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AAD members vote to remove board member
Members of the American Academy of Dermatology have voted to remove a board member for launching an organization that offered board certification to physician assistants (PAs).
Of 6,467 votes cast, , which met the two-thirds threshold required for board removal. The vote follows a unanimous decision by the AAD/A board to present AAD members with a resolution to dismiss Dr. Dinehart for his involvement with the American Board of Dermatology Physician Assistants (ABDPA), an organization that planned to offer board certification to PAs who work with dermatologists. Dr. Dinehart’s association with the group violated his fiduciary duties to the AAD/A and represented a conflict of interest, according to the AAD/A board.
In an interview with Dermatology News, Dr. Dinehart said it was an honor and privilege to serve on the board, and that he was disappointed by those who chose to rescind his election. Most people who study the issue will realize the recent events were precipitated by a turf battle between dermatologists and dermatology PAs, he added.
“I want to emphasize my record of service to dermatology not only in Arkansas but also across the United States and internationally,” Dr. Dinehart said in the interview. “I have always been committed to doing what is best for patients and our specialty and will continue to do so. In addition to providing direct patient care, I am a tireless educator, willing to teach all health professionals whether they are medical students, physician assistants, residents, family doctors, or other physician specialists. I appreciate the opportunity I have had to serve you and look forward to continuing to express my vision for excellence in dermatology as I move forward in my career.”
In a statement to members, AAD/A Secretary Treasurer Marta Van Beek, MD, said the issue has been a difficult matter for the AAD/A to address, but that the voting results clearly represent the will of members.
“I want to thank the members for their thoughtful participation in the process and their continued engagement with the AAD/A as we return our focus to the important work that we are undertaking on behalf of our specialty and our patients,” Dr. Van Beek, professor of dermatology, University of Iowa, Iowa City, said in the statement.
The ABDPA was formed legally at the end of September and announced its official launch on Oct. 7. The new organization immediately drew criticism from dermatologists and triggered an online petition that denounced the group and called for Dr Dinehart’s removal from the AAD/A board. The petition, started by an anonymous dermatologist, states Dr. Dinehart’s concurrent relationships with the AAD and the ABDPA represent a major conflict of interest. As of Oct. 31, the petition had collected 4,200 signatures.
AAD President George J. Hruza, MD, said that Dr. Dinehart’s action to incorporate and organize the for-profit entity ABDPA LLC was in direct contradiction to the AAD’s Truth in Advertising and Professional Disclosure policy that states that practitioners should not advertise that they are board certified unless they are certified by an American Board of Medical Specialties or American Osteopathic Association medical board. The for-profit venture would enable PAs to advertise themselves as board certified, Dr. Hruza said in a previous interview with Dermatology News. He added that the group was “set up to potentially mislead patients into thinking that physician assistants with this certification would have training and experience equivalent to an ABD-certified dermatologist.
In a letter to AAD members, Dr. Dinehart however, said the ABDPA was intended to improve patient care by establishing certain educational, training, and professional standards for the growing number of PAs in dermatology. That mission was not in conflict with AAD’s values, but rather, the ABDPA would have furthered AAD’s purpose “to promote the highest standards in allied health professionals and services as they relate to dermatology,” according to Dr. Dinehart. He called the removal vote a drastic measure and contended that his actions did not justify dismissal from the AAD/A board.
After learning of the board’s concerns, Dr. Dinehart discontinued his relationship with the ABDPA and ended its operations.
Members voted on Dr. Dinehart’s position from Oct. 21 to Oct. 29. The seat vacated by the recall election will be filled through the AAD/A’s annual election, which opens Saturday, March 21, 2020, according to the AAD/A. The successful candidate will be selected to start their term immediately and fill the vacated seat until the close of the 2022 AAD/A Annual Meeting.
Members of the American Academy of Dermatology have voted to remove a board member for launching an organization that offered board certification to physician assistants (PAs).
Of 6,467 votes cast, , which met the two-thirds threshold required for board removal. The vote follows a unanimous decision by the AAD/A board to present AAD members with a resolution to dismiss Dr. Dinehart for his involvement with the American Board of Dermatology Physician Assistants (ABDPA), an organization that planned to offer board certification to PAs who work with dermatologists. Dr. Dinehart’s association with the group violated his fiduciary duties to the AAD/A and represented a conflict of interest, according to the AAD/A board.
In an interview with Dermatology News, Dr. Dinehart said it was an honor and privilege to serve on the board, and that he was disappointed by those who chose to rescind his election. Most people who study the issue will realize the recent events were precipitated by a turf battle between dermatologists and dermatology PAs, he added.
“I want to emphasize my record of service to dermatology not only in Arkansas but also across the United States and internationally,” Dr. Dinehart said in the interview. “I have always been committed to doing what is best for patients and our specialty and will continue to do so. In addition to providing direct patient care, I am a tireless educator, willing to teach all health professionals whether they are medical students, physician assistants, residents, family doctors, or other physician specialists. I appreciate the opportunity I have had to serve you and look forward to continuing to express my vision for excellence in dermatology as I move forward in my career.”
In a statement to members, AAD/A Secretary Treasurer Marta Van Beek, MD, said the issue has been a difficult matter for the AAD/A to address, but that the voting results clearly represent the will of members.
“I want to thank the members for their thoughtful participation in the process and their continued engagement with the AAD/A as we return our focus to the important work that we are undertaking on behalf of our specialty and our patients,” Dr. Van Beek, professor of dermatology, University of Iowa, Iowa City, said in the statement.
The ABDPA was formed legally at the end of September and announced its official launch on Oct. 7. The new organization immediately drew criticism from dermatologists and triggered an online petition that denounced the group and called for Dr Dinehart’s removal from the AAD/A board. The petition, started by an anonymous dermatologist, states Dr. Dinehart’s concurrent relationships with the AAD and the ABDPA represent a major conflict of interest. As of Oct. 31, the petition had collected 4,200 signatures.
AAD President George J. Hruza, MD, said that Dr. Dinehart’s action to incorporate and organize the for-profit entity ABDPA LLC was in direct contradiction to the AAD’s Truth in Advertising and Professional Disclosure policy that states that practitioners should not advertise that they are board certified unless they are certified by an American Board of Medical Specialties or American Osteopathic Association medical board. The for-profit venture would enable PAs to advertise themselves as board certified, Dr. Hruza said in a previous interview with Dermatology News. He added that the group was “set up to potentially mislead patients into thinking that physician assistants with this certification would have training and experience equivalent to an ABD-certified dermatologist.
In a letter to AAD members, Dr. Dinehart however, said the ABDPA was intended to improve patient care by establishing certain educational, training, and professional standards for the growing number of PAs in dermatology. That mission was not in conflict with AAD’s values, but rather, the ABDPA would have furthered AAD’s purpose “to promote the highest standards in allied health professionals and services as they relate to dermatology,” according to Dr. Dinehart. He called the removal vote a drastic measure and contended that his actions did not justify dismissal from the AAD/A board.
After learning of the board’s concerns, Dr. Dinehart discontinued his relationship with the ABDPA and ended its operations.
Members voted on Dr. Dinehart’s position from Oct. 21 to Oct. 29. The seat vacated by the recall election will be filled through the AAD/A’s annual election, which opens Saturday, March 21, 2020, according to the AAD/A. The successful candidate will be selected to start their term immediately and fill the vacated seat until the close of the 2022 AAD/A Annual Meeting.
Members of the American Academy of Dermatology have voted to remove a board member for launching an organization that offered board certification to physician assistants (PAs).
Of 6,467 votes cast, , which met the two-thirds threshold required for board removal. The vote follows a unanimous decision by the AAD/A board to present AAD members with a resolution to dismiss Dr. Dinehart for his involvement with the American Board of Dermatology Physician Assistants (ABDPA), an organization that planned to offer board certification to PAs who work with dermatologists. Dr. Dinehart’s association with the group violated his fiduciary duties to the AAD/A and represented a conflict of interest, according to the AAD/A board.
In an interview with Dermatology News, Dr. Dinehart said it was an honor and privilege to serve on the board, and that he was disappointed by those who chose to rescind his election. Most people who study the issue will realize the recent events were precipitated by a turf battle between dermatologists and dermatology PAs, he added.
“I want to emphasize my record of service to dermatology not only in Arkansas but also across the United States and internationally,” Dr. Dinehart said in the interview. “I have always been committed to doing what is best for patients and our specialty and will continue to do so. In addition to providing direct patient care, I am a tireless educator, willing to teach all health professionals whether they are medical students, physician assistants, residents, family doctors, or other physician specialists. I appreciate the opportunity I have had to serve you and look forward to continuing to express my vision for excellence in dermatology as I move forward in my career.”
In a statement to members, AAD/A Secretary Treasurer Marta Van Beek, MD, said the issue has been a difficult matter for the AAD/A to address, but that the voting results clearly represent the will of members.
“I want to thank the members for their thoughtful participation in the process and their continued engagement with the AAD/A as we return our focus to the important work that we are undertaking on behalf of our specialty and our patients,” Dr. Van Beek, professor of dermatology, University of Iowa, Iowa City, said in the statement.
The ABDPA was formed legally at the end of September and announced its official launch on Oct. 7. The new organization immediately drew criticism from dermatologists and triggered an online petition that denounced the group and called for Dr Dinehart’s removal from the AAD/A board. The petition, started by an anonymous dermatologist, states Dr. Dinehart’s concurrent relationships with the AAD and the ABDPA represent a major conflict of interest. As of Oct. 31, the petition had collected 4,200 signatures.
AAD President George J. Hruza, MD, said that Dr. Dinehart’s action to incorporate and organize the for-profit entity ABDPA LLC was in direct contradiction to the AAD’s Truth in Advertising and Professional Disclosure policy that states that practitioners should not advertise that they are board certified unless they are certified by an American Board of Medical Specialties or American Osteopathic Association medical board. The for-profit venture would enable PAs to advertise themselves as board certified, Dr. Hruza said in a previous interview with Dermatology News. He added that the group was “set up to potentially mislead patients into thinking that physician assistants with this certification would have training and experience equivalent to an ABD-certified dermatologist.
In a letter to AAD members, Dr. Dinehart however, said the ABDPA was intended to improve patient care by establishing certain educational, training, and professional standards for the growing number of PAs in dermatology. That mission was not in conflict with AAD’s values, but rather, the ABDPA would have furthered AAD’s purpose “to promote the highest standards in allied health professionals and services as they relate to dermatology,” according to Dr. Dinehart. He called the removal vote a drastic measure and contended that his actions did not justify dismissal from the AAD/A board.
After learning of the board’s concerns, Dr. Dinehart discontinued his relationship with the ABDPA and ended its operations.
Members voted on Dr. Dinehart’s position from Oct. 21 to Oct. 29. The seat vacated by the recall election will be filled through the AAD/A’s annual election, which opens Saturday, March 21, 2020, according to the AAD/A. The successful candidate will be selected to start their term immediately and fill the vacated seat until the close of the 2022 AAD/A Annual Meeting.
The challenges of contracting for value, not volume in prescription drugs
NATIONAL HARBOR, MD. – Paying for value over volume is being seen as a key part of driving down the cost of prescription drugs. But setting up value-based contracts can be a challenge.
“In Utah, we thought we would be an appropriate laboratory to try and figure out, ‘Is there a way that we can do this different?’ ” Diana Brixner, PhD, of the University of Utah, Salt Lake City, said at the annual meeting of the Academy of Managed Care Pharmacy. “How can we be creative and have alternatives to high-deductible plans in Utah through value-based–type programs?”
