ThedaCare, a Wisconsin-based health system recent adopted a policy change to end free samples and prohibit drug and medical manufacturer representatives from making in-clinic visits had been reported on industry websites and outlets like the USA Today. We have taken a great interest in this story and we reached out to ThedaCare, along with other Wisconsin-based health systems, for further comment.
The USA Today article, which printed earlier reporting completed by Gannett Wisconsin Media, quotes Dr. Mark Hallett, senior medical director for ThedaCare Physicians. Dr. Hallett said provision of the new Affordable Care Act, the Physician Payment Sunshine Act, is a driver of their decision to end visits. The act says health care organizations must reveal anything of value given to physicians by reps. Samples are excluded from that rule.
"It gives us the ability to really eliminate the possibility of value transfers that could make the individual physician and the organization look as though they are influenced. That's difficult to assure," he said.
Policy and Medicine reaches out to ThedaCare
We asked Dr. Hallett to describe the policy change in more detail. He first provided a brief history:
"The original conversation began with Leadership Council of ThedaCare Physicians, ThedaCare's employed primary care group, understanding the brand risk posed by the Sunshine Act on both individual clinicians as well as the organization. It was evident that we needed to modify our existing policies regarding both conflicts of interest for clinicians and interactions with pharmaceutical reps and samples to mitigate the brand risk."
ThedaCare's bigger picture:
"We then put this into the bigger picture context of the value-based reimbursement environment into which we are heading, as well as the results of recent studies showing the impact of sampling causing higher pharmacy and total health care costs. We also talked about the chronically uncomfortable dilemma created by stocking samples – the safety risks of not managing the inventory like pharmacies do, and the prohibitive costs associated with hiring additional staff to do so. We talked about persistent patient misperceptions about our relationships with pharmaceutical companies, despite the fact that we've had a policy restricting these relationships since 2004."
The Leadership Council's ultimate decision and steps moving forward:
"We decided by consensus that we could move forward more safely, better for patients, and less expensively without samples. The Council identified three requirements that we needed to meet in order to be successful with this transition: we develop a patient prescription assistance process that helps patients afford the medications that they need, we determine the medications that we must have in the clinic for medical urgencies and patient education and provide those, and we develop a reliable process to educate clinicians on new medications. We are currently reallocating existing samples to help sample-dependent patients until they can get on prescription assistance programs, planning for an October rapid-improvement event to build a better prescription assistance process, and planning for our first pharmacist-delivered value-based prescribing pharmaceutical update in November."
Dr. Hallett confirmed this policy is system-wide, including all ThedaCare hospitals.
We appreciate Dr. Hallett taking the time to answer some of our questions. Policy and Medicine is continuing to learn more about ThedaCare's new policy and have reached out to learn more about their plans to educate clinicians on new medications and if there will be an outlet for interaction between innovative medical product companies and ThedaCare providers. Updates will be posted if they become available.
However, in the USA Today, Dr. Hallett did say that patient privacy rules mean salespeople have to be kept out of patient-care areas and away from patient information. He argued that it creates logistical problems within clinics.
Dr. Hallett said reps are good people, but at the end of the day are working for their employers.
"Among other goals, their job is to influence prescribers," he said.
The root of the problem is that many drugs are unaffordable, Hallett said. Health care organizations, historically, have done a poor job of getting patients into cost-assistance programs. ThedaCare plans a rapid-improvement event in October to educate its people on those programs.
Industry comments in the USA Today
The pharmaceutical industry is keeping a watchful eye on the trend and is concerned it will become widespread, said Kendra Martello, deputy vice president for PhRMA, a trade group that represents companies like Merck and Pfizer.
"We worry about what it means for patient care and access to safety and treatment information for a certain product," Martello said. "Samples also serve an important function since they provide immediate feedback on if a medicine works (or) has side effects for that patient."
Comparing the sampling policy to other Wisconsin providers
According to the USA Today: Green Bay's Bellin Health stopped giving out samples several years ago, replacing them with vouchers and, like ThedaCare, is establishing better processes for getting patients into cost-assistance programs.
