Managing Your Practice

Tune in daily for social media coverage of AAGL 2015 from OBG Management and ObGyn News. Share your thoughts with us, and we may highlight them below. Thank you for your social contributions!

Tune in daily for social media coverage of AAGL 2015 from OBG Management and ObGyn News. Share your thoughts with us, and we may highlight them below. Thank you for your social contributions!

Tune in daily for social media coverage of AAGL 2015 from OBG Management and ObGyn News. Share your thoughts with us, and we may highlight them below. Thank you for your social contributions!

The Susan G. Komen Foundation estimates that 84% of breast cancers are found through mammography.¹ Clearly, the value of mammography is proven. But controversy and confusion abound on how much mammography, and beginning at what age, is best for women.

Currently, the United States Preventive Services Task Force (USPSTF), the American Cancer Society (ACS), and the American College of Obstetricians and Gynecologists (ACOG) all have differing recommendations about mammography and about the importance of clinical breast examinations. These inconsistencies largely are due to different interpretations of the same data, not the data itself, and tend to center on how harm is defined and measured. Importantly, these differences can wreak havoc on our patients’ confidence in our counsel and decision making, and can complicate women’s access to screening. Under the Affordable Care Act, women are guaranteed coverage of annual mammograms, but new USPSTF recommendations, due out soon, may undermine that guarantee.

On October 20, ACOG responded to the ACS’ new recommendations on breast cancer screening by emphasizing our continued advice that women should begin annual mammography screening at age 40, along with a clinical breast exam.²

Consensus conference plansIn an effort to address widespread confusion among patients, health care professionals, and payers, ACOG is convening a consensus conference in January 2016, with the goal of arriving at a consistent set of guidelines that can be agreed to, implemented clinically across the country, and hopefully adopted by insurers, as well. Major organizations and providers of women’s health care, including ACS, will gather to evaluate and interpret the data in greater detail and to consider the available data in the broader context of patient care.

Without doubt, guidelines and recommendations will need to evolve as new evidence emerges, but our hope is that scientific and medical organizations can look at the same evidence and speak with one voice on what is best for women’s health. Our patients would benefit from that alone.

ACOG’s recommendations, summarized

• Clinical breast examination every year for women aged 19 and older.
• Screening mammography every year for women aged 40 and older.
• Breast self-awareness has the potential to detect palpable breast cancer and can be recommended.²

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

The Susan G. Komen Foundation estimates that 84% of breast cancers are found through mammography.¹ Clearly, the value of mammography is proven. But controversy and confusion abound on how much mammography, and beginning at what age, is best for women.

Currently, the United States Preventive Services Task Force (USPSTF), the American Cancer Society (ACS), and the American College of Obstetricians and Gynecologists (ACOG) all have differing recommendations about mammography and about the importance of clinical breast examinations. These inconsistencies largely are due to different interpretations of the same data, not the data itself, and tend to center on how harm is defined and measured. Importantly, these differences can wreak havoc on our patients’ confidence in our counsel and decision making, and can complicate women’s access to screening. Under the Affordable Care Act, women are guaranteed coverage of annual mammograms, but new USPSTF recommendations, due out soon, may undermine that guarantee.

On October 20, ACOG responded to the ACS’ new recommendations on breast cancer screening by emphasizing our continued advice that women should begin annual mammography screening at age 40, along with a clinical breast exam.²

Consensus conference plansIn an effort to address widespread confusion among patients, health care professionals, and payers, ACOG is convening a consensus conference in January 2016, with the goal of arriving at a consistent set of guidelines that can be agreed to, implemented clinically across the country, and hopefully adopted by insurers, as well. Major organizations and providers of women’s health care, including ACS, will gather to evaluate and interpret the data in greater detail and to consider the available data in the broader context of patient care.

Without doubt, guidelines and recommendations will need to evolve as new evidence emerges, but our hope is that scientific and medical organizations can look at the same evidence and speak with one voice on what is best for women’s health. Our patients would benefit from that alone.

ACOG’s recommendations, summarized

• Clinical breast examination every year for women aged 19 and older.
• Screening mammography every year for women aged 40 and older.
• Breast self-awareness has the potential to detect palpable breast cancer and can be recommended.²

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

The Susan G. Komen Foundation estimates that 84% of breast cancers are found through mammography.¹ Clearly, the value of mammography is proven. But controversy and confusion abound on how much mammography, and beginning at what age, is best for women.

Currently, the United States Preventive Services Task Force (USPSTF), the American Cancer Society (ACS), and the American College of Obstetricians and Gynecologists (ACOG) all have differing recommendations about mammography and about the importance of clinical breast examinations. These inconsistencies largely are due to different interpretations of the same data, not the data itself, and tend to center on how harm is defined and measured. Importantly, these differences can wreak havoc on our patients’ confidence in our counsel and decision making, and can complicate women’s access to screening. Under the Affordable Care Act, women are guaranteed coverage of annual mammograms, but new USPSTF recommendations, due out soon, may undermine that guarantee.

On October 20, ACOG responded to the ACS’ new recommendations on breast cancer screening by emphasizing our continued advice that women should begin annual mammography screening at age 40, along with a clinical breast exam.²

Consensus conference plansIn an effort to address widespread confusion among patients, health care professionals, and payers, ACOG is convening a consensus conference in January 2016, with the goal of arriving at a consistent set of guidelines that can be agreed to, implemented clinically across the country, and hopefully adopted by insurers, as well. Major organizations and providers of women’s health care, including ACS, will gather to evaluate and interpret the data in greater detail and to consider the available data in the broader context of patient care.

Without doubt, guidelines and recommendations will need to evolve as new evidence emerges, but our hope is that scientific and medical organizations can look at the same evidence and speak with one voice on what is best for women’s health. Our patients would benefit from that alone.

ACOG’s recommendations, summarized

• Clinical breast examination every year for women aged 19 and older.
• Screening mammography every year for women aged 40 and older.
• Breast self-awareness has the potential to detect palpable breast cancer and can be recommended.²

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

It was a long road to approval by the US Food and Drug Administration (FDA), but flibanserin (Addyi) got the nod on 
August 18, 2015. Its New Drug Application (NDA) originally was filed October 27, 2009. The drug launched October 17, 2015.

Although there has been a lot of fanfare about approval of this drug, most of the coverage has focused on its status as the “first female Viagra”—a less than accurate depiction. For a more realistic and practical assessment of the drug, OBG Management turned to Michael Krychman, MD, executive director of the Southern California Center for Sexual Health and Survivorship Medicine in Newport Beach, to determine the types of information clinicians need to know to begin prescribing flibanserin. This article highlights 11 questions (and answers) to help you get started.

1. How did the FDA arrive 
at its approval?
In 2012, the agency determined that female sexual dysfunction was one of 20 disease areas that warranted focused attention. In October 2014, as part of its intensified look at female sexual dysfunction, the FDA convened a 2-day meeting “to advance our understanding,” reports Andrea Fischer, FDA press officer.

“During the first day of the meeting, the FDA solicited patients’ perspectives on their condition and its impact on daily life. While this meeting did not focus on flibanserin, it provided an opportunity for the FDA to hear directly from patients about the impact of their condition,” Ms. Fischer says. During the second day of the meeting, the FDA “discussed scientific issues and challenges with experts in sexual medicine.”

As a result, by the time of the FDA’s 
June 4, 2015 Advisory Committee meeting on the flibanserin NDA, FDA physician-scientists were well versed in many nuances of female sexual function. That meeting included an open public hearing “that provided an opportunity for members of the public, including patients, to provide input specifically on the flibanserin application,” Ms. Fischer notes.

Nuances of the deliberations
“The FDA’s regulatory decision making on any drug product is a science-based process that carefully weighs each drug in terms of its risks and benefits to the patient population for which the drug would be indicated,” says Ms. Fischer.

The challenge in the case of flibanserin was determining whether the drug provides “clinically meaningful” improvements in sexual activity and desire.

“For many conditions and diseases, what constitutes ‘clinically meaningful’ is well known and accepted,” Ms. Fischer notes, “such as when something is cured or a severe symptom that is life-altering resolves completely. For others, this is not the case. For example, a condition that has a wide range of degree of severity can offer challenges in assessing what constitutes a clinically meaningful treatment effect. Ascertaining this requires a comprehensive knowledge of the disease, affected patient population, management strategies and the drug in question, as well as an ability to look at the clinical trial data taking this all into account.”

“In clinical trials, an important method for assessing the impact of a treatment on a patient’s symptoms, mental state, or functional status is through direct self-report using well developed and thoughtfully integrated patient-reported outcome (PRO) assessments,” Ms. Fischer says. “PROs can provide valuable information on the patient perspective when determining whether benefits outweigh risks, and they also are used to support medical product labeling claims, which are a key source of information for both health care providers and patients. PROs have been and continue to be a high priority as part of FDA’s commitment to advance patient-focused drug development, and we fully expect this to continue. The clinical trials in the flibanserin NDA all utilized PRO assessments.”

Those assessments found that patients taking flibanserin had a significant increase in “sexually satisfying events.” Three 24-week randomized controlled trials explored this endpoint for flibanserin (studies 1–3).

As for improvements in desire, the first 
2 trials utilized an e-diary to assess this aspect of sexual function, while the 3rd trial utilized the Female Sexual Function Index (FSFI).

Although the e-diary reflected no statistically significant improvement in desire in the first 2 trials, the FSFI did find significant improvement in the 3rd trial. In addition, when the FSFI was considered across all 3 trials, results in the desire domain were consistent. (The FSFI was used as a secondary tool in the first 2 trials.)

In addition, sexual distress, as measured by the Female Sexual Distress Scale (FSDS), was decreased in the trials with use of flibanserin, notes Dr. Krychman. The Advisory 
Committee determined that these findings were sufficient to demonstrate clinically meaningful improvements with use of the drug.

Although the drug was approved by the FDA, the agency was sufficiently concerned about some of its potential risks (see questions 4 and 5) that it implemented rigorous mitigation strategies (see question 7). Additional investigations were requested by the agency, including drug-drug interaction, alcohol challenge, and driving studies.

2. What are the indications?
Flibanserin is intended for use in premenopausal women who have acquired, generalized hypoactive sexual desire disorder (HSDD). That diagnosis no longer is included in the 5th edition of the Diagnostic and 
Statistical Manual of Mental Disorders but is described in drug package labeling as “low sexual desire that causes marked distress or interpersonal difficulty and is not due to:

Although the drug has been tested in both premenopausal and postmenopausal women, it was approved for use only in premenopausal women. Also note inclusion of the term “acquired” before the diagnosis of HSDD, indicating that the drug is inappropriate for women who have never experienced a period of normal sexual desire.

3. How is HSDD diagnosed?
One of the best screening tools is the 
Decreased Sexual Desire Screener, says 
Dr. Krychman. It is available at http://obgynalliance.com/files/fsd/DSDS_Pocketcard.pdf. This tool is a validated instrument to help clinicians identify what HSDD is and is not.

4. Does the drug carry 
any warnings?
Yes, it carries a black box warning about the risks of hypotension and syncope:

5. Are there any other risks worth noting?
The medication can increase the risks of hypotension and syncope even without concomitant use of alcohol. For example, in clinical trials, hypotension was reported in 0.2% of flibanserin-treated women versus less than 0.1% of placebo users. And syncope was reported in 0.4% of flibanserin users versus 0.2% of placebo-treated patients. Flibanserin is prescribed as a once-daily medication that is to be taken at bedtime; the risks of hypotension and syncope are increased if flibanserin is taken during waking hours.

The risk of adverse effects when flibanserin is taken with alcohol is highlighted by one case reported in package labeling: A 54-year-old postmenopausal woman died after taking flibanserin (100 mg daily at bedtime) for 14 days. This patient had a history of hypertension and hypercholesterolemia and consumed a baseline amount of 1 to 3 alcoholic beverages daily. She died of acute alcohol intoxication, with a blood alcohol concentration of 0.289 g/dL.¹ Whether this patient’s death was related to flibanserin use is unknown.¹

It is interesting to note that, in the studies of flibanserin leading up to the drug’s 
approval, alcohol use was not an exclusion, says Dr. Krychman. “Approximately 58% of women were self-described as mild to moderate drinkers. The clinical program was extremely large—more than 11,000 women were studied.”

Flibanserin is currently not approved for use in postmenopausal women, and concomitant alcohol consumption is contraindicated.

6. What is the dose?
The recommended dose is one tablet of 
100 mg daily. The drug is to be taken at 
bedtime to reduce the risks of hypotension, syncope, accidental injury, and central nervous system (CNS) depression, which can occur even in the absence of alcohol.

7. Are there any requirements for clinicians who want to prescribe the drug?
Yes. Because of the risks of hypotension, syncope, and CNS depression, the drug is subject to Risk Evaluation and Mitigation Strategies (REMS), as determined by the FDA. To prescribe the drug, providers must:

Before giving a patient her initial prescription, the provider must counsel her about the risks of hypotension and syncope and the interaction with alcohol using the Patient-Provider Agreement Form. The provider must then complete that form, provide a designated portion of it to the patient, and retain the remainder for the patient’s file.

For more information and to download the relevant forms, visit https://www.addyirems.com.

8. What are the most common 
adverse reactions to the drug?
According to package labeling, the most common adverse reactions, with an incidence greater than 2%, are dizziness, somnolence, nausea, fatigue, insomnia, and dry mouth.

Less common reactions include anxiety, constipation, abdominal pain, rash, sedation, and vertigo.

In studies of the drug, appendicitis was reported among 0.2% of flibanserin-treated patients, compared with no reports of appendicitis among placebo-treated patients. The FDA has requested additional investigation of the association, if any, between flibanserin 
and appendicitis.

9. What drug interactions are notable?
As stated earlier, the concomitant use of flibanserin with alcohol or a moderate or strong CYP3A4 inhibitor can result in severe hypotension and syncope. Flibanserin also should not be prescribed for patients who use other CNS depressants such as diphenhydramine, opioids, benzodiazepines, and hypnotic agents.

Some examples of strong CYP3A4 inhibitors are ketoconazole, itraconazole, posaconazole, clarithromycin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, boceprevir, telaprevir, telithromycin, and conivaptan.

Moderate CYP3A4 inhibitors include amprenavir, atazanavir, ciprofloxacin, diltiazem, erythromycin, fluconazole, fosamprenavir, verapamil, and grapefruit juice.

In addition, the concomitant use of flibanserin with multiple weak CYP3A4 inhibitors—which include herbal supplements such as ginkgo and resveratrol and nonprescription drugs such as cimetidine—also may increase the risks of hypotension and syncope.

The concomitant use of flibanserin with digoxin increases the digoxin concentration and may lead to toxicity.

10. Is the drug safe in pregnancy 
and lactation?
There are currently no data on the use of flibanserin in human pregnancy. In animals, fetal toxicity occurred only in the presence of significant maternal toxicity. Adverse effects included decreased fetal weight, structural anomalies, and increases in fetal loss when exposure exceeded 15 times the recommended human dosage.

As for the advisability of using flibanserin during lactation, it is unknown whether the drug is excreted in human milk, whether it might have adverse effects in the breastfed infant, or whether it affects milk production. Package labeling states: “Because of the potential for serious adverse reactions, including sedation in a breastfed infant, breastfeeding is not recommended during treatment with [flibanserin].”¹

11. When should the drug 
be discontinued?
If there is no improvement in sexual desire after an 8-week trial of flibanserin, the drug should be 
discontinued.