The state considered three different options, she noted. The first option was value-based drug coverage, which pays for only those drugs that are deemed valuable by an independent source. Uptake on these types of contracts has been slow, Dr. Brixner noted, particularly as patient advocates have argued that some drugs may not be cost effective but are still the best choice for certain patients. In those cases, value-based drug coverage has the potential to hinder access.
“There are certainly still different areas and issues that need to be worked out, but in concept, this could potentially help the solution of getting more affordable care to patients,” Dr. Brixner said.
The second option is outcomes-based contracting, which involves working with manufacturers to determine appropriate disease states with vetted outcomes measures and building pharmacy contracts around them.
“We are very optimistic about the potential for outcomes-based contracting as well,” Dr. Brixner said.
CVS has looked into zero copays for preventive medicines, Dr. Brixner said. She added that studies have shown the potential for millions in savings from these kinds of arrangements.
But there are concerns with all of these designs. Drug manufacturers, for instance, have concerns about getting accurate data to determine the payment parameters. Another concern from the manufacturer side is the inability to discuss information about off-label drug use that could be important to negotiating a value-based contract.
For payers, a key concern is making sure there are measurable outcomes, as well as appropriate risk sharing.
In the end, different conditions lend themselves to different types of value-based contracting, Dr. Brixner said. For example, multiple sclerosis is better suited to a value-based drug coverage contract, while rheumatoid arthritis fits better in an outcomes-based contracting design.
Kenneth Schaecher, MD, associate chief medical officer of the University of Utah Health Plan, highlighted some of the challenges of value-based care from a payer perspective, including determining outcomes to use in contracts.
“One of the challenges that we get is trying to decide what is a measure that is important to both the health plans and the patients and the providers,” he said. “If the measure is not reflective of an outcome relative to those, it is going to be very hard to impact it” through a value-based contract. He noted that patient-reported outcomes do not work well in value-based contracts.
The timeliness of the data can also present a challenge, especially when factoring in member turnover from health plans.
But there are examples of success, he noted. Dr. Schaecher highlighted a few examples, including an outcomes-based contract between Cigna and Merck for Januvia and Janumet, which included higher discounts for improvements in hemoglobin A1c across the insured population. Additional discounts were offered if adherence improved. And if both outcomes and adherence improved, Cigna would move the drugs to formulary tiers with lower copays.
NATIONAL HARBOR, MD. – Paying for value over volume is being seen as a key part of driving down the cost of prescription drugs. But setting up value-based contracts can be a challenge.
“In Utah, we thought we would be an appropriate laboratory to try and figure out, ‘Is there a way that we can do this different?’ ” Diana Brixner, PhD, of the University of Utah, Salt Lake City, said at the annual meeting of the Academy of Managed Care Pharmacy. “How can we be creative and have alternatives to high-deductible plans in Utah through value-based–type programs?”
The state considered three different options, she noted. The first option was value-based drug coverage, which pays for only those drugs that are deemed valuable by an independent source. Uptake on these types of contracts has been slow, Dr. Brixner noted, particularly as patient advocates have argued that some drugs may not be cost effective but are still the best choice for certain patients. In those cases, value-based drug coverage has the potential to hinder access.
“There are certainly still different areas and issues that need to be worked out, but in concept, this could potentially help the solution of getting more affordable care to patients,” Dr. Brixner said.
The second option is outcomes-based contracting, which involves working with manufacturers to determine appropriate disease states with vetted outcomes measures and building pharmacy contracts around them.
“We are very optimistic about the potential for outcomes-based contracting as well,” Dr. Brixner said.
CVS has looked into zero copays for preventive medicines, Dr. Brixner said. She added that studies have shown the potential for millions in savings from these kinds of arrangements.
But there are concerns with all of these designs. Drug manufacturers, for instance, have concerns about getting accurate data to determine the payment parameters. Another concern from the manufacturer side is the inability to discuss information about off-label drug use that could be important to negotiating a value-based contract.
For payers, a key concern is making sure there are measurable outcomes, as well as appropriate risk sharing.
In the end, different conditions lend themselves to different types of value-based contracting, Dr. Brixner said. For example, multiple sclerosis is better suited to a value-based drug coverage contract, while rheumatoid arthritis fits better in an outcomes-based contracting design.
Kenneth Schaecher, MD, associate chief medical officer of the University of Utah Health Plan, highlighted some of the challenges of value-based care from a payer perspective, including determining outcomes to use in contracts.
“One of the challenges that we get is trying to decide what is a measure that is important to both the health plans and the patients and the providers,” he said. “If the measure is not reflective of an outcome relative to those, it is going to be very hard to impact it” through a value-based contract. He noted that patient-reported outcomes do not work well in value-based contracts.
The timeliness of the data can also present a challenge, especially when factoring in member turnover from health plans.
But there are examples of success, he noted. Dr. Schaecher highlighted a few examples, including an outcomes-based contract between Cigna and Merck for Januvia and Janumet, which included higher discounts for improvements in hemoglobin A1c across the insured population. Additional discounts were offered if adherence improved. And if both outcomes and adherence improved, Cigna would move the drugs to formulary tiers with lower copays.
NATIONAL HARBOR, MD. – Paying for value over volume is being seen as a key part of driving down the cost of prescription drugs. But setting up value-based contracts can be a challenge.
“In Utah, we thought we would be an appropriate laboratory to try and figure out, ‘Is there a way that we can do this different?’ ” Diana Brixner, PhD, of the University of Utah, Salt Lake City, said at the annual meeting of the Academy of Managed Care Pharmacy. “How can we be creative and have alternatives to high-deductible plans in Utah through value-based–type programs?”
The state considered three different options, she noted. The first option was value-based drug coverage, which pays for only those drugs that are deemed valuable by an independent source. Uptake on these types of contracts has been slow, Dr. Brixner noted, particularly as patient advocates have argued that some drugs may not be cost effective but are still the best choice for certain patients. In those cases, value-based drug coverage has the potential to hinder access.
“There are certainly still different areas and issues that need to be worked out, but in concept, this could potentially help the solution of getting more affordable care to patients,” Dr. Brixner said.
The second option is outcomes-based contracting, which involves working with manufacturers to determine appropriate disease states with vetted outcomes measures and building pharmacy contracts around them.
“We are very optimistic about the potential for outcomes-based contracting as well,” Dr. Brixner said.
CVS has looked into zero copays for preventive medicines, Dr. Brixner said. She added that studies have shown the potential for millions in savings from these kinds of arrangements.
But there are concerns with all of these designs. Drug manufacturers, for instance, have concerns about getting accurate data to determine the payment parameters. Another concern from the manufacturer side is the inability to discuss information about off-label drug use that could be important to negotiating a value-based contract.
For payers, a key concern is making sure there are measurable outcomes, as well as appropriate risk sharing.
In the end, different conditions lend themselves to different types of value-based contracting, Dr. Brixner said. For example, multiple sclerosis is better suited to a value-based drug coverage contract, while rheumatoid arthritis fits better in an outcomes-based contracting design.
Kenneth Schaecher, MD, associate chief medical officer of the University of Utah Health Plan, highlighted some of the challenges of value-based care from a payer perspective, including determining outcomes to use in contracts.
“One of the challenges that we get is trying to decide what is a measure that is important to both the health plans and the patients and the providers,” he said. “If the measure is not reflective of an outcome relative to those, it is going to be very hard to impact it” through a value-based contract. He noted that patient-reported outcomes do not work well in value-based contracts.
The timeliness of the data can also present a challenge, especially when factoring in member turnover from health plans.
But there are examples of success, he noted. Dr. Schaecher highlighted a few examples, including an outcomes-based contract between Cigna and Merck for Januvia and Janumet, which included higher discounts for improvements in hemoglobin A1c across the insured population. Additional discounts were offered if adherence improved. And if both outcomes and adherence improved, Cigna would move the drugs to formulary tiers with lower copays.
REPORTING FROM AMCP NEXUS 2019
Technology softens prior authorization pain points
NATIONAL HARBOR, MD. – Nebulous pricing associated with prior authorization continues to be a major pain point for health care professionals, but this may become a thing of the past – thanks to a technology called real-time pharmacy benefit.
Real-time pharmacy benefits (RTPB) is software or a software component that allows practicing clinicians to look up a patient’s out-of-pocket costs for a specific drug, regardless of the patient’s health insurance coverage. Users can see the costs, copayment, and deductible for branded and generic, as well as compare insurance costs versus cash pricing.
Lindsey Colbert, RN, program manager for care team efficiency at HealthPartners, and Leann McDowell, PharmD, supervisor, pharmacy utilization management at HealthPartners, investigated how integrating RTPB software into their existing platforms and operations could help address pricing nuances and their associated burden on patients and health care professionals. They presented the results of their pilot test and post–pilot test expansion at the annual meeting of the Academy of Managed Care Pharmacy.
“Historically, clinicians were told not to quote prices, because having numerous insurance plans made it difficult to know what was going to be covered,” Ms. Colbert said. “Now, with real-time benefits, clinicians have pricing information readily available to them.”
HealthPartners pilot-tested RTPB at two locations before expanding to additional sites. They found that integrating real-time pharmacy benefits information improved the user experience and added cost savings for patients while improving workflow efficiency.
Health care professionals were more like to use RTPB for inquiries when the perceived patient cost was $50 or more – a price many clinicians perceive to be too expensive for many patients.
Before RTPB implementation, participating health care professionals reported waiting at least 45 minutes to get pricing on drugs requiring prior authorization. Integrating the RTPB software shaved the wait time down to 4 minutes – allowing them to quote drug prices to patients at the point of service.
Despite the benefits, everyone is not on board with RTPB.
Health care professionals already feel burdened by the information requirements of their electronic health records systems. They “count the number of computer clicks they have to make, so getting them to make an additional click to use RTPB requires another buy-in,” Ms. Colbert said.
While participating health care professionals were asked to run every prescription through RTPB, they reported using the software only when they knew a patient would either perceive cost as a potential barrier, or if they knew a drug would be expensive.
Investigators said they plan to continue working with clinicians to make RTPB integration more user-friendly by eventually eliminating the additional computer click required to run the program. They also plan to monitor the progress of the National Council for Prescription Drug Programs – developer of RTPB – regarding its adaptation of its new standard.
NATIONAL HARBOR, MD. – Nebulous pricing associated with prior authorization continues to be a major pain point for health care professionals, but this may become a thing of the past – thanks to a technology called real-time pharmacy benefit.
Real-time pharmacy benefits (RTPB) is software or a software component that allows practicing clinicians to look up a patient’s out-of-pocket costs for a specific drug, regardless of the patient’s health insurance coverage. Users can see the costs, copayment, and deductible for branded and generic, as well as compare insurance costs versus cash pricing.
Lindsey Colbert, RN, program manager for care team efficiency at HealthPartners, and Leann McDowell, PharmD, supervisor, pharmacy utilization management at HealthPartners, investigated how integrating RTPB software into their existing platforms and operations could help address pricing nuances and their associated burden on patients and health care professionals. They presented the results of their pilot test and post–pilot test expansion at the annual meeting of the Academy of Managed Care Pharmacy.
“Historically, clinicians were told not to quote prices, because having numerous insurance plans made it difficult to know what was going to be covered,” Ms. Colbert said. “Now, with real-time benefits, clinicians have pricing information readily available to them.”
