If you work on the front lines of medical care treating patients with hepatitis, you may not have time to review all the hepatitis research that enters the medical literature every month. Here’s a quick look at some notable news items and journal articles published over the past month, covering a variety of the major hepatitis viruses.

Although hepatitis E virus infections are increasingly recognized as a global public health problem, there are “few methods for prevention and treatment that are widely available,” according to a recent analysis.

©Zerbor/Thinkstock

A “suboptimal plasma level of the antiviral drug daclatasvir allows the selection of resistance-associated variants” and fails to contribute to antiviral activity in HIV-hepatitis C virus (HCV) coinfected patients, according to a recent study, although no definite reason for the low daclatasvir level was found.

The new preservative-free inactivated hepatitis A vaccine (Healive) in two doses showed better persistence of antibody concentrations for 5 years after full-course immunization among children, compared with Havrix. The endurance of protective immunogenicity was estimated for at least 20 years.

Because of transplacental transfer of antihepatitis B virus antibodies (anti-HBVs), high levels of maternal anti-HBVs may suppress infants’ immune response to standard HBV vaccination, according to an analysis in the Journal of Viral Hepatitis.

The gamma-glutamyl transpeptidase-to-platelet ratio (GPR) is “a new serum model for the diagnosis” of liver fibrosis and cirrhosis, according to a recent study. Researchers said it shows advantages in Chinese hepatitis Be antigen (HBeAg)-positive patients with hepatitis B virus DNA greater than or equal to 5 log₁₀ copies/mL and ALT less than or equal to two times ULN (upper limit of normal), compared with APRI (aspartate aminotransferase to platelet ratio index) and Fibrosis-4.

A baseline quantitative hepatitis B surface antigen (HBsAg) threshold of 3.141 log₁₀ IU/mL and a baseline quantitative hepatitis B core-related antigen 3.450 log₁₀ U/mL threshold, used separately or in combination, allow prediction of response to pegylated interferon-alpha-2a (PegIFN)-based “precision therapy” for hepatitis B virus infection, a new study found.

Male sex, age over 40 years, cirrhotic liver, and long length of stay are significant factors associated with death in hepatitis A virus-hospitalized cases, according to a study in the Journal of Viral Hepatitis.

Chronic kidney disease patients receiving three doses of hepatitis B adjuvanted vaccine were three times more likely to seroconvert than patients immunized with nonadjuvanted vaccines, according to results of a Spanish study. This meant fewer patients needed a second course of HBV vaccination and there were fewer outpatient visits.

Acute kidney injury is closely linked with increased short-term mortality in Chinese hepatitis B virus-related, acute-on-chronic liver failure patients, according to a study in the Journal of Viral Hepatitis.

Italian investigators attempted “to predict susceptibility of healthy patients to de novo HBV infection using a cultured IFN-gamma enzyme-linked immunospot (ELISPOT) assay.” Although the prognostic value of the assay was not demonstrated, data suggested that the subjects may be at risk for HBV infection.

Investigators demonstrated that treatment with sofosbuvir and simeprevir was effective in a real-life cohort of patients with hepatitis C virus genotype 4 infection and advanced liver fibrosis/cirrhosis. They said that adding ribavirin could be considered in treatment-experienced patients.

The presence of specific anti-envelope antibodies may be a factor that helps individuals at high risk of hepatitis C virus to resist infection, according to a study in the Journal of Viral Hepatitis.

A Chinese study determined that certain social network structural characteristics are related to hepatitis C virus infections in people who inject drugs, and used the data to identify the most susceptible individuals for HCV transmission in a network of people who inject drugs.

Drug resistance analyses of protease inhibitors that treat hepatitis C virus infection can be useful and essential in revealing the particular variants responsible for pretreatment natural resistance and also the particular mutations responsible for the viral breakthrough that may develop during the treatment, according to a study in the International Journal of Infectious Diseases.

Routine vaccination of toddlers against hepatitis A virus would be cost effective in Mexico using a single-dose vaccination strategy, according to a recent study, although the authors said the cost efficacy of a second dose depends on the assumptions of added safeguards by immune memory protection and the time horizon over which the analysis is enacted.

Hepatitis C virus-infected patients undergoing ribavirin-free sofosbuvir and velpatasvir regimens had significantly better patient-reported outcome scores during therapy, compared with those undergoing the ribavirin-containing regimen, a recent study found.

An analysis in Infectious Diseases in Clinical Practice reported the first case of visual hallucinations during chronic hepatitis C treatment with sofosbuvir and simeprevir. Investigators said hallucinations stopped upon starting antipsychotic medication, and the remainder of treatment was safe.

Sustained virologic response can be attained with pegylated interferon-alpha plus ribavirin combination therapy in hepatitis C virus–infected patients, but a relapse may occur in some patients, according to a recent study.

A quantitative HBsAg test can be used to ascertain high levels of hepatitis B viremia in women who might transmit the virus to their children, rather than a test for HBeAg or HBV DNA, according to a research letter in Hepatology.

A Chinese study found a robust relationship between Helicobacter pylori infection and chronic hepatitis B. This is especially true during hepatitis B virus progression.

The prevalence of antihepatitis E virus (HEV) antibodies was 49% (153/313) among blood donors in central Italy, according to a study published in Eurosurveillance. The authors said HEV infection is hyperendemic among blood donors (80% men, 18- to 64-years-old) from central Italy and associated with local dietary habits, such as eating raw dried pig liver sausage.

[email protected]

On Twitter @richpizzi

If you work on the front lines of medical care treating patients with hepatitis, you may not have time to review all the hepatitis research that enters the medical literature every month. Here’s a quick look at some notable news items and journal articles published over the past month, covering a variety of the major hepatitis viruses.

Although hepatitis E virus infections are increasingly recognized as a global public health problem, there are “few methods for prevention and treatment that are widely available,” according to a recent analysis.

©Zerbor/Thinkstock

A “suboptimal plasma level of the antiviral drug daclatasvir allows the selection of resistance-associated variants” and fails to contribute to antiviral activity in HIV-hepatitis C virus (HCV) coinfected patients, according to a recent study, although no definite reason for the low daclatasvir level was found.

The new preservative-free inactivated hepatitis A vaccine (Healive) in two doses showed better persistence of antibody concentrations for 5 years after full-course immunization among children, compared with Havrix. The endurance of protective immunogenicity was estimated for at least 20 years.

Because of transplacental transfer of antihepatitis B virus antibodies (anti-HBVs), high levels of maternal anti-HBVs may suppress infants’ immune response to standard HBV vaccination, according to an analysis in the Journal of Viral Hepatitis.

The gamma-glutamyl transpeptidase-to-platelet ratio (GPR) is “a new serum model for the diagnosis” of liver fibrosis and cirrhosis, according to a recent study. Researchers said it shows advantages in Chinese hepatitis Be antigen (HBeAg)-positive patients with hepatitis B virus DNA greater than or equal to 5 log₁₀ copies/mL and ALT less than or equal to two times ULN (upper limit of normal), compared with APRI (aspartate aminotransferase to platelet ratio index) and Fibrosis-4.

A baseline quantitative hepatitis B surface antigen (HBsAg) threshold of 3.141 log₁₀ IU/mL and a baseline quantitative hepatitis B core-related antigen 3.450 log₁₀ U/mL threshold, used separately or in combination, allow prediction of response to pegylated interferon-alpha-2a (PegIFN)-based “precision therapy” for hepatitis B virus infection, a new study found.

Male sex, age over 40 years, cirrhotic liver, and long length of stay are significant factors associated with death in hepatitis A virus-hospitalized cases, according to a study in the Journal of Viral Hepatitis.

Chronic kidney disease patients receiving three doses of hepatitis B adjuvanted vaccine were three times more likely to seroconvert than patients immunized with nonadjuvanted vaccines, according to results of a Spanish study. This meant fewer patients needed a second course of HBV vaccination and there were fewer outpatient visits.

Acute kidney injury is closely linked with increased short-term mortality in Chinese hepatitis B virus-related, acute-on-chronic liver failure patients, according to a study in the Journal of Viral Hepatitis.

Italian investigators attempted “to predict susceptibility of healthy patients to de novo HBV infection using a cultured IFN-gamma enzyme-linked immunospot (ELISPOT) assay.” Although the prognostic value of the assay was not demonstrated, data suggested that the subjects may be at risk for HBV infection.

Investigators demonstrated that treatment with sofosbuvir and simeprevir was effective in a real-life cohort of patients with hepatitis C virus genotype 4 infection and advanced liver fibrosis/cirrhosis. They said that adding ribavirin could be considered in treatment-experienced patients.

