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Pathways to new therapeutic agents for human coronaviruses
No specific treatment is currently available for human coronaviruses to date, but numerous antiviral agents are being identified through a variety of approaches, according to Thanigaimalai Pillaiyar, PhD, and colleagues in a review published in Drug Discovery Today.
Using the six previously discovered human coronaviruses – human CoV 229E (HCoV-229E), OC43 (HCoV-OC43), NL63 (HCoV-NL63), HKU1 (HCoV-HKU1); severe acute respiratory syndrome (SARS) CoV; and Middle East respiratory syndrome (MERS) CoV – the investigators examined progress in the use and development of therapeutic drugs, focusing on the potential roles of virus inhibitors.
“Research has mainly been focused on SARS- and MERS-CoV infections, because they were responsible for severe illness when compared with other CoVs,” Dr. Pillaiyar, of the department of pharmaceutical and medicinal chemistry at the University of Bonn (Germany), and colleagues wrote.
2019-nCov has been linked genomically as most closely related to SARS, and the Coronavirus Study Group of the International Committee on Virus Taxonomy, which has the responsibility for naming viruses, has designated the new virus SARS-CoV-2.
Examining extant drugs
The first approach to identifying possible antiviral agents reevaluates known, broadly acting antiviral drugs that have been used for other viral infections or other indications. The initial research into coronavirus therapeutics, in particular, has examined current antiviral therapeutics for their effectiveness against both SARS-CoV and MERS-CoV, but with mixed results.
For example, in a search of potential antiviral agents against CoVs, researchers identified four drugs – chloroquine, chlorpromazine, loperamide, and lopinavir – by screening drug libraries approved by the Food and Drug Administration. They were all able to inhibit the replication of MERS-CoV, SARS-CoV, and HCoV-229E in the low-micromolar range, which suggested that they could be used for broad-spectrum antiviral activity, according to Dr. Pillaiyar and colleagues.
Other research groups have also reported the discovery of antiviral drugs using this drug-repurposing approach, which included a number of broad-spectrum inhibitors of HCoVs (lycorine, emetine, monensin sodium, mycophenolate mofetil, mycophenolic acid, phenazopyridine, and pyrvinium pamoate) that showed strong inhibition of replication by four CoVs in vitro at low-micromolar concentrations and suppressed the replication of all CoVs in a dose-dependent manner. Findings from in vivo studies showed lycorine protected mice against lethal HCoV-OC43 infection.
Along with the aforementioned drugs, a number of others have also shown potential usefulness, but, as yet, none has been validated for use in humans.
Developing new antivirals
The second approach for anti-CoV drug discovery involves the development of new therapeutics based on the genomic and biophysical understanding of the individual CoV in order to interfere with the virus itself or to disrupt its direct metabolic requirements. This can take several approaches.
MERS-CoV and SARS-CoV PL protease inhibitors
Of particular interest are antiviral therapies that attack papain-like protease, which is an important target because it is a multifunctional protein involved in proteolytic deubiquitination and viral evasion of the innate immune response. One such potential therapeutic that takes advantage of this target is disulfiram, an FDA-approved drug for use in alcohol-aversion therapy. Disulfiram has been reported as an allosteric inhibitor of MERS-CoV papain-like protease. Numerous other drug categories are being examined, with promising results in targeting the papain-like protease enzymes of both SARS and MERS.
Replicase inhibitors
Helicase (nsP13) protein is a crucial component required for virus replication in host cells and could serve as a feasible target for anti-MERS and anti-SARS chemical therapies, the review authors wrote, citing as an example, the recent development of a small 1,2,4-triazole derivative that inhibited the viral NTPase/helicase of SARS- and MERS-CoVs and demonstrated high antiviral activity and low cytotoxicity.
Membrane-bound viral RNA synthesis inhibitors
Antiviral agents that target membrane-bound coronaviral RNA synthesis represent a novel and attractive approach, according to Dr. Pillaiyar and colleagues. And recently, an inhibitor was developed that targets membrane-bound coronaviral RNA synthesis and “showed potent antiviral activity of MERS-CoV infection with remarkable efficacy.”
Host-based, anti-CoV treatment options
An alternate therapeutic tactic is to bolster host defenses or to modify host susceptibilities to prevent virus infection or replication. The innate interferon response of the host is crucial for the control of viral replication after infection, and the addition of exogenous recombinant interferon or use of drugs to stimulate the normal host interferon response are both potential therapeutic avenues. For example, nitazoxanide is a potent type I interferon inducer that has been used in humans for parasitic infections, and a synthetic nitrothiazolyl-salicylamide derivative was found to exhibit broad-spectrum antiviral activities against RNA and DNA viruses, including some coronaviruses.
Numerous other host pathways are being investigated as potential areas to enhance defense against infection and replication, for example, using inhibitors to block nucleic acid synthesis has been shown to provide broad-spectrum activity against SARS-CoV and MERS-CoV.
One particular example is remdesivir, a novel nucleotide analog antiviral drug, that was developed as a therapy for Ebola virus disease and Marburg virus infections. It was later shown to provide “reasonable antiviral activity against more distantly related viruses, such as respiratory syncytial virus, Junin virus, Lassa fever virus, and MERS-CoV,” the authors wrote.
Also of interest regarding remdesivir’s potential broad-spectrum use is that it has shown potent in vitro “antiviral activity against Malaysian and Bangladesh genotypes of Nipah virus (an RNA virus, although not a coronavirus, that infects both humans and animals) and reduced replication of Malaysian Nipah virus in primary human lung microvascular endothelial cells by more than four orders of magnitude,” Dr. Pillaiyar and colleagues added. Of particular note, all remdesivir-treated, Nipah virus–infected animals “survived the lethal challenge, indicating that remdesivir represents a promising antiviral treatment.”
In a press briefing earlier this month, Anthony S. Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, reported that a randomized, controlled, phase 3 trial of the antiviral drug remdesivir is currently underway in China to establish whether the drug would be an effective and safe treatment for adults patients with mild or moderate 2019 Novel Coronavirus (2019-nCoV) disease.
“Our increasing understanding of novel emerging coronaviruses will be accompanied by increasing opportunities for the reasonable design of therapeutics. Importantly, understanding this basic information about CoV protease targets will not only aid the public health against SARS-CoV and MERS-CoV but also help in advance to target new coronaviruses that might emerge in the future,” the authors concluded.
Dr. Pillaiyar and colleagues reported that they had no financial conflicts of interest.
SOURCE: Pillaiyar T et al. Drug Discov Today. 2020 Jan 30. doi: 10.1016/j.drudis.2020.01.015.
No specific treatment is currently available for human coronaviruses to date, but numerous antiviral agents are being identified through a variety of approaches, according to Thanigaimalai Pillaiyar, PhD, and colleagues in a review published in Drug Discovery Today.
Using the six previously discovered human coronaviruses – human CoV 229E (HCoV-229E), OC43 (HCoV-OC43), NL63 (HCoV-NL63), HKU1 (HCoV-HKU1); severe acute respiratory syndrome (SARS) CoV; and Middle East respiratory syndrome (MERS) CoV – the investigators examined progress in the use and development of therapeutic drugs, focusing on the potential roles of virus inhibitors.
“Research has mainly been focused on SARS- and MERS-CoV infections, because they were responsible for severe illness when compared with other CoVs,” Dr. Pillaiyar, of the department of pharmaceutical and medicinal chemistry at the University of Bonn (Germany), and colleagues wrote.
2019-nCov has been linked genomically as most closely related to SARS, and the Coronavirus Study Group of the International Committee on Virus Taxonomy, which has the responsibility for naming viruses, has designated the new virus SARS-CoV-2.
Examining extant drugs
The first approach to identifying possible antiviral agents reevaluates known, broadly acting antiviral drugs that have been used for other viral infections or other indications. The initial research into coronavirus therapeutics, in particular, has examined current antiviral therapeutics for their effectiveness against both SARS-CoV and MERS-CoV, but with mixed results.
For example, in a search of potential antiviral agents against CoVs, researchers identified four drugs – chloroquine, chlorpromazine, loperamide, and lopinavir – by screening drug libraries approved by the Food and Drug Administration. They were all able to inhibit the replication of MERS-CoV, SARS-CoV, and HCoV-229E in the low-micromolar range, which suggested that they could be used for broad-spectrum antiviral activity, according to Dr. Pillaiyar and colleagues.
Other research groups have also reported the discovery of antiviral drugs using this drug-repurposing approach, which included a number of broad-spectrum inhibitors of HCoVs (lycorine, emetine, monensin sodium, mycophenolate mofetil, mycophenolic acid, phenazopyridine, and pyrvinium pamoate) that showed strong inhibition of replication by four CoVs in vitro at low-micromolar concentrations and suppressed the replication of all CoVs in a dose-dependent manner. Findings from in vivo studies showed lycorine protected mice against lethal HCoV-OC43 infection.
Along with the aforementioned drugs, a number of others have also shown potential usefulness, but, as yet, none has been validated for use in humans.
Developing new antivirals
The second approach for anti-CoV drug discovery involves the development of new therapeutics based on the genomic and biophysical understanding of the individual CoV in order to interfere with the virus itself or to disrupt its direct metabolic requirements. This can take several approaches.
MERS-CoV and SARS-CoV PL protease inhibitors
Of particular interest are antiviral therapies that attack papain-like protease, which is an important target because it is a multifunctional protein involved in proteolytic deubiquitination and viral evasion of the innate immune response. One such potential therapeutic that takes advantage of this target is disulfiram, an FDA-approved drug for use in alcohol-aversion therapy. Disulfiram has been reported as an allosteric inhibitor of MERS-CoV papain-like protease. Numerous other drug categories are being examined, with promising results in targeting the papain-like protease enzymes of both SARS and MERS.
Replicase inhibitors
Helicase (nsP13) protein is a crucial component required for virus replication in host cells and could serve as a feasible target for anti-MERS and anti-SARS chemical therapies, the review authors wrote, citing as an example, the recent development of a small 1,2,4-triazole derivative that inhibited the viral NTPase/helicase of SARS- and MERS-CoVs and demonstrated high antiviral activity and low cytotoxicity.
Membrane-bound viral RNA synthesis inhibitors
Antiviral agents that target membrane-bound coronaviral RNA synthesis represent a novel and attractive approach, according to Dr. Pillaiyar and colleagues. And recently, an inhibitor was developed that targets membrane-bound coronaviral RNA synthesis and “showed potent antiviral activity of MERS-CoV infection with remarkable efficacy.”
Host-based, anti-CoV treatment options
An alternate therapeutic tactic is to bolster host defenses or to modify host susceptibilities to prevent virus infection or replication. The innate interferon response of the host is crucial for the control of viral replication after infection, and the addition of exogenous recombinant interferon or use of drugs to stimulate the normal host interferon response are both potential therapeutic avenues. For example, nitazoxanide is a potent type I interferon inducer that has been used in humans for parasitic infections, and a synthetic nitrothiazolyl-salicylamide derivative was found to exhibit broad-spectrum antiviral activities against RNA and DNA viruses, including some coronaviruses.
Numerous other host pathways are being investigated as potential areas to enhance defense against infection and replication, for example, using inhibitors to block nucleic acid synthesis has been shown to provide broad-spectrum activity against SARS-CoV and MERS-CoV.
One particular example is remdesivir, a novel nucleotide analog antiviral drug, that was developed as a therapy for Ebola virus disease and Marburg virus infections. It was later shown to provide “reasonable antiviral activity against more distantly related viruses, such as respiratory syncytial virus, Junin virus, Lassa fever virus, and MERS-CoV,” the authors wrote.
Also of interest regarding remdesivir’s potential broad-spectrum use is that it has shown potent in vitro “antiviral activity against Malaysian and Bangladesh genotypes of Nipah virus (an RNA virus, although not a coronavirus, that infects both humans and animals) and reduced replication of Malaysian Nipah virus in primary human lung microvascular endothelial cells by more than four orders of magnitude,” Dr. Pillaiyar and colleagues added. Of particular note, all remdesivir-treated, Nipah virus–infected animals “survived the lethal challenge, indicating that remdesivir represents a promising antiviral treatment.”
In a press briefing earlier this month, Anthony S. Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, reported that a randomized, controlled, phase 3 trial of the antiviral drug remdesivir is currently underway in China to establish whether the drug would be an effective and safe treatment for adults patients with mild or moderate 2019 Novel Coronavirus (2019-nCoV) disease.
“Our increasing understanding of novel emerging coronaviruses will be accompanied by increasing opportunities for the reasonable design of therapeutics. Importantly, understanding this basic information about CoV protease targets will not only aid the public health against SARS-CoV and MERS-CoV but also help in advance to target new coronaviruses that might emerge in the future,” the authors concluded.
Dr. Pillaiyar and colleagues reported that they had no financial conflicts of interest.
SOURCE: Pillaiyar T et al. Drug Discov Today. 2020 Jan 30. doi: 10.1016/j.drudis.2020.01.015.
No specific treatment is currently available for human coronaviruses to date, but numerous antiviral agents are being identified through a variety of approaches, according to Thanigaimalai Pillaiyar, PhD, and colleagues in a review published in Drug Discovery Today.
Using the six previously discovered human coronaviruses – human CoV 229E (HCoV-229E), OC43 (HCoV-OC43), NL63 (HCoV-NL63), HKU1 (HCoV-HKU1); severe acute respiratory syndrome (SARS) CoV; and Middle East respiratory syndrome (MERS) CoV – the investigators examined progress in the use and development of therapeutic drugs, focusing on the potential roles of virus inhibitors.
“Research has mainly been focused on SARS- and MERS-CoV infections, because they were responsible for severe illness when compared with other CoVs,” Dr. Pillaiyar, of the department of pharmaceutical and medicinal chemistry at the University of Bonn (Germany), and colleagues wrote.
2019-nCov has been linked genomically as most closely related to SARS, and the Coronavirus Study Group of the International Committee on Virus Taxonomy, which has the responsibility for naming viruses, has designated the new virus SARS-CoV-2.
Examining extant drugs
The first approach to identifying possible antiviral agents reevaluates known, broadly acting antiviral drugs that have been used for other viral infections or other indications. The initial research into coronavirus therapeutics, in particular, has examined current antiviral therapeutics for their effectiveness against both SARS-CoV and MERS-CoV, but with mixed results.
For example, in a search of potential antiviral agents against CoVs, researchers identified four drugs – chloroquine, chlorpromazine, loperamide, and lopinavir – by screening drug libraries approved by the Food and Drug Administration. They were all able to inhibit the replication of MERS-CoV, SARS-CoV, and HCoV-229E in the low-micromolar range, which suggested that they could be used for broad-spectrum antiviral activity, according to Dr. Pillaiyar and colleagues.
Other research groups have also reported the discovery of antiviral drugs using this drug-repurposing approach, which included a number of broad-spectrum inhibitors of HCoVs (lycorine, emetine, monensin sodium, mycophenolate mofetil, mycophenolic acid, phenazopyridine, and pyrvinium pamoate) that showed strong inhibition of replication by four CoVs in vitro at low-micromolar concentrations and suppressed the replication of all CoVs in a dose-dependent manner. Findings from in vivo studies showed lycorine protected mice against lethal HCoV-OC43 infection.
Along with the aforementioned drugs, a number of others have also shown potential usefulness, but, as yet, none has been validated for use in humans.
Developing new antivirals
The second approach for anti-CoV drug discovery involves the development of new therapeutics based on the genomic and biophysical understanding of the individual CoV in order to interfere with the virus itself or to disrupt its direct metabolic requirements. This can take several approaches.
MERS-CoV and SARS-CoV PL protease inhibitors
Of particular interest are antiviral therapies that attack papain-like protease, which is an important target because it is a multifunctional protein involved in proteolytic deubiquitination and viral evasion of the innate immune response. One such potential therapeutic that takes advantage of this target is disulfiram, an FDA-approved drug for use in alcohol-aversion therapy. Disulfiram has been reported as an allosteric inhibitor of MERS-CoV papain-like protease. Numerous other drug categories are being examined, with promising results in targeting the papain-like protease enzymes of both SARS and MERS.
Replicase inhibitors
Helicase (nsP13) protein is a crucial component required for virus replication in host cells and could serve as a feasible target for anti-MERS and anti-SARS chemical therapies, the review authors wrote, citing as an example, the recent development of a small 1,2,4-triazole derivative that inhibited the viral NTPase/helicase of SARS- and MERS-CoVs and demonstrated high antiviral activity and low cytotoxicity.