HealthPartners pilot-tested RTPB at two locations before expanding to additional sites. They found that integrating real-time pharmacy benefits information improved the user experience and added cost savings for patients while improving workflow efficiency.
Health care professionals were more like to use RTPB for inquiries when the perceived patient cost was $50 or more – a price many clinicians perceive to be too expensive for many patients.
Before RTPB implementation, participating health care professionals reported waiting at least 45 minutes to get pricing on drugs requiring prior authorization. Integrating the RTPB software shaved the wait time down to 4 minutes – allowing them to quote drug prices to patients at the point of service.
Despite the benefits, everyone is not on board with RTPB.
Health care professionals already feel burdened by the information requirements of their electronic health records systems. They “count the number of computer clicks they have to make, so getting them to make an additional click to use RTPB requires another buy-in,” Ms. Colbert said.
While participating health care professionals were asked to run every prescription through RTPB, they reported using the software only when they knew a patient would either perceive cost as a potential barrier, or if they knew a drug would be expensive.
Investigators said they plan to continue working with clinicians to make RTPB integration more user-friendly by eventually eliminating the additional computer click required to run the program. They also plan to monitor the progress of the National Council for Prescription Drug Programs – developer of RTPB – regarding its adaptation of its new standard.
NATIONAL HARBOR, MD. – Nebulous pricing associated with prior authorization continues to be a major pain point for health care professionals, but this may become a thing of the past – thanks to a technology called real-time pharmacy benefit.
Real-time pharmacy benefits (RTPB) is software or a software component that allows practicing clinicians to look up a patient’s out-of-pocket costs for a specific drug, regardless of the patient’s health insurance coverage. Users can see the costs, copayment, and deductible for branded and generic, as well as compare insurance costs versus cash pricing.
Lindsey Colbert, RN, program manager for care team efficiency at HealthPartners, and Leann McDowell, PharmD, supervisor, pharmacy utilization management at HealthPartners, investigated how integrating RTPB software into their existing platforms and operations could help address pricing nuances and their associated burden on patients and health care professionals. They presented the results of their pilot test and post–pilot test expansion at the annual meeting of the Academy of Managed Care Pharmacy.
“Historically, clinicians were told not to quote prices, because having numerous insurance plans made it difficult to know what was going to be covered,” Ms. Colbert said. “Now, with real-time benefits, clinicians have pricing information readily available to them.”
HealthPartners pilot-tested RTPB at two locations before expanding to additional sites. They found that integrating real-time pharmacy benefits information improved the user experience and added cost savings for patients while improving workflow efficiency.
Health care professionals were more like to use RTPB for inquiries when the perceived patient cost was $50 or more – a price many clinicians perceive to be too expensive for many patients.
Before RTPB implementation, participating health care professionals reported waiting at least 45 minutes to get pricing on drugs requiring prior authorization. Integrating the RTPB software shaved the wait time down to 4 minutes – allowing them to quote drug prices to patients at the point of service.
Despite the benefits, everyone is not on board with RTPB.
Health care professionals already feel burdened by the information requirements of their electronic health records systems. They “count the number of computer clicks they have to make, so getting them to make an additional click to use RTPB requires another buy-in,” Ms. Colbert said.
While participating health care professionals were asked to run every prescription through RTPB, they reported using the software only when they knew a patient would either perceive cost as a potential barrier, or if they knew a drug would be expensive.
Investigators said they plan to continue working with clinicians to make RTPB integration more user-friendly by eventually eliminating the additional computer click required to run the program. They also plan to monitor the progress of the National Council for Prescription Drug Programs – developer of RTPB – regarding its adaptation of its new standard.
REPORTING FROM AMCP NEXUS 2019
Get ready for changes in polypharmacy quality ratings
NATIONAL HARBOR, MD. – and managed care organizations should start preparing now for the shift.
Panelists at an Oct. 30 session at the annual meeting of the Academy of Managed Care Pharmacy presented strategies for addressing the three areas of polypharmacy that will be tracked in the new rating system, which will replace the current high-risk medication measurement that is being retired this year.
Anticholinergic medications
The first area presented by the panelists was polypharmacy use of multiple anticholinergic medications in older adults (Poly-ACH). The new quality measure will examine the percentage of members aged 65 years or older who are using two or more anticholinergic medications concurrently.
“We know that anticholinergic burden increases the risk of cognitive decline in particular, but it’s also associated with a higher risk of falls, an increased number of hospitalizations, and [diminished] physical function,” said Marti Groeneweg, PharmD, supervisor of clinical pharmacy services at Kaiser Permanente.
Dr. Groeneweg noted that, in addition to using multiple drugs in this class, patients can also benefit from a decrease in the dosage of their drugs, so that should also be considered in managing the medication of beneficiaries.
She highlighted a program Kaiser Permanente started in the Northwest United States to reduce the concurrent use of these drugs. The program targeted tricyclic antidepressants – nortriptyline, in particular.
The company instituted a multipronged approach that included provider detailing of the risks of using multiple drugs and how they could taper schedules, as well as providing them with other supporting resources and a list of safer, alternative drugs. It also reached out to patients to educate them about the risks of their medications and why it was important for them to taper their medications. The third part of the approach was to use the EHR to provide doctors with the best-available information at the point of prescribing. And finally, there was a pharmacist review process put in place for more complex cases.
Dr. Groeneweg emphasized that this information was incorporated into existing programs.
The intervention, which is fairly new, has not been in place long enough to know exactly how well it is working, but early indicators suggest “we are on the right track,” she said, noting that to date there has been a decrease of 28% in the number of tricyclic antidepressant prescriptions per 1,000 Medicare members per month.
CNS medications
The second area the panelists addressed was the polypharmacy use of multiple CNS-active medications in older adults (Poly-CNS).
Rainelle Gaddy, PharmD, Rx clinical programs pharmacy lead at Humana Pharmacy Solutions, , noted that the clinical rationale for this measure was the “increased risk of falls and fractures when these medications are taken concurrently.”
She pointed out that taking one or more of the CNS medications can result in a 1.5-fold increase in the risk for falls, and that risk increases to 2.5-fold if two or more drugs are taken. In addition, a high-dose of these medications can lead to a threefold increase in risk of recurrent falls.
Dr. Gaddy highlighted a number of interventions that could be implemented when the managed care organization is not integrated in the way Kaiser Permanente is.
“Pharmacists can pay a pivotal role [in helping] patients who are receiving these Poly-CNS medications because they are able to interact and talk through the actual patient picture for all their medications ... because pharmacists have always been seen as being a trusted source,” she said.
Dr. Gaddy added that health plans can take a more direct role in reaching out to patients, for example, through telephone outreach, as well as direct mail, email, and newsletters.
“We want to make sure that members have as much information as possible,” she said.
She added that it is very important to include physicians and other prescribers in this process through faxes and information included in EHRs.
Opioids and benzodiazepines
The final measure highlighted during the session was the one measuring the concurrent use of opioids and benzodiazepines.
Dr. Gaddy noted that taking the two concurrently is associated with a fourfold increase in risk of opioid overdose and death, compared with opioid use without a benzodiazepine.
She noted that a black box warning on the risks of concurrent use was added to both opioids and benzodiazepines in August 2016 and that resulted in a 10% decrease in the concurrent use.
“This new measure is intended to ensure that the downward trend continues. CMS has indicated as such,” Dr. Gaddy said.
Most of the intervention strategies she highlighted were similar to those for the Poly-CNS category, including the use of medication therapy management programs and targeted interventions, telephone outreach to members, and provider detailing and outreach.
“Provider detailing is really key,” Dr. Gaddy said. “On any given day, it’s so easy for physicians to see 30 patients. The great thing about the provider detailing is that you are able to give the provider a ‘packet’ of their members, you can identify and/or aid in showing them the risk assessment associated with members taking these medications, and then equip them with pocket guides and [materials so they can] streamline the medications.”
NATIONAL HARBOR, MD. – and managed care organizations should start preparing now for the shift.
Panelists at an Oct. 30 session at the annual meeting of the Academy of Managed Care Pharmacy presented strategies for addressing the three areas of polypharmacy that will be tracked in the new rating system, which will replace the current high-risk medication measurement that is being retired this year.
Anticholinergic medications
The first area presented by the panelists was polypharmacy use of multiple anticholinergic medications in older adults (Poly-ACH). The new quality measure will examine the percentage of members aged 65 years or older who are using two or more anticholinergic medications concurrently.
“We know that anticholinergic burden increases the risk of cognitive decline in particular, but it’s also associated with a higher risk of falls, an increased number of hospitalizations, and [diminished] physical function,” said Marti Groeneweg, PharmD, supervisor of clinical pharmacy services at Kaiser Permanente.
Dr. Groeneweg noted that, in addition to using multiple drugs in this class, patients can also benefit from a decrease in the dosage of their drugs, so that should also be considered in managing the medication of beneficiaries.
She highlighted a program Kaiser Permanente started in the Northwest United States to reduce the concurrent use of these drugs. The program targeted tricyclic antidepressants – nortriptyline, in particular.
The company instituted a multipronged approach that included provider detailing of the risks of using multiple drugs and how they could taper schedules, as well as providing them with other supporting resources and a list of safer, alternative drugs. It also reached out to patients to educate them about the risks of their medications and why it was important for them to taper their medications. The third part of the approach was to use the EHR to provide doctors with the best-available information at the point of prescribing. And finally, there was a pharmacist review process put in place for more complex cases.
Dr. Groeneweg emphasized that this information was incorporated into existing programs.
The intervention, which is fairly new, has not been in place long enough to know exactly how well it is working, but early indicators suggest “we are on the right track,” she said, noting that to date there has been a decrease of 28% in the number of tricyclic antidepressant prescriptions per 1,000 Medicare members per month.
CNS medications
The second area the panelists addressed was the polypharmacy use of multiple CNS-active medications in older adults (Poly-CNS).
Rainelle Gaddy, PharmD, Rx clinical programs pharmacy lead at Humana Pharmacy Solutions, , noted that the clinical rationale for this measure was the “increased risk of falls and fractures when these medications are taken concurrently.”
She pointed out that taking one or more of the CNS medications can result in a 1.5-fold increase in the risk for falls, and that risk increases to 2.5-fold if two or more drugs are taken. In addition, a high-dose of these medications can lead to a threefold increase in risk of recurrent falls.
Dr. Gaddy highlighted a number of interventions that could be implemented when the managed care organization is not integrated in the way Kaiser Permanente is.
“Pharmacists can pay a pivotal role [in helping] patients who are receiving these Poly-CNS medications because they are able to interact and talk through the actual patient picture for all their medications ... because pharmacists have always been seen as being a trusted source,” she said.
Dr. Gaddy added that health plans can take a more direct role in reaching out to patients, for example, through telephone outreach, as well as direct mail, email, and newsletters.
“We want to make sure that members have as much information as possible,” she said.
She added that it is very important to include physicians and other prescribers in this process through faxes and information included in EHRs.
Opioids and benzodiazepines
The final measure highlighted during the session was the one measuring the concurrent use of opioids and benzodiazepines.
Dr. Gaddy noted that taking the two concurrently is associated with a fourfold increase in risk of opioid overdose and death, compared with opioid use without a benzodiazepine.
She noted that a black box warning on the risks of concurrent use was added to both opioids and benzodiazepines in August 2016 and that resulted in a 10% decrease in the concurrent use.