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

It was a long road to approval by the US Food and Drug Administration (FDA), but flibanserin (Addyi) got the nod on 
August 18, 2015. Its New Drug Application (NDA) originally was filed October 27, 2009. The drug launched October 17, 2015.

Although there has been a lot of fanfare about approval of this drug, most of the coverage has focused on its status as the “first female Viagra”—a less than accurate depiction. For a more realistic and practical assessment of the drug, OBG Management turned to Michael Krychman, MD, executive director of the Southern California Center for Sexual Health and Survivorship Medicine in Newport Beach, to determine the types of information clinicians need to know to begin prescribing flibanserin. This article highlights 11 questions (and answers) to help you get started.

1. How did the FDA arrive 
at its approval?
In 2012, the agency determined that female sexual dysfunction was one of 20 disease areas that warranted focused attention. In October 2014, as part of its intensified look at female sexual dysfunction, the FDA convened a 2-day meeting “to advance our understanding,” reports Andrea Fischer, FDA press officer.

“During the first day of the meeting, the FDA solicited patients’ perspectives on their condition and its impact on daily life. While this meeting did not focus on flibanserin, it provided an opportunity for the FDA to hear directly from patients about the impact of their condition,” Ms. Fischer says. During the second day of the meeting, the FDA “discussed scientific issues and challenges with experts in sexual medicine.”

As a result, by the time of the FDA’s 
June 4, 2015 Advisory Committee meeting on the flibanserin NDA, FDA physician-scientists were well versed in many nuances of female sexual function. That meeting included an open public hearing “that provided an opportunity for members of the public, including patients, to provide input specifically on the flibanserin application,” Ms. Fischer notes.

Nuances of the deliberations
“The FDA’s regulatory decision making on any drug product is a science-based process that carefully weighs each drug in terms of its risks and benefits to the patient population for which the drug would be indicated,” says Ms. Fischer.

The challenge in the case of flibanserin was determining whether the drug provides “clinically meaningful” improvements in sexual activity and desire.

“For many conditions and diseases, what constitutes ‘clinically meaningful’ is well known and accepted,” Ms. Fischer notes, “such as when something is cured or a severe symptom that is life-altering resolves completely. For others, this is not the case. For example, a condition that has a wide range of degree of severity can offer challenges in assessing what constitutes a clinically meaningful treatment effect. Ascertaining this requires a comprehensive knowledge of the disease, affected patient population, management strategies and the drug in question, as well as an ability to look at the clinical trial data taking this all into account.”

“In clinical trials, an important method for assessing the impact of a treatment on a patient’s symptoms, mental state, or functional status is through direct self-report using well developed and thoughtfully integrated patient-reported outcome (PRO) assessments,” Ms. Fischer says. “PROs can provide valuable information on the patient perspective when determining whether benefits outweigh risks, and they also are used to support medical product labeling claims, which are a key source of information for both health care providers and patients. PROs have been and continue to be a high priority as part of FDA’s commitment to advance patient-focused drug development, and we fully expect this to continue. The clinical trials in the flibanserin NDA all utilized PRO assessments.”

Those assessments found that patients taking flibanserin had a significant increase in “sexually satisfying events.” Three 24-week randomized controlled trials explored this endpoint for flibanserin (studies 1–3).

As for improvements in desire, the first 
2 trials utilized an e-diary to assess this aspect of sexual function, while the 3rd trial utilized the Female Sexual Function Index (FSFI).

Although the e-diary reflected no statistically significant improvement in desire in the first 2 trials, the FSFI did find significant improvement in the 3rd trial. In addition, when the FSFI was considered across all 3 trials, results in the desire domain were consistent. (The FSFI was used as a secondary tool in the first 2 trials.)

In addition, sexual distress, as measured by the Female Sexual Distress Scale (FSDS), was decreased in the trials with use of flibanserin, notes Dr. Krychman. The Advisory 
Committee determined that these findings were sufficient to demonstrate clinically meaningful improvements with use of the drug.

Although the drug was approved by the FDA, the agency was sufficiently concerned about some of its potential risks (see questions 4 and 5) that it implemented rigorous mitigation strategies (see question 7). Additional investigations were requested by the agency, including drug-drug interaction, alcohol challenge, and driving studies.

2. What are the indications?
Flibanserin is intended for use in premenopausal women who have acquired, generalized hypoactive sexual desire disorder (HSDD). That diagnosis no longer is included in the 5th edition of the Diagnostic and 
Statistical Manual of Mental Disorders but is described in drug package labeling as “low sexual desire that causes marked distress or interpersonal difficulty and is not due to:

Although the drug has been tested in both premenopausal and postmenopausal women, it was approved for use only in premenopausal women. Also note inclusion of the term “acquired” before the diagnosis of HSDD, indicating that the drug is inappropriate for women who have never experienced a period of normal sexual desire.

3. How is HSDD diagnosed?
One of the best screening tools is the 
Decreased Sexual Desire Screener, says 
Dr. Krychman. It is available at http://obgynalliance.com/files/fsd/DSDS_Pocketcard.pdf. This tool is a validated instrument to help clinicians identify what HSDD is and is not.

4. Does the drug carry 
any warnings?
Yes, it carries a black box warning about the risks of hypotension and syncope:

5. Are there any other risks worth noting?
The medication can increase the risks of hypotension and syncope even without concomitant use of alcohol. For example, in clinical trials, hypotension was reported in 0.2% of flibanserin-treated women versus less than 0.1% of placebo users. And syncope was reported in 0.4% of flibanserin users versus 0.2% of placebo-treated patients. Flibanserin is prescribed as a once-daily medication that is to be taken at bedtime; the risks of hypotension and syncope are increased if flibanserin is taken during waking hours.

The risk of adverse effects when flibanserin is taken with alcohol is highlighted by one case reported in package labeling: A 54-year-old postmenopausal woman died after taking flibanserin (100 mg daily at bedtime) for 14 days. This patient had a history of hypertension and hypercholesterolemia and consumed a baseline amount of 1 to 3 alcoholic beverages daily. She died of acute alcohol intoxication, with a blood alcohol concentration of 0.289 g/dL.¹ Whether this patient’s death was related to flibanserin use is unknown.¹

It is interesting to note that, in the studies of flibanserin leading up to the drug’s 
approval, alcohol use was not an exclusion, says Dr. Krychman. “Approximately 58% of women were self-described as mild to moderate drinkers. The clinical program was extremely large—more than 11,000 women were studied.”

Flibanserin is currently not approved for use in postmenopausal women, and concomitant alcohol consumption is contraindicated.

6. What is the dose?
The recommended dose is one tablet of 
100 mg daily. The drug is to be taken at 
bedtime to reduce the risks of hypotension, syncope, accidental injury, and central nervous system (CNS) depression, which can occur even in the absence of alcohol.

7. Are there any requirements for clinicians who want to prescribe the drug?
Yes. Because of the risks of hypotension, syncope, and CNS depression, the drug is subject to Risk Evaluation and Mitigation Strategies (REMS), as determined by the FDA. To prescribe the drug, providers must:

Before giving a patient her initial prescription, the provider must counsel her about the risks of hypotension and syncope and the interaction with alcohol using the Patient-Provider Agreement Form. The provider must then complete that form, provide a designated portion of it to the patient, and retain the remainder for the patient’s file.

For more information and to download the relevant forms, visit https://www.addyirems.com.

8. What are the most common 
adverse reactions to the drug?
According to package labeling, the most common adverse reactions, with an incidence greater than 2%, are dizziness, somnolence, nausea, fatigue, insomnia, and dry mouth.

Less common reactions include anxiety, constipation, abdominal pain, rash, sedation, and vertigo.

In studies of the drug, appendicitis was reported among 0.2% of flibanserin-treated patients, compared with no reports of appendicitis among placebo-treated patients. The FDA has requested additional investigation of the association, if any, between flibanserin 
and appendicitis.

9. What drug interactions are notable?
As stated earlier, the concomitant use of flibanserin with alcohol or a moderate or strong CYP3A4 inhibitor can result in severe hypotension and syncope. Flibanserin also should not be prescribed for patients who use other CNS depressants such as diphenhydramine, opioids, benzodiazepines, and hypnotic agents.

Some examples of strong CYP3A4 inhibitors are ketoconazole, itraconazole, posaconazole, clarithromycin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, boceprevir, telaprevir, telithromycin, and conivaptan.

Moderate CYP3A4 inhibitors include amprenavir, atazanavir, ciprofloxacin, diltiazem, erythromycin, fluconazole, fosamprenavir, verapamil, and grapefruit juice.

In addition, the concomitant use of flibanserin with multiple weak CYP3A4 inhibitors—which include herbal supplements such as ginkgo and resveratrol and nonprescription drugs such as cimetidine—also may increase the risks of hypotension and syncope.

The concomitant use of flibanserin with digoxin increases the digoxin concentration and may lead to toxicity.

10. Is the drug safe in pregnancy 
and lactation?
There are currently no data on the use of flibanserin in human pregnancy. In animals, fetal toxicity occurred only in the presence of significant maternal toxicity. Adverse effects included decreased fetal weight, structural anomalies, and increases in fetal loss when exposure exceeded 15 times the recommended human dosage.

As for the advisability of using flibanserin during lactation, it is unknown whether the drug is excreted in human milk, whether it might have adverse effects in the breastfed infant, or whether it affects milk production. Package labeling states: “Because of the potential for serious adverse reactions, including sedation in a breastfed infant, breastfeeding is not recommended during treatment with [flibanserin].”¹

11. When should the drug 
be discontinued?
If there is no improvement in sexual desire after an 8-week trial of flibanserin, the drug should be 
discontinued.

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

It was a long road to approval by the US Food and Drug Administration (FDA), but flibanserin (Addyi) got the nod on 
August 18, 2015. Its New Drug Application (NDA) originally was filed October 27, 2009. The drug launched October 17, 2015.

Although there has been a lot of fanfare about approval of this drug, most of the coverage has focused on its status as the “first female Viagra”—a less than accurate depiction. For a more realistic and practical assessment of the drug, OBG Management turned to Michael Krychman, MD, executive director of the Southern California Center for Sexual Health and Survivorship Medicine in Newport Beach, to determine the types of information clinicians need to know to begin prescribing flibanserin. This article highlights 11 questions (and answers) to help you get started.

1. How did the FDA arrive 
at its approval?
In 2012, the agency determined that female sexual dysfunction was one of 20 disease areas that warranted focused attention. In October 2014, as part of its intensified look at female sexual dysfunction, the FDA convened a 2-day meeting “to advance our understanding,” reports Andrea Fischer, FDA press officer.

“During the first day of the meeting, the FDA solicited patients’ perspectives on their condition and its impact on daily life. While this meeting did not focus on flibanserin, it provided an opportunity for the FDA to hear directly from patients about the impact of their condition,” Ms. Fischer says. During the second day of the meeting, the FDA “discussed scientific issues and challenges with experts in sexual medicine.”

As a result, by the time of the FDA’s 
June 4, 2015 Advisory Committee meeting on the flibanserin NDA, FDA physician-scientists were well versed in many nuances of female sexual function. That meeting included an open public hearing “that provided an opportunity for members of the public, including patients, to provide input specifically on the flibanserin application,” Ms. Fischer notes.

Nuances of the deliberations
“The FDA’s regulatory decision making on any drug product is a science-based process that carefully weighs each drug in terms of its risks and benefits to the patient population for which the drug would be indicated,” says Ms. Fischer.

The challenge in the case of flibanserin was determining whether the drug provides “clinically meaningful” improvements in sexual activity and desire.

“For many conditions and diseases, what constitutes ‘clinically meaningful’ is well known and accepted,” Ms. Fischer notes, “such as when something is cured or a severe symptom that is life-altering resolves completely. For others, this is not the case. For example, a condition that has a wide range of degree of severity can offer challenges in assessing what constitutes a clinically meaningful treatment effect. Ascertaining this requires a comprehensive knowledge of the disease, affected patient population, management strategies and the drug in question, as well as an ability to look at the clinical trial data taking this all into account.”

“In clinical trials, an important method for assessing the impact of a treatment on a patient’s symptoms, mental state, or functional status is through direct self-report using well developed and thoughtfully integrated patient-reported outcome (PRO) assessments,” Ms. Fischer says. “PROs can provide valuable information on the patient perspective when determining whether benefits outweigh risks, and they also are used to support medical product labeling claims, which are a key source of information for both health care providers and patients. PROs have been and continue to be a high priority as part of FDA’s commitment to advance patient-focused drug development, and we fully expect this to continue. The clinical trials in the flibanserin NDA all utilized PRO assessments.”

Those assessments found that patients taking flibanserin had a significant increase in “sexually satisfying events.” Three 24-week randomized controlled trials explored this endpoint for flibanserin (studies 1–3).

As for improvements in desire, the first 
2 trials utilized an e-diary to assess this aspect of sexual function, while the 3rd trial utilized the Female Sexual Function Index (FSFI).

Although the e-diary reflected no statistically significant improvement in desire in the first 2 trials, the FSFI did find significant improvement in the 3rd trial. In addition, when the FSFI was considered across all 3 trials, results in the desire domain were consistent. (The FSFI was used as a secondary tool in the first 2 trials.)

In addition, sexual distress, as measured by the Female Sexual Distress Scale (FSDS), was decreased in the trials with use of flibanserin, notes Dr. Krychman. The Advisory 
Committee determined that these findings were sufficient to demonstrate clinically meaningful improvements with use of the drug.

Although the drug was approved by the FDA, the agency was sufficiently concerned about some of its potential risks (see questions 4 and 5) that it implemented rigorous mitigation strategies (see question 7). Additional investigations were requested by the agency, including drug-drug interaction, alcohol challenge, and driving studies.

2. What are the indications?
Flibanserin is intended for use in premenopausal women who have acquired, generalized hypoactive sexual desire disorder (HSDD). That diagnosis no longer is included in the 5th edition of the Diagnostic and 
Statistical Manual of Mental Disorders but is described in drug package labeling as “low sexual desire that causes marked distress or interpersonal difficulty and is not due to:

Although the drug has been tested in both premenopausal and postmenopausal women, it was approved for use only in premenopausal women. Also note inclusion of the term “acquired” before the diagnosis of HSDD, indicating that the drug is inappropriate for women who have never experienced a period of normal sexual desire.

3. How is HSDD diagnosed?
One of the best screening tools is the 
Decreased Sexual Desire Screener, says 
Dr. Krychman. It is available at http://obgynalliance.com/files/fsd/DSDS_Pocketcard.pdf. This tool is a validated instrument to help clinicians identify what HSDD is and is not.

4. Does the drug carry 
any warnings?
Yes, it carries a black box warning about the risks of hypotension and syncope:

5. Are there any other risks worth noting?
The medication can increase the risks of hypotension and syncope even without concomitant use of alcohol. For example, in clinical trials, hypotension was reported in 0.2% of flibanserin-treated women versus less than 0.1% of placebo users. And syncope was reported in 0.4% of flibanserin users versus 0.2% of placebo-treated patients. Flibanserin is prescribed as a once-daily medication that is to be taken at bedtime; the risks of hypotension and syncope are increased if flibanserin is taken during waking hours.