Membrane-bound viral RNA synthesis inhibitors
Antiviral agents that target membrane-bound coronaviral RNA synthesis represent a novel and attractive approach, according to Dr. Pillaiyar and colleagues. And recently, an inhibitor was developed that targets membrane-bound coronaviral RNA synthesis and “showed potent antiviral activity of MERS-CoV infection with remarkable efficacy.”
Host-based, anti-CoV treatment options
An alternate therapeutic tactic is to bolster host defenses or to modify host susceptibilities to prevent virus infection or replication. The innate interferon response of the host is crucial for the control of viral replication after infection, and the addition of exogenous recombinant interferon or use of drugs to stimulate the normal host interferon response are both potential therapeutic avenues. For example, nitazoxanide is a potent type I interferon inducer that has been used in humans for parasitic infections, and a synthetic nitrothiazolyl-salicylamide derivative was found to exhibit broad-spectrum antiviral activities against RNA and DNA viruses, including some coronaviruses.
Numerous other host pathways are being investigated as potential areas to enhance defense against infection and replication, for example, using inhibitors to block nucleic acid synthesis has been shown to provide broad-spectrum activity against SARS-CoV and MERS-CoV.
One particular example is remdesivir, a novel nucleotide analog antiviral drug, that was developed as a therapy for Ebola virus disease and Marburg virus infections. It was later shown to provide “reasonable antiviral activity against more distantly related viruses, such as respiratory syncytial virus, Junin virus, Lassa fever virus, and MERS-CoV,” the authors wrote.
Also of interest regarding remdesivir’s potential broad-spectrum use is that it has shown potent in vitro “antiviral activity against Malaysian and Bangladesh genotypes of Nipah virus (an RNA virus, although not a coronavirus, that infects both humans and animals) and reduced replication of Malaysian Nipah virus in primary human lung microvascular endothelial cells by more than four orders of magnitude,” Dr. Pillaiyar and colleagues added. Of particular note, all remdesivir-treated, Nipah virus–infected animals “survived the lethal challenge, indicating that remdesivir represents a promising antiviral treatment.”
In a press briefing earlier this month, Anthony S. Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, reported that a randomized, controlled, phase 3 trial of the antiviral drug remdesivir is currently underway in China to establish whether the drug would be an effective and safe treatment for adults patients with mild or moderate 2019 Novel Coronavirus (2019-nCoV) disease.
“Our increasing understanding of novel emerging coronaviruses will be accompanied by increasing opportunities for the reasonable design of therapeutics. Importantly, understanding this basic information about CoV protease targets will not only aid the public health against SARS-CoV and MERS-CoV but also help in advance to target new coronaviruses that might emerge in the future,” the authors concluded.
Dr. Pillaiyar and colleagues reported that they had no financial conflicts of interest.
SOURCE: Pillaiyar T et al. Drug Discov Today. 2020 Jan 30. doi: 10.1016/j.drudis.2020.01.015.
FROM DRUG DISCOVERY TODAY
Newborn transfer may not reflect true rate of complications
Neonatal transfer was the factor most often associated with unexpected, severe complications at birth, particularly at hospitals that had the highest rates of complications, according to a cross-sectional study published online in JAMA Network Open (2020;3[2]:e1919498).
The Joint Commission recently included unexpected complications in term newborns as a marker of quality of obstetric care, but it does not currently recommend any risk adjustment for the metric. The authors aimed to learn which factors regarding patients and hospitals were associated with such complications. Severe, unexpected newborn complications include death, seizure, use of assisted ventilation for at least 6 hours, transfer to another facility, or a 5-minute Apgar score of 3 or less.
“This measure has been proposed to serve as a balancing measure to maternal metrics, such as the rate of nulliparous, term, singleton, vertex-presenting cesarean deliveries,” the authors explained.
This study was supported by a Health Policy Award from the Society for Maternal-Fetal Medicine. The authors reported no relevant financial disclosures.
This story first appeared on Medscape.
Neonatal transfer was the factor most often associated with unexpected, severe complications at birth, particularly at hospitals that had the highest rates of complications, according to a cross-sectional study published online in JAMA Network Open (2020;3[2]:e1919498).
The Joint Commission recently included unexpected complications in term newborns as a marker of quality of obstetric care, but it does not currently recommend any risk adjustment for the metric. The authors aimed to learn which factors regarding patients and hospitals were associated with such complications. Severe, unexpected newborn complications include death, seizure, use of assisted ventilation for at least 6 hours, transfer to another facility, or a 5-minute Apgar score of 3 or less.
“This measure has been proposed to serve as a balancing measure to maternal metrics, such as the rate of nulliparous, term, singleton, vertex-presenting cesarean deliveries,” the authors explained.
This study was supported by a Health Policy Award from the Society for Maternal-Fetal Medicine. The authors reported no relevant financial disclosures.
This story first appeared on Medscape.
Neonatal transfer was the factor most often associated with unexpected, severe complications at birth, particularly at hospitals that had the highest rates of complications, according to a cross-sectional study published online in JAMA Network Open (2020;3[2]:e1919498).
The Joint Commission recently included unexpected complications in term newborns as a marker of quality of obstetric care, but it does not currently recommend any risk adjustment for the metric. The authors aimed to learn which factors regarding patients and hospitals were associated with such complications. Severe, unexpected newborn complications include death, seizure, use of assisted ventilation for at least 6 hours, transfer to another facility, or a 5-minute Apgar score of 3 or less.
“This measure has been proposed to serve as a balancing measure to maternal metrics, such as the rate of nulliparous, term, singleton, vertex-presenting cesarean deliveries,” the authors explained.
This study was supported by a Health Policy Award from the Society for Maternal-Fetal Medicine. The authors reported no relevant financial disclosures.
This story first appeared on Medscape.
FROM JAMA NETWORK OPEN
Tools for preventing heart failure
SNOWMASS, COLO. – If ever there was a major chronic disease that’s teed up and ready to be stamped into submission through diligent application of preventive medicine, it’s the epidemic of heart failure.
“The best way to treat heart failure is to prevent it in the first place. There will be more than 1 million new cases of heart failure this year, and the vast majority of them could have been prevented,” Gregg C. Fonarow, MD, asserted at the annual Cardiovascular Conference at Snowmass sponsored by the American College of Cardiology.
Using firmly evidence-based, guideline-directed therapies, it’s often possible to prevent patients at high risk for developing heart failure (HF) from actually doing so. Or, in the terminology of the ACC/American Heart Association heart failure guidelines coauthored by Dr. Fonarow, the goal is to keep patients who are stage A – that is, pre-HF but at high risk because of hypertension, coronary artery disease, diabetes, family history of cardiomyopathy, or other reasons – from progressing to stage B, marked by asymptomatic left ventricular dysfunction, a prior MI, or asymptomatic valvular disease; and blocking those who are stage B from then moving on to stage C, the classic symptomatic form of HF; and thence to end-stage stage D disease.
Heart failure is an enormous public health problem, and one of the most expensive of all diseases. The prognostic impact of newly diagnosed HF is profound, with 10-15 years of life lost, compared with the general population. Even today, roughly one in five newly diagnosed patients won’t survive for a year, and the 5-year mortality is about 50%, said Dr. Fonarow, who is professor of cardiovascular medicine and chief of the division of cardiology at the University of California, Los Angeles, and director of the Ahmanson-UCLA Cardiomyopathy Center, also in Los Angeles.
Symptomatic stage C is “the tip of the iceberg,” the cardiologist stressed. Vastly more patients are in stages A and B. In order to keep them from progressing to stage C, it’s first necessary to identify them. That’s why the 2013 guidelines give a class IC recommendation for periodic evaluation for signs and symptoms of HF in patients who are at high risk, and for a noninvasive assessment of left ventricular ejection fraction in those with a strong family history of cardiomyopathy or who are on cardiotoxic drugs (J Am Coll Cardiol. 2013 Oct 15;62[16]:e147-239).
The two biggest risk factors for the development of symptomatic stage C HF are hypertension and atherosclerotic cardiovascular disease. Close to 80% of patients presenting with heart failure have prevalent hypertension, and a history of ischemic heart disease is nearly as common.
Other major modifiable risk factors are diabetes, overweight and obesity, metabolic syndrome, dyslipidemia, smoking, valvular heart disease, and chronic kidney disease.
Hypertension
Most patients with high blood pressure believe they’re on antihypertensive medication to prevent MI and stroke, but in reality the largest benefit is what Dr. Fonarow termed the “phenomenal” reduction in the risk of developing HF, which amounted to a 52% relative risk reduction in one meta-analysis of older randomized trials. In the contemporary era, the landmark SPRINT trial of close to 10,000 randomized hypertensive patients showed that more-intensive blood pressure lowering to a target systolic BP of less than 120 mm Hg resulted in a 38% reduction in the risk of new-onset HF, compared with standard treatment to a target of less than 140 mm Hg. That’s why the 2017 focused update of the HF guidelines gives a strong class IB recommendation for a target blood pressure of less than 130/80 mm Hg in hypertensive patients with stage A HF (J Am Coll Cardiol. 2017 Aug 8;70[6]:776-803).
Atherosclerotic cardiovascular disease
Within 6 years after diagnosis of an MI, 22% of men and 46% of women will develop symptomatic heart failure. Intensive statin therapy gets a strong recommendation post MI in the guidelines, not only because in a meta-analysis of four major randomized trials it resulted in a further 64% reduction in the risk of coronary death or recurrent MI, compared with moderate statin therapy, but also because of the 27% relative risk reduction in new-onset HF. ACE inhibitors get a class IA recommendation for prevention of symptomatic HF in patients who are stage A with a history of atherosclerotic disease, diabetes, or hypertension. Angiotensin receptor blockers get a class IC recommendation.
Diabetes
Diabetes markedly increases the risk of developing HF: by two to four times overall and by four to eight times in younger diabetes patients. The two chronic diseases are highly comorbid, with roughly 45% of patients with HF also having diabetes. Moreover, diabetes in HF patients is associated with a substantially worse prognosis, even when standard HF therapies are applied.
Choices regarding glycemic management can markedly affect HF risk and outcomes. Randomized trials show that the peroxisome proliferator-activated receptor agonists double the risk of HF. The glucagonlike peptide–1 receptor agonists are absolutely neutral with regard to HF outcomes. Similarly, the dipeptidyl peptidase–4 inhibitors have no impact on the risks of major adverse cardiovascular events or HF. Intensive glycemic control has no impact on the risk of new-onset HF. Insulin therapy, too, is neutral on this score.
“Depressingly, even lifestyle modification with weight loss, once you have type 2 diabetes, does not lower the risk,” Dr. Fonarow continued.
In contrast, the sodium-glucose transporter 2 (SGLT2) inhibitors have impressive cardiovascular and renal protective benefits in patients with type 2 diabetes, as demonstrated in a meta-analysis of more than 34,000 participants in the randomized trials of empagliflozin (Jardiance) in EMPA-REG OUTCOME, canagliflozin (Invokana) in CANVAS/CANVAS-R, and dapagliflozin (Farxiga) in DECLARE-TIMI 58. The SGLT2 inhibitors collectively reduced the risk of HF hospitalization by 21% in participants with no baseline history of the disease and by 29% in those with a history of HF. Moreover, the risk of progression of renal disease was reduced by 45% (Lancet. 2019 Jan 5;393[10166]:31-9).
More recently, the landmark DAPA-HF trial established SGLT2 inhibitor therapy as part of standard-of-care, guideline-directed medical therapy for patients with HF with reduced ejection fraction regardless of whether they have comorbid type 2 diabetes (N Engl J Med. 2019 Nov 21;381[21]:1995-2008).
These are remarkable medications, generally very well tolerated, and it’s critical that cardiologists get on board in prescribing them, Dr. Fonarow emphasized. He alerted his colleagues to what he called an “incredibly helpful” review article that provides practical guidance for cardiologists in how to start using the SGLT2 inhibitors (JACC Heart Fail. 2019 Feb;7[2]:169-72).
“It’s pretty straightforward,” according to Dr. Fonarow. “If you’re comfortable enough in using ACE inhibitors, angiotensin receptor blockers, and beta-blockers, I think you’ll find these medications fit similarly when you actually get experience in utilizing them.”
He reported serving as a consultant to 10 pharmaceutical or medical device companies.
SNOWMASS, COLO. – If ever there was a major chronic disease that’s teed up and ready to be stamped into submission through diligent application of preventive medicine, it’s the epidemic of heart failure.
“The best way to treat heart failure is to prevent it in the first place. There will be more than 1 million new cases of heart failure this year, and the vast majority of them could have been prevented,” Gregg C. Fonarow, MD, asserted at the annual Cardiovascular Conference at Snowmass sponsored by the American College of Cardiology.
Using firmly evidence-based, guideline-directed therapies, it’s often possible to prevent patients at high risk for developing heart failure (HF) from actually doing so. Or, in the terminology of the ACC/American Heart Association heart failure guidelines coauthored by Dr. Fonarow, the goal is to keep patients who are stage A – that is, pre-HF but at high risk because of hypertension, coronary artery disease, diabetes, family history of cardiomyopathy, or other reasons – from progressing to stage B, marked by asymptomatic left ventricular dysfunction, a prior MI, or asymptomatic valvular disease; and blocking those who are stage B from then moving on to stage C, the classic symptomatic form of HF; and thence to end-stage stage D disease.
Heart failure is an enormous public health problem, and one of the most expensive of all diseases. The prognostic impact of newly diagnosed HF is profound, with 10-15 years of life lost, compared with the general population. Even today, roughly one in five newly diagnosed patients won’t survive for a year, and the 5-year mortality is about 50%, said Dr. Fonarow, who is professor of cardiovascular medicine and chief of the division of cardiology at the University of California, Los Angeles, and director of the Ahmanson-UCLA Cardiomyopathy Center, also in Los Angeles.
Symptomatic stage C is “the tip of the iceberg,” the cardiologist stressed. Vastly more patients are in stages A and B. In order to keep them from progressing to stage C, it’s first necessary to identify them. That’s why the 2013 guidelines give a class IC recommendation for periodic evaluation for signs and symptoms of HF in patients who are at high risk, and for a noninvasive assessment of left ventricular ejection fraction in those with a strong family history of cardiomyopathy or who are on cardiotoxic drugs (J Am Coll Cardiol. 2013 Oct 15;62[16]:e147-239).
The two biggest risk factors for the development of symptomatic stage C HF are hypertension and atherosclerotic cardiovascular disease. Close to 80% of patients presenting with heart failure have prevalent hypertension, and a history of ischemic heart disease is nearly as common.
Other major modifiable risk factors are diabetes, overweight and obesity, metabolic syndrome, dyslipidemia, smoking, valvular heart disease, and chronic kidney disease.
Hypertension
Most patients with high blood pressure believe they’re on antihypertensive medication to prevent MI and stroke, but in reality the largest benefit is what Dr. Fonarow termed the “phenomenal” reduction in the risk of developing HF, which amounted to a 52% relative risk reduction in one meta-analysis of older randomized trials. In the contemporary era, the landmark SPRINT trial of close to 10,000 randomized hypertensive patients showed that more-intensive blood pressure lowering to a target systolic BP of less than 120 mm Hg resulted in a 38% reduction in the risk of new-onset HF, compared with standard treatment to a target of less than 140 mm Hg. That’s why the 2017 focused update of the HF guidelines gives a strong class IB recommendation for a target blood pressure of less than 130/80 mm Hg in hypertensive patients with stage A HF (J Am Coll Cardiol. 2017 Aug 8;70[6]:776-803).
Atherosclerotic cardiovascular disease
Within 6 years after diagnosis of an MI, 22% of men and 46% of women will develop symptomatic heart failure. Intensive statin therapy gets a strong recommendation post MI in the guidelines, not only because in a meta-analysis of four major randomized trials it resulted in a further 64% reduction in the risk of coronary death or recurrent MI, compared with moderate statin therapy, but also because of the 27% relative risk reduction in new-onset HF. ACE inhibitors get a class IA recommendation for prevention of symptomatic HF in patients who are stage A with a history of atherosclerotic disease, diabetes, or hypertension. Angiotensin receptor blockers get a class IC recommendation.
