The Do’s and Don’ts of Pharma and Homecare Relationships
(Adapted from the presentation by Brendan Hayes of the National Hemophilia Foundation)
Choosing a Provider
When choosing a factor provider, the questions you ask are important, so choose wisely. You should ask yourself the following questions: What product(s) and services do I need for my/my child’s care? Does my insurance plan dictate my choice of providers? If so, who are the preferred providers? What is my financial responsibility under my health plan?
Now that you have identified your needs, you can interview potential providers. Here are some sample questions: Do you carry all brands and assay sizes of clotting factor? What ancillary products and services are available (i.e. needles, syringes, home nursing, etc.)? Are you a preferred provider in my network? How long have you been a provider?
Expectations for your provider can be determined by choice, law, and/or standards. When setting expectations, make sure you clearly communicate, set realistic and achievable expectations, and know the “cans” and “cannots.” Industry and provider expectations may be impacted by laws and standards.
Industry and the Consumer
It’s important to be aware of certain aspects of the law that can affect your expectations and interactions with providers and industry. The Office of the Inspector General (OIG) regulates the behavior of manufacturers and homecare/specialty pharmacy providers through advisory opinions. In the past, guidelines were more stringent on manufacturers than specialty pharmacy, but this has changed over time.
Manufacturers cannot give items or support of any monetary nature directly to patients or potential patients. These laws also regulate how industry interacts with doctors, nurses, social workers, etc. Regulations are issued at both the federal and state level. In addition, PhRMA (Pharma Research and Manufacturers Assoc.) issues guidelines governing manufacturers as well.
In 2009 stricter guidelines were put into place for manufacturers. Giveaways are being scrutinized. Any item not “medically based” can be construed as inappropriate. Representatives from companies are having to work with their legal departments on what is and is not “ok” (ex. volunteering at camp). WHY? Liability Issues! Legal departments are becoming more conservative and the bottom line is becoming tighter.
Some examples of regulations issued by OIG related to hemophilia specifically. August 30, 2002, the OIG issued a Special Advisory Bulletin on “Offering Gifts and Other Inducements to Beneficiaries.” Advisory Opinion No. 02-14, issued September 30, 2002, regarding the provision of certain “free goods” to individuals with hemophilia.
Here are a list of questions and answers regarding the OIG Opinion:
Standards and Guidelines
Who creates guidelines from the patient perspective? Who is MASAC? In 1954 NHF formed a medical advisory council to advance clinical care and promote hemophilia research ((the Medical and Scientific Advisory Council or MASAC). Scientists, physicians, and other treatment professionals who are internationally recognized as experts in the broad field of bleeding disorders research and care. What do they do? They establish quality of care guidelines for the treatment of hemophilia and other bleeding disorders. They also meet twice a year to issue and update recommendations.