Health Policy

Children in military families face unique challenges that other children do not face. Knee pathologies predict accelerated knee osteoarthritis, patients with a poor-prognosis cancer have a higher risk of suicide in the first year, and Nuedexta is mainly being prescribed for dementia and Parkinson’s.

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Children in military families face unique challenges that other children do not face. Knee pathologies predict accelerated knee osteoarthritis, patients with a poor-prognosis cancer have a higher risk of suicide in the first year, and Nuedexta is mainly being prescribed for dementia and Parkinson’s.

Amazon Alexa

Apple Podcasts

Google Podcasts

Spotify
 

Children in military families face unique challenges that other children do not face. Knee pathologies predict accelerated knee osteoarthritis, patients with a poor-prognosis cancer have a higher risk of suicide in the first year, and Nuedexta is mainly being prescribed for dementia and Parkinson’s.

Amazon Alexa

Apple Podcasts

Google Podcasts

Spotify
 

In a position statement published online ahead of print Jan. 2 in Neurology, the American Academy of Neurology urges uniformity in the laws, policies, and practices related to brain death. Such uniformity would reduce uncertainty and improve patient care, according to the authors. The statement, which was drafted by the AAN’s Brain Death Working Group, also supports the development of uniform policies regarding brain death and its determination within American medical institutions. Finally, the document provides neurologists with guidance for responding to requests for accommodation, including objections to the determination of brain death and to the withdrawal of organ-sustaining technology.

The AAN defines brain death as death resulting from irreversible loss of function of the entire brain. The Uniform Determination of Death Act of 1981 held that brain death and circulatory death (that is, death resulting from irreversible loss of function of the circulatory system) are equivalent, and the AAN acknowledges this equivalence.

The two current medical standards for brain death are the AAN’s 2010 Evidence-Based Guideline Update: Determining Brain Death in Adults and the 2011 Guidelines for the Determination of Brain Death in Infants and Children, which was published by the pediatric section of the Society of Critical Care Medicine, the sections of neurology and critical care of the American Academy of Pediatrics, and the Child Neurology Society. “The AAN is unaware of any cases in which compliant application of the brain death guidelines led to inaccurate determination of death with return of any brain function, including consciousness, brainstem reflexes, or ventilatory effort,” according to their 2019 statement.

The only jurisdiction with laws that specifically defer to these standards, however, is Nevada. The vagueness of most states’ laws has contributed to divergent legal interpretations and idiosyncratic standards for determining brain death, according to the statement.

“The AAN believes that a specific, uniform standard for the determination of brain death is critically important to provide the highest quality patient-centered neurologic and end-of-life care,” said James Russell, DO, MS, a neurologist at Lahey Hospital and Medical Center in Burlington, Mass., and lead author of the position statement. “The AAN supports the development of legislation in every state modeled after the Nevada statute, which specifically defers to these current adult and pediatric brain death guidelines and any future updates.”

In addition to uniform institutional policies for determining brain death within U.S. medical facilities, the AAN calls for the development of training programs and credentialing mechanisms for physicians who determine brain death, regardless of their specialties. The association also supports research that enhances understanding of brain death and enhanced professional and public education.

While expressing respect and sympathy for requests for limited accommodation, the AAN asserts that these requests “must be based on the values of the patient, and not those of loved ones or other surrogate decision makers.” The association further observes that physicians have no ethical obligation to provide medical treatment to a deceased patient. New Jersey is the only state that legally obliges physicians to provide indefinite accommodation and continued application of organ-sustaining technology.

“The AAN believes that its members have both the moral authority and professional responsibility, when lawful, to perform a brain death evaluation, including apnea testing, after informing a patient’s loved ones or lawful surrogates of that intention, but without obligation to obtain informed consent,” according to the statement. “This position is analogous to the authority and responsibility historically granted to the medical profession to determine circulatory death without the requirement for additional informed consent.”

If a dispute about indefinite accommodation cannot be resolved, it is acceptable for a physician to withdraw organ-sustaining technology unilaterally over the objection of loved ones when legally permitted, according to the AAN. Such unilateral action is a measure of last resort and does not apply when the patient is a pregnant woman, said the authors. In the latter case, the ethical analysis should focus mainly on the welfare of the fetus.

The AAN provided financial support for the Brain Death Working Group’s efforts. The statement’s authors reported no relevant disclosures. The American Neurological Association and the Child Neurology Society have endorsed the AAN’s position statement.

[email protected]

SOURCE: Russell JA et al. Neurology. 2018 Jan 2. doi: 10.1212/WNL.0000000000006750.
 

In a position statement published online ahead of print Jan. 2 in Neurology, the American Academy of Neurology urges uniformity in the laws, policies, and practices related to brain death. Such uniformity would reduce uncertainty and improve patient care, according to the authors. The statement, which was drafted by the AAN’s Brain Death Working Group, also supports the development of uniform policies regarding brain death and its determination within American medical institutions. Finally, the document provides neurologists with guidance for responding to requests for accommodation, including objections to the determination of brain death and to the withdrawal of organ-sustaining technology.

The AAN defines brain death as death resulting from irreversible loss of function of the entire brain. The Uniform Determination of Death Act of 1981 held that brain death and circulatory death (that is, death resulting from irreversible loss of function of the circulatory system) are equivalent, and the AAN acknowledges this equivalence.

The two current medical standards for brain death are the AAN’s 2010 Evidence-Based Guideline Update: Determining Brain Death in Adults and the 2011 Guidelines for the Determination of Brain Death in Infants and Children, which was published by the pediatric section of the Society of Critical Care Medicine, the sections of neurology and critical care of the American Academy of Pediatrics, and the Child Neurology Society. “The AAN is unaware of any cases in which compliant application of the brain death guidelines led to inaccurate determination of death with return of any brain function, including consciousness, brainstem reflexes, or ventilatory effort,” according to their 2019 statement.

The only jurisdiction with laws that specifically defer to these standards, however, is Nevada. The vagueness of most states’ laws has contributed to divergent legal interpretations and idiosyncratic standards for determining brain death, according to the statement.

“The AAN believes that a specific, uniform standard for the determination of brain death is critically important to provide the highest quality patient-centered neurologic and end-of-life care,” said James Russell, DO, MS, a neurologist at Lahey Hospital and Medical Center in Burlington, Mass., and lead author of the position statement. “The AAN supports the development of legislation in every state modeled after the Nevada statute, which specifically defers to these current adult and pediatric brain death guidelines and any future updates.”

In addition to uniform institutional policies for determining brain death within U.S. medical facilities, the AAN calls for the development of training programs and credentialing mechanisms for physicians who determine brain death, regardless of their specialties. The association also supports research that enhances understanding of brain death and enhanced professional and public education.

While expressing respect and sympathy for requests for limited accommodation, the AAN asserts that these requests “must be based on the values of the patient, and not those of loved ones or other surrogate decision makers.” The association further observes that physicians have no ethical obligation to provide medical treatment to a deceased patient. New Jersey is the only state that legally obliges physicians to provide indefinite accommodation and continued application of organ-sustaining technology.

“The AAN believes that its members have both the moral authority and professional responsibility, when lawful, to perform a brain death evaluation, including apnea testing, after informing a patient’s loved ones or lawful surrogates of that intention, but without obligation to obtain informed consent,” according to the statement. “This position is analogous to the authority and responsibility historically granted to the medical profession to determine circulatory death without the requirement for additional informed consent.”

If a dispute about indefinite accommodation cannot be resolved, it is acceptable for a physician to withdraw organ-sustaining technology unilaterally over the objection of loved ones when legally permitted, according to the AAN. Such unilateral action is a measure of last resort and does not apply when the patient is a pregnant woman, said the authors. In the latter case, the ethical analysis should focus mainly on the welfare of the fetus.

The AAN provided financial support for the Brain Death Working Group’s efforts. The statement’s authors reported no relevant disclosures. The American Neurological Association and the Child Neurology Society have endorsed the AAN’s position statement.

[email protected]

SOURCE: Russell JA et al. Neurology. 2018 Jan 2. doi: 10.1212/WNL.0000000000006750.
 

In a position statement published online ahead of print Jan. 2 in Neurology, the American Academy of Neurology urges uniformity in the laws, policies, and practices related to brain death. Such uniformity would reduce uncertainty and improve patient care, according to the authors. The statement, which was drafted by the AAN’s Brain Death Working Group, also supports the development of uniform policies regarding brain death and its determination within American medical institutions. Finally, the document provides neurologists with guidance for responding to requests for accommodation, including objections to the determination of brain death and to the withdrawal of organ-sustaining technology.

The AAN defines brain death as death resulting from irreversible loss of function of the entire brain. The Uniform Determination of Death Act of 1981 held that brain death and circulatory death (that is, death resulting from irreversible loss of function of the circulatory system) are equivalent, and the AAN acknowledges this equivalence.

