Susan Kreimer

Inappropriate use of prescription opioids is a major public health challenge, prompting the U.S. Food and Drug Administration (FDA) to issue a draft guidance document aimed at helping industry create new formulations of opioids with abuse-deterrent properties.

Released in January, “Guidance for Industry: Abuse-Deterrent Opioids—Evaluation and Labeling” provides recommendations for conducting studies to prove that a particular formulation contains abuse-deterrent properties. It also explains how the FDA will review the results and determine which labeling claims to approve.

This announcement is “one component of our larger effort to prevent prescription drug abuse and misuse, while ensuring that patients in pain continue to have access to these important medicines,” Douglas Throckmorton, MD, deputy director for regulatory programs in the FDA’s Center for Drug Evaluation and Research, said during a teleconference.

According to the FDA guidance, opioid analgesics can be abused in a variety of ways:

• Swallowed whole;
• Crushed and swallowed;
• Crushed and snorted;
• Crushed and smoked; or
• Crushed, dissolved, and injected.

With the science of abuse deterrence being relatively new, the FDA plans to take a flexible and adaptive approach. That’s because the analytical, clinical, and statistical methods for evaluating formulation technologies are still evolving.

“Physicians should care about this because the government is regulating prescribing practices more directly than in the past, especially with pain drugs,” says Daniel Carpenter, PhD, a Harvard University government professor and author on FDA pharmaceutical regulation. “The FDA and federal agencies are going to be leaning more heavily upon physicians.”

To date, the majority of current abuse-deterrent technologies have not been effective in preventing the most widespread type of abuse—ingesting a number of pills or tablets to reach a state of euphoria.

Science points toward ways that formulations can help thwart abuse. For instance, adding an opioid antagonist can hinder, limit, or defeat euphoria. An antagonist can be sequestered and released only upon the product’s manipulation. In one such scenario, the substance acting as an antagonist could be clinically inactive when swallowed, but then would become active if the product is crushed and injected or snorted.

“The guidance describes advice for the development of abuse-deterrent opioids and does not describe practice guidelines,” says Christopher Kelly, an FDA spokesman. However, he adds, “[FDA] urges all prescribers of extended-release and long-acting opioids to participate in the training under the Risk Evaluation and Mitigation Strategy (REMS).” The first REMS-compliant training is expected to become available by March 1.

Such a strategy is intended to manage known or potential serious risks associated with a drug product. The FDA requires it to ensure that the benefits of a drug outweigh its risks.

Manufacturers of opioid analgesics have worked with the FDA to produce materials for the REMS program that would inform healthcare professionals about safe prescribing. Continuing-education providers also are designing accredited training. (For more information, listen to this NIH podcast about training to help providers prescribe painkillers properly.)

Prescribers are advised to complete a REMS-compliant program through an accredited continuing-education provider for their discipline. They should discuss the safe use, serious risks, storage, and disposal of opioids with patients and caregivers each time they prescribe these medicines. It’s also essential to stress the importance of reading the medication guide they will receive from the pharmacist at drug-dispensing time.

Whether the FDA’s industry guidance for the development of abuse-deterrent opioids will make a difference remains to be seen, according to Carpenter. The addictive potential of opioids has created “a kind of public health epidemic,” he says. “It’s not an infectious epidemic in the sense of the flu, but it’s socially and behaviorally infectious and very destructive.”

 

Creating better tamper-resistant drugs could impede someone from “taking a longer-acting version and breaking it down into a much more toxic soup for other purposes,” Carpenter says. However, he concedes it won’t be impossible to swallow one or more pills too many, leading to this very common form of pharmaceutical abuse.

The FDA is accepting public comment on the draft guidance, while encouraging further scientific and clinical research to advance the development and assessment of abuse-deterrent technologies.

Susan Kreimer is a freelance writer based in New York.

 

 

Inappropriate use of prescription opioids is a major public health challenge, prompting the U.S. Food and Drug Administration (FDA) to issue a draft guidance document aimed at helping industry create new formulations of opioids with abuse-deterrent properties.

Released in January, “Guidance for Industry: Abuse-Deterrent Opioids—Evaluation and Labeling” provides recommendations for conducting studies to prove that a particular formulation contains abuse-deterrent properties. It also explains how the FDA will review the results and determine which labeling claims to approve.

This announcement is “one component of our larger effort to prevent prescription drug abuse and misuse, while ensuring that patients in pain continue to have access to these important medicines,” Douglas Throckmorton, MD, deputy director for regulatory programs in the FDA’s Center for Drug Evaluation and Research, said during a teleconference.

According to the FDA guidance, opioid analgesics can be abused in a variety of ways:

• Swallowed whole;
• Crushed and swallowed;
• Crushed and snorted;
• Crushed and smoked; or
• Crushed, dissolved, and injected.

With the science of abuse deterrence being relatively new, the FDA plans to take a flexible and adaptive approach. That’s because the analytical, clinical, and statistical methods for evaluating formulation technologies are still evolving.

“Physicians should care about this because the government is regulating prescribing practices more directly than in the past, especially with pain drugs,” says Daniel Carpenter, PhD, a Harvard University government professor and author on FDA pharmaceutical regulation. “The FDA and federal agencies are going to be leaning more heavily upon physicians.”

To date, the majority of current abuse-deterrent technologies have not been effective in preventing the most widespread type of abuse—ingesting a number of pills or tablets to reach a state of euphoria.

Science points toward ways that formulations can help thwart abuse. For instance, adding an opioid antagonist can hinder, limit, or defeat euphoria. An antagonist can be sequestered and released only upon the product’s manipulation. In one such scenario, the substance acting as an antagonist could be clinically inactive when swallowed, but then would become active if the product is crushed and injected or snorted.

“The guidance describes advice for the development of abuse-deterrent opioids and does not describe practice guidelines,” says Christopher Kelly, an FDA spokesman. However, he adds, “[FDA] urges all prescribers of extended-release and long-acting opioids to participate in the training under the Risk Evaluation and Mitigation Strategy (REMS).” The first REMS-compliant training is expected to become available by March 1.

Such a strategy is intended to manage known or potential serious risks associated with a drug product. The FDA requires it to ensure that the benefits of a drug outweigh its risks.

Manufacturers of opioid analgesics have worked with the FDA to produce materials for the REMS program that would inform healthcare professionals about safe prescribing. Continuing-education providers also are designing accredited training. (For more information, listen to this NIH podcast about training to help providers prescribe painkillers properly.)

Prescribers are advised to complete a REMS-compliant program through an accredited continuing-education provider for their discipline. They should discuss the safe use, serious risks, storage, and disposal of opioids with patients and caregivers each time they prescribe these medicines. It’s also essential to stress the importance of reading the medication guide they will receive from the pharmacist at drug-dispensing time.

Whether the FDA’s industry guidance for the development of abuse-deterrent opioids will make a difference remains to be seen, according to Carpenter. The addictive potential of opioids has created “a kind of public health epidemic,” he says. “It’s not an infectious epidemic in the sense of the flu, but it’s socially and behaviorally infectious and very destructive.”

 

Creating better tamper-resistant drugs could impede someone from “taking a longer-acting version and breaking it down into a much more toxic soup for other purposes,” Carpenter says. However, he concedes it won’t be impossible to swallow one or more pills too many, leading to this very common form of pharmaceutical abuse.

The FDA is accepting public comment on the draft guidance, while encouraging further scientific and clinical research to advance the development and assessment of abuse-deterrent technologies.

Susan Kreimer is a freelance writer based in New York.

 

 

Inappropriate use of prescription opioids is a major public health challenge, prompting the U.S. Food and Drug Administration (FDA) to issue a draft guidance document aimed at helping industry create new formulations of opioids with abuse-deterrent properties.

Released in January, “Guidance for Industry: Abuse-Deterrent Opioids—Evaluation and Labeling” provides recommendations for conducting studies to prove that a particular formulation contains abuse-deterrent properties. It also explains how the FDA will review the results and determine which labeling claims to approve.

This announcement is “one component of our larger effort to prevent prescription drug abuse and misuse, while ensuring that patients in pain continue to have access to these important medicines,” Douglas Throckmorton, MD, deputy director for regulatory programs in the FDA’s Center for Drug Evaluation and Research, said during a teleconference.

According to the FDA guidance, opioid analgesics can be abused in a variety of ways:

• Swallowed whole;
• Crushed and swallowed;
• Crushed and snorted;
• Crushed and smoked; or
• Crushed, dissolved, and injected.

With the science of abuse deterrence being relatively new, the FDA plans to take a flexible and adaptive approach. That’s because the analytical, clinical, and statistical methods for evaluating formulation technologies are still evolving.

“Physicians should care about this because the government is regulating prescribing practices more directly than in the past, especially with pain drugs,” says Daniel Carpenter, PhD, a Harvard University government professor and author on FDA pharmaceutical regulation. “The FDA and federal agencies are going to be leaning more heavily upon physicians.”

To date, the majority of current abuse-deterrent technologies have not been effective in preventing the most widespread type of abuse—ingesting a number of pills or tablets to reach a state of euphoria.

Science points toward ways that formulations can help thwart abuse. For instance, adding an opioid antagonist can hinder, limit, or defeat euphoria. An antagonist can be sequestered and released only upon the product’s manipulation. In one such scenario, the substance acting as an antagonist could be clinically inactive when swallowed, but then would become active if the product is crushed and injected or snorted.

“The guidance describes advice for the development of abuse-deterrent opioids and does not describe practice guidelines,” says Christopher Kelly, an FDA spokesman. However, he adds, “[FDA] urges all prescribers of extended-release and long-acting opioids to participate in the training under the Risk Evaluation and Mitigation Strategy (REMS).” The first REMS-compliant training is expected to become available by March 1.

Such a strategy is intended to manage known or potential serious risks associated with a drug product. The FDA requires it to ensure that the benefits of a drug outweigh its risks.

Manufacturers of opioid analgesics have worked with the FDA to produce materials for the REMS program that would inform healthcare professionals about safe prescribing. Continuing-education providers also are designing accredited training. (For more information, listen to this NIH podcast about training to help providers prescribe painkillers properly.)

Prescribers are advised to complete a REMS-compliant program through an accredited continuing-education provider for their discipline. They should discuss the safe use, serious risks, storage, and disposal of opioids with patients and caregivers each time they prescribe these medicines. It’s also essential to stress the importance of reading the medication guide they will receive from the pharmacist at drug-dispensing time.

Whether the FDA’s industry guidance for the development of abuse-deterrent opioids will make a difference remains to be seen, according to Carpenter. The addictive potential of opioids has created “a kind of public health epidemic,” he says. “It’s not an infectious epidemic in the sense of the flu, but it’s socially and behaviorally infectious and very destructive.”

 

Creating better tamper-resistant drugs could impede someone from “taking a longer-acting version and breaking it down into a much more toxic soup for other purposes,” Carpenter says. However, he concedes it won’t be impossible to swallow one or more pills too many, leading to this very common form of pharmaceutical abuse.

The FDA is accepting public comment on the draft guidance, while encouraging further scientific and clinical research to advance the development and assessment of abuse-deterrent technologies.

Susan Kreimer is a freelance writer based in New York.

 

 

Click here to listen to Dr. Hausfeld, managing director of FMS Financial Solutions, Greenbelt, Md., co-founder and treasurer of the Society of Physician Entrepreneurs.

Click here to listen to Dr. Hausfeld, managing director of FMS Financial Solutions, Greenbelt, Md., co-founder and treasurer of the Society of Physician Entrepreneurs.

Click here to listen to Dr. Hausfeld, managing director of FMS Financial Solutions, Greenbelt, Md., co-founder and treasurer of the Society of Physician Entrepreneurs.

After years of juggling more than one career, Kulleni Gebreyes, MD, MBA, had a tough decision to make. "I'm a little bit of a glutton for punishment," she admits with a chuckle. While overseeing quality improvement (QI) for a healthcare foundation, she had negotiated to take off every other Friday and work several ED shifts per month on weekends at two local hospitals.

Then, in January 2012, Dr. Gebreyes began a new full-time position as a director at PricewaterhouseCoopers in McLean, Va. It became too time-consuming and exhausting to treat patients and consult in healthcare industries, says the mother of two children, who are 7 and 4.

Dr. Gebreyes is among a growing number of physicians who, after a number of years, opt to give up clinical medicine for nonclinical roles in healthcare or other industries altogether. "You are ready for transition when the new choice excites and energizes you," she explains, "and not necessarily when your first choice disappoints you."

A career shift offers new opportunities for broadening one's horizons while often striking a better work-life balance. Many clinicians make the transition slowly and wisely, and some take an expected financial hit as they carve out an entrepreneurial and creative path.

"Modern medicine is very difficult. You can burn out if you're not careful," says Dan Hale, MD, FAAP, a pediatric hospitalist in the Floating Hospital for Children at Tufts Medical Center in Boston.

Stepping off the merry-go-round can help you regroup. Fortunately, he adds, hospitalists can exercise more flexibility in scheduling than physicians in different specialties. Some hospitalists prefer to work nights and weekends in order to free up weekdays for other activities. Others decrease their clinical shifts and devote more time to teaching, research, or administration.

For those who decide to leave medicine completely, "hospitalists definitely have people skills day to day in their jobs that are applicable in multiple other careers," says Dr. Hale, a Team Hospitalist member. "Becoming a physician requires so much dedication and hard work, so you will succeed in whatever career you choose."

The Society of Physician Entrepreneurs (www.sopenet.org) is expanding by about 150 to 200 new members each month. Founded in 2008 and officially launched in January 2011, the society has more than 4,700 members globally. The interdisciplinary network includes physicians and innovators in other professions—from law to information technology to product development.

Its purpose is to "bring all the stakeholders together in one virtual space to collaborate," says co-founder and president Arlen Meyers, MD, MBA, professor in the departments of otolaryngology, dentistry, and engineering at the University of Colorado Denver, where he directs the graduate program in bio-innovation and entrepreneurship.

"The opportunities for physician entrepreneurs include working with industry, consulting, creating their own company, and much more," Dr. Meyers says. "As domain experts, physicians are in a unique position to add value to the innovation chain.