The presence of specific anti-envelope antibodies may be a factor that helps individuals at high risk of hepatitis C virus to resist infection, according to a study in the Journal of Viral Hepatitis.

A Chinese study determined that certain social network structural characteristics are related to hepatitis C virus infections in people who inject drugs, and used the data to identify the most susceptible individuals for HCV transmission in a network of people who inject drugs.

Drug resistance analyses of protease inhibitors that treat hepatitis C virus infection can be useful and essential in revealing the particular variants responsible for pretreatment natural resistance and also the particular mutations responsible for the viral breakthrough that may develop during the treatment, according to a study in the International Journal of Infectious Diseases.

Routine vaccination of toddlers against hepatitis A virus would be cost effective in Mexico using a single-dose vaccination strategy, according to a recent study, although the authors said the cost efficacy of a second dose depends on the assumptions of added safeguards by immune memory protection and the time horizon over which the analysis is enacted.

Hepatitis C virus-infected patients undergoing ribavirin-free sofosbuvir and velpatasvir regimens had significantly better patient-reported outcome scores during therapy, compared with those undergoing the ribavirin-containing regimen, a recent study found.

An analysis in Infectious Diseases in Clinical Practice reported the first case of visual hallucinations during chronic hepatitis C treatment with sofosbuvir and simeprevir. Investigators said hallucinations stopped upon starting antipsychotic medication, and the remainder of treatment was safe.

Sustained virologic response can be attained with pegylated interferon-alpha plus ribavirin combination therapy in hepatitis C virus–infected patients, but a relapse may occur in some patients, according to a recent study.

A quantitative HBsAg test can be used to ascertain high levels of hepatitis B viremia in women who might transmit the virus to their children, rather than a test for HBeAg or HBV DNA, according to a research letter in Hepatology.

A Chinese study found a robust relationship between Helicobacter pylori infection and chronic hepatitis B. This is especially true during hepatitis B virus progression.

The prevalence of antihepatitis E virus (HEV) antibodies was 49% (153/313) among blood donors in central Italy, according to a study published in Eurosurveillance. The authors said HEV infection is hyperendemic among blood donors (80% men, 18- to 64-years-old) from central Italy and associated with local dietary habits, such as eating raw dried pig liver sausage.

[email protected]

On Twitter @richpizzi

If you work on the front lines of medical care treating patients with hepatitis, you may not have time to review all the hepatitis research that enters the medical literature every month. Here’s a quick look at some notable news items and journal articles published over the past month, covering a variety of the major hepatitis viruses.

Although hepatitis E virus infections are increasingly recognized as a global public health problem, there are “few methods for prevention and treatment that are widely available,” according to a recent analysis.

©Zerbor/Thinkstock

A “suboptimal plasma level of the antiviral drug daclatasvir allows the selection of resistance-associated variants” and fails to contribute to antiviral activity in HIV-hepatitis C virus (HCV) coinfected patients, according to a recent study, although no definite reason for the low daclatasvir level was found.

The new preservative-free inactivated hepatitis A vaccine (Healive) in two doses showed better persistence of antibody concentrations for 5 years after full-course immunization among children, compared with Havrix. The endurance of protective immunogenicity was estimated for at least 20 years.

Because of transplacental transfer of antihepatitis B virus antibodies (anti-HBVs), high levels of maternal anti-HBVs may suppress infants’ immune response to standard HBV vaccination, according to an analysis in the Journal of Viral Hepatitis.

The gamma-glutamyl transpeptidase-to-platelet ratio (GPR) is “a new serum model for the diagnosis” of liver fibrosis and cirrhosis, according to a recent study. Researchers said it shows advantages in Chinese hepatitis Be antigen (HBeAg)-positive patients with hepatitis B virus DNA greater than or equal to 5 log₁₀ copies/mL and ALT less than or equal to two times ULN (upper limit of normal), compared with APRI (aspartate aminotransferase to platelet ratio index) and Fibrosis-4.

A baseline quantitative hepatitis B surface antigen (HBsAg) threshold of 3.141 log₁₀ IU/mL and a baseline quantitative hepatitis B core-related antigen 3.450 log₁₀ U/mL threshold, used separately or in combination, allow prediction of response to pegylated interferon-alpha-2a (PegIFN)-based “precision therapy” for hepatitis B virus infection, a new study found.

Male sex, age over 40 years, cirrhotic liver, and long length of stay are significant factors associated with death in hepatitis A virus-hospitalized cases, according to a study in the Journal of Viral Hepatitis.

Chronic kidney disease patients receiving three doses of hepatitis B adjuvanted vaccine were three times more likely to seroconvert than patients immunized with nonadjuvanted vaccines, according to results of a Spanish study. This meant fewer patients needed a second course of HBV vaccination and there were fewer outpatient visits.

Acute kidney injury is closely linked with increased short-term mortality in Chinese hepatitis B virus-related, acute-on-chronic liver failure patients, according to a study in the Journal of Viral Hepatitis.

Italian investigators attempted “to predict susceptibility of healthy patients to de novo HBV infection using a cultured IFN-gamma enzyme-linked immunospot (ELISPOT) assay.” Although the prognostic value of the assay was not demonstrated, data suggested that the subjects may be at risk for HBV infection.

Investigators demonstrated that treatment with sofosbuvir and simeprevir was effective in a real-life cohort of patients with hepatitis C virus genotype 4 infection and advanced liver fibrosis/cirrhosis. They said that adding ribavirin could be considered in treatment-experienced patients.

The presence of specific anti-envelope antibodies may be a factor that helps individuals at high risk of hepatitis C virus to resist infection, according to a study in the Journal of Viral Hepatitis.

A Chinese study determined that certain social network structural characteristics are related to hepatitis C virus infections in people who inject drugs, and used the data to identify the most susceptible individuals for HCV transmission in a network of people who inject drugs.

Drug resistance analyses of protease inhibitors that treat hepatitis C virus infection can be useful and essential in revealing the particular variants responsible for pretreatment natural resistance and also the particular mutations responsible for the viral breakthrough that may develop during the treatment, according to a study in the International Journal of Infectious Diseases.

Routine vaccination of toddlers against hepatitis A virus would be cost effective in Mexico using a single-dose vaccination strategy, according to a recent study, although the authors said the cost efficacy of a second dose depends on the assumptions of added safeguards by immune memory protection and the time horizon over which the analysis is enacted.

Hepatitis C virus-infected patients undergoing ribavirin-free sofosbuvir and velpatasvir regimens had significantly better patient-reported outcome scores during therapy, compared with those undergoing the ribavirin-containing regimen, a recent study found.

An analysis in Infectious Diseases in Clinical Practice reported the first case of visual hallucinations during chronic hepatitis C treatment with sofosbuvir and simeprevir. Investigators said hallucinations stopped upon starting antipsychotic medication, and the remainder of treatment was safe.

Sustained virologic response can be attained with pegylated interferon-alpha plus ribavirin combination therapy in hepatitis C virus–infected patients, but a relapse may occur in some patients, according to a recent study.

A quantitative HBsAg test can be used to ascertain high levels of hepatitis B viremia in women who might transmit the virus to their children, rather than a test for HBeAg or HBV DNA, according to a research letter in Hepatology.

A Chinese study found a robust relationship between Helicobacter pylori infection and chronic hepatitis B. This is especially true during hepatitis B virus progression.

The prevalence of antihepatitis E virus (HEV) antibodies was 49% (153/313) among blood donors in central Italy, according to a study published in Eurosurveillance. The authors said HEV infection is hyperendemic among blood donors (80% men, 18- to 64-years-old) from central Italy and associated with local dietary habits, such as eating raw dried pig liver sausage.