The two current medical standards for brain death are the AAN’s 2010 Evidence-Based Guideline Update: Determining Brain Death in Adults and the 2011 Guidelines for the Determination of Brain Death in Infants and Children, which was published by the pediatric section of the Society of Critical Care Medicine, the sections of neurology and critical care of the American Academy of Pediatrics, and the Child Neurology Society. “The AAN is unaware of any cases in which compliant application of the brain death guidelines led to inaccurate determination of death with return of any brain function, including consciousness, brainstem reflexes, or ventilatory effort,” according to their 2019 statement.

The only jurisdiction with laws that specifically defer to these standards, however, is Nevada. The vagueness of most states’ laws has contributed to divergent legal interpretations and idiosyncratic standards for determining brain death, according to the statement.

“The AAN believes that a specific, uniform standard for the determination of brain death is critically important to provide the highest quality patient-centered neurologic and end-of-life care,” said James Russell, DO, MS, a neurologist at Lahey Hospital and Medical Center in Burlington, Mass., and lead author of the position statement. “The AAN supports the development of legislation in every state modeled after the Nevada statute, which specifically defers to these current adult and pediatric brain death guidelines and any future updates.”

In addition to uniform institutional policies for determining brain death within U.S. medical facilities, the AAN calls for the development of training programs and credentialing mechanisms for physicians who determine brain death, regardless of their specialties. The association also supports research that enhances understanding of brain death and enhanced professional and public education.

While expressing respect and sympathy for requests for limited accommodation, the AAN asserts that these requests “must be based on the values of the patient, and not those of loved ones or other surrogate decision makers.” The association further observes that physicians have no ethical obligation to provide medical treatment to a deceased patient. New Jersey is the only state that legally obliges physicians to provide indefinite accommodation and continued application of organ-sustaining technology.

“The AAN believes that its members have both the moral authority and professional responsibility, when lawful, to perform a brain death evaluation, including apnea testing, after informing a patient’s loved ones or lawful surrogates of that intention, but without obligation to obtain informed consent,” according to the statement. “This position is analogous to the authority and responsibility historically granted to the medical profession to determine circulatory death without the requirement for additional informed consent.”

If a dispute about indefinite accommodation cannot be resolved, it is acceptable for a physician to withdraw organ-sustaining technology unilaterally over the objection of loved ones when legally permitted, according to the AAN. Such unilateral action is a measure of last resort and does not apply when the patient is a pregnant woman, said the authors. In the latter case, the ethical analysis should focus mainly on the welfare of the fetus.

The AAN provided financial support for the Brain Death Working Group’s efforts. The statement’s authors reported no relevant disclosures. The American Neurological Association and the Child Neurology Society have endorsed the AAN’s position statement.

[email protected]

SOURCE: Russell JA et al. Neurology. 2018 Jan 2. doi: 10.1212/WNL.0000000000006750.
 

CASE 1 Huge out-of-pocket cost makes patient forego treatment

Ms. M. is a 28-year-old patient who recently posted this on her Facebook page: “I went to the drugstore this morning to pick up a prescription, and as the pharmacist handed it to me she said, ‘That will be $180.00.’ And that’s after insurance coverage! Wow! I think I’ll pass!”

Our patients probably experience this type of situation more commonly than we know.

CASE 2 Catastrophic medical costs bankrupt family

A middle-class couple who had college degrees and full-time jobs with health insurance had twins at 24 weeks’ gestation. They accrued $450,000 in medical debt after exceeding the $2 million cap of their insurance policy. Having premature twins cost them everything. They liquidated their retirement and savings accounts, sold everything they had, and still ended up filing for bankruptcy.¹

Costs indeed matter to patients, and we have a professional responsibility to help our patients navigate the murky waters of health care so that they can maintain financial as well as physical health.

Rising costs, lower yield,and opportunities for change

Rising health care costs are unsustainable for both our patients and our society. Although the United States spends more on health care than any other developed country, our health outcomes are actually worse—ranking at or near the bottom in both prevalence and mortality for multiple diseases, risk factors, and injuries.²

Of the 171 countries included in a study by the United Nations Maternal Mortality Estimation Inter-Agency Group, the United States was 1 of 13 countries that had an increasing maternal mortality and the only developed nation with an increasing maternal mortality rate.³ This tells us that, as our country spends more on health care, our patients’ health is not improving. For individuals, medical bills are now the leading cause of personal bankruptcy in the United States, even for those who are insured.⁴

ObGyns play an important leadership role in the practice of cost-conscious health care, as 25% of hospitalizations in the United States are pregnancy related.^5,6 In addition, the wide scope of ObGyn practice reaches beyond pregnancy-related conditions and provides multiple opportunities to decrease the use of unnecessary tests and treatments.

The good news is that approximately 30% of health care costs are wasted on unnecessary care that could be eliminated without decreasing the quality of care.⁷

High-value change #1: Eliminate use of expensive products

Embarking on a high-value care improvement project, experts at Greenville Health System examined the cost of different topical pain medications for perineal pain after a vaginal delivery. They found that Epifoam (hydrocortisone acetate/pramoxine hydrochloride) was ordered 2,287 times over the course of a year.

The study intervention consisted of an educational grand rounds and discussion of a Cochrane review, which concluded there was no difference in pain relief with topical anesthetics compared with placebo.⁸ Less expensive options for pain relief were discussed, and the department agreed to remove Epifoam as a standing order.

After the intervention, Epifoam was ordered 228 times, a 90% reduction. Over the period of a year, this translated to a cost savings of $92,655 for the hospital, with reduced charges passed on to patients.⁹ Thus, a seemingly small individual cost ($45.00 per can of Epifoam) can add up to a substantial sum in a large health care system.

Continue to: High-value change #2: Stop ordering unnecessary lab work...

High-value change #2: Stop ordering unnecessary lab work

Another high-value change to consider: Examine each laboratory test order to understand if the test results will really alter the care of a patient. Providers vary, and ordering lab tests to “make sure” can add up as financial expense.

Best practices from the American College of Obstetricians and Gynecologists (ACOG) and other professional societies can help guide decision-making as we order lab tests. Think twice, for example, about whether every evaluation for preeclampsia requires a uric acid test, since ACOG does not endorse that as part of the diagnostic criteria. While a single uric acid test costs only $8.00 to $38.00 (according to Healthcare Bluebook), testing uric acid in many patients over the course of a year can add up to significant dollars.¹¹

High-value change #3: Consider care redesign

In addition to seeking opportunities to use more cost-effective products and reduce the use of unnecessary tests, “care redesign” is an innovative way to provide high-quality care (and increased patient satisfaction) at a lower cost for both the health care system and the patient. A prime example of care redesign is using telehealth to enhance prenatal care.

Several health systems around the country are piloting and implementing remote blood pressure monitoring, app-based prenatal education, and telehealth visits to enhance prenatal care.^12,13 Use of a home blood pressure monitor can reduce in-person visits for low-risk prenatal care and open up access for other patients. Additionally, allowing the patient to participate in her own care at home or work can eliminate drives to and waits in the office and reduce absence from work because of a doctor visit.

A systematic review of more than 60,000 women showed that low-risk women who attend 5 to 9 prenatal visits have the same outcomes as women who attend the standard schedule of 13 to 15 visits.¹⁴ Although patient satisfaction was higher with more visits, when a bidirectional app or a telehealth visit is offered as an option, then patient satisfaction is equivalent to that in the standard schedule group.¹² So why not expand the choice for patients?

The challenge of teaching high-value care: Medical education responds

In a 2010 article in the New England Journal of Medicine, Dr. Molly Cooke commented on medical education’s responsibility regarding cost consciousness in patient care, and she highlighted the importance of teaching medical students and residents about considering cost in treating patients.¹⁵ Similarly, the Accreditation Council for Graduate Medical Education asks residents to consider cost and stewardship of medical resources as one of its system-based practice competencies.¹⁶ In 2012, the Choosing Wisely campaign, initiated by the American Board of Internal Medicine Foundation, asked specialty society members to identify tests or procedures commonly used in their field whose necessity should be questioned and discussed.¹⁷ ACOG and other women’s health specialty societies participate in this campaign.

From an educational standpoint, ACOG’s Council on Resident Education in Obstetrics and Gynecology has developed a curriculum resource, “Cases in High Value Care,” that can be used by any women’s health department to start the conversation on high-value care.¹⁸ The web program encourages medical students and residents to submit clinical vignettes that demonstrate examples of low- and high-value care. These cases can be used for discussion and debate and can serve as high-value care performance improvement projects in your own department.

Other useful publications are available outside the ObGyn specialty. Consider the Society of Hospital Medicine’s article series in the Journal of Hospital Medicine, “Choosing Wisely: Things We Do for No Reason”and “Choosing Wisely: Next Steps in Improving Healthcare Value.”¹⁹ The former focuses on discussing practices (tests, procedures, supplies, and prescriptions) that may be poorly supported by evidence or are part of standard practice even though other less expensive, higher-value alternatives may be available. The latter highlights perspective pieces that describe health care value initiatives relating to the practice of hospital medicine.

Continue to: The bottom line...

The bottom line

ObGyns and other health care providers are concerned about providing high-value care to patients and are working toward improving performance in this area. We really do care about the health care–related financial burdens that confront Ms. M., the premature twins’ parents, and all our patients.