"However, to leave practice and be successful at something nonclinical requires education, experience, and networks," he says. "Doing what you did successfully in your last career won't be a guarantee of success in your next career, so you have to be willing to pay your dues and accept the risk."

The Writer

Deborah Shlian, MD, MBA, a former family medicine physician and managed-care executive in California, has evolved into a medical management consultant and an author of both fiction and nonfiction titles. Dr. Shlian, who now lives in Boca Raton, Fla., had always wanted to write. Her father, an internist, encouraged the pursuit of medicine, so she followed in his footsteps.

 

"I wanted to emulate what he did," she says. Over time, she realized that "doctors have a lot of skills that are applicable to other endeavors."

She and her husband, Joel Shlian, MD, MBA, also a former family medicine physician, fully gave up clinical practice about 10 years ago after doing it part time for a decade. The Shlians met as students at the University of Maryland School of Medicine in 1970. Initially, their new business concentrated on physician executive recruitment. As clients requested other services, the Shlians helped identify nonphysician managers as well. Clients included established, as well as start-up health plans, academic institutions, utilization review, and healthcare consulting companies.

Given the accelerated changes in healthcare delivery, earning a graduate education in business is not a quick and easy avenue to another career. "An MBA should never be viewed as the means to 'get out of medical practice,'" Dr. Shlian says in her new book, "Lessons Learned: Stories from Women in Medical Management," released this month by the American College of Physician Executives.

"In fact, I would submit that if you really hate clinical medicine, medical management is not for you," she says. "It can be every bit as demanding and frustrating as clinical practice."

The Entrepreneur

Jeffrey N. Hausfeld, MD, MBA, FACS, completed an MBA program on evenings and weekends. After graduation in 2005, he gave up his 24-year practice of otolaryngology and facial plastic surgery. He continued his education by obtaining a graduate certificate in leadership coaching and organizational development. Then he became involved in the first of several business ventures, capitalizing on his clinical experience.

"Doctors don't have a trusted partner to do their debt collections," says Dr. Hausfeld, co-founder and treasurer of the Society of Physician Entrepreneurs. His own negative experiences with debt-collection agencies contributed to his "understanding the obstacles and objections to create this kind of an entity."

Hence the emergence of FMS Financial Solutions, based in Greenbelt, Md. "This seemed to be a very natural fit for me," says Dr. Hausfeld, who is the managing director. By collecting money owed to physicians, hospitals, and surgical centers, he has increased the revenues of his business fourfold since 2006. The company has 24 full- and part-time workers.

Meanwhile, his son, Joshua, who joined him in the healthcare MBA program at Johns Hopkins University in Baltimore and now works for an investment banking firm that provides real estate loans for senior housing, introduced Dr. Hausfeld to a group of Midwest-based assisted-living-facility developers. Four years ago, they struck a deal to provide private equity funding and create Memory Care Communities of Illinois, with Dr. Hausfeld serving as president. The 24-hour residential facilities are home to patients with Alzheimer's disease and dementia.

To some degree, he misses practicing medicine, but Dr. Hausfeld is enthusiastic about making a difference in even more people's lives than he did as a physician and surgeon.

"I've done 10,000 ear, nose, and throat operations. If I did 1,000 more, how much would I be changing the world?" Dr. Hausfeld says. Ultimately, "you find a way to leave a bigger footprint."

Deborah Shlian, MD, MBA

His entrepreneurial spirit has led to other consulting roles. For instance, he is trying to help two startup companies—one in the medical device arena, the other in information technology—grow by leaps and bounds.

 

The Director

Maren Grainger-Monsen, MD, has made her mark as an award-winning physician filmmaker. She is filmmaker-in-residence and director of the bioethics and film program at the Stanford Center for Biomedical Ethics in Palo Alto, Calif. She studied at the London Film School and received her medical training at the University of Washington in Seattle and Stanford University School of Medicine.

"I have really enjoyed using all of my medical background and knowledge and applying it toward film," Dr. Grainger-Monsen says of her position at Stanford, which she has held since 1998. "It's very grounding. It gives you a purpose."

Her one-hour documentary "Rare," which features a family with a very uncommon genetic disease, aired last August on PBS. Another film, "The Revolutionary Optimists," follows a group of aspiring youngsters in the slums of Calcutta, India, who battle poverty and transform their neighborhoods from the inside out. One-hour and 80-minute versions of the film are slated to air on the PBS series "Independent Lens" as part of the Women and Girls Lead Global partnership.

Dr. Grainger-Monsen co-produced and co-directed both films with Nicole Newnham, an independent documentary filmmaker who is in residence at Stanford's bioethics and film program.

As an undergraduate art history major, Dr. Grainger-Monsen became interested in social and ethical issues in medicine. Later, films shown in medical school struck a chord with her. She was amazed at how images could resonate with viewers and trigger animated debate. During the summer between her first and second years of medical school, she was inspired to study film at New York University.

Dr. Grainger-Monsen eventually trained in emergency medicine at Stanford and completed a fellowship in palliative care at Stanford-affiliated Palo Alto Veterans Administration Hospital. For years, she split her career between working in community ER clinics and producing films. Her films are large-scale projects that may take five years or longer to make, and she raises all the funds to bring them to fruition.

"I really do find documentary filmmaking tremendously gratifying," Dr. Grainger-Monsen says of the chance "to talk with all different kinds of people in all different situations and walk in their shoes, with them, for a time. That is what I'm trying to share with the audience."

In creating character-driven documentaries, she aims to spark discussions about important issues in contemporary medicine. "I hope my films can help increase understanding and empathy," she says, "and result in improvements to the delivery of healthcare and reduction of disparities on multiple levels."

---

Susan Kreimer is a freelance writer in New York.

After years of juggling more than one career, Kulleni Gebreyes, MD, MBA, had a tough decision to make. "I'm a little bit of a glutton for punishment," she admits with a chuckle. While overseeing quality improvement (QI) for a healthcare foundation, she had negotiated to take off every other Friday and work several ED shifts per month on weekends at two local hospitals.

Then, in January 2012, Dr. Gebreyes began a new full-time position as a director at PricewaterhouseCoopers in McLean, Va. It became too time-consuming and exhausting to treat patients and consult in healthcare industries, says the mother of two children, who are 7 and 4.

Dr. Gebreyes is among a growing number of physicians who, after a number of years, opt to give up clinical medicine for nonclinical roles in healthcare or other industries altogether. "You are ready for transition when the new choice excites and energizes you," she explains, "and not necessarily when your first choice disappoints you."

A career shift offers new opportunities for broadening one's horizons while often striking a better work-life balance. Many clinicians make the transition slowly and wisely, and some take an expected financial hit as they carve out an entrepreneurial and creative path.

"Modern medicine is very difficult. You can burn out if you're not careful," says Dan Hale, MD, FAAP, a pediatric hospitalist in the Floating Hospital for Children at Tufts Medical Center in Boston.

Stepping off the merry-go-round can help you regroup. Fortunately, he adds, hospitalists can exercise more flexibility in scheduling than physicians in different specialties. Some hospitalists prefer to work nights and weekends in order to free up weekdays for other activities. Others decrease their clinical shifts and devote more time to teaching, research, or administration.

For those who decide to leave medicine completely, "hospitalists definitely have people skills day to day in their jobs that are applicable in multiple other careers," says Dr. Hale, a Team Hospitalist member. "Becoming a physician requires so much dedication and hard work, so you will succeed in whatever career you choose."

The Society of Physician Entrepreneurs (www.sopenet.org) is expanding by about 150 to 200 new members each month. Founded in 2008 and officially launched in January 2011, the society has more than 4,700 members globally. The interdisciplinary network includes physicians and innovators in other professions—from law to information technology to product development.

Its purpose is to "bring all the stakeholders together in one virtual space to collaborate," says co-founder and president Arlen Meyers, MD, MBA, professor in the departments of otolaryngology, dentistry, and engineering at the University of Colorado Denver, where he directs the graduate program in bio-innovation and entrepreneurship.

"The opportunities for physician entrepreneurs include working with industry, consulting, creating their own company, and much more," Dr. Meyers says. "As domain experts, physicians are in a unique position to add value to the innovation chain.

"However, to leave practice and be successful at something nonclinical requires education, experience, and networks," he says. "Doing what you did successfully in your last career won't be a guarantee of success in your next career, so you have to be willing to pay your dues and accept the risk."

The Writer

Deborah Shlian, MD, MBA, a former family medicine physician and managed-care executive in California, has evolved into a medical management consultant and an author of both fiction and nonfiction titles. Dr. Shlian, who now lives in Boca Raton, Fla., had always wanted to write. Her father, an internist, encouraged the pursuit of medicine, so she followed in his footsteps.

 

"I wanted to emulate what he did," she says. Over time, she realized that "doctors have a lot of skills that are applicable to other endeavors."

She and her husband, Joel Shlian, MD, MBA, also a former family medicine physician, fully gave up clinical practice about 10 years ago after doing it part time for a decade. The Shlians met as students at the University of Maryland School of Medicine in 1970. Initially, their new business concentrated on physician executive recruitment. As clients requested other services, the Shlians helped identify nonphysician managers as well. Clients included established, as well as start-up health plans, academic institutions, utilization review, and healthcare consulting companies.

Given the accelerated changes in healthcare delivery, earning a graduate education in business is not a quick and easy avenue to another career. "An MBA should never be viewed as the means to 'get out of medical practice,'" Dr. Shlian says in her new book, "Lessons Learned: Stories from Women in Medical Management," released this month by the American College of Physician Executives.

"In fact, I would submit that if you really hate clinical medicine, medical management is not for you," she says. "It can be every bit as demanding and frustrating as clinical practice."

The Entrepreneur

Jeffrey N. Hausfeld, MD, MBA, FACS, completed an MBA program on evenings and weekends. After graduation in 2005, he gave up his 24-year practice of otolaryngology and facial plastic surgery. He continued his education by obtaining a graduate certificate in leadership coaching and organizational development. Then he became involved in the first of several business ventures, capitalizing on his clinical experience.

"Doctors don't have a trusted partner to do their debt collections," says Dr. Hausfeld, co-founder and treasurer of the Society of Physician Entrepreneurs. His own negative experiences with debt-collection agencies contributed to his "understanding the obstacles and objections to create this kind of an entity."

Hence the emergence of FMS Financial Solutions, based in Greenbelt, Md. "This seemed to be a very natural fit for me," says Dr. Hausfeld, who is the managing director. By collecting money owed to physicians, hospitals, and surgical centers, he has increased the revenues of his business fourfold since 2006. The company has 24 full- and part-time workers.

Meanwhile, his son, Joshua, who joined him in the healthcare MBA program at Johns Hopkins University in Baltimore and now works for an investment banking firm that provides real estate loans for senior housing, introduced Dr. Hausfeld to a group of Midwest-based assisted-living-facility developers. Four years ago, they struck a deal to provide private equity funding and create Memory Care Communities of Illinois, with Dr. Hausfeld serving as president. The 24-hour residential facilities are home to patients with Alzheimer's disease and dementia.

To some degree, he misses practicing medicine, but Dr. Hausfeld is enthusiastic about making a difference in even more people's lives than he did as a physician and surgeon.

"I've done 10,000 ear, nose, and throat operations. If I did 1,000 more, how much would I be changing the world?" Dr. Hausfeld says. Ultimately, "you find a way to leave a bigger footprint."

Deborah Shlian, MD, MBA

His entrepreneurial spirit has led to other consulting roles. For instance, he is trying to help two startup companies—one in the medical device arena, the other in information technology—grow by leaps and bounds.

 

The Director

Maren Grainger-Monsen, MD, has made her mark as an award-winning physician filmmaker. She is filmmaker-in-residence and director of the bioethics and film program at the Stanford Center for Biomedical Ethics in Palo Alto, Calif. She studied at the London Film School and received her medical training at the University of Washington in Seattle and Stanford University School of Medicine.

"I have really enjoyed using all of my medical background and knowledge and applying it toward film," Dr. Grainger-Monsen says of her position at Stanford, which she has held since 1998. "It's very grounding. It gives you a purpose."

Her one-hour documentary "Rare," which features a family with a very uncommon genetic disease, aired last August on PBS. Another film, "The Revolutionary Optimists," follows a group of aspiring youngsters in the slums of Calcutta, India, who battle poverty and transform their neighborhoods from the inside out. One-hour and 80-minute versions of the film are slated to air on the PBS series "Independent Lens" as part of the Women and Girls Lead Global partnership.

Dr. Grainger-Monsen co-produced and co-directed both films with Nicole Newnham, an independent documentary filmmaker who is in residence at Stanford's bioethics and film program.

As an undergraduate art history major, Dr. Grainger-Monsen became interested in social and ethical issues in medicine. Later, films shown in medical school struck a chord with her. She was amazed at how images could resonate with viewers and trigger animated debate. During the summer between her first and second years of medical school, she was inspired to study film at New York University.

Dr. Grainger-Monsen eventually trained in emergency medicine at Stanford and completed a fellowship in palliative care at Stanford-affiliated Palo Alto Veterans Administration Hospital. For years, she split her career between working in community ER clinics and producing films. Her films are large-scale projects that may take five years or longer to make, and she raises all the funds to bring them to fruition.

"I really do find documentary filmmaking tremendously gratifying," Dr. Grainger-Monsen says of the chance "to talk with all different kinds of people in all different situations and walk in their shoes, with them, for a time. That is what I'm trying to share with the audience."

In creating character-driven documentaries, she aims to spark discussions about important issues in contemporary medicine. "I hope my films can help increase understanding and empathy," she says, "and result in improvements to the delivery of healthcare and reduction of disparities on multiple levels."

---

Susan Kreimer is a freelance writer in New York.

After years of juggling more than one career, Kulleni Gebreyes, MD, MBA, had a tough decision to make. "I'm a little bit of a glutton for punishment," she admits with a chuckle. While overseeing quality improvement (QI) for a healthcare foundation, she had negotiated to take off every other Friday and work several ED shifts per month on weekends at two local hospitals.

Then, in January 2012, Dr. Gebreyes began a new full-time position as a director at PricewaterhouseCoopers in McLean, Va. It became too time-consuming and exhausting to treat patients and consult in healthcare industries, says the mother of two children, who are 7 and 4.