[email protected]

On Twitter @richpizzi

To improve patient care and outcomes, leading dermatologists offered their recommendations on lip balms. Consideration must be given to:
 

• Aquaphor Lip Repair
  Beiersdorf, Inc
  Recommended by Gary Goldenberg, MD, New York, New York
   
• CeraVe Healing Ointment
  Valeant Pharmaceuticals North America LLC
  “Combining ceramides with hyaluronic acid in a waxy ointment base, it hydrates, protects, and repairs the damaged skin barrier.”—Joshua Zeichner, MD, New York, New York
   
• Lip Balm #1
  Kiehl’s
  “It is quite moisturizing with squalene, aloe vera, vitamin E, and wheat germ oil.”—Anthony M. Rossi, MD, New York, New York
   
• Lip Renewal SPF 50
  June Jacobs Laboratories LLC
  “This lip balm contains shea butter and vitamin E for hydration with a hint of pomegranate flavor. It also provides photoprotection for daily use.”—Cherise M. Levi, DO, New York, New York
   
• Neutrogena Revitalizing Lip Balm SPF 20
  Johnson & Johnson Consumer Inc
  “It moisturizes the lips, protects from UV rays, and is available in a variety of shades. It should be reapplied frequently for UV protection.”—Shari Lipner, MD, PhD, New York, New York
   
• Vanicream Lip Protectant SPF 30
  Pharmaceutical Specialties, Inc
  “It has titanium dioxide for good UV protection.”—Anthony M. Rossi, MD, New York, New York
   
• Xtend Your Youth Lip Filler & Volumizer
  Dr. Brandt Skincare
  “This unique formula restores moisture and smooths the lip surface, creating a canvas for longer-lasting lip color. Its potent blend of antioxidants including vitamin E, green tea, white tea, and grape seed extract protects lips from free radical damage, while also working to reduce the look of lines and wrinkles.”—Whitney Bowe, MD, New York, New York
   

Cutis invites readers to send us their recommendations. Self-tanners and cleansing devices will be featured in upcoming editions of Cosmetic Corner. Please e-mail your recommendation(s) to the Editorial Office.

Disclaimer: Opinions expressed herein do not necessarily reflect those of Cutis or Frontline Medical Communications Inc. and shall not be used for product endorsement purposes. Any reference made to a specific commercial product does not indicate or imply that Cutis or Frontline Medical Communications Inc. endorses, recommends, or favors the product mentioned. No guarantee is given to the effects of recommended products.

To improve patient care and outcomes, leading dermatologists offered their recommendations on lip balms. Consideration must be given to:
 

• Aquaphor Lip Repair
  Beiersdorf, Inc
  Recommended by Gary Goldenberg, MD, New York, New York
   
• CeraVe Healing Ointment
  Valeant Pharmaceuticals North America LLC
  “Combining ceramides with hyaluronic acid in a waxy ointment base, it hydrates, protects, and repairs the damaged skin barrier.”—Joshua Zeichner, MD, New York, New York
   
• Lip Balm #1
  Kiehl’s
  “It is quite moisturizing with squalene, aloe vera, vitamin E, and wheat germ oil.”—Anthony M. Rossi, MD, New York, New York
   
• Lip Renewal SPF 50
  June Jacobs Laboratories LLC
  “This lip balm contains shea butter and vitamin E for hydration with a hint of pomegranate flavor. It also provides photoprotection for daily use.”—Cherise M. Levi, DO, New York, New York
   
• Neutrogena Revitalizing Lip Balm SPF 20
  Johnson & Johnson Consumer Inc
  “It moisturizes the lips, protects from UV rays, and is available in a variety of shades. It should be reapplied frequently for UV protection.”—Shari Lipner, MD, PhD, New York, New York
   
• Vanicream Lip Protectant SPF 30
  Pharmaceutical Specialties, Inc
  “It has titanium dioxide for good UV protection.”—Anthony M. Rossi, MD, New York, New York
   
• Xtend Your Youth Lip Filler & Volumizer
  Dr. Brandt Skincare
  “This unique formula restores moisture and smooths the lip surface, creating a canvas for longer-lasting lip color. Its potent blend of antioxidants including vitamin E, green tea, white tea, and grape seed extract protects lips from free radical damage, while also working to reduce the look of lines and wrinkles.”—Whitney Bowe, MD, New York, New York
   

Cutis invites readers to send us their recommendations. Self-tanners and cleansing devices will be featured in upcoming editions of Cosmetic Corner. Please e-mail your recommendation(s) to the Editorial Office.

Disclaimer: Opinions expressed herein do not necessarily reflect those of Cutis or Frontline Medical Communications Inc. and shall not be used for product endorsement purposes. Any reference made to a specific commercial product does not indicate or imply that Cutis or Frontline Medical Communications Inc. endorses, recommends, or favors the product mentioned. No guarantee is given to the effects of recommended products.

To improve patient care and outcomes, leading dermatologists offered their recommendations on lip balms. Consideration must be given to:
 

• Aquaphor Lip Repair
  Beiersdorf, Inc
  Recommended by Gary Goldenberg, MD, New York, New York
   
• CeraVe Healing Ointment
  Valeant Pharmaceuticals North America LLC
  “Combining ceramides with hyaluronic acid in a waxy ointment base, it hydrates, protects, and repairs the damaged skin barrier.”—Joshua Zeichner, MD, New York, New York
   
• Lip Balm #1
  Kiehl’s
  “It is quite moisturizing with squalene, aloe vera, vitamin E, and wheat germ oil.”—Anthony M. Rossi, MD, New York, New York
   
• Lip Renewal SPF 50
  June Jacobs Laboratories LLC
  “This lip balm contains shea butter and vitamin E for hydration with a hint of pomegranate flavor. It also provides photoprotection for daily use.”—Cherise M. Levi, DO, New York, New York
   
• Neutrogena Revitalizing Lip Balm SPF 20
  Johnson & Johnson Consumer Inc
  “It moisturizes the lips, protects from UV rays, and is available in a variety of shades. It should be reapplied frequently for UV protection.”—Shari Lipner, MD, PhD, New York, New York
   
• Vanicream Lip Protectant SPF 30
  Pharmaceutical Specialties, Inc
  “It has titanium dioxide for good UV protection.”—Anthony M. Rossi, MD, New York, New York
   
• Xtend Your Youth Lip Filler & Volumizer
  Dr. Brandt Skincare
  “This unique formula restores moisture and smooths the lip surface, creating a canvas for longer-lasting lip color. Its potent blend of antioxidants including vitamin E, green tea, white tea, and grape seed extract protects lips from free radical damage, while also working to reduce the look of lines and wrinkles.”—Whitney Bowe, MD, New York, New York
   

Cutis invites readers to send us their recommendations. Self-tanners and cleansing devices will be featured in upcoming editions of Cosmetic Corner. Please e-mail your recommendation(s) to the Editorial Office.

Disclaimer: Opinions expressed herein do not necessarily reflect those of Cutis or Frontline Medical Communications Inc. and shall not be used for product endorsement purposes. Any reference made to a specific commercial product does not indicate or imply that Cutis or Frontline Medical Communications Inc. endorses, recommends, or favors the product mentioned. No guarantee is given to the effects of recommended products.

Receiving notice from a payor that you are being audited can be alarming. Questions will inevitably run through your mind, such as, Why? How? How much will this cost?

Understanding the types of payor audits and how to navigate the process can make answering those questions easier. In addition, advanced preparation and knowing when to engage legal counsel can be critical to a successful audit outcome.

Audit Types

There are three general types of audits that providers face: Medicare audits, Medicaid audits, and private payor audits.

Medicare audits: The agency responsible for Medicare audits is the Centers for Medicare & Medicaid Services (CMS). There are three types of Medicare audits. Comprehensive Error Rate Testing (CERT) audits focus on providers who deliver high-cost items or services, have high volume, and/or have atypical billing or coding practices. Private contractors perform Recovery Audit Contractor (RAC) program audits; these contractors are paid a percentage of the amount of any improper payment discovered. Finally, Zone Program Integrity Contractor (ZPIC) audits are the most serious of the three audit types. ZPIC audits are performed by CMS contractors who mine the provider’s data for compliance with Medicare coverage and coding policies, investigate fraud, and may prepare cases for civil or criminal referral to CMS or law enforcement agencies.

Medicaid audits: Medicaid audits evaluate compliance with both CMS and applicable state regulations and investigate fraud. Evidence of fraud will be reported to the state attorney general for further review and prosecution.

Private payor audits: Private payor audits consist of informal reviews and formal audits. These audits can be triggered by actual allegations or evidence of noncompliance, or they can be random, in which general compliance is assessed. Audit procedures are typically determined by contract or the payor’s provider handbook and in accordance with applicable state law. The process can consist of prepayment reviews, in which the sufficiency of a claim and its supporting documentation is determined before payment is made to the provider, or post-payment reviews, during which claims are analyzed after the provider has been paid to determine if an overpayment was made and the amount of such overpayment. In the event an overpayment is discovered, a recoupment will be sought from the provider.

Focus

Consistent billing by a provider of high volumes of certain high-level services, high volumes of evaluation and management services, or consistently referring patients for certain testing can create suspicion in mayors.

