re trying to create a newsletter and offer meetings with content that practitioners will see as valuable. Ensuring that the chapter’s governing documents match the organization’s needs and demographics is another issue,” he noted. Therefore, the group changed its by-laws so that the board’s make-up can be flexible in terms of size and location of board members. “Our membership is scattered. No two people on the board live in the same city, so it’s a challenge for us to gather or to schedule meetings that everyone can attend,” he explained. Enabling a board that can be smaller—or larger–if necessary or that includes more practitioners from the same region can enhance involvement and decision-making.

 

“We only have 140 nursing facilities in the state,” said Dr. Gilson, “and I’m medical director for five of them, so there just aren’t that many medical directors in Oregon. Many facilities have problems finding a physician leader. We plan to reach out to the Oregon Health Care Alliance and work with facilities to build awareness of the profession and make medical direction a career track for more physicians.”

 

Todd Goldberg, MD, who is revitalizing the West Virginia state chapter, has reached out to other organizations for support. For example, he is working with another geriatrics-related state chapter to develop a membership brochure. They then will coordinate a mailing to prospective members.

 

While partnerships and relationships with other groups can be enormously helpful, Dr. Gilson learned not to be too dependent on others to provide leadership for state chapter activities. His group had partnered with another state organization to present educational programs. However, when Dr. Gilson went off the Oregon state chapter board and was no longer involved in meeting/education planning, these activities fell by the wayside. “We need to communicate in person and via conference calls more frequently, and we need to make sure that people follow through on assignments and responsibilities. You can’t assume someone else is doing things,” he said. Dr. Gilson added, “We need to keep track and make sure goals are set and reached to maintain and build momentum.”

 

Todd Goldberg, MD has determined that less is more. “We need a different approach from chapters in larger states, including smaller activities regionally. We’re planning some small dinner educational programs throughout the year to try to reach more people in various parts of the state,” he said.

What are you doing in your state to strengthen your state chapter?

State Chapters Can Improve Physician-Surveyor Relationships

AMDA state chapter leaders can do much to help their members establish and maintain positive relationships with state surveyors. Dr. Crecelius suggested, “Start by choosing an area of mutual interest—one that is not on the front burner and that doesn’t involve conflict.” It is essential to start and maintain relationships on an even keel, where no side feels threatened by or acrimonious toward the other.

“If you must address a ‘hot’ topic, keep the focus on the positive—how to make improvements—and not on what either side is doing wrong,” Dr. Crecelius suggested. “Keep it strictly educational,” he added. Another way to safely address a hot-button issue is to partner with the state Quality Improvement Organization to keep the focus on quality improvement.

In meeting with surveyors, remember that it is “not a forum to hash out disagreements or argue about a past survey. Keep self-interests out of all interactions. “Surveyors need to see that the focus is on quality care and not ‘dings,’” said Dr. Crecelius.

One important way to establish and maintain relationships with state surveyors is to help fill their educational needs. Offering to speak at surveyor meetings and volunteering as a informative—and objective—resource on resident care issues likely will be welcome. As surveyors are hungry for education, inviting them to state chapter meetings is useful; but it calls for some preparation. Remember that surveyors can’t accept “freebies,” so consider offering scholarships to enable them to participate.

“Remind your members and other meeting participants that surveyors are not the enemy and that we all need to work together on a common goal of quality care,” Dr. Kerr said, emphasizing, “Chapter leaders need to set the tone for these meetings.” Adversarial comments, hostile questions, and complaints should be avoided at all costs. “If you invite surveyors to your meet and your members gang up on them when they come, you’ll never get them to another meeting,” he said.

What have you done to establish relationships with surveyors in your state?

What topics or issues did you first start discussing with them?

Missouri Sets Tone for Work with Surveyors

Physicians in states such as Missouri have established relationships with surveyors by working with them and their agency. According to AMDA President Charles Crecelius, MD, CMD, a multi-facility medical director in the state:

We have evolved our surveyor agency physician advisory board into a best practices group that holds meetings and includes representatives of the home associations, administrators, ombudsman, local federal surveyors office and state surveyors office, Center for Practical Bioethics, and interested parties such as the state hospital association or Medicaid office–depending on what subjects we are discussing. We meet at the state Quality Improvement Organization (QIO) offices; and we address variety of subjects, such as uniform transfer forms, nursing education, intimacy in nursing homes, survey problems “de jour,” and other issues. The group has been quite effective and productive. Our main challenge is how to improve communication between and among group members and how to implement best practices we identify.”

Missouri Medical Director Jeffrey Kerr, MD, CMD, added, “Surveyors learn so much from these meetings; and many good things have come out of them.” For example, working with the Missouri End of Life Coalition and the Missouri Department of Senior Services, the group developed an end-of-life manual for the state that can be downloaded from the Internet. It tells facilities how to care plan for end-of-life patients and how to develop a palliative care plan.

How did you work with surveyors in your state to resolve an issue or problem?