Otolaryngologists agree with their fellow physicians who prescribe drugs-pharmaceutical companies have no business buying or using information on how and when they prescribe particular drugs, nor do they want to be confronted by pharmaceutical company representatives in their office about why they do or don’t prescribe that company’s products.
I feel that it is an invasion of privacy to allow pharmaceutical companies to use doctor’s prescribing information, said Stephen Wetmore, MD, MBA, Professor and Chair of Otolaryngology at West Virginia University School of Medicine in Morgantown. This information should not be sold or made available to pharmacy benefit management companies, he added.
So many physicians agree with Dr. Wetmore that the American Medical Association (AMA) has announced the launch of a new Web-based Prescription Data Restriction Program (PDRP) that will allow physicians to opt out of having their prescribing data history sold or shared with drug companies or their partner companies. If a physician chooses to opt out he or she will have his or her name specifically marked on the AMA’s Masterfile, a database that includes specific physician data. Health Information Organizations (HIOs) and pharmaceutical companies that now use the extensive database will still be able to view the individual doctor’s information but will not be permitted to use it for marketing purposes if that physician has registered with the opt-out program.
There was a lot of confusion among doctors about how this information was being used and what could be done about it. What came through clearly in the survey was that physicians overwhelmingly felt that they should have the option to keep their records private. – -Robert Musacchio
AMA Institutes Opt Out
AMA officials estimate that it will take approximately 90 days for the red flag to be put on the physician’s file information. The PDRP program officially began July 1, but was actually up and running May 1. Robert Musacchio, Senior Vice President of Business and Publishing for the AMA told ENToday that by mid-June approximately 1500 physicians had already registered for the program via the AMA’s Web site. Mr. Musacchio spearheaded efforts in the past three years to strike a balance between individual physician wishes and what the organization sees as an industry practice that promotes evidence-based health-care research and the advancement of science. We need a policy that is not so draconian that it cripples business or too lax so that we lose the respect of our members, he said.
AMA contends the PDRP program will allow the practice of selling drug prescribing data only for those physicians who have no objections. However, it is not just the AMA member physicians who reject the selling of their practice information. State legislators in four states have introduced legislation to ban the practice entirely, a move that the AMA is strongly against. In New Hampshire, House Bill 1346 was approved unanimously by the State Senate after similar approval by the State House and was signed by the Governor June 30. It became effective immediately. The bill allows for the use of prescribing data for research and public health purposes, but bans the use for marketing purposes (see highlights from the bill text, right).
But Dr. Wetmore said the AMA’s opt-out program may not be enough. Providing an opt-out provision is insufficient if we are not informed of the use of the pharmacy data, he said. Dr. Wetmore wishes the West Virginia legislature had acted on that state’s proposed bill that died in committee. I am sorry that the law to protect the privacy of this information did not pass the West Virginia Legislature this past year. It is an invasion of my privacy if drug companies or drug benefit managers use prescribing information, even if patient identifiers are not included, he added.
Physician support for changes in the law and for the new program ultimately comes down to privacy. I am not a big prescriber of drugs in my practice, but I totally agree that what I do in this regard as an otolaryngologist should be private, said Phillip Daspit, MD, an otolaryngologist-head and neck surgeon in Phoenix, Ariz. I should definitely have the ability to tell a drug company that they have no right to know what drugs I prescribe in my practice, he said. Dr. Daspit supports a bill introduced in the Arizona legislature earlier this year. That bill, HB 2800 that failed to be voted out of committee, would make the release or sale of confidential prescription information an act of unprofessional conduct. Likewise, Dr. Daspit said he intends to sign up for the AMA opt-out program even though his information is limited.
I feel that it is an invasion of privacy to allow pharmaceutical companies to use doctor’s prescribing information. This information should not be sold or made available to pharmacy benefit management companies. – -Stephen Wetmore, MD, MBA
Since 2000, the AMA has been hearing from its members about the obtrusive techniques of sales representatives in their offices. By 2003, said Mr. Musacchio, the pressure on the AMA to do something to protect physician privacy was overwhelming. The group conducted an extensive telephone survey of close to 7000 physicians across the country, including both AMA members and non-members. There was a lot of confusion among doctors about how this information was being used and what could be done about it, he said. What came through clearly in the survey was that physicians overwhelmingly felt that they should have the option to keep their records private, he added.
Other medical groups had also expressed concerns to the AMA about the sharing of this information. The American College of Physicians (ACP) expressed its concerns to both the AMA and to the Office of the Inspector General (OIG) of the US Department of Health and Human Services in 2003. ACP said in a letter to the OIG that, The sale of physician prescribing habits by pharmacists to outside parties is a common practice and can unduly influence medical choices by physicians. The group representing internists and medical students further asked the federal government to promulgate regulations ensuring the confidentiality of this data and proscribing its sale or release to outside parties.