In recent years, the primary focus of audits has been medical necessity due to payor concerns about specific fraud and abuse issues. Documentation of medical necessity is required during an audit. However, proving medical necessity can be difficult as the definition of “medical necessity” can vary by payor and within a payor depending on the underlying plan. In addition, private payors often have arbitrary and vague guidelines for defining and determining medical necessity, particularly when dealing with physicians or ordering clinicians. For this reason, it is critical that providers read their payor contracts and manuals carefully. If those materials are unclear, it is best to confirm requirements with the payor.

Regardless of the definition, medical necessity is a precondition to coverage for all payors. Proof is required that the services were reasonable and necessary to diagnosis or treat a patient’s medical condition. To satisfy this standard, providers should document the diagnosis for all procedures performed and all diagnostic tests ordered. In the case of repeat procedures, providers should clearly note the outcome of the previous procedure and the basis for reordering.

Responding to an Audit Request

All audit requests must be taken very seriously. Payors tend to copy what other payors are doing, and a problematic audit with one payor can cause other payors to initiate their own audits. Therefore, it is critical to respond appropriately to each audit request. Also, auditors often only check a few billing records. If errors are found, they will then extrapolate those findings, and the provider may be penalized.

Upon receipt of an audit request, it is important to immediately engage legal counsel well-versed in handling payor audits. Having an attorney who understands the audit process and has experience responding to audit requests can help ensure the best possible audit outcome. A negative outcome could result in recovery of overpayments, civil and/or criminal penalties, and exclusion from government programs.

Providers should work with such legal counsel to review the audit request and supply everything reasonably requested. A concerted effort should be made to submit all information to the auditor at one time. If information is missing, the auditor may determine that a significant error rate exists, which could cause the auditor to review all CPT codes to calculate the overpayment made to the provider. If it is not possible to gather the requested material before the auditor’s deadline, an extension should be requested. Any extensions granted should be documented.

It is important that an audit response and supporting documentation be thorough, clear, and concise. It should be submitted in a manner that allows the auditor to quickly review the information and understand the provider’s arguments. It should clearly state what measures the provider has already taken to terminate existing problems and prevent future issues. Competent legal counsel will be able to address procedural, legal, or factual flaws in the auditor’s position.

Advanced Preparation

The best way to ensure compliance and audit readiness is to develop and implement a compliance plan well in advance of any audit. Experienced legal counsel should play a pivotal role in development of such plan. As always, periodic self-audits or independent audits are necessary to proactively identify compliance issues and mitigate their impact.

Finally, regular and periodic training and education should be conducted regarding audit response obligations and responsibilities. Performing these tasks will help ensure a smooth audit experience with minimal infractions and penalties. TH

Receiving notice from a payor that you are being audited can be alarming. Questions will inevitably run through your mind, such as, Why? How? How much will this cost?

Understanding the types of payor audits and how to navigate the process can make answering those questions easier. In addition, advanced preparation and knowing when to engage legal counsel can be critical to a successful audit outcome.

Audit Types

There are three general types of audits that providers face: Medicare audits, Medicaid audits, and private payor audits.

Medicare audits: The agency responsible for Medicare audits is the Centers for Medicare & Medicaid Services (CMS). There are three types of Medicare audits. Comprehensive Error Rate Testing (CERT) audits focus on providers who deliver high-cost items or services, have high volume, and/or have atypical billing or coding practices. Private contractors perform Recovery Audit Contractor (RAC) program audits; these contractors are paid a percentage of the amount of any improper payment discovered. Finally, Zone Program Integrity Contractor (ZPIC) audits are the most serious of the three audit types. ZPIC audits are performed by CMS contractors who mine the provider’s data for compliance with Medicare coverage and coding policies, investigate fraud, and may prepare cases for civil or criminal referral to CMS or law enforcement agencies.

Medicaid audits: Medicaid audits evaluate compliance with both CMS and applicable state regulations and investigate fraud. Evidence of fraud will be reported to the state attorney general for further review and prosecution.

Private payor audits: Private payor audits consist of informal reviews and formal audits. These audits can be triggered by actual allegations or evidence of noncompliance, or they can be random, in which general compliance is assessed. Audit procedures are typically determined by contract or the payor’s provider handbook and in accordance with applicable state law. The process can consist of prepayment reviews, in which the sufficiency of a claim and its supporting documentation is determined before payment is made to the provider, or post-payment reviews, during which claims are analyzed after the provider has been paid to determine if an overpayment was made and the amount of such overpayment. In the event an overpayment is discovered, a recoupment will be sought from the provider.

Focus

Consistent billing by a provider of high volumes of certain high-level services, high volumes of evaluation and management services, or consistently referring patients for certain testing can create suspicion in mayors.

In recent years, the primary focus of audits has been medical necessity due to payor concerns about specific fraud and abuse issues. Documentation of medical necessity is required during an audit. However, proving medical necessity can be difficult as the definition of “medical necessity” can vary by payor and within a payor depending on the underlying plan. In addition, private payors often have arbitrary and vague guidelines for defining and determining medical necessity, particularly when dealing with physicians or ordering clinicians. For this reason, it is critical that providers read their payor contracts and manuals carefully. If those materials are unclear, it is best to confirm requirements with the payor.

Regardless of the definition, medical necessity is a precondition to coverage for all payors. Proof is required that the services were reasonable and necessary to diagnosis or treat a patient’s medical condition. To satisfy this standard, providers should document the diagnosis for all procedures performed and all diagnostic tests ordered. In the case of repeat procedures, providers should clearly note the outcome of the previous procedure and the basis for reordering.

Responding to an Audit Request

All audit requests must be taken very seriously. Payors tend to copy what other payors are doing, and a problematic audit with one payor can cause other payors to initiate their own audits. Therefore, it is critical to respond appropriately to each audit request. Also, auditors often only check a few billing records. If errors are found, they will then extrapolate those findings, and the provider may be penalized.

Upon receipt of an audit request, it is important to immediately engage legal counsel well-versed in handling payor audits. Having an attorney who understands the audit process and has experience responding to audit requests can help ensure the best possible audit outcome. A negative outcome could result in recovery of overpayments, civil and/or criminal penalties, and exclusion from government programs.

Providers should work with such legal counsel to review the audit request and supply everything reasonably requested. A concerted effort should be made to submit all information to the auditor at one time. If information is missing, the auditor may determine that a significant error rate exists, which could cause the auditor to review all CPT codes to calculate the overpayment made to the provider. If it is not possible to gather the requested material before the auditor’s deadline, an extension should be requested. Any extensions granted should be documented.

It is important that an audit response and supporting documentation be thorough, clear, and concise. It should be submitted in a manner that allows the auditor to quickly review the information and understand the provider’s arguments. It should clearly state what measures the provider has already taken to terminate existing problems and prevent future issues. Competent legal counsel will be able to address procedural, legal, or factual flaws in the auditor’s position.

Advanced Preparation

The best way to ensure compliance and audit readiness is to develop and implement a compliance plan well in advance of any audit. Experienced legal counsel should play a pivotal role in development of such plan. As always, periodic self-audits or independent audits are necessary to proactively identify compliance issues and mitigate their impact.

Finally, regular and periodic training and education should be conducted regarding audit response obligations and responsibilities. Performing these tasks will help ensure a smooth audit experience with minimal infractions and penalties. TH

Receiving notice from a payor that you are being audited can be alarming. Questions will inevitably run through your mind, such as, Why? How? How much will this cost?

Understanding the types of payor audits and how to navigate the process can make answering those questions easier. In addition, advanced preparation and knowing when to engage legal counsel can be critical to a successful audit outcome.

Audit Types

There are three general types of audits that providers face: Medicare audits, Medicaid audits, and private payor audits.

Medicare audits: The agency responsible for Medicare audits is the Centers for Medicare & Medicaid Services (CMS). There are three types of Medicare audits. Comprehensive Error Rate Testing (CERT) audits focus on providers who deliver high-cost items or services, have high volume, and/or have atypical billing or coding practices. Private contractors perform Recovery Audit Contractor (RAC) program audits; these contractors are paid a percentage of the amount of any improper payment discovered. Finally, Zone Program Integrity Contractor (ZPIC) audits are the most serious of the three audit types. ZPIC audits are performed by CMS contractors who mine the provider’s data for compliance with Medicare coverage and coding policies, investigate fraud, and may prepare cases for civil or criminal referral to CMS or law enforcement agencies.

Medicaid audits: Medicaid audits evaluate compliance with both CMS and applicable state regulations and investigate fraud. Evidence of fraud will be reported to the state attorney general for further review and prosecution.