CASE 1 Huge out-of-pocket cost makes patient forego treatment

Ms. M. is a 28-year-old patient who recently posted this on her Facebook page: “I went to the drugstore this morning to pick up a prescription, and as the pharmacist handed it to me she said, ‘That will be $180.00.’ And that’s after insurance coverage! Wow! I think I’ll pass!”

Our patients probably experience this type of situation more commonly than we know.

CASE 2 Catastrophic medical costs bankrupt family

A middle-class couple who had college degrees and full-time jobs with health insurance had twins at 24 weeks’ gestation. They accrued $450,000 in medical debt after exceeding the $2 million cap of their insurance policy. Having premature twins cost them everything. They liquidated their retirement and savings accounts, sold everything they had, and still ended up filing for bankruptcy.¹

Costs indeed matter to patients, and we have a professional responsibility to help our patients navigate the murky waters of health care so that they can maintain financial as well as physical health.

Rising costs, lower yield,and opportunities for change

Rising health care costs are unsustainable for both our patients and our society. Although the United States spends more on health care than any other developed country, our health outcomes are actually worse—ranking at or near the bottom in both prevalence and mortality for multiple diseases, risk factors, and injuries.²

Of the 171 countries included in a study by the United Nations Maternal Mortality Estimation Inter-Agency Group, the United States was 1 of 13 countries that had an increasing maternal mortality and the only developed nation with an increasing maternal mortality rate.³ This tells us that, as our country spends more on health care, our patients’ health is not improving. For individuals, medical bills are now the leading cause of personal bankruptcy in the United States, even for those who are insured.⁴

ObGyns play an important leadership role in the practice of cost-conscious health care, as 25% of hospitalizations in the United States are pregnancy related.^5,6 In addition, the wide scope of ObGyn practice reaches beyond pregnancy-related conditions and provides multiple opportunities to decrease the use of unnecessary tests and treatments.

The good news is that approximately 30% of health care costs are wasted on unnecessary care that could be eliminated without decreasing the quality of care.⁷

High-value change #1: Eliminate use of expensive products

Embarking on a high-value care improvement project, experts at Greenville Health System examined the cost of different topical pain medications for perineal pain after a vaginal delivery. They found that Epifoam (hydrocortisone acetate/pramoxine hydrochloride) was ordered 2,287 times over the course of a year.

The study intervention consisted of an educational grand rounds and discussion of a Cochrane review, which concluded there was no difference in pain relief with topical anesthetics compared with placebo.⁸ Less expensive options for pain relief were discussed, and the department agreed to remove Epifoam as a standing order.

After the intervention, Epifoam was ordered 228 times, a 90% reduction. Over the period of a year, this translated to a cost savings of $92,655 for the hospital, with reduced charges passed on to patients.⁹ Thus, a seemingly small individual cost ($45.00 per can of Epifoam) can add up to a substantial sum in a large health care system.

Continue to: High-value change #2: Stop ordering unnecessary lab work...

High-value change #2: Stop ordering unnecessary lab work

Another high-value change to consider: Examine each laboratory test order to understand if the test results will really alter the care of a patient. Providers vary, and ordering lab tests to “make sure” can add up as financial expense.

Best practices from the American College of Obstetricians and Gynecologists (ACOG) and other professional societies can help guide decision-making as we order lab tests. Think twice, for example, about whether every evaluation for preeclampsia requires a uric acid test, since ACOG does not endorse that as part of the diagnostic criteria. While a single uric acid test costs only $8.00 to $38.00 (according to Healthcare Bluebook), testing uric acid in many patients over the course of a year can add up to significant dollars.¹¹

High-value change #3: Consider care redesign

In addition to seeking opportunities to use more cost-effective products and reduce the use of unnecessary tests, “care redesign” is an innovative way to provide high-quality care (and increased patient satisfaction) at a lower cost for both the health care system and the patient. A prime example of care redesign is using telehealth to enhance prenatal care.

Several health systems around the country are piloting and implementing remote blood pressure monitoring, app-based prenatal education, and telehealth visits to enhance prenatal care.^12,13 Use of a home blood pressure monitor can reduce in-person visits for low-risk prenatal care and open up access for other patients. Additionally, allowing the patient to participate in her own care at home or work can eliminate drives to and waits in the office and reduce absence from work because of a doctor visit.

A systematic review of more than 60,000 women showed that low-risk women who attend 5 to 9 prenatal visits have the same outcomes as women who attend the standard schedule of 13 to 15 visits.¹⁴ Although patient satisfaction was higher with more visits, when a bidirectional app or a telehealth visit is offered as an option, then patient satisfaction is equivalent to that in the standard schedule group.¹² So why not expand the choice for patients?

The challenge of teaching high-value care: Medical education responds

In a 2010 article in the New England Journal of Medicine, Dr. Molly Cooke commented on medical education’s responsibility regarding cost consciousness in patient care, and she highlighted the importance of teaching medical students and residents about considering cost in treating patients.¹⁵ Similarly, the Accreditation Council for Graduate Medical Education asks residents to consider cost and stewardship of medical resources as one of its system-based practice competencies.¹⁶ In 2012, the Choosing Wisely campaign, initiated by the American Board of Internal Medicine Foundation, asked specialty society members to identify tests or procedures commonly used in their field whose necessity should be questioned and discussed.¹⁷ ACOG and other women’s health specialty societies participate in this campaign.

From an educational standpoint, ACOG’s Council on Resident Education in Obstetrics and Gynecology has developed a curriculum resource, “Cases in High Value Care,” that can be used by any women’s health department to start the conversation on high-value care.¹⁸ The web program encourages medical students and residents to submit clinical vignettes that demonstrate examples of low- and high-value care. These cases can be used for discussion and debate and can serve as high-value care performance improvement projects in your own department.

Other useful publications are available outside the ObGyn specialty. Consider the Society of Hospital Medicine’s article series in the Journal of Hospital Medicine, “Choosing Wisely: Things We Do for No Reason”and “Choosing Wisely: Next Steps in Improving Healthcare Value.”¹⁹ The former focuses on discussing practices (tests, procedures, supplies, and prescriptions) that may be poorly supported by evidence or are part of standard practice even though other less expensive, higher-value alternatives may be available. The latter highlights perspective pieces that describe health care value initiatives relating to the practice of hospital medicine.

Continue to: The bottom line...

The bottom line

ObGyns and other health care providers are concerned about providing high-value care to patients and are working toward improving performance in this area. We really do care about the health care–related financial burdens that confront Ms. M., the premature twins’ parents, and all our patients.

CASE 1 Huge out-of-pocket cost makes patient forego treatment

Ms. M. is a 28-year-old patient who recently posted this on her Facebook page: “I went to the drugstore this morning to pick up a prescription, and as the pharmacist handed it to me she said, ‘That will be $180.00.’ And that’s after insurance coverage! Wow! I think I’ll pass!”

Our patients probably experience this type of situation more commonly than we know.

CASE 2 Catastrophic medical costs bankrupt family

A middle-class couple who had college degrees and full-time jobs with health insurance had twins at 24 weeks’ gestation. They accrued $450,000 in medical debt after exceeding the $2 million cap of their insurance policy. Having premature twins cost them everything. They liquidated their retirement and savings accounts, sold everything they had, and still ended up filing for bankruptcy.¹

Costs indeed matter to patients, and we have a professional responsibility to help our patients navigate the murky waters of health care so that they can maintain financial as well as physical health.

Rising costs, lower yield,and opportunities for change

Rising health care costs are unsustainable for both our patients and our society. Although the United States spends more on health care than any other developed country, our health outcomes are actually worse—ranking at or near the bottom in both prevalence and mortality for multiple diseases, risk factors, and injuries.²

Of the 171 countries included in a study by the United Nations Maternal Mortality Estimation Inter-Agency Group, the United States was 1 of 13 countries that had an increasing maternal mortality and the only developed nation with an increasing maternal mortality rate.³ This tells us that, as our country spends more on health care, our patients’ health is not improving. For individuals, medical bills are now the leading cause of personal bankruptcy in the United States, even for those who are insured.⁴

ObGyns play an important leadership role in the practice of cost-conscious health care, as 25% of hospitalizations in the United States are pregnancy related.^5,6 In addition, the wide scope of ObGyn practice reaches beyond pregnancy-related conditions and provides multiple opportunities to decrease the use of unnecessary tests and treatments.

The good news is that approximately 30% of health care costs are wasted on unnecessary care that could be eliminated without decreasing the quality of care.⁷

High-value change #1: Eliminate use of expensive products

Embarking on a high-value care improvement project, experts at Greenville Health System examined the cost of different topical pain medications for perineal pain after a vaginal delivery. They found that Epifoam (hydrocortisone acetate/pramoxine hydrochloride) was ordered 2,287 times over the course of a year.

The study intervention consisted of an educational grand rounds and discussion of a Cochrane review, which concluded there was no difference in pain relief with topical anesthetics compared with placebo.⁸ Less expensive options for pain relief were discussed, and the department agreed to remove Epifoam as a standing order.