Diabetes
Diabetes markedly increases the risk of developing HF: by two to four times overall and by four to eight times in younger diabetes patients. The two chronic diseases are highly comorbid, with roughly 45% of patients with HF also having diabetes. Moreover, diabetes in HF patients is associated with a substantially worse prognosis, even when standard HF therapies are applied.
Choices regarding glycemic management can markedly affect HF risk and outcomes. Randomized trials show that the peroxisome proliferator-activated receptor agonists double the risk of HF. The glucagonlike peptide–1 receptor agonists are absolutely neutral with regard to HF outcomes. Similarly, the dipeptidyl peptidase–4 inhibitors have no impact on the risks of major adverse cardiovascular events or HF. Intensive glycemic control has no impact on the risk of new-onset HF. Insulin therapy, too, is neutral on this score.
“Depressingly, even lifestyle modification with weight loss, once you have type 2 diabetes, does not lower the risk,” Dr. Fonarow continued.
In contrast, the sodium-glucose transporter 2 (SGLT2) inhibitors have impressive cardiovascular and renal protective benefits in patients with type 2 diabetes, as demonstrated in a meta-analysis of more than 34,000 participants in the randomized trials of empagliflozin (Jardiance) in EMPA-REG OUTCOME, canagliflozin (Invokana) in CANVAS/CANVAS-R, and dapagliflozin (Farxiga) in DECLARE-TIMI 58. The SGLT2 inhibitors collectively reduced the risk of HF hospitalization by 21% in participants with no baseline history of the disease and by 29% in those with a history of HF. Moreover, the risk of progression of renal disease was reduced by 45% (Lancet. 2019 Jan 5;393[10166]:31-9).
More recently, the landmark DAPA-HF trial established SGLT2 inhibitor therapy as part of standard-of-care, guideline-directed medical therapy for patients with HF with reduced ejection fraction regardless of whether they have comorbid type 2 diabetes (N Engl J Med. 2019 Nov 21;381[21]:1995-2008).
These are remarkable medications, generally very well tolerated, and it’s critical that cardiologists get on board in prescribing them, Dr. Fonarow emphasized. He alerted his colleagues to what he called an “incredibly helpful” review article that provides practical guidance for cardiologists in how to start using the SGLT2 inhibitors (JACC Heart Fail. 2019 Feb;7[2]:169-72).
“It’s pretty straightforward,” according to Dr. Fonarow. “If you’re comfortable enough in using ACE inhibitors, angiotensin receptor blockers, and beta-blockers, I think you’ll find these medications fit similarly when you actually get experience in utilizing them.”
He reported serving as a consultant to 10 pharmaceutical or medical device companies.
SNOWMASS, COLO. – If ever there was a major chronic disease that’s teed up and ready to be stamped into submission through diligent application of preventive medicine, it’s the epidemic of heart failure.
“The best way to treat heart failure is to prevent it in the first place. There will be more than 1 million new cases of heart failure this year, and the vast majority of them could have been prevented,” Gregg C. Fonarow, MD, asserted at the annual Cardiovascular Conference at Snowmass sponsored by the American College of Cardiology.
Using firmly evidence-based, guideline-directed therapies, it’s often possible to prevent patients at high risk for developing heart failure (HF) from actually doing so. Or, in the terminology of the ACC/American Heart Association heart failure guidelines coauthored by Dr. Fonarow, the goal is to keep patients who are stage A – that is, pre-HF but at high risk because of hypertension, coronary artery disease, diabetes, family history of cardiomyopathy, or other reasons – from progressing to stage B, marked by asymptomatic left ventricular dysfunction, a prior MI, or asymptomatic valvular disease; and blocking those who are stage B from then moving on to stage C, the classic symptomatic form of HF; and thence to end-stage stage D disease.
Heart failure is an enormous public health problem, and one of the most expensive of all diseases. The prognostic impact of newly diagnosed HF is profound, with 10-15 years of life lost, compared with the general population. Even today, roughly one in five newly diagnosed patients won’t survive for a year, and the 5-year mortality is about 50%, said Dr. Fonarow, who is professor of cardiovascular medicine and chief of the division of cardiology at the University of California, Los Angeles, and director of the Ahmanson-UCLA Cardiomyopathy Center, also in Los Angeles.
Symptomatic stage C is “the tip of the iceberg,” the cardiologist stressed. Vastly more patients are in stages A and B. In order to keep them from progressing to stage C, it’s first necessary to identify them. That’s why the 2013 guidelines give a class IC recommendation for periodic evaluation for signs and symptoms of HF in patients who are at high risk, and for a noninvasive assessment of left ventricular ejection fraction in those with a strong family history of cardiomyopathy or who are on cardiotoxic drugs (J Am Coll Cardiol. 2013 Oct 15;62[16]:e147-239).
The two biggest risk factors for the development of symptomatic stage C HF are hypertension and atherosclerotic cardiovascular disease. Close to 80% of patients presenting with heart failure have prevalent hypertension, and a history of ischemic heart disease is nearly as common.
Other major modifiable risk factors are diabetes, overweight and obesity, metabolic syndrome, dyslipidemia, smoking, valvular heart disease, and chronic kidney disease.
Hypertension
Most patients with high blood pressure believe they’re on antihypertensive medication to prevent MI and stroke, but in reality the largest benefit is what Dr. Fonarow termed the “phenomenal” reduction in the risk of developing HF, which amounted to a 52% relative risk reduction in one meta-analysis of older randomized trials. In the contemporary era, the landmark SPRINT trial of close to 10,000 randomized hypertensive patients showed that more-intensive blood pressure lowering to a target systolic BP of less than 120 mm Hg resulted in a 38% reduction in the risk of new-onset HF, compared with standard treatment to a target of less than 140 mm Hg. That’s why the 2017 focused update of the HF guidelines gives a strong class IB recommendation for a target blood pressure of less than 130/80 mm Hg in hypertensive patients with stage A HF (J Am Coll Cardiol. 2017 Aug 8;70[6]:776-803).
Atherosclerotic cardiovascular disease
Within 6 years after diagnosis of an MI, 22% of men and 46% of women will develop symptomatic heart failure. Intensive statin therapy gets a strong recommendation post MI in the guidelines, not only because in a meta-analysis of four major randomized trials it resulted in a further 64% reduction in the risk of coronary death or recurrent MI, compared with moderate statin therapy, but also because of the 27% relative risk reduction in new-onset HF. ACE inhibitors get a class IA recommendation for prevention of symptomatic HF in patients who are stage A with a history of atherosclerotic disease, diabetes, or hypertension. Angiotensin receptor blockers get a class IC recommendation.
Diabetes
Diabetes markedly increases the risk of developing HF: by two to four times overall and by four to eight times in younger diabetes patients. The two chronic diseases are highly comorbid, with roughly 45% of patients with HF also having diabetes. Moreover, diabetes in HF patients is associated with a substantially worse prognosis, even when standard HF therapies are applied.
Choices regarding glycemic management can markedly affect HF risk and outcomes. Randomized trials show that the peroxisome proliferator-activated receptor agonists double the risk of HF. The glucagonlike peptide–1 receptor agonists are absolutely neutral with regard to HF outcomes. Similarly, the dipeptidyl peptidase–4 inhibitors have no impact on the risks of major adverse cardiovascular events or HF. Intensive glycemic control has no impact on the risk of new-onset HF. Insulin therapy, too, is neutral on this score.
“Depressingly, even lifestyle modification with weight loss, once you have type 2 diabetes, does not lower the risk,” Dr. Fonarow continued.
In contrast, the sodium-glucose transporter 2 (SGLT2) inhibitors have impressive cardiovascular and renal protective benefits in patients with type 2 diabetes, as demonstrated in a meta-analysis of more than 34,000 participants in the randomized trials of empagliflozin (Jardiance) in EMPA-REG OUTCOME, canagliflozin (Invokana) in CANVAS/CANVAS-R, and dapagliflozin (Farxiga) in DECLARE-TIMI 58. The SGLT2 inhibitors collectively reduced the risk of HF hospitalization by 21% in participants with no baseline history of the disease and by 29% in those with a history of HF. Moreover, the risk of progression of renal disease was reduced by 45% (Lancet. 2019 Jan 5;393[10166]:31-9).
More recently, the landmark DAPA-HF trial established SGLT2 inhibitor therapy as part of standard-of-care, guideline-directed medical therapy for patients with HF with reduced ejection fraction regardless of whether they have comorbid type 2 diabetes (N Engl J Med. 2019 Nov 21;381[21]:1995-2008).
These are remarkable medications, generally very well tolerated, and it’s critical that cardiologists get on board in prescribing them, Dr. Fonarow emphasized. He alerted his colleagues to what he called an “incredibly helpful” review article that provides practical guidance for cardiologists in how to start using the SGLT2 inhibitors (JACC Heart Fail. 2019 Feb;7[2]:169-72).
“It’s pretty straightforward,” according to Dr. Fonarow. “If you’re comfortable enough in using ACE inhibitors, angiotensin receptor blockers, and beta-blockers, I think you’ll find these medications fit similarly when you actually get experience in utilizing them.”
He reported serving as a consultant to 10 pharmaceutical or medical device companies.
EXPERT ANALYSIS FROM ACC SNOWMASS 2020
Work the program for NP/PAs, and the program will work
A ‘knowledge gap’ in best practices exists
Hospital medicine has been the fastest growing medical specialty since the term “hospitalist” was coined by Bob Wachter, MD, in the famous 1996 New England Journal of Medicine article (doi: 10.1056/NEJM199608153350713). The growth and change within this specialty is also reflected in the changing and migrating target of hospitals and hospital systems as they continue to effectively and safely move from fee-for-service to a payer model that rewards value and improvement in the health of a population – both in and outside of hospital walls.
In a short time, nurse practitioners and physician assistants have become a growing population in the hospital medicine workforce. The 2018 State of Hospital Medicine Report notes a 42% increase in 4 years, and about 75% of hospital medicine groups across the country currently incorporate NP/PAs within a hospital medicine practice. This evolution has occurred in the setting of a looming and well-documented physician shortage, a variety of cost pressures on hospitals that reflect the need for an efficient and cost-effective care delivery model, an increasing NP/PA workforce (the Department of Labor notes increases of 35% and 36% respectively by 2036), and data that indicates similar outcomes, for example, HCAHPS (the Hospital Consumer Assessment of Healthcare Providers and Systems), readmission, and morbidity and mortality in NP/PA-driven care.
This evolution, however, reveals a true knowledge gap in best practices related to integration of these providers. This is impacted by wide variability in the preparation of NPs – they may enter hospitalist practice from a variety of clinical exposures and training, for example, adult gerontology acute care, adult, or even, in some states, family NPs. For PAs, this is reflected in the variety of clinical rotations and pregraduate clinical exposure.
This variability is compounded, too, by the lack of standardization of hospital medicine practices, both with site size and patient acuity, a variety of challenges that drive the need for integration of NP/PA providers, and by-laws that define advanced practice clinical models and function.
In that perspective, it is important to define what constitutes a leading and successful advanced practice provider (APP) integration program. I would suggest:
- A structured and formalized transition-to-practice program for all new graduates and those new to hospital medicine. This program should consist of clinical volume progression, formalized didactic congruent with the Society of Hospital Medicine Core Competencies, and a process for evaluating knowledge and decision making throughout the program and upon completion.
- Development of physician competencies related to APP integration. Physicians are not prepared in their medical school training or residency to understand the differences and similarities of NP/PA providers. These competencies should be required and can best be developed through steady leadership, formalized instruction and accountability for professional teamwork.
- Allowance for NP/PA providers to work at the top of their skills and license. This means utilizing NP/PAs as providers who care for patients – not as scribes or clerical workers. The evolution of the acuity of patients provided for may evolve with the skill set and experience of NP/PAs, but it will evolve – especially if steps 1 and 2 are in place.
- Productivity expectations that reach near physician level of volume. In 2016 State of Hospital Medicine Report data, yearly billable encounters for NP/PAs were within 10% of that of physicians. I think 15% is a reasonable goal.
- Implementation and support of APP administrative leadership structure at the system/site level. This can be as simple as having APPs on the same leadership committees as physician team members, being involved in hiring and training newer physicians and NP/PAs or as broad as having all NP/PAs report to an APP leader. Having an intentional leadership structure that demonstrates and reflects inclusivity and belonging is crucial.
Consistent application of these frameworks will provide a strong infrastructure for successful NP/PA practice.
Ms. Cardin is currently the vice president of advanced practice providers at Sound Physicians and serves on SHM’s board of directors as its secretary. This article appeared initially at the Hospital Leader, the official blog of SHM.
A ‘knowledge gap’ in best practices exists
A ‘knowledge gap’ in best practices exists
Hospital medicine has been the fastest growing medical specialty since the term “hospitalist” was coined by Bob Wachter, MD, in the famous 1996 New England Journal of Medicine article (doi: 10.1056/NEJM199608153350713). The growth and change within this specialty is also reflected in the changing and migrating target of hospitals and hospital systems as they continue to effectively and safely move from fee-for-service to a payer model that rewards value and improvement in the health of a population – both in and outside of hospital walls.
In a short time, nurse practitioners and physician assistants have become a growing population in the hospital medicine workforce. The 2018 State of Hospital Medicine Report notes a 42% increase in 4 years, and about 75% of hospital medicine groups across the country currently incorporate NP/PAs within a hospital medicine practice. This evolution has occurred in the setting of a looming and well-documented physician shortage, a variety of cost pressures on hospitals that reflect the need for an efficient and cost-effective care delivery model, an increasing NP/PA workforce (the Department of Labor notes increases of 35% and 36% respectively by 2036), and data that indicates similar outcomes, for example, HCAHPS (the Hospital Consumer Assessment of Healthcare Providers and Systems), readmission, and morbidity and mortality in NP/PA-driven care.
This evolution, however, reveals a true knowledge gap in best practices related to integration of these providers. This is impacted by wide variability in the preparation of NPs – they may enter hospitalist practice from a variety of clinical exposures and training, for example, adult gerontology acute care, adult, or even, in some states, family NPs. For PAs, this is reflected in the variety of clinical rotations and pregraduate clinical exposure.
This variability is compounded, too, by the lack of standardization of hospital medicine practices, both with site size and patient acuity, a variety of challenges that drive the need for integration of NP/PA providers, and by-laws that define advanced practice clinical models and function.
In that perspective, it is important to define what constitutes a leading and successful advanced practice provider (APP) integration program. I would suggest:
- A structured and formalized transition-to-practice program for all new graduates and those new to hospital medicine. This program should consist of clinical volume progression, formalized didactic congruent with the Society of Hospital Medicine Core Competencies, and a process for evaluating knowledge and decision making throughout the program and upon completion.
- Development of physician competencies related to APP integration. Physicians are not prepared in their medical school training or residency to understand the differences and similarities of NP/PA providers. These competencies should be required and can best be developed through steady leadership, formalized instruction and accountability for professional teamwork.
- Allowance for NP/PA providers to work at the top of their skills and license. This means utilizing NP/PAs as providers who care for patients – not as scribes or clerical workers. The evolution of the acuity of patients provided for may evolve with the skill set and experience of NP/PAs, but it will evolve – especially if steps 1 and 2 are in place.
- Productivity expectations that reach near physician level of volume. In 2016 State of Hospital Medicine Report data, yearly billable encounters for NP/PAs were within 10% of that of physicians. I think 15% is a reasonable goal.
- Implementation and support of APP administrative leadership structure at the system/site level. This can be as simple as having APPs on the same leadership committees as physician team members, being involved in hiring and training newer physicians and NP/PAs or as broad as having all NP/PAs report to an APP leader. Having an intentional leadership structure that demonstrates and reflects inclusivity and belonging is crucial.
Consistent application of these frameworks will provide a strong infrastructure for successful NP/PA practice.
Ms. Cardin is currently the vice president of advanced practice providers at Sound Physicians and serves on SHM’s board of directors as its secretary. This article appeared initially at the Hospital Leader, the official blog of SHM.
Hospital medicine has been the fastest growing medical specialty since the term “hospitalist” was coined by Bob Wachter, MD, in the famous 1996 New England Journal of Medicine article (doi: 10.1056/NEJM199608153350713). The growth and change within this specialty is also reflected in the changing and migrating target of hospitals and hospital systems as they continue to effectively and safely move from fee-for-service to a payer model that rewards value and improvement in the health of a population – both in and outside of hospital walls.