"Vouchers are easier to control. They don't expire and they don't walk off the shelf," said Amy Dettman, vice president of Bellin's physician division. "You still need a prescription to go with it."
Individual hospital staffs are charged with checking samples to ensure they aren't expired, said Roslyne Schulman, director of policy for the American Hospital Association.
"We do not have data indicating how common this practice (of banning samples) is," Schulman wrote in an email.
Prevea Health of Ashwaubenon began phasing out sample distributions a year ago, driven in part by the cost of inventory control and of disposing expired samples that sometimes made up 30 percent of the supply.
"When they expire, we have to pay to get rid of them," said Samantha Tonn, vice president of quality, risk and compliance. "There's a huge housekeeping issue. To manage inventories with as much safety and security as pharmacies does costs staff time."
It's also easier to track which drugs patients are getting if they have a prescription, Tonn said.
Aurora Health Care, which partners with BayCare Clinics in Green Bay, generally prohibits handing out drug samples, also with the idea that prescriptions should be based on which drugs best fit the situation, not which are most promoted, said Nancy Vogt, director of compliance.
Differing views on pharmaceutical and medical equipment representative visits with doctors
The USA Today notes: ThedaCare is ending the practice, Prevea and Bellin allow the visits, although in Bellin's case, after a prior-approval process. Drop-ins are not allowed by either.
"We do that so providers can learn about new products and medications," Tonn said. "It's the education that our physicians are interested in."
That's the same reason Bellin continues to allow visits, Dettman said.
"There may be new medications, new research studies. They do sometimes bring experts in," she said. "They are not the only source of information for our physicians."
Other Wisconsin providers
We reached out to several other providers with facilities located in Wisconsin. As seen in the USA Today story, most prohibit sample medication, but have mechanisms in place to allow for sale representative visits under certain circumstances. A selected portion from each is printed below:
Mayo Clinic Health System
Mayo Clinic has had a policy that prohibits the acceptance and distribution of medication samples for many years.
Mayo's policy on sales representatives covers all types of non-employees visits, including contract, labor and sales representatives. Mayo Clinic does not differentiate between different sectors of the sales industry. They all use the same policies: no samples, no free goods, no food. They are allowed to meet with physicians/clinicians, but only on the physicians/clinicians' terms.
Vendor personnel shall not solicit at any UW Health facility with the exception of the following circumstances: (1) They are contacted by a UW Health faculty or staff member who requests an appointment. "Cold calling" or approaching UW Health faculty or staff without appointments is expressly forbidden. The VLO can assist vendor personnel with making new contact with individual UW Health faculty and staff; (2) To deliver new product information for evaluation by UW Health faculty, staff, departments or committees, vendor representatives shall make an appointment at least one week in advance with the appropriate personnel; (3) To deliver new products to be considered for evaluation to the respective UW Health faculty, staff, department or committee after prior approval. Adequate descriptive literature shall accompany the product for evaluation purposes. UW Health policies on sampling must be followed; (4) To expedite the removal of recalled products from the appropriate personnel.
Use and storage of sample medications at UW Hospital has been banned for 13 years. There is a mechanism to provide vouchers for medications in limited circumstances.
Gundersen Health System
On site visits from drug and medical device representatives are permitted; however, representatives and the company that they represent must be registered in Gundersen's vendor management system in which background checks are conducted and agreement to our policies and procedures is confirmed. On site access is limited and monitored.
Several years ago Gundersen implemented a more restrictive and formalized vendor management program than what is required in the Physician Sunshine Act. In addition, Gundersen has a long standing policy that places controls and restrictions on the distribution of sample drugs.
Health Systems are becoming more and more restrictive on the sales process and distribution of samples, especially in the Northeast, Upper Midwest and Western US. This should cause pharmaceutical and device companies to reconsider their strategies on reaching physicians and how to offer samples. Listing sunshine as a reason is a new one, but given the intense scrutiny that these rules have on physicians and teaching hospitals, one can expect an ever more restrictive sales environment.
Unfortunately, as seen in a study last year, physicians practice far worse without information on new drugs and products or warnings of problems with existing drugs, provided by sales reps. Patient's physicians may miss out on vital product information, which could be lost in the translation if product information is only available through a gate keeper.