Private payor audits: Private payor audits consist of informal reviews and formal audits. These audits can be triggered by actual allegations or evidence of noncompliance, or they can be random, in which general compliance is assessed. Audit procedures are typically determined by contract or the payor’s provider handbook and in accordance with applicable state law. The process can consist of prepayment reviews, in which the sufficiency of a claim and its supporting documentation is determined before payment is made to the provider, or post-payment reviews, during which claims are analyzed after the provider has been paid to determine if an overpayment was made and the amount of such overpayment. In the event an overpayment is discovered, a recoupment will be sought from the provider.

Focus

Consistent billing by a provider of high volumes of certain high-level services, high volumes of evaluation and management services, or consistently referring patients for certain testing can create suspicion in mayors.

In recent years, the primary focus of audits has been medical necessity due to payor concerns about specific fraud and abuse issues. Documentation of medical necessity is required during an audit. However, proving medical necessity can be difficult as the definition of “medical necessity” can vary by payor and within a payor depending on the underlying plan. In addition, private payors often have arbitrary and vague guidelines for defining and determining medical necessity, particularly when dealing with physicians or ordering clinicians. For this reason, it is critical that providers read their payor contracts and manuals carefully. If those materials are unclear, it is best to confirm requirements with the payor.

Regardless of the definition, medical necessity is a precondition to coverage for all payors. Proof is required that the services were reasonable and necessary to diagnosis or treat a patient’s medical condition. To satisfy this standard, providers should document the diagnosis for all procedures performed and all diagnostic tests ordered. In the case of repeat procedures, providers should clearly note the outcome of the previous procedure and the basis for reordering.

Responding to an Audit Request

All audit requests must be taken very seriously. Payors tend to copy what other payors are doing, and a problematic audit with one payor can cause other payors to initiate their own audits. Therefore, it is critical to respond appropriately to each audit request. Also, auditors often only check a few billing records. If errors are found, they will then extrapolate those findings, and the provider may be penalized.

Upon receipt of an audit request, it is important to immediately engage legal counsel well-versed in handling payor audits. Having an attorney who understands the audit process and has experience responding to audit requests can help ensure the best possible audit outcome. A negative outcome could result in recovery of overpayments, civil and/or criminal penalties, and exclusion from government programs.

Providers should work with such legal counsel to review the audit request and supply everything reasonably requested. A concerted effort should be made to submit all information to the auditor at one time. If information is missing, the auditor may determine that a significant error rate exists, which could cause the auditor to review all CPT codes to calculate the overpayment made to the provider. If it is not possible to gather the requested material before the auditor’s deadline, an extension should be requested. Any extensions granted should be documented.

It is important that an audit response and supporting documentation be thorough, clear, and concise. It should be submitted in a manner that allows the auditor to quickly review the information and understand the provider’s arguments. It should clearly state what measures the provider has already taken to terminate existing problems and prevent future issues. Competent legal counsel will be able to address procedural, legal, or factual flaws in the auditor’s position.

Advanced Preparation

The best way to ensure compliance and audit readiness is to develop and implement a compliance plan well in advance of any audit. Experienced legal counsel should play a pivotal role in development of such plan. As always, periodic self-audits or independent audits are necessary to proactively identify compliance issues and mitigate their impact.

Finally, regular and periodic training and education should be conducted regarding audit response obligations and responsibilities. Performing these tasks will help ensure a smooth audit experience with minimal infractions and penalties. TH

Colony of iPSCs

Image from Salk Institute

New research suggests the type of founder cell used to generate induced pluripotent stem cells (iPSCs) does not affect the iPSCs’ ability to differentiate into hematopoietic cells.

Instead, researchers found the expression of certain genes and DNA methylations were better indicators of the efficiency at which a cell line could be differentiated into the hematopoietic lineage.

The team reported these findings in Cell Stem Cell.

The researchers assessed the hematopoietic differentiation capacities of 35 iPSC lines derived from 4 types of somatic tissues—human dermal fibroblasts, hematopoietic cells such as cord blood and peripheral blood, dental pulp cells, and keratinocytes—from 15 donors.

The team also assessed 4 embryonic stem cell lines in early phase and late phase.

The researchers found that hematopoietic commitment capacity was associated with expression of IGF2 in undifferentiated iPSCs, but not with type of founder cell.

Higher expression of IFG2 was indicative of iPSCs initiating their conversion into hematopoietic cells. Even though IFG2 itself is not directly related to hematopoiesis, its uptake corresponded to an increase in the expression of genes that are.

Although IFG2 marked the beginnings of differentiation to hematopoietic lineage, the completion of differentiation was marked by the methylation profiles of the iPSC DNA.

“DNA methylation has an effect on a cell staying pluripotent or differentiating,” explained study author Yoshinori Yoshida, MD, PhD, of the Center for iPS Cell Research and Application at Kyoto University in Japan.

The completion of differentiation correlated with less aberrant methylation during the reprogramming process.

Hematopoietic founder cells showed a much lower propensity for aberrant methylation than did other founder cells, which could explain why, in the past, scientists attributed the founder cell to the effectiveness of differentiating iPSCs to the hematopoietic lineage.

Dr Yoshida and his colleagues said this research revealed molecular factors that can be used to evaluate the differentiation potential of different cell lines, which should expedite the progress of iPSCs to clinical use.

Colony of iPSCs

Image from Salk Institute

New research suggests the type of founder cell used to generate induced pluripotent stem cells (iPSCs) does not affect the iPSCs’ ability to differentiate into hematopoietic cells.

Instead, researchers found the expression of certain genes and DNA methylations were better indicators of the efficiency at which a cell line could be differentiated into the hematopoietic lineage.

The team reported these findings in Cell Stem Cell.

The researchers assessed the hematopoietic differentiation capacities of 35 iPSC lines derived from 4 types of somatic tissues—human dermal fibroblasts, hematopoietic cells such as cord blood and peripheral blood, dental pulp cells, and keratinocytes—from 15 donors.

The team also assessed 4 embryonic stem cell lines in early phase and late phase.

The researchers found that hematopoietic commitment capacity was associated with expression of IGF2 in undifferentiated iPSCs, but not with type of founder cell.

Higher expression of IFG2 was indicative of iPSCs initiating their conversion into hematopoietic cells. Even though IFG2 itself is not directly related to hematopoiesis, its uptake corresponded to an increase in the expression of genes that are.

Although IFG2 marked the beginnings of differentiation to hematopoietic lineage, the completion of differentiation was marked by the methylation profiles of the iPSC DNA.

“DNA methylation has an effect on a cell staying pluripotent or differentiating,” explained study author Yoshinori Yoshida, MD, PhD, of the Center for iPS Cell Research and Application at Kyoto University in Japan.

The completion of differentiation correlated with less aberrant methylation during the reprogramming process.

Hematopoietic founder cells showed a much lower propensity for aberrant methylation than did other founder cells, which could explain why, in the past, scientists attributed the founder cell to the effectiveness of differentiating iPSCs to the hematopoietic lineage.

Dr Yoshida and his colleagues said this research revealed molecular factors that can be used to evaluate the differentiation potential of different cell lines, which should expedite the progress of iPSCs to clinical use.

Colony of iPSCs

Image from Salk Institute

New research suggests the type of founder cell used to generate induced pluripotent stem cells (iPSCs) does not affect the iPSCs’ ability to differentiate into hematopoietic cells.

Instead, researchers found the expression of certain genes and DNA methylations were better indicators of the efficiency at which a cell line could be differentiated into the hematopoietic lineage.

The team reported these findings in Cell Stem Cell.

The researchers assessed the hematopoietic differentiation capacities of 35 iPSC lines derived from 4 types of somatic tissues—human dermal fibroblasts, hematopoietic cells such as cord blood and peripheral blood, dental pulp cells, and keratinocytes—from 15 donors.

The team also assessed 4 embryonic stem cell lines in early phase and late phase.

The researchers found that hematopoietic commitment capacity was associated with expression of IGF2 in undifferentiated iPSCs, but not with type of founder cell.

Higher expression of IFG2 was indicative of iPSCs initiating their conversion into hematopoietic cells. Even though IFG2 itself is not directly related to hematopoiesis, its uptake corresponded to an increase in the expression of genes that are.

Although IFG2 marked the beginnings of differentiation to hematopoietic lineage, the completion of differentiation was marked by the methylation profiles of the iPSC DNA.

“DNA methylation has an effect on a cell staying pluripotent or differentiating,” explained study author Yoshinori Yoshida, MD, PhD, of the Center for iPS Cell Research and Application at Kyoto University in Japan.