“This new measure is intended to ensure that the downward trend continues. CMS has indicated as such,” Dr. Gaddy said.
Most of the intervention strategies she highlighted were similar to those for the Poly-CNS category, including the use of medication therapy management programs and targeted interventions, telephone outreach to members, and provider detailing and outreach.
“Provider detailing is really key,” Dr. Gaddy said. “On any given day, it’s so easy for physicians to see 30 patients. The great thing about the provider detailing is that you are able to give the provider a ‘packet’ of their members, you can identify and/or aid in showing them the risk assessment associated with members taking these medications, and then equip them with pocket guides and [materials so they can] streamline the medications.”
NATIONAL HARBOR, MD. – and managed care organizations should start preparing now for the shift.
Panelists at an Oct. 30 session at the annual meeting of the Academy of Managed Care Pharmacy presented strategies for addressing the three areas of polypharmacy that will be tracked in the new rating system, which will replace the current high-risk medication measurement that is being retired this year.
Anticholinergic medications
The first area presented by the panelists was polypharmacy use of multiple anticholinergic medications in older adults (Poly-ACH). The new quality measure will examine the percentage of members aged 65 years or older who are using two or more anticholinergic medications concurrently.
“We know that anticholinergic burden increases the risk of cognitive decline in particular, but it’s also associated with a higher risk of falls, an increased number of hospitalizations, and [diminished] physical function,” said Marti Groeneweg, PharmD, supervisor of clinical pharmacy services at Kaiser Permanente.
Dr. Groeneweg noted that, in addition to using multiple drugs in this class, patients can also benefit from a decrease in the dosage of their drugs, so that should also be considered in managing the medication of beneficiaries.
She highlighted a program Kaiser Permanente started in the Northwest United States to reduce the concurrent use of these drugs. The program targeted tricyclic antidepressants – nortriptyline, in particular.
The company instituted a multipronged approach that included provider detailing of the risks of using multiple drugs and how they could taper schedules, as well as providing them with other supporting resources and a list of safer, alternative drugs. It also reached out to patients to educate them about the risks of their medications and why it was important for them to taper their medications. The third part of the approach was to use the EHR to provide doctors with the best-available information at the point of prescribing. And finally, there was a pharmacist review process put in place for more complex cases.
Dr. Groeneweg emphasized that this information was incorporated into existing programs.
The intervention, which is fairly new, has not been in place long enough to know exactly how well it is working, but early indicators suggest “we are on the right track,” she said, noting that to date there has been a decrease of 28% in the number of tricyclic antidepressant prescriptions per 1,000 Medicare members per month.
CNS medications
The second area the panelists addressed was the polypharmacy use of multiple CNS-active medications in older adults (Poly-CNS).
Rainelle Gaddy, PharmD, Rx clinical programs pharmacy lead at Humana Pharmacy Solutions, , noted that the clinical rationale for this measure was the “increased risk of falls and fractures when these medications are taken concurrently.”
She pointed out that taking one or more of the CNS medications can result in a 1.5-fold increase in the risk for falls, and that risk increases to 2.5-fold if two or more drugs are taken. In addition, a high-dose of these medications can lead to a threefold increase in risk of recurrent falls.
Dr. Gaddy highlighted a number of interventions that could be implemented when the managed care organization is not integrated in the way Kaiser Permanente is.
“Pharmacists can pay a pivotal role [in helping] patients who are receiving these Poly-CNS medications because they are able to interact and talk through the actual patient picture for all their medications ... because pharmacists have always been seen as being a trusted source,” she said.
Dr. Gaddy added that health plans can take a more direct role in reaching out to patients, for example, through telephone outreach, as well as direct mail, email, and newsletters.
“We want to make sure that members have as much information as possible,” she said.
She added that it is very important to include physicians and other prescribers in this process through faxes and information included in EHRs.
Opioids and benzodiazepines
The final measure highlighted during the session was the one measuring the concurrent use of opioids and benzodiazepines.
Dr. Gaddy noted that taking the two concurrently is associated with a fourfold increase in risk of opioid overdose and death, compared with opioid use without a benzodiazepine.
She noted that a black box warning on the risks of concurrent use was added to both opioids and benzodiazepines in August 2016 and that resulted in a 10% decrease in the concurrent use.
“This new measure is intended to ensure that the downward trend continues. CMS has indicated as such,” Dr. Gaddy said.
Most of the intervention strategies she highlighted were similar to those for the Poly-CNS category, including the use of medication therapy management programs and targeted interventions, telephone outreach to members, and provider detailing and outreach.
“Provider detailing is really key,” Dr. Gaddy said. “On any given day, it’s so easy for physicians to see 30 patients. The great thing about the provider detailing is that you are able to give the provider a ‘packet’ of their members, you can identify and/or aid in showing them the risk assessment associated with members taking these medications, and then equip them with pocket guides and [materials so they can] streamline the medications.”
REPORTING FROM AMCP NEXUS 2019
Synchronizing refills saves money, improves outcomes
NATIONAL HARBOR, MD. – according to research presented at the annual meeting of the Academy of Managed Care Pharmacy.
Investigators with Pharmacy Quality Alliance (PQA) used data from Truven MarketScan Research Databases to conduct a retrospective cohort study of more than 20,000 patients eligible for inclusion in PQA’s diabetes medication adherence measure. To be included, patients needed to have two or more prescriptions for diabetes medications (excluding insulin), statins, or renin-angiotensin system antagonists. About 80% of patients were commercially insured and 20% came from Medicare supplement insurance (Medigap) plans.
Commercially insured patients whose medication refills were synchronized had better medication adherence than did matched controls (67.7% vs. 57.4%) and lower median health care expenditures ($3,687 vs. $7,480).
The same was true for patients with Medicare supplemental insurance. Synchronized patients in this group also had better medication adherence than controls, at 86.5% vs. 70.4% and lower median health care expenditures ($7,353 vs. $10,592).
Based on their findings in diabetes patients, “I think we should synchronize refills,” Matthew K. Pickering, PharmD, senior director of research and quality strategies at PQA, said. “However, there are populations that were not represented in this, like COPD [chronic obstructive pulmonary disease]. That’s another high-comorbidity, high-cost population that should be studied.”
Session moderator Laura Happe, PharmD, editor in chief of the Journal of Managed Care and Specialty Pharmacy, questioned Dr. Pickering about the barriers to medication synchronization.
In previous research, “we discovered that some patients were resistant to synchronizing their medication refills because of the copays – having all of their copays at one time, rather than spreading them out over the month,” Dr. Happe said.
“Certainly, patients may not be able to afford all their copays at one time, so that can be a barrier,” Dr. Pickering said. “With medication synchronization programs, there’s a lot of variation across the board. Patients can choose which medication to synchronize in some programs. Others only synchronize the three-star medication, etc. But there are real barriers and they should be explored.”
Pharmacy Quality Alliance is a nonprofit public-private partnership that develops pharmacy quality measures in collaboration with the Centers for Medicare & Medicaid Services.
Dr. Pickering disclosed no relevant conflicts of interest.
NATIONAL HARBOR, MD. – according to research presented at the annual meeting of the Academy of Managed Care Pharmacy.
Investigators with Pharmacy Quality Alliance (PQA) used data from Truven MarketScan Research Databases to conduct a retrospective cohort study of more than 20,000 patients eligible for inclusion in PQA’s diabetes medication adherence measure. To be included, patients needed to have two or more prescriptions for diabetes medications (excluding insulin), statins, or renin-angiotensin system antagonists. About 80% of patients were commercially insured and 20% came from Medicare supplement insurance (Medigap) plans.
Commercially insured patients whose medication refills were synchronized had better medication adherence than did matched controls (67.7% vs. 57.4%) and lower median health care expenditures ($3,687 vs. $7,480).
The same was true for patients with Medicare supplemental insurance. Synchronized patients in this group also had better medication adherence than controls, at 86.5% vs. 70.4% and lower median health care expenditures ($7,353 vs. $10,592).
Based on their findings in diabetes patients, “I think we should synchronize refills,” Matthew K. Pickering, PharmD, senior director of research and quality strategies at PQA, said. “However, there are populations that were not represented in this, like COPD [chronic obstructive pulmonary disease]. That’s another high-comorbidity, high-cost population that should be studied.”
Session moderator Laura Happe, PharmD, editor in chief of the Journal of Managed Care and Specialty Pharmacy, questioned Dr. Pickering about the barriers to medication synchronization.
In previous research, “we discovered that some patients were resistant to synchronizing their medication refills because of the copays – having all of their copays at one time, rather than spreading them out over the month,” Dr. Happe said.
“Certainly, patients may not be able to afford all their copays at one time, so that can be a barrier,” Dr. Pickering said. “With medication synchronization programs, there’s a lot of variation across the board. Patients can choose which medication to synchronize in some programs. Others only synchronize the three-star medication, etc. But there are real barriers and they should be explored.”
Pharmacy Quality Alliance is a nonprofit public-private partnership that develops pharmacy quality measures in collaboration with the Centers for Medicare & Medicaid Services.
Dr. Pickering disclosed no relevant conflicts of interest.
NATIONAL HARBOR, MD. – according to research presented at the annual meeting of the Academy of Managed Care Pharmacy.
Investigators with Pharmacy Quality Alliance (PQA) used data from Truven MarketScan Research Databases to conduct a retrospective cohort study of more than 20,000 patients eligible for inclusion in PQA’s diabetes medication adherence measure. To be included, patients needed to have two or more prescriptions for diabetes medications (excluding insulin), statins, or renin-angiotensin system antagonists. About 80% of patients were commercially insured and 20% came from Medicare supplement insurance (Medigap) plans.
Commercially insured patients whose medication refills were synchronized had better medication adherence than did matched controls (67.7% vs. 57.4%) and lower median health care expenditures ($3,687 vs. $7,480).
The same was true for patients with Medicare supplemental insurance. Synchronized patients in this group also had better medication adherence than controls, at 86.5% vs. 70.4% and lower median health care expenditures ($7,353 vs. $10,592).
Based on their findings in diabetes patients, “I think we should synchronize refills,” Matthew K. Pickering, PharmD, senior director of research and quality strategies at PQA, said. “However, there are populations that were not represented in this, like COPD [chronic obstructive pulmonary disease]. That’s another high-comorbidity, high-cost population that should be studied.”
Session moderator Laura Happe, PharmD, editor in chief of the Journal of Managed Care and Specialty Pharmacy, questioned Dr. Pickering about the barriers to medication synchronization.
In previous research, “we discovered that some patients were resistant to synchronizing their medication refills because of the copays – having all of their copays at one time, rather than spreading them out over the month,” Dr. Happe said.
“Certainly, patients may not be able to afford all their copays at one time, so that can be a barrier,” Dr. Pickering said. “With medication synchronization programs, there’s a lot of variation across the board. Patients can choose which medication to synchronize in some programs. Others only synchronize the three-star medication, etc. But there are real barriers and they should be explored.”
Pharmacy Quality Alliance is a nonprofit public-private partnership that develops pharmacy quality measures in collaboration with the Centers for Medicare & Medicaid Services.
Dr. Pickering disclosed no relevant conflicts of interest.
REPORTING FROM AMCP NEXUS 2019
Expect some congressional action on drug prices, but not major reform
NATIONAL HARBOR, MD – Congress is considering two separate, comprehensive proposals to address the escalating cost of drug prices, but neither is expected to make it to the President’s desk.