The risk of adverse effects when flibanserin is taken with alcohol is highlighted by one case reported in package labeling: A 54-year-old postmenopausal woman died after taking flibanserin (100 mg daily at bedtime) for 14 days. This patient had a history of hypertension and hypercholesterolemia and consumed a baseline amount of 1 to 3 alcoholic beverages daily. She died of acute alcohol intoxication, with a blood alcohol concentration of 0.289 g/dL.¹ Whether this patient’s death was related to flibanserin use is unknown.¹

It is interesting to note that, in the studies of flibanserin leading up to the drug’s 
approval, alcohol use was not an exclusion, says Dr. Krychman. “Approximately 58% of women were self-described as mild to moderate drinkers. The clinical program was extremely large—more than 11,000 women were studied.”

Flibanserin is currently not approved for use in postmenopausal women, and concomitant alcohol consumption is contraindicated.

6. What is the dose?
The recommended dose is one tablet of 
100 mg daily. The drug is to be taken at 
bedtime to reduce the risks of hypotension, syncope, accidental injury, and central nervous system (CNS) depression, which can occur even in the absence of alcohol.

7. Are there any requirements for clinicians who want to prescribe the drug?
Yes. Because of the risks of hypotension, syncope, and CNS depression, the drug is subject to Risk Evaluation and Mitigation Strategies (REMS), as determined by the FDA. To prescribe the drug, providers must:

Before giving a patient her initial prescription, the provider must counsel her about the risks of hypotension and syncope and the interaction with alcohol using the Patient-Provider Agreement Form. The provider must then complete that form, provide a designated portion of it to the patient, and retain the remainder for the patient’s file.

For more information and to download the relevant forms, visit https://www.addyirems.com.

8. What are the most common 
adverse reactions to the drug?
According to package labeling, the most common adverse reactions, with an incidence greater than 2%, are dizziness, somnolence, nausea, fatigue, insomnia, and dry mouth.

Less common reactions include anxiety, constipation, abdominal pain, rash, sedation, and vertigo.

In studies of the drug, appendicitis was reported among 0.2% of flibanserin-treated patients, compared with no reports of appendicitis among placebo-treated patients. The FDA has requested additional investigation of the association, if any, between flibanserin 
and appendicitis.

9. What drug interactions are notable?
As stated earlier, the concomitant use of flibanserin with alcohol or a moderate or strong CYP3A4 inhibitor can result in severe hypotension and syncope. Flibanserin also should not be prescribed for patients who use other CNS depressants such as diphenhydramine, opioids, benzodiazepines, and hypnotic agents.

Some examples of strong CYP3A4 inhibitors are ketoconazole, itraconazole, posaconazole, clarithromycin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, boceprevir, telaprevir, telithromycin, and conivaptan.

Moderate CYP3A4 inhibitors include amprenavir, atazanavir, ciprofloxacin, diltiazem, erythromycin, fluconazole, fosamprenavir, verapamil, and grapefruit juice.

In addition, the concomitant use of flibanserin with multiple weak CYP3A4 inhibitors—which include herbal supplements such as ginkgo and resveratrol and nonprescription drugs such as cimetidine—also may increase the risks of hypotension and syncope.

The concomitant use of flibanserin with digoxin increases the digoxin concentration and may lead to toxicity.

10. Is the drug safe in pregnancy 
and lactation?
There are currently no data on the use of flibanserin in human pregnancy. In animals, fetal toxicity occurred only in the presence of significant maternal toxicity. Adverse effects included decreased fetal weight, structural anomalies, and increases in fetal loss when exposure exceeded 15 times the recommended human dosage.

As for the advisability of using flibanserin during lactation, it is unknown whether the drug is excreted in human milk, whether it might have adverse effects in the breastfed infant, or whether it affects milk production. Package labeling states: “Because of the potential for serious adverse reactions, including sedation in a breastfed infant, breastfeeding is not recommended during treatment with [flibanserin].”¹

11. When should the drug 
be discontinued?
If there is no improvement in sexual desire after an 8-week trial of flibanserin, the drug should be 
discontinued.

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

Over the last couple of years, I’ve written quite a lot about the trend toward consolidation. That trend shows no sign of abating; more and more soloists and small groups are selling or merging their practices with hospitals, multispecialty groups, or other large entities.

I have seen evidence, though, that many sellers are not receiving a fair price for the equity that they have worked so hard to build over several decades. If you are contemplating selling or merging, it is important that you not simply take the buyer’s word for how much your practice is worth. You need an impartial appraisal.

Of course, a medical practice is trickier to value than an ordinary business, and usually requires the services of an experienced professional appraiser. Entire books have been written about the process, so I can’t hope to cover it completely in 750 words; but three basic yardsticks are essential for a practice appraisal:

• Tangible assets. Equipment, cash, accounts receivable and other property owned by the practice.

• Liabilities. Accounts payable, outstanding loans, and anything else owed to others.

• Intangible assets. Sometimes called “good will” – the reputation of the physicians, the location and name recognition of the practice, the loyalty and volume of patients, and other, well, intangibles.

Armed with those numbers, an appraiser can then determine the equity, or book value, of the practice.

Valuing tangible assets is comparatively straightforward, but there are several ways to do it, and when reviewing a practice appraisal you should ask which of them was used. Depreciated value is the book value of equipment and supplies as determined by their purchase price, less the amount their value has decreased since purchase. Remaining useful life value estimates how long the equipment can be expected to last. Market (or replacement) value is the amount it would cost on the open market to replace all equipment and supplies.

Intangible assets are more difficult to value. Many components are analyzed, including location, interior and exterior decor, accessibility to patients, age and functional status of equipment, systems in place to promote efficiency, reasons why patients come back (if in fact they do), and the overall reputation of the practice in the community. Other important factors include the “payer mix” (what percentage pays cash, how many third-party contracts are in place and how well they pay, etc.), the extent and strength of the referral base, and the presence of clinical studies or other supplemental income streams.

It is also important to determine to what extent intangible assets are transferable. For example, unique skills with a laser, neurotoxins, or filler substances, or extraordinary personal charisma, may increase your practice’s value to you, but they are worthless to the next owner, and he or she will be unwilling to pay for them unless your services become part of the deal.

Once again, there are many ways to estimate intangible asset value, and once again you should ask which were used. Cash Flow Analysis works on the assumption that cash flow is a measure of intangible value. Capitalization of Earnings puts a value, or capitalization, on the practice’s income streams using a variety of assumptions. Guideline Comparison uses various databases to compare your practice with other, similar ones that have changed hands in the past.

Two newer techniques, which some consider a better estimate of intangible assets, are the replacement method, which estimates the costs of starting the practice over again in the current market; and the excess earnings method, which measures how far above average your practice’s earnings (and thus its overall value) are.

Asset-based valuation is the most popular, but by no means the only method available. Income-based valuation looks at the source and strength of a practice’s income stream as a creator of value, as well as whether or not its income stream under a different owner would mirror its present one. This in turn becomes the basis for an understanding of the fair market value of both tangible and intangible assets. Market valuation combines the asset-based and income-based approaches, along with an analysis of sales and mergers of comparable practices in the community, to determine the value of a practice in its local market.

Whatever methods are used, it is important that the appraisal be done by an experienced financial consultant, that all techniques used in the valuation be divulged and explained, and that documentation is supplied to support the conclusions reached. This is especially important if the appraisal will be relied upon in the sale or merger of the practice. I’ll cover some sale and merger options that you may not have thought of next month.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].

Over the last couple of years, I’ve written quite a lot about the trend toward consolidation. That trend shows no sign of abating; more and more soloists and small groups are selling or merging their practices with hospitals, multispecialty groups, or other large entities.

I have seen evidence, though, that many sellers are not receiving a fair price for the equity that they have worked so hard to build over several decades. If you are contemplating selling or merging, it is important that you not simply take the buyer’s word for how much your practice is worth. You need an impartial appraisal.

Of course, a medical practice is trickier to value than an ordinary business, and usually requires the services of an experienced professional appraiser. Entire books have been written about the process, so I can’t hope to cover it completely in 750 words; but three basic yardsticks are essential for a practice appraisal:

• Tangible assets. Equipment, cash, accounts receivable and other property owned by the practice.

• Liabilities. Accounts payable, outstanding loans, and anything else owed to others.

• Intangible assets. Sometimes called “good will” – the reputation of the physicians, the location and name recognition of the practice, the loyalty and volume of patients, and other, well, intangibles.

Armed with those numbers, an appraiser can then determine the equity, or book value, of the practice.

Valuing tangible assets is comparatively straightforward, but there are several ways to do it, and when reviewing a practice appraisal you should ask which of them was used. Depreciated value is the book value of equipment and supplies as determined by their purchase price, less the amount their value has decreased since purchase. Remaining useful life value estimates how long the equipment can be expected to last. Market (or replacement) value is the amount it would cost on the open market to replace all equipment and supplies.

Intangible assets are more difficult to value. Many components are analyzed, including location, interior and exterior decor, accessibility to patients, age and functional status of equipment, systems in place to promote efficiency, reasons why patients come back (if in fact they do), and the overall reputation of the practice in the community. Other important factors include the “payer mix” (what percentage pays cash, how many third-party contracts are in place and how well they pay, etc.), the extent and strength of the referral base, and the presence of clinical studies or other supplemental income streams.

It is also important to determine to what extent intangible assets are transferable. For example, unique skills with a laser, neurotoxins, or filler substances, or extraordinary personal charisma, may increase your practice’s value to you, but they are worthless to the next owner, and he or she will be unwilling to pay for them unless your services become part of the deal.

Once again, there are many ways to estimate intangible asset value, and once again you should ask which were used. Cash Flow Analysis works on the assumption that cash flow is a measure of intangible value. Capitalization of Earnings puts a value, or capitalization, on the practice’s income streams using a variety of assumptions. Guideline Comparison uses various databases to compare your practice with other, similar ones that have changed hands in the past.

Two newer techniques, which some consider a better estimate of intangible assets, are the replacement method, which estimates the costs of starting the practice over again in the current market; and the excess earnings method, which measures how far above average your practice’s earnings (and thus its overall value) are.

Asset-based valuation is the most popular, but by no means the only method available. Income-based valuation looks at the source and strength of a practice’s income stream as a creator of value, as well as whether or not its income stream under a different owner would mirror its present one. This in turn becomes the basis for an understanding of the fair market value of both tangible and intangible assets. Market valuation combines the asset-based and income-based approaches, along with an analysis of sales and mergers of comparable practices in the community, to determine the value of a practice in its local market.

Whatever methods are used, it is important that the appraisal be done by an experienced financial consultant, that all techniques used in the valuation be divulged and explained, and that documentation is supplied to support the conclusions reached. This is especially important if the appraisal will be relied upon in the sale or merger of the practice. I’ll cover some sale and merger options that you may not have thought of next month.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].

Over the last couple of years, I’ve written quite a lot about the trend toward consolidation. That trend shows no sign of abating; more and more soloists and small groups are selling or merging their practices with hospitals, multispecialty groups, or other large entities.

I have seen evidence, though, that many sellers are not receiving a fair price for the equity that they have worked so hard to build over several decades. If you are contemplating selling or merging, it is important that you not simply take the buyer’s word for how much your practice is worth. You need an impartial appraisal.

Of course, a medical practice is trickier to value than an ordinary business, and usually requires the services of an experienced professional appraiser. Entire books have been written about the process, so I can’t hope to cover it completely in 750 words; but three basic yardsticks are essential for a practice appraisal:

• Tangible assets. Equipment, cash, accounts receivable and other property owned by the practice.

• Liabilities. Accounts payable, outstanding loans, and anything else owed to others.

• Intangible assets. Sometimes called “good will” – the reputation of the physicians, the location and name recognition of the practice, the loyalty and volume of patients, and other, well, intangibles.

Armed with those numbers, an appraiser can then determine the equity, or book value, of the practice.

Valuing tangible assets is comparatively straightforward, but there are several ways to do it, and when reviewing a practice appraisal you should ask which of them was used. Depreciated value is the book value of equipment and supplies as determined by their purchase price, less the amount their value has decreased since purchase. Remaining useful life value estimates how long the equipment can be expected to last. Market (or replacement) value is the amount it would cost on the open market to replace all equipment and supplies.

Intangible assets are more difficult to value. Many components are analyzed, including location, interior and exterior decor, accessibility to patients, age and functional status of equipment, systems in place to promote efficiency, reasons why patients come back (if in fact they do), and the overall reputation of the practice in the community. Other important factors include the “payer mix” (what percentage pays cash, how many third-party contracts are in place and how well they pay, etc.), the extent and strength of the referral base, and the presence of clinical studies or other supplemental income streams.

It is also important to determine to what extent intangible assets are transferable. For example, unique skills with a laser, neurotoxins, or filler substances, or extraordinary personal charisma, may increase your practice’s value to you, but they are worthless to the next owner, and he or she will be unwilling to pay for them unless your services become part of the deal.

Once again, there are many ways to estimate intangible asset value, and once again you should ask which were used. Cash Flow Analysis works on the assumption that cash flow is a measure of intangible value. Capitalization of Earnings puts a value, or capitalization, on the practice’s income streams using a variety of assumptions. Guideline Comparison uses various databases to compare your practice with other, similar ones that have changed hands in the past.

Two newer techniques, which some consider a better estimate of intangible assets, are the replacement method, which estimates the costs of starting the practice over again in the current market; and the excess earnings method, which measures how far above average your practice’s earnings (and thus its overall value) are.

Asset-based valuation is the most popular, but by no means the only method available. Income-based valuation looks at the source and strength of a practice’s income stream as a creator of value, as well as whether or not its income stream under a different owner would mirror its present one. This in turn becomes the basis for an understanding of the fair market value of both tangible and intangible assets. Market valuation combines the asset-based and income-based approaches, along with an analysis of sales and mergers of comparable practices in the community, to determine the value of a practice in its local market.

Whatever methods are used, it is important that the appraisal be done by an experienced financial consultant, that all techniques used in the valuation be divulged and explained, and that documentation is supplied to support the conclusions reached. This is especially important if the appraisal will be relied upon in the sale or merger of the practice. I’ll cover some sale and merger options that you may not have thought of next month.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].

An OBG Management reader recently requested assistance finding an app or Web site that would be helpful for International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10) coding, particularly for practicing ObGyns. It is not surprising that I have received this question, as we already are seeing a ton of smartphone apps that promise to search through the code descriptions quickly. None of these apps are ObGyn-specific but, given the vast amount, deciding which one is the best option to purchase and download can be a challenge.

Purchase considerations

Before you buy, decide what features you are looking for and make sure the app you have chosen can deliver what you need. Pay special attention to any reviews to learn the app’s pros and the cons. For instance, some apps offer code conversion from ICD-9 to ICD-10. Keep in mind, however, that not all conversions are accurate, and your search may just lead you to another unspecified code. Some apps will offer a decision tree, which is ideal. What you would like to avoid is an app that generates a list of 200 codes from a single search term.

A useful resource that I have found is this Buyers Guide to Mobile ICD-10 Apps from mHealthNews.¹ This guide compares and contrasts the available apps (as of March 2014) for Android and Apple products. Some, you will note, are free; others are not. Try out a few before choosing. While several companies have developed products geared for ICD-10, many are not geared for mobile use and may have a substantial purchase price. Many of them also seem to be geared toward coders, not toward physician users.

My picks

ICD-10 Search was developed by e-MDs.² It appears that this search program is part of a more extensive product that e-MDs sells, but for the time being, is free. This app deserves a look, especially because the decision tree format quickly gets you to the most specific code.