Dr. Gebreyes is among a growing number of physicians who, after a number of years, opt to give up clinical medicine for nonclinical roles in healthcare or other industries altogether. "You are ready for transition when the new choice excites and energizes you," she explains, "and not necessarily when your first choice disappoints you."

A career shift offers new opportunities for broadening one's horizons while often striking a better work-life balance. Many clinicians make the transition slowly and wisely, and some take an expected financial hit as they carve out an entrepreneurial and creative path.

"Modern medicine is very difficult. You can burn out if you're not careful," says Dan Hale, MD, FAAP, a pediatric hospitalist in the Floating Hospital for Children at Tufts Medical Center in Boston.

Stepping off the merry-go-round can help you regroup. Fortunately, he adds, hospitalists can exercise more flexibility in scheduling than physicians in different specialties. Some hospitalists prefer to work nights and weekends in order to free up weekdays for other activities. Others decrease their clinical shifts and devote more time to teaching, research, or administration.

For those who decide to leave medicine completely, "hospitalists definitely have people skills day to day in their jobs that are applicable in multiple other careers," says Dr. Hale, a Team Hospitalist member. "Becoming a physician requires so much dedication and hard work, so you will succeed in whatever career you choose."

The Society of Physician Entrepreneurs (www.sopenet.org) is expanding by about 150 to 200 new members each month. Founded in 2008 and officially launched in January 2011, the society has more than 4,700 members globally. The interdisciplinary network includes physicians and innovators in other professions—from law to information technology to product development.

Its purpose is to "bring all the stakeholders together in one virtual space to collaborate," says co-founder and president Arlen Meyers, MD, MBA, professor in the departments of otolaryngology, dentistry, and engineering at the University of Colorado Denver, where he directs the graduate program in bio-innovation and entrepreneurship.

"The opportunities for physician entrepreneurs include working with industry, consulting, creating their own company, and much more," Dr. Meyers says. "As domain experts, physicians are in a unique position to add value to the innovation chain.

"However, to leave practice and be successful at something nonclinical requires education, experience, and networks," he says. "Doing what you did successfully in your last career won't be a guarantee of success in your next career, so you have to be willing to pay your dues and accept the risk."

The Writer

Deborah Shlian, MD, MBA, a former family medicine physician and managed-care executive in California, has evolved into a medical management consultant and an author of both fiction and nonfiction titles. Dr. Shlian, who now lives in Boca Raton, Fla., had always wanted to write. Her father, an internist, encouraged the pursuit of medicine, so she followed in his footsteps.

 

"I wanted to emulate what he did," she says. Over time, she realized that "doctors have a lot of skills that are applicable to other endeavors."

She and her husband, Joel Shlian, MD, MBA, also a former family medicine physician, fully gave up clinical practice about 10 years ago after doing it part time for a decade. The Shlians met as students at the University of Maryland School of Medicine in 1970. Initially, their new business concentrated on physician executive recruitment. As clients requested other services, the Shlians helped identify nonphysician managers as well. Clients included established, as well as start-up health plans, academic institutions, utilization review, and healthcare consulting companies.

Given the accelerated changes in healthcare delivery, earning a graduate education in business is not a quick and easy avenue to another career. "An MBA should never be viewed as the means to 'get out of medical practice,'" Dr. Shlian says in her new book, "Lessons Learned: Stories from Women in Medical Management," released this month by the American College of Physician Executives.

"In fact, I would submit that if you really hate clinical medicine, medical management is not for you," she says. "It can be every bit as demanding and frustrating as clinical practice."

The Entrepreneur

Jeffrey N. Hausfeld, MD, MBA, FACS, completed an MBA program on evenings and weekends. After graduation in 2005, he gave up his 24-year practice of otolaryngology and facial plastic surgery. He continued his education by obtaining a graduate certificate in leadership coaching and organizational development. Then he became involved in the first of several business ventures, capitalizing on his clinical experience.

"Doctors don't have a trusted partner to do their debt collections," says Dr. Hausfeld, co-founder and treasurer of the Society of Physician Entrepreneurs. His own negative experiences with debt-collection agencies contributed to his "understanding the obstacles and objections to create this kind of an entity."

Hence the emergence of FMS Financial Solutions, based in Greenbelt, Md. "This seemed to be a very natural fit for me," says Dr. Hausfeld, who is the managing director. By collecting money owed to physicians, hospitals, and surgical centers, he has increased the revenues of his business fourfold since 2006. The company has 24 full- and part-time workers.

Meanwhile, his son, Joshua, who joined him in the healthcare MBA program at Johns Hopkins University in Baltimore and now works for an investment banking firm that provides real estate loans for senior housing, introduced Dr. Hausfeld to a group of Midwest-based assisted-living-facility developers. Four years ago, they struck a deal to provide private equity funding and create Memory Care Communities of Illinois, with Dr. Hausfeld serving as president. The 24-hour residential facilities are home to patients with Alzheimer's disease and dementia.

To some degree, he misses practicing medicine, but Dr. Hausfeld is enthusiastic about making a difference in even more people's lives than he did as a physician and surgeon.

"I've done 10,000 ear, nose, and throat operations. If I did 1,000 more, how much would I be changing the world?" Dr. Hausfeld says. Ultimately, "you find a way to leave a bigger footprint."

Deborah Shlian, MD, MBA

His entrepreneurial spirit has led to other consulting roles. For instance, he is trying to help two startup companies—one in the medical device arena, the other in information technology—grow by leaps and bounds.

 

The Director

Maren Grainger-Monsen, MD, has made her mark as an award-winning physician filmmaker. She is filmmaker-in-residence and director of the bioethics and film program at the Stanford Center for Biomedical Ethics in Palo Alto, Calif. She studied at the London Film School and received her medical training at the University of Washington in Seattle and Stanford University School of Medicine.

"I have really enjoyed using all of my medical background and knowledge and applying it toward film," Dr. Grainger-Monsen says of her position at Stanford, which she has held since 1998. "It's very grounding. It gives you a purpose."

Her one-hour documentary "Rare," which features a family with a very uncommon genetic disease, aired last August on PBS. Another film, "The Revolutionary Optimists," follows a group of aspiring youngsters in the slums of Calcutta, India, who battle poverty and transform their neighborhoods from the inside out. One-hour and 80-minute versions of the film are slated to air on the PBS series "Independent Lens" as part of the Women and Girls Lead Global partnership.

Dr. Grainger-Monsen co-produced and co-directed both films with Nicole Newnham, an independent documentary filmmaker who is in residence at Stanford's bioethics and film program.

As an undergraduate art history major, Dr. Grainger-Monsen became interested in social and ethical issues in medicine. Later, films shown in medical school struck a chord with her. She was amazed at how images could resonate with viewers and trigger animated debate. During the summer between her first and second years of medical school, she was inspired to study film at New York University.

Dr. Grainger-Monsen eventually trained in emergency medicine at Stanford and completed a fellowship in palliative care at Stanford-affiliated Palo Alto Veterans Administration Hospital. For years, she split her career between working in community ER clinics and producing films. Her films are large-scale projects that may take five years or longer to make, and she raises all the funds to bring them to fruition.

"I really do find documentary filmmaking tremendously gratifying," Dr. Grainger-Monsen says of the chance "to talk with all different kinds of people in all different situations and walk in their shoes, with them, for a time. That is what I'm trying to share with the audience."

In creating character-driven documentaries, she aims to spark discussions about important issues in contemporary medicine. "I hope my films can help increase understanding and empathy," she says, "and result in improvements to the delivery of healthcare and reduction of disparities on multiple levels."

---

Susan Kreimer is a freelance writer in New York.

Q&A with Philippa Kennealy, MD, MPH, CPCC, PCC, founder and owner of The Entrepreneurial MD (www.entrepreneurialmd.com).

Question: What type of business do you operate?

Answer: I’m a physician development and business coach. My role is to help physicians who are struggling with launching a nonclinical career or a new business, or revamping a medical practice to become a satisfying venture. Although I am personally based in Los Angeles, The Entrepreneurial MD clients can be located anywhere in the world as long as we both have phone or Internet access. About 95% of my clients are not located in Los Angeles. I’m 57 years old. I was 41 when I left medical practice and went on to have several more careers.

Q: Why did you give up the practice of medicine?

A: I left my five-member private family practice in mid-1996, after joining my group in the middle of 1988. I realized that not only was I feeling unfulfilled and frustrated by work, but that I was even starting to dread it. I particularly dreaded the nights and weekends on call—for the latter, I started getting that “sick in the stomach” feeling on Mondays. I also realized that I had become bored with the repetition of the work and loved the idea of learning a whole lot of new stuff. I had embarked on my master’s degree in public health at UCLA around that time (mid-1995) and became completely energized by being a student again in a class of adult learners.

In short, I was deeply restless, in my early 40s, and ready for a change.

Q: How would you advise other MDs who are considering the pros/cons of not seeing patients anymore?

A: Above all else, it is important to get to really know yourself. Give yourself the gift of real reflection rather than just reaction. Upon such reflection, I knew that what truly energized me in clinical practice was my connection to people rather than being able to use a stethoscope or remove a mole. I also recognized that this “passion” was portable—unless I was locked away in a room with only a computer for company, I would thrive professionally no matter what I chose next, as long as it involved being in a helping relationship with others.

Engage in conversation with others who are like-minded—your mentors, people who have made career changes, your significant others. Do your homework and recognize that in the end, it is only you who can make the decision whether to stay or leave. Be compelled to make changes in your life because you are moving toward new opportunities rather than merely running away.

Q: Can you name some pros and cons for physicians interested in a career change?

A: The pros: interesting challenges, a chance to remake your career, re-engage your brain, feel challenged; reinvent yourself, strive for the dream(s) that you may have put on hold many years before or gave up because you did medicine to please others; acquire new skills, which may be fun.

The cons: risky if unplanned, you may have to take an income hit for a while, you may be a victim of “the grass is always greener” [mindset], you may never discover what you really want if you are simply acting from dissatisfaction and aren’t willing to do the work of change. It feels scary, and it takes a certain amount of inner courage and external support to make the move.

Q&A with Philippa Kennealy, MD, MPH, CPCC, PCC, founder and owner of The Entrepreneurial MD (www.entrepreneurialmd.com).

Question: What type of business do you operate?

Answer: I’m a physician development and business coach. My role is to help physicians who are struggling with launching a nonclinical career or a new business, or revamping a medical practice to become a satisfying venture. Although I am personally based in Los Angeles, The Entrepreneurial MD clients can be located anywhere in the world as long as we both have phone or Internet access. About 95% of my clients are not located in Los Angeles. I’m 57 years old. I was 41 when I left medical practice and went on to have several more careers.

Q: Why did you give up the practice of medicine?

A: I left my five-member private family practice in mid-1996, after joining my group in the middle of 1988. I realized that not only was I feeling unfulfilled and frustrated by work, but that I was even starting to dread it. I particularly dreaded the nights and weekends on call—for the latter, I started getting that “sick in the stomach” feeling on Mondays. I also realized that I had become bored with the repetition of the work and loved the idea of learning a whole lot of new stuff. I had embarked on my master’s degree in public health at UCLA around that time (mid-1995) and became completely energized by being a student again in a class of adult learners.

In short, I was deeply restless, in my early 40s, and ready for a change.

Q: How would you advise other MDs who are considering the pros/cons of not seeing patients anymore?

A: Above all else, it is important to get to really know yourself. Give yourself the gift of real reflection rather than just reaction. Upon such reflection, I knew that what truly energized me in clinical practice was my connection to people rather than being able to use a stethoscope or remove a mole. I also recognized that this “passion” was portable—unless I was locked away in a room with only a computer for company, I would thrive professionally no matter what I chose next, as long as it involved being in a helping relationship with others.

Engage in conversation with others who are like-minded—your mentors, people who have made career changes, your significant others. Do your homework and recognize that in the end, it is only you who can make the decision whether to stay or leave. Be compelled to make changes in your life because you are moving toward new opportunities rather than merely running away.

Q: Can you name some pros and cons for physicians interested in a career change?

A: The pros: interesting challenges, a chance to remake your career, re-engage your brain, feel challenged; reinvent yourself, strive for the dream(s) that you may have put on hold many years before or gave up because you did medicine to please others; acquire new skills, which may be fun.

The cons: risky if unplanned, you may have to take an income hit for a while, you may be a victim of “the grass is always greener” [mindset], you may never discover what you really want if you are simply acting from dissatisfaction and aren’t willing to do the work of change. It feels scary, and it takes a certain amount of inner courage and external support to make the move.

Q&A with Philippa Kennealy, MD, MPH, CPCC, PCC, founder and owner of The Entrepreneurial MD (www.entrepreneurialmd.com).

Question: What type of business do you operate?

Answer: I’m a physician development and business coach. My role is to help physicians who are struggling with launching a nonclinical career or a new business, or revamping a medical practice to become a satisfying venture. Although I am personally based in Los Angeles, The Entrepreneurial MD clients can be located anywhere in the world as long as we both have phone or Internet access. About 95% of my clients are not located in Los Angeles. I’m 57 years old. I was 41 when I left medical practice and went on to have several more careers.

Q: Why did you give up the practice of medicine?

A: I left my five-member private family practice in mid-1996, after joining my group in the middle of 1988. I realized that not only was I feeling unfulfilled and frustrated by work, but that I was even starting to dread it. I particularly dreaded the nights and weekends on call—for the latter, I started getting that “sick in the stomach” feeling on Mondays. I also realized that I had become bored with the repetition of the work and loved the idea of learning a whole lot of new stuff. I had embarked on my master’s degree in public health at UCLA around that time (mid-1995) and became completely energized by being a student again in a class of adult learners.

In short, I was deeply restless, in my early 40s, and ready for a change.

Q: How would you advise other MDs who are considering the pros/cons of not seeing patients anymore?

A: Above all else, it is important to get to really know yourself. Give yourself the gift of real reflection rather than just reaction. Upon such reflection, I knew that what truly energized me in clinical practice was my connection to people rather than being able to use a stethoscope or remove a mole. I also recognized that this “passion” was portable—unless I was locked away in a room with only a computer for company, I would thrive professionally no matter what I chose next, as long as it involved being in a helping relationship with others.