The more likely scenario is that parts of these bills aimed at reforming the Medicare Part D prescription drug program could be added on to a must-pass budget bill before the end of 2019, according to Ross Margulies, senior associate in the Washington office of the law firm Foley Hoag.
A bill championed by House Speaker Nancy Pelosi (D-Calif.), H.R. 3, is considered dead on arrival in the Senate since Senate Majority Leader Mitch McConnell (R-Ky.) has stated that the upper chamber will not take it up, Mr. Margulies said at the annual meeting of the Academy of Managed Care Pharmacy.
Despite this, the House is expected to move on H.R. 3 in mid-November. The bill has gone through three committee markups, and each have amended its language. The final bill language has not been released yet.
Meanwhile in the Senate, the Prescription Drug Pricing Reduction Act (S. 2543) enjoys some bipartisan support, but Mr. Margulies questioned whether there was enough to pass it.
But there are some provisions in both pieces of legislation that have bipartisan support and could ultimately be passed though other legislative vehicles, he said.
One proposal that is common to both bills is a cap on out-of-pocket spending by Part D beneficiaries, though the bills differ on how high to set the cap. The House bill caps annual beneficiary spending at $2,000, while the Senate proposal caps it at $3,600.
The lack of a cap “has increasingly raised some issues over the years as we have seen more and more specialty drugs come on the market that push individuals into the catastrophic phase in that first or second phase of that first or second refill,” Mr. Margulies said.
Another area that is garnering bipartisan support is reforming the structure of Medicare Part D.
Mr. Margulies noted that generally the Part D program has enjoyed bipartisan and consumer support and there “hasn’t been a major restructuring of the Part D benefit since its creation more than a decade ago.”
“I really think this is an area where Congress is in a bipartisan way very focused,” he added.
The redesign proposals in the two bills would fundamentally change how the catastrophic phase is covered. The out-of-pocket limits would eliminate beneficiary cost sharing in this phase, currently set at 5% of list price with no cap on spending, and dramatically reduce the government’s financial exposure during this phase.
Currently, the federal government covers 80% of the cost of drugs for beneficiaries in catastrophic coverage, and the plan sponsors cover the remaining 15%. The House and Senate plans both reduce government coverage to 20%. Under the House proposal, drug plans would be responsible for 50% while manufacturers would cover the remaining 30%. The Senate bill proposes a split of 60% for plans and 20% for manufacturers.
“Under either of these proposals, manufacturers with the highest-priced specialty drugs are probably going to fare the worst because you have that new open-ended liability in the catastrophic phase,” Mr. Margulies said.
On the plan side, “plans will face increased pressure to control costs/utilization,” he added.
These proposals could encourage manufacturers to reduce list prices and drug plans to more aggressively negotiate rebates and discounts.
One element of H.R. 3 that is not a part of the Senate bill is the requirement that the secretary of the Department of Health & Human Services negotiate drug prices for a certain number of high-cost drugs each year. Those negotiations would be backstopped by an international pricing index, with the aim of bringing the prices paid in the United States much closer to the lower prices paid internationally.
H.R. 3 also includes a hefty excise tax for manufacturers who either don’t participate in the negotiations or fail to offer price reductions that are within a specified percentage of the international pricing index.
Mr. Margulies noted that Speaker Pelosi was hoping to get White House endorsement on the drug negotiation provision, since it is similar to regulations proposed by HHS earlier this year, but impeachment proceedings have derailed any chance of getting that endorsement.
Mr. Margulies made no financial disclosures related to his presentation.
NATIONAL HARBOR, MD – Congress is considering two separate, comprehensive proposals to address the escalating cost of drug prices, but neither is expected to make it to the President’s desk.
The more likely scenario is that parts of these bills aimed at reforming the Medicare Part D prescription drug program could be added on to a must-pass budget bill before the end of 2019, according to Ross Margulies, senior associate in the Washington office of the law firm Foley Hoag.
A bill championed by House Speaker Nancy Pelosi (D-Calif.), H.R. 3, is considered dead on arrival in the Senate since Senate Majority Leader Mitch McConnell (R-Ky.) has stated that the upper chamber will not take it up, Mr. Margulies said at the annual meeting of the Academy of Managed Care Pharmacy.
Despite this, the House is expected to move on H.R. 3 in mid-November. The bill has gone through three committee markups, and each have amended its language. The final bill language has not been released yet.
Meanwhile in the Senate, the Prescription Drug Pricing Reduction Act (S. 2543) enjoys some bipartisan support, but Mr. Margulies questioned whether there was enough to pass it.
But there are some provisions in both pieces of legislation that have bipartisan support and could ultimately be passed though other legislative vehicles, he said.
One proposal that is common to both bills is a cap on out-of-pocket spending by Part D beneficiaries, though the bills differ on how high to set the cap. The House bill caps annual beneficiary spending at $2,000, while the Senate proposal caps it at $3,600.
The lack of a cap “has increasingly raised some issues over the years as we have seen more and more specialty drugs come on the market that push individuals into the catastrophic phase in that first or second phase of that first or second refill,” Mr. Margulies said.
Another area that is garnering bipartisan support is reforming the structure of Medicare Part D.
Mr. Margulies noted that generally the Part D program has enjoyed bipartisan and consumer support and there “hasn’t been a major restructuring of the Part D benefit since its creation more than a decade ago.”
“I really think this is an area where Congress is in a bipartisan way very focused,” he added.
The redesign proposals in the two bills would fundamentally change how the catastrophic phase is covered. The out-of-pocket limits would eliminate beneficiary cost sharing in this phase, currently set at 5% of list price with no cap on spending, and dramatically reduce the government’s financial exposure during this phase.
Currently, the federal government covers 80% of the cost of drugs for beneficiaries in catastrophic coverage, and the plan sponsors cover the remaining 15%. The House and Senate plans both reduce government coverage to 20%. Under the House proposal, drug plans would be responsible for 50% while manufacturers would cover the remaining 30%. The Senate bill proposes a split of 60% for plans and 20% for manufacturers.
“Under either of these proposals, manufacturers with the highest-priced specialty drugs are probably going to fare the worst because you have that new open-ended liability in the catastrophic phase,” Mr. Margulies said.
On the plan side, “plans will face increased pressure to control costs/utilization,” he added.
These proposals could encourage manufacturers to reduce list prices and drug plans to more aggressively negotiate rebates and discounts.
One element of H.R. 3 that is not a part of the Senate bill is the requirement that the secretary of the Department of Health & Human Services negotiate drug prices for a certain number of high-cost drugs each year. Those negotiations would be backstopped by an international pricing index, with the aim of bringing the prices paid in the United States much closer to the lower prices paid internationally.
H.R. 3 also includes a hefty excise tax for manufacturers who either don’t participate in the negotiations or fail to offer price reductions that are within a specified percentage of the international pricing index.
Mr. Margulies noted that Speaker Pelosi was hoping to get White House endorsement on the drug negotiation provision, since it is similar to regulations proposed by HHS earlier this year, but impeachment proceedings have derailed any chance of getting that endorsement.
Mr. Margulies made no financial disclosures related to his presentation.
NATIONAL HARBOR, MD – Congress is considering two separate, comprehensive proposals to address the escalating cost of drug prices, but neither is expected to make it to the President’s desk.
The more likely scenario is that parts of these bills aimed at reforming the Medicare Part D prescription drug program could be added on to a must-pass budget bill before the end of 2019, according to Ross Margulies, senior associate in the Washington office of the law firm Foley Hoag.
A bill championed by House Speaker Nancy Pelosi (D-Calif.), H.R. 3, is considered dead on arrival in the Senate since Senate Majority Leader Mitch McConnell (R-Ky.) has stated that the upper chamber will not take it up, Mr. Margulies said at the annual meeting of the Academy of Managed Care Pharmacy.
Despite this, the House is expected to move on H.R. 3 in mid-November. The bill has gone through three committee markups, and each have amended its language. The final bill language has not been released yet.
Meanwhile in the Senate, the Prescription Drug Pricing Reduction Act (S. 2543) enjoys some bipartisan support, but Mr. Margulies questioned whether there was enough to pass it.
But there are some provisions in both pieces of legislation that have bipartisan support and could ultimately be passed though other legislative vehicles, he said.
One proposal that is common to both bills is a cap on out-of-pocket spending by Part D beneficiaries, though the bills differ on how high to set the cap. The House bill caps annual beneficiary spending at $2,000, while the Senate proposal caps it at $3,600.
The lack of a cap “has increasingly raised some issues over the years as we have seen more and more specialty drugs come on the market that push individuals into the catastrophic phase in that first or second phase of that first or second refill,” Mr. Margulies said.
Another area that is garnering bipartisan support is reforming the structure of Medicare Part D.
Mr. Margulies noted that generally the Part D program has enjoyed bipartisan and consumer support and there “hasn’t been a major restructuring of the Part D benefit since its creation more than a decade ago.”
“I really think this is an area where Congress is in a bipartisan way very focused,” he added.
The redesign proposals in the two bills would fundamentally change how the catastrophic phase is covered. The out-of-pocket limits would eliminate beneficiary cost sharing in this phase, currently set at 5% of list price with no cap on spending, and dramatically reduce the government’s financial exposure during this phase.
Currently, the federal government covers 80% of the cost of drugs for beneficiaries in catastrophic coverage, and the plan sponsors cover the remaining 15%. The House and Senate plans both reduce government coverage to 20%. Under the House proposal, drug plans would be responsible for 50% while manufacturers would cover the remaining 30%. The Senate bill proposes a split of 60% for plans and 20% for manufacturers.
“Under either of these proposals, manufacturers with the highest-priced specialty drugs are probably going to fare the worst because you have that new open-ended liability in the catastrophic phase,” Mr. Margulies said.
On the plan side, “plans will face increased pressure to control costs/utilization,” he added.
These proposals could encourage manufacturers to reduce list prices and drug plans to more aggressively negotiate rebates and discounts.
One element of H.R. 3 that is not a part of the Senate bill is the requirement that the secretary of the Department of Health & Human Services negotiate drug prices for a certain number of high-cost drugs each year. Those negotiations would be backstopped by an international pricing index, with the aim of bringing the prices paid in the United States much closer to the lower prices paid internationally.
H.R. 3 also includes a hefty excise tax for manufacturers who either don’t participate in the negotiations or fail to offer price reductions that are within a specified percentage of the international pricing index.
Mr. Margulies noted that Speaker Pelosi was hoping to get White House endorsement on the drug negotiation provision, since it is similar to regulations proposed by HHS earlier this year, but impeachment proceedings have derailed any chance of getting that endorsement.
Mr. Margulies made no financial disclosures related to his presentation.
REPORTING FROM AMCP NEXUS 2019
Management program improves adherence in specialty pharmacy patients
NATIONAL HARBOR, MD. – , according to research presented at the annual meeting of the Academy of Managed Care Pharmacy.
Patient management programs can help improve quality, satisfaction, and health outcomes for pharmacy patients, according to Brian MacDonald, PharmD, of Magellan Rx Management, and colleagues.
“The goal of a successful patient management program is to improve medication use and overall wellness, which can be achieved through patient engagement and empowerment,” they wrote in a poster presented at the meeting, adding that engaging patients can be a challenge.
Dr. MacDonald and colleagues analyzed claims data from January 2016 through April 2019 for more than 14,000 specialty pharmacy patients aged 18 years and older. Eligible patients – defined as those with at least one paid claim for a self-administered specialty drug in 10 eligible categories – were offered monthly coaching services via a patient management program. Baseline data were collected in 2016.