ICD-10 Code Lookup is the official offering from the Centers for Medicare & Medicaid Services (CMS).³ After you type in the term you are looking for, you get the search results in code order. The more specific your search terms, the closer you will get to the needed code. One caveat: the search mode is not set up to accept all clinical terms. For instance, I typed in "menorrhagia" and got 0 results; I typed in “menstruation, frequent” and I received 2 codes.

I hope this information is helpful, and I wish you an easy transition from ICD-9 to ICD-10.

WE WANT TO HEAR FROM YOU!
Drop us a line and let us know what you think about current articles, which topics you'd like to see covered in future issues, and what challenges you face in daily practice. Tell us what you think by emailing us at: [email protected]

An OBG Management reader recently requested assistance finding an app or Web site that would be helpful for International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10) coding, particularly for practicing ObGyns. It is not surprising that I have received this question, as we already are seeing a ton of smartphone apps that promise to search through the code descriptions quickly. None of these apps are ObGyn-specific but, given the vast amount, deciding which one is the best option to purchase and download can be a challenge.

Purchase considerations

Before you buy, decide what features you are looking for and make sure the app you have chosen can deliver what you need. Pay special attention to any reviews to learn the app’s pros and the cons. For instance, some apps offer code conversion from ICD-9 to ICD-10. Keep in mind, however, that not all conversions are accurate, and your search may just lead you to another unspecified code. Some apps will offer a decision tree, which is ideal. What you would like to avoid is an app that generates a list of 200 codes from a single search term.

A useful resource that I have found is this Buyers Guide to Mobile ICD-10 Apps from mHealthNews.¹ This guide compares and contrasts the available apps (as of March 2014) for Android and Apple products. Some, you will note, are free; others are not. Try out a few before choosing. While several companies have developed products geared for ICD-10, many are not geared for mobile use and may have a substantial purchase price. Many of them also seem to be geared toward coders, not toward physician users.

My picks

ICD-10 Search was developed by e-MDs.² It appears that this search program is part of a more extensive product that e-MDs sells, but for the time being, is free. This app deserves a look, especially because the decision tree format quickly gets you to the most specific code.

ICD-10 Code Lookup is the official offering from the Centers for Medicare & Medicaid Services (CMS).³ After you type in the term you are looking for, you get the search results in code order. The more specific your search terms, the closer you will get to the needed code. One caveat: the search mode is not set up to accept all clinical terms. For instance, I typed in "menorrhagia" and got 0 results; I typed in “menstruation, frequent” and I received 2 codes.

I hope this information is helpful, and I wish you an easy transition from ICD-9 to ICD-10.

WE WANT TO HEAR FROM YOU!
Drop us a line and let us know what you think about current articles, which topics you'd like to see covered in future issues, and what challenges you face in daily practice. Tell us what you think by emailing us at: [email protected]

An OBG Management reader recently requested assistance finding an app or Web site that would be helpful for International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10) coding, particularly for practicing ObGyns. It is not surprising that I have received this question, as we already are seeing a ton of smartphone apps that promise to search through the code descriptions quickly. None of these apps are ObGyn-specific but, given the vast amount, deciding which one is the best option to purchase and download can be a challenge.

Purchase considerations

Before you buy, decide what features you are looking for and make sure the app you have chosen can deliver what you need. Pay special attention to any reviews to learn the app’s pros and the cons. For instance, some apps offer code conversion from ICD-9 to ICD-10. Keep in mind, however, that not all conversions are accurate, and your search may just lead you to another unspecified code. Some apps will offer a decision tree, which is ideal. What you would like to avoid is an app that generates a list of 200 codes from a single search term.

A useful resource that I have found is this Buyers Guide to Mobile ICD-10 Apps from mHealthNews.¹ This guide compares and contrasts the available apps (as of March 2014) for Android and Apple products. Some, you will note, are free; others are not. Try out a few before choosing. While several companies have developed products geared for ICD-10, many are not geared for mobile use and may have a substantial purchase price. Many of them also seem to be geared toward coders, not toward physician users.

My picks

ICD-10 Search was developed by e-MDs.² It appears that this search program is part of a more extensive product that e-MDs sells, but for the time being, is free. This app deserves a look, especially because the decision tree format quickly gets you to the most specific code.

ICD-10 Code Lookup is the official offering from the Centers for Medicare & Medicaid Services (CMS).³ After you type in the term you are looking for, you get the search results in code order. The more specific your search terms, the closer you will get to the needed code. One caveat: the search mode is not set up to accept all clinical terms. For instance, I typed in "menorrhagia" and got 0 results; I typed in “menstruation, frequent” and I received 2 codes.

I hope this information is helpful, and I wish you an easy transition from ICD-9 to ICD-10.

WE WANT TO HEAR FROM YOU!
Drop us a line and let us know what you think about current articles, which topics you'd like to see covered in future issues, and what challenges you face in daily practice. Tell us what you think by emailing us at: [email protected]

Menopause experts Andrew M. Kaunitz, MD, and JoAnn E. Manson, MD, DrPH, provide a comprehensive review of various treatments for menopausal symptoms in an article recently published ahead of print in Obstetrics and Gynecology.¹ They discuss hormonal and nonhormonal options to treat vasomotor symptoms, genitourinary syndrome of menopause (GSM), and considerations for the use of hormone therapy in special populations: women with early menopause, women with a history of breast cancer and those who carry the BRCA gene mutation, and women with a history of venous thrombosis.¹

The authors write that, “given the lower rates of adverse events on HT among women close to menopause onset and at lower baseline risk of cardiovascular disease, risk stratification and personalized risk assessment appear to represent a sound strategy for optimizing the benefit–risk profile and safety of HT.”¹ They suggest that instead of stopping systemic HT at age 65 years, the length of treatment be individualized based on a woman’s risk profile and preferences. The authors encourage gynecologists and other clinicians to use benefit–risk profile tools for both hormonal and nonhormonal options to help women make sound decisions on treating menopausal symptoms.¹

Readthe full Clinical Expert Series here.

Menopause experts Andrew M. Kaunitz, MD, and JoAnn E. Manson, MD, DrPH, provide a comprehensive review of various treatments for menopausal symptoms in an article recently published ahead of print in Obstetrics and Gynecology.¹ They discuss hormonal and nonhormonal options to treat vasomotor symptoms, genitourinary syndrome of menopause (GSM), and considerations for the use of hormone therapy in special populations: women with early menopause, women with a history of breast cancer and those who carry the BRCA gene mutation, and women with a history of venous thrombosis.¹

The authors write that, “given the lower rates of adverse events on HT among women close to menopause onset and at lower baseline risk of cardiovascular disease, risk stratification and personalized risk assessment appear to represent a sound strategy for optimizing the benefit–risk profile and safety of HT.”¹ They suggest that instead of stopping systemic HT at age 65 years, the length of treatment be individualized based on a woman’s risk profile and preferences. The authors encourage gynecologists and other clinicians to use benefit–risk profile tools for both hormonal and nonhormonal options to help women make sound decisions on treating menopausal symptoms.¹

Readthe full Clinical Expert Series here.

Menopause experts Andrew M. Kaunitz, MD, and JoAnn E. Manson, MD, DrPH, provide a comprehensive review of various treatments for menopausal symptoms in an article recently published ahead of print in Obstetrics and Gynecology.¹ They discuss hormonal and nonhormonal options to treat vasomotor symptoms, genitourinary syndrome of menopause (GSM), and considerations for the use of hormone therapy in special populations: women with early menopause, women with a history of breast cancer and those who carry the BRCA gene mutation, and women with a history of venous thrombosis.¹

The authors write that, “given the lower rates of adverse events on HT among women close to menopause onset and at lower baseline risk of cardiovascular disease, risk stratification and personalized risk assessment appear to represent a sound strategy for optimizing the benefit–risk profile and safety of HT.”¹ They suggest that instead of stopping systemic HT at age 65 years, the length of treatment be individualized based on a woman’s risk profile and preferences. The authors encourage gynecologists and other clinicians to use benefit–risk profile tools for both hormonal and nonhormonal options to help women make sound decisions on treating menopausal symptoms.¹

Readthe full Clinical Expert Series here.

Recently I received a lengthy e-mail from a very worried woman. She claimed to be an established patient in my office, which I had no way of confirming because she did not sign her message. She asked many questions about sexually transmitted diseases and how they might affect her and a new boyfriend.

I was undecided on how to reply – or even whether to reply at all – so I queried several dozen dermatology colleagues around the country, as well as a few physician friends and acquaintances in other specialties.

Responses varied all over the map – from “I never answer patient e-mails,” to “What harm could it do, she’s better off getting correct answers from you than incorrect answers from some ‘advocacy’ web site” – and everything in between.

Clearly, this is a controversial issue which will only get more controversial in the future, so I decided to look at what has been published on the subject.

It turns out that as early as 1998, a group of investigators asked this same question and designed a study to address it. (Eysenbach and Diepgen: “Responses to unsolicited patient e-mail requests for medical advice on the World Wide Web. JAMA. 1998;280[15]:1333-5). Posing as a fictitious patient, they sent e-mails to random dermatologists describing an acute dermatological problem, tallied the responses they received, and followed up with a questionnaire to responders and nonresponders alike.

As with my informal survey, the authors found what they termed “a striking lack of consensus” on how to deal with this situation: Fifty percent responded to the fictitious patient’s e-mail. Of those, 31% refused to give advice without seeing the patient, but 59% offered a diagnosis, and a third of that group went on to provide specific advice about therapy. In response to the questionnaire, 28% said that they tended not to answer any patient e-mails, 24% said they usually replied with a standard message, and 24% said they answer each request individually. The authors concluded that “standards for physician response to unsolicited patient e-mail are needed.”

Indeed; but my own survey suggests that, 17 years later, there is still nothing resembling a consensus on this issue. In the interim, several groups, including the American Medical Informatics Association, Medem, and the AMA have proposed guidelines; but none have been generally accepted.

Until such time as that happens, it seems advisable for each individual practice to take the time to adopt its own guidelines. For ideas, take a look at the examples I’ve listed, plus any others you can find. When you’re done, consider running your list past your lawyer to make sure you haven’t forgotten anything, and that there are no peculiar requirements in your state.

Your guidelines may be very simple (if you decide never to answer any queries) or very complex, depending on your situation and personal philosophy. But all guidelines should cover such issues of authentication of patient correspondents, informed consent of those patients, licensing jurisdiction (if you receive e-mails from states in which you are not licensed), and above all, confidentiality.

Contrary to popular belief, the Health Insurance Portability and Accountability Act (HIPAA) does not prohibit such communication, nor require that it be encrypted. The HIPAA website says, “Patients may initiate communications with a provider using e-mail. If this situation occurs, the health care provider can assume (unless the patient has explicitly stated otherwise) that e-mail communications are acceptable to the individual.”

Still, if the lack of encryption and other privacy safeguards makes you (or your patients) uncomfortable, encryption software can be added to your practice’s e-mail system. Enli (www.enli.net), Sigaba (www.sigaba.com), Tumbleweed (www.axway.com), Zix (www.zixcorp.com), and many other vendors sell encryption packages. (As always, I have no financial interest in any product or enterprise mentioned in this column.)

But rather than simply encrypting your e-mail, consider adopting web-based messaging. Patients enter your web site and send a message using an electronic template that you design. You (or a designated staffer) will be notified by regular e-mail when messages are received, and you can post a reply on a page that can be accessed only by the patient. Besides enhancing privacy and security, you can state your guidelines in plain English to preclude any misunderstanding of what you will and will not address online.

Web-based messaging services can be freestanding or incorporated into existing secure websites. Medfusion (www.medfusion.net), and RelayHealth (www.relayhealth.com) are among the leading vendors of secure messaging services.

As for the e-mail query which triggered all this: I responded, but I told the patient I could not provide specific answers to such personal questions over the Internet, particularly when they were asked anonymously; but I would be happy to address her concerns in person, in my office.

And now, I’m writing my guidelines.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].

Recently I received a lengthy e-mail from a very worried woman. She claimed to be an established patient in my office, which I had no way of confirming because she did not sign her message. She asked many questions about sexually transmitted diseases and how they might affect her and a new boyfriend.

I was undecided on how to reply – or even whether to reply at all – so I queried several dozen dermatology colleagues around the country, as well as a few physician friends and acquaintances in other specialties.

Responses varied all over the map – from “I never answer patient e-mails,” to “What harm could it do, she’s better off getting correct answers from you than incorrect answers from some ‘advocacy’ web site” – and everything in between.

Clearly, this is a controversial issue which will only get more controversial in the future, so I decided to look at what has been published on the subject.

It turns out that as early as 1998, a group of investigators asked this same question and designed a study to address it. (Eysenbach and Diepgen: “Responses to unsolicited patient e-mail requests for medical advice on the World Wide Web. JAMA. 1998;280[15]:1333-5). Posing as a fictitious patient, they sent e-mails to random dermatologists describing an acute dermatological problem, tallied the responses they received, and followed up with a questionnaire to responders and nonresponders alike.

As with my informal survey, the authors found what they termed “a striking lack of consensus” on how to deal with this situation: Fifty percent responded to the fictitious patient’s e-mail. Of those, 31% refused to give advice without seeing the patient, but 59% offered a diagnosis, and a third of that group went on to provide specific advice about therapy. In response to the questionnaire, 28% said that they tended not to answer any patient e-mails, 24% said they usually replied with a standard message, and 24% said they answer each request individually. The authors concluded that “standards for physician response to unsolicited patient e-mail are needed.”

Indeed; but my own survey suggests that, 17 years later, there is still nothing resembling a consensus on this issue. In the interim, several groups, including the American Medical Informatics Association, Medem, and the AMA have proposed guidelines; but none have been generally accepted.

Until such time as that happens, it seems advisable for each individual practice to take the time to adopt its own guidelines. For ideas, take a look at the examples I’ve listed, plus any others you can find. When you’re done, consider running your list past your lawyer to make sure you haven’t forgotten anything, and that there are no peculiar requirements in your state.

Your guidelines may be very simple (if you decide never to answer any queries) or very complex, depending on your situation and personal philosophy. But all guidelines should cover such issues of authentication of patient correspondents, informed consent of those patients, licensing jurisdiction (if you receive e-mails from states in which you are not licensed), and above all, confidentiality.

Contrary to popular belief, the Health Insurance Portability and Accountability Act (HIPAA) does not prohibit such communication, nor require that it be encrypted. The HIPAA website says, “Patients may initiate communications with a provider using e-mail. If this situation occurs, the health care provider can assume (unless the patient has explicitly stated otherwise) that e-mail communications are acceptable to the individual.”

Still, if the lack of encryption and other privacy safeguards makes you (or your patients) uncomfortable, encryption software can be added to your practice’s e-mail system. Enli (www.enli.net), Sigaba (www.sigaba.com), Tumbleweed (www.axway.com), Zix (www.zixcorp.com), and many other vendors sell encryption packages. (As always, I have no financial interest in any product or enterprise mentioned in this column.)

But rather than simply encrypting your e-mail, consider adopting web-based messaging. Patients enter your web site and send a message using an electronic template that you design. You (or a designated staffer) will be notified by regular e-mail when messages are received, and you can post a reply on a page that can be accessed only by the patient. Besides enhancing privacy and security, you can state your guidelines in plain English to preclude any misunderstanding of what you will and will not address online.

Web-based messaging services can be freestanding or incorporated into existing secure websites. Medfusion (www.medfusion.net), and RelayHealth (www.relayhealth.com) are among the leading vendors of secure messaging services.

As for the e-mail query which triggered all this: I responded, but I told the patient I could not provide specific answers to such personal questions over the Internet, particularly when they were asked anonymously; but I would be happy to address her concerns in person, in my office.