After the intervention, Epifoam was ordered 228 times, a 90% reduction. Over the period of a year, this translated to a cost savings of $92,655 for the hospital, with reduced charges passed on to patients.⁹ Thus, a seemingly small individual cost ($45.00 per can of Epifoam) can add up to a substantial sum in a large health care system.

Continue to: High-value change #2: Stop ordering unnecessary lab work...

High-value change #2: Stop ordering unnecessary lab work

Another high-value change to consider: Examine each laboratory test order to understand if the test results will really alter the care of a patient. Providers vary, and ordering lab tests to “make sure” can add up as financial expense.

Best practices from the American College of Obstetricians and Gynecologists (ACOG) and other professional societies can help guide decision-making as we order lab tests. Think twice, for example, about whether every evaluation for preeclampsia requires a uric acid test, since ACOG does not endorse that as part of the diagnostic criteria. While a single uric acid test costs only $8.00 to $38.00 (according to Healthcare Bluebook), testing uric acid in many patients over the course of a year can add up to significant dollars.¹¹

High-value change #3: Consider care redesign

In addition to seeking opportunities to use more cost-effective products and reduce the use of unnecessary tests, “care redesign” is an innovative way to provide high-quality care (and increased patient satisfaction) at a lower cost for both the health care system and the patient. A prime example of care redesign is using telehealth to enhance prenatal care.

Several health systems around the country are piloting and implementing remote blood pressure monitoring, app-based prenatal education, and telehealth visits to enhance prenatal care.^12,13 Use of a home blood pressure monitor can reduce in-person visits for low-risk prenatal care and open up access for other patients. Additionally, allowing the patient to participate in her own care at home or work can eliminate drives to and waits in the office and reduce absence from work because of a doctor visit.

A systematic review of more than 60,000 women showed that low-risk women who attend 5 to 9 prenatal visits have the same outcomes as women who attend the standard schedule of 13 to 15 visits.¹⁴ Although patient satisfaction was higher with more visits, when a bidirectional app or a telehealth visit is offered as an option, then patient satisfaction is equivalent to that in the standard schedule group.¹² So why not expand the choice for patients?

The challenge of teaching high-value care: Medical education responds

In a 2010 article in the New England Journal of Medicine, Dr. Molly Cooke commented on medical education’s responsibility regarding cost consciousness in patient care, and she highlighted the importance of teaching medical students and residents about considering cost in treating patients.¹⁵ Similarly, the Accreditation Council for Graduate Medical Education asks residents to consider cost and stewardship of medical resources as one of its system-based practice competencies.¹⁶ In 2012, the Choosing Wisely campaign, initiated by the American Board of Internal Medicine Foundation, asked specialty society members to identify tests or procedures commonly used in their field whose necessity should be questioned and discussed.¹⁷ ACOG and other women’s health specialty societies participate in this campaign.

From an educational standpoint, ACOG’s Council on Resident Education in Obstetrics and Gynecology has developed a curriculum resource, “Cases in High Value Care,” that can be used by any women’s health department to start the conversation on high-value care.¹⁸ The web program encourages medical students and residents to submit clinical vignettes that demonstrate examples of low- and high-value care. These cases can be used for discussion and debate and can serve as high-value care performance improvement projects in your own department.

Other useful publications are available outside the ObGyn specialty. Consider the Society of Hospital Medicine’s article series in the Journal of Hospital Medicine, “Choosing Wisely: Things We Do for No Reason”and “Choosing Wisely: Next Steps in Improving Healthcare Value.”¹⁹ The former focuses on discussing practices (tests, procedures, supplies, and prescriptions) that may be poorly supported by evidence or are part of standard practice even though other less expensive, higher-value alternatives may be available. The latter highlights perspective pieces that describe health care value initiatives relating to the practice of hospital medicine.

Continue to: The bottom line...

The bottom line

ObGyns and other health care providers are concerned about providing high-value care to patients and are working toward improving performance in this area. We really do care about the health care–related financial burdens that confront Ms. M., the premature twins’ parents, and all our patients.

The US Food and Drug Administration (FDA) recently extended the approval for Gardasil 9 (to prevent HPV-associated cancers, cancer precursors, and genital lesions) to men and women aged 27 to 45.¹ In this editorial, we discuss the evolution of the HPV vaccine since its initial approval more than 10 years ago, the benefits of primary prevention with the HPV vaccine, and the case for the FDA’s recent extension of coverage to older men and women.

The evolution of the HPV vaccine

Since recognition in the 1980s and 90s that high-risk strains of HPV, notably HPV types 16 and 18, were linked to cervical cancer, there have been exciting advances in detection and prevention of high-risk HPV infection. About 70% of cervical cancers are attributable to these 2 oncogenic types.² The first vaccine licensed, Gardasil (Merck), was approved in 2006 for girls and women aged 9 through 26 to prevent HPV-related diseases caused by types 6, 11, 16, and 18.³ The vaccine was effective for prevention of cervical cancer; genital warts; and grades 2 and 3 of cervical, vulvar, and vaginal intraepithelial neoplasia. In 2008, prevention of vulvar and vaginal cancers was added to the indication. By 2009, prevention of genital warts was added, and use in males aged 9 to 15 was approved. By 2010 sufficient data were accumulated to document prevention of anal cancer and anal intraepithelial neoplasia in men and women, and this indication was added.

In 2014 Gardasil 9 was approved to extend coverage to an additional 5 oncogenic HPV types (31, 33, 45, 52, and 58), now covering an additional 20% of cervical cancers, and in 2015 Gardasil 9 indications were expanded to include boys and men 9 to 26 years of age. Immunogenicity studies were performed to infer effectiveness of a 2-dose regimen in boys and girls aged 9 to 14 years, which was recommended by the Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention (CDC) in late 2016.⁴

Until October 2018, Gardasil 9 was indicated for prevention of genital warts, cervical, vaginal, vulvar and anal cancers and cancer precursors for males and females aged 9 to 26 years. In October the FDA extended approval of the 3-dose vaccine regimen to men and women up to age 45.

HPV vaccine uptake

HPV vaccination has been underutilized in the United States. In 2017, a disappointing 49% of adolescents were up to date on vaccination, and 66% had received at least one dose.⁵ In rural areas the vaccination rates are 11 points lower than in urban regions.⁶ The CDC notes an increasing number of HPV-associated cancers—from 30,000 per year in 1999 to 43,000 per year in 2015—due mostly to increases in oral and anal carcinomas. Vaccination with Gardasil 9 could prevent 90% of those cases.⁷

Non-US successes. HPV vaccine uptake in Australia provides an excellent opportunity to study the impact of universally available, school-based vaccinations. In 2007 Australia implemented a program of free HPV vaccination distributed through schools. Boys and girls aged 12 and 13 were targeted that year, with catch-up vaccinations for those aged 13 to 18 in 2007-2009 in schools and for those aged 18 to 26 reached in the community.⁸ 

Continue to: Ali and colleagues studied the... 

Ali and colleagues studied the preprogram and postprogram incidence of genital warts.⁹ About 83% received at least 1 dose of vaccine, and 73% of the eligible population completed the 3-dose regimen. There was a significant reduction in warts in both men and women younger than age 21 from 2007 to 2011 (12.1% to 2.2% in men and 11.5% to 0.85% in women). In the 21 to 30 age group there were similar reductions. This study demonstrates that with universal access and public implementation, the rates of HPV-associated disease can be reduced dramatically.

Data informing expanded vaccination ages

Will vaccination of an older population, with presumably many of whom sexually active and at risk for prior exposure to multiple HPV types, have a reasonable impact on lowering HPV-associated cancers? Are HPV-detected lesions in 27- to 45-year-old women the result of reactivation of latent HPV infection, or are they related to new-onset exposure? The FDA reviewed data from 3 studies of HPV vaccination in women aged 27 to 45. The first enrolled women who were naïve to oncogenic HPV types and provided all 3 doses of quadrivalent vaccine were followed for 4 years, along with a comparison group of nonvaccinated women. The second study allowed the nonvaccinated group to receive vaccine in year 4. Both groups were followed up to 10 years with the relevant outcome defined as cumulative incidence of HPV 6/11/16/18-related CIN and condyloma. The third study looked at the same outcomes in a set of all women—whether HPV high-risk naïve or not—after receiving vaccine and followed more than 10 years.⁷ This last study is most relevant to ObGyns, as it is closest to how we would consider vaccinating our patients.

The study findings are reassuring: A large proportion of HPV infections in women between 27 and 45 are the result of new exposure/infection. A study of 420 online daters aged 25 to 65 showed an annual incidence of high-risk HPV types in vaginal swabs of 25.4%, of which 64% were likely new acquisitions.¹⁰ The 2013-2014 National Health and Nutrition Examination Survey of 1,757 men aged 18 to 59 estimated approximately 45% had genital HPV infection. There was a bimodal distribution of disease with peaks at 28 to 32 and a larger second peak at 58 to 59 years of age.¹¹ Bottom line: Men and women older than age 26 who are sexually active likely acquire new HPV infections with oncogenic types. Exposure to high-risk HPV types prior to vaccination—as we would expect in the real-world setting—did not eliminate the substantial benefit of immunization.