Engage in conversation with others who are like-minded—your mentors, people who have made career changes, your significant others. Do your homework and recognize that in the end, it is only you who can make the decision whether to stay or leave. Be compelled to make changes in your life because you are moving toward new opportunities rather than merely running away.

Q: Can you name some pros and cons for physicians interested in a career change?

A: The pros: interesting challenges, a chance to remake your career, re-engage your brain, feel challenged; reinvent yourself, strive for the dream(s) that you may have put on hold many years before or gave up because you did medicine to please others; acquire new skills, which may be fun.

The cons: risky if unplanned, you may have to take an income hit for a while, you may be a victim of “the grass is always greener” [mindset], you may never discover what you really want if you are simply acting from dissatisfaction and aren’t willing to do the work of change. It feels scary, and it takes a certain amount of inner courage and external support to make the move.

Opioid overuse can spell the onset of onerous consequences. The analgesics can slow breathing to dangerous levels and lead to dizziness, nausea, and falls.

Citing these concerns, The Joint Commission issued a Sentinel Event Alert in August 2012 that urged hospitals to take specific measures to help avoid serious complications and even deaths from the use of such opioids as morphine, oxycodone, and methadone.

“The Joint Commission recognizes that there is an opportunity to improve the care of patients on opioids in acute-care settings,” spokeswoman Elizabeth Eaken Zhani says. “Healthcare workers need to be aware of the risks to patients in prescribing opioids.”

Adverse events involving opioids include dosing errors and improper monitoring of patients and drug interactions. Patients who have sleep apnea, are obese, or very ill—with such conditions as pulmonary disease, congestive heart failure, or impaired renal function—might be at higher risk for harm from opioids.

“The alert was issued in response to concerns that opioid analgesics are among the top three drugs in which medication-related adverse events are reported to The Joint Commission,” Zhani says. “They also rank among the drugs most frequently associated with adverse drug events.”

Opioids are associated with numerous problems—underprescribing, overprescribing, tolerance, dependence, and drug abuse. To prevent accidental overuse, The Joint Commission recommends that healthcare organizations provide ongoing oversight of patients receiving these drugs. Pain-management specialists or pharmacists should review treatment plans and also track incidents involving opioids.

Harnessing available technology also helps improve prescribing safety. In addition to creating alerts for dosing limits, The Joint Commission suggests using “tall man” lettering in electronic ordering systems, conversion support to calculate correct dosages, and patient-controlled analgesia. Education and training in the safe use of opioids should be provided for clinicians, staff, and patients. And standardized tools should be employed to screen patients for risk factors, such as oversedation and respiratory depression.

“Opioids aren’t dangerous in themselves,” says Solomon Liao, MD, FAAHPM, a hospitalist and director of palliative-care services at the University of California at Irvine. “Opioids are dangerous when prescribers don’t know what they’re doing. It’s like the old saying, ‘Guns don’t kill people; people kill people.’”

Overdose deaths from opioid pain relievers have escalated, nearly quadrupling from 1999 to 2008. These deaths now exceed fatalities due to heroin and cocaine combined. In 2008, drug overdoses in the United States caused 36,450 deaths; opioid analgesics were involved in 14,800 (73.8%) of 20,044 prescription drug overdose deaths, according to the Centers for Disease Control and Prevention.¹

Vital statistics data suggest that methadone is involved in one-third of opioid pain-reliever-related overdose deaths, even though it accounts for only a small percentage of prescriptions for opioid analgesics. The rate of methadone overdose deaths in the U.S. in 2009 was 5.5 times the rate in 1999, prompting an urgent call for interventions to address misuse and abuse.²

“The greatest safety concern The Joint Commission’s report cites is that sedation precedes respiratory depression in many cases, and clinicians need to pay more attention to that side effect and patients who are inherently at risk for developing respiratory problems related to opioids,” says Paul Arnstein, RN, PhD, FAAN, Connell Nursing Research Scholar and clinical nurse specialist for pain relief at Massachusetts General Hospital in Boston.

 

A Double-Edged Sword

Opioids deliver good pain control with minimal adverse effects for some patients but not for others, and there is insufficient evidence to foresee who will fare well and who won’t. “What we can predict,” Arnstein says, “is that certain patients—the very old, very young, very ill, and those receiving medicines that interact with opioids—are vulnerable to some of the more dangerous effects.”

The risk of respiratory depression also mounts in those who are opioid-naïve, as well as in an increasingly obese population.

“This does not mean we withhold pain relief,” says Judith A. Paice, PhD, RN, a contributor to The Joint Commission’s alert and director of the cancer pain program in the hematology-oncology division at Northwestern University’s Feinberg School of Medicine. Instead, “we need to determine the most effective monitoring techniques in a setting where hospitals are cutting back on staffing,” she adds.

Other risk factors for respiratory depression include sleep apnea (correlated with obesity but also possible in the absence of excess weight), large thoracic or abdominal incisions, and use of other sedating drugs. Among patients in the chronic cancer pain or palliative-care setting, respiratory depression is highly unusual because dosages are increased gradually, Paice says. Strong consensus supports prescribing opioids for acute episodes of pain, as well as chronic management of cancer and other life-threatening illnesses, including HIV/AIDS and cardiac and neuromuscular conditions.

Considerable variations exist in screening for risk of opioid-induced sedation and hospital monitoring practices. There is also a shortage of information and no consensus on the advantages of costly technology-supported monitoring, such as pulse oximetry (measuring oxygen saturation) and capnography (measuring end-tidal carbon dioxide), in hospitalized patients receiving opioids for pain therapy, according to guidelines from the American Society for Pain Management Nursing.³

Although technological monitoring adds valuable data to patient status, it does not replace frequent assessments—the most important intervention in detecting sedation before respiratory depression. Technological monitoring should be considered for patients at high risk for decline, says the guidelines’ lead author, Donna Jarzyna, MS, RN-BC, CNS-BC, an adult health clinical nurse specialist consulting in an alumna role for the University of Arizona Medical Center in Tucson. “Many organizations are currently making an effort,” she says, “to determine which patients should be monitored with a higher degree of intensity and with greater frequency.”

Patient-controlled analgesia (PCA) also has some limitations. In theory, it offers built-in safety features—if patients become too sedated, they can’t push a button for extra doses—but that isn’t always the case. For instance, some patients may have “stacked” three to four doses before sedation and respiratory depression develop. “When things go wrong with PCA, patients are four times more likely to be seriously harmed than when nurses administer the medications,” says Arnstein, who is a past president of the American Society for Pain Management Nursing. “Thus, vigilant nurse-supervised opioid therapy is vitally important.”

Simple Steps Save Lives

Most critical events associated with opioids occur during the first 24 hours of post-operative care. Combined with close monitoring, understanding the risk factors for respiratory depression and making adjustments based on an individual’s needs and response helps prevent a precarious situation in which a patient vacillates quickly from a wide-awake status to a sleepy state.

 

“There’s a very progressive amount of sedation,” says Deb Gordon, RN, DNP, FAAN, a contributor to The Joint Commission’s alert and a teaching associate in the department of anesthesiology and pain medicine at the University of Washington in Seattle.

Developing a pain treatment plan with a reassessment component is essential to exercising caution against potential harm from opioids.

“The Joint Commission’s guidance is wonderfully helpful and will benefit patients,” says Beth B. Murinson, MS, MD, PhD, associate professor and director of pain education in the department of neurology at Johns Hopkins University School of Medicine in Baltimore. “Getting opioid pain relief right is critically important as lives are hanging in the balance on both sides of this problem: Too little pain relief and millions will suffer; too much and lives are at risk.”

Hospitalists should be familiar with a few opioids that they feel comfortable prescribing, Dr. Murinson says. Be prepared to easily identify the major idiosyncratic effects and ordinary side effects of these medications and become well versed in opioid conversion.

“This is a classic problem in the field because, although the opioids are generally similar in their efficacy against pain, they have markedly different potencies against pain,” she explains. “A dose of 2 mg of morphine may need to be ‘converted’ to X mg of another opioid, depending on local practice patterns and preferences.”

Some drugs pose special risks. For example, transdermal fentanyl is “appropriate only for use in people who need opioid-level analgesia for an extended period of time and whose analgesic requirements are stable. This is not the case for folks with acute pain or who are just starting on opioids,” cautions Scott Strassels, PhD, PharmD, BCPS, assistant professor in the College of Pharmacy at the University of Texas in Austin and a board member of the American Pain Society. “Similarly, methadone is a good analgesic, but it requires very careful use due to its pharmacokinetic profile.”

Healthcare professionals from a variety of disciplines should be involved in pain-management efforts within a hospital setting. As for who takes the initiative, “it probably should be the person who is most qualified—be it a physician, nurse, or pharmacist,” Strassels says. “I’ve seen pharmacist-led teams, nurse-led teams, and those with physicians leading the effort.”

Clinicians who prescribe pain medications should be cognizant of nonpharmacologic alternatives to opioids. Multimodal options include physical therapy, acupuncture, manipulation or massage, and non-narcotic analgesics, such as acetaminophen and muscle relaxants. Non-narcotics may lower the dose of opioids needed to effectively manage pain, according to The Joint Commission.

The alert also provides information on suggested actions to avoid unintended consequences of using opioids. Hospitals should fully inform and provide written instructions to the patient and family or caregiver about the potential risks of tolerance, addiction, physical dependency, and withdrawal from opioids. When providing this information at discharge, the hospital also should list phone numbers to call if there are any questions.

In some unfortunate cases, opioids prescribed for pain also are used by patients’ family members, friends, and others. In such instances, says Northwestern’s Paice, usage occurs commonly with polypharmacy and without monitoring, and this contributes to an increased risk of death associated with opioids.

“There is concern that drugs prescribed for legitimate purposes are reaching the wrong hands,” Paice says. “We need to make the public, particularly patients and their family members, aware of safety strategies.”

---

Susan Kreimer is a freelance writer in New York City.

 

References

1. Centers for Disease Control and Prevention. Vital signs: overdoses of prescription opioid pain relievers—United States, 1999-2008. MMWR Morb Mortal Wkly Rep. 2011;60(43):1487-1492.
2. Centers for Disease Control and Prevention. Vital signs: risk for overdose from methadone used for pain relief—United States, 1999-2010. MMWR Morb Mortal Wkly Rep. 2012;61(26):493-497.
3. Jarzyna D, Jungquist CR, Pasero C, et al. American Society for Pain Management Nursing guidelines on monitoring for opioid-induced sedation and respiratory depression. Pain Manag Nurs. 2011;12(3):118-145.

Opioid overuse can spell the onset of onerous consequences. The analgesics can slow breathing to dangerous levels and lead to dizziness, nausea, and falls.

Citing these concerns, The Joint Commission issued a Sentinel Event Alert in August 2012 that urged hospitals to take specific measures to help avoid serious complications and even deaths from the use of such opioids as morphine, oxycodone, and methadone.

“The Joint Commission recognizes that there is an opportunity to improve the care of patients on opioids in acute-care settings,” spokeswoman Elizabeth Eaken Zhani says. “Healthcare workers need to be aware of the risks to patients in prescribing opioids.”

Adverse events involving opioids include dosing errors and improper monitoring of patients and drug interactions. Patients who have sleep apnea, are obese, or very ill—with such conditions as pulmonary disease, congestive heart failure, or impaired renal function—might be at higher risk for harm from opioids.

“The alert was issued in response to concerns that opioid analgesics are among the top three drugs in which medication-related adverse events are reported to The Joint Commission,” Zhani says. “They also rank among the drugs most frequently associated with adverse drug events.”

Opioids are associated with numerous problems—underprescribing, overprescribing, tolerance, dependence, and drug abuse. To prevent accidental overuse, The Joint Commission recommends that healthcare organizations provide ongoing oversight of patients receiving these drugs. Pain-management specialists or pharmacists should review treatment plans and also track incidents involving opioids.

Harnessing available technology also helps improve prescribing safety. In addition to creating alerts for dosing limits, The Joint Commission suggests using “tall man” lettering in electronic ordering systems, conversion support to calculate correct dosages, and patient-controlled analgesia. Education and training in the safe use of opioids should be provided for clinicians, staff, and patients. And standardized tools should be employed to screen patients for risk factors, such as oversedation and respiratory depression.

“Opioids aren’t dangerous in themselves,” says Solomon Liao, MD, FAAHPM, a hospitalist and director of palliative-care services at the University of California at Irvine. “Opioids are dangerous when prescribers don’t know what they’re doing. It’s like the old saying, ‘Guns don’t kill people; people kill people.’”

Overdose deaths from opioid pain relievers have escalated, nearly quadrupling from 1999 to 2008. These deaths now exceed fatalities due to heroin and cocaine combined. In 2008, drug overdoses in the United States caused 36,450 deaths; opioid analgesics were involved in 14,800 (73.8%) of 20,044 prescription drug overdose deaths, according to the Centers for Disease Control and Prevention.¹

Vital statistics data suggest that methadone is involved in one-third of opioid pain-reliever-related overdose deaths, even though it accounts for only a small percentage of prescriptions for opioid analgesics. The rate of methadone overdose deaths in the U.S. in 2009 was 5.5 times the rate in 1999, prompting an urgent call for interventions to address misuse and abuse.²

“The greatest safety concern The Joint Commission’s report cites is that sedation precedes respiratory depression in many cases, and clinicians need to pay more attention to that side effect and patients who are inherently at risk for developing respiratory problems related to opioids,” says Paul Arnstein, RN, PhD, FAAN, Connell Nursing Research Scholar and clinical nurse specialist for pain relief at Massachusetts General Hospital in Boston.

 

A Double-Edged Sword

Opioids deliver good pain control with minimal adverse effects for some patients but not for others, and there is insufficient evidence to foresee who will fare well and who won’t. “What we can predict,” Arnstein says, “is that certain patients—the very old, very young, very ill, and those receiving medicines that interact with opioids—are vulnerable to some of the more dangerous effects.”

The risk of respiratory depression also mounts in those who are opioid-naïve, as well as in an increasingly obese population.

“This does not mean we withhold pain relief,” says Judith A. Paice, PhD, RN, a contributor to The Joint Commission’s alert and director of the cancer pain program in the hematology-oncology division at Northwestern University’s Feinberg School of Medicine. Instead, “we need to determine the most effective monitoring techniques in a setting where hospitals are cutting back on staffing,” she adds.