The completion of differentiation correlated with less aberrant methylation during the reprogramming process.

Hematopoietic founder cells showed a much lower propensity for aberrant methylation than did other founder cells, which could explain why, in the past, scientists attributed the founder cell to the effectiveness of differentiating iPSCs to the hematopoietic lineage.

Dr Yoshida and his colleagues said this research revealed molecular factors that can be used to evaluate the differentiation potential of different cell lines, which should expedite the progress of iPSCs to clinical use.

Micrograph showing MDS

Next-generation sequencing (NGS) of cell-free DNA should be the method of choice to confirm the diagnosis of myelodysplastic syndromes (MDS), according to researchers.

The team found that using NGS to analyze samples from MDS patients yielded more accurate results than Sanger sequencing.

And sequencing cell-free DNA rather than peripheral blood cell DNA increased the likelihood of detecting mutations associated with MDS.

The team reported these findings in Genetic Testing and Molecular Biomarkers. This research was funded by NeoGenomics Laboratories.

For this study, the researchers performed NGS on a panel of 14 target genes using total nucleic acid extracted from the plasma of 16 patients with early MDS (blasts <5%). The team also performed Sanger sequencing and NGS on peripheral blood cell DNA from the same patients.

The researchers found that NGS of cell-free DNA confirmed the diagnosis of MDS in all 16 patients.

In addition, NGS of cell-free DNA revealed abnormalities in 5 patients (31%) that were not detected by Sanger sequencing of peripheral blood cell DNA.

NGS of peripheral blood cell DNA produced the same results as NGS of cell-free DNA for 4 of the 5 patients. However, NGS of peripheral blood cell DNA did not detect a mutation in the RUNX1 gene that was evident in cell-free DNA from 1 patient.

Overall, the researchers found that mutant allele frequency was significantly higher in cell-free DNA than cellular DNA (P=0.008).

The team therefore concluded that cell-free DNA is more reliable than peripheral blood cell DNA for detecting molecular abnormalities in patients with MDS, and NGS is more accurate than Sanger sequencing.

Micrograph showing MDS

Next-generation sequencing (NGS) of cell-free DNA should be the method of choice to confirm the diagnosis of myelodysplastic syndromes (MDS), according to researchers.

The team found that using NGS to analyze samples from MDS patients yielded more accurate results than Sanger sequencing.

And sequencing cell-free DNA rather than peripheral blood cell DNA increased the likelihood of detecting mutations associated with MDS.

The team reported these findings in Genetic Testing and Molecular Biomarkers. This research was funded by NeoGenomics Laboratories.

For this study, the researchers performed NGS on a panel of 14 target genes using total nucleic acid extracted from the plasma of 16 patients with early MDS (blasts <5%). The team also performed Sanger sequencing and NGS on peripheral blood cell DNA from the same patients.

The researchers found that NGS of cell-free DNA confirmed the diagnosis of MDS in all 16 patients.

In addition, NGS of cell-free DNA revealed abnormalities in 5 patients (31%) that were not detected by Sanger sequencing of peripheral blood cell DNA.

NGS of peripheral blood cell DNA produced the same results as NGS of cell-free DNA for 4 of the 5 patients. However, NGS of peripheral blood cell DNA did not detect a mutation in the RUNX1 gene that was evident in cell-free DNA from 1 patient.

Overall, the researchers found that mutant allele frequency was significantly higher in cell-free DNA than cellular DNA (P=0.008).

The team therefore concluded that cell-free DNA is more reliable than peripheral blood cell DNA for detecting molecular abnormalities in patients with MDS, and NGS is more accurate than Sanger sequencing.

Micrograph showing MDS

Next-generation sequencing (NGS) of cell-free DNA should be the method of choice to confirm the diagnosis of myelodysplastic syndromes (MDS), according to researchers.

The team found that using NGS to analyze samples from MDS patients yielded more accurate results than Sanger sequencing.

And sequencing cell-free DNA rather than peripheral blood cell DNA increased the likelihood of detecting mutations associated with MDS.

The team reported these findings in Genetic Testing and Molecular Biomarkers. This research was funded by NeoGenomics Laboratories.

For this study, the researchers performed NGS on a panel of 14 target genes using total nucleic acid extracted from the plasma of 16 patients with early MDS (blasts <5%). The team also performed Sanger sequencing and NGS on peripheral blood cell DNA from the same patients.

The researchers found that NGS of cell-free DNA confirmed the diagnosis of MDS in all 16 patients.

In addition, NGS of cell-free DNA revealed abnormalities in 5 patients (31%) that were not detected by Sanger sequencing of peripheral blood cell DNA.

NGS of peripheral blood cell DNA produced the same results as NGS of cell-free DNA for 4 of the 5 patients. However, NGS of peripheral blood cell DNA did not detect a mutation in the RUNX1 gene that was evident in cell-free DNA from 1 patient.

Overall, the researchers found that mutant allele frequency was significantly higher in cell-free DNA than cellular DNA (P=0.008).

The team therefore concluded that cell-free DNA is more reliable than peripheral blood cell DNA for detecting molecular abnormalities in patients with MDS, and NGS is more accurate than Sanger sequencing.

Patient consults pharmacist

Photo by Rhoda Baer

Physicians may still prescribe a controversial drug combination despite safety concerns, according to a study published in Pharmacology Research & Perspectives.

Regulatory agencies have warned against prescribing the antiplatelet agent clopidogrel with the proton pump inhibitors (PPIs) omeprazole and esomeprazole.

A PPI may be prescribed with clopidogrel to reduce the risk of gastrointestinal bleeding associated with antiplatelet therapy.

However, concomitant use of clopidogrel and esomeprazole/omeprazole is thought by some to reduce the pharmacological activity of clopidogrel.

In 2009 and 2010, regulatory agencies in Europe and the US published statements advising against concomitant use of clopidogrel and the aforementioned PPIs.

Willemien J. Kruik-Kolloffel, PharmD, of Medisch Spectrum Twente in Enschede, The Netherlands, and his colleagues wanted to determine if this recommendation was followed in The Netherlands.

The researchers studied data spanning the period from 2008 to 2011 and encompassing 39,496 patients. Forty percent of the patients did not use gastroprotective drugs at all during the study period.

Twenty-seven percent of patients were taking gastroprotective drugs before starting clopidogrel, 23% started gastroprotective drugs and clopidogrel concomitantly, and 10% started gastroprotective drugs at least 4 weeks after starting clopidogrel.

Among the patients who started a gastroprotective drug and clopidogrel concomitantly, an average of 40% started on esomeprazole/omeprazole before the first statement from a regulatory agency was released in January 2009.

This percentage decreased to around 20% after the statements were released. The percentage of patients starting on other PPIs rose from 60% to about 80%.

After the last statement was released in February 2010, there was an 11.9% decrease in dispensation of omeprazole and esomeprazole and an increase of 16.0% for other PPIs.

Results were similar among the patients who started taking a gastroprotective drug at least 4 weeks after starting clopidogrel.

These data suggest the regulatory agencies’ advice was followed, though not fully. The researchers said this may be, in part, because physicians doubt the suggested interaction between clopidogrel and esomeprazole/omeprazole.

“Regulatory agencies should base their advice on sound scientific data to convince prescribers,” Dr Kruik-Kolloffel said. “We, the authors, doubt the interaction, as do a lot of professionals all around the world.”

Patient consults pharmacist

Photo by Rhoda Baer

Physicians may still prescribe a controversial drug combination despite safety concerns, according to a study published in Pharmacology Research & Perspectives.

Regulatory agencies have warned against prescribing the antiplatelet agent clopidogrel with the proton pump inhibitors (PPIs) omeprazole and esomeprazole.

A PPI may be prescribed with clopidogrel to reduce the risk of gastrointestinal bleeding associated with antiplatelet therapy.

However, concomitant use of clopidogrel and esomeprazole/omeprazole is thought by some to reduce the pharmacological activity of clopidogrel.

In 2009 and 2010, regulatory agencies in Europe and the US published statements advising against concomitant use of clopidogrel and the aforementioned PPIs.

Willemien J. Kruik-Kolloffel, PharmD, of Medisch Spectrum Twente in Enschede, The Netherlands, and his colleagues wanted to determine if this recommendation was followed in The Netherlands.

The researchers studied data spanning the period from 2008 to 2011 and encompassing 39,496 patients. Forty percent of the patients did not use gastroprotective drugs at all during the study period.