Based on these study results, and extrapolation to the 9-valent vaccine, the FDA extended the approval of Gardasil 9 to men and women from age 9 to 45. The indications and usage will remain the same: for prevention of cervical, vulvar, vaginal, and anal cancer and genital warts as well as precancerous or dysplastic lesions of the cervix, vulva, vagina, and anus related to HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58.

Continue to: Impact of the new... 

Impact of the new indication on HPV-related disease

As described above, widespread vaccination of young girls and boys is going to have major impact on HPV-related disease, including precancer and cancer. Because there is evidence that older women and men are at risk for new HPV infection,¹⁰ there likely will be some benefit from vaccination of adults. It is difficult, however, to extrapolate the degree to which adult vaccination will impact HPV-related disease. This is because we do not fully understand the rates at which new HPV infection in the cervices of older women will progress to high-grade dysplasia or cancer. Further, the pathophysiology of HPV-related cancers at other anogenital sites and new oral-pharyngeal infection is poorly understood in comparison with our knowledge of the natural history of high-risk HPV infection in younger women. That said, because of the outstanding efficacy of HPV vaccination and the low-risk profile, even if the actual impact on prevention of cancer or morbidity from dysplasia is relatively low, adult vaccination benefits outweigh the limited risks.

It may be that increased vaccination and awareness of vaccination for adults may enhance the adherence and acceptance of widespread vaccination of boys and girls. Adult vaccination could create a cultural shift toward HPV vaccination acceptance when adult parents and loved ones of vaccine-age boys and girls have been vaccinated themselves.

Current and future insurance coverage

The Affordable Care Act, otherwise known as Obamacare, mandates coverage for all immunizations recommended by the ACIP. HPV vaccination up to age 26 is fully covered, without copay or deductible. The ACIP did consider extension of the indications for HPV vaccination to men and women up to age 45 at their October 2018 meeting. They are tasked with considering not only safety and efficacy but also the cost effectiveness of implementing vaccination. They continue to study the costs and potential benefits of extending HPV vaccination to age 45. Their recommendations may be determined at the February 2019 meeting—or even later in 2019. The American College of Obstetricians and Gynecologists (ACOG) relies upon ACIP for practice guidance. Once the ACIP has made a determination, and if new guidelines are published in the Morbidity and Mortality Weekly Report, insurance coverage and ACOG guidance will be updated.

How should we react and change practice based on this new indication?

Given the information reviewed by the FDA, ObGyns will want to discuss the availability of Gardasil 9 with our patients between ages 27 and 45 who have not been previously immunized.

Especially for our patients with exposure to multiple or new sexual partners, immunization against oncogenic HPV viral types is effective in providing protection from cancer precursors and cancers of the cervix, vulva, vagina, and anus—and of course from genital warts. They should understand that, until formal recommendations are published by the ACIP, they are likely to be responsible for the cost of the vaccination series. These conversations will also remind our patients to immunize their teens against HPV. The more conversation we have regarding the benefits of vaccination against high-risk HPV types, the more likely we are to be able to achieve the impressive results seen in Australia.

The US Food and Drug Administration (FDA) recently extended the approval for Gardasil 9 (to prevent HPV-associated cancers, cancer precursors, and genital lesions) to men and women aged 27 to 45.¹ In this editorial, we discuss the evolution of the HPV vaccine since its initial approval more than 10 years ago, the benefits of primary prevention with the HPV vaccine, and the case for the FDA’s recent extension of coverage to older men and women.

The evolution of the HPV vaccine

Since recognition in the 1980s and 90s that high-risk strains of HPV, notably HPV types 16 and 18, were linked to cervical cancer, there have been exciting advances in detection and prevention of high-risk HPV infection. About 70% of cervical cancers are attributable to these 2 oncogenic types.² The first vaccine licensed, Gardasil (Merck), was approved in 2006 for girls and women aged 9 through 26 to prevent HPV-related diseases caused by types 6, 11, 16, and 18.³ The vaccine was effective for prevention of cervical cancer; genital warts; and grades 2 and 3 of cervical, vulvar, and vaginal intraepithelial neoplasia. In 2008, prevention of vulvar and vaginal cancers was added to the indication. By 2009, prevention of genital warts was added, and use in males aged 9 to 15 was approved. By 2010 sufficient data were accumulated to document prevention of anal cancer and anal intraepithelial neoplasia in men and women, and this indication was added.

In 2014 Gardasil 9 was approved to extend coverage to an additional 5 oncogenic HPV types (31, 33, 45, 52, and 58), now covering an additional 20% of cervical cancers, and in 2015 Gardasil 9 indications were expanded to include boys and men 9 to 26 years of age. Immunogenicity studies were performed to infer effectiveness of a 2-dose regimen in boys and girls aged 9 to 14 years, which was recommended by the Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention (CDC) in late 2016.⁴

Until October 2018, Gardasil 9 was indicated for prevention of genital warts, cervical, vaginal, vulvar and anal cancers and cancer precursors for males and females aged 9 to 26 years. In October the FDA extended approval of the 3-dose vaccine regimen to men and women up to age 45.

HPV vaccine uptake

HPV vaccination has been underutilized in the United States. In 2017, a disappointing 49% of adolescents were up to date on vaccination, and 66% had received at least one dose.⁵ In rural areas the vaccination rates are 11 points lower than in urban regions.⁶ The CDC notes an increasing number of HPV-associated cancers—from 30,000 per year in 1999 to 43,000 per year in 2015—due mostly to increases in oral and anal carcinomas. Vaccination with Gardasil 9 could prevent 90% of those cases.⁷

Non-US successes. HPV vaccine uptake in Australia provides an excellent opportunity to study the impact of universally available, school-based vaccinations. In 2007 Australia implemented a program of free HPV vaccination distributed through schools. Boys and girls aged 12 and 13 were targeted that year, with catch-up vaccinations for those aged 13 to 18 in 2007-2009 in schools and for those aged 18 to 26 reached in the community.⁸ 

Continue to: Ali and colleagues studied the... 

Ali and colleagues studied the preprogram and postprogram incidence of genital warts.⁹ About 83% received at least 1 dose of vaccine, and 73% of the eligible population completed the 3-dose regimen. There was a significant reduction in warts in both men and women younger than age 21 from 2007 to 2011 (12.1% to 2.2% in men and 11.5% to 0.85% in women). In the 21 to 30 age group there were similar reductions. This study demonstrates that with universal access and public implementation, the rates of HPV-associated disease can be reduced dramatically.

Data informing expanded vaccination ages

Will vaccination of an older population, with presumably many of whom sexually active and at risk for prior exposure to multiple HPV types, have a reasonable impact on lowering HPV-associated cancers? Are HPV-detected lesions in 27- to 45-year-old women the result of reactivation of latent HPV infection, or are they related to new-onset exposure? The FDA reviewed data from 3 studies of HPV vaccination in women aged 27 to 45. The first enrolled women who were naïve to oncogenic HPV types and provided all 3 doses of quadrivalent vaccine were followed for 4 years, along with a comparison group of nonvaccinated women. The second study allowed the nonvaccinated group to receive vaccine in year 4. Both groups were followed up to 10 years with the relevant outcome defined as cumulative incidence of HPV 6/11/16/18-related CIN and condyloma. The third study looked at the same outcomes in a set of all women—whether HPV high-risk naïve or not—after receiving vaccine and followed more than 10 years.⁷ This last study is most relevant to ObGyns, as it is closest to how we would consider vaccinating our patients.

The study findings are reassuring: A large proportion of HPV infections in women between 27 and 45 are the result of new exposure/infection. A study of 420 online daters aged 25 to 65 showed an annual incidence of high-risk HPV types in vaginal swabs of 25.4%, of which 64% were likely new acquisitions.¹⁰ The 2013-2014 National Health and Nutrition Examination Survey of 1,757 men aged 18 to 59 estimated approximately 45% had genital HPV infection. There was a bimodal distribution of disease with peaks at 28 to 32 and a larger second peak at 58 to 59 years of age.¹¹ Bottom line: Men and women older than age 26 who are sexually active likely acquire new HPV infections with oncogenic types. Exposure to high-risk HPV types prior to vaccination—as we would expect in the real-world setting—did not eliminate the substantial benefit of immunization.

Based on these study results, and extrapolation to the 9-valent vaccine, the FDA extended the approval of Gardasil 9 to men and women from age 9 to 45. The indications and usage will remain the same: for prevention of cervical, vulvar, vaginal, and anal cancer and genital warts as well as precancerous or dysplastic lesions of the cervix, vulva, vagina, and anus related to HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58.

Continue to: Impact of the new... 