Other risk factors for respiratory depression include sleep apnea (correlated with obesity but also possible in the absence of excess weight), large thoracic or abdominal incisions, and use of other sedating drugs. Among patients in the chronic cancer pain or palliative-care setting, respiratory depression is highly unusual because dosages are increased gradually, Paice says. Strong consensus supports prescribing opioids for acute episodes of pain, as well as chronic management of cancer and other life-threatening illnesses, including HIV/AIDS and cardiac and neuromuscular conditions.

Considerable variations exist in screening for risk of opioid-induced sedation and hospital monitoring practices. There is also a shortage of information and no consensus on the advantages of costly technology-supported monitoring, such as pulse oximetry (measuring oxygen saturation) and capnography (measuring end-tidal carbon dioxide), in hospitalized patients receiving opioids for pain therapy, according to guidelines from the American Society for Pain Management Nursing.³

Although technological monitoring adds valuable data to patient status, it does not replace frequent assessments—the most important intervention in detecting sedation before respiratory depression. Technological monitoring should be considered for patients at high risk for decline, says the guidelines’ lead author, Donna Jarzyna, MS, RN-BC, CNS-BC, an adult health clinical nurse specialist consulting in an alumna role for the University of Arizona Medical Center in Tucson. “Many organizations are currently making an effort,” she says, “to determine which patients should be monitored with a higher degree of intensity and with greater frequency.”

Patient-controlled analgesia (PCA) also has some limitations. In theory, it offers built-in safety features—if patients become too sedated, they can’t push a button for extra doses—but that isn’t always the case. For instance, some patients may have “stacked” three to four doses before sedation and respiratory depression develop. “When things go wrong with PCA, patients are four times more likely to be seriously harmed than when nurses administer the medications,” says Arnstein, who is a past president of the American Society for Pain Management Nursing. “Thus, vigilant nurse-supervised opioid therapy is vitally important.”

Simple Steps Save Lives

Most critical events associated with opioids occur during the first 24 hours of post-operative care. Combined with close monitoring, understanding the risk factors for respiratory depression and making adjustments based on an individual’s needs and response helps prevent a precarious situation in which a patient vacillates quickly from a wide-awake status to a sleepy state.

 

“There’s a very progressive amount of sedation,” says Deb Gordon, RN, DNP, FAAN, a contributor to The Joint Commission’s alert and a teaching associate in the department of anesthesiology and pain medicine at the University of Washington in Seattle.

Developing a pain treatment plan with a reassessment component is essential to exercising caution against potential harm from opioids.

“The Joint Commission’s guidance is wonderfully helpful and will benefit patients,” says Beth B. Murinson, MS, MD, PhD, associate professor and director of pain education in the department of neurology at Johns Hopkins University School of Medicine in Baltimore. “Getting opioid pain relief right is critically important as lives are hanging in the balance on both sides of this problem: Too little pain relief and millions will suffer; too much and lives are at risk.”

Hospitalists should be familiar with a few opioids that they feel comfortable prescribing, Dr. Murinson says. Be prepared to easily identify the major idiosyncratic effects and ordinary side effects of these medications and become well versed in opioid conversion.

“This is a classic problem in the field because, although the opioids are generally similar in their efficacy against pain, they have markedly different potencies against pain,” she explains. “A dose of 2 mg of morphine may need to be ‘converted’ to X mg of another opioid, depending on local practice patterns and preferences.”

Some drugs pose special risks. For example, transdermal fentanyl is “appropriate only for use in people who need opioid-level analgesia for an extended period of time and whose analgesic requirements are stable. This is not the case for folks with acute pain or who are just starting on opioids,” cautions Scott Strassels, PhD, PharmD, BCPS, assistant professor in the College of Pharmacy at the University of Texas in Austin and a board member of the American Pain Society. “Similarly, methadone is a good analgesic, but it requires very careful use due to its pharmacokinetic profile.”

Healthcare professionals from a variety of disciplines should be involved in pain-management efforts within a hospital setting. As for who takes the initiative, “it probably should be the person who is most qualified—be it a physician, nurse, or pharmacist,” Strassels says. “I’ve seen pharmacist-led teams, nurse-led teams, and those with physicians leading the effort.”

Clinicians who prescribe pain medications should be cognizant of nonpharmacologic alternatives to opioids. Multimodal options include physical therapy, acupuncture, manipulation or massage, and non-narcotic analgesics, such as acetaminophen and muscle relaxants. Non-narcotics may lower the dose of opioids needed to effectively manage pain, according to The Joint Commission.

The alert also provides information on suggested actions to avoid unintended consequences of using opioids. Hospitals should fully inform and provide written instructions to the patient and family or caregiver about the potential risks of tolerance, addiction, physical dependency, and withdrawal from opioids. When providing this information at discharge, the hospital also should list phone numbers to call if there are any questions.

In some unfortunate cases, opioids prescribed for pain also are used by patients’ family members, friends, and others. In such instances, says Northwestern’s Paice, usage occurs commonly with polypharmacy and without monitoring, and this contributes to an increased risk of death associated with opioids.

“There is concern that drugs prescribed for legitimate purposes are reaching the wrong hands,” Paice says. “We need to make the public, particularly patients and their family members, aware of safety strategies.”

---

Susan Kreimer is a freelance writer in New York City.

 

References

1. Centers for Disease Control and Prevention. Vital signs: overdoses of prescription opioid pain relievers—United States, 1999-2008. MMWR Morb Mortal Wkly Rep. 2011;60(43):1487-1492.
2. Centers for Disease Control and Prevention. Vital signs: risk for overdose from methadone used for pain relief—United States, 1999-2010. MMWR Morb Mortal Wkly Rep. 2012;61(26):493-497.
3. Jarzyna D, Jungquist CR, Pasero C, et al. American Society for Pain Management Nursing guidelines on monitoring for opioid-induced sedation and respiratory depression. Pain Manag Nurs. 2011;12(3):118-145.

Opioid overuse can spell the onset of onerous consequences. The analgesics can slow breathing to dangerous levels and lead to dizziness, nausea, and falls.

Citing these concerns, The Joint Commission issued a Sentinel Event Alert in August 2012 that urged hospitals to take specific measures to help avoid serious complications and even deaths from the use of such opioids as morphine, oxycodone, and methadone.

“The Joint Commission recognizes that there is an opportunity to improve the care of patients on opioids in acute-care settings,” spokeswoman Elizabeth Eaken Zhani says. “Healthcare workers need to be aware of the risks to patients in prescribing opioids.”

Adverse events involving opioids include dosing errors and improper monitoring of patients and drug interactions. Patients who have sleep apnea, are obese, or very ill—with such conditions as pulmonary disease, congestive heart failure, or impaired renal function—might be at higher risk for harm from opioids.

“The alert was issued in response to concerns that opioid analgesics are among the top three drugs in which medication-related adverse events are reported to The Joint Commission,” Zhani says. “They also rank among the drugs most frequently associated with adverse drug events.”

Opioids are associated with numerous problems—underprescribing, overprescribing, tolerance, dependence, and drug abuse. To prevent accidental overuse, The Joint Commission recommends that healthcare organizations provide ongoing oversight of patients receiving these drugs. Pain-management specialists or pharmacists should review treatment plans and also track incidents involving opioids.

Harnessing available technology also helps improve prescribing safety. In addition to creating alerts for dosing limits, The Joint Commission suggests using “tall man” lettering in electronic ordering systems, conversion support to calculate correct dosages, and patient-controlled analgesia. Education and training in the safe use of opioids should be provided for clinicians, staff, and patients. And standardized tools should be employed to screen patients for risk factors, such as oversedation and respiratory depression.

“Opioids aren’t dangerous in themselves,” says Solomon Liao, MD, FAAHPM, a hospitalist and director of palliative-care services at the University of California at Irvine. “Opioids are dangerous when prescribers don’t know what they’re doing. It’s like the old saying, ‘Guns don’t kill people; people kill people.’”

Overdose deaths from opioid pain relievers have escalated, nearly quadrupling from 1999 to 2008. These deaths now exceed fatalities due to heroin and cocaine combined. In 2008, drug overdoses in the United States caused 36,450 deaths; opioid analgesics were involved in 14,800 (73.8%) of 20,044 prescription drug overdose deaths, according to the Centers for Disease Control and Prevention.¹

Vital statistics data suggest that methadone is involved in one-third of opioid pain-reliever-related overdose deaths, even though it accounts for only a small percentage of prescriptions for opioid analgesics. The rate of methadone overdose deaths in the U.S. in 2009 was 5.5 times the rate in 1999, prompting an urgent call for interventions to address misuse and abuse.²

“The greatest safety concern The Joint Commission’s report cites is that sedation precedes respiratory depression in many cases, and clinicians need to pay more attention to that side effect and patients who are inherently at risk for developing respiratory problems related to opioids,” says Paul Arnstein, RN, PhD, FAAN, Connell Nursing Research Scholar and clinical nurse specialist for pain relief at Massachusetts General Hospital in Boston.

 

A Double-Edged Sword

Opioids deliver good pain control with minimal adverse effects for some patients but not for others, and there is insufficient evidence to foresee who will fare well and who won’t. “What we can predict,” Arnstein says, “is that certain patients—the very old, very young, very ill, and those receiving medicines that interact with opioids—are vulnerable to some of the more dangerous effects.”

The risk of respiratory depression also mounts in those who are opioid-naïve, as well as in an increasingly obese population.

“This does not mean we withhold pain relief,” says Judith A. Paice, PhD, RN, a contributor to The Joint Commission’s alert and director of the cancer pain program in the hematology-oncology division at Northwestern University’s Feinberg School of Medicine. Instead, “we need to determine the most effective monitoring techniques in a setting where hospitals are cutting back on staffing,” she adds.

Other risk factors for respiratory depression include sleep apnea (correlated with obesity but also possible in the absence of excess weight), large thoracic or abdominal incisions, and use of other sedating drugs. Among patients in the chronic cancer pain or palliative-care setting, respiratory depression is highly unusual because dosages are increased gradually, Paice says. Strong consensus supports prescribing opioids for acute episodes of pain, as well as chronic management of cancer and other life-threatening illnesses, including HIV/AIDS and cardiac and neuromuscular conditions.

Considerable variations exist in screening for risk of opioid-induced sedation and hospital monitoring practices. There is also a shortage of information and no consensus on the advantages of costly technology-supported monitoring, such as pulse oximetry (measuring oxygen saturation) and capnography (measuring end-tidal carbon dioxide), in hospitalized patients receiving opioids for pain therapy, according to guidelines from the American Society for Pain Management Nursing.³

Although technological monitoring adds valuable data to patient status, it does not replace frequent assessments—the most important intervention in detecting sedation before respiratory depression. Technological monitoring should be considered for patients at high risk for decline, says the guidelines’ lead author, Donna Jarzyna, MS, RN-BC, CNS-BC, an adult health clinical nurse specialist consulting in an alumna role for the University of Arizona Medical Center in Tucson. “Many organizations are currently making an effort,” she says, “to determine which patients should be monitored with a higher degree of intensity and with greater frequency.”

Patient-controlled analgesia (PCA) also has some limitations. In theory, it offers built-in safety features—if patients become too sedated, they can’t push a button for extra doses—but that isn’t always the case. For instance, some patients may have “stacked” three to four doses before sedation and respiratory depression develop. “When things go wrong with PCA, patients are four times more likely to be seriously harmed than when nurses administer the medications,” says Arnstein, who is a past president of the American Society for Pain Management Nursing. “Thus, vigilant nurse-supervised opioid therapy is vitally important.”

Simple Steps Save Lives

Most critical events associated with opioids occur during the first 24 hours of post-operative care. Combined with close monitoring, understanding the risk factors for respiratory depression and making adjustments based on an individual’s needs and response helps prevent a precarious situation in which a patient vacillates quickly from a wide-awake status to a sleepy state.

 

“There’s a very progressive amount of sedation,” says Deb Gordon, RN, DNP, FAAN, a contributor to The Joint Commission’s alert and a teaching associate in the department of anesthesiology and pain medicine at the University of Washington in Seattle.

Developing a pain treatment plan with a reassessment component is essential to exercising caution against potential harm from opioids.

“The Joint Commission’s guidance is wonderfully helpful and will benefit patients,” says Beth B. Murinson, MS, MD, PhD, associate professor and director of pain education in the department of neurology at Johns Hopkins University School of Medicine in Baltimore. “Getting opioid pain relief right is critically important as lives are hanging in the balance on both sides of this problem: Too little pain relief and millions will suffer; too much and lives are at risk.”

Hospitalists should be familiar with a few opioids that they feel comfortable prescribing, Dr. Murinson says. Be prepared to easily identify the major idiosyncratic effects and ordinary side effects of these medications and become well versed in opioid conversion.

“This is a classic problem in the field because, although the opioids are generally similar in their efficacy against pain, they have markedly different potencies against pain,” she explains. “A dose of 2 mg of morphine may need to be ‘converted’ to X mg of another opioid, depending on local practice patterns and preferences.”

Some drugs pose special risks. For example, transdermal fentanyl is “appropriate only for use in people who need opioid-level analgesia for an extended period of time and whose analgesic requirements are stable. This is not the case for folks with acute pain or who are just starting on opioids,” cautions Scott Strassels, PhD, PharmD, BCPS, assistant professor in the College of Pharmacy at the University of Texas in Austin and a board member of the American Pain Society. “Similarly, methadone is a good analgesic, but it requires very careful use due to its pharmacokinetic profile.”

Healthcare professionals from a variety of disciplines should be involved in pain-management efforts within a hospital setting. As for who takes the initiative, “it probably should be the person who is most qualified—be it a physician, nurse, or pharmacist,” Strassels says. “I’ve seen pharmacist-led teams, nurse-led teams, and those with physicians leading the effort.”

Clinicians who prescribe pain medications should be cognizant of nonpharmacologic alternatives to opioids. Multimodal options include physical therapy, acupuncture, manipulation or massage, and non-narcotic analgesics, such as acetaminophen and muscle relaxants. Non-narcotics may lower the dose of opioids needed to effectively manage pain, according to The Joint Commission.