In a short time, nurse practitioners and physician assistants have become a growing population in the hospital medicine workforce. The 2018 State of Hospital Medicine Report notes a 42% increase in 4 years, and about 75% of hospital medicine groups across the country currently incorporate NP/PAs within a hospital medicine practice. This evolution has occurred in the setting of a looming and well-documented physician shortage, a variety of cost pressures on hospitals that reflect the need for an efficient and cost-effective care delivery model, an increasing NP/PA workforce (the Department of Labor notes increases of 35% and 36% respectively by 2036), and data that indicates similar outcomes, for example, HCAHPS (the Hospital Consumer Assessment of Healthcare Providers and Systems), readmission, and morbidity and mortality in NP/PA-driven care.
This evolution, however, reveals a true knowledge gap in best practices related to integration of these providers. This is impacted by wide variability in the preparation of NPs – they may enter hospitalist practice from a variety of clinical exposures and training, for example, adult gerontology acute care, adult, or even, in some states, family NPs. For PAs, this is reflected in the variety of clinical rotations and pregraduate clinical exposure.
This variability is compounded, too, by the lack of standardization of hospital medicine practices, both with site size and patient acuity, a variety of challenges that drive the need for integration of NP/PA providers, and by-laws that define advanced practice clinical models and function.
In that perspective, it is important to define what constitutes a leading and successful advanced practice provider (APP) integration program. I would suggest:
- A structured and formalized transition-to-practice program for all new graduates and those new to hospital medicine. This program should consist of clinical volume progression, formalized didactic congruent with the Society of Hospital Medicine Core Competencies, and a process for evaluating knowledge and decision making throughout the program and upon completion.
- Development of physician competencies related to APP integration. Physicians are not prepared in their medical school training or residency to understand the differences and similarities of NP/PA providers. These competencies should be required and can best be developed through steady leadership, formalized instruction and accountability for professional teamwork.
- Allowance for NP/PA providers to work at the top of their skills and license. This means utilizing NP/PAs as providers who care for patients – not as scribes or clerical workers. The evolution of the acuity of patients provided for may evolve with the skill set and experience of NP/PAs, but it will evolve – especially if steps 1 and 2 are in place.
- Productivity expectations that reach near physician level of volume. In 2016 State of Hospital Medicine Report data, yearly billable encounters for NP/PAs were within 10% of that of physicians. I think 15% is a reasonable goal.
- Implementation and support of APP administrative leadership structure at the system/site level. This can be as simple as having APPs on the same leadership committees as physician team members, being involved in hiring and training newer physicians and NP/PAs or as broad as having all NP/PAs report to an APP leader. Having an intentional leadership structure that demonstrates and reflects inclusivity and belonging is crucial.
Consistent application of these frameworks will provide a strong infrastructure for successful NP/PA practice.
Ms. Cardin is currently the vice president of advanced practice providers at Sound Physicians and serves on SHM’s board of directors as its secretary. This article appeared initially at the Hospital Leader, the official blog of SHM.
CDC confirms 13th case of coronavirus in U.S.
The Centers for Disease Control and Prevention announced the number of confirmed cases of the 2019 Novel Coronavirus (2019-nCoV) in the United States has reached 13.
The latest case, announced Feb. 11, 2020, by the CDC, was in a person in California who was previously under federal quarantine because the patient had traveled to Wuhan, China.
The CDC is currently looking into who the patient may have come in contact with to understand the potential for further spread of the coronavirus.
“The contact investigation is ongoing,” CDC principal deputy director Anne Schuchat, MD, said during a Feb. 11 press conference to provide an update on coronavirus containment activities being taken by the CDC.
Dr. Schuchat also addressed issues related to the laboratory test, as the patient in California was initially thought to be negative for the coronavirus.
“With other cases around the country that we are evaluating, we have been doing serial tests to understand whether they are still infectious” and to gather other information about how results change over time, Dr. Schuchat said.
She noted that the CDC does not “have as much information as we would like on the severity of the virus,” noting that there are many cases in China with severe reactions, while the 13 cases in the United States represent a much more mild reaction to the virus so far.
With the latest case in California, she noted that there was “probably a mix-up and the original test wasn’t negative,” although she did not elaborate on what the nature of the mix-up was, stating that was all the information that she had.
In general, Dr. Schuchat touted the actions taken by the CDC and the federal government focused primarily on containing the spread of the virus in the United States, including the implementation of travel advisories, quarantining passengers returning from China, as well as the new test kits that are being distributed by the agency across the nation and around the world. She also mentioned CDC staff are being deployed around the world to monitor the spreading of the disease and highlighted the outreach efforts to keep the public informed.
Dr. Schuchat highlighted the fact that, of the 13 cases in the United States, 11 were with patients that were in Wuhan, and only 2 were because of close contact with a patient, something that she attributed to the actions being taken.
She also noted that cases in the United States have not been as severe as they have been in China, where deaths have been attributed to the coronavirus outbreak. She added that there have been only two deaths outside of mainland China attributed to the coronavirus.
“Some of the steps the CDC has taken have really put us in better shape should widespread transmission occur in the United States,” she said.
Dr. Schuchat also highlighted that the first charter flight of people quarantined after returning from Wuhan have reached the 14-day milestone and should be on their way home beginning today.
The Centers for Disease Control and Prevention announced the number of confirmed cases of the 2019 Novel Coronavirus (2019-nCoV) in the United States has reached 13.
The latest case, announced Feb. 11, 2020, by the CDC, was in a person in California who was previously under federal quarantine because the patient had traveled to Wuhan, China.
The CDC is currently looking into who the patient may have come in contact with to understand the potential for further spread of the coronavirus.
“The contact investigation is ongoing,” CDC principal deputy director Anne Schuchat, MD, said during a Feb. 11 press conference to provide an update on coronavirus containment activities being taken by the CDC.
Dr. Schuchat also addressed issues related to the laboratory test, as the patient in California was initially thought to be negative for the coronavirus.
“With other cases around the country that we are evaluating, we have been doing serial tests to understand whether they are still infectious” and to gather other information about how results change over time, Dr. Schuchat said.
She noted that the CDC does not “have as much information as we would like on the severity of the virus,” noting that there are many cases in China with severe reactions, while the 13 cases in the United States represent a much more mild reaction to the virus so far.
With the latest case in California, she noted that there was “probably a mix-up and the original test wasn’t negative,” although she did not elaborate on what the nature of the mix-up was, stating that was all the information that she had.
In general, Dr. Schuchat touted the actions taken by the CDC and the federal government focused primarily on containing the spread of the virus in the United States, including the implementation of travel advisories, quarantining passengers returning from China, as well as the new test kits that are being distributed by the agency across the nation and around the world. She also mentioned CDC staff are being deployed around the world to monitor the spreading of the disease and highlighted the outreach efforts to keep the public informed.
Dr. Schuchat highlighted the fact that, of the 13 cases in the United States, 11 were with patients that were in Wuhan, and only 2 were because of close contact with a patient, something that she attributed to the actions being taken.
She also noted that cases in the United States have not been as severe as they have been in China, where deaths have been attributed to the coronavirus outbreak. She added that there have been only two deaths outside of mainland China attributed to the coronavirus.
“Some of the steps the CDC has taken have really put us in better shape should widespread transmission occur in the United States,” she said.
Dr. Schuchat also highlighted that the first charter flight of people quarantined after returning from Wuhan have reached the 14-day milestone and should be on their way home beginning today.
The Centers for Disease Control and Prevention announced the number of confirmed cases of the 2019 Novel Coronavirus (2019-nCoV) in the United States has reached 13.
The latest case, announced Feb. 11, 2020, by the CDC, was in a person in California who was previously under federal quarantine because the patient had traveled to Wuhan, China.
The CDC is currently looking into who the patient may have come in contact with to understand the potential for further spread of the coronavirus.
“The contact investigation is ongoing,” CDC principal deputy director Anne Schuchat, MD, said during a Feb. 11 press conference to provide an update on coronavirus containment activities being taken by the CDC.
Dr. Schuchat also addressed issues related to the laboratory test, as the patient in California was initially thought to be negative for the coronavirus.
“With other cases around the country that we are evaluating, we have been doing serial tests to understand whether they are still infectious” and to gather other information about how results change over time, Dr. Schuchat said.
She noted that the CDC does not “have as much information as we would like on the severity of the virus,” noting that there are many cases in China with severe reactions, while the 13 cases in the United States represent a much more mild reaction to the virus so far.
With the latest case in California, she noted that there was “probably a mix-up and the original test wasn’t negative,” although she did not elaborate on what the nature of the mix-up was, stating that was all the information that she had.
In general, Dr. Schuchat touted the actions taken by the CDC and the federal government focused primarily on containing the spread of the virus in the United States, including the implementation of travel advisories, quarantining passengers returning from China, as well as the new test kits that are being distributed by the agency across the nation and around the world. She also mentioned CDC staff are being deployed around the world to monitor the spreading of the disease and highlighted the outreach efforts to keep the public informed.
Dr. Schuchat highlighted the fact that, of the 13 cases in the United States, 11 were with patients that were in Wuhan, and only 2 were because of close contact with a patient, something that she attributed to the actions being taken.
She also noted that cases in the United States have not been as severe as they have been in China, where deaths have been attributed to the coronavirus outbreak. She added that there have been only two deaths outside of mainland China attributed to the coronavirus.
“Some of the steps the CDC has taken have really put us in better shape should widespread transmission occur in the United States,” she said.
Dr. Schuchat also highlighted that the first charter flight of people quarantined after returning from Wuhan have reached the 14-day milestone and should be on their way home beginning today.
Consider PET/CT when infectious source is a puzzler
CHICAGO – Dual positron emission tomography-computed tomography (PET/CT) scans changed the treatment course of nearly half of patients whose scans were positive for infection. In a single-center systematic review of 18fluorodeoxyglucose (FDG)–PET/CT scans, 55 of the 138 scans (40%) changed clinical management.
Presenting the findings at the annual meeting of the Radiological Society of North America, Benjamin Viglianti, MD, PhD, said that PET/CT had particular utility in cases of bacteremia and endocarditis, in which the scans changed treatment in 46% of those cases.
Dr. Viglianti, a radiologist at the University of Michigan, Ann Arbor, explained that medical student and first author Anitha Menon, himself, and their collaborators deliberately used a broad definition of clinical management change. The management course was considered to change not only if an unknown infection site was discovered or if a new intervention was initiated after the scan, but also if antibiotic choice or duration was changed or an additional specialty was consulted.
Scans were included in the study if an infectious etiology was found in the scan and if the patient received an infectious disease consult. Bacteremia and endocarditis were the most frequent indications for scans and also the indications for which management was most frequently changed. When a vascular cause was the indication for the scan, management changed 41% of the time. For fevers of unknown origin, the scan changed management in 30% of the cases, while for osteomyelitis, management was changed for 28% of patients.
The investigators identified several broad themes from their review that pointed toward when clinicians might consider FDG-PET/CT imaging in infectious disease management.
The first, said Dr. Viglianti, was that “for patients with suspected vascular graft infection, PET/CT using FDG may be a good first-choice imaging modality.” He pointed to an illustrative case of a patient who was 1 month out from open repair of a thoracoabdominal aortic aneurysm. The patient had abdominal pain, epigastric tenderness and nausea, as well as an erythematous incision site. A CT scan just revealed an abdominal fluid collection, but the PET/CT scan showed radiotracer uptake at the prior repair site, indicating infection.
For patients with bacteremia, the investigators judged that FDG-PET/CT might be particularly useful in patients who have a graft, prosthetic valve, or cardiac device. Here, Dr. Viglianti and his collaborators highlighted the scan of a woman with DiGeorge syndrome who had received aortic root replacement for truncus arteriosis. She had been found to have persistent enterococcal bacteremia at high levels, but had been symptom free. To take a close look at the suspected infectious nidus, a transesophageal echocardiogram had been obtained, but this study didn’t turn up any clear masses or vegetations. The PET/CT scan, though, revealed avid FDG uptake in the area of the prosthesis.
Management course was not likely to be changed for patients with fever of unknown origin, but the investigators did note that whole-body PET/CT was useful to distinguish infectious etiologies from hematologic and oncologic processes. Their review included a patient who had Crohn’s disease and fever, myalgias, and upper abdominal pain, as well as liver enzyme elevation. The PET/CT showed radiotracer uptake within the spleen, which was enlarged. The scan also showed bone marrow uptake; these findings pointed toward hemophagocytic lymphohistiocytosis rather than an infectious etiology.
For osteomyelitis, said Dr. Viglianti, FDG-PET may have limited utility; it might be most useful when MRI is contraindicated. Within the study population, the investigators identified a patient who had chills and fever along with focal tenderness over the lumbar spine in the context of recent pyelonephritis of a graft kidney. Here, MRI findings were suspicious for osteomyelitis and diskitis, and the FDG uptake at the L4-L5 vertebral levels confirmed the MRI results.
When a patient with a prosthetic valve is suspected of having endocarditis, “cardiac PET/CT may be of high diagnostic value,” said Dr. Viglianti. For patients with endocarditis of native valves, though, a full-body FDG-PET/CT scan may spot septic emboli. A patient identified in the investigators’ review had been admitted for methicillin-resistant Staphylococcus aureus endocarditis. The patient, who had a history of intravenous drug use, received a transesophageal echocardiogram that found severe tricuspid valve regurgitation and vegetations. The whole-body PET/CT scan, though, revealed avid uptake in both buttocks, as well as thigh, ankle and calf muscles – a pattern “suspicious for infectious myositis,” said the researchers.
In discussion during the poster session, Dr. Viglianti said that, although reimbursement for PET/CT scans for infectious etiologies might not be feasible, it can still be a reasonable and even cost-effective choice. At his institution, he said, the requisite radioisotope is made in-house, twice daily, so it’s relatively easy to arrange scans. Since PET/CT scans can be acquired relatively quickly and there’s no delay while waiting for radiotracer uptake, clinical decisions can be made more quickly than when waiting for bone uptake for a technetium-99 scan, he said. This can have the effect of saving a night of hospitalization in many cases.
Dr. Viglianti and Ms. Menon reported that they had no relevant conflicts of interest. No outside sources of funding were reported.
SOURCE: Menon A et al. RSNA 2019, Abstract NM203-SDSUB1.
CHICAGO – Dual positron emission tomography-computed tomography (PET/CT) scans changed the treatment course of nearly half of patients whose scans were positive for infection. In a single-center systematic review of 18fluorodeoxyglucose (FDG)–PET/CT scans, 55 of the 138 scans (40%) changed clinical management.
Presenting the findings at the annual meeting of the Radiological Society of North America, Benjamin Viglianti, MD, PhD, said that PET/CT had particular utility in cases of bacteremia and endocarditis, in which the scans changed treatment in 46% of those cases.
Dr. Viglianti, a radiologist at the University of Michigan, Ann Arbor, explained that medical student and first author Anitha Menon, himself, and their collaborators deliberately used a broad definition of clinical management change. The management course was considered to change not only if an unknown infection site was discovered or if a new intervention was initiated after the scan, but also if antibiotic choice or duration was changed or an additional specialty was consulted.
Scans were included in the study if an infectious etiology was found in the scan and if the patient received an infectious disease consult. Bacteremia and endocarditis were the most frequent indications for scans and also the indications for which management was most frequently changed. When a vascular cause was the indication for the scan, management changed 41% of the time. For fevers of unknown origin, the scan changed management in 30% of the cases, while for osteomyelitis, management was changed for 28% of patients.
The investigators identified several broad themes from their review that pointed toward when clinicians might consider FDG-PET/CT imaging in infectious disease management.
The first, said Dr. Viglianti, was that “for patients with suspected vascular graft infection, PET/CT using FDG may be a good first-choice imaging modality.” He pointed to an illustrative case of a patient who was 1 month out from open repair of a thoracoabdominal aortic aneurysm. The patient had abdominal pain, epigastric tenderness and nausea, as well as an erythematous incision site. A CT scan just revealed an abdominal fluid collection, but the PET/CT scan showed radiotracer uptake at the prior repair site, indicating infection.