Impact of the new indication on HPV-related disease

As described above, widespread vaccination of young girls and boys is going to have major impact on HPV-related disease, including precancer and cancer. Because there is evidence that older women and men are at risk for new HPV infection,¹⁰ there likely will be some benefit from vaccination of adults. It is difficult, however, to extrapolate the degree to which adult vaccination will impact HPV-related disease. This is because we do not fully understand the rates at which new HPV infection in the cervices of older women will progress to high-grade dysplasia or cancer. Further, the pathophysiology of HPV-related cancers at other anogenital sites and new oral-pharyngeal infection is poorly understood in comparison with our knowledge of the natural history of high-risk HPV infection in younger women. That said, because of the outstanding efficacy of HPV vaccination and the low-risk profile, even if the actual impact on prevention of cancer or morbidity from dysplasia is relatively low, adult vaccination benefits outweigh the limited risks.

It may be that increased vaccination and awareness of vaccination for adults may enhance the adherence and acceptance of widespread vaccination of boys and girls. Adult vaccination could create a cultural shift toward HPV vaccination acceptance when adult parents and loved ones of vaccine-age boys and girls have been vaccinated themselves.

Current and future insurance coverage

The Affordable Care Act, otherwise known as Obamacare, mandates coverage for all immunizations recommended by the ACIP. HPV vaccination up to age 26 is fully covered, without copay or deductible. The ACIP did consider extension of the indications for HPV vaccination to men and women up to age 45 at their October 2018 meeting. They are tasked with considering not only safety and efficacy but also the cost effectiveness of implementing vaccination. They continue to study the costs and potential benefits of extending HPV vaccination to age 45. Their recommendations may be determined at the February 2019 meeting—or even later in 2019. The American College of Obstetricians and Gynecologists (ACOG) relies upon ACIP for practice guidance. Once the ACIP has made a determination, and if new guidelines are published in the Morbidity and Mortality Weekly Report, insurance coverage and ACOG guidance will be updated.

How should we react and change practice based on this new indication?

Given the information reviewed by the FDA, ObGyns will want to discuss the availability of Gardasil 9 with our patients between ages 27 and 45 who have not been previously immunized.

Especially for our patients with exposure to multiple or new sexual partners, immunization against oncogenic HPV viral types is effective in providing protection from cancer precursors and cancers of the cervix, vulva, vagina, and anus—and of course from genital warts. They should understand that, until formal recommendations are published by the ACIP, they are likely to be responsible for the cost of the vaccination series. These conversations will also remind our patients to immunize their teens against HPV. The more conversation we have regarding the benefits of vaccination against high-risk HPV types, the more likely we are to be able to achieve the impressive results seen in Australia.

The US Food and Drug Administration (FDA) recently extended the approval for Gardasil 9 (to prevent HPV-associated cancers, cancer precursors, and genital lesions) to men and women aged 27 to 45.¹ In this editorial, we discuss the evolution of the HPV vaccine since its initial approval more than 10 years ago, the benefits of primary prevention with the HPV vaccine, and the case for the FDA’s recent extension of coverage to older men and women.

The evolution of the HPV vaccine

Since recognition in the 1980s and 90s that high-risk strains of HPV, notably HPV types 16 and 18, were linked to cervical cancer, there have been exciting advances in detection and prevention of high-risk HPV infection. About 70% of cervical cancers are attributable to these 2 oncogenic types.² The first vaccine licensed, Gardasil (Merck), was approved in 2006 for girls and women aged 9 through 26 to prevent HPV-related diseases caused by types 6, 11, 16, and 18.³ The vaccine was effective for prevention of cervical cancer; genital warts; and grades 2 and 3 of cervical, vulvar, and vaginal intraepithelial neoplasia. In 2008, prevention of vulvar and vaginal cancers was added to the indication. By 2009, prevention of genital warts was added, and use in males aged 9 to 15 was approved. By 2010 sufficient data were accumulated to document prevention of anal cancer and anal intraepithelial neoplasia in men and women, and this indication was added.

In 2014 Gardasil 9 was approved to extend coverage to an additional 5 oncogenic HPV types (31, 33, 45, 52, and 58), now covering an additional 20% of cervical cancers, and in 2015 Gardasil 9 indications were expanded to include boys and men 9 to 26 years of age. Immunogenicity studies were performed to infer effectiveness of a 2-dose regimen in boys and girls aged 9 to 14 years, which was recommended by the Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention (CDC) in late 2016.⁴

Until October 2018, Gardasil 9 was indicated for prevention of genital warts, cervical, vaginal, vulvar and anal cancers and cancer precursors for males and females aged 9 to 26 years. In October the FDA extended approval of the 3-dose vaccine regimen to men and women up to age 45.

HPV vaccine uptake

HPV vaccination has been underutilized in the United States. In 2017, a disappointing 49% of adolescents were up to date on vaccination, and 66% had received at least one dose.⁵ In rural areas the vaccination rates are 11 points lower than in urban regions.⁶ The CDC notes an increasing number of HPV-associated cancers—from 30,000 per year in 1999 to 43,000 per year in 2015—due mostly to increases in oral and anal carcinomas. Vaccination with Gardasil 9 could prevent 90% of those cases.⁷

Non-US successes. HPV vaccine uptake in Australia provides an excellent opportunity to study the impact of universally available, school-based vaccinations. In 2007 Australia implemented a program of free HPV vaccination distributed through schools. Boys and girls aged 12 and 13 were targeted that year, with catch-up vaccinations for those aged 13 to 18 in 2007-2009 in schools and for those aged 18 to 26 reached in the community.⁸ 

Continue to: Ali and colleagues studied the... 

Ali and colleagues studied the preprogram and postprogram incidence of genital warts.⁹ About 83% received at least 1 dose of vaccine, and 73% of the eligible population completed the 3-dose regimen. There was a significant reduction in warts in both men and women younger than age 21 from 2007 to 2011 (12.1% to 2.2% in men and 11.5% to 0.85% in women). In the 21 to 30 age group there were similar reductions. This study demonstrates that with universal access and public implementation, the rates of HPV-associated disease can be reduced dramatically.

Data informing expanded vaccination ages

Will vaccination of an older population, with presumably many of whom sexually active and at risk for prior exposure to multiple HPV types, have a reasonable impact on lowering HPV-associated cancers? Are HPV-detected lesions in 27- to 45-year-old women the result of reactivation of latent HPV infection, or are they related to new-onset exposure? The FDA reviewed data from 3 studies of HPV vaccination in women aged 27 to 45. The first enrolled women who were naïve to oncogenic HPV types and provided all 3 doses of quadrivalent vaccine were followed for 4 years, along with a comparison group of nonvaccinated women. The second study allowed the nonvaccinated group to receive vaccine in year 4. Both groups were followed up to 10 years with the relevant outcome defined as cumulative incidence of HPV 6/11/16/18-related CIN and condyloma. The third study looked at the same outcomes in a set of all women—whether HPV high-risk naïve or not—after receiving vaccine and followed more than 10 years.⁷ This last study is most relevant to ObGyns, as it is closest to how we would consider vaccinating our patients.

The study findings are reassuring: A large proportion of HPV infections in women between 27 and 45 are the result of new exposure/infection. A study of 420 online daters aged 25 to 65 showed an annual incidence of high-risk HPV types in vaginal swabs of 25.4%, of which 64% were likely new acquisitions.¹⁰ The 2013-2014 National Health and Nutrition Examination Survey of 1,757 men aged 18 to 59 estimated approximately 45% had genital HPV infection. There was a bimodal distribution of disease with peaks at 28 to 32 and a larger second peak at 58 to 59 years of age.¹¹ Bottom line: Men and women older than age 26 who are sexually active likely acquire new HPV infections with oncogenic types. Exposure to high-risk HPV types prior to vaccination—as we would expect in the real-world setting—did not eliminate the substantial benefit of immunization.

Based on these study results, and extrapolation to the 9-valent vaccine, the FDA extended the approval of Gardasil 9 to men and women from age 9 to 45. The indications and usage will remain the same: for prevention of cervical, vulvar, vaginal, and anal cancer and genital warts as well as precancerous or dysplastic lesions of the cervix, vulva, vagina, and anus related to HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58.

Continue to: Impact of the new... 

Impact of the new indication on HPV-related disease

As described above, widespread vaccination of young girls and boys is going to have major impact on HPV-related disease, including precancer and cancer. Because there is evidence that older women and men are at risk for new HPV infection,¹⁰ there likely will be some benefit from vaccination of adults. It is difficult, however, to extrapolate the degree to which adult vaccination will impact HPV-related disease. This is because we do not fully understand the rates at which new HPV infection in the cervices of older women will progress to high-grade dysplasia or cancer. Further, the pathophysiology of HPV-related cancers at other anogenital sites and new oral-pharyngeal infection is poorly understood in comparison with our knowledge of the natural history of high-risk HPV infection in younger women. That said, because of the outstanding efficacy of HPV vaccination and the low-risk profile, even if the actual impact on prevention of cancer or morbidity from dysplasia is relatively low, adult vaccination benefits outweigh the limited risks.

It may be that increased vaccination and awareness of vaccination for adults may enhance the adherence and acceptance of widespread vaccination of boys and girls. Adult vaccination could create a cultural shift toward HPV vaccination acceptance when adult parents and loved ones of vaccine-age boys and girls have been vaccinated themselves.