The alert also provides information on suggested actions to avoid unintended consequences of using opioids. Hospitals should fully inform and provide written instructions to the patient and family or caregiver about the potential risks of tolerance, addiction, physical dependency, and withdrawal from opioids. When providing this information at discharge, the hospital also should list phone numbers to call if there are any questions.

In some unfortunate cases, opioids prescribed for pain also are used by patients’ family members, friends, and others. In such instances, says Northwestern’s Paice, usage occurs commonly with polypharmacy and without monitoring, and this contributes to an increased risk of death associated with opioids.

“There is concern that drugs prescribed for legitimate purposes are reaching the wrong hands,” Paice says. “We need to make the public, particularly patients and their family members, aware of safety strategies.”

---

Susan Kreimer is a freelance writer in New York City.

 

References

1. Centers for Disease Control and Prevention. Vital signs: overdoses of prescription opioid pain relievers—United States, 1999-2008. MMWR Morb Mortal Wkly Rep. 2011;60(43):1487-1492.
2. Centers for Disease Control and Prevention. Vital signs: risk for overdose from methadone used for pain relief—United States, 1999-2010. MMWR Morb Mortal Wkly Rep. 2012;61(26):493-497.
3. Jarzyna D, Jungquist CR, Pasero C, et al. American Society for Pain Management Nursing guidelines on monitoring for opioid-induced sedation and respiratory depression. Pain Manag Nurs. 2011;12(3):118-145.

Click here to listen to Scott Strassels, PhD, PharmD, BCPS, an assistant professor in the College of Pharmacy at the University of Texas at Austin and a board member of the American Pain Society, discuss the risks and rewards of opioid therapies, and why continuing education is important for all clinicians.

 

Click here to listen to Scott Strassels, PhD, PharmD, BCPS, an assistant professor in the College of Pharmacy at the University of Texas at Austin and a board member of the American Pain Society, discuss the risks and rewards of opioid therapies, and why continuing education is important for all clinicians.

 

Click here to listen to Scott Strassels, PhD, PharmD, BCPS, an assistant professor in the College of Pharmacy at the University of Texas at Austin and a board member of the American Pain Society, discuss the risks and rewards of opioid therapies, and why continuing education is important for all clinicians.

 

Pain is one of the chief complaints that results in patient admissions to the hospital. Hospitalists inevitably confront pain issues every day, says Joe A. Contreras, MD, FAAHPM, chair of the Pain and Palliative Medicine Institute at Hackensack University Medical Center in Hackensack, N.J. As a result, “it is expected that all physicians who take care of sick people have some baseline knowledge of opioids use,” Dr. Contreras says.

There is a preference on the public’s part and, consequently, from the physician’s perspective to treat pain with opioids, even though minor cases can be controlled without pharmacologic interventions, Dr. Contreras says. Patients might receive some relief from repositioning, hot or cold packs, extra pillows, Reiki therapy, and other soothing modalities. Additionally, hospitals can benefit from having a pain champion on staff to safely manage various situations.

Tapping the insight of in-house pain services is even more important in complex cases, says hospitalist Solomon Liao, MD, FAAHPM, director of palliative-care services at the University of California at Irvine. He recommends turning to a board-certified pain specialist or a palliative-care expert. Some hospitals also employ or offer access to addiction specialists. At a minimum, a pharmacist or pain consultant should be available.

A hospitalist should still obtain important and relevant information when a patient is admitted. This includes the pain medicine the patient is taking and how often, who prescribed it, whether it helps, and if the patient has experienced side effects.

“As the primary-care physician in the hospital,” Dr. Liao says, “the hospitalist is ultimately responsible.”

Special attention is needed during care transitions.

“This is when patients are most vulnerable,” says Beth B. Murinson, MS, MD, PhD, associate professor and director of pain education in the department of neurology at Johns Hopkins University School of Medicine in Baltimore.

These situations occur during transfers from the ED or recovery room to an inpatient unit, and from hospital to home or skilled nursing facility. Patients being discharged must be thoroughly informed about their opioid pain relievers, Dr. Murinson says, with instructions to store them in a secure place. TH

Susan Kreimer is a freelance writer in New York City.

 

Pain is one of the chief complaints that results in patient admissions to the hospital. Hospitalists inevitably confront pain issues every day, says Joe A. Contreras, MD, FAAHPM, chair of the Pain and Palliative Medicine Institute at Hackensack University Medical Center in Hackensack, N.J. As a result, “it is expected that all physicians who take care of sick people have some baseline knowledge of opioids use,” Dr. Contreras says.

There is a preference on the public’s part and, consequently, from the physician’s perspective to treat pain with opioids, even though minor cases can be controlled without pharmacologic interventions, Dr. Contreras says. Patients might receive some relief from repositioning, hot or cold packs, extra pillows, Reiki therapy, and other soothing modalities. Additionally, hospitals can benefit from having a pain champion on staff to safely manage various situations.

Tapping the insight of in-house pain services is even more important in complex cases, says hospitalist Solomon Liao, MD, FAAHPM, director of palliative-care services at the University of California at Irvine. He recommends turning to a board-certified pain specialist or a palliative-care expert. Some hospitals also employ or offer access to addiction specialists. At a minimum, a pharmacist or pain consultant should be available.

A hospitalist should still obtain important and relevant information when a patient is admitted. This includes the pain medicine the patient is taking and how often, who prescribed it, whether it helps, and if the patient has experienced side effects.

“As the primary-care physician in the hospital,” Dr. Liao says, “the hospitalist is ultimately responsible.”

Special attention is needed during care transitions.

“This is when patients are most vulnerable,” says Beth B. Murinson, MS, MD, PhD, associate professor and director of pain education in the department of neurology at Johns Hopkins University School of Medicine in Baltimore.

These situations occur during transfers from the ED or recovery room to an inpatient unit, and from hospital to home or skilled nursing facility. Patients being discharged must be thoroughly informed about their opioid pain relievers, Dr. Murinson says, with instructions to store them in a secure place. TH

Susan Kreimer is a freelance writer in New York City.

 

Pain is one of the chief complaints that results in patient admissions to the hospital. Hospitalists inevitably confront pain issues every day, says Joe A. Contreras, MD, FAAHPM, chair of the Pain and Palliative Medicine Institute at Hackensack University Medical Center in Hackensack, N.J. As a result, “it is expected that all physicians who take care of sick people have some baseline knowledge of opioids use,” Dr. Contreras says.

There is a preference on the public’s part and, consequently, from the physician’s perspective to treat pain with opioids, even though minor cases can be controlled without pharmacologic interventions, Dr. Contreras says. Patients might receive some relief from repositioning, hot or cold packs, extra pillows, Reiki therapy, and other soothing modalities. Additionally, hospitals can benefit from having a pain champion on staff to safely manage various situations.

Tapping the insight of in-house pain services is even more important in complex cases, says hospitalist Solomon Liao, MD, FAAHPM, director of palliative-care services at the University of California at Irvine. He recommends turning to a board-certified pain specialist or a palliative-care expert. Some hospitals also employ or offer access to addiction specialists. At a minimum, a pharmacist or pain consultant should be available.

A hospitalist should still obtain important and relevant information when a patient is admitted. This includes the pain medicine the patient is taking and how often, who prescribed it, whether it helps, and if the patient has experienced side effects.

“As the primary-care physician in the hospital,” Dr. Liao says, “the hospitalist is ultimately responsible.”

Special attention is needed during care transitions.

“This is when patients are most vulnerable,” says Beth B. Murinson, MS, MD, PhD, associate professor and director of pain education in the department of neurology at Johns Hopkins University School of Medicine in Baltimore.

These situations occur during transfers from the ED or recovery room to an inpatient unit, and from hospital to home or skilled nursing facility. Patients being discharged must be thoroughly informed about their opioid pain relievers, Dr. Murinson says, with instructions to store them in a secure place. TH

Susan Kreimer is a freelance writer in New York City.

 

Click here to listen to Sherri Dumford

 

Click here to listen to Sherri Dumford

 

Click here to listen to Sherri Dumford

 

The intricacies of billing and coding typically aren’t taught in physician residency training programs.

“Residents want to learn how to take care of patients. They’re not really focused on learning [Centers for Medicare & Medicaid Services] rules,” says Balazs Zsenits, MD, FACP, SFHM, medical director of the Rochester General Hospitalist Group in Rochester, N.Y. As a result, “there’s a knowledge gap” between newly minted physicians and experienced practitioners when it comes to documenting their work.

To bridge that gap, some hospitalist groups offer training on the business side of medicine during physician orientation, as well as provide constructive reviews of hospitalists’ progress notes on a periodic basis. Some hospitals provide seminars in proper documentation.

“I’ve seen a lot of hospitals do ‘lunch and learn’” sessions on documentation requirements, says Angie Comfort, RHIT, CCS, a director of HIM Solutions at the American Health Information Management Association. The goal is to facilitate reimbursement for the hospital from patients’ insurance providers.

“If more specific documentation is not in the record, the coder must ask the physician for additional clarification,” Comfort says. “Without the clarification, sometimes the conditions are not able to be coded.”

The HM group in Rochester, which employs 46 hospitalists, provides about six hours of billing compliance education for new hires during orientation and holds regular, topic-based presentations at weekly staff meetings.

Physicians “need timely information as we submit our own charges, and we set up our productivity bonus so that it depends on our billing accuracy, not just volume,” Dr. Zsenits says. Using an internal Web portal, physicians can look up billing codes and explanations. “They realize the risks involved if they don’t do it right,” she says, so they also accept feedback from reviews of their patient charts.

Easy-to-access information is key to helping hospitalists learn coding requirements. “We have a Web-based documentation education module, so the provider is able to log on from home,” says David Grace, MD, FHM, senior medical officer at The Schumacher Group’s hospital medicine division in Lafayette, La. The practice management company employs hospitalists in 12 states.

Its initial module takes about an hour to review. For those who are already proficient in billing and coding, a test-out option lasting 10 to 15 minutes is available online as well. Pocket cards are provided as a reference thereafter.

“Documentation and coding is a complex entity, and certainly we don’t expect them to remember all the details after one educational module,” Dr. Grace says. “They do have access to be able to go back to it for a refresher whenever they want.”

Internal coding experts audit about 20% of the hospitalists’ work, and audited physicians are provided feedback on compliance. The Schumacher Group also uses a proprietary template to help hospitalists capture the important data points in their patient progress notes.

“Physicians are under a lot of scrutiny by regulatory agencies,” says Peter Thompson, MD, chief of clinical operations at Apogee Physicians, a national hospitalist management company based in Phoenix.

At new hospitalist orientation, called Apogee University, providers spend several hours learning the rules for documentation. The group follows up with regular reviews of hospitalists’ notes through an audit system. A program director “breaks down the components that make it a compliant note or not,” Dr. Thompson says. Audits are performed monthly on every physician.

“It takes a commitment to knowing what the requirements are,” he adds. “And it takes repetition and it takes practice to make something a habit.”

Susan Kreimer is a freelance medical writer in New York.

The intricacies of billing and coding typically aren’t taught in physician residency training programs.

“Residents want to learn how to take care of patients. They’re not really focused on learning [Centers for Medicare & Medicaid Services] rules,” says Balazs Zsenits, MD, FACP, SFHM, medical director of the Rochester General Hospitalist Group in Rochester, N.Y. As a result, “there’s a knowledge gap” between newly minted physicians and experienced practitioners when it comes to documenting their work.

To bridge that gap, some hospitalist groups offer training on the business side of medicine during physician orientation, as well as provide constructive reviews of hospitalists’ progress notes on a periodic basis. Some hospitals provide seminars in proper documentation.

“I’ve seen a lot of hospitals do ‘lunch and learn’” sessions on documentation requirements, says Angie Comfort, RHIT, CCS, a director of HIM Solutions at the American Health Information Management Association. The goal is to facilitate reimbursement for the hospital from patients’ insurance providers.

“If more specific documentation is not in the record, the coder must ask the physician for additional clarification,” Comfort says. “Without the clarification, sometimes the conditions are not able to be coded.”

The HM group in Rochester, which employs 46 hospitalists, provides about six hours of billing compliance education for new hires during orientation and holds regular, topic-based presentations at weekly staff meetings.

Physicians “need timely information as we submit our own charges, and we set up our productivity bonus so that it depends on our billing accuracy, not just volume,” Dr. Zsenits says. Using an internal Web portal, physicians can look up billing codes and explanations. “They realize the risks involved if they don’t do it right,” she says, so they also accept feedback from reviews of their patient charts.

Easy-to-access information is key to helping hospitalists learn coding requirements. “We have a Web-based documentation education module, so the provider is able to log on from home,” says David Grace, MD, FHM, senior medical officer at The Schumacher Group’s hospital medicine division in Lafayette, La. The practice management company employs hospitalists in 12 states.

Its initial module takes about an hour to review. For those who are already proficient in billing and coding, a test-out option lasting 10 to 15 minutes is available online as well. Pocket cards are provided as a reference thereafter.

“Documentation and coding is a complex entity, and certainly we don’t expect them to remember all the details after one educational module,” Dr. Grace says. “They do have access to be able to go back to it for a refresher whenever they want.”

Internal coding experts audit about 20% of the hospitalists’ work, and audited physicians are provided feedback on compliance. The Schumacher Group also uses a proprietary template to help hospitalists capture the important data points in their patient progress notes.

“Physicians are under a lot of scrutiny by regulatory agencies,” says Peter Thompson, MD, chief of clinical operations at Apogee Physicians, a national hospitalist management company based in Phoenix.

At new hospitalist orientation, called Apogee University, providers spend several hours learning the rules for documentation. The group follows up with regular reviews of hospitalists’ notes through an audit system. A program director “breaks down the components that make it a compliant note or not,” Dr. Thompson says. Audits are performed monthly on every physician.

“It takes a commitment to knowing what the requirements are,” he adds. “And it takes repetition and it takes practice to make something a habit.”

Susan Kreimer is a freelance medical writer in New York.

The intricacies of billing and coding typically aren’t taught in physician residency training programs.