Twenty-seven percent of patients were taking gastroprotective drugs before starting clopidogrel, 23% started gastroprotective drugs and clopidogrel concomitantly, and 10% started gastroprotective drugs at least 4 weeks after starting clopidogrel.

Among the patients who started a gastroprotective drug and clopidogrel concomitantly, an average of 40% started on esomeprazole/omeprazole before the first statement from a regulatory agency was released in January 2009.

This percentage decreased to around 20% after the statements were released. The percentage of patients starting on other PPIs rose from 60% to about 80%.

After the last statement was released in February 2010, there was an 11.9% decrease in dispensation of omeprazole and esomeprazole and an increase of 16.0% for other PPIs.

Results were similar among the patients who started taking a gastroprotective drug at least 4 weeks after starting clopidogrel.

These data suggest the regulatory agencies’ advice was followed, though not fully. The researchers said this may be, in part, because physicians doubt the suggested interaction between clopidogrel and esomeprazole/omeprazole.

“Regulatory agencies should base their advice on sound scientific data to convince prescribers,” Dr Kruik-Kolloffel said. “We, the authors, doubt the interaction, as do a lot of professionals all around the world.”

Patient consults pharmacist

Photo by Rhoda Baer

Physicians may still prescribe a controversial drug combination despite safety concerns, according to a study published in Pharmacology Research & Perspectives.

Regulatory agencies have warned against prescribing the antiplatelet agent clopidogrel with the proton pump inhibitors (PPIs) omeprazole and esomeprazole.

A PPI may be prescribed with clopidogrel to reduce the risk of gastrointestinal bleeding associated with antiplatelet therapy.

However, concomitant use of clopidogrel and esomeprazole/omeprazole is thought by some to reduce the pharmacological activity of clopidogrel.

In 2009 and 2010, regulatory agencies in Europe and the US published statements advising against concomitant use of clopidogrel and the aforementioned PPIs.

Willemien J. Kruik-Kolloffel, PharmD, of Medisch Spectrum Twente in Enschede, The Netherlands, and his colleagues wanted to determine if this recommendation was followed in The Netherlands.

The researchers studied data spanning the period from 2008 to 2011 and encompassing 39,496 patients. Forty percent of the patients did not use gastroprotective drugs at all during the study period.

Twenty-seven percent of patients were taking gastroprotective drugs before starting clopidogrel, 23% started gastroprotective drugs and clopidogrel concomitantly, and 10% started gastroprotective drugs at least 4 weeks after starting clopidogrel.

Among the patients who started a gastroprotective drug and clopidogrel concomitantly, an average of 40% started on esomeprazole/omeprazole before the first statement from a regulatory agency was released in January 2009.

This percentage decreased to around 20% after the statements were released. The percentage of patients starting on other PPIs rose from 60% to about 80%.

After the last statement was released in February 2010, there was an 11.9% decrease in dispensation of omeprazole and esomeprazole and an increase of 16.0% for other PPIs.

Results were similar among the patients who started taking a gastroprotective drug at least 4 weeks after starting clopidogrel.

These data suggest the regulatory agencies’ advice was followed, though not fully. The researchers said this may be, in part, because physicians doubt the suggested interaction between clopidogrel and esomeprazole/omeprazole.

“Regulatory agencies should base their advice on sound scientific data to convince prescribers,” Dr Kruik-Kolloffel said. “We, the authors, doubt the interaction, as do a lot of professionals all around the world.”

Plasmodium parasite

infecting a red blood cell

Photo courtesy of St. Jude

Children’s Research Hospital

New research helps explain how one of Plasmodium falciparum’s best weapons against antimalarial drugs can actually be exploited to treat malaria.

Investigators believe the findings, published in PLOS Pathogens, might be used to stop the emergence and spread of drug-resistant malaria.

The team noted that mutations in the P falciparum chloroquine resistance transporter (PfCRT) confer resistance to

chloroquine and related antimalarial drugs by enabling the protein to transport the drugs away from their targets within the parasite’s digestive vacuole.

However, chloroquine resistance-conferring isoforms of PfCRT (PfCRT^CQR) also render the parasite hypersensitive to a subset of structurally diverse drugs. And mutations in PfCRT^CQR that suppress this hypersensitivity simultaneously reinstate sensitivity to chloroquine and related drugs.

With this study, the investigators uncovered 2 mechanisms by which PfCRT causes P falciparum to become hypersensitive to antimalarial drugs.

First, they found that quinine, which normally exerts its killing effect within the parasite’s digestive vacuole, can bind tightly to certain forms of PfCRT. This blocks the function of the protein, which is essential to the parasite’s survival.

Second, the team found that amantadine, which normally sequesters within the digestive vacuole as well, is leaked back into the cytosol via PfCRT.

The investigators noted that, in both of these cases, mutations that suppress hypersensitivity also revoke PfCRT’s ability to transport chloroquine, which explains why rescue from hypersensitivity restores the parasite’s sensitivity to chloroquine.

“[C]hanges that allow the protein to move chloroquine away from its antimalarial target simultaneously enable the protein to deliver other drugs to their antimalarial targets,” explained study author Rowena Martin, PhD, of Australian National University in Canberra.

“[W]hen the protein adapts itself to fend off one of these drugs, it is no longer able to deal with chloroquine and, hence, the parasite is re-sensitized to chloroquine. Essentially, the parasite can’t have its cake and eat it too. So if chloroquine or a related drug is paired with a drug that is super-active against the modified protein, no matter what the parasite tries to do, it’s ‘checkmate’ for malaria.”

Dr Martin and her colleagues believe their findings provide a foundation for understanding and exploiting the hypersensitivity of chloroquine-resistant parasites to several antimalarial drugs that are currently available.

“Health authorities could use our research to find ways to prolong the lifespan of antimalarial drugs,” said Sashika Richards, a PhD student at Australian National University.

“The current frontline antimalarial drug, artemisinin, is already failing in Asia, and we don’t have anything to replace it. It will be at least 5 years before the next new drug makes it to market. The low-hanging fruit is gone, and it’s now very costly and time-consuming to develop new treatments for malaria.”

Plasmodium parasite

infecting a red blood cell

Photo courtesy of St. Jude

Children’s Research Hospital

New research helps explain how one of Plasmodium falciparum’s best weapons against antimalarial drugs can actually be exploited to treat malaria.

Investigators believe the findings, published in PLOS Pathogens, might be used to stop the emergence and spread of drug-resistant malaria.

The team noted that mutations in the P falciparum chloroquine resistance transporter (PfCRT) confer resistance to

chloroquine and related antimalarial drugs by enabling the protein to transport the drugs away from their targets within the parasite’s digestive vacuole.

However, chloroquine resistance-conferring isoforms of PfCRT (PfCRT^CQR) also render the parasite hypersensitive to a subset of structurally diverse drugs. And mutations in PfCRT^CQR that suppress this hypersensitivity simultaneously reinstate sensitivity to chloroquine and related drugs.

With this study, the investigators uncovered 2 mechanisms by which PfCRT causes P falciparum to become hypersensitive to antimalarial drugs.

First, they found that quinine, which normally exerts its killing effect within the parasite’s digestive vacuole, can bind tightly to certain forms of PfCRT. This blocks the function of the protein, which is essential to the parasite’s survival.

Second, the team found that amantadine, which normally sequesters within the digestive vacuole as well, is leaked back into the cytosol via PfCRT.

The investigators noted that, in both of these cases, mutations that suppress hypersensitivity also revoke PfCRT’s ability to transport chloroquine, which explains why rescue from hypersensitivity restores the parasite’s sensitivity to chloroquine.

“[C]hanges that allow the protein to move chloroquine away from its antimalarial target simultaneously enable the protein to deliver other drugs to their antimalarial targets,” explained study author Rowena Martin, PhD, of Australian National University in Canberra.

“[W]hen the protein adapts itself to fend off one of these drugs, it is no longer able to deal with chloroquine and, hence, the parasite is re-sensitized to chloroquine. Essentially, the parasite can’t have its cake and eat it too. So if chloroquine or a related drug is paired with a drug that is super-active against the modified protein, no matter what the parasite tries to do, it’s ‘checkmate’ for malaria.”

Dr Martin and her colleagues believe their findings provide a foundation for understanding and exploiting the hypersensitivity of chloroquine-resistant parasites to several antimalarial drugs that are currently available.

“Health authorities could use our research to find ways to prolong the lifespan of antimalarial drugs,” said Sashika Richards, a PhD student at Australian National University.