Current and future insurance coverage

The Affordable Care Act, otherwise known as Obamacare, mandates coverage for all immunizations recommended by the ACIP. HPV vaccination up to age 26 is fully covered, without copay or deductible. The ACIP did consider extension of the indications for HPV vaccination to men and women up to age 45 at their October 2018 meeting. They are tasked with considering not only safety and efficacy but also the cost effectiveness of implementing vaccination. They continue to study the costs and potential benefits of extending HPV vaccination to age 45. Their recommendations may be determined at the February 2019 meeting—or even later in 2019. The American College of Obstetricians and Gynecologists (ACOG) relies upon ACIP for practice guidance. Once the ACIP has made a determination, and if new guidelines are published in the Morbidity and Mortality Weekly Report, insurance coverage and ACOG guidance will be updated.

How should we react and change practice based on this new indication?

Given the information reviewed by the FDA, ObGyns will want to discuss the availability of Gardasil 9 with our patients between ages 27 and 45 who have not been previously immunized.

Especially for our patients with exposure to multiple or new sexual partners, immunization against oncogenic HPV viral types is effective in providing protection from cancer precursors and cancers of the cervix, vulva, vagina, and anus—and of course from genital warts. They should understand that, until formal recommendations are published by the ACIP, they are likely to be responsible for the cost of the vaccination series. These conversations will also remind our patients to immunize their teens against HPV. The more conversation we have regarding the benefits of vaccination against high-risk HPV types, the more likely we are to be able to achieve the impressive results seen in Australia.

Children who are exposed to valproate in utero were more likely to be diagnosed with ADHD. Also today, one expert calls for better ways to preserve beta cell function in youth, synthetic opioids drive a spike in the number of fatal overdoses, and mothers may play a role in the link between depression in fathers and daughters.

Amazon Alexa
Apple Podcasts
Google Podcasts
Spotify
 

Children who are exposed to valproate in utero were more likely to be diagnosed with ADHD. Also today, one expert calls for better ways to preserve beta cell function in youth, synthetic opioids drive a spike in the number of fatal overdoses, and mothers may play a role in the link between depression in fathers and daughters.

Amazon Alexa
Apple Podcasts
Google Podcasts
Spotify
 

Children who are exposed to valproate in utero were more likely to be diagnosed with ADHD. Also today, one expert calls for better ways to preserve beta cell function in youth, synthetic opioids drive a spike in the number of fatal overdoses, and mothers may play a role in the link between depression in fathers and daughters.

Amazon Alexa
Apple Podcasts
Google Podcasts
Spotify
 

In December 2018, Federal Practitioner sat down with Surgeon General VADM Jerome M. Adams, MD, MPH to discuss recent initiatives to combat the opioid epidemic and to improve health care engagement and delivery in this exclusive video interview. During 2018, the Office of the Surgeon General took a number of steps to address the ongoing opioid crisis, releasing a public health advisory to urge increased use of naloxone, which can reverse the effects of an opioid overdose. In addition, the office of the Surgeon General released a postcard with 5 actions every person can take to address the opioid epidemic.

Increasing Health Care Engagement

Vidyard Video

Next: Community health and economic prosperity, What health care providers can do for prevention, expanding the PHS mission, the Surgeon General's challenge on opioids

 

 

Community Health and Economic Prosperity

Vidyard Video

Next: What health care providers can do for prevention, expanding the PHS mission, the Surgeon General's challenge on opioids

 

 

What Health Care Providers Can Do for Prevention

Vidyard Video

Next: Expanding the PHS mission, the Surgeon General's challenge on opioids

 

 

Expanding the PHS Mission

Vidyard Video

Next: The Surgeon General's challenge on opioids

 

 

The Surgeon General's Challenge on Opioids

Vidyard Video

Postcard

In December 2018, Federal Practitioner sat down with Surgeon General VADM Jerome M. Adams, MD, MPH to discuss recent initiatives to combat the opioid epidemic and to improve health care engagement and delivery in this exclusive video interview. During 2018, the Office of the Surgeon General took a number of steps to address the ongoing opioid crisis, releasing a public health advisory to urge increased use of naloxone, which can reverse the effects of an opioid overdose. In addition, the office of the Surgeon General released a postcard with 5 actions every person can take to address the opioid epidemic.

Increasing Health Care Engagement

Vidyard Video

Next: Community health and economic prosperity, What health care providers can do for prevention, expanding the PHS mission, the Surgeon General's challenge on opioids

 

 

Community Health and Economic Prosperity

Vidyard Video

Next: What health care providers can do for prevention, expanding the PHS mission, the Surgeon General's challenge on opioids

 

 

What Health Care Providers Can Do for Prevention

Vidyard Video

Next: Expanding the PHS mission, the Surgeon General's challenge on opioids

 

 

Expanding the PHS Mission

Vidyard Video

Next: The Surgeon General's challenge on opioids

 

 

The Surgeon General's Challenge on Opioids

Vidyard Video

Postcard

In December 2018, Federal Practitioner sat down with Surgeon General VADM Jerome M. Adams, MD, MPH to discuss recent initiatives to combat the opioid epidemic and to improve health care engagement and delivery in this exclusive video interview. During 2018, the Office of the Surgeon General took a number of steps to address the ongoing opioid crisis, releasing a public health advisory to urge increased use of naloxone, which can reverse the effects of an opioid overdose. In addition, the office of the Surgeon General released a postcard with 5 actions every person can take to address the opioid epidemic.

Increasing Health Care Engagement

Vidyard Video

Next: Community health and economic prosperity, What health care providers can do for prevention, expanding the PHS mission, the Surgeon General's challenge on opioids

 

 

Community Health and Economic Prosperity

Vidyard Video

Next: What health care providers can do for prevention, expanding the PHS mission, the Surgeon General's challenge on opioids

 

 

What Health Care Providers Can Do for Prevention

Vidyard Video

Next: Expanding the PHS mission, the Surgeon General's challenge on opioids

 

 

Expanding the PHS Mission

Vidyard Video

Next: The Surgeon General's challenge on opioids

 

 

The Surgeon General's Challenge on Opioids

Vidyard Video

Postcard

Patients with hypertension who show substantial progression of cerebral small vessel disease have a sixfold higher odds of developing mild cognitive impairment compared with similar patients who do not have signs of progression. Also today, antidepressants are tied to greater hip fracture incidence, a hospital readmission reduction program may be doing more harm than good, and the flu season rages on with 19 states showing high activity in the final week of 2018.

Amazon Alexa
Apple Podcasts
Google Podcasts
Spotify
 

Patients with hypertension who show substantial progression of cerebral small vessel disease have a sixfold higher odds of developing mild cognitive impairment compared with similar patients who do not have signs of progression. Also today, antidepressants are tied to greater hip fracture incidence, a hospital readmission reduction program may be doing more harm than good, and the flu season rages on with 19 states showing high activity in the final week of 2018.

Amazon Alexa
Apple Podcasts
Google Podcasts
Spotify
 

Patients with hypertension who show substantial progression of cerebral small vessel disease have a sixfold higher odds of developing mild cognitive impairment compared with similar patients who do not have signs of progression. Also today, antidepressants are tied to greater hip fracture incidence, a hospital readmission reduction program may be doing more harm than good, and the flu season rages on with 19 states showing high activity in the final week of 2018.

Amazon Alexa
Apple Podcasts
Google Podcasts
Spotify
 

Raymond Barfield, MD, nearly left medicine altogether after experiencing burnout. Now, he joins the Postcall Podcast to discuss why he’s back, what he’s working on to prevent burnout, and how he wants to remake pre-med education. You can read more from Dr. Barfield’s story here.

Apple Podcasts

Google Podcasts

Spotify
 

Raymond Barfield, MD, nearly left medicine altogether after experiencing burnout. Now, he joins the Postcall Podcast to discuss why he’s back, what he’s working on to prevent burnout, and how he wants to remake pre-med education. You can read more from Dr. Barfield’s story here.

Apple Podcasts

Google Podcasts

Spotify
 

Raymond Barfield, MD, nearly left medicine altogether after experiencing burnout. Now, he joins the Postcall Podcast to discuss why he’s back, what he’s working on to prevent burnout, and how he wants to remake pre-med education. You can read more from Dr. Barfield’s story here.

Apple Podcasts

Google Podcasts

Spotify
 

It used to be the stuff of stoner comedies and “Just Say No” campaigns. Today, marijuana is becoming mainstream as voters across the country approve ballot questions for legalization or medical use.

JasonDoiy/iStock/Getty Images Plus

In response, state governments are testing ways to ensure that the integration of this once-illicit substance into everyday life doesn’t create new public health risks. These efforts are sparking a difficult question: At what point is someone too high to get behind the wheel?

The answer is complicated. Brain scientists and pharmacologists don’t know how to measure if and to what extent marijuana causes impairment.

The reason: Existing blood and urine tests can detect marijuana use, but, because traces of the drug stay in the human body for a long time, those tests can’t specify whether the use occurred earlier that day or that month. They also don’t indicate the level at which a driver would be considered “under the influence.”