“Residents want to learn how to take care of patients. They’re not really focused on learning [Centers for Medicare & Medicaid Services] rules,” says Balazs Zsenits, MD, FACP, SFHM, medical director of the Rochester General Hospitalist Group in Rochester, N.Y. As a result, “there’s a knowledge gap” between newly minted physicians and experienced practitioners when it comes to documenting their work.

To bridge that gap, some hospitalist groups offer training on the business side of medicine during physician orientation, as well as provide constructive reviews of hospitalists’ progress notes on a periodic basis. Some hospitals provide seminars in proper documentation.

“I’ve seen a lot of hospitals do ‘lunch and learn’” sessions on documentation requirements, says Angie Comfort, RHIT, CCS, a director of HIM Solutions at the American Health Information Management Association. The goal is to facilitate reimbursement for the hospital from patients’ insurance providers.

“If more specific documentation is not in the record, the coder must ask the physician for additional clarification,” Comfort says. “Without the clarification, sometimes the conditions are not able to be coded.”

The HM group in Rochester, which employs 46 hospitalists, provides about six hours of billing compliance education for new hires during orientation and holds regular, topic-based presentations at weekly staff meetings.

Physicians “need timely information as we submit our own charges, and we set up our productivity bonus so that it depends on our billing accuracy, not just volume,” Dr. Zsenits says. Using an internal Web portal, physicians can look up billing codes and explanations. “They realize the risks involved if they don’t do it right,” she says, so they also accept feedback from reviews of their patient charts.

Easy-to-access information is key to helping hospitalists learn coding requirements. “We have a Web-based documentation education module, so the provider is able to log on from home,” says David Grace, MD, FHM, senior medical officer at The Schumacher Group’s hospital medicine division in Lafayette, La. The practice management company employs hospitalists in 12 states.

Its initial module takes about an hour to review. For those who are already proficient in billing and coding, a test-out option lasting 10 to 15 minutes is available online as well. Pocket cards are provided as a reference thereafter.

“Documentation and coding is a complex entity, and certainly we don’t expect them to remember all the details after one educational module,” Dr. Grace says. “They do have access to be able to go back to it for a refresher whenever they want.”

Internal coding experts audit about 20% of the hospitalists’ work, and audited physicians are provided feedback on compliance. The Schumacher Group also uses a proprietary template to help hospitalists capture the important data points in their patient progress notes.

“Physicians are under a lot of scrutiny by regulatory agencies,” says Peter Thompson, MD, chief of clinical operations at Apogee Physicians, a national hospitalist management company based in Phoenix.

At new hospitalist orientation, called Apogee University, providers spend several hours learning the rules for documentation. The group follows up with regular reviews of hospitalists’ notes through an audit system. A program director “breaks down the components that make it a compliant note or not,” Dr. Thompson says. Audits are performed monthly on every physician.

“It takes a commitment to knowing what the requirements are,” he adds. “And it takes repetition and it takes practice to make something a habit.”

Susan Kreimer is a freelance medical writer in New York.

Documentation, CPT codes, modifiers—it’s not glamorous, but it’s an integral part of a 21st-century physician’s job description. The Hospitalist queried more than a handful of billing and coding experts about the advice they would dispense to clinicians navigating the reimbursement maze.

“Physicians often do more than what is reflected in the documentation,” says Barb Pierce, CCS-P, ACS-EM, a national coding consultant based in West Des Moines, Iowa, and CODE-H faculty. “They can’t always bill for everything they do, but they certainly can document and code to obtain the appropriate levels of service.”

Meanwhile, hospitalists have to be careful they aren’t excessive in their billing practices. “The name of the game isn’t just to bill higher,” Pierce adds, “but to make sure that your documentation supports the service being billed, and Medicare is watching. They’re doing a lot of focused audits.”

Some hospitalists might opt for a lower level of service, suspecting they’re less likely to be audited. Other hospitalists might seek reimbursement for more of their time and efforts.

“You have both ends of the spectrum,” says Raemarie Jimenez, CPC, CPMA, CPC-I, CANPC, CRHC, director of education for AAPC, formerly known as the American Academy of Professional Coders. “There are a lot of factors that would go into why a provider would code something incorrectly.”

Here’s how to land somewhere in the middle.

1 Be thorough in documenting the initial hospital visit.

When selecting the level of service for an initial hospital visit, the documentation consists of three key components: history, physical examination, and medical decision-making. The history includes the chief complaint as well as the review of systems. This is “an inventory of the patient’s organ systems.” Both the complaint and the systems review are often incorporated in the history of present illness, says Mary Mulholland, MHA, BSN, RN, CPC, senior coding and education specialist in the Department of Medicine at the Perelman School of Medicine at the University of Pennsylvania in Philadelphia.

A patient’s family history is commonly overlooked in a hospitalist’s notes, primarily when they know the patient from previous admissions for chronic diseases and when the family history will likely not have an impact on treatment. “If they do not document a complete review of systems or miss one of the histories, the service will definitely be down-coded,” Mulholland says, “no matter how complete the exam and medical decision-making documentation.”

2 Familiarize yourself with Medicare reimbursement rules in the state where you practice.

In some states, Medicare contractors require providers to document the status of each organ system reviewed individually. In other states, it’s acceptable to document a system review with pertinent findings, “whether positive or negative,” and the statement of “all other systems negative,” Mulholland says.

The auditor will give credit for the review based on the number of organ systems documented. “If you miss one system review, it will take down what otherwise would be a Level Three hospital admission to a Level One,” she says. “So there would be a significant financial impact.”

Medicare reimbursement for a Level Three initial visit in Mulholland’s area of practice—Philadelphia County in Pennsylvania—is $206.57, compared with $104.69 for a Level One. During this visit, each of the key components—history, exam, and medical decision-making—need to be documented completely for the provider to receive the highest level of reimbursement.

3 Ask about a patient’s social history.

Social history can be obtained by querying the patient about smoking, drug and alcohol use, his or her occupation, marital status, and type of living arrangement.

“Knowing the social history helps the hospitalist understand the home situation or social circumstances that may have contributed to the hospitalization or may complicate the discharge plan,” Mulholland says.

 

This is particularly important in decision-making that involves elderly patients. The clinician should “think down the road” as to where the patient will be discharged and if a social worker’s assistance will be needed. It’s about “seeing the whole patient,” she says, “not just the disease.”

4 Remember to include the actual diagnosis.

“As coders, we can see all the clinical indicators of a particular diagnosis,” says Kathryn DeVault, RHIA, CCS, CCS-P, a director at HIM Solutions at the American Health Management Association. However, “unless [physicians] write down the diagnosis, we can’t code it.”

Documents without a diagnosis are more common than one would expect. For example, if a patient has pain when urinating, the hospitalist typically orders a culture. If the result is positive, the hospitalist prescribes an antibiotic for the infection, and too often “the story ends there.” From experience, DeVault can decipher that the patient is being treated for a urinary tract infection, but she can’t assign a code without querying the physician. Hospitalists, she suggests, should try to “close the loop in their documentation.”

5 Be specific in your written assessment of the patient’s condition.

“The main thing that we see is missing documentation,” says Angie Comfort, RHIT, CCS, a director at HIM Solutions. For instance, if a hospitalist documents congestive heart failure, it’s important to indicate whether the condition is chronic or acute and systolic or diastolic.

In the case of a diabetic patient, the notes should specify the type of diabetes. Not doing so “could be a reimbursement-changer,” Comfort says. In contrast, documenting such specifics could result in higher reimbursement, especially if a patient has complications from Type 1 diabetes.

6 Note the severity of the patient’s case.

Hospitalists’ documentation doesn’t always capture everything they’re evaluating for patients. “I’ve seen notes to the extent of ‘patient doing well; waiting on test results,’” the AAPC’s Jimenez says. “If they’re doing certain tests, why are they doing them? What are they trying to diagnose for the patient? What treatment are they considering?”

The reasons for the tests need to be explained. When a provider is monitoring someone in the hospital, the documentation should elaborate on the patient’s response to a treatment, and whether the patient’s condition is better, stable, or worse. This information helps put the severity in perspective.

“A diabetic could be a diabetic out of control. It could be a diabetic who’s not responding or who has comorbidities,” Jimenez says. “No one diagnosis is the same for every patient.”

7 Indicate which aspect of the patient’s condition you are treating.

When multiple providers are involved in a hospitalized patient’s care, it’s important to document your specific role apart from the services rendered by specialists, Jimenez says. The codes billed must be supported by the documentation for each service. Many providers contribute to the inpatient documentation, so it must be clear what each clinician personally performs.

Only report the diagnosis you are treating or the diagnoses that affect the ones you are managing. If a specialist has been brought in to take over treatment for a specific condition, a hospitalist would not bill for that diagnosis code.

 

8 Note your personal review of medical records and reports from other clinicians.

Hospitalists should document their review of lab data or radiology reports, discussion of the case with other providers, or collection of the history from someone other than the patient. It’s also helpful to document your personal review of any images, such as a chest X-ray or MRI. Examining the images yourself might lead to higher reimbursement, Mulholland says.

Providers also should note when they request or review old records, and they should include a short synopsis of the information obtained and how it contributed to the current treatment plan.

9 Learn the correct coding for patients being transferred.

A transfer can occur either from a different facility or from a hospital floor to a rehabilitation unit. Either way, the patient is seen twice in one day, with each visit covered by the same hospitalist practice.

“Both physicians often report a separate independent visit. However, because these services occurred on the same day, it is not appropriate to bill for two separate subsequent or initial hospital codes,” says Sherri Dumford, MBA, CHBME, director of operations and past president of the Healthcare Billing and Management Association. “Often what will happen is both services will be reported and get through the billing system. The second claim is just written off as a denied service, when, in fact, you could combine the elements of service of both visits and possibly bill for a single higher level of visit.”

10 Consider delegating to a coding expert.

While smaller hospitalist groups can turn to a coding consultant on an as-needed basis, larger groups might consider bringing a certified coder on staff. This person would inform physicians about proper coding, review their documentation, and “give real-time feedback,” Pierce says.

An internal audit would show if the documentation meets selected evaluation management codes. Also, it usually takes a coding professional to determine whether prolonged services are an option for the team on any given date of service. Someone would need to internally “add together” multiple services on one date to see if there is sufficient time documented to allow billing for these add-on codes, Pierce says. Similarly, critical-care time needs to be accumulated during a date of service.

11 Indicate the number of minutes spent arranging for a patient’s discharge.

Discharging a patient involves various steps, says Peter Thompson, MD, chief of clinical operations at the Phoenix headquarters of Apogee Physicians, a hospitalist management company that employs about 750 hospitalists across the country. Hospitalists discuss the hospital stay with the patient and family members, prescribe medications, issue discharge recommendations, set up follow-up care, and coordinate with the case manager, specialists, and primary-care physician.

“It generally is one sequential event after the other,” lasting between 20 and 40 minutes and leading up to discharge, Thompson says. Reimbursement for a high-level discharge constitutes more than 30 minutes. However, without proper documentation, he cautions, the claim could be downgraded or denied.

12 Don’t forget to sign, date, and time your progress note.

Last but not least, when it comes to reimbursement, your signature really does matter.

“For an illegible signature, Medicare and the insurance companies have the option of not paying for the service,” Mulholland says. “They’re trying to establish or authenticate who provided the service.”

 

And they want to know when the hospitalist saw the patient, so it’s a good idea to indicate the exact time of your visit.

---

Susan Kreimer is a freelance medical writer in New York.

Documentation, CPT codes, modifiers—it’s not glamorous, but it’s an integral part of a 21st-century physician’s job description. The Hospitalist queried more than a handful of billing and coding experts about the advice they would dispense to clinicians navigating the reimbursement maze.

“Physicians often do more than what is reflected in the documentation,” says Barb Pierce, CCS-P, ACS-EM, a national coding consultant based in West Des Moines, Iowa, and CODE-H faculty. “They can’t always bill for everything they do, but they certainly can document and code to obtain the appropriate levels of service.”

Meanwhile, hospitalists have to be careful they aren’t excessive in their billing practices. “The name of the game isn’t just to bill higher,” Pierce adds, “but to make sure that your documentation supports the service being billed, and Medicare is watching. They’re doing a lot of focused audits.”

Some hospitalists might opt for a lower level of service, suspecting they’re less likely to be audited. Other hospitalists might seek reimbursement for more of their time and efforts.

“You have both ends of the spectrum,” says Raemarie Jimenez, CPC, CPMA, CPC-I, CANPC, CRHC, director of education for AAPC, formerly known as the American Academy of Professional Coders. “There are a lot of factors that would go into why a provider would code something incorrectly.”

Here’s how to land somewhere in the middle.

1 Be thorough in documenting the initial hospital visit.

When selecting the level of service for an initial hospital visit, the documentation consists of three key components: history, physical examination, and medical decision-making. The history includes the chief complaint as well as the review of systems. This is “an inventory of the patient’s organ systems.” Both the complaint and the systems review are often incorporated in the history of present illness, says Mary Mulholland, MHA, BSN, RN, CPC, senior coding and education specialist in the Department of Medicine at the Perelman School of Medicine at the University of Pennsylvania in Philadelphia.

A patient’s family history is commonly overlooked in a hospitalist’s notes, primarily when they know the patient from previous admissions for chronic diseases and when the family history will likely not have an impact on treatment. “If they do not document a complete review of systems or miss one of the histories, the service will definitely be down-coded,” Mulholland says, “no matter how complete the exam and medical decision-making documentation.”

2 Familiarize yourself with Medicare reimbursement rules in the state where you practice.

In some states, Medicare contractors require providers to document the status of each organ system reviewed individually. In other states, it’s acceptable to document a system review with pertinent findings, “whether positive or negative,” and the statement of “all other systems negative,” Mulholland says.

The auditor will give credit for the review based on the number of organ systems documented. “If you miss one system review, it will take down what otherwise would be a Level Three hospital admission to a Level One,” she says. “So there would be a significant financial impact.”

Medicare reimbursement for a Level Three initial visit in Mulholland’s area of practice—Philadelphia County in Pennsylvania—is $206.57, compared with $104.69 for a Level One. During this visit, each of the key components—history, exam, and medical decision-making—need to be documented completely for the provider to receive the highest level of reimbursement.