And now, I’m writing my guidelines.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].

Recently I received a lengthy e-mail from a very worried woman. She claimed to be an established patient in my office, which I had no way of confirming because she did not sign her message. She asked many questions about sexually transmitted diseases and how they might affect her and a new boyfriend.

I was undecided on how to reply – or even whether to reply at all – so I queried several dozen dermatology colleagues around the country, as well as a few physician friends and acquaintances in other specialties.

Responses varied all over the map – from “I never answer patient e-mails,” to “What harm could it do, she’s better off getting correct answers from you than incorrect answers from some ‘advocacy’ web site” – and everything in between.

Clearly, this is a controversial issue which will only get more controversial in the future, so I decided to look at what has been published on the subject.

It turns out that as early as 1998, a group of investigators asked this same question and designed a study to address it. (Eysenbach and Diepgen: “Responses to unsolicited patient e-mail requests for medical advice on the World Wide Web. JAMA. 1998;280[15]:1333-5). Posing as a fictitious patient, they sent e-mails to random dermatologists describing an acute dermatological problem, tallied the responses they received, and followed up with a questionnaire to responders and nonresponders alike.

As with my informal survey, the authors found what they termed “a striking lack of consensus” on how to deal with this situation: Fifty percent responded to the fictitious patient’s e-mail. Of those, 31% refused to give advice without seeing the patient, but 59% offered a diagnosis, and a third of that group went on to provide specific advice about therapy. In response to the questionnaire, 28% said that they tended not to answer any patient e-mails, 24% said they usually replied with a standard message, and 24% said they answer each request individually. The authors concluded that “standards for physician response to unsolicited patient e-mail are needed.”

Indeed; but my own survey suggests that, 17 years later, there is still nothing resembling a consensus on this issue. In the interim, several groups, including the American Medical Informatics Association, Medem, and the AMA have proposed guidelines; but none have been generally accepted.

Until such time as that happens, it seems advisable for each individual practice to take the time to adopt its own guidelines. For ideas, take a look at the examples I’ve listed, plus any others you can find. When you’re done, consider running your list past your lawyer to make sure you haven’t forgotten anything, and that there are no peculiar requirements in your state.

Your guidelines may be very simple (if you decide never to answer any queries) or very complex, depending on your situation and personal philosophy. But all guidelines should cover such issues of authentication of patient correspondents, informed consent of those patients, licensing jurisdiction (if you receive e-mails from states in which you are not licensed), and above all, confidentiality.

Contrary to popular belief, the Health Insurance Portability and Accountability Act (HIPAA) does not prohibit such communication, nor require that it be encrypted. The HIPAA website says, “Patients may initiate communications with a provider using e-mail. If this situation occurs, the health care provider can assume (unless the patient has explicitly stated otherwise) that e-mail communications are acceptable to the individual.”

Still, if the lack of encryption and other privacy safeguards makes you (or your patients) uncomfortable, encryption software can be added to your practice’s e-mail system. Enli (www.enli.net), Sigaba (www.sigaba.com), Tumbleweed (www.axway.com), Zix (www.zixcorp.com), and many other vendors sell encryption packages. (As always, I have no financial interest in any product or enterprise mentioned in this column.)

But rather than simply encrypting your e-mail, consider adopting web-based messaging. Patients enter your web site and send a message using an electronic template that you design. You (or a designated staffer) will be notified by regular e-mail when messages are received, and you can post a reply on a page that can be accessed only by the patient. Besides enhancing privacy and security, you can state your guidelines in plain English to preclude any misunderstanding of what you will and will not address online.

Web-based messaging services can be freestanding or incorporated into existing secure websites. Medfusion (www.medfusion.net), and RelayHealth (www.relayhealth.com) are among the leading vendors of secure messaging services.

As for the e-mail query which triggered all this: I responded, but I told the patient I could not provide specific answers to such personal questions over the Internet, particularly when they were asked anonymously; but I would be happy to address her concerns in person, in my office.

And now, I’m writing my guidelines.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].

Over the past 15 years a technological tsunami has swept through the health care industry, and few physicians were prepared for the changes wrought by this tidal wave. It now is clear, however, that we are and will have to continue to navigate a future increasingly powered and populated by technology if we are to be successful clinicians. In addition, we must learn to take advantage of all that technology has to offer without compromising the quality of care and compassion we offer our patients. We are fortunate that technology has much to offer to enhance patient care.

One big change under way: Technology 
is leveling the playing field between 
doctors—once the high priests of medicine—and ordinary people. SMART (social, mobile, aware, and real-time) technologies such as cloud computing will broaden the setting of health care interventions from hospital rooms and doctors’ offices to patients’ everyday lives. Cloud computing involves the use of a network of remote servers hosted on the Internet to store, manage, and process data, rather than a local server or a desktop computer located in the doctor’s office. It is possible that, instead of being episodic, health care will be conducted continuously—and anywhere the patient wants it.

Without a doubt, the pace at which new technology affects our lives is increasing at lightning speeds. Today, 29% of Americans say their phone is the first and the last thing they look at each day, a telling sign of how dependent we are becoming on technology.¹ In this article, we look at 4 technologies that can be effective in the clinical setting, attracting new patients and enhancing productivity, communication, and patient care.

1. A mobile-friendly Web site

According to Wikipedia, there are 
327,577,529 mobile phones in the 
United States, give or take a few thousand. As of July 4, 2014, the US population was 318,881,992. That means there are more mobile phones in this country than there 
are people!²

Mobile phones are becoming more like personal assistants than phones. People are not just making calls, they’re buying movie tickets, checking the weather, sending and receiving emails, texting, making reservations, checking Web sites … and the list goes on.

According to a recent report from the Pew Research Center, almost two-thirds of Americans own a smartphone, and 62% of smartphone owners have used it to look up information on a health condition.³ Moreover, 15% of smartphone owners say they have a limited number of ways to access the Internet other than their cell phone.³

All the more reason for your Web site to be mobile-friendly. With a mobile- 
friendly site, the content is displayed in a more streamlined fashion on mobile phones, with larger type to make it more readable. See, for example, the FIGURE, which shows Dr. Baum’s regular Web site side by side with the mobile-friendly view.

There is another reason why you should ensure that your site is mobile-friendly: Google recently changed its algorithms so that, when someone searches for information on a mobile phone, only mobile- 
friendly sites make it into the top search results. Google wants mobile phone users to have a positive experience online. It is so adamant about this desire that it will lower your rankings or not show your Web site at all in search results if you fail to comply.

New patient acquisition is critical for any ObGyn practice, and we already know that just about everyone goes online to search for health information and solutions to their medical problems. If you want your practice to survive and thrive, you need to attract new patients online. If a visitor to your site cannot read the text and has to keep resizing the screen and scrolling left and right, you will lose that visitor in a hurry.

We all want to find what we are looking for quickly. In our experience, when we check Google Analytics reports for our 
ObGyn clients, we find that visitors to a nonresponsive site spend much less time there and do not visit as many pages as they do when a site is mobile-responsive.

To check your Web site’s mobile rating, go to http://www.google.com/webmasters/tools/mobile-friendly. Google also offers tips on making your site mobile-friendly at https://support.google.com/webmasters/answer/6001177?hl=en.

Once your site is up to snuff, you should test it from multiple devices to ensure that the pages are easily readable on all types of phones and computers.

2. Voice recognition software

Speech recognition is the ability of a machine or program to identify words and phrases in spoken language and convert them to a digital format. This tool can help you generate clinical notes and charting without having to stop and type into a computer. This can enhance your interactions with patients by freeing you from the computer during examinations and counseling and allows you to look at the patient and not at the computer.

According to data from June 2000, approximately 5% of physicians used speech recognition to generate text in their offices.⁴ A white paper from 2008 found that approximately 20% of physicians are using more advanced, more reliable voice recognition technology and saving both time and money.⁵ This report cited 2007 data showing that:

• 76% of clinicians who used “desktop speech recognition” (directly controlling an electronic health record [EHR] system via speech) reported faster turnaround time, better patient care, and quicker reimbursement
• Nearly 30% reported lower costs and increased productivity as benefits. The lower costs arise from reduced transcription and overhead expenses associated with billings and collection.⁵

The voice recognition software used in Dr. Neil Baum’s office is Dragon 
Medical Practice Edition 2 (www.dragonmedicalpractice.com). Dragon requires a good processor and a minimum of 4 gigabytes of RAM and will run with VMware, Boot Camp, Parallels, and other programs for Mac users. The software contains 80 subspecialty medical vocabularies and is easy to install. After a few minutes, the program learns how you speak and will understand you well with remarkable accuracy. However, to get the greatest benefit from the technology, you will need to invest in training, implementation, and workflow services to allow you to use the program to its full potential in record time.

Dr. Baum uses The Dragon People voice recognition software (www.thedragonpeople.com).

Although voice recognition software can reduce or eliminate transcription costs, improve documentation time, and boost the quality of medical notes, it is critical that you investigate how a particular program fits with your EHR prior to purchasing it—and a salesperson may try to gloss over this issue. In addition, the more you use voice recognition instead of checking off pull-down boxes for your clinical notes, the more difficult it will be to mine your data for quality metrics and pay-for-performance information. For that reason, voice recognition technology may be strongly discouraged by your employer or governing organization.

3. Online lab result reporting

TeleVox’s automated lab results (www
.televox.com/lab-test-results-delivery) allow physicians or staff to assign lab result messages quickly and easily with the click of a mouse. Patients call an 800 number or use an Internet connection to retrieve their results, using a unique PIN to ensure privacy.

Practices that implement this technology see immediate improvements in 3 areas:

• Streamlined operations. This technology allows lab result messages to be assigned to patients with a few mouse clicks, saving time spent on phone calls and mailing coordination.
• Reduced costs. Automated lab result reporting reduces staff labor and mailing costs.
• Ease of access. Patients have round-the-clock access to their information—no more waiting for mail delivery or a phone call. Patients also can choose to be notified when their results are ready, which helps alleviate anxiety.

4. Automated wait-time notification

The most common complaint patients have about their health care experience is the excessive wait times they often experience. Now there are technologies that can provide automated information to let patients know how long they will have to wait to be seen.

A program such as MedWaitTime (www.medwaittime.com) can alert patients about the estimated wait time at a cost of approximately $50 per month per physician. Patients access the service for free.

In addition, many EHRs include practice management features to notify the staff and physician whether he or she is on time. These features may include a tie-in to alert patients as well.

The bottom line

Carefully selected technological tools have much to offer busy clinicians. By ensuring that your practice Web site is mobile- 
friendly, you stand to attract new patients. And the time you save with voice recognition software and computerized lab test result notification can allow you to spend more time with your patients. It can also help eliminate the lag in your patient schedule, keeping the women in your waiting room happy. Remember, a happy patient means a happy doctor!

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

Over the past 15 years a technological tsunami has swept through the health care industry, and few physicians were prepared for the changes wrought by this tidal wave. It now is clear, however, that we are and will have to continue to navigate a future increasingly powered and populated by technology if we are to be successful clinicians. In addition, we must learn to take advantage of all that technology has to offer without compromising the quality of care and compassion we offer our patients. We are fortunate that technology has much to offer to enhance patient care.

One big change under way: Technology 
is leveling the playing field between 
doctors—once the high priests of medicine—and ordinary people. SMART (social, mobile, aware, and real-time) technologies such as cloud computing will broaden the setting of health care interventions from hospital rooms and doctors’ offices to patients’ everyday lives. Cloud computing involves the use of a network of remote servers hosted on the Internet to store, manage, and process data, rather than a local server or a desktop computer located in the doctor’s office. It is possible that, instead of being episodic, health care will be conducted continuously—and anywhere the patient wants it.

Without a doubt, the pace at which new technology affects our lives is increasing at lightning speeds. Today, 29% of Americans say their phone is the first and the last thing they look at each day, a telling sign of how dependent we are becoming on technology.¹ In this article, we look at 4 technologies that can be effective in the clinical setting, attracting new patients and enhancing productivity, communication, and patient care.

1. A mobile-friendly Web site

According to Wikipedia, there are 
327,577,529 mobile phones in the 
United States, give or take a few thousand. As of July 4, 2014, the US population was 318,881,992. That means there are more mobile phones in this country than there 
are people!²

Mobile phones are becoming more like personal assistants than phones. People are not just making calls, they’re buying movie tickets, checking the weather, sending and receiving emails, texting, making reservations, checking Web sites … and the list goes on.

According to a recent report from the Pew Research Center, almost two-thirds of Americans own a smartphone, and 62% of smartphone owners have used it to look up information on a health condition.³ Moreover, 15% of smartphone owners say they have a limited number of ways to access the Internet other than their cell phone.³

All the more reason for your Web site to be mobile-friendly. With a mobile- 
friendly site, the content is displayed in a more streamlined fashion on mobile phones, with larger type to make it more readable. See, for example, the FIGURE, which shows Dr. Baum’s regular Web site side by side with the mobile-friendly view.

There is another reason why you should ensure that your site is mobile-friendly: Google recently changed its algorithms so that, when someone searches for information on a mobile phone, only mobile- 
friendly sites make it into the top search results. Google wants mobile phone users to have a positive experience online. It is so adamant about this desire that it will lower your rankings or not show your Web site at all in search results if you fail to comply.

New patient acquisition is critical for any ObGyn practice, and we already know that just about everyone goes online to search for health information and solutions to their medical problems. If you want your practice to survive and thrive, you need to attract new patients online. If a visitor to your site cannot read the text and has to keep resizing the screen and scrolling left and right, you will lose that visitor in a hurry.

We all want to find what we are looking for quickly. In our experience, when we check Google Analytics reports for our 
ObGyn clients, we find that visitors to a nonresponsive site spend much less time there and do not visit as many pages as they do when a site is mobile-responsive.

To check your Web site’s mobile rating, go to http://www.google.com/webmasters/tools/mobile-friendly. Google also offers tips on making your site mobile-friendly at https://support.google.com/webmasters/answer/6001177?hl=en.

Once your site is up to snuff, you should test it from multiple devices to ensure that the pages are easily readable on all types of phones and computers.

2. Voice recognition software

Speech recognition is the ability of a machine or program to identify words and phrases in spoken language and convert them to a digital format. This tool can help you generate clinical notes and charting without having to stop and type into a computer. This can enhance your interactions with patients by freeing you from the computer during examinations and counseling and allows you to look at the patient and not at the computer.

According to data from June 2000, approximately 5% of physicians used speech recognition to generate text in their offices.⁴ A white paper from 2008 found that approximately 20% of physicians are using more advanced, more reliable voice recognition technology and saving both time and money.⁵ This report cited 2007 data showing that:

• 76% of clinicians who used “desktop speech recognition” (directly controlling an electronic health record [EHR] system via speech) reported faster turnaround time, better patient care, and quicker reimbursement
• Nearly 30% reported lower costs and increased productivity as benefits. The lower costs arise from reduced transcription and overhead expenses associated with billings and collection.⁵

The voice recognition software used in Dr. Neil Baum’s office is Dragon 
Medical Practice Edition 2 (www.dragonmedicalpractice.com). Dragon requires a good processor and a minimum of 4 gigabytes of RAM and will run with VMware, Boot Camp, Parallels, and other programs for Mac users. The software contains 80 subspecialty medical vocabularies and is easy to install. After a few minutes, the program learns how you speak and will understand you well with remarkable accuracy. However, to get the greatest benefit from the technology, you will need to invest in training, implementation, and workflow services to allow you to use the program to its full potential in record time.

