By Dawn Rotellini, Sr. Vice President Chapter Development & Education, NHF
Michelle Rice, Sr. Vice President Public Policy & Stakeholder Relations, NHF
How many of you remember the first time you heard the terms Hemophilia, VonWillebrands or even “bleeding disorder”? Whether you have a family history of bleeding disorders or not, diagnosis can be frightening. Adding to the fear is the use of new terminology, clotting factor, HTC, specialty pharmacy, etc. If you do not have a family history, another factor contributing to your fear is not knowing anyone else affected and not knowing what to expect.
Comprised of patients, families, friends, local and national advocacy organizations, health care providers, manufacturers and pharmacy providers, the bleeding disorder “community” is a vital resource for those affected and their families. Very few communities are able to come together and support each other the way this community has for many years.
While the spirit of the community hasn’t changed, its membership has grown and various rules and regulations have been put into place that impact the way some of these members interact. For example, over the years, the number of manufacturers and pharmacies serving the community has grown.
NHF often receives calls inquiring about the “relationship” between industry and patients and/or chapters and whether or not NHF has established any guidelines relative to these relationships. These inquiries have increased as consumers have transitioned into positions within industry. We understand that our industry partners are important to NHF, chapters and patients. While NHF does not have a formal set of guidelines, we choose to follow the rules/laws established by state and federal government and the trade associations representing manufacturers and specialty pharmacies. We encourage our member chapters to follow that same path. In addition, over the past few year NHF has developed a series of educational modules entitled “How to Be a Good Consumer” to inform consumers about these rules and how they may impact them.
The relationship that Industry (pharmaceutical companies and homecare companies) has with patients has changed over the past several years. This is due to changes in laws, regulations and oversight that government agencies have seen to be corrective action. What were they correcting? In the old days, you might say, things were just fine… many companies took care of needs that a patient or family might have because they were on their service (for homecare companies) or because they used that particular factor product. What was wrong with that practice? The government began to view this as inducements by companies to increase their business.
Whether or not you feel that the laws are justified, the fact is there are laws in place now that help to regulate the actions of companies and how they interact with patients. The Office of the Inspector General of the United States Department of Health and Human Services (OIG) regulates the behavior of manufacturers and homecare companies through Advisory Opinions. While traditionally, manufacturers of factor products have been held under more stringent guidelines than homecare companies, that has also changed over time.
Focusing on manufacturers, they cannot give any items or support of monetary nature directly to patients or potential patients. Manufacturers are also regulated on how they do business with doctors, nurses, social workers, etc. They are regulated by federal and state laws. These laws are changing constantly – recently pharmaceutical companies have stopped providing pens and sticky pads and other giveaways with their logos on them at our Chapter meetings due to these changing laws. Currently, any item that is not “medically based” can be construed as inappropriate.
Turning our attention to homecare companies, in September 2002, the OIG issued an Advisory Opinion #02-14 regarding the provision of certain free goods to individuals with hemophilia. This Advisory Opinion was drafted in response to a request by a home infusion provider seeking guidance on the legality of providing free “safety related” goods to hemophilia patients. In addition, a Special Advisory Bulletin was offered by OIG to homecare companies on “offering gifts and other inducements to beneficiaries”.
So what does this mean to you the patient or to the companies? Here are some simple questions and answers found on the OIG’s website that may help:
- Why were the Advisory Bulletin and the Advisory Opinion issued? To give healthcare providers and suppliers a better general understanding of the provisions of the federal Anti-Beneficiary Inducement Regulation. Safety items mentioned include, among other things, helmets, kneepads, medic alert bracelets, and pagers.
- What items can a home infusion company provide to hemophilia patients for free? The monetary value will dictate, not the description of the item, what is and is not legal to be given to a patient. Items of “nominal” value do not violate the federal Anti-Beneficiary Inducement Regulation and the Anti-Kickback Statute. The limits of “nominal” value are set at $10 per individual item and no more than $50 worth of items per individual per year. The Advisory Opinion does specifically prohibit the provision of pagers to patients because they exceed this set financial limit.
- My homecare company has been paying for me to go to regional or national education meetings such as HFA or NHF Annual Meetings. Does this violate the policies? YES! As long as the support or gift value of more than $10 per item or $50 per year per person, it is not legal under OIG’s guidance. The regulation prohibits gifts or payments in order “to induce patients” to select a particular supplier or provider of healthcare items or services.
- What are the consequences if I or my homecare company break this law? Fines of up to $10,000 per violation for the homecare company or supplier. If it is determined that the Anti-Kickback Statute was violated, fines, exclusion from Medicare and Medicaid and, criminal sanctions including jail sentences could be invoked upon a party giving or receiving prohibited remuneration.
NHF & chapters understand the value and importance of relationships formed within the community. In our role as advocates it is our job to lead by example and to ensure that the community is aware of the rules/laws and guidelines that govern the consumer/industry relationship. EDUCATION is the key to reducing the risk of unknowingly violating the rules and the potential consequences of that action.
It is also important for consumers to recognize that they have control over their personal health information and should consider how and when they want to share it with others. For example, there are many educational programs and events offered to members of the hemophilia community, some by your local chapters and others by members of industry. It is important to know what type of information you have to share when attending these programs and how is that information utilized. For example:
- Do I have to provide my contact information? (Industry members are often required to provide information on number of attendees, etc at events they sponsor, that being said, you can choose how much information you want to provide, ie full name or initials)
- Do I have to share my diagnosis? What about the product I use? (the answer is NO)
- The event includes a raffle that I want to participate in but I am required to give my contact information, what do I do? (this is up to you as an individual; a few things to consider, does the raffle ticket state that by participating you will be added to a mailing list? Is there an “opt out” option” ? If you voluntarily provide your contact information, do not be surprised if you are later contacted)
The bottom line is that if you are asked to share more than you are comfortable with, you always have the option of saying you do not wish to participate. If you are not sure what is going to be expected, ASK before you agree to attend.
Ultimately we all have a responsibility to take care of one another and the best way to do that is to know, understand and follow the rules and regulations in place so that the amazing relationships we develop as part of this community are not jeopardized!