For patients with bacteremia, the investigators judged that FDG-PET/CT might be particularly useful in patients who have a graft, prosthetic valve, or cardiac device. Here, Dr. Viglianti and his collaborators highlighted the scan of a woman with DiGeorge syndrome who had received aortic root replacement for truncus arteriosis. She had been found to have persistent enterococcal bacteremia at high levels, but had been symptom free. To take a close look at the suspected infectious nidus, a transesophageal echocardiogram had been obtained, but this study didn’t turn up any clear masses or vegetations. The PET/CT scan, though, revealed avid FDG uptake in the area of the prosthesis.
Management course was not likely to be changed for patients with fever of unknown origin, but the investigators did note that whole-body PET/CT was useful to distinguish infectious etiologies from hematologic and oncologic processes. Their review included a patient who had Crohn’s disease and fever, myalgias, and upper abdominal pain, as well as liver enzyme elevation. The PET/CT showed radiotracer uptake within the spleen, which was enlarged. The scan also showed bone marrow uptake; these findings pointed toward hemophagocytic lymphohistiocytosis rather than an infectious etiology.
For osteomyelitis, said Dr. Viglianti, FDG-PET may have limited utility; it might be most useful when MRI is contraindicated. Within the study population, the investigators identified a patient who had chills and fever along with focal tenderness over the lumbar spine in the context of recent pyelonephritis of a graft kidney. Here, MRI findings were suspicious for osteomyelitis and diskitis, and the FDG uptake at the L4-L5 vertebral levels confirmed the MRI results.
When a patient with a prosthetic valve is suspected of having endocarditis, “cardiac PET/CT may be of high diagnostic value,” said Dr. Viglianti. For patients with endocarditis of native valves, though, a full-body FDG-PET/CT scan may spot septic emboli. A patient identified in the investigators’ review had been admitted for methicillin-resistant Staphylococcus aureus endocarditis. The patient, who had a history of intravenous drug use, received a transesophageal echocardiogram that found severe tricuspid valve regurgitation and vegetations. The whole-body PET/CT scan, though, revealed avid uptake in both buttocks, as well as thigh, ankle and calf muscles – a pattern “suspicious for infectious myositis,” said the researchers.
In discussion during the poster session, Dr. Viglianti said that, although reimbursement for PET/CT scans for infectious etiologies might not be feasible, it can still be a reasonable and even cost-effective choice. At his institution, he said, the requisite radioisotope is made in-house, twice daily, so it’s relatively easy to arrange scans. Since PET/CT scans can be acquired relatively quickly and there’s no delay while waiting for radiotracer uptake, clinical decisions can be made more quickly than when waiting for bone uptake for a technetium-99 scan, he said. This can have the effect of saving a night of hospitalization in many cases.
Dr. Viglianti and Ms. Menon reported that they had no relevant conflicts of interest. No outside sources of funding were reported.
SOURCE: Menon A et al. RSNA 2019, Abstract NM203-SDSUB1.
CHICAGO – Dual positron emission tomography-computed tomography (PET/CT) scans changed the treatment course of nearly half of patients whose scans were positive for infection. In a single-center systematic review of 18fluorodeoxyglucose (FDG)–PET/CT scans, 55 of the 138 scans (40%) changed clinical management.
Presenting the findings at the annual meeting of the Radiological Society of North America, Benjamin Viglianti, MD, PhD, said that PET/CT had particular utility in cases of bacteremia and endocarditis, in which the scans changed treatment in 46% of those cases.
Dr. Viglianti, a radiologist at the University of Michigan, Ann Arbor, explained that medical student and first author Anitha Menon, himself, and their collaborators deliberately used a broad definition of clinical management change. The management course was considered to change not only if an unknown infection site was discovered or if a new intervention was initiated after the scan, but also if antibiotic choice or duration was changed or an additional specialty was consulted.
Scans were included in the study if an infectious etiology was found in the scan and if the patient received an infectious disease consult. Bacteremia and endocarditis were the most frequent indications for scans and also the indications for which management was most frequently changed. When a vascular cause was the indication for the scan, management changed 41% of the time. For fevers of unknown origin, the scan changed management in 30% of the cases, while for osteomyelitis, management was changed for 28% of patients.
The investigators identified several broad themes from their review that pointed toward when clinicians might consider FDG-PET/CT imaging in infectious disease management.
The first, said Dr. Viglianti, was that “for patients with suspected vascular graft infection, PET/CT using FDG may be a good first-choice imaging modality.” He pointed to an illustrative case of a patient who was 1 month out from open repair of a thoracoabdominal aortic aneurysm. The patient had abdominal pain, epigastric tenderness and nausea, as well as an erythematous incision site. A CT scan just revealed an abdominal fluid collection, but the PET/CT scan showed radiotracer uptake at the prior repair site, indicating infection.
For patients with bacteremia, the investigators judged that FDG-PET/CT might be particularly useful in patients who have a graft, prosthetic valve, or cardiac device. Here, Dr. Viglianti and his collaborators highlighted the scan of a woman with DiGeorge syndrome who had received aortic root replacement for truncus arteriosis. She had been found to have persistent enterococcal bacteremia at high levels, but had been symptom free. To take a close look at the suspected infectious nidus, a transesophageal echocardiogram had been obtained, but this study didn’t turn up any clear masses or vegetations. The PET/CT scan, though, revealed avid FDG uptake in the area of the prosthesis.
Management course was not likely to be changed for patients with fever of unknown origin, but the investigators did note that whole-body PET/CT was useful to distinguish infectious etiologies from hematologic and oncologic processes. Their review included a patient who had Crohn’s disease and fever, myalgias, and upper abdominal pain, as well as liver enzyme elevation. The PET/CT showed radiotracer uptake within the spleen, which was enlarged. The scan also showed bone marrow uptake; these findings pointed toward hemophagocytic lymphohistiocytosis rather than an infectious etiology.
For osteomyelitis, said Dr. Viglianti, FDG-PET may have limited utility; it might be most useful when MRI is contraindicated. Within the study population, the investigators identified a patient who had chills and fever along with focal tenderness over the lumbar spine in the context of recent pyelonephritis of a graft kidney. Here, MRI findings were suspicious for osteomyelitis and diskitis, and the FDG uptake at the L4-L5 vertebral levels confirmed the MRI results.
When a patient with a prosthetic valve is suspected of having endocarditis, “cardiac PET/CT may be of high diagnostic value,” said Dr. Viglianti. For patients with endocarditis of native valves, though, a full-body FDG-PET/CT scan may spot septic emboli. A patient identified in the investigators’ review had been admitted for methicillin-resistant Staphylococcus aureus endocarditis. The patient, who had a history of intravenous drug use, received a transesophageal echocardiogram that found severe tricuspid valve regurgitation and vegetations. The whole-body PET/CT scan, though, revealed avid uptake in both buttocks, as well as thigh, ankle and calf muscles – a pattern “suspicious for infectious myositis,” said the researchers.
In discussion during the poster session, Dr. Viglianti said that, although reimbursement for PET/CT scans for infectious etiologies might not be feasible, it can still be a reasonable and even cost-effective choice. At his institution, he said, the requisite radioisotope is made in-house, twice daily, so it’s relatively easy to arrange scans. Since PET/CT scans can be acquired relatively quickly and there’s no delay while waiting for radiotracer uptake, clinical decisions can be made more quickly than when waiting for bone uptake for a technetium-99 scan, he said. This can have the effect of saving a night of hospitalization in many cases.
Dr. Viglianti and Ms. Menon reported that they had no relevant conflicts of interest. No outside sources of funding were reported.
SOURCE: Menon A et al. RSNA 2019, Abstract NM203-SDSUB1.
REPORTING FROM RSNA 2019
What you absolutely need to know about tail coverage
A 28-year-old pediatrician working in a large group practice in California found a new job in Pennsylvania. The job would allow her to live with her husband, who was a nonphysician.
On her last day of work at the California job, the practice’s office manager asked her, “Do you know about the tail coverage?”
He explained that it is malpractice insurance for any cases filed against her after leaving the job. Without it, he said, she would not be covered for those claims.
The physician (who asked not to be identified) had very little savings and suddenly had to pay a five-figure bill for tail coverage. To provide the extra malpractice coverage, she and her husband had to use savings they’d set aside to buy a house.
Getting tail coverage, known formally as an extended reporting endorsement, often comes as a complete and costly surprise for new doctors, says Dennis Hursh, Esq, a health care attorney based in Middletown, Penn., who deals with physicians’ employment contracts.
“Having to pay for a tail can disrupt lives,” Hursh said. “A tail can cost about one third of a young doctor’s salary. If you don’t feel you can afford to pay that, you may be forced to stay with a job you don’t like.”
Most medical residents don’t think about tail coverage until they apply for their first job, but last year, residents at Hahnemann University Hospital in Philadelphia got a painful early lesson.
In the summer, the hospital went out of business because of financial problems. Hundreds of medical residents and fellows not only were forced to find new programs but also had to prepare to buy tail coverage for their training years at Hahnemann.
“All the guarantees have been yanked out from under us,” said Tom Sibert, MD, a former internal medicine resident at the hospital, who is now finishing his training in California. “Residents don’t have that kind of money.”
Hahnemann trainees have asked the judge in the bankruptcy proceedings to put them ahead of other creditors and to ensure their tail coverage is paid. As of early February, the issue had not been resolved.
Meanwhile, Sibert and many other former trainees were trying to get quotes for purchasing tail coverage. They have been shocked by the amounts they would have to pay.
How tail coverage works
Medical malpractice tail coverage protects from incidents that took place when doctors were at their previous jobs but that later resulted in malpractice claims after they had left that employer.
One type of malpractice insurance, an occurrence policy, does not need tail coverage. Occurrence policies cover any incident that occurred when the policy was in force, no matter when a claim was filed – even if it is filed many years after the claims-filing period of the policy ends.
However, most malpractice policies – as many as 85%, according to one estimate – are claims-made policies. Claims-made policies are more much common because they’re significantly less expensive than occurrence policies.
Under a claims-made policy, coverage for malpractice claims completely stops when the policy ends. It does not cover incidents that occurred when the policy was in force but for which the patients later filed claims, as the occurrence policy does. So a tail is needed to cover these claims.
Physicians in all stages of their career may need tail coverage when they leave a job, change malpractice carriers, or retire.
But young physicians often have greater problems with tail coverage, for several reasons. They tend to be employed, and as such, they cannot choose the coverage they want. As a result, they most likely get claims-made coverage. In addition, the job turnover tends to be higher for these doctors. When leaving a job, the tail comes into play. More than half of new physicians leave their first job within 5 years, and of those, more than half leave after only 1 or 2 years.
Young physicians have no experience with tails and may not even know what they are. “In training, malpractice coverage is not a problem because the program handles it,” Mr. Hursh said. Accreditation standards require that teaching hospitals buy coverage, including a tail when residents leave.
So when young physicians are offered their first job and are handed an employment contract to sign, they may not even look for tail coverage, says Mr. Hursh, who wrote The Final Hurdle, a Physician’s Guide to Negotiating a Fair Employment Agreement. Instead, “young physicians tend to focus on issues like salary, benefits, and signing bonuses,” he said.
Mr. Hursh says the tail is usually the most expensive potential cost in the contract.
There’s no easy way to get out of paying the tail coverage once it is enshrined in the contract. The full tail can cost five or even six figures, depending on the physicians’ specialty, the local malpractice premium, and the physician’s own claims history.
Can you negotiate your tail coverage?
Negotiating tail coverage in the employment contract involves some familiarity with medical malpractice insurance and a close reading of the contract. First, you have to determine that the employer is providing claims-made coverage, which would require a tail if you leave. Then you have to determine whether the employer will pay for the tail coverage.
Often, the contract does not even mention tail coverage. “It could merely state that the practice will be responsible for malpractice coverage while you are working there,” Mr. Hursh said. Although it never specifies the tail, this language indicates that you will be paying for it, he says.
Therefore, it’s wise to have a conversation with your prospective employer about the tail. “Some new doctors never ask the question ‘What happens if I leave? Do I get tail coverage?’ ” said Israel Teitelbaum, an attorney who is chairman of Contemporary Insurance Services, an insurance broker in Silver Spring, Md.
Talking about the tail, however, can be a touchy subject for many young doctors applying for their first job. The tail matters only if you leave the job, and you may not want to imply that you would ever want to leave. Too much money, however, is on the line for you not to ask, Mr. Teitelbaum said.
Even if the employer verbally agrees to pay for the tail coverage, experts advise that you try to get the employer’s commitment in writing and have it put it into the contract.
Getting the employer to cover the tail in the initial contract is crucial because once you have agreed to work there, “it’s much more difficult to get it changed,” Mr. Teitelbaum said. However, even if tail coverage is not in the first contract, you shouldn’t give up, he says. You should try again in the next contract a few years later.
“It’s never too late to bring it up,” Mr. Teitelbaum said. After a few years of employment, you have a track record at the job. “A doctor who is very desirable to the employer may be able to get tail coverage on contract renewal.”
Coverage: Large employers vs. small employers
Willingness to pay for an employee’s tail coverage varies depending on the size of the employer. Large employers – systems, hospitals, and large practices – are much more likely to cover the tail than small and medium-sized practices.
Large employers tend to pay for at least part of the tail because they realize that it is in their interest to do so. Since they have the deepest pockets, they’re often the first to be named in a lawsuit. They might have to pay the whole claim if the physician did not have tail coverage.
However, many large employers want to use tail coverage as a bargaining chip to make sure doctors stay for a while at least. One typical arrangement, Mr. Hursh says, is to pay only one-fifth of the tail if the physician leaves in the first year of employment and then to pay one fifth more in each succeeding year until year five, when the employer assumes the entire cost of the tail.
Smaller practices, on the other hand, are usually close-fisted about tail coverage. “They tend to view the tail as an unnecessary expense,” Mr. Hursh said. “They don’t want to pay for a doctor who is not generating revenue for them any more.”
Traditionally, when physicians become partners, practices are more generous and agree to pay their tails if they leave, Mr. Hursh says. But he thinks this is changing, too – recent partnership contracts he has reviewed did not provide for tail coverage.
Times you don’t need to pay for tail coverage
Even if you’re responsible for the tail coverage, your insurance arrangement may be such that you don’t have to pay for it, says Michelle Perron, a malpractice insurance broker in North Hampton, N.H.
For example, if the carrier at your new job is the same as the one at your old job, your coverage would continue with no break, and you would not need a tail, she says. Even if you move to another state, your old carrier might also sell policies there, and you would then likely have seamless coverage, Ms. Perron says. This would be handy if you could choose your new carrier.
Even when you change carriers, Ms. Perron says, the new one might agree to pick up the old carrier’s coverage in return for getting your business, assuming you are an independent physician buying your own coverage. The new carrier would issue prior acts coverage, also known as nose coverage.
Older doctors going into retirement also have a potential tail coverage problem, but their tail coverage premium is often waived, Ms. Perron says. The need for a tail has to do with claims arising post retirement, after your coverage has ended. Typically, if you have been with the carrier for at least 5 years and you are age 55 years or older, your carrier will waive the tail coverage premium, she says.
However, if the retired doctor starts practicing again, even part time, the carrier may want to take back the free tail, she says. Some retired doctors get around this by buying a lower-priced tail from another company, but the former carrier may still want its money back, Ms. Perron says.
Can you just go without tail coverage?
What happens if physicians with a tail commitment choose to wing it and not pay for the tail? If a claim was never made against them, they may believe that the expense is unnecessary. The situation, however, is not so simple.
Some states require having tail coverage. Malpractice coverage is required in seven states, and at least some of those states explicitly extend this requirement to tails. They are Colorado, Connecticut, Kansas, Massachusetts, New Jersey, Rhode Island, and Wisconsin. Eleven more states tie malpractice coverage, perhaps including tails, to some benefit for the doctor, such as tort reform. These states include Indiana, Nebraska, New Mexico, New York, and Pennsylvania.
Many hospitals require tail coverage for privileges, and some insurers do as well. In addition, Ms. Perron says a missing tail reduces your prospects when looking for a job. “For the employer, having to pay coverage for a new hire will cost more than starting fresh with someone else,” she said.
Still, it’s important to remember the risk of being sued. “If you don’t buy the tail coverage, you are at risk for a lawsuit for many years to come,” Mr. Teitelbaum said.
Doctors should consider their potential lifetime risk, not just their current risk. Although only 8% of doctors younger than age 40 have been sued for malpractice, that figure climbs to almost half by the time doctors reach age 55.
The risks are higher in some specialties. About 63% of general surgeons and ob.gyns. have been sued.
