• Bleeding Disorder Basics
• Emergency Management Guidelines

• National Bleeding Disorders Foundation (NBDF)
• Hemophilia Federation of America (HFA)

The Emergency Assistance program is designed to provide emergency relief for individuals with bleeding disorder and their families.

The intent of the program is providing temporary help to families/ individuals that find themselves in hardship and need assistance with emergency medical treatment, supplies, assistance during a hospital stay, assistance with travel for medical attention, and assistance in case of family illness and death. The application process requires a completed application, a description of the need, verification of Bleeding Disorder, and verification of need. Funding is limited to $500 per individual with a bleeding disorder per 12-month period (January to December). Special requests that do not fit within the categories listed above require special approval from PNWBD Executive Committee. Persons requesting assistance that would exceed the $500 per individual annual limit requires special approval from PNWBD Executive Committee.

Contact our office for more details or an application.

Go to Dinner… Go to Jail?

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
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:

1. 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. (A homecare company asked for help!)
2. 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.
3. Can my specialty pharmacy pay for me to attend regional or national education meetings such as HFA or NHF Annual Meetings? Does this violate the policies? NO! – If the support or gift value is more than $10 per item or $50 per year per person, it is illegal 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. (Dinner?)
4. What are the consequences if my specialty pharmacy provider or I break this law? Fines of up to $10,000 per violation for the specialty pharmacy providers 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.
5. Does this law only apply to those who are on Medicaid or Medicare? No, many states apply those “Medicare and Medicaid” anti-kickback laws to private insurance as well. State Anti-Kickback Laws. Anti-kickback laws make it a criminal offense to knowingly and willingly offer, pay, solicit or receive a kickback, bribe or rebate or to induce or reward referrals or items or services reimbursable to a government health care program. As of July 2009, the federal government, 36 states and the District of Columbia had anti-kickback laws. State anti-kickback laws usually apply to all payers; the federal law applies only to federal health care program pay­ments. In one state, the state law preempts state Medicaid anti-kickback laws.

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.