Dr. Baum uses The Dragon People voice recognition software (www.thedragonpeople.com).

Although voice recognition software can reduce or eliminate transcription costs, improve documentation time, and boost the quality of medical notes, it is critical that you investigate how a particular program fits with your EHR prior to purchasing it—and a salesperson may try to gloss over this issue. In addition, the more you use voice recognition instead of checking off pull-down boxes for your clinical notes, the more difficult it will be to mine your data for quality metrics and pay-for-performance information. For that reason, voice recognition technology may be strongly discouraged by your employer or governing organization.

3. Online lab result reporting

TeleVox’s automated lab results (www
.televox.com/lab-test-results-delivery) allow physicians or staff to assign lab result messages quickly and easily with the click of a mouse. Patients call an 800 number or use an Internet connection to retrieve their results, using a unique PIN to ensure privacy.

Practices that implement this technology see immediate improvements in 3 areas:

• Streamlined operations. This technology allows lab result messages to be assigned to patients with a few mouse clicks, saving time spent on phone calls and mailing coordination.
• Reduced costs. Automated lab result reporting reduces staff labor and mailing costs.
• Ease of access. Patients have round-the-clock access to their information—no more waiting for mail delivery or a phone call. Patients also can choose to be notified when their results are ready, which helps alleviate anxiety.

4. Automated wait-time notification

The most common complaint patients have about their health care experience is the excessive wait times they often experience. Now there are technologies that can provide automated information to let patients know how long they will have to wait to be seen.

A program such as MedWaitTime (www.medwaittime.com) can alert patients about the estimated wait time at a cost of approximately $50 per month per physician. Patients access the service for free.

In addition, many EHRs include practice management features to notify the staff and physician whether he or she is on time. These features may include a tie-in to alert patients as well.

The bottom line

Carefully selected technological tools have much to offer busy clinicians. By ensuring that your practice Web site is mobile- 
friendly, you stand to attract new patients. And the time you save with voice recognition software and computerized lab test result notification can allow you to spend more time with your patients. It can also help eliminate the lag in your patient schedule, keeping the women in your waiting room happy. Remember, a happy patient means a happy doctor!

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

Over the past 15 years a technological tsunami has swept through the health care industry, and few physicians were prepared for the changes wrought by this tidal wave. It now is clear, however, that we are and will have to continue to navigate a future increasingly powered and populated by technology if we are to be successful clinicians. In addition, we must learn to take advantage of all that technology has to offer without compromising the quality of care and compassion we offer our patients. We are fortunate that technology has much to offer to enhance patient care.

One big change under way: Technology 
is leveling the playing field between 
doctors—once the high priests of medicine—and ordinary people. SMART (social, mobile, aware, and real-time) technologies such as cloud computing will broaden the setting of health care interventions from hospital rooms and doctors’ offices to patients’ everyday lives. Cloud computing involves the use of a network of remote servers hosted on the Internet to store, manage, and process data, rather than a local server or a desktop computer located in the doctor’s office. It is possible that, instead of being episodic, health care will be conducted continuously—and anywhere the patient wants it.

Without a doubt, the pace at which new technology affects our lives is increasing at lightning speeds. Today, 29% of Americans say their phone is the first and the last thing they look at each day, a telling sign of how dependent we are becoming on technology.¹ In this article, we look at 4 technologies that can be effective in the clinical setting, attracting new patients and enhancing productivity, communication, and patient care.

1. A mobile-friendly Web site

According to Wikipedia, there are 
327,577,529 mobile phones in the 
United States, give or take a few thousand. As of July 4, 2014, the US population was 318,881,992. That means there are more mobile phones in this country than there 
are people!²

Mobile phones are becoming more like personal assistants than phones. People are not just making calls, they’re buying movie tickets, checking the weather, sending and receiving emails, texting, making reservations, checking Web sites … and the list goes on.

According to a recent report from the Pew Research Center, almost two-thirds of Americans own a smartphone, and 62% of smartphone owners have used it to look up information on a health condition.³ Moreover, 15% of smartphone owners say they have a limited number of ways to access the Internet other than their cell phone.³

All the more reason for your Web site to be mobile-friendly. With a mobile- 
friendly site, the content is displayed in a more streamlined fashion on mobile phones, with larger type to make it more readable. See, for example, the FIGURE, which shows Dr. Baum’s regular Web site side by side with the mobile-friendly view.

There is another reason why you should ensure that your site is mobile-friendly: Google recently changed its algorithms so that, when someone searches for information on a mobile phone, only mobile- 
friendly sites make it into the top search results. Google wants mobile phone users to have a positive experience online. It is so adamant about this desire that it will lower your rankings or not show your Web site at all in search results if you fail to comply.

New patient acquisition is critical for any ObGyn practice, and we already know that just about everyone goes online to search for health information and solutions to their medical problems. If you want your practice to survive and thrive, you need to attract new patients online. If a visitor to your site cannot read the text and has to keep resizing the screen and scrolling left and right, you will lose that visitor in a hurry.

We all want to find what we are looking for quickly. In our experience, when we check Google Analytics reports for our 
ObGyn clients, we find that visitors to a nonresponsive site spend much less time there and do not visit as many pages as they do when a site is mobile-responsive.

To check your Web site’s mobile rating, go to http://www.google.com/webmasters/tools/mobile-friendly. Google also offers tips on making your site mobile-friendly at https://support.google.com/webmasters/answer/6001177?hl=en.

Once your site is up to snuff, you should test it from multiple devices to ensure that the pages are easily readable on all types of phones and computers.

2. Voice recognition software

Speech recognition is the ability of a machine or program to identify words and phrases in spoken language and convert them to a digital format. This tool can help you generate clinical notes and charting without having to stop and type into a computer. This can enhance your interactions with patients by freeing you from the computer during examinations and counseling and allows you to look at the patient and not at the computer.

According to data from June 2000, approximately 5% of physicians used speech recognition to generate text in their offices.⁴ A white paper from 2008 found that approximately 20% of physicians are using more advanced, more reliable voice recognition technology and saving both time and money.⁵ This report cited 2007 data showing that:

• 76% of clinicians who used “desktop speech recognition” (directly controlling an electronic health record [EHR] system via speech) reported faster turnaround time, better patient care, and quicker reimbursement
• Nearly 30% reported lower costs and increased productivity as benefits. The lower costs arise from reduced transcription and overhead expenses associated with billings and collection.⁵

The voice recognition software used in Dr. Neil Baum’s office is Dragon 
Medical Practice Edition 2 (www.dragonmedicalpractice.com). Dragon requires a good processor and a minimum of 4 gigabytes of RAM and will run with VMware, Boot Camp, Parallels, and other programs for Mac users. The software contains 80 subspecialty medical vocabularies and is easy to install. After a few minutes, the program learns how you speak and will understand you well with remarkable accuracy. However, to get the greatest benefit from the technology, you will need to invest in training, implementation, and workflow services to allow you to use the program to its full potential in record time.

Dr. Baum uses The Dragon People voice recognition software (www.thedragonpeople.com).

Although voice recognition software can reduce or eliminate transcription costs, improve documentation time, and boost the quality of medical notes, it is critical that you investigate how a particular program fits with your EHR prior to purchasing it—and a salesperson may try to gloss over this issue. In addition, the more you use voice recognition instead of checking off pull-down boxes for your clinical notes, the more difficult it will be to mine your data for quality metrics and pay-for-performance information. For that reason, voice recognition technology may be strongly discouraged by your employer or governing organization.

3. Online lab result reporting

TeleVox’s automated lab results (www
.televox.com/lab-test-results-delivery) allow physicians or staff to assign lab result messages quickly and easily with the click of a mouse. Patients call an 800 number or use an Internet connection to retrieve their results, using a unique PIN to ensure privacy.

Practices that implement this technology see immediate improvements in 3 areas:

• Streamlined operations. This technology allows lab result messages to be assigned to patients with a few mouse clicks, saving time spent on phone calls and mailing coordination.
• Reduced costs. Automated lab result reporting reduces staff labor and mailing costs.
• Ease of access. Patients have round-the-clock access to their information—no more waiting for mail delivery or a phone call. Patients also can choose to be notified when their results are ready, which helps alleviate anxiety.

4. Automated wait-time notification

The most common complaint patients have about their health care experience is the excessive wait times they often experience. Now there are technologies that can provide automated information to let patients know how long they will have to wait to be seen.

A program such as MedWaitTime (www.medwaittime.com) can alert patients about the estimated wait time at a cost of approximately $50 per month per physician. Patients access the service for free.

In addition, many EHRs include practice management features to notify the staff and physician whether he or she is on time. These features may include a tie-in to alert patients as well.

The bottom line

Carefully selected technological tools have much to offer busy clinicians. By ensuring that your practice Web site is mobile- 
friendly, you stand to attract new patients. And the time you save with voice recognition software and computerized lab test result notification can allow you to spend more time with your patients. It can also help eliminate the lag in your patient schedule, keeping the women in your waiting room happy. Remember, a happy patient means a happy doctor!

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

A group of 3 busy orthopedists attended coding education each year and did their best to accurately code and document their services. As a risk-reduction strategy, the group engaged our firm to conduct an audit to determine whether they were documenting their services properly and to provide feedback about how they could improve.

What we found was shocking to the surgeons, but all too common, as we review thousands of orthopedic visit notes every year: The same examination had been documented for all visits, with physicians stating in their notes that the examination was medically necessary. In addition, their documentation supported Current Procedural Terminology (CPT) code 99214 at every visit, with visit frequencies of 2 weeks to 4 months.

The culprit of all this sameness? The practice’s electronic health record (EHR).

“Practices with EHRs often have a large volume of visit notes that look almost identical for a patient who is seen for multiple visits,” explains Mary LeGrand, RN, MA, CCS-P, CPC, KarenZupko & Associates consultant and coding educator. “And that is putting physicians at higher risk of being audited or of not passing an audit.”

According to LeGrand, this is because physicians are using the practice’s EHR to “pull forward” the patient’s previous visit note for the current visit, but failing to customize it for the current visit. The unintended consequence of this workflow efficiency is twofold:

1. It creates documentation that looks strikingly similar to, if not exactly like, the patient’s last billed visit note. This is often referred to as note “cloning.”

2. It creates documentation that includes a lot of unnecessary detail that, even if delivered and documented, doesn’t match the medical necessity of the visit, based on the history of present illness statements.

Both of these things can come back to bite you.

Zero in on the Risk

If your practice has an EHR, it is important that you evaluate whether certain workflow efficiency features are putting the practice at risk. You do not necessarily need to dump the EHR, but you may need to take action to reduce the risk of using these features.

In a pre-EHR practice, physicians began each visit with a blank piece of paper or dictated the entire visit. Then along came EHR vendors who, in an effort to make things easier and more efficient, created visit templates and the ability to “pull forward” the last visit note and use it as a basis for the current visit. The intention was always that physicians would modify it based on the current visit. But the reality is that physicians are busy, editing is time-consuming, and the unintended consequence is cloning.

“If you pull in unnecessary history or exam information from a previous visit that’s not relevant to the current visit, you can get dinged in an audit for not customizing the note to the patient’s specific presenting complaint,” LeGrand explains, “or, for attempting to bill a higher-level code by unintentionally padding the note with irrelevant information. What is documented for ‘reference’ has to be separated from what can be used to select the level of service.”

Your first documentation risk-reduction strategy is to review notes and look for signs of cloning.

LeGrand explains that a practice may be predisposed to cloning simply because of the way the EHR templates and workflow were set up when the system was implemented. “But,” she says, “‘the EHR made me do it’ defense won’t hold water, because it’s still the physician’s responsibility to customize or remove the information from templates and make the note unique to the visit.”

Yes, physician time is precious. But the reality is that the onus is on the physician to integrate EHR features with clinic workflow and to follow documentation rules.

The second documentation risk-reduction strategy is to make sure the level of evaluation and management (E/M) service billed is supported by medical necessity, not only by documentation artifacts that were relevant to the patient in the past but irrelevant to his or her current presenting complaint or condition.

“Medicare won’t pay for services that aren’t supported by medical necessity,” says LeGrand, “and you can’t achieve medical necessity by simply documenting additional E/M elements.”

This has always been the rule, LeGrand says. “But with the increased use of EHRs, and templates that automatically document visit elements and drive visits to a higher level of service, the Centers for Medicare & Medicaid Services [CMS] and private payers have added scrutiny to medical necessity reviews. They want to validate that higher-level visits billed indeed required a higher level of history and/or exam.”

To do this, the Office of the Inspector General (OIG) has supplemented its audit team with registered nurses. “The nurses assist certified coders by determining whether medical necessity has been met,” explains LeGrand.

 Look at a patient who presents with toe pain. You take a detailed family history, conduct a review of systems (ROS), bill a high-level code, and document all the elements to support it. LeGrand explains, “There is no medical necessity to support doing an eye exam for a patient with toe pain in the absence of any other medical history, or performing a ROS to correlate an eye exam with toe pain. So, even if you do it and document it, the higher-level code won’t pass muster in an audit because the information documented is not medically necessary.”

According to LeGrand, the extent of the history and examination should be based on the presenting problem and the patient’s condition. “If an ankle sprain patient returns 2 weeks after the initial evaluation of the injury with a negative medical or surgical history, and the patient has been treated conservatively, it’s probably not necessary to conduct a ROS that includes 10 organ systems,” she says. “If your standard of care is to perform this level of service, no one will fault you for your care delivery; however, if you also choose a level of service based on this system review, without relevance to the presenting problem, and you bill a higher level of service than is supported by the nature of the presenting problem or the plan of care, the documentation probably won’t hold up in an audit where medical necessity is valued into the equation.”

On the other hand, LeGrand adds, if a patient presents to the emergency department after an automobile accident with an open fracture and other injuries, and the surgeon performs a complete ROS, the medical necessity would most likely be supported as the surgeon is preparing the patient for surgery.

Based on LeGrand’s work with practices, this distinction about medical necessity is news to many nonclinical billing staff. “They confuse medical necessity with medical decision-making, an E/M code documentation component, and incorrectly bill for a high-level visit because medical decision-making elements meet the documentation requirements—yet the code is not supported by medical necessity of the presenting problem.”

Talk with your billing team to make sure all staff members understand this critical difference. They must comprehend that the medically necessary level of service is determined by a number of clinical factors, not medical decision-making. Describe some of these clinical factors, which include, but are not limited to, chief complaint, clinical judgment, standards of practice, acute exacerbations/onsets of medical conditions or injuries, and comorbidities.

EHR Dos and Don’ts

LeGrand recommends the following best practices for using EHR documentation features:

 1. DON’T simply cut and paste from a previous note. “This is what leads to verbose notes that have little to do with the patient you are documenting,” she says. “If you don’t cut and paste, you’ll avoid the root cause of this risk.”

2. DON’T pull forward information from previous visit notes that have nothing to do with the nature of the patient’s problem. “We understand that this takes extra time because physicians must review the previous note,” LeGrand says. “So if you don’t have time to review the past note, just don’t pull it forward. Start fresh with a new drop-down menu and select elements pertinent to the current visit. Or, dictate or type a note relevant to the current condition and presenting problems.”

How you choose to work this into your process will vary depending on which EHR system you use. “One surgeon I work with dictates everything because the drop-down menus and templates are cumbersome,” LeGrand says. “Some groups find it faster to use the EHR templates that they have customized. Others find their EHR’s point-and-click features most efficient for customizing quickly.”