Many of these claims are without merit, and doctors pay only the legal expenses of defending the case. Some doctors may think they could risk frivolous suits and cover legal expenses out of pocket. An American Medical Association survey showed that 68% of closed claims against doctors were dropped, dismissed, or withdrawn. It said these claims cost an average of more than $30,000 to defend.
However, Mr. Teitelbaum puts the defense costs for so-called frivolous suits much higher than the AMA, at $250,000 or more. “Even if you’re sure you won’t have to pay a claim, you still have to defend yourself against frivolous suits,” he said. “You won’t recover those expenses.”
How to lower your tail coverage cost
Physicians typically have 60 days to buy tail coverage after their regular coverage has ended. Specialized brokers such as Mr. Teitelbaum and Ms. Perron help physicians look for the best tails to buy.
The cost of the tail depends on how long you’ve been at your job when you leave it, Ms. Perron says. If you leave in the first 1 or 2 years of the policy, she says, the tail price will be lower because the coverage period is shorter.
Usually the most expensive tail available is from the carrier that issued the original policy. Why is this? “Carriers rarely sell a tail that undercuts their retail price,” Mr. Teitelbaum said. “They don’t want to compete with themselves, and in fact doing so could pose regulatory problems for them.”
Instead of buying from their own carrier, doctors can purchase stand-alone tails from competitors, which Mr. Teitelbaum says are 10%-30% less expensive than the policy the original carrier issues. However, stand-alone tails are not always easy to find, especially for high-cost specialties such as neurosurgery and ob.gyn., he says.
Some physicians try to bring down the cost of the tail by limiting the duration of the tail. You can buy tails that only cover claims filed 1-5 years after the incident took place, rather than indefinitely. These limits mirror the typical statute of limitations – the time limit to file a claim in each state. This limit is as little as 2 years in some states, though it can be as long as 6 years in others.
However, some states make exceptions to the statute of limitations. The 2- to 6-year clock doesn’t start ticking until the mistake is discovered or, in the case of children, when they reach adulthood. “This means that with a limited tail, you always have risk,” Perron said.
And yet some doctors insist on these time-limited tails. “If a doctor opts for 3 years’ coverage, that’s better than no years,” Mr. Teitelbaum said. “But I would advise them to take at least 5 years because that gives you coverage for the basic statute of limitations in most states. Three-year tails do yield savings, but often they’re not enough to warrant the risk.”
Another way to reduce costs is to lower the coverage limits of the tail. The standard coverage limit is $1 million per case and $3 million per year, so doctors might be able to save money on the premium by buying limits of $200,000/$600,000. But Mr. Teitelbaum says most companies would refuse to sell a policy with a limit lower than that of the expiring policy.
Further ways to reduce the cost of the tail include buying tail coverage that doesn’t give the physician the right to approve a settlement or that doesn’t include legal fees in the coverage limits. But these options, too, raise the physician’s risks. Whichever option you choose, the important thing is to protect yourself against costly lawsuits.
This article first appeared on Medscape.com.
A 28-year-old pediatrician working in a large group practice in California found a new job in Pennsylvania. The job would allow her to live with her husband, who was a nonphysician.
On her last day of work at the California job, the practice’s office manager asked her, “Do you know about the tail coverage?”
He explained that it is malpractice insurance for any cases filed against her after leaving the job. Without it, he said, she would not be covered for those claims.
The physician (who asked not to be identified) had very little savings and suddenly had to pay a five-figure bill for tail coverage. To provide the extra malpractice coverage, she and her husband had to use savings they’d set aside to buy a house.
Getting tail coverage, known formally as an extended reporting endorsement, often comes as a complete and costly surprise for new doctors, says Dennis Hursh, Esq, a health care attorney based in Middletown, Penn., who deals with physicians’ employment contracts.
“Having to pay for a tail can disrupt lives,” Hursh said. “A tail can cost about one third of a young doctor’s salary. If you don’t feel you can afford to pay that, you may be forced to stay with a job you don’t like.”
Most medical residents don’t think about tail coverage until they apply for their first job, but last year, residents at Hahnemann University Hospital in Philadelphia got a painful early lesson.
In the summer, the hospital went out of business because of financial problems. Hundreds of medical residents and fellows not only were forced to find new programs but also had to prepare to buy tail coverage for their training years at Hahnemann.
“All the guarantees have been yanked out from under us,” said Tom Sibert, MD, a former internal medicine resident at the hospital, who is now finishing his training in California. “Residents don’t have that kind of money.”
Hahnemann trainees have asked the judge in the bankruptcy proceedings to put them ahead of other creditors and to ensure their tail coverage is paid. As of early February, the issue had not been resolved.
Meanwhile, Sibert and many other former trainees were trying to get quotes for purchasing tail coverage. They have been shocked by the amounts they would have to pay.
How tail coverage works
Medical malpractice tail coverage protects from incidents that took place when doctors were at their previous jobs but that later resulted in malpractice claims after they had left that employer.
One type of malpractice insurance, an occurrence policy, does not need tail coverage. Occurrence policies cover any incident that occurred when the policy was in force, no matter when a claim was filed – even if it is filed many years after the claims-filing period of the policy ends.
However, most malpractice policies – as many as 85%, according to one estimate – are claims-made policies. Claims-made policies are more much common because they’re significantly less expensive than occurrence policies.
Under a claims-made policy, coverage for malpractice claims completely stops when the policy ends. It does not cover incidents that occurred when the policy was in force but for which the patients later filed claims, as the occurrence policy does. So a tail is needed to cover these claims.
Physicians in all stages of their career may need tail coverage when they leave a job, change malpractice carriers, or retire.
But young physicians often have greater problems with tail coverage, for several reasons. They tend to be employed, and as such, they cannot choose the coverage they want. As a result, they most likely get claims-made coverage. In addition, the job turnover tends to be higher for these doctors. When leaving a job, the tail comes into play. More than half of new physicians leave their first job within 5 years, and of those, more than half leave after only 1 or 2 years.
Young physicians have no experience with tails and may not even know what they are. “In training, malpractice coverage is not a problem because the program handles it,” Mr. Hursh said. Accreditation standards require that teaching hospitals buy coverage, including a tail when residents leave.
So when young physicians are offered their first job and are handed an employment contract to sign, they may not even look for tail coverage, says Mr. Hursh, who wrote The Final Hurdle, a Physician’s Guide to Negotiating a Fair Employment Agreement. Instead, “young physicians tend to focus on issues like salary, benefits, and signing bonuses,” he said.
Mr. Hursh says the tail is usually the most expensive potential cost in the contract.
There’s no easy way to get out of paying the tail coverage once it is enshrined in the contract. The full tail can cost five or even six figures, depending on the physicians’ specialty, the local malpractice premium, and the physician’s own claims history.
Can you negotiate your tail coverage?
Negotiating tail coverage in the employment contract involves some familiarity with medical malpractice insurance and a close reading of the contract. First, you have to determine that the employer is providing claims-made coverage, which would require a tail if you leave. Then you have to determine whether the employer will pay for the tail coverage.
Often, the contract does not even mention tail coverage. “It could merely state that the practice will be responsible for malpractice coverage while you are working there,” Mr. Hursh said. Although it never specifies the tail, this language indicates that you will be paying for it, he says.
Therefore, it’s wise to have a conversation with your prospective employer about the tail. “Some new doctors never ask the question ‘What happens if I leave? Do I get tail coverage?’ ” said Israel Teitelbaum, an attorney who is chairman of Contemporary Insurance Services, an insurance broker in Silver Spring, Md.
Talking about the tail, however, can be a touchy subject for many young doctors applying for their first job. The tail matters only if you leave the job, and you may not want to imply that you would ever want to leave. Too much money, however, is on the line for you not to ask, Mr. Teitelbaum said.
Even if the employer verbally agrees to pay for the tail coverage, experts advise that you try to get the employer’s commitment in writing and have it put it into the contract.
Getting the employer to cover the tail in the initial contract is crucial because once you have agreed to work there, “it’s much more difficult to get it changed,” Mr. Teitelbaum said. However, even if tail coverage is not in the first contract, you shouldn’t give up, he says. You should try again in the next contract a few years later.
“It’s never too late to bring it up,” Mr. Teitelbaum said. After a few years of employment, you have a track record at the job. “A doctor who is very desirable to the employer may be able to get tail coverage on contract renewal.”
Coverage: Large employers vs. small employers
Willingness to pay for an employee’s tail coverage varies depending on the size of the employer. Large employers – systems, hospitals, and large practices – are much more likely to cover the tail than small and medium-sized practices.
Large employers tend to pay for at least part of the tail because they realize that it is in their interest to do so. Since they have the deepest pockets, they’re often the first to be named in a lawsuit. They might have to pay the whole claim if the physician did not have tail coverage.
However, many large employers want to use tail coverage as a bargaining chip to make sure doctors stay for a while at least. One typical arrangement, Mr. Hursh says, is to pay only one-fifth of the tail if the physician leaves in the first year of employment and then to pay one fifth more in each succeeding year until year five, when the employer assumes the entire cost of the tail.
Smaller practices, on the other hand, are usually close-fisted about tail coverage. “They tend to view the tail as an unnecessary expense,” Mr. Hursh said. “They don’t want to pay for a doctor who is not generating revenue for them any more.”
Traditionally, when physicians become partners, practices are more generous and agree to pay their tails if they leave, Mr. Hursh says. But he thinks this is changing, too – recent partnership contracts he has reviewed did not provide for tail coverage.
Times you don’t need to pay for tail coverage
Even if you’re responsible for the tail coverage, your insurance arrangement may be such that you don’t have to pay for it, says Michelle Perron, a malpractice insurance broker in North Hampton, N.H.
For example, if the carrier at your new job is the same as the one at your old job, your coverage would continue with no break, and you would not need a tail, she says. Even if you move to another state, your old carrier might also sell policies there, and you would then likely have seamless coverage, Ms. Perron says. This would be handy if you could choose your new carrier.
Even when you change carriers, Ms. Perron says, the new one might agree to pick up the old carrier’s coverage in return for getting your business, assuming you are an independent physician buying your own coverage. The new carrier would issue prior acts coverage, also known as nose coverage.
Older doctors going into retirement also have a potential tail coverage problem, but their tail coverage premium is often waived, Ms. Perron says. The need for a tail has to do with claims arising post retirement, after your coverage has ended. Typically, if you have been with the carrier for at least 5 years and you are age 55 years or older, your carrier will waive the tail coverage premium, she says.
However, if the retired doctor starts practicing again, even part time, the carrier may want to take back the free tail, she says. Some retired doctors get around this by buying a lower-priced tail from another company, but the former carrier may still want its money back, Ms. Perron says.
Can you just go without tail coverage?
What happens if physicians with a tail commitment choose to wing it and not pay for the tail? If a claim was never made against them, they may believe that the expense is unnecessary. The situation, however, is not so simple.
Some states require having tail coverage. Malpractice coverage is required in seven states, and at least some of those states explicitly extend this requirement to tails. They are Colorado, Connecticut, Kansas, Massachusetts, New Jersey, Rhode Island, and Wisconsin. Eleven more states tie malpractice coverage, perhaps including tails, to some benefit for the doctor, such as tort reform. These states include Indiana, Nebraska, New Mexico, New York, and Pennsylvania.
Many hospitals require tail coverage for privileges, and some insurers do as well. In addition, Ms. Perron says a missing tail reduces your prospects when looking for a job. “For the employer, having to pay coverage for a new hire will cost more than starting fresh with someone else,” she said.
Still, it’s important to remember the risk of being sued. “If you don’t buy the tail coverage, you are at risk for a lawsuit for many years to come,” Mr. Teitelbaum said.
Doctors should consider their potential lifetime risk, not just their current risk. Although only 8% of doctors younger than age 40 have been sued for malpractice, that figure climbs to almost half by the time doctors reach age 55.
The risks are higher in some specialties. About 63% of general surgeons and ob.gyns. have been sued.
Many of these claims are without merit, and doctors pay only the legal expenses of defending the case. Some doctors may think they could risk frivolous suits and cover legal expenses out of pocket. An American Medical Association survey showed that 68% of closed claims against doctors were dropped, dismissed, or withdrawn. It said these claims cost an average of more than $30,000 to defend.
However, Mr. Teitelbaum puts the defense costs for so-called frivolous suits much higher than the AMA, at $250,000 or more. “Even if you’re sure you won’t have to pay a claim, you still have to defend yourself against frivolous suits,” he said. “You won’t recover those expenses.”
How to lower your tail coverage cost
Physicians typically have 60 days to buy tail coverage after their regular coverage has ended. Specialized brokers such as Mr. Teitelbaum and Ms. Perron help physicians look for the best tails to buy.
The cost of the tail depends on how long you’ve been at your job when you leave it, Ms. Perron says. If you leave in the first 1 or 2 years of the policy, she says, the tail price will be lower because the coverage period is shorter.
Usually the most expensive tail available is from the carrier that issued the original policy. Why is this? “Carriers rarely sell a tail that undercuts their retail price,” Mr. Teitelbaum said. “They don’t want to compete with themselves, and in fact doing so could pose regulatory problems for them.”
Instead of buying from their own carrier, doctors can purchase stand-alone tails from competitors, which Mr. Teitelbaum says are 10%-30% less expensive than the policy the original carrier issues. However, stand-alone tails are not always easy to find, especially for high-cost specialties such as neurosurgery and ob.gyn., he says.
Some physicians try to bring down the cost of the tail by limiting the duration of the tail. You can buy tails that only cover claims filed 1-5 years after the incident took place, rather than indefinitely. These limits mirror the typical statute of limitations – the time limit to file a claim in each state. This limit is as little as 2 years in some states, though it can be as long as 6 years in others.
However, some states make exceptions to the statute of limitations. The 2- to 6-year clock doesn’t start ticking until the mistake is discovered or, in the case of children, when they reach adulthood. “This means that with a limited tail, you always have risk,” Perron said.
And yet some doctors insist on these time-limited tails. “If a doctor opts for 3 years’ coverage, that’s better than no years,” Mr. Teitelbaum said. “But I would advise them to take at least 5 years because that gives you coverage for the basic statute of limitations in most states. Three-year tails do yield savings, but often they’re not enough to warrant the risk.”
Another way to reduce costs is to lower the coverage limits of the tail. The standard coverage limit is $1 million per case and $3 million per year, so doctors might be able to save money on the premium by buying limits of $200,000/$600,000. But Mr. Teitelbaum says most companies would refuse to sell a policy with a limit lower than that of the expiring policy.
Further ways to reduce the cost of the tail include buying tail coverage that doesn’t give the physician the right to approve a settlement or that doesn’t include legal fees in the coverage limits. But these options, too, raise the physician’s risks. Whichever option you choose, the important thing is to protect yourself against costly lawsuits.
This article first appeared on Medscape.com.
A 28-year-old pediatrician working in a large group practice in California found a new job in Pennsylvania. The job would allow her to live with her husband, who was a nonphysician.
On her last day of work at the California job, the practice’s office manager asked her, “Do you know about the tail coverage?”
He explained that it is malpractice insurance for any cases filed against her after leaving the job. Without it, he said, she would not be covered for those claims.
The physician (who asked not to be identified) had very little savings and suddenly had to pay a five-figure bill for tail coverage. To provide the extra malpractice coverage, she and her husband had to use savings they’d set aside to buy a house.
Getting tail coverage, known formally as an extended reporting endorsement, often comes as a complete and costly surprise for new doctors, says Dennis Hursh, Esq, a health care attorney based in Middletown, Penn., who deals with physicians’ employment contracts.
“Having to pay for a tail can disrupt lives,” Hursh said. “A tail can cost about one third of a young doctor’s salary. If you don’t feel you can afford to pay that, you may be forced to stay with a job you don’t like.”
Most medical residents don’t think about tail coverage until they apply for their first job, but last year, residents at Hahnemann University Hospital in Philadelphia got a painful early lesson.
In the summer, the hospital went out of business because of financial problems. Hundreds of medical residents and fellows not only were forced to find new programs but also had to prepare to buy tail coverage for their training years at Hahnemann.
“All the guarantees have been yanked out from under us,” said Tom Sibert, MD, a former internal medicine resident at the hospital, who is now finishing his training in California. “Residents don’t have that kind of money.”
Hahnemann trainees have asked the judge in the bankruptcy proceedings to put them ahead of other creditors and to ensure their tail coverage is paid. As of early February, the issue had not been resolved.