Over the course of the intervention, several changes were made to the patient management program in an effort to improve patient satisfaction.
Staffing was increased and priority was given to new patients. In addition, digital support tools were expanded, and staff engaged in continuous attempts to engage patients.
Patient engagement in the management program increased significantly from 21.6% in the baseline period to 33.4% during the intervention, and increased across all disease categories.
Patients eligible for the management program showed improved medication adherence, measured by the proportion of days covered, at 89.4% vs. 88.1% for ineligible patients. Further, a significantly greater percentage of eligible patients reached a target adherence of more than 85% over that same time period.
The investigators noted that a longer follow-up period may provide improved information on the impact of patient management programs on improved adherence and medical outcomes.
Magellan Rx Management funded the study. Dr. MacDonald and his colleagues are employees of the company.
SOURCE: MacDonald B et al. AMCP Nexus 2019, poster U11.
NATIONAL HARBOR, MD. – , according to research presented at the annual meeting of the Academy of Managed Care Pharmacy.
Patient management programs can help improve quality, satisfaction, and health outcomes for pharmacy patients, according to Brian MacDonald, PharmD, of Magellan Rx Management, and colleagues.
“The goal of a successful patient management program is to improve medication use and overall wellness, which can be achieved through patient engagement and empowerment,” they wrote in a poster presented at the meeting, adding that engaging patients can be a challenge.
Dr. MacDonald and colleagues analyzed claims data from January 2016 through April 2019 for more than 14,000 specialty pharmacy patients aged 18 years and older. Eligible patients – defined as those with at least one paid claim for a self-administered specialty drug in 10 eligible categories – were offered monthly coaching services via a patient management program. Baseline data were collected in 2016.
Over the course of the intervention, several changes were made to the patient management program in an effort to improve patient satisfaction.
Staffing was increased and priority was given to new patients. In addition, digital support tools were expanded, and staff engaged in continuous attempts to engage patients.
Patient engagement in the management program increased significantly from 21.6% in the baseline period to 33.4% during the intervention, and increased across all disease categories.
Patients eligible for the management program showed improved medication adherence, measured by the proportion of days covered, at 89.4% vs. 88.1% for ineligible patients. Further, a significantly greater percentage of eligible patients reached a target adherence of more than 85% over that same time period.
The investigators noted that a longer follow-up period may provide improved information on the impact of patient management programs on improved adherence and medical outcomes.
Magellan Rx Management funded the study. Dr. MacDonald and his colleagues are employees of the company.
SOURCE: MacDonald B et al. AMCP Nexus 2019, poster U11.
NATIONAL HARBOR, MD. – , according to research presented at the annual meeting of the Academy of Managed Care Pharmacy.
Patient management programs can help improve quality, satisfaction, and health outcomes for pharmacy patients, according to Brian MacDonald, PharmD, of Magellan Rx Management, and colleagues.
“The goal of a successful patient management program is to improve medication use and overall wellness, which can be achieved through patient engagement and empowerment,” they wrote in a poster presented at the meeting, adding that engaging patients can be a challenge.
Dr. MacDonald and colleagues analyzed claims data from January 2016 through April 2019 for more than 14,000 specialty pharmacy patients aged 18 years and older. Eligible patients – defined as those with at least one paid claim for a self-administered specialty drug in 10 eligible categories – were offered monthly coaching services via a patient management program. Baseline data were collected in 2016.
Over the course of the intervention, several changes were made to the patient management program in an effort to improve patient satisfaction.
Staffing was increased and priority was given to new patients. In addition, digital support tools were expanded, and staff engaged in continuous attempts to engage patients.
Patient engagement in the management program increased significantly from 21.6% in the baseline period to 33.4% during the intervention, and increased across all disease categories.
Patients eligible for the management program showed improved medication adherence, measured by the proportion of days covered, at 89.4% vs. 88.1% for ineligible patients. Further, a significantly greater percentage of eligible patients reached a target adherence of more than 85% over that same time period.
The investigators noted that a longer follow-up period may provide improved information on the impact of patient management programs on improved adherence and medical outcomes.
Magellan Rx Management funded the study. Dr. MacDonald and his colleagues are employees of the company.
SOURCE: MacDonald B et al. AMCP Nexus 2019, poster U11.
REPORTING FROM AMCP NEXUS 2019
Net prices of drugs rising four-times faster than inflation
NATIONAL HARBOR, MD. – The net prices of drugs are increasing four times faster than the rate of inflation, despite being offset 43% from list prices.
List prices increased by 232% from 2007 to 2018 (12% per year) and net prices increased 133% during that same time period. For Medicaid, the gross-to-net discount increased from 40% in 2007 to 68% in 2018. For all other payers, the increase was 22%-50% during that same period, Inmaculada Hernandez, PharmD, and colleagues reported at annual meeting of the Academy of Managed Care Pharmacy.
The investigators also found a wide variation on discounts across therapeutic classes. For example, list price for drugs in the multiple sclerosis category increased 407% over the study period while net price increased 221%. Insulins came in second in terms of gross price increases (337%) but saw only net prices increases by 83% due to increasing discounts, according to Dr. Hernandez, assistant professor of pharmacy and therapeutics at the University of Pittsburgh.
List prices for noninsulin diabetes treatments tripled during the observation period, but net prices went up only 24%. List price increases were lowest in the antineoplastic class, averaging 135%, though there were only 34% in rebates to offset the list price, resulting in an average net price increase of 89%.
Research was based on pricing data supplied by investment firm SSR Health for branded products and U.S. sales reported by publicly traded companies. The National Heart, Lung, and Blood Institute sponsored the study.
SOURCE: Hernandez I et a. AMCP Nexus, poster U2.
NATIONAL HARBOR, MD. – The net prices of drugs are increasing four times faster than the rate of inflation, despite being offset 43% from list prices.
List prices increased by 232% from 2007 to 2018 (12% per year) and net prices increased 133% during that same time period. For Medicaid, the gross-to-net discount increased from 40% in 2007 to 68% in 2018. For all other payers, the increase was 22%-50% during that same period, Inmaculada Hernandez, PharmD, and colleagues reported at annual meeting of the Academy of Managed Care Pharmacy.
The investigators also found a wide variation on discounts across therapeutic classes. For example, list price for drugs in the multiple sclerosis category increased 407% over the study period while net price increased 221%. Insulins came in second in terms of gross price increases (337%) but saw only net prices increases by 83% due to increasing discounts, according to Dr. Hernandez, assistant professor of pharmacy and therapeutics at the University of Pittsburgh.
List prices for noninsulin diabetes treatments tripled during the observation period, but net prices went up only 24%. List price increases were lowest in the antineoplastic class, averaging 135%, though there were only 34% in rebates to offset the list price, resulting in an average net price increase of 89%.
Research was based on pricing data supplied by investment firm SSR Health for branded products and U.S. sales reported by publicly traded companies. The National Heart, Lung, and Blood Institute sponsored the study.
SOURCE: Hernandez I et a. AMCP Nexus, poster U2.
NATIONAL HARBOR, MD. – The net prices of drugs are increasing four times faster than the rate of inflation, despite being offset 43% from list prices.
List prices increased by 232% from 2007 to 2018 (12% per year) and net prices increased 133% during that same time period. For Medicaid, the gross-to-net discount increased from 40% in 2007 to 68% in 2018. For all other payers, the increase was 22%-50% during that same period, Inmaculada Hernandez, PharmD, and colleagues reported at annual meeting of the Academy of Managed Care Pharmacy.
The investigators also found a wide variation on discounts across therapeutic classes. For example, list price for drugs in the multiple sclerosis category increased 407% over the study period while net price increased 221%. Insulins came in second in terms of gross price increases (337%) but saw only net prices increases by 83% due to increasing discounts, according to Dr. Hernandez, assistant professor of pharmacy and therapeutics at the University of Pittsburgh.
List prices for noninsulin diabetes treatments tripled during the observation period, but net prices went up only 24%. List price increases were lowest in the antineoplastic class, averaging 135%, though there were only 34% in rebates to offset the list price, resulting in an average net price increase of 89%.
Research was based on pricing data supplied by investment firm SSR Health for branded products and U.S. sales reported by publicly traded companies. The National Heart, Lung, and Blood Institute sponsored the study.
SOURCE: Hernandez I et a. AMCP Nexus, poster U2.
REPORTING FROM AMCP NEXUS 2019
Judge blocks Alabama abortion ban
A federal judge has temporarily barred Alabama’s near total abortion ban from taking effect.
In an Oct. 29 decision, Myron H. Thompson, District Court Judge for the Middle District of Alabama, North Division, wrote . Judge Thompson halted the measure, which was scheduled to take effect on Nov. 15, while the lawsuit continues through the courts.
“As stated previously, banning abortion before viability violates Supreme Court precedent,” Judge Thompson wrote in the opinion. “No alleged state interest can overcome this clear mandate. Thus, as a ban on pre-viability abortion, the act contravenes established law.”
Alabama Gov. Kay Ivey (R) signed the “Human Life Protection Act” into law on May 15. The measure bans abortion at every pregnancy stage and penalizes physicians with a Class A felony for performing an abortion and charges them with a Class C felony for attempting to perform an abortion. The law includes an exception if a woman’s life is at risk, but not for cases of rape or incest.
The federal court’s decision affirms that women have a right to access safe, legal abortion, Alexis McGill Johnson, president and CEO of Planned Parenthood Federation of America said in a statement. Planned Parenthood Federation of America, The American Civil Liberties Union, and the ACLU of Alabama are representing the plaintiffs in the lawsuit, which include Alabama physicians and patients.
“Politicians in Alabama, and across the country, are putting people’s health and lives at risk in their attempts to ban abortion outright in this country,” Ms. Johnson said in the statement. “Today’s victory means people can still access the health care they need across Alabama – for now. We will continue to fight to ensure that everyone can access health care – including safe, legal abortion.”
Alabama Attorney General Steve Marshall said the district court’s decision to temporarily halt the law was not unexpected.
“As we have stated before, the state’s objective is to advance our case to the U.S. Supreme Court where we intend to submit evidence that supports our argument that Roe and Casey were wrongly decided and that the Constitution does not prohibit states from protecting unborn children from abortion,” Mr. Marshall said in a statement.
The Alabama decision comes just weeks after the U.S. Supreme Court agreed to hear an abortion-related challenge out of Louisiana. June Medical Services v. Gee centers on the constitutionality of a Louisiana law that requires any doctor performing an abortion to have admitting privileges at a nearby hospital. The high court likely will hear that case in early 2020.
A federal judge has temporarily barred Alabama’s near total abortion ban from taking effect.
In an Oct. 29 decision, Myron H. Thompson, District Court Judge for the Middle District of Alabama, North Division, wrote . Judge Thompson halted the measure, which was scheduled to take effect on Nov. 15, while the lawsuit continues through the courts.
“As stated previously, banning abortion before viability violates Supreme Court precedent,” Judge Thompson wrote in the opinion. “No alleged state interest can overcome this clear mandate. Thus, as a ban on pre-viability abortion, the act contravenes established law.”
Alabama Gov. Kay Ivey (R) signed the “Human Life Protection Act” into law on May 15. The measure bans abortion at every pregnancy stage and penalizes physicians with a Class A felony for performing an abortion and charges them with a Class C felony for attempting to perform an abortion. The law includes an exception if a woman’s life is at risk, but not for cases of rape or incest.