3. DO customize your EHR visit templates if the use of templates is critical to your efficiency. “This is the most overlooked step in the EHR implementation process because it takes a fair amount of time to do,” LeGrand says. She suggests avoiding the use of multisystem examination templates created for medicine specialties altogether, and insists, “Don’t assume ‘that is how the vendor built it so we have to use it.’ Customize a template for each of your visit types so you can document in the EHR in the same fashion as when you used a paper system. Doing so will save you loads of documentation time.”

4. DO review your E/M code distribution. Generate a CPT frequency report for each physician and for the practice as a whole. Compare the data with state and national usage in orthopedics as a baseline. The American Academy of Orthopaedic Surgeon’s Code-X tool enables easy comparison of your practice’s E/M code usage with state and national data for orthopedics. Simply generate a CPT frequency report from your practice management system and enter the E/M data. Line graphs are automatically generated, making trends and patterns easy to see (Figure).

“Identify your outliers, pull charts randomly, and review the notes,” recommends LeGrand. “Make sure there is medical necessity for the level of code that’s been billed and that documentation supports it.”

You may be surprised to find you are an outlier on inpatient hospital codes, or your distribution of level-2 or -3 codes varies from your practice, state, or national data. Orthopedic surgeons don’t typically report high volumes of CPT codes 99204, 99205 or 99215, but if your practice does and you are an outlier, best to pay attention before someone else does.

 5. DO select auditors with the right skill sets. Evaluating medical necessity in the note requires a clinical background. “If internal documentation reviews are conducted by the billing team, that’s fine,” LeGrand advises. “Just add a physician assistant or nurse to your internal review team. They can provide clinical oversight and review the note when necessary for medical necessity.”

If you are contracting with external auditors or consultants, verify auditor credentials and skill sets to ensure they can abstract and incorporate medical necessity into the review. “Auditors must be able to do more than count elements,” LeGrand says. “They must have clinical knowledge, and expertise in orthopedics is critical. This knowledge should be used to verify that medical necessity is present in every note.” LeGrand is quick to point out that not every note will be at risk, based on the amount of work performed and documented and the level of service billed. “But medical necessity must always be present.”

The addition of nurses to the OIG’s audit team is a big change and will refine the auditing process by adding more clinical scrutiny. The EHR documentation features are intended to improve efficiency, but only a clinician can determine and document unique visit elements and medical necessity.

Address these intersections of risk by ensuring your documentation meets medical necessity as well as E/M documentation elements. Conduct internal audits bi-annually to verify that E/M usage patterns align with peers and physician documentation is appropriate. And be sure there is clinical expertise on your audit team, whether it is internal or external. CMS now has it, and your practice should too.  ◾

A group of 3 busy orthopedists attended coding education each year and did their best to accurately code and document their services. As a risk-reduction strategy, the group engaged our firm to conduct an audit to determine whether they were documenting their services properly and to provide feedback about how they could improve.

What we found was shocking to the surgeons, but all too common, as we review thousands of orthopedic visit notes every year: The same examination had been documented for all visits, with physicians stating in their notes that the examination was medically necessary. In addition, their documentation supported Current Procedural Terminology (CPT) code 99214 at every visit, with visit frequencies of 2 weeks to 4 months.

The culprit of all this sameness? The practice’s electronic health record (EHR).

“Practices with EHRs often have a large volume of visit notes that look almost identical for a patient who is seen for multiple visits,” explains Mary LeGrand, RN, MA, CCS-P, CPC, KarenZupko & Associates consultant and coding educator. “And that is putting physicians at higher risk of being audited or of not passing an audit.”

According to LeGrand, this is because physicians are using the practice’s EHR to “pull forward” the patient’s previous visit note for the current visit, but failing to customize it for the current visit. The unintended consequence of this workflow efficiency is twofold:

1. It creates documentation that looks strikingly similar to, if not exactly like, the patient’s last billed visit note. This is often referred to as note “cloning.”

2. It creates documentation that includes a lot of unnecessary detail that, even if delivered and documented, doesn’t match the medical necessity of the visit, based on the history of present illness statements.

Both of these things can come back to bite you.

Zero in on the Risk

If your practice has an EHR, it is important that you evaluate whether certain workflow efficiency features are putting the practice at risk. You do not necessarily need to dump the EHR, but you may need to take action to reduce the risk of using these features.

In a pre-EHR practice, physicians began each visit with a blank piece of paper or dictated the entire visit. Then along came EHR vendors who, in an effort to make things easier and more efficient, created visit templates and the ability to “pull forward” the last visit note and use it as a basis for the current visit. The intention was always that physicians would modify it based on the current visit. But the reality is that physicians are busy, editing is time-consuming, and the unintended consequence is cloning.

“If you pull in unnecessary history or exam information from a previous visit that’s not relevant to the current visit, you can get dinged in an audit for not customizing the note to the patient’s specific presenting complaint,” LeGrand explains, “or, for attempting to bill a higher-level code by unintentionally padding the note with irrelevant information. What is documented for ‘reference’ has to be separated from what can be used to select the level of service.”

Your first documentation risk-reduction strategy is to review notes and look for signs of cloning.

LeGrand explains that a practice may be predisposed to cloning simply because of the way the EHR templates and workflow were set up when the system was implemented. “But,” she says, “‘the EHR made me do it’ defense won’t hold water, because it’s still the physician’s responsibility to customize or remove the information from templates and make the note unique to the visit.”

Yes, physician time is precious. But the reality is that the onus is on the physician to integrate EHR features with clinic workflow and to follow documentation rules.

The second documentation risk-reduction strategy is to make sure the level of evaluation and management (E/M) service billed is supported by medical necessity, not only by documentation artifacts that were relevant to the patient in the past but irrelevant to his or her current presenting complaint or condition.

“Medicare won’t pay for services that aren’t supported by medical necessity,” says LeGrand, “and you can’t achieve medical necessity by simply documenting additional E/M elements.”

This has always been the rule, LeGrand says. “But with the increased use of EHRs, and templates that automatically document visit elements and drive visits to a higher level of service, the Centers for Medicare & Medicaid Services [CMS] and private payers have added scrutiny to medical necessity reviews. They want to validate that higher-level visits billed indeed required a higher level of history and/or exam.”

To do this, the Office of the Inspector General (OIG) has supplemented its audit team with registered nurses. “The nurses assist certified coders by determining whether medical necessity has been met,” explains LeGrand.

 Look at a patient who presents with toe pain. You take a detailed family history, conduct a review of systems (ROS), bill a high-level code, and document all the elements to support it. LeGrand explains, “There is no medical necessity to support doing an eye exam for a patient with toe pain in the absence of any other medical history, or performing a ROS to correlate an eye exam with toe pain. So, even if you do it and document it, the higher-level code won’t pass muster in an audit because the information documented is not medically necessary.”

According to LeGrand, the extent of the history and examination should be based on the presenting problem and the patient’s condition. “If an ankle sprain patient returns 2 weeks after the initial evaluation of the injury with a negative medical or surgical history, and the patient has been treated conservatively, it’s probably not necessary to conduct a ROS that includes 10 organ systems,” she says. “If your standard of care is to perform this level of service, no one will fault you for your care delivery; however, if you also choose a level of service based on this system review, without relevance to the presenting problem, and you bill a higher level of service than is supported by the nature of the presenting problem or the plan of care, the documentation probably won’t hold up in an audit where medical necessity is valued into the equation.”

On the other hand, LeGrand adds, if a patient presents to the emergency department after an automobile accident with an open fracture and other injuries, and the surgeon performs a complete ROS, the medical necessity would most likely be supported as the surgeon is preparing the patient for surgery.

Based on LeGrand’s work with practices, this distinction about medical necessity is news to many nonclinical billing staff. “They confuse medical necessity with medical decision-making, an E/M code documentation component, and incorrectly bill for a high-level visit because medical decision-making elements meet the documentation requirements—yet the code is not supported by medical necessity of the presenting problem.”

Talk with your billing team to make sure all staff members understand this critical difference. They must comprehend that the medically necessary level of service is determined by a number of clinical factors, not medical decision-making. Describe some of these clinical factors, which include, but are not limited to, chief complaint, clinical judgment, standards of practice, acute exacerbations/onsets of medical conditions or injuries, and comorbidities.

EHR Dos and Don’ts

LeGrand recommends the following best practices for using EHR documentation features:

 1. DON’T simply cut and paste from a previous note. “This is what leads to verbose notes that have little to do with the patient you are documenting,” she says. “If you don’t cut and paste, you’ll avoid the root cause of this risk.”

2. DON’T pull forward information from previous visit notes that have nothing to do with the nature of the patient’s problem. “We understand that this takes extra time because physicians must review the previous note,” LeGrand says. “So if you don’t have time to review the past note, just don’t pull it forward. Start fresh with a new drop-down menu and select elements pertinent to the current visit. Or, dictate or type a note relevant to the current condition and presenting problems.”

How you choose to work this into your process will vary depending on which EHR system you use. “One surgeon I work with dictates everything because the drop-down menus and templates are cumbersome,” LeGrand says. “Some groups find it faster to use the EHR templates that they have customized. Others find their EHR’s point-and-click features most efficient for customizing quickly.”

3. DO customize your EHR visit templates if the use of templates is critical to your efficiency. “This is the most overlooked step in the EHR implementation process because it takes a fair amount of time to do,” LeGrand says. She suggests avoiding the use of multisystem examination templates created for medicine specialties altogether, and insists, “Don’t assume ‘that is how the vendor built it so we have to use it.’ Customize a template for each of your visit types so you can document in the EHR in the same fashion as when you used a paper system. Doing so will save you loads of documentation time.”

4. DO review your E/M code distribution. Generate a CPT frequency report for each physician and for the practice as a whole. Compare the data with state and national usage in orthopedics as a baseline. The American Academy of Orthopaedic Surgeon’s Code-X tool enables easy comparison of your practice’s E/M code usage with state and national data for orthopedics. Simply generate a CPT frequency report from your practice management system and enter the E/M data. Line graphs are automatically generated, making trends and patterns easy to see (Figure).

“Identify your outliers, pull charts randomly, and review the notes,” recommends LeGrand. “Make sure there is medical necessity for the level of code that’s been billed and that documentation supports it.”

You may be surprised to find you are an outlier on inpatient hospital codes, or your distribution of level-2 or -3 codes varies from your practice, state, or national data. Orthopedic surgeons don’t typically report high volumes of CPT codes 99204, 99205 or 99215, but if your practice does and you are an outlier, best to pay attention before someone else does.

 5. DO select auditors with the right skill sets. Evaluating medical necessity in the note requires a clinical background. “If internal documentation reviews are conducted by the billing team, that’s fine,” LeGrand advises. “Just add a physician assistant or nurse to your internal review team. They can provide clinical oversight and review the note when necessary for medical necessity.”

If you are contracting with external auditors or consultants, verify auditor credentials and skill sets to ensure they can abstract and incorporate medical necessity into the review. “Auditors must be able to do more than count elements,” LeGrand says. “They must have clinical knowledge, and expertise in orthopedics is critical. This knowledge should be used to verify that medical necessity is present in every note.” LeGrand is quick to point out that not every note will be at risk, based on the amount of work performed and documented and the level of service billed. “But medical necessity must always be present.”

The addition of nurses to the OIG’s audit team is a big change and will refine the auditing process by adding more clinical scrutiny. The EHR documentation features are intended to improve efficiency, but only a clinician can determine and document unique visit elements and medical necessity.

Address these intersections of risk by ensuring your documentation meets medical necessity as well as E/M documentation elements. Conduct internal audits bi-annually to verify that E/M usage patterns align with peers and physician documentation is appropriate. And be sure there is clinical expertise on your audit team, whether it is internal or external. CMS now has it, and your practice should too.  ◾

A group of 3 busy orthopedists attended coding education each year and did their best to accurately code and document their services. As a risk-reduction strategy, the group engaged our firm to conduct an audit to determine whether they were documenting their services properly and to provide feedback about how they could improve.

What we found was shocking to the surgeons, but all too common, as we review thousands of orthopedic visit notes every year: The same examination had been documented for all visits, with physicians stating in their notes that the examination was medically necessary. In addition, their documentation supported Current Procedural Terminology (CPT) code 99214 at every visit, with visit frequencies of 2 weeks to 4 months.

The culprit of all this sameness? The practice’s electronic health record (EHR).

“Practices with EHRs often have a large volume of visit notes that look almost identical for a patient who is seen for multiple visits,” explains Mary LeGrand, RN, MA, CCS-P, CPC, KarenZupko & Associates consultant and coding educator. “And that is putting physicians at higher risk of being audited or of not passing an audit.”

According to LeGrand, this is because physicians are using the practice’s EHR to “pull forward” the patient’s previous visit note for the current visit, but failing to customize it for the current visit. The unintended consequence of this workflow efficiency is twofold:

1. It creates documentation that looks strikingly similar to, if not exactly like, the patient’s last billed visit note. This is often referred to as note “cloning.”

2. It creates documentation that includes a lot of unnecessary detail that, even if delivered and documented, doesn’t match the medical necessity of the visit, based on the history of present illness statements.

Both of these things can come back to bite you.

Zero in on the Risk

If your practice has an EHR, it is important that you evaluate whether certain workflow efficiency features are putting the practice at risk. You do not necessarily need to dump the EHR, but you may need to take action to reduce the risk of using these features.

In a pre-EHR practice, physicians began each visit with a blank piece of paper or dictated the entire visit. Then along came EHR vendors who, in an effort to make things easier and more efficient, created visit templates and the ability to “pull forward” the last visit note and use it as a basis for the current visit. The intention was always that physicians would modify it based on the current visit. But the reality is that physicians are busy, editing is time-consuming, and the unintended consequence is cloning.

“If you pull in unnecessary history or exam information from a previous visit that’s not relevant to the current visit, you can get dinged in an audit for not customizing the note to the patient’s specific presenting complaint,” LeGrand explains, “or, for attempting to bill a higher-level code by unintentionally padding the note with irrelevant information. What is documented for ‘reference’ has to be separated from what can be used to select the level of service.”

Your first documentation risk-reduction strategy is to review notes and look for signs of cloning.

LeGrand explains that a practice may be predisposed to cloning simply because of the way the EHR templates and workflow were set up when the system was implemented. “But,” she says, “‘the EHR made me do it’ defense won’t hold water, because it’s still the physician’s responsibility to customize or remove the information from templates and make the note unique to the visit.”

Yes, physician time is precious. But the reality is that the onus is on the physician to integrate EHR features with clinic workflow and to follow documentation rules.

The second documentation risk-reduction strategy is to make sure the level of evaluation and management (E/M) service billed is supported by medical necessity, not only by documentation artifacts that were relevant to the patient in the past but irrelevant to his or her current presenting complaint or condition.

“Medicare won’t pay for services that aren’t supported by medical necessity,” says LeGrand, “and you can’t achieve medical necessity by simply documenting additional E/M elements.”

This has always been the rule, LeGrand says. “But with the increased use of EHRs, and templates that automatically document visit elements and drive visits to a higher level of service, the Centers for Medicare & Medicaid Services [CMS] and private payers have added scrutiny to medical necessity reviews. They want to validate that higher-level visits billed indeed required a higher level of history and/or exam.”

To do this, the Office of the Inspector General (OIG) has supplemented its audit team with registered nurses. “The nurses assist certified coders by determining whether medical necessity has been met,” explains LeGrand.