Meanwhile, Sibert and many other former trainees were trying to get quotes for purchasing tail coverage. They have been shocked by the amounts they would have to pay.
How tail coverage works
Medical malpractice tail coverage protects from incidents that took place when doctors were at their previous jobs but that later resulted in malpractice claims after they had left that employer.
One type of malpractice insurance, an occurrence policy, does not need tail coverage. Occurrence policies cover any incident that occurred when the policy was in force, no matter when a claim was filed – even if it is filed many years after the claims-filing period of the policy ends.
However, most malpractice policies – as many as 85%, according to one estimate – are claims-made policies. Claims-made policies are more much common because they’re significantly less expensive than occurrence policies.
Under a claims-made policy, coverage for malpractice claims completely stops when the policy ends. It does not cover incidents that occurred when the policy was in force but for which the patients later filed claims, as the occurrence policy does. So a tail is needed to cover these claims.
Physicians in all stages of their career may need tail coverage when they leave a job, change malpractice carriers, or retire.
But young physicians often have greater problems with tail coverage, for several reasons. They tend to be employed, and as such, they cannot choose the coverage they want. As a result, they most likely get claims-made coverage. In addition, the job turnover tends to be higher for these doctors. When leaving a job, the tail comes into play. More than half of new physicians leave their first job within 5 years, and of those, more than half leave after only 1 or 2 years.
Young physicians have no experience with tails and may not even know what they are. “In training, malpractice coverage is not a problem because the program handles it,” Mr. Hursh said. Accreditation standards require that teaching hospitals buy coverage, including a tail when residents leave.
So when young physicians are offered their first job and are handed an employment contract to sign, they may not even look for tail coverage, says Mr. Hursh, who wrote The Final Hurdle, a Physician’s Guide to Negotiating a Fair Employment Agreement. Instead, “young physicians tend to focus on issues like salary, benefits, and signing bonuses,” he said.
Mr. Hursh says the tail is usually the most expensive potential cost in the contract.
There’s no easy way to get out of paying the tail coverage once it is enshrined in the contract. The full tail can cost five or even six figures, depending on the physicians’ specialty, the local malpractice premium, and the physician’s own claims history.
Can you negotiate your tail coverage?
Negotiating tail coverage in the employment contract involves some familiarity with medical malpractice insurance and a close reading of the contract. First, you have to determine that the employer is providing claims-made coverage, which would require a tail if you leave. Then you have to determine whether the employer will pay for the tail coverage.
Often, the contract does not even mention tail coverage. “It could merely state that the practice will be responsible for malpractice coverage while you are working there,” Mr. Hursh said. Although it never specifies the tail, this language indicates that you will be paying for it, he says.
Therefore, it’s wise to have a conversation with your prospective employer about the tail. “Some new doctors never ask the question ‘What happens if I leave? Do I get tail coverage?’ ” said Israel Teitelbaum, an attorney who is chairman of Contemporary Insurance Services, an insurance broker in Silver Spring, Md.
Talking about the tail, however, can be a touchy subject for many young doctors applying for their first job. The tail matters only if you leave the job, and you may not want to imply that you would ever want to leave. Too much money, however, is on the line for you not to ask, Mr. Teitelbaum said.
Even if the employer verbally agrees to pay for the tail coverage, experts advise that you try to get the employer’s commitment in writing and have it put it into the contract.
Getting the employer to cover the tail in the initial contract is crucial because once you have agreed to work there, “it’s much more difficult to get it changed,” Mr. Teitelbaum said. However, even if tail coverage is not in the first contract, you shouldn’t give up, he says. You should try again in the next contract a few years later.
“It’s never too late to bring it up,” Mr. Teitelbaum said. After a few years of employment, you have a track record at the job. “A doctor who is very desirable to the employer may be able to get tail coverage on contract renewal.”
Coverage: Large employers vs. small employers
Willingness to pay for an employee’s tail coverage varies depending on the size of the employer. Large employers – systems, hospitals, and large practices – are much more likely to cover the tail than small and medium-sized practices.
Large employers tend to pay for at least part of the tail because they realize that it is in their interest to do so. Since they have the deepest pockets, they’re often the first to be named in a lawsuit. They might have to pay the whole claim if the physician did not have tail coverage.
However, many large employers want to use tail coverage as a bargaining chip to make sure doctors stay for a while at least. One typical arrangement, Mr. Hursh says, is to pay only one-fifth of the tail if the physician leaves in the first year of employment and then to pay one fifth more in each succeeding year until year five, when the employer assumes the entire cost of the tail.
Smaller practices, on the other hand, are usually close-fisted about tail coverage. “They tend to view the tail as an unnecessary expense,” Mr. Hursh said. “They don’t want to pay for a doctor who is not generating revenue for them any more.”
Traditionally, when physicians become partners, practices are more generous and agree to pay their tails if they leave, Mr. Hursh says. But he thinks this is changing, too – recent partnership contracts he has reviewed did not provide for tail coverage.
Times you don’t need to pay for tail coverage
Even if you’re responsible for the tail coverage, your insurance arrangement may be such that you don’t have to pay for it, says Michelle Perron, a malpractice insurance broker in North Hampton, N.H.
For example, if the carrier at your new job is the same as the one at your old job, your coverage would continue with no break, and you would not need a tail, she says. Even if you move to another state, your old carrier might also sell policies there, and you would then likely have seamless coverage, Ms. Perron says. This would be handy if you could choose your new carrier.
Even when you change carriers, Ms. Perron says, the new one might agree to pick up the old carrier’s coverage in return for getting your business, assuming you are an independent physician buying your own coverage. The new carrier would issue prior acts coverage, also known as nose coverage.
Older doctors going into retirement also have a potential tail coverage problem, but their tail coverage premium is often waived, Ms. Perron says. The need for a tail has to do with claims arising post retirement, after your coverage has ended. Typically, if you have been with the carrier for at least 5 years and you are age 55 years or older, your carrier will waive the tail coverage premium, she says.
However, if the retired doctor starts practicing again, even part time, the carrier may want to take back the free tail, she says. Some retired doctors get around this by buying a lower-priced tail from another company, but the former carrier may still want its money back, Ms. Perron says.
Can you just go without tail coverage?
What happens if physicians with a tail commitment choose to wing it and not pay for the tail? If a claim was never made against them, they may believe that the expense is unnecessary. The situation, however, is not so simple.
Some states require having tail coverage. Malpractice coverage is required in seven states, and at least some of those states explicitly extend this requirement to tails. They are Colorado, Connecticut, Kansas, Massachusetts, New Jersey, Rhode Island, and Wisconsin. Eleven more states tie malpractice coverage, perhaps including tails, to some benefit for the doctor, such as tort reform. These states include Indiana, Nebraska, New Mexico, New York, and Pennsylvania.
Many hospitals require tail coverage for privileges, and some insurers do as well. In addition, Ms. Perron says a missing tail reduces your prospects when looking for a job. “For the employer, having to pay coverage for a new hire will cost more than starting fresh with someone else,” she said.
Still, it’s important to remember the risk of being sued. “If you don’t buy the tail coverage, you are at risk for a lawsuit for many years to come,” Mr. Teitelbaum said.
Doctors should consider their potential lifetime risk, not just their current risk. Although only 8% of doctors younger than age 40 have been sued for malpractice, that figure climbs to almost half by the time doctors reach age 55.
The risks are higher in some specialties. About 63% of general surgeons and ob.gyns. have been sued.
Many of these claims are without merit, and doctors pay only the legal expenses of defending the case. Some doctors may think they could risk frivolous suits and cover legal expenses out of pocket. An American Medical Association survey showed that 68% of closed claims against doctors were dropped, dismissed, or withdrawn. It said these claims cost an average of more than $30,000 to defend.
However, Mr. Teitelbaum puts the defense costs for so-called frivolous suits much higher than the AMA, at $250,000 or more. “Even if you’re sure you won’t have to pay a claim, you still have to defend yourself against frivolous suits,” he said. “You won’t recover those expenses.”
How to lower your tail coverage cost
Physicians typically have 60 days to buy tail coverage after their regular coverage has ended. Specialized brokers such as Mr. Teitelbaum and Ms. Perron help physicians look for the best tails to buy.
The cost of the tail depends on how long you’ve been at your job when you leave it, Ms. Perron says. If you leave in the first 1 or 2 years of the policy, she says, the tail price will be lower because the coverage period is shorter.
Usually the most expensive tail available is from the carrier that issued the original policy. Why is this? “Carriers rarely sell a tail that undercuts their retail price,” Mr. Teitelbaum said. “They don’t want to compete with themselves, and in fact doing so could pose regulatory problems for them.”
Instead of buying from their own carrier, doctors can purchase stand-alone tails from competitors, which Mr. Teitelbaum says are 10%-30% less expensive than the policy the original carrier issues. However, stand-alone tails are not always easy to find, especially for high-cost specialties such as neurosurgery and ob.gyn., he says.
Some physicians try to bring down the cost of the tail by limiting the duration of the tail. You can buy tails that only cover claims filed 1-5 years after the incident took place, rather than indefinitely. These limits mirror the typical statute of limitations – the time limit to file a claim in each state. This limit is as little as 2 years in some states, though it can be as long as 6 years in others.
However, some states make exceptions to the statute of limitations. The 2- to 6-year clock doesn’t start ticking until the mistake is discovered or, in the case of children, when they reach adulthood. “This means that with a limited tail, you always have risk,” Perron said.
And yet some doctors insist on these time-limited tails. “If a doctor opts for 3 years’ coverage, that’s better than no years,” Mr. Teitelbaum said. “But I would advise them to take at least 5 years because that gives you coverage for the basic statute of limitations in most states. Three-year tails do yield savings, but often they’re not enough to warrant the risk.”
Another way to reduce costs is to lower the coverage limits of the tail. The standard coverage limit is $1 million per case and $3 million per year, so doctors might be able to save money on the premium by buying limits of $200,000/$600,000. But Mr. Teitelbaum says most companies would refuse to sell a policy with a limit lower than that of the expiring policy.
Further ways to reduce the cost of the tail include buying tail coverage that doesn’t give the physician the right to approve a settlement or that doesn’t include legal fees in the coverage limits. But these options, too, raise the physician’s risks. Whichever option you choose, the important thing is to protect yourself against costly lawsuits.
This article first appeared on Medscape.com.
Medicare study evaluates impact of U.S. Hospital Readmissions Reduction Program
Research offers evidence against calls to curtail the program
Among Medicare beneficiaries admitted to the hospital between 2008 and 2016, there was an increase in postdischarge 30-day mortality for patients with heart failure, but not for those with acute myocardial infarction or pneumonia.
The finding comes from an effort to evaluate the use of services soon after discharge for conditions targeted in the U.S. Hospital Readmissions Reduction Program (HRRP), and patients’ outcomes.
“The announcement and implementation of the HRRP were associated with a reduction in readmissions within 30 days of discharge for heart failure, acute myocardial infarction, and pneumonia, as shown by a decrease in the overall national rate of readmissions,” first author Rohan Khera, MD, and colleagues wrote in a study published online Jan. 15, 2020, in the British Medical Journal (doi:10.1136/bmj.l6831).
“Concerns existed that pressures to reduce readmissions had led to the evolution of care patterns that may have adverse consequences through reducing access to care in appropriate settings. Therefore, determining whether patients who are seen in acute care settings, but not admitted to hospital, experience an increased risk of mortality is essential.”
Dr. Khera, a cardiologist at the University of Texas Southwestern Medical Center, Dallas, and colleagues limited the analysis to Medicare claims data from patients who were admitted to the hospital with heart failure, acute myocardial infarction (MI), or pneumonia between 2008 and 2016. Key outcomes of interest were: (1) postdischarge 30-day mortality; and (2) acute care utilization in inpatient units, observation units, and the ED during the postdischarge period.
During the study period there were 3,772,924 hospital admissions for heart failure, 1,570,113 for acute MI, and 3,131,162 for pneumonia. The greatest number of readmissions within 30 days of discharge was for heart failure patients (22.5%), followed by acute MI (17.5%), and pneumonia (17.2%).
The overall rates of observation stays were 1.7% for heart failure, 2.6% for acute MI, and 1.4% for pneumonia, while the overall rates of emergency department visits were 6.4% for heart failure, 6.8% for acute MI, and 6.3% for pneumonia. Cumulatively, about one-third of all admissions – 30.7% for heart failure, 26.9% for acute MI, and 24.8% for pneumonia – received postdischarge care in any acute care setting.
Dr. Khera and colleagues found that overall postdischarge 30-day mortality was 8.7% for heart failure, 7.3% for acute MI, and 8.4% for pneumonia. At the same time, postdischarge 30-day mortality was higher in patients with readmissions (13.2% for heart failure, 12.7% for acute MI, and 15.3% for pneumonia), compared with those who had observation stays (4.5% for heart failure, 2.7% for acute MI, and 4.6% for pneumonia), emergency department visits (9.7% for heart failure, 8.8% for acute MI, and 7.8% for pneumonia), or no postdischarge acute care (7.2% for heart failure, 6.0% for acute MI, and 6.9% for pneumonia). Risk adjusted mortality increased annually by 0.05% only for heart failure, while it decreased by 0.06% for acute MI, and did not significantly change for pneumonia.
“The study strongly suggests that the HRRP did not lead to harm through inappropriate triage of patients at high risk to observation units and the emergency department, and therefore provides evidence against calls to curtail the program owing to this theoretical concern (see JAMA 2018;320:2539-41),” the researchers concluded.
They acknowledged certain limitations of the study, including the fact that they were “unable to identify patterns of acute care during the index hospital admission that would be associated with a higher rate of postdischarge acute care in observation units and emergency departments and whether these visits represented avenues for planned postdischarge follow-up care. Moreover, the proportion of these care encounters that were preventable remains poorly understood.”
Dr. Khera disclosed that he is supported by the National Center for Advancing Translational Sciences of the National Institutes of Health. His coauthors reported having numerous disclosures.
SOURCE: Khera et al. BMJ 2020;368:l6831.
Research offers evidence against calls to curtail the program
Research offers evidence against calls to curtail the program
Among Medicare beneficiaries admitted to the hospital between 2008 and 2016, there was an increase in postdischarge 30-day mortality for patients with heart failure, but not for those with acute myocardial infarction or pneumonia.
The finding comes from an effort to evaluate the use of services soon after discharge for conditions targeted in the U.S. Hospital Readmissions Reduction Program (HRRP), and patients’ outcomes.
“The announcement and implementation of the HRRP were associated with a reduction in readmissions within 30 days of discharge for heart failure, acute myocardial infarction, and pneumonia, as shown by a decrease in the overall national rate of readmissions,” first author Rohan Khera, MD, and colleagues wrote in a study published online Jan. 15, 2020, in the British Medical Journal (doi:10.1136/bmj.l6831).
“Concerns existed that pressures to reduce readmissions had led to the evolution of care patterns that may have adverse consequences through reducing access to care in appropriate settings. Therefore, determining whether patients who are seen in acute care settings, but not admitted to hospital, experience an increased risk of mortality is essential.”
Dr. Khera, a cardiologist at the University of Texas Southwestern Medical Center, Dallas, and colleagues limited the analysis to Medicare claims data from patients who were admitted to the hospital with heart failure, acute myocardial infarction (MI), or pneumonia between 2008 and 2016. Key outcomes of interest were: (1) postdischarge 30-day mortality; and (2) acute care utilization in inpatient units, observation units, and the ED during the postdischarge period.
During the study period there were 3,772,924 hospital admissions for heart failure, 1,570,113 for acute MI, and 3,131,162 for pneumonia. The greatest number of readmissions within 30 days of discharge was for heart failure patients (22.5%), followed by acute MI (17.5%), and pneumonia (17.2%).
The overall rates of observation stays were 1.7% for heart failure, 2.6% for acute MI, and 1.4% for pneumonia, while the overall rates of emergency department visits were 6.4% for heart failure, 6.8% for acute MI, and 6.3% for pneumonia. Cumulatively, about one-third of all admissions – 30.7% for heart failure, 26.9% for acute MI, and 24.8% for pneumonia – received postdischarge care in any acute care setting.