The federal court’s decision affirms that women have a right to access safe, legal abortion, Alexis McGill Johnson, president and CEO of Planned Parenthood Federation of America said in a statement. Planned Parenthood Federation of America, The American Civil Liberties Union, and the ACLU of Alabama are representing the plaintiffs in the lawsuit, which include Alabama physicians and patients.
“Politicians in Alabama, and across the country, are putting people’s health and lives at risk in their attempts to ban abortion outright in this country,” Ms. Johnson said in the statement. “Today’s victory means people can still access the health care they need across Alabama – for now. We will continue to fight to ensure that everyone can access health care – including safe, legal abortion.”
Alabama Attorney General Steve Marshall said the district court’s decision to temporarily halt the law was not unexpected.
“As we have stated before, the state’s objective is to advance our case to the U.S. Supreme Court where we intend to submit evidence that supports our argument that Roe and Casey were wrongly decided and that the Constitution does not prohibit states from protecting unborn children from abortion,” Mr. Marshall said in a statement.
The Alabama decision comes just weeks after the U.S. Supreme Court agreed to hear an abortion-related challenge out of Louisiana. June Medical Services v. Gee centers on the constitutionality of a Louisiana law that requires any doctor performing an abortion to have admitting privileges at a nearby hospital. The high court likely will hear that case in early 2020.
A federal judge has temporarily barred Alabama’s near total abortion ban from taking effect.
In an Oct. 29 decision, Myron H. Thompson, District Court Judge for the Middle District of Alabama, North Division, wrote . Judge Thompson halted the measure, which was scheduled to take effect on Nov. 15, while the lawsuit continues through the courts.
“As stated previously, banning abortion before viability violates Supreme Court precedent,” Judge Thompson wrote in the opinion. “No alleged state interest can overcome this clear mandate. Thus, as a ban on pre-viability abortion, the act contravenes established law.”
Alabama Gov. Kay Ivey (R) signed the “Human Life Protection Act” into law on May 15. The measure bans abortion at every pregnancy stage and penalizes physicians with a Class A felony for performing an abortion and charges them with a Class C felony for attempting to perform an abortion. The law includes an exception if a woman’s life is at risk, but not for cases of rape or incest.
The federal court’s decision affirms that women have a right to access safe, legal abortion, Alexis McGill Johnson, president and CEO of Planned Parenthood Federation of America said in a statement. Planned Parenthood Federation of America, The American Civil Liberties Union, and the ACLU of Alabama are representing the plaintiffs in the lawsuit, which include Alabama physicians and patients.
“Politicians in Alabama, and across the country, are putting people’s health and lives at risk in their attempts to ban abortion outright in this country,” Ms. Johnson said in the statement. “Today’s victory means people can still access the health care they need across Alabama – for now. We will continue to fight to ensure that everyone can access health care – including safe, legal abortion.”
Alabama Attorney General Steve Marshall said the district court’s decision to temporarily halt the law was not unexpected.
“As we have stated before, the state’s objective is to advance our case to the U.S. Supreme Court where we intend to submit evidence that supports our argument that Roe and Casey were wrongly decided and that the Constitution does not prohibit states from protecting unborn children from abortion,” Mr. Marshall said in a statement.
The Alabama decision comes just weeks after the U.S. Supreme Court agreed to hear an abortion-related challenge out of Louisiana. June Medical Services v. Gee centers on the constitutionality of a Louisiana law that requires any doctor performing an abortion to have admitting privileges at a nearby hospital. The high court likely will hear that case in early 2020.
‘Time lost is brain lost’
Question: Which of the following statements regarding “common knowledge” is correct?
A. In any negligence action absent common knowledge, expert testimony is then required to prove requisite standard of care and causation.
B.
C. An expert is needed in the first place to establish whether something constitutes common knowledge.
D. The jury is the one who determines whether a plaintiff can invoke the common knowledge exception.
E. An example of common knowledge in malpractice law is where a delay in stroke diagnosis results in loss of brain function.
Answer: B. The judge, not the jury or anyone else, makes the decision regarding res ipsa loquitur (the thing speaks for itself) or common knowledge, which exempts a plaintiff from producing an expert witness to testify as to the standard of care and causation. However, this is only true in actions arising out of professional negligence such as medical malpractice, whereas most common negligence actions – for example, slips and falls – do not require expert testimony.
Only a professional, duly qualified by the court as an expert witness, is allowed to offer medical testimony, while the plaintiff will typically be disqualified from playing this role because of the complexity of issues involved unless there is common knowledge. In general, courts are reluctant to grant this exception, which favors the plaintiff.
The best example of res ipsa loquitur is where a surgeon inadvertently leaves behind a sponge or instrument inside a body cavity. Other successfully litigated examples include cardiac arrest in the operating room, hypoxia in the recovery room, burns to the buttock, gangrene after the accidental injection of penicillin into an artery, air trapped subcutaneously from a displaced needle, and a pierced eyeball during a procedure. The factual circumstances of each case are critical to its outcome. For example, in a 2013 New York case, the plaintiff was barred from using the res doctrine.1 The defendant doctor had left a guide wire in the plaintiff’s chest following a biopsy and retrieved it 2 months later. The plaintiff did not call any expert witness, relying instead on the “foreign object” basis for invoking the res doctrine. However, the Court of Appeals reasoned that the object was left behind deliberately, not unintentionally, and that under the circumstances of the case, an expert witness was needed to set out the applicable standard of care, without which a jury could not determine whether the doctor’s professional judgment breached the requisite standard.
The Supreme Court of Kentucky recently rejected the use of common knowledge in a stroke case.2 In 2010, David Shackelford’s rheumatologist referred him to Paul Lewis, MD, an interventional radiologist, for a four-vessel cerebral angiogram to assist with diagnosing the cause of Mr. Shackelford’s chronic headaches. The procedure itself was uneventful, but while in the recovery room, Mr. Shackelford reported a frontal headache and scotoma, which resolved on its own. The headache improved with medication, and the patient experienced no other symptoms. There were no other visual changes, weakness, slurred speech, or facial palsies. Mr. Shackelford was discharged but had to return to the hospital the next morning via ambulance after becoming disoriented at his home. An MRI indicated multiple scattered small infarcts, and he was left with residual short-term memory loss and visual problems.
There was no allegation that the stroke itself was caused by negligence; rather, Mr. Shackelford alleged that the failure to examine and diagnose the stroke after the angiogram was negligent and caused injury greater than that which the stroke would have caused with earlier intervention. To support his claims, Mr. Shackelford’s expert, Michael David Khoury, MD, a vascular surgeon, criticized Dr. Lewis’s failure to examine Mr. Shackelford when his symptoms were consistent with a stroke. However, Dr. Khoury did not opine that Dr. Lewis could have limited the effects of the stroke through earlier intervention. When asked specifically whether he could state within a reasonable degree of medical probability that Dr. Lewis’s postprocedure care was a substantial factor in causing harm to Mr. Shackelford, Dr. Khoury responded that it was “impossible to tell.”
Based largely upon Dr. Khoury’s deposition testimony, the defendants successfully moved for summary judgment on the basis that the expert had failed to opine that the alleged negligence caused any injury to Mr. Shackelford. As a result, Mr. Shackelford could not prove an essential element of his medical malpractice claim. Defense expert Peter J. Pema, MD, a neuroradiologist, acknowledged the general proposition that strokes require timely diagnosis and treatment but did not provide an opinion on causation under the specific facts of this case. Another defense expert, Gregory Postal, MD, opined that Mr. Shackelford began to present symptoms of a stroke after leaving the hospital.
Notwithstanding the lower court’s ruling to summarily dismiss the case, the Court of Appeals found that, in this case, the issue of causation did not require expert medical testimony. It explained that given the ubiquity of information regarding stroke symptom identification and the necessity of prompt treatment, it had become common knowledge that “time lost is brain lost” as to timely medical intervention. In other words, a jury of laymen with this general knowledge could resolve the causation issue without the aid of expert testimony.
However, the Supreme Court of Kentucky held otherwise, writing: “We disagree with the Court of Appeals’ analysis. Although public service campaigns have increased public awareness and knowledge about stroke symptoms and timely intervention, that general information cannot provide the medical expertise necessary to evaluate this particular claim of medical malpractice. In other words, the question is not simply whether ‘time lost is brain lost.’ Rather, the specific facts and circumstances of this case play a significant role in determining whether the alleged negligent conduct was a substantial factor in Shackelford’s injuries, and to what extent. For example, as Dr. Lewis’s deposition testimony illustrates, a variety of factors influenced his diagnosis and treatment of Shackelford, including Shackelford’s medical history and history of cluster headaches; the common side effects of the angiogram procedure, including headache and scotoma; and the manner in which Shackelford’s headache and scotoma presented, as well as their timing. The complexities of these factors and how they affected Dr. Lewis’s evaluation of Shackelford may have also influenced the severity of the injury. These matters are clearly relevant to the determination of an alleged breach of the standard of care. Despite public perception about timely intervention, the average layperson cannot properly weigh such complex medical evidence without the aid of expert opinion. … To conclude otherwise is to drastically expand the res ipsa loquitor exception and to virtually eliminate the need for expert opinion evidence in similar medical malpractice actions that involve common or highly publicized conditions (e.g., stroke, heart attack, and even some cancers).”
Dr. Tan is professor emeritus of medicine and former adjunct professor of law at the University of Hawaii, Honolulu. This article is meant to be educational and does not constitute medical, ethical or legal advice. The author published an earlier version of this topic in the April 19, 2016, issue of Internal Medicine News, available at https://www.mdedge.com/internalmedicine/law-medicine. For additional information, readers may contact the author at siang@hawaii.edu.
References
1. James v. Wormuth, 997 N.E.2d 133 (N.Y. 2013).
2. Lewis/Ashland Hospital v. Shackelford, Supreme Court of Kentucky, Opinion of the Court by Justice Keller, rendered August 29, 2019.
Question: Which of the following statements regarding “common knowledge” is correct?
A. In any negligence action absent common knowledge, expert testimony is then required to prove requisite standard of care and causation.
B.
C. An expert is needed in the first place to establish whether something constitutes common knowledge.
D. The jury is the one who determines whether a plaintiff can invoke the common knowledge exception.
E. An example of common knowledge in malpractice law is where a delay in stroke diagnosis results in loss of brain function.
Answer: B. The judge, not the jury or anyone else, makes the decision regarding res ipsa loquitur (the thing speaks for itself) or common knowledge, which exempts a plaintiff from producing an expert witness to testify as to the standard of care and causation. However, this is only true in actions arising out of professional negligence such as medical malpractice, whereas most common negligence actions – for example, slips and falls – do not require expert testimony.
Only a professional, duly qualified by the court as an expert witness, is allowed to offer medical testimony, while the plaintiff will typically be disqualified from playing this role because of the complexity of issues involved unless there is common knowledge. In general, courts are reluctant to grant this exception, which favors the plaintiff.