Mr. Musacchio said much of the concern expressed by physicians about the sharing of prescribing data is tied more to the individual practices of sales representatives rather than the actual sharing of this data. In addition to making it possible for individual physicians to opt out of this information sharing, he said the AMA will also initiate education on responsible use of the data to pharmaceutical companies and HIOs-and to physician groups on the benefits of sharing prescribing data.
The PDRP is described in an editorial in the AMA publication American Medical News as, a painless way for physicians to push back. The AMA said it has never compiled or sold physician prescribing data. Mr. Musacchio explains that HIOs routinely obtain prescribing data from pharmacies, claims processors, and pharmacy benefit managers and append the data to a variety of physician databases including the AMA’s Masterfile. This compiled data is then packaged and licensed to the pharmaceutical industry. According to AMA, prescribing data used by HIOs are subject to HIPAA privacy requirements and do not contain patient identifiable information.
AMA said it supports this data profiling because it can be used to detect drug diversion, target promotional and marketing materials, and distribute pertinent drug samples and educational materials to physicians. Absent specific prescribing data, pharmaceutical companies would likely market products and deliver drug samples by geographic location and practice specialty, resulting in irrelevant sales calls and product samples, said information on the Prescribing Data Information Center listed on the AMA Web site. This center includes information on what the AMA considers responsible use of prescribing data by HIOs and drug companies. The AMA has also developed guidelines for industry on the use of physician data.
In addition to allowing individual physicians the opportunity to opt out of pharmacy data sharing, the new AMA program also gives physicians the opportunity to register complaints against a company or individual who has used the information inappropriately. The AMA will take appropriate action on behalf of the physician based on specifics of the complaint, said the association.
AMA tells Pharma to Heal Thyself Before the Government Does
Part of our role is to help the pharmaceutical industry understand that its representatives are not following guidelines on discussions with physicians and are alienating the people they are reaching out to, said Mr. Musacchio. He said the AMA plans to work with the pharmaceutical industry to improve relationships and best practices before state legislators make the practice of information sharing illegal.
Physician support for changes in the law and for the new program ultimately comes down to privacy.
The New Hampshire legislation is unnecessary, but I can’t blame them for going ahead with the legislation because the opt-out program was not in place, he said. The AMA has strongly opposed state legislation, although state physician groups such as the New Hampshire Medical Society have supported it.
In addition to New Hampshire, West Virginia, and Arizona, Hawaii lawmakers have also introduced legislation banning the practice. The legal basis varies by state. West Virginia’s HB 4676 would make the sale of prescription information a violation of fair trade practices. Hawaii’s HB 1873 was approved by the State House but failed in the State Senate. It would prohibit the sale or transfer of patient prescription information as an unfair and deceptive act in the conduct of trade or commerce.
New Hampshire Law
Prescription Information to be Kept Confidential-Records relative to prescription information containing patient-identifiable and prescriber-identifiable data shall not be licensed, transferred, used, or sold by any pharmacy benefits manager, insurance company, electronic transmission intermediary, retail, mail order, or Internet pharmacy or other similar entity, for any commercial purpose, except for the limited purposes of pharmacy reimbursement; formulary compliance; care management; utilization review by a health care provider, the patient’s insurance provider, or the agent of either; health care research; or as otherwise provided by law. Commercial purpose includes, but is not limited to, advertising, marketing, promotion, or any activity that could be used to influence sales or market share of a pharmaceutical product, influence or evaluate the prescribing behavior of an individual health care professional, or evaluate the effectiveness of a professional pharmaceutical detailing sales force.
Nothing in this section shall prohibit the dispensing of prescription medications to a patient or to the patient’s authorized representative; the transmission of prescription information between an authorized prescriber and a licensed pharmacy; the transfer of prescription information between licensed pharmacies; the transfer of prescription records that may occur in the event a pharmacy ownership is changed or transferred; care management educational communications provided to a patient about the patient’s health condition, adherence to a prescribed course of therapy, or other information about the drug being dispensed, treatment options, or clinical trials. Nothing in this section shall prohibit the collection, use, transfer, or sale of patient and prescriber de-identified data by zip code, geographic region, or medical specialty for commercial purposes.
In addition to other appropriate remedies under this chapter, a violation of this section is an unfair or deceptive act or practice within the meaning of RSA 358-A:2. Any right or remedy set forth in RSA 358-A may be used to enforce the provisions of this section.
©2006 The Triological Society