3 Ask about a patient’s social history.

Social history can be obtained by querying the patient about smoking, drug and alcohol use, his or her occupation, marital status, and type of living arrangement.

“Knowing the social history helps the hospitalist understand the home situation or social circumstances that may have contributed to the hospitalization or may complicate the discharge plan,” Mulholland says.

 

This is particularly important in decision-making that involves elderly patients. The clinician should “think down the road” as to where the patient will be discharged and if a social worker’s assistance will be needed. It’s about “seeing the whole patient,” she says, “not just the disease.”

4 Remember to include the actual diagnosis.

“As coders, we can see all the clinical indicators of a particular diagnosis,” says Kathryn DeVault, RHIA, CCS, CCS-P, a director at HIM Solutions at the American Health Management Association. However, “unless [physicians] write down the diagnosis, we can’t code it.”

Documents without a diagnosis are more common than one would expect. For example, if a patient has pain when urinating, the hospitalist typically orders a culture. If the result is positive, the hospitalist prescribes an antibiotic for the infection, and too often “the story ends there.” From experience, DeVault can decipher that the patient is being treated for a urinary tract infection, but she can’t assign a code without querying the physician. Hospitalists, she suggests, should try to “close the loop in their documentation.”

5 Be specific in your written assessment of the patient’s condition.

“The main thing that we see is missing documentation,” says Angie Comfort, RHIT, CCS, a director at HIM Solutions. For instance, if a hospitalist documents congestive heart failure, it’s important to indicate whether the condition is chronic or acute and systolic or diastolic.

In the case of a diabetic patient, the notes should specify the type of diabetes. Not doing so “could be a reimbursement-changer,” Comfort says. In contrast, documenting such specifics could result in higher reimbursement, especially if a patient has complications from Type 1 diabetes.

6 Note the severity of the patient’s case.

Hospitalists’ documentation doesn’t always capture everything they’re evaluating for patients. “I’ve seen notes to the extent of ‘patient doing well; waiting on test results,’” the AAPC’s Jimenez says. “If they’re doing certain tests, why are they doing them? What are they trying to diagnose for the patient? What treatment are they considering?”

The reasons for the tests need to be explained. When a provider is monitoring someone in the hospital, the documentation should elaborate on the patient’s response to a treatment, and whether the patient’s condition is better, stable, or worse. This information helps put the severity in perspective.

“A diabetic could be a diabetic out of control. It could be a diabetic who’s not responding or who has comorbidities,” Jimenez says. “No one diagnosis is the same for every patient.”

7 Indicate which aspect of the patient’s condition you are treating.

When multiple providers are involved in a hospitalized patient’s care, it’s important to document your specific role apart from the services rendered by specialists, Jimenez says. The codes billed must be supported by the documentation for each service. Many providers contribute to the inpatient documentation, so it must be clear what each clinician personally performs.

Only report the diagnosis you are treating or the diagnoses that affect the ones you are managing. If a specialist has been brought in to take over treatment for a specific condition, a hospitalist would not bill for that diagnosis code.

 

8 Note your personal review of medical records and reports from other clinicians.

Hospitalists should document their review of lab data or radiology reports, discussion of the case with other providers, or collection of the history from someone other than the patient. It’s also helpful to document your personal review of any images, such as a chest X-ray or MRI. Examining the images yourself might lead to higher reimbursement, Mulholland says.

Providers also should note when they request or review old records, and they should include a short synopsis of the information obtained and how it contributed to the current treatment plan.

9 Learn the correct coding for patients being transferred.

A transfer can occur either from a different facility or from a hospital floor to a rehabilitation unit. Either way, the patient is seen twice in one day, with each visit covered by the same hospitalist practice.

“Both physicians often report a separate independent visit. However, because these services occurred on the same day, it is not appropriate to bill for two separate subsequent or initial hospital codes,” says Sherri Dumford, MBA, CHBME, director of operations and past president of the Healthcare Billing and Management Association. “Often what will happen is both services will be reported and get through the billing system. The second claim is just written off as a denied service, when, in fact, you could combine the elements of service of both visits and possibly bill for a single higher level of visit.”

10 Consider delegating to a coding expert.

While smaller hospitalist groups can turn to a coding consultant on an as-needed basis, larger groups might consider bringing a certified coder on staff. This person would inform physicians about proper coding, review their documentation, and “give real-time feedback,” Pierce says.

An internal audit would show if the documentation meets selected evaluation management codes. Also, it usually takes a coding professional to determine whether prolonged services are an option for the team on any given date of service. Someone would need to internally “add together” multiple services on one date to see if there is sufficient time documented to allow billing for these add-on codes, Pierce says. Similarly, critical-care time needs to be accumulated during a date of service.

11 Indicate the number of minutes spent arranging for a patient’s discharge.

Discharging a patient involves various steps, says Peter Thompson, MD, chief of clinical operations at the Phoenix headquarters of Apogee Physicians, a hospitalist management company that employs about 750 hospitalists across the country. Hospitalists discuss the hospital stay with the patient and family members, prescribe medications, issue discharge recommendations, set up follow-up care, and coordinate with the case manager, specialists, and primary-care physician.

“It generally is one sequential event after the other,” lasting between 20 and 40 minutes and leading up to discharge, Thompson says. Reimbursement for a high-level discharge constitutes more than 30 minutes. However, without proper documentation, he cautions, the claim could be downgraded or denied.

12 Don’t forget to sign, date, and time your progress note.

Last but not least, when it comes to reimbursement, your signature really does matter.

“For an illegible signature, Medicare and the insurance companies have the option of not paying for the service,” Mulholland says. “They’re trying to establish or authenticate who provided the service.”

 

And they want to know when the hospitalist saw the patient, so it’s a good idea to indicate the exact time of your visit.

---

Susan Kreimer is a freelance medical writer in New York.

Documentation, CPT codes, modifiers—it’s not glamorous, but it’s an integral part of a 21st-century physician’s job description. The Hospitalist queried more than a handful of billing and coding experts about the advice they would dispense to clinicians navigating the reimbursement maze.

“Physicians often do more than what is reflected in the documentation,” says Barb Pierce, CCS-P, ACS-EM, a national coding consultant based in West Des Moines, Iowa, and CODE-H faculty. “They can’t always bill for everything they do, but they certainly can document and code to obtain the appropriate levels of service.”

Meanwhile, hospitalists have to be careful they aren’t excessive in their billing practices. “The name of the game isn’t just to bill higher,” Pierce adds, “but to make sure that your documentation supports the service being billed, and Medicare is watching. They’re doing a lot of focused audits.”

Some hospitalists might opt for a lower level of service, suspecting they’re less likely to be audited. Other hospitalists might seek reimbursement for more of their time and efforts.

“You have both ends of the spectrum,” says Raemarie Jimenez, CPC, CPMA, CPC-I, CANPC, CRHC, director of education for AAPC, formerly known as the American Academy of Professional Coders. “There are a lot of factors that would go into why a provider would code something incorrectly.”

Here’s how to land somewhere in the middle.

1 Be thorough in documenting the initial hospital visit.

When selecting the level of service for an initial hospital visit, the documentation consists of three key components: history, physical examination, and medical decision-making. The history includes the chief complaint as well as the review of systems. This is “an inventory of the patient’s organ systems.” Both the complaint and the systems review are often incorporated in the history of present illness, says Mary Mulholland, MHA, BSN, RN, CPC, senior coding and education specialist in the Department of Medicine at the Perelman School of Medicine at the University of Pennsylvania in Philadelphia.

A patient’s family history is commonly overlooked in a hospitalist’s notes, primarily when they know the patient from previous admissions for chronic diseases and when the family history will likely not have an impact on treatment. “If they do not document a complete review of systems or miss one of the histories, the service will definitely be down-coded,” Mulholland says, “no matter how complete the exam and medical decision-making documentation.”

2 Familiarize yourself with Medicare reimbursement rules in the state where you practice.

In some states, Medicare contractors require providers to document the status of each organ system reviewed individually. In other states, it’s acceptable to document a system review with pertinent findings, “whether positive or negative,” and the statement of “all other systems negative,” Mulholland says.

The auditor will give credit for the review based on the number of organ systems documented. “If you miss one system review, it will take down what otherwise would be a Level Three hospital admission to a Level One,” she says. “So there would be a significant financial impact.”

Medicare reimbursement for a Level Three initial visit in Mulholland’s area of practice—Philadelphia County in Pennsylvania—is $206.57, compared with $104.69 for a Level One. During this visit, each of the key components—history, exam, and medical decision-making—need to be documented completely for the provider to receive the highest level of reimbursement.

3 Ask about a patient’s social history.

Social history can be obtained by querying the patient about smoking, drug and alcohol use, his or her occupation, marital status, and type of living arrangement.

“Knowing the social history helps the hospitalist understand the home situation or social circumstances that may have contributed to the hospitalization or may complicate the discharge plan,” Mulholland says.

 

This is particularly important in decision-making that involves elderly patients. The clinician should “think down the road” as to where the patient will be discharged and if a social worker’s assistance will be needed. It’s about “seeing the whole patient,” she says, “not just the disease.”

4 Remember to include the actual diagnosis.

“As coders, we can see all the clinical indicators of a particular diagnosis,” says Kathryn DeVault, RHIA, CCS, CCS-P, a director at HIM Solutions at the American Health Management Association. However, “unless [physicians] write down the diagnosis, we can’t code it.”

Documents without a diagnosis are more common than one would expect. For example, if a patient has pain when urinating, the hospitalist typically orders a culture. If the result is positive, the hospitalist prescribes an antibiotic for the infection, and too often “the story ends there.” From experience, DeVault can decipher that the patient is being treated for a urinary tract infection, but she can’t assign a code without querying the physician. Hospitalists, she suggests, should try to “close the loop in their documentation.”

5 Be specific in your written assessment of the patient’s condition.

“The main thing that we see is missing documentation,” says Angie Comfort, RHIT, CCS, a director at HIM Solutions. For instance, if a hospitalist documents congestive heart failure, it’s important to indicate whether the condition is chronic or acute and systolic or diastolic.

In the case of a diabetic patient, the notes should specify the type of diabetes. Not doing so “could be a reimbursement-changer,” Comfort says. In contrast, documenting such specifics could result in higher reimbursement, especially if a patient has complications from Type 1 diabetes.

6 Note the severity of the patient’s case.

Hospitalists’ documentation doesn’t always capture everything they’re evaluating for patients. “I’ve seen notes to the extent of ‘patient doing well; waiting on test results,’” the AAPC’s Jimenez says. “If they’re doing certain tests, why are they doing them? What are they trying to diagnose for the patient? What treatment are they considering?”

The reasons for the tests need to be explained. When a provider is monitoring someone in the hospital, the documentation should elaborate on the patient’s response to a treatment, and whether the patient’s condition is better, stable, or worse. This information helps put the severity in perspective.

“A diabetic could be a diabetic out of control. It could be a diabetic who’s not responding or who has comorbidities,” Jimenez says. “No one diagnosis is the same for every patient.”

7 Indicate which aspect of the patient’s condition you are treating.

When multiple providers are involved in a hospitalized patient’s care, it’s important to document your specific role apart from the services rendered by specialists, Jimenez says. The codes billed must be supported by the documentation for each service. Many providers contribute to the inpatient documentation, so it must be clear what each clinician personally performs.

Only report the diagnosis you are treating or the diagnoses that affect the ones you are managing. If a specialist has been brought in to take over treatment for a specific condition, a hospitalist would not bill for that diagnosis code.

 

8 Note your personal review of medical records and reports from other clinicians.

Hospitalists should document their review of lab data or radiology reports, discussion of the case with other providers, or collection of the history from someone other than the patient. It’s also helpful to document your personal review of any images, such as a chest X-ray or MRI. Examining the images yourself might lead to higher reimbursement, Mulholland says.

Providers also should note when they request or review old records, and they should include a short synopsis of the information obtained and how it contributed to the current treatment plan.

9 Learn the correct coding for patients being transferred.

A transfer can occur either from a different facility or from a hospital floor to a rehabilitation unit. Either way, the patient is seen twice in one day, with each visit covered by the same hospitalist practice.

“Both physicians often report a separate independent visit. However, because these services occurred on the same day, it is not appropriate to bill for two separate subsequent or initial hospital codes,” says Sherri Dumford, MBA, CHBME, director of operations and past president of the Healthcare Billing and Management Association. “Often what will happen is both services will be reported and get through the billing system. The second claim is just written off as a denied service, when, in fact, you could combine the elements of service of both visits and possibly bill for a single higher level of visit.”

10 Consider delegating to a coding expert.

While smaller hospitalist groups can turn to a coding consultant on an as-needed basis, larger groups might consider bringing a certified coder on staff. This person would inform physicians about proper coding, review their documentation, and “give real-time feedback,” Pierce says.

An internal audit would show if the documentation meets selected evaluation management codes. Also, it usually takes a coding professional to determine whether prolonged services are an option for the team on any given date of service. Someone would need to internally “add together” multiple services on one date to see if there is sufficient time documented to allow billing for these add-on codes, Pierce says. Similarly, critical-care time needs to be accumulated during a date of service.

11 Indicate the number of minutes spent arranging for a patient’s discharge.

Discharging a patient involves various steps, says Peter Thompson, MD, chief of clinical operations at the Phoenix headquarters of Apogee Physicians, a hospitalist management company that employs about 750 hospitalists across the country. Hospitalists discuss the hospital stay with the patient and family members, prescribe medications, issue discharge recommendations, set up follow-up care, and coordinate with the case manager, specialists, and primary-care physician.

“It generally is one sequential event after the other,” lasting between 20 and 40 minutes and leading up to discharge, Thompson says. Reimbursement for a high-level discharge constitutes more than 30 minutes. However, without proper documentation, he cautions, the claim could be downgraded or denied.

12 Don’t forget to sign, date, and time your progress note.

Last but not least, when it comes to reimbursement, your signature really does matter.

“For an illegible signature, Medicare and the insurance companies have the option of not paying for the service,” Mulholland says. “They’re trying to establish or authenticate who provided the service.”

 

And they want to know when the hospitalist saw the patient, so it’s a good idea to indicate the exact time of your visit.

---

Susan Kreimer is a freelance medical writer in New York.