“It’s a really hard problem,” said Keith Humphreys, a psychiatry professor and drug policy expert at Stanford University (Calif.), the first state to legalize medical marijuana and where recreational pot use among adults became legal in 2016. “We don’t really have good evidence – even if we know someone has been using – [to gauge] what their level of impairment is.”

Marijuana is now legal for recreational use in 10 states and the District of Columbia – including Michigan, where a ballot initiative passed in November 2018 took effect Dec. 6. In New York, the governor said Dec. 17 that legalization would be a top priority for 2019. And nearly three dozen states have cleared the use of medical cannabis.

For alcohol, there is a clear, national standard. If your blood alcohol content is 0.08% or higher, you’re considered cognitively impaired at a level that is unsafe to drive. Extensive research supports this determination, and the clarity makes enforcement of drunken-driving laws easier.

Setting a marijuana-related impairment level is a much murkier proposition. But states that have legalized pot have to figure it out, experts said.

“You can’t legalize a substance and not have a coherent policy for controlling driving under the influence of that substance,” said Steven Davenport, an assistant policy researcher at the nonprofit Rand Corporation, who specializes in marijuana research.

Marijuana, after all, weakens a driver’s ability to maintain focus, and it slows reflexes. But regulators are “playing catch-up,” suggested Thomas Marcotte, a psychiatry professor at the University of California, San Diego, and one of a number of academics around the country who is researching driving while high.

States have put forth a bevy of approaches. At least five have what’s called a “per se” law, which outlaws driving if someone’s blood level of tetrahydrocannabinol, or THC, exceeds a set amount. THC is marijuana’s main intoxicant.

Colorado, where voters approved legalization of recreational marijuana in 2012, has this type of driving law on the books. It took 3 years to pass amid fiery debate and deems “intoxicated” any driver who tests higher than 5 ng of THC per milliliter of blood.

Indiana, Pennsylvania and Rhode Island are among states that forbid driving at any THC level. Still others say drivers should be penalized only if they are impaired by the chemical – a standard that sounds reasonable but quickly gets difficult to measure or even define.

None of these approaches offers an ideal solution, experts said.

“We’re still definitely evaluating which policies are the most effective,” said Ann Kitch, who tracks the marijuana and driving issue for the National Conference of State Legislatures.

Kaiser Health News is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.

It used to be the stuff of stoner comedies and “Just Say No” campaigns. Today, marijuana is becoming mainstream as voters across the country approve ballot questions for legalization or medical use.

JasonDoiy/iStock/Getty Images Plus

In response, state governments are testing ways to ensure that the integration of this once-illicit substance into everyday life doesn’t create new public health risks. These efforts are sparking a difficult question: At what point is someone too high to get behind the wheel?

The answer is complicated. Brain scientists and pharmacologists don’t know how to measure if and to what extent marijuana causes impairment.

The reason: Existing blood and urine tests can detect marijuana use, but, because traces of the drug stay in the human body for a long time, those tests can’t specify whether the use occurred earlier that day or that month. They also don’t indicate the level at which a driver would be considered “under the influence.”

“It’s a really hard problem,” said Keith Humphreys, a psychiatry professor and drug policy expert at Stanford University (Calif.), the first state to legalize medical marijuana and where recreational pot use among adults became legal in 2016. “We don’t really have good evidence – even if we know someone has been using – [to gauge] what their level of impairment is.”

Marijuana is now legal for recreational use in 10 states and the District of Columbia – including Michigan, where a ballot initiative passed in November 2018 took effect Dec. 6. In New York, the governor said Dec. 17 that legalization would be a top priority for 2019. And nearly three dozen states have cleared the use of medical cannabis.

For alcohol, there is a clear, national standard. If your blood alcohol content is 0.08% or higher, you’re considered cognitively impaired at a level that is unsafe to drive. Extensive research supports this determination, and the clarity makes enforcement of drunken-driving laws easier.

Setting a marijuana-related impairment level is a much murkier proposition. But states that have legalized pot have to figure it out, experts said.

“You can’t legalize a substance and not have a coherent policy for controlling driving under the influence of that substance,” said Steven Davenport, an assistant policy researcher at the nonprofit Rand Corporation, who specializes in marijuana research.

Marijuana, after all, weakens a driver’s ability to maintain focus, and it slows reflexes. But regulators are “playing catch-up,” suggested Thomas Marcotte, a psychiatry professor at the University of California, San Diego, and one of a number of academics around the country who is researching driving while high.

States have put forth a bevy of approaches. At least five have what’s called a “per se” law, which outlaws driving if someone’s blood level of tetrahydrocannabinol, or THC, exceeds a set amount. THC is marijuana’s main intoxicant.

Colorado, where voters approved legalization of recreational marijuana in 2012, has this type of driving law on the books. It took 3 years to pass amid fiery debate and deems “intoxicated” any driver who tests higher than 5 ng of THC per milliliter of blood.

Indiana, Pennsylvania and Rhode Island are among states that forbid driving at any THC level. Still others say drivers should be penalized only if they are impaired by the chemical – a standard that sounds reasonable but quickly gets difficult to measure or even define.

None of these approaches offers an ideal solution, experts said.

“We’re still definitely evaluating which policies are the most effective,” said Ann Kitch, who tracks the marijuana and driving issue for the National Conference of State Legislatures.

Kaiser Health News is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.

It used to be the stuff of stoner comedies and “Just Say No” campaigns. Today, marijuana is becoming mainstream as voters across the country approve ballot questions for legalization or medical use.

JasonDoiy/iStock/Getty Images Plus

In response, state governments are testing ways to ensure that the integration of this once-illicit substance into everyday life doesn’t create new public health risks. These efforts are sparking a difficult question: At what point is someone too high to get behind the wheel?

The answer is complicated. Brain scientists and pharmacologists don’t know how to measure if and to what extent marijuana causes impairment.

The reason: Existing blood and urine tests can detect marijuana use, but, because traces of the drug stay in the human body for a long time, those tests can’t specify whether the use occurred earlier that day or that month. They also don’t indicate the level at which a driver would be considered “under the influence.”

“It’s a really hard problem,” said Keith Humphreys, a psychiatry professor and drug policy expert at Stanford University (Calif.), the first state to legalize medical marijuana and where recreational pot use among adults became legal in 2016. “We don’t really have good evidence – even if we know someone has been using – [to gauge] what their level of impairment is.”

Marijuana is now legal for recreational use in 10 states and the District of Columbia – including Michigan, where a ballot initiative passed in November 2018 took effect Dec. 6. In New York, the governor said Dec. 17 that legalization would be a top priority for 2019. And nearly three dozen states have cleared the use of medical cannabis.

For alcohol, there is a clear, national standard. If your blood alcohol content is 0.08% or higher, you’re considered cognitively impaired at a level that is unsafe to drive. Extensive research supports this determination, and the clarity makes enforcement of drunken-driving laws easier.

Setting a marijuana-related impairment level is a much murkier proposition. But states that have legalized pot have to figure it out, experts said.

“You can’t legalize a substance and not have a coherent policy for controlling driving under the influence of that substance,” said Steven Davenport, an assistant policy researcher at the nonprofit Rand Corporation, who specializes in marijuana research.

Marijuana, after all, weakens a driver’s ability to maintain focus, and it slows reflexes. But regulators are “playing catch-up,” suggested Thomas Marcotte, a psychiatry professor at the University of California, San Diego, and one of a number of academics around the country who is researching driving while high.

States have put forth a bevy of approaches. At least five have what’s called a “per se” law, which outlaws driving if someone’s blood level of tetrahydrocannabinol, or THC, exceeds a set amount. THC is marijuana’s main intoxicant.

Colorado, where voters approved legalization of recreational marijuana in 2012, has this type of driving law on the books. It took 3 years to pass amid fiery debate and deems “intoxicated” any driver who tests higher than 5 ng of THC per milliliter of blood.

Indiana, Pennsylvania and Rhode Island are among states that forbid driving at any THC level. Still others say drivers should be penalized only if they are impaired by the chemical – a standard that sounds reasonable but quickly gets difficult to measure or even define.

None of these approaches offers an ideal solution, experts said.

“We’re still definitely evaluating which policies are the most effective,” said Ann Kitch, who tracks the marijuana and driving issue for the National Conference of State Legislatures.

Kaiser Health News is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.

Electronic health records predict physician burnout. Also today, a new risk-prediction model for diabetes under development, firibastat is looking good for difficult-to-treat hypertension, and differences in gut bacteria can distinguish IBD from IBS.

Amazon Alexa
Apple Podcasts
Google Podcasts
Spotify
 

Electronic health records predict physician burnout. Also today, a new risk-prediction model for diabetes under development, firibastat is looking good for difficult-to-treat hypertension, and differences in gut bacteria can distinguish IBD from IBS.

Amazon Alexa
Apple Podcasts
Google Podcasts
Spotify
 

Electronic health records predict physician burnout. Also today, a new risk-prediction model for diabetes under development, firibastat is looking good for difficult-to-treat hypertension, and differences in gut bacteria can distinguish IBD from IBS.

Amazon Alexa
Apple Podcasts
Google Podcasts
Spotify