Will vendors now boycott Massachusetts?

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Medical device development in Massachusetts

Speaking as a member of the orthopedic medical device industry, it is our hope that the regulatory process will allow input from industry to develop reasonable disclosure guidelines without stifling activities that are beneficial to Massachusetts healthcare consumers.

Below is an abbreviated letter which was sent to Governor Patrick, which includes our recommendations to improve the bill.

It is very important to note that the pharmaceutical and medical device industries are very different. Proper implantation of a medical device requires ongoing consultation and evaluation from surgeons, as well as continual training of surgeons on the proper use of the devices, which, in our industry (orthopedics) vary significantly from manufacturer to manufacturer. Restraining these activities in the interest of disclosure is a bad trade-off, and may very well drive up the cost of supplying advanced devices to the state.

Here are excerpts from our letter to Gov. Patrick:


We are in favor of meaningful disclosure of information related to relationships between healthcare providers and the medical device industry. It is appropriate for the medical device industry to disclose payments to healthcare providers who are engaged in consulting relationships with manufacturers, or are in receipt of significant grants or donations. This is information that could potentially benefit the healthcare consumers of Massachusetts. Biomet and its major competitors already disclose this information on our websites (see, for example, www.biomet.com).



However, S. 2863, as written, requires disclosure of each and every transfer of ?economic value? of $50 or more to any healthcare provider, for any reason, with no exceptions. This bill will give Massachusetts the reputation as the most difficult state in the country in which develop, evaluate and deliver innovative medical devices.


If, for example, a hospital negotiates a contract that includes a discount on medical devices, the bill, as written, could be interpreted as requiring that the value of the discount be disclosed. The administrative burden of disclosure and the accompanying disclosure fee required by S. 2863 reduce the likelihood of manufacturers negotiating discounts with Massachusetts hospitals. The unintended, but real, consequence of this bill is that manufacturers will have to incur higher costs, which will make their products more expensive to deliver in the state of Massachusetts. We do not believe that the benefit of this disclosure outweighs the potential cost of more expensive healthcare in Massachusetts.


The bill creates unnecessary restrictions on patient education


Many medical companies provide useful patient education tools to doctors. These may include samples of medical devices, educational brochures, flipcharts, and other materials which help doctors educate patients on how devices are used and what to expect from surgery. The AdvaMed code reasonably makes exceptions for such materials, whereas S. 2863 does not. This bill will deprive patients of useful education, with no offsetting benefit. Since providing such materials is routinely done by device manufacturers, this activity cannot be construed as an inducement to prescribe any individual company?s device. Because S. 2863 will require burdensome disclosure of such activities, they will likely be curtailed or cease, to the detriment of patient education.


We recommend that S. 2863 be modified so that Massachusetts adopt the AdvaMed and PhRMA code, and strike the language that the code of conduct be ?no less restrictive
than the most recent version? of these codes. The state can benefit from the significant amount of time and effort that AdvaMed and PhRMA have put into developing these codes, in order to develop a reasonable balance between promoting ethical conduct and allowing reasonable business practices which benefit all stakeholders in the healthcare system.


Training of surgeons in Massachusetts will be unnecessarily discouraged, to the detriment of patient care.


Medical device manufacturers are required to train surgeons on the safe and effective use of our products, either by FDA mandate or by our obligation to promote proper implantation of the devices.


Biomet has held several successful training courses in Boston for our Oxford partial knee, a unique, minimally invasive device which allows for greater bone preservation, reduced pain, and faster recovery than total knee replacements. It is beneficial to Massachusetts patients that their surgeons offer this device. The FDA has mandated that no surgeon may implant the Oxford without first attending Biomet-sponsored training.


Over the past 18 months, we have held two courses in Boston, each of which attracted over 200 orthopedic surgeons. Courses of this size, which include hands-on laboratories, cannot be held in a doctor?s office or a hospital. As written, S. 2863 would not allow us to provide a coffee break to any Massachusetts surgeon attending such a meeting.


By creating barriers to training surgeons, S. 2863 discourages medical device companies from bringing their most advanced technologies to Massachusetts. This is not in the best interests of patients who could benefit from the Oxford partial knee, the only device of its kind available in the United States.


We recommend that S. 2863 spell out clear exemptions for meals provided at legitimate non-CME training courses, and that these meals be allowed in settings other than a hospital or doctor?s office.


The AdvaMed code already provides reasonable restrictions on providing meals that are either lavish or not accompanied by appropriate business-related discussions. S. 2863 merely provides unnecessary and redundant restrictions on reasonable business practices, and will create unintended, negative economic consequences to the state.


The bill will impede surgeon freedom to choose the best implants for their patients, and slow down clinical decision-making


S. 2863 also states that reasonable expenses may be paid for necessary training, but only if it is part of a purchase agreement contract with the hospital.


This creates two problems. First, most surgeons will not decide to implant a medical device without first being trained on its features and proper use. Thus, a surgeon must first be trained before a purchase agreement is signed. The bill, as written, will put surgeons in the difficult position of having to decide to implant a device before receiving proper education on its safe and effective use.


Second, the vast majority of hospitals with which we do business do not require written agreements. Typically, a surgeon will choose the appropriate implant for a patient, and the hospital issues a purchase order following the surgery.


If training must be included in a contract, then all hospitals will require contracts in order for a device to be brought in to a hospital, creating additional delays, and adding cost and burden to Massachusetts hospitals.


Surgeons must be free to choose whichever implant they need to best meet the patient?s needs, often on short notice. Hospitals purchase agreements will serve as barriers to free choice and rapid decision-making, to the detriment of patient care.


Medical device manufacturers are happy to absorb the cost of necessary training. Creating barriers to training will simply drive up the cost and the risk of surgery involving medical devices in Massachusetts.


We recommend that S. 2863 include an exemption that allows manufacturers to provide free training that is not included in a purchase contract, without the burden of disclosure.


Massachusetts? most innovative physicians will be discouraged from commercializing their inventions


In order to develop products, engineers from companies such as Biomet must meet with surgeons, review x-rays, conduct bench studies at our facility and other research facilities, and conduct ongoing clinical follow-up. Much of this activity, of necessity, takes place outside of a physician?s office, hospital setting, or home town.


The bill clearly states that medical device manufacturers must provide no meals outside of a hospital or doctor?s office. This is unreasonably restrictive, creating unnecessary barriers to developing products with Massachusetts doctors, which will have the unintended consequence of stifling innovation. Whatever savings are contemplated by this bill will be offset by the loss of revenue coming into the state as a result of innovation moving elsewhere.


Further, the fees and administrative burden associated with disclosure simply make it more expensive to work with Massachusetts surgeons.


We recommend that S. 2863 be modified to provide clear exemptions for meals and other expenses provided in the delivery of bona fide consulting and product development services.


Conclusion: As written, the bill is overly broad and restrictive. With appropriate, clearly-written exemptions, the bill could achieve its goal of disclosing those relationships which are of interest to its citizens, without stifling innovation and training, and without driving up the cost of healthcare in Massachusetts.

Posted by: bkolter   Posted on: 08/11/08 You are currently: a Guest | Members login | Terms of Use

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