Dr. Khera and colleagues found that overall postdischarge 30-day mortality was 8.7% for heart failure, 7.3% for acute MI, and 8.4% for pneumonia. At the same time, postdischarge 30-day mortality was higher in patients with readmissions (13.2% for heart failure, 12.7% for acute MI, and 15.3% for pneumonia), compared with those who had observation stays (4.5% for heart failure, 2.7% for acute MI, and 4.6% for pneumonia), emergency department visits (9.7% for heart failure, 8.8% for acute MI, and 7.8% for pneumonia), or no postdischarge acute care (7.2% for heart failure, 6.0% for acute MI, and 6.9% for pneumonia). Risk adjusted mortality increased annually by 0.05% only for heart failure, while it decreased by 0.06% for acute MI, and did not significantly change for pneumonia.
“The study strongly suggests that the HRRP did not lead to harm through inappropriate triage of patients at high risk to observation units and the emergency department, and therefore provides evidence against calls to curtail the program owing to this theoretical concern (see JAMA 2018;320:2539-41),” the researchers concluded.
They acknowledged certain limitations of the study, including the fact that they were “unable to identify patterns of acute care during the index hospital admission that would be associated with a higher rate of postdischarge acute care in observation units and emergency departments and whether these visits represented avenues for planned postdischarge follow-up care. Moreover, the proportion of these care encounters that were preventable remains poorly understood.”
Dr. Khera disclosed that he is supported by the National Center for Advancing Translational Sciences of the National Institutes of Health. His coauthors reported having numerous disclosures.
SOURCE: Khera et al. BMJ 2020;368:l6831.
Among Medicare beneficiaries admitted to the hospital between 2008 and 2016, there was an increase in postdischarge 30-day mortality for patients with heart failure, but not for those with acute myocardial infarction or pneumonia.
The finding comes from an effort to evaluate the use of services soon after discharge for conditions targeted in the U.S. Hospital Readmissions Reduction Program (HRRP), and patients’ outcomes.
“The announcement and implementation of the HRRP were associated with a reduction in readmissions within 30 days of discharge for heart failure, acute myocardial infarction, and pneumonia, as shown by a decrease in the overall national rate of readmissions,” first author Rohan Khera, MD, and colleagues wrote in a study published online Jan. 15, 2020, in the British Medical Journal (doi:10.1136/bmj.l6831).
“Concerns existed that pressures to reduce readmissions had led to the evolution of care patterns that may have adverse consequences through reducing access to care in appropriate settings. Therefore, determining whether patients who are seen in acute care settings, but not admitted to hospital, experience an increased risk of mortality is essential.”
Dr. Khera, a cardiologist at the University of Texas Southwestern Medical Center, Dallas, and colleagues limited the analysis to Medicare claims data from patients who were admitted to the hospital with heart failure, acute myocardial infarction (MI), or pneumonia between 2008 and 2016. Key outcomes of interest were: (1) postdischarge 30-day mortality; and (2) acute care utilization in inpatient units, observation units, and the ED during the postdischarge period.
During the study period there were 3,772,924 hospital admissions for heart failure, 1,570,113 for acute MI, and 3,131,162 for pneumonia. The greatest number of readmissions within 30 days of discharge was for heart failure patients (22.5%), followed by acute MI (17.5%), and pneumonia (17.2%).
The overall rates of observation stays were 1.7% for heart failure, 2.6% for acute MI, and 1.4% for pneumonia, while the overall rates of emergency department visits were 6.4% for heart failure, 6.8% for acute MI, and 6.3% for pneumonia. Cumulatively, about one-third of all admissions – 30.7% for heart failure, 26.9% for acute MI, and 24.8% for pneumonia – received postdischarge care in any acute care setting.
Dr. Khera and colleagues found that overall postdischarge 30-day mortality was 8.7% for heart failure, 7.3% for acute MI, and 8.4% for pneumonia. At the same time, postdischarge 30-day mortality was higher in patients with readmissions (13.2% for heart failure, 12.7% for acute MI, and 15.3% for pneumonia), compared with those who had observation stays (4.5% for heart failure, 2.7% for acute MI, and 4.6% for pneumonia), emergency department visits (9.7% for heart failure, 8.8% for acute MI, and 7.8% for pneumonia), or no postdischarge acute care (7.2% for heart failure, 6.0% for acute MI, and 6.9% for pneumonia). Risk adjusted mortality increased annually by 0.05% only for heart failure, while it decreased by 0.06% for acute MI, and did not significantly change for pneumonia.
“The study strongly suggests that the HRRP did not lead to harm through inappropriate triage of patients at high risk to observation units and the emergency department, and therefore provides evidence against calls to curtail the program owing to this theoretical concern (see JAMA 2018;320:2539-41),” the researchers concluded.
They acknowledged certain limitations of the study, including the fact that they were “unable to identify patterns of acute care during the index hospital admission that would be associated with a higher rate of postdischarge acute care in observation units and emergency departments and whether these visits represented avenues for planned postdischarge follow-up care. Moreover, the proportion of these care encounters that were preventable remains poorly understood.”
Dr. Khera disclosed that he is supported by the National Center for Advancing Translational Sciences of the National Institutes of Health. His coauthors reported having numerous disclosures.
SOURCE: Khera et al. BMJ 2020;368:l6831.
FROM BMJ
Flu activity increases for third straight week
For the second time during the 2019-2020 flu season, activity measures have climbed into noteworthy territory.
The proportion of outpatient visits for influenza-like illness (ILI) reached its highest December level, 7.1%, since 2003 and then dropped for 2 weeks. Three weeks of increases since then, however, have the outpatient-visit rate at 6.7% for the week ending Feb. 1, 2020, the Centers for Disease Control and Prevention reported. The baseline rate for the United States is 2.4%.
That rate of 6.7% is already above the highest rates recorded in eight of the last nine flu seasons, and another increase could mean a second, separate trip above 7.0% in the 2019-2020 season – something that has not occurred since national tracking began in 1997, CDC data show.
Those same data also show that,
Another important measure on the rise, the proportion of respiratory specimens testing positive for influenza, reached a new high for the season, 29.8%, during the week of Feb. 1, the CDC’s influenza division said.
Tests at clinical laboratories also show that predominance is continuing to switch from type B (45.6%) to type A (54.4%), the influenza division noted. Overall predominance for the season, however, continues to favor type B, 59.3% to 40.7%.
The percentage of deaths caused by pneumonia and influenza, which passed the threshold for epidemic of 7.2% back in early January, has been trending downward for the last 3 weeks and was 7.1% as of Feb. 1, according to the influenza division.
ILI-related deaths among children continue to remain high, with a total count of 78 for the season after another 10 deaths were reported during the week ending Feb. 1, the CDC reported. Comparable numbers for the last three seasons are 44 (2018-2019), 97 (2017-2018), and 35 (2016-2017).
The CDC estimates put the total number of ILIs at around 22 million for the season so far, leading to 210,000 hospitalizations. The agency said that it expects to release estimates of vaccine effectiveness later this month.
For the second time during the 2019-2020 flu season, activity measures have climbed into noteworthy territory.
The proportion of outpatient visits for influenza-like illness (ILI) reached its highest December level, 7.1%, since 2003 and then dropped for 2 weeks. Three weeks of increases since then, however, have the outpatient-visit rate at 6.7% for the week ending Feb. 1, 2020, the Centers for Disease Control and Prevention reported. The baseline rate for the United States is 2.4%.
That rate of 6.7% is already above the highest rates recorded in eight of the last nine flu seasons, and another increase could mean a second, separate trip above 7.0% in the 2019-2020 season – something that has not occurred since national tracking began in 1997, CDC data show.
Those same data also show that,
Another important measure on the rise, the proportion of respiratory specimens testing positive for influenza, reached a new high for the season, 29.8%, during the week of Feb. 1, the CDC’s influenza division said.
Tests at clinical laboratories also show that predominance is continuing to switch from type B (45.6%) to type A (54.4%), the influenza division noted. Overall predominance for the season, however, continues to favor type B, 59.3% to 40.7%.
The percentage of deaths caused by pneumonia and influenza, which passed the threshold for epidemic of 7.2% back in early January, has been trending downward for the last 3 weeks and was 7.1% as of Feb. 1, according to the influenza division.
ILI-related deaths among children continue to remain high, with a total count of 78 for the season after another 10 deaths were reported during the week ending Feb. 1, the CDC reported. Comparable numbers for the last three seasons are 44 (2018-2019), 97 (2017-2018), and 35 (2016-2017).
The CDC estimates put the total number of ILIs at around 22 million for the season so far, leading to 210,000 hospitalizations. The agency said that it expects to release estimates of vaccine effectiveness later this month.
For the second time during the 2019-2020 flu season, activity measures have climbed into noteworthy territory.
The proportion of outpatient visits for influenza-like illness (ILI) reached its highest December level, 7.1%, since 2003 and then dropped for 2 weeks. Three weeks of increases since then, however, have the outpatient-visit rate at 6.7% for the week ending Feb. 1, 2020, the Centers for Disease Control and Prevention reported. The baseline rate for the United States is 2.4%.
That rate of 6.7% is already above the highest rates recorded in eight of the last nine flu seasons, and another increase could mean a second, separate trip above 7.0% in the 2019-2020 season – something that has not occurred since national tracking began in 1997, CDC data show.
Those same data also show that,
Another important measure on the rise, the proportion of respiratory specimens testing positive for influenza, reached a new high for the season, 29.8%, during the week of Feb. 1, the CDC’s influenza division said.
Tests at clinical laboratories also show that predominance is continuing to switch from type B (45.6%) to type A (54.4%), the influenza division noted. Overall predominance for the season, however, continues to favor type B, 59.3% to 40.7%.
The percentage of deaths caused by pneumonia and influenza, which passed the threshold for epidemic of 7.2% back in early January, has been trending downward for the last 3 weeks and was 7.1% as of Feb. 1, according to the influenza division.
ILI-related deaths among children continue to remain high, with a total count of 78 for the season after another 10 deaths were reported during the week ending Feb. 1, the CDC reported. Comparable numbers for the last three seasons are 44 (2018-2019), 97 (2017-2018), and 35 (2016-2017).
The CDC estimates put the total number of ILIs at around 22 million for the season so far, leading to 210,000 hospitalizations. The agency said that it expects to release estimates of vaccine effectiveness later this month.
Remdesivir under study as treatment for novel coronavirus
“What they’re looking at is the effect of this drug -- either the drug plus standard of care versus standard of care alone,” Anthony S. Fauci, MD, reported Feb. 7 during a press briefing held by members of President Trump’s Coronavirus Task Force. “I think pretty soon we are going to get a definitive answer, whether one of these among several drugs works.”
Dr. Fauci, director of the National Institute of Allergy and Infectious Diseases, added that several organizations and individual investigators are developing vaccines for 2019-nCoV. In one such effort, the National Institutes of Health is working with Moderna Inc. to develop a vaccine built on a messenger RNA platform. “One of the first steps is to successfully get that [novel coronavirus] gene and insert it into the messenger RNA platform successfully and allow it to express proteins,” Dr. Fauci explained. “We’ve succeeded in that. The next [step] is to put it in a mouse animal model to induce immunogenicity, and to get the company to make [gold nanoparticle] products. All of those have been successfully implemented. There have been no glitches so far. If that continues, we will be in Phase 1 trials in people within the next two-and-a-half months.”
In another development on the same day, Robert R. Redfield, MD, director of the Centers for Disease Control and Prevention, announced that Heath & Human Services issued an interim final rule to amend foreign quarantine regulations in the wake of the public health threat posed by the 2019-nCoV. “This will enable CDC to collect certain contact information data regarding airline passengers and crew when they arrive from other countries. . .and may be exposed to communicable disease,” Dr. Redfield said. “This action is part of our multi-layered approach to the U.S. response and demonstrates our commitment to take all necessary actions to protect the American people.”
According to Alex Azar, secretary of Health and Human Services, and chair of President Trump’s Coronavirus Task Force, there are 12 confirmed cases of the novel coronavirus in the United States, including two cases of transmission to people who had not recently been in China. “Although the virus represents a potentially very serious public health threat, and we expect to continue seeing more cases here, the immediate risk to the American public is low at this time,” Mr. Azar said. “We are working as quickly as possible on the many unanswered questions about this virus. That includes exactly how it spreads, how deadly it is, whether it’s commonly transmitted by patients who are not yet displaying symptoms, and other issues.”
“What they’re looking at is the effect of this drug -- either the drug plus standard of care versus standard of care alone,” Anthony S. Fauci, MD, reported Feb. 7 during a press briefing held by members of President Trump’s Coronavirus Task Force. “I think pretty soon we are going to get a definitive answer, whether one of these among several drugs works.”
Dr. Fauci, director of the National Institute of Allergy and Infectious Diseases, added that several organizations and individual investigators are developing vaccines for 2019-nCoV. In one such effort, the National Institutes of Health is working with Moderna Inc. to develop a vaccine built on a messenger RNA platform. “One of the first steps is to successfully get that [novel coronavirus] gene and insert it into the messenger RNA platform successfully and allow it to express proteins,” Dr. Fauci explained. “We’ve succeeded in that. The next [step] is to put it in a mouse animal model to induce immunogenicity, and to get the company to make [gold nanoparticle] products. All of those have been successfully implemented. There have been no glitches so far. If that continues, we will be in Phase 1 trials in people within the next two-and-a-half months.”
In another development on the same day, Robert R. Redfield, MD, director of the Centers for Disease Control and Prevention, announced that Heath & Human Services issued an interim final rule to amend foreign quarantine regulations in the wake of the public health threat posed by the 2019-nCoV. “This will enable CDC to collect certain contact information data regarding airline passengers and crew when they arrive from other countries. . .and may be exposed to communicable disease,” Dr. Redfield said. “This action is part of our multi-layered approach to the U.S. response and demonstrates our commitment to take all necessary actions to protect the American people.”
According to Alex Azar, secretary of Health and Human Services, and chair of President Trump’s Coronavirus Task Force, there are 12 confirmed cases of the novel coronavirus in the United States, including two cases of transmission to people who had not recently been in China. “Although the virus represents a potentially very serious public health threat, and we expect to continue seeing more cases here, the immediate risk to the American public is low at this time,” Mr. Azar said. “We are working as quickly as possible on the many unanswered questions about this virus. That includes exactly how it spreads, how deadly it is, whether it’s commonly transmitted by patients who are not yet displaying symptoms, and other issues.”
“What they’re looking at is the effect of this drug -- either the drug plus standard of care versus standard of care alone,” Anthony S. Fauci, MD, reported Feb. 7 during a press briefing held by members of President Trump’s Coronavirus Task Force. “I think pretty soon we are going to get a definitive answer, whether one of these among several drugs works.”
Dr. Fauci, director of the National Institute of Allergy and Infectious Diseases, added that several organizations and individual investigators are developing vaccines for 2019-nCoV. In one such effort, the National Institutes of Health is working with Moderna Inc. to develop a vaccine built on a messenger RNA platform. “One of the first steps is to successfully get that [novel coronavirus] gene and insert it into the messenger RNA platform successfully and allow it to express proteins,” Dr. Fauci explained. “We’ve succeeded in that. The next [step] is to put it in a mouse animal model to induce immunogenicity, and to get the company to make [gold nanoparticle] products. All of those have been successfully implemented. There have been no glitches so far. If that continues, we will be in Phase 1 trials in people within the next two-and-a-half months.”
In another development on the same day, Robert R. Redfield, MD, director of the Centers for Disease Control and Prevention, announced that Heath & Human Services issued an interim final rule to amend foreign quarantine regulations in the wake of the public health threat posed by the 2019-nCoV. “This will enable CDC to collect certain contact information data regarding airline passengers and crew when they arrive from other countries. . .and may be exposed to communicable disease,” Dr. Redfield said. “This action is part of our multi-layered approach to the U.S. response and demonstrates our commitment to take all necessary actions to protect the American people.”
According to Alex Azar, secretary of Health and Human Services, and chair of President Trump’s Coronavirus Task Force, there are 12 confirmed cases of the novel coronavirus in the United States, including two cases of transmission to people who had not recently been in China. “Although the virus represents a potentially very serious public health threat, and we expect to continue seeing more cases here, the immediate risk to the American public is low at this time,” Mr. Azar said. “We are working as quickly as possible on the many unanswered questions about this virus. That includes exactly how it spreads, how deadly it is, whether it’s commonly transmitted by patients who are not yet displaying symptoms, and other issues.”