 Look at a patient who presents with toe pain. You take a detailed family history, conduct a review of systems (ROS), bill a high-level code, and document all the elements to support it. LeGrand explains, “There is no medical necessity to support doing an eye exam for a patient with toe pain in the absence of any other medical history, or performing a ROS to correlate an eye exam with toe pain. So, even if you do it and document it, the higher-level code won’t pass muster in an audit because the information documented is not medically necessary.”

According to LeGrand, the extent of the history and examination should be based on the presenting problem and the patient’s condition. “If an ankle sprain patient returns 2 weeks after the initial evaluation of the injury with a negative medical or surgical history, and the patient has been treated conservatively, it’s probably not necessary to conduct a ROS that includes 10 organ systems,” she says. “If your standard of care is to perform this level of service, no one will fault you for your care delivery; however, if you also choose a level of service based on this system review, without relevance to the presenting problem, and you bill a higher level of service than is supported by the nature of the presenting problem or the plan of care, the documentation probably won’t hold up in an audit where medical necessity is valued into the equation.”

On the other hand, LeGrand adds, if a patient presents to the emergency department after an automobile accident with an open fracture and other injuries, and the surgeon performs a complete ROS, the medical necessity would most likely be supported as the surgeon is preparing the patient for surgery.

Based on LeGrand’s work with practices, this distinction about medical necessity is news to many nonclinical billing staff. “They confuse medical necessity with medical decision-making, an E/M code documentation component, and incorrectly bill for a high-level visit because medical decision-making elements meet the documentation requirements—yet the code is not supported by medical necessity of the presenting problem.”

Talk with your billing team to make sure all staff members understand this critical difference. They must comprehend that the medically necessary level of service is determined by a number of clinical factors, not medical decision-making. Describe some of these clinical factors, which include, but are not limited to, chief complaint, clinical judgment, standards of practice, acute exacerbations/onsets of medical conditions or injuries, and comorbidities.

EHR Dos and Don’ts

LeGrand recommends the following best practices for using EHR documentation features:

 1. DON’T simply cut and paste from a previous note. “This is what leads to verbose notes that have little to do with the patient you are documenting,” she says. “If you don’t cut and paste, you’ll avoid the root cause of this risk.”

2. DON’T pull forward information from previous visit notes that have nothing to do with the nature of the patient’s problem. “We understand that this takes extra time because physicians must review the previous note,” LeGrand says. “So if you don’t have time to review the past note, just don’t pull it forward. Start fresh with a new drop-down menu and select elements pertinent to the current visit. Or, dictate or type a note relevant to the current condition and presenting problems.”

How you choose to work this into your process will vary depending on which EHR system you use. “One surgeon I work with dictates everything because the drop-down menus and templates are cumbersome,” LeGrand says. “Some groups find it faster to use the EHR templates that they have customized. Others find their EHR’s point-and-click features most efficient for customizing quickly.”

3. DO customize your EHR visit templates if the use of templates is critical to your efficiency. “This is the most overlooked step in the EHR implementation process because it takes a fair amount of time to do,” LeGrand says. She suggests avoiding the use of multisystem examination templates created for medicine specialties altogether, and insists, “Don’t assume ‘that is how the vendor built it so we have to use it.’ Customize a template for each of your visit types so you can document in the EHR in the same fashion as when you used a paper system. Doing so will save you loads of documentation time.”

4. DO review your E/M code distribution. Generate a CPT frequency report for each physician and for the practice as a whole. Compare the data with state and national usage in orthopedics as a baseline. The American Academy of Orthopaedic Surgeon’s Code-X tool enables easy comparison of your practice’s E/M code usage with state and national data for orthopedics. Simply generate a CPT frequency report from your practice management system and enter the E/M data. Line graphs are automatically generated, making trends and patterns easy to see (Figure).

“Identify your outliers, pull charts randomly, and review the notes,” recommends LeGrand. “Make sure there is medical necessity for the level of code that’s been billed and that documentation supports it.”

You may be surprised to find you are an outlier on inpatient hospital codes, or your distribution of level-2 or -3 codes varies from your practice, state, or national data. Orthopedic surgeons don’t typically report high volumes of CPT codes 99204, 99205 or 99215, but if your practice does and you are an outlier, best to pay attention before someone else does.

 5. DO select auditors with the right skill sets. Evaluating medical necessity in the note requires a clinical background. “If internal documentation reviews are conducted by the billing team, that’s fine,” LeGrand advises. “Just add a physician assistant or nurse to your internal review team. They can provide clinical oversight and review the note when necessary for medical necessity.”

If you are contracting with external auditors or consultants, verify auditor credentials and skill sets to ensure they can abstract and incorporate medical necessity into the review. “Auditors must be able to do more than count elements,” LeGrand says. “They must have clinical knowledge, and expertise in orthopedics is critical. This knowledge should be used to verify that medical necessity is present in every note.” LeGrand is quick to point out that not every note will be at risk, based on the amount of work performed and documented and the level of service billed. “But medical necessity must always be present.”

The addition of nurses to the OIG’s audit team is a big change and will refine the auditing process by adding more clinical scrutiny. The EHR documentation features are intended to improve efficiency, but only a clinician can determine and document unique visit elements and medical necessity.

Address these intersections of risk by ensuring your documentation meets medical necessity as well as E/M documentation elements. Conduct internal audits bi-annually to verify that E/M usage patterns align with peers and physician documentation is appropriate. And be sure there is clinical expertise on your audit team, whether it is internal or external. CMS now has it, and your practice should too.  ◾

Long-time readers will chuckle – but after years of affirming and reaffirming that I would never adopt electronic records in my practice, I’m in the process of doing just that. It still runs contrary to my better judgment; but the advent of ICD-10, combined with space issues and other factors that I won’t bore you with, has forced my hand.

Before implementing any electronic health record system, you first must sign an end-user license agreement (EULA) with the EHR vendor. The sales manager for the company I had chosen assured me that the EULA was a “routine” document.

“Just sign it,” he said. “It’s all basic stuff ... but you can read it, if you would like.” Of course I would like. First, it was quite clear that the agreement was designed primarily to protect the vendor. (Not surprising, since the company’s lawyer wrote it.) But then I noticed that the vendor assumed no liability at all in the event of accidental destruction of my records. And when I saw, a few paragraphs later, that the vendor would have the unrestricted right to sell my practice data to third parties, I knew I would not be “just signing” anything.

My attorney referred me to a colleague with expertise in technology contracts and HIPAA law. I asked him if EULAs were always this one-sided. “Some are much worse,” he replied. Why would any physician sign such an egregious document, I asked? “Because most of them never read it.”

Wow.

A couple of weeks later, my attorney and the vendor’s counsel signed off on a much fairer agreement. The bill was significant – but it was money well spent.

A EULA details your and your vendor’s responsibilities relating to installation of your EHR, training your staff, and ongoing software and hardware support. Sales reps will often chide you (as mine did) for “taking this much too seriously.” Any legal document that you sign – and by which you will be bound for the foreseeable future – must be taken seriously. You should never allow yourself to be pressured into signing anything that you cannot comfortably live with in perpetuity.

So if you are taking the EHR plunge, find a lawyer who understands tech contracts and medical privacy laws before you sign anything. Make certain that he or she knows your concerns, and the provisions that you can and cannot live with. Among other things, my attorney succeeded in removing clauses requiring a minimum contract term, and a hefty fee if I wanted out; a nondisclosure clause preventing any public criticism of the vendor; and that crazy provision giving them the right to sell or give practice data to anyone who asked for it.

One EHR installation in three ultimately fails, according to one management firm; so more than anything else, you need to be certain that you do not get locked into a long-term contract should your EHR turn out to be a poor performer. Be sure that the agreement allows you to terminate the contract if the product’s performance – by your criteria – proves to be inadequate.

Some seemingly obvious considerations need to be spelled out; for example, that you will have ownership of your data. You need to know exactly what happens to your data if the vendor goes out of business, or if a flood wipes out its servers, or your contract is terminated by either party, or anything else that forces you to switch vendors. The process of migrating your records to a new platform can go smoothly, or it can be a nightmare – depending on the agreement in place. It should include specific methods by which data will be migrated; and be sure to lose any clauses that force you to pay a “ransom” to regain control of your own records.

You will want to know how your data is backed up – and how the backup is backed up – and whether you can maintain a separate backup in-house if necessary. My attorney also insisted on a “guarantee of system uptime,” including the steps the vendor agrees to take in the event of a significant crash or other prolonged downtime.

The basic point, of course, is never sign a EULA without having it reviewed by an experienced technology attorney. A good one should be able to eliminate the more onerous clauses; but don’t expect perfection. My vendor refused to cave on several of my attorney’s concerns. “The agreement is still one-sided,” he told me, but it’s the best we will get at this point. Once there is more competition in the EHR field, things will be different.”

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News.

Long-time readers will chuckle – but after years of affirming and reaffirming that I would never adopt electronic records in my practice, I’m in the process of doing just that. It still runs contrary to my better judgment; but the advent of ICD-10, combined with space issues and other factors that I won’t bore you with, has forced my hand.

Before implementing any electronic health record system, you first must sign an end-user license agreement (EULA) with the EHR vendor. The sales manager for the company I had chosen assured me that the EULA was a “routine” document.

“Just sign it,” he said. “It’s all basic stuff ... but you can read it, if you would like.” Of course I would like. First, it was quite clear that the agreement was designed primarily to protect the vendor. (Not surprising, since the company’s lawyer wrote it.) But then I noticed that the vendor assumed no liability at all in the event of accidental destruction of my records. And when I saw, a few paragraphs later, that the vendor would have the unrestricted right to sell my practice data to third parties, I knew I would not be “just signing” anything.

My attorney referred me to a colleague with expertise in technology contracts and HIPAA law. I asked him if EULAs were always this one-sided. “Some are much worse,” he replied. Why would any physician sign such an egregious document, I asked? “Because most of them never read it.”

Wow.

A couple of weeks later, my attorney and the vendor’s counsel signed off on a much fairer agreement. The bill was significant – but it was money well spent.

A EULA details your and your vendor’s responsibilities relating to installation of your EHR, training your staff, and ongoing software and hardware support. Sales reps will often chide you (as mine did) for “taking this much too seriously.” Any legal document that you sign – and by which you will be bound for the foreseeable future – must be taken seriously. You should never allow yourself to be pressured into signing anything that you cannot comfortably live with in perpetuity.

So if you are taking the EHR plunge, find a lawyer who understands tech contracts and medical privacy laws before you sign anything. Make certain that he or she knows your concerns, and the provisions that you can and cannot live with. Among other things, my attorney succeeded in removing clauses requiring a minimum contract term, and a hefty fee if I wanted out; a nondisclosure clause preventing any public criticism of the vendor; and that crazy provision giving them the right to sell or give practice data to anyone who asked for it.

One EHR installation in three ultimately fails, according to one management firm; so more than anything else, you need to be certain that you do not get locked into a long-term contract should your EHR turn out to be a poor performer. Be sure that the agreement allows you to terminate the contract if the product’s performance – by your criteria – proves to be inadequate.

Some seemingly obvious considerations need to be spelled out; for example, that you will have ownership of your data. You need to know exactly what happens to your data if the vendor goes out of business, or if a flood wipes out its servers, or your contract is terminated by either party, or anything else that forces you to switch vendors. The process of migrating your records to a new platform can go smoothly, or it can be a nightmare – depending on the agreement in place. It should include specific methods by which data will be migrated; and be sure to lose any clauses that force you to pay a “ransom” to regain control of your own records.

You will want to know how your data is backed up – and how the backup is backed up – and whether you can maintain a separate backup in-house if necessary. My attorney also insisted on a “guarantee of system uptime,” including the steps the vendor agrees to take in the event of a significant crash or other prolonged downtime.

The basic point, of course, is never sign a EULA without having it reviewed by an experienced technology attorney. A good one should be able to eliminate the more onerous clauses; but don’t expect perfection. My vendor refused to cave on several of my attorney’s concerns. “The agreement is still one-sided,” he told me, but it’s the best we will get at this point. Once there is more competition in the EHR field, things will be different.”

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News.

Long-time readers will chuckle – but after years of affirming and reaffirming that I would never adopt electronic records in my practice, I’m in the process of doing just that. It still runs contrary to my better judgment; but the advent of ICD-10, combined with space issues and other factors that I won’t bore you with, has forced my hand.

Before implementing any electronic health record system, you first must sign an end-user license agreement (EULA) with the EHR vendor. The sales manager for the company I had chosen assured me that the EULA was a “routine” document.

“Just sign it,” he said. “It’s all basic stuff ... but you can read it, if you would like.” Of course I would like. First, it was quite clear that the agreement was designed primarily to protect the vendor. (Not surprising, since the company’s lawyer wrote it.) But then I noticed that the vendor assumed no liability at all in the event of accidental destruction of my records. And when I saw, a few paragraphs later, that the vendor would have the unrestricted right to sell my practice data to third parties, I knew I would not be “just signing” anything.

My attorney referred me to a colleague with expertise in technology contracts and HIPAA law. I asked him if EULAs were always this one-sided. “Some are much worse,” he replied. Why would any physician sign such an egregious document, I asked? “Because most of them never read it.”

Wow.

A couple of weeks later, my attorney and the vendor’s counsel signed off on a much fairer agreement. The bill was significant – but it was money well spent.

A EULA details your and your vendor’s responsibilities relating to installation of your EHR, training your staff, and ongoing software and hardware support. Sales reps will often chide you (as mine did) for “taking this much too seriously.” Any legal document that you sign – and by which you will be bound for the foreseeable future – must be taken seriously. You should never allow yourself to be pressured into signing anything that you cannot comfortably live with in perpetuity.

So if you are taking the EHR plunge, find a lawyer who understands tech contracts and medical privacy laws before you sign anything. Make certain that he or she knows your concerns, and the provisions that you can and cannot live with. Among other things, my attorney succeeded in removing clauses requiring a minimum contract term, and a hefty fee if I wanted out; a nondisclosure clause preventing any public criticism of the vendor; and that crazy provision giving them the right to sell or give practice data to anyone who asked for it.

One EHR installation in three ultimately fails, according to one management firm; so more than anything else, you need to be certain that you do not get locked into a long-term contract should your EHR turn out to be a poor performer. Be sure that the agreement allows you to terminate the contract if the product’s performance – by your criteria – proves to be inadequate.

Some seemingly obvious considerations need to be spelled out; for example, that you will have ownership of your data. You need to know exactly what happens to your data if the vendor goes out of business, or if a flood wipes out its servers, or your contract is terminated by either party, or anything else that forces you to switch vendors. The process of migrating your records to a new platform can go smoothly, or it can be a nightmare – depending on the agreement in place. It should include specific methods by which data will be migrated; and be sure to lose any clauses that force you to pay a “ransom” to regain control of your own records.

You will want to know how your data is backed up – and how the backup is backed up – and whether you can maintain a separate backup in-house if necessary. My attorney also insisted on a “guarantee of system uptime,” including the steps the vendor agrees to take in the event of a significant crash or other prolonged downtime.

The basic point, of course, is never sign a EULA without having it reviewed by an experienced technology attorney. A good one should be able to eliminate the more onerous clauses; but don’t expect perfection. My vendor refused to cave on several of my attorney’s concerns. “The agreement is still one-sided,” he told me, but it’s the best we will get at this point. Once there is more competition in the EHR field, things will be different.”

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News.