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Reimbursement issues
How will pharmacists be reimbursed if BTC were to come to pass? "The critical thing would be reimbursement for the medicine, but also some payment for the pharmacist's clinical services," said Zellmer, adding, " I don't think we are talking about a system that would be comparable to an OTC medicine, where the pharmacy derives its margin through a markup on the medicine, but reimbursement by the insurance company for the product and compensation for the pharmacist for his or her professional time."
Hogue suggested that ads for BTC products alert consumers to the fact that they have to pay R.Ph.s for their services. "There needs to be some consumer messaging that is incorporated as part of the release of BTC products to help consumers understand that they won't have a doctor's office visit, but they will have to be evaluated by a pharmacist. It may require blood testing and either they or their insurer will have to pay for that," he said.
Harry Hagel, R.Ph., senior VP of government and professional affairs at the American Pharmacists Association, believes that Medicare Part D and MTM have paved the way for pharmacists to get paid for patient care services in a BTC world. "We are seeing some evolution in the business model of pharmacy as we see greater pharmacist/patient interaction and we do have models of payment out there for pharmacists. We have several states that have state-funded programs where they are paying pharmacists for MTM. Profitability is not really the driver. It's really about the delivery of services we believe will benefit the patient and the healthcare system in general and it's about a financial model for that," he said. He added, "We would hope that any BTC proposal would include recognition that the pharmacist should be paid for providing these additional services. CMS would have to decide that Medicaid or Medicare would pay for these services or commercial health plans would have to see benefit in it to their beneficiaries and do their cost-benefit analysis."
Hogue took Hagel's thoughts one step further. "The challenge we will have if BTC is created is that insurance companies have often used the movement of Rx drugs to OTC status as a great excuse to not cover those drugs any longer. I think that is wrong and that could potentially be a major drawback to the BTC category. There is going to have to be reform in the insurance industry to require insurers to cover drugs that are available BTC and OTC."
The state Medicaid agencies, Hogue pointed out, are a good example of insurers that have recognized the value of nonprescription drugs and the cost savings that can occur from adding nonprescription drugs to their formularies as a preferred agent.
More liability?
The creation of a BTC class of drugs also raises questions about whether pharmacists would end up with increased liability?
"There is no question that this is a higher level activity (than dispensing), but this is what being a healthcare professional is all about—recognizing that there are risks. We exist to provide a service and sometimes risk goes along with providing that service," said Zellmer.
Nicholson said he would expect manufacturers to provide labeling and packaging information so that pharmacists could provide appropriate information to patients to help supplement their counseling. "That would be helpful to mitigate some of the liability concerns," he said.
Hogue believes it will be necessary for pharmacists to have liability insurance—either they will have to purchase it or their employer will have to provide it. "With increased responsibility comes increased liability. That's absolutely one of the things that pharmacists will have to accept," he said.
Hagel added, "Pharmacist/patient interactions and interventions are within the scope of practice of pharmacists' role. In our statement to the FDA, we quoted a tremendous number of research articles which demonstrate that interactions exist and they have benefits. We don't see it as increased liability. We see it as within the scope of the pharmacists' practice."
Reimbursement issues
How will pharmacists be reimbursed if BTC were to come to pass? "The critical thing would be reimbursement for the medicine, but also some payment for the pharmacist's clinical services," said Zellmer, adding, " I don't think we are talking about a system that would be comparable to an OTC medicine, where the pharmacy derives its margin through a markup on the medicine, but reimbursement by the insurance company for the product and compensation for the pharmacist for his or her professional time."
Hogue suggested that ads for BTC products alert consumers to the fact that they have to pay R.Ph.s for their services. "There needs to be some consumer messaging that is incorporated as part of the release of BTC products to help consumers understand that they won't have a doctor's office visit, but they will have to be evaluated by a pharmacist. It may require blood testing and either they or their insurer will have to pay for that," he said.
Harry Hagel, R.Ph., senior VP of government and professional affairs at the American Pharmacists Association, believes that Medicare Part D and MTM have paved the way for pharmacists to get paid for patient care services in a BTC world. "We are seeing some evolution in the business model of pharmacy as we see greater pharmacist/patient interaction and we do have models of payment out there for pharmacists. We have several states that have state-funded programs where they are paying pharmacists for MTM. Profitability is not really the driver. It's really about the delivery of services we believe will benefit the patient and the healthcare system in general and it's about a financial model for that," he said. He added, "We would hope that any BTC proposal would include recognition that the pharmacist should be paid for providing these additional services. CMS would have to decide that Medicaid or Medicare would pay for these services or commercial health plans would have to see benefit in it to their beneficiaries and do their cost-benefit analysis."
Hogue took Hagel's thoughts one step further. "The challenge we will have if BTC is created is that insurance companies have often used the movement of Rx drugs to OTC status as a great excuse to not cover those drugs any longer. I think that is wrong and that could potentially be a major drawback to the BTC category. There is going to have to be reform in the insurance industry to require insurers to cover drugs that are available BTC and OTC."
The state Medicaid agencies, Hogue pointed out, are a good example of insurers that have recognized the value of nonprescription drugs and the cost savings that can occur from adding nonprescription drugs to their formularies as a preferred agent.
More liability?
The creation of a BTC class of drugs also raises questions about whether pharmacists would end up with increased liability?
"There is no question that this is a higher level activity (than dispensing), but this is what being a healthcare professional is all about—recognizing that there are risks. We exist to provide a service and sometimes risk goes along with providing that service," said Zellmer.
Nicholson said he would expect manufacturers to provide labeling and packaging information so that pharmacists could provide appropriate information to patients to help supplement their counseling. "That would be helpful to mitigate some of the liability concerns," he said.
Hogue believes it will be necessary for pharmacists to have liability insurance—either they will have to purchase it or their employer will have to provide it. "With increased responsibility comes increased liability. That's absolutely one of the things that pharmacists will have to accept," he said.
Hagel added, "Pharmacist/patient interactions and interventions are within the scope of practice of pharmacists' role. In our statement to the FDA, we quoted a tremendous number of research articles which demonstrate that interactions exist and they have benefits. We don't see it as increased liability. We see it as within the scope of the pharmacists' practice."

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