The best example of res ipsa loquitur is where a surgeon inadvertently leaves behind a sponge or instrument inside a body cavity. Other successfully litigated examples include cardiac arrest in the operating room, hypoxia in the recovery room, burns to the buttock, gangrene after the accidental injection of penicillin into an artery, air trapped subcutaneously from a displaced needle, and a pierced eyeball during a procedure. The factual circumstances of each case are critical to its outcome. For example, in a 2013 New York case, the plaintiff was barred from using the res doctrine.1 The defendant doctor had left a guide wire in the plaintiff’s chest following a biopsy and retrieved it 2 months later. The plaintiff did not call any expert witness, relying instead on the “foreign object” basis for invoking the res doctrine. However, the Court of Appeals reasoned that the object was left behind deliberately, not unintentionally, and that under the circumstances of the case, an expert witness was needed to set out the applicable standard of care, without which a jury could not determine whether the doctor’s professional judgment breached the requisite standard.
The Supreme Court of Kentucky recently rejected the use of common knowledge in a stroke case.2 In 2010, David Shackelford’s rheumatologist referred him to Paul Lewis, MD, an interventional radiologist, for a four-vessel cerebral angiogram to assist with diagnosing the cause of Mr. Shackelford’s chronic headaches. The procedure itself was uneventful, but while in the recovery room, Mr. Shackelford reported a frontal headache and scotoma, which resolved on its own. The headache improved with medication, and the patient experienced no other symptoms. There were no other visual changes, weakness, slurred speech, or facial palsies. Mr. Shackelford was discharged but had to return to the hospital the next morning via ambulance after becoming disoriented at his home. An MRI indicated multiple scattered small infarcts, and he was left with residual short-term memory loss and visual problems.
There was no allegation that the stroke itself was caused by negligence; rather, Mr. Shackelford alleged that the failure to examine and diagnose the stroke after the angiogram was negligent and caused injury greater than that which the stroke would have caused with earlier intervention. To support his claims, Mr. Shackelford’s expert, Michael David Khoury, MD, a vascular surgeon, criticized Dr. Lewis’s failure to examine Mr. Shackelford when his symptoms were consistent with a stroke. However, Dr. Khoury did not opine that Dr. Lewis could have limited the effects of the stroke through earlier intervention. When asked specifically whether he could state within a reasonable degree of medical probability that Dr. Lewis’s postprocedure care was a substantial factor in causing harm to Mr. Shackelford, Dr. Khoury responded that it was “impossible to tell.”
Based largely upon Dr. Khoury’s deposition testimony, the defendants successfully moved for summary judgment on the basis that the expert had failed to opine that the alleged negligence caused any injury to Mr. Shackelford. As a result, Mr. Shackelford could not prove an essential element of his medical malpractice claim. Defense expert Peter J. Pema, MD, a neuroradiologist, acknowledged the general proposition that strokes require timely diagnosis and treatment but did not provide an opinion on causation under the specific facts of this case. Another defense expert, Gregory Postal, MD, opined that Mr. Shackelford began to present symptoms of a stroke after leaving the hospital.
Notwithstanding the lower court’s ruling to summarily dismiss the case, the Court of Appeals found that, in this case, the issue of causation did not require expert medical testimony. It explained that given the ubiquity of information regarding stroke symptom identification and the necessity of prompt treatment, it had become common knowledge that “time lost is brain lost” as to timely medical intervention. In other words, a jury of laymen with this general knowledge could resolve the causation issue without the aid of expert testimony.
However, the Supreme Court of Kentucky held otherwise, writing: “We disagree with the Court of Appeals’ analysis. Although public service campaigns have increased public awareness and knowledge about stroke symptoms and timely intervention, that general information cannot provide the medical expertise necessary to evaluate this particular claim of medical malpractice. In other words, the question is not simply whether ‘time lost is brain lost.’ Rather, the specific facts and circumstances of this case play a significant role in determining whether the alleged negligent conduct was a substantial factor in Shackelford’s injuries, and to what extent. For example, as Dr. Lewis’s deposition testimony illustrates, a variety of factors influenced his diagnosis and treatment of Shackelford, including Shackelford’s medical history and history of cluster headaches; the common side effects of the angiogram procedure, including headache and scotoma; and the manner in which Shackelford’s headache and scotoma presented, as well as their timing. The complexities of these factors and how they affected Dr. Lewis’s evaluation of Shackelford may have also influenced the severity of the injury. These matters are clearly relevant to the determination of an alleged breach of the standard of care. Despite public perception about timely intervention, the average layperson cannot properly weigh such complex medical evidence without the aid of expert opinion. … To conclude otherwise is to drastically expand the res ipsa loquitor exception and to virtually eliminate the need for expert opinion evidence in similar medical malpractice actions that involve common or highly publicized conditions (e.g., stroke, heart attack, and even some cancers).”
Dr. Tan is professor emeritus of medicine and former adjunct professor of law at the University of Hawaii, Honolulu. This article is meant to be educational and does not constitute medical, ethical or legal advice. The author published an earlier version of this topic in the April 19, 2016, issue of Internal Medicine News, available at https://www.mdedge.com/internalmedicine/law-medicine. For additional information, readers may contact the author at siang@hawaii.edu.
References
1. James v. Wormuth, 997 N.E.2d 133 (N.Y. 2013).
2. Lewis/Ashland Hospital v. Shackelford, Supreme Court of Kentucky, Opinion of the Court by Justice Keller, rendered August 29, 2019.
Question: Which of the following statements regarding “common knowledge” is correct?
A. In any negligence action absent common knowledge, expert testimony is then required to prove requisite standard of care and causation.
B.
C. An expert is needed in the first place to establish whether something constitutes common knowledge.
D. The jury is the one who determines whether a plaintiff can invoke the common knowledge exception.
E. An example of common knowledge in malpractice law is where a delay in stroke diagnosis results in loss of brain function.
Answer: B. The judge, not the jury or anyone else, makes the decision regarding res ipsa loquitur (the thing speaks for itself) or common knowledge, which exempts a plaintiff from producing an expert witness to testify as to the standard of care and causation. However, this is only true in actions arising out of professional negligence such as medical malpractice, whereas most common negligence actions – for example, slips and falls – do not require expert testimony.
Only a professional, duly qualified by the court as an expert witness, is allowed to offer medical testimony, while the plaintiff will typically be disqualified from playing this role because of the complexity of issues involved unless there is common knowledge. In general, courts are reluctant to grant this exception, which favors the plaintiff.
The best example of res ipsa loquitur is where a surgeon inadvertently leaves behind a sponge or instrument inside a body cavity. Other successfully litigated examples include cardiac arrest in the operating room, hypoxia in the recovery room, burns to the buttock, gangrene after the accidental injection of penicillin into an artery, air trapped subcutaneously from a displaced needle, and a pierced eyeball during a procedure. The factual circumstances of each case are critical to its outcome. For example, in a 2013 New York case, the plaintiff was barred from using the res doctrine.1 The defendant doctor had left a guide wire in the plaintiff’s chest following a biopsy and retrieved it 2 months later. The plaintiff did not call any expert witness, relying instead on the “foreign object” basis for invoking the res doctrine. However, the Court of Appeals reasoned that the object was left behind deliberately, not unintentionally, and that under the circumstances of the case, an expert witness was needed to set out the applicable standard of care, without which a jury could not determine whether the doctor’s professional judgment breached the requisite standard.
The Supreme Court of Kentucky recently rejected the use of common knowledge in a stroke case.2 In 2010, David Shackelford’s rheumatologist referred him to Paul Lewis, MD, an interventional radiologist, for a four-vessel cerebral angiogram to assist with diagnosing the cause of Mr. Shackelford’s chronic headaches. The procedure itself was uneventful, but while in the recovery room, Mr. Shackelford reported a frontal headache and scotoma, which resolved on its own. The headache improved with medication, and the patient experienced no other symptoms. There were no other visual changes, weakness, slurred speech, or facial palsies. Mr. Shackelford was discharged but had to return to the hospital the next morning via ambulance after becoming disoriented at his home. An MRI indicated multiple scattered small infarcts, and he was left with residual short-term memory loss and visual problems.
There was no allegation that the stroke itself was caused by negligence; rather, Mr. Shackelford alleged that the failure to examine and diagnose the stroke after the angiogram was negligent and caused injury greater than that which the stroke would have caused with earlier intervention. To support his claims, Mr. Shackelford’s expert, Michael David Khoury, MD, a vascular surgeon, criticized Dr. Lewis’s failure to examine Mr. Shackelford when his symptoms were consistent with a stroke. However, Dr. Khoury did not opine that Dr. Lewis could have limited the effects of the stroke through earlier intervention. When asked specifically whether he could state within a reasonable degree of medical probability that Dr. Lewis’s postprocedure care was a substantial factor in causing harm to Mr. Shackelford, Dr. Khoury responded that it was “impossible to tell.”
Based largely upon Dr. Khoury’s deposition testimony, the defendants successfully moved for summary judgment on the basis that the expert had failed to opine that the alleged negligence caused any injury to Mr. Shackelford. As a result, Mr. Shackelford could not prove an essential element of his medical malpractice claim. Defense expert Peter J. Pema, MD, a neuroradiologist, acknowledged the general proposition that strokes require timely diagnosis and treatment but did not provide an opinion on causation under the specific facts of this case. Another defense expert, Gregory Postal, MD, opined that Mr. Shackelford began to present symptoms of a stroke after leaving the hospital.
Notwithstanding the lower court’s ruling to summarily dismiss the case, the Court of Appeals found that, in this case, the issue of causation did not require expert medical testimony. It explained that given the ubiquity of information regarding stroke symptom identification and the necessity of prompt treatment, it had become common knowledge that “time lost is brain lost” as to timely medical intervention. In other words, a jury of laymen with this general knowledge could resolve the causation issue without the aid of expert testimony.
However, the Supreme Court of Kentucky held otherwise, writing: “We disagree with the Court of Appeals’ analysis. Although public service campaigns have increased public awareness and knowledge about stroke symptoms and timely intervention, that general information cannot provide the medical expertise necessary to evaluate this particular claim of medical malpractice. In other words, the question is not simply whether ‘time lost is brain lost.’ Rather, the specific facts and circumstances of this case play a significant role in determining whether the alleged negligent conduct was a substantial factor in Shackelford’s injuries, and to what extent. For example, as Dr. Lewis’s deposition testimony illustrates, a variety of factors influenced his diagnosis and treatment of Shackelford, including Shackelford’s medical history and history of cluster headaches; the common side effects of the angiogram procedure, including headache and scotoma; and the manner in which Shackelford’s headache and scotoma presented, as well as their timing. The complexities of these factors and how they affected Dr. Lewis’s evaluation of Shackelford may have also influenced the severity of the injury. These matters are clearly relevant to the determination of an alleged breach of the standard of care. Despite public perception about timely intervention, the average layperson cannot properly weigh such complex medical evidence without the aid of expert opinion. … To conclude otherwise is to drastically expand the res ipsa loquitor exception and to virtually eliminate the need for expert opinion evidence in similar medical malpractice actions that involve common or highly publicized conditions (e.g., stroke, heart attack, and even some cancers).”
Dr. Tan is professor emeritus of medicine and former adjunct professor of law at the University of Hawaii, Honolulu. This article is meant to be educational and does not constitute medical, ethical or legal advice. The author published an earlier version of this topic in the April 19, 2016, issue of Internal Medicine News, available at https://www.mdedge.com/internalmedicine/law-medicine. For additional information, readers may contact the author at siang@hawaii.edu.
References
1. James v. Wormuth, 997 N.E.2d 133 (N.Y. 2013).
2. Lewis/Ashland Hospital v. Shackelford, Supreme Court of Kentucky, Opinion of the Court by Justice Keller, rendered August 29, 2019.