“The current frontline antimalarial drug, artemisinin, is already failing in Asia, and we don’t have anything to replace it. It will be at least 5 years before the next new drug makes it to market. The low-hanging fruit is gone, and it’s now very costly and time-consuming to develop new treatments for malaria.”

Plasmodium parasite

infecting a red blood cell

Photo courtesy of St. Jude

Children’s Research Hospital

New research helps explain how one of Plasmodium falciparum’s best weapons against antimalarial drugs can actually be exploited to treat malaria.

Investigators believe the findings, published in PLOS Pathogens, might be used to stop the emergence and spread of drug-resistant malaria.

The team noted that mutations in the P falciparum chloroquine resistance transporter (PfCRT) confer resistance to

chloroquine and related antimalarial drugs by enabling the protein to transport the drugs away from their targets within the parasite’s digestive vacuole.

However, chloroquine resistance-conferring isoforms of PfCRT (PfCRT^CQR) also render the parasite hypersensitive to a subset of structurally diverse drugs. And mutations in PfCRT^CQR that suppress this hypersensitivity simultaneously reinstate sensitivity to chloroquine and related drugs.

With this study, the investigators uncovered 2 mechanisms by which PfCRT causes P falciparum to become hypersensitive to antimalarial drugs.

First, they found that quinine, which normally exerts its killing effect within the parasite’s digestive vacuole, can bind tightly to certain forms of PfCRT. This blocks the function of the protein, which is essential to the parasite’s survival.

Second, the team found that amantadine, which normally sequesters within the digestive vacuole as well, is leaked back into the cytosol via PfCRT.

The investigators noted that, in both of these cases, mutations that suppress hypersensitivity also revoke PfCRT’s ability to transport chloroquine, which explains why rescue from hypersensitivity restores the parasite’s sensitivity to chloroquine.

“[C]hanges that allow the protein to move chloroquine away from its antimalarial target simultaneously enable the protein to deliver other drugs to their antimalarial targets,” explained study author Rowena Martin, PhD, of Australian National University in Canberra.

“[W]hen the protein adapts itself to fend off one of these drugs, it is no longer able to deal with chloroquine and, hence, the parasite is re-sensitized to chloroquine. Essentially, the parasite can’t have its cake and eat it too. So if chloroquine or a related drug is paired with a drug that is super-active against the modified protein, no matter what the parasite tries to do, it’s ‘checkmate’ for malaria.”

Dr Martin and her colleagues believe their findings provide a foundation for understanding and exploiting the hypersensitivity of chloroquine-resistant parasites to several antimalarial drugs that are currently available.

“Health authorities could use our research to find ways to prolong the lifespan of antimalarial drugs,” said Sashika Richards, a PhD student at Australian National University.

“The current frontline antimalarial drug, artemisinin, is already failing in Asia, and we don’t have anything to replace it. It will be at least 5 years before the next new drug makes it to market. The low-hanging fruit is gone, and it’s now very costly and time-consuming to develop new treatments for malaria.”

SCOTTSDALE, ARIZ. – Serum vitamin D level was not significantly associated with atopic dermatitis or disease severity in a single-center study of more than 600 children and adolescents.

However, “we did observe a strong correlation between average serum vitamin D levels and skin type, as well as body mass index,” said Kavita Darji, a medical student at Saint Louis (Mo.) University, who presented the findings in a poster at the annual meeting of the Society for Investigative Dermatology. Those findings challenge the logic of following universal definitions of vitamin D deficiency, especially given the phenotypic heterogeneity of patients in the United States, she added in an interview.

Amy Karon/Frontline Medical News

Serum vitamin D testing is one of most common laboratory assays in this country, but clinicians still debate the risks and benefits of supplementing children and adolescents who test below the Endocrine Society’s threshold for sufficiency (30.0 ng/mL).

To identify factors affecting vitamin D levels, Ms. Darji and her associates reviewed electronic medical charts for patients under age 22 years at Saint Louis University medical centers between 2009 and 2014. The cohort of 655 patients was primarily white (64%) or black (29%), and was nearly equally balanced by gender; their average age was 10 years. The researchers analyzed only the first vitamin D serum measurement for each patient, and defined deficiency as a level under 20 ng/mL, insufficiency as a level between 20 and 29.9 ng/mL, and sufficiency as a level of at least 30 ng/mL.

Serum vitamin D levels were slightly lower among atopic patients, compared with those without atopy, but the difference did not reach statistical significance (about 25 ng/mL vs. about 38 ng/mL; P greater than .05). “We also did not find an association between AD severity and vitamin D level,” Ms. Darji reported. Instead, race and body mass index were the most significant predictors of vitamin D deficiency, probably because these factors directly affect cutaneous photo-induced vitamin D synthesis and the sequestration of fat-soluble vitamins in adipose tissue, she said.

Using the standard definitions, more than 50% of black patients were vitamin D deficient, while less than 30% had sufficient vitamin D levels. In contrast, about 25% of white patients were vitamin D deficient, while nearly 40% had sufficient vitamin D levels (P less than .0001 for proportions of deficiency by race). Furthermore, only about 10% of obese children (those who exceeded the 99th percentile of BMI for age) had sufficient vitamin D levels, compared with more than 40% of underweight children and about 30% of normal-weight children (P less than .00001).

Since vitamin D deficiency was more common among black and obese patients, “maybe they could benefit from a different cut-off value than the standard 30 ng per mL that we used,” Ms. Darji said. “The question is, do they really require these supplements? It may be beneficial to look at the unique characteristics of each patient before supplementing, because the risks of supplementation are considerable in terms of bone health and cardiovascular disease.”

Vitamin D levels did not vary significantly by gender or by month or season measured, Ms. Darji noted. She reported no funding sources and had no disclosures.

SCOTTSDALE, ARIZ. – Serum vitamin D level was not significantly associated with atopic dermatitis or disease severity in a single-center study of more than 600 children and adolescents.

However, “we did observe a strong correlation between average serum vitamin D levels and skin type, as well as body mass index,” said Kavita Darji, a medical student at Saint Louis (Mo.) University, who presented the findings in a poster at the annual meeting of the Society for Investigative Dermatology. Those findings challenge the logic of following universal definitions of vitamin D deficiency, especially given the phenotypic heterogeneity of patients in the United States, she added in an interview.

Amy Karon/Frontline Medical News

Serum vitamin D testing is one of most common laboratory assays in this country, but clinicians still debate the risks and benefits of supplementing children and adolescents who test below the Endocrine Society’s threshold for sufficiency (30.0 ng/mL).

To identify factors affecting vitamin D levels, Ms. Darji and her associates reviewed electronic medical charts for patients under age 22 years at Saint Louis University medical centers between 2009 and 2014. The cohort of 655 patients was primarily white (64%) or black (29%), and was nearly equally balanced by gender; their average age was 10 years. The researchers analyzed only the first vitamin D serum measurement for each patient, and defined deficiency as a level under 20 ng/mL, insufficiency as a level between 20 and 29.9 ng/mL, and sufficiency as a level of at least 30 ng/mL.

Serum vitamin D levels were slightly lower among atopic patients, compared with those without atopy, but the difference did not reach statistical significance (about 25 ng/mL vs. about 38 ng/mL; P greater than .05). “We also did not find an association between AD severity and vitamin D level,” Ms. Darji reported. Instead, race and body mass index were the most significant predictors of vitamin D deficiency, probably because these factors directly affect cutaneous photo-induced vitamin D synthesis and the sequestration of fat-soluble vitamins in adipose tissue, she said.

Using the standard definitions, more than 50% of black patients were vitamin D deficient, while less than 30% had sufficient vitamin D levels. In contrast, about 25% of white patients were vitamin D deficient, while nearly 40% had sufficient vitamin D levels (P less than .0001 for proportions of deficiency by race). Furthermore, only about 10% of obese children (those who exceeded the 99th percentile of BMI for age) had sufficient vitamin D levels, compared with more than 40% of underweight children and about 30% of normal-weight children (P less than .00001).

Since vitamin D deficiency was more common among black and obese patients, “maybe they could benefit from a different cut-off value than the standard 30 ng per mL that we used,” Ms. Darji said. “The question is, do they really require these supplements? It may be beneficial to look at the unique characteristics of each patient before supplementing, because the risks of supplementation are considerable in terms of bone health and cardiovascular disease.”

Vitamin D levels did not vary significantly by gender or by month or season measured, Ms. Darji noted. She reported no funding sources and had no disclosures.

SCOTTSDALE, ARIZ. – Serum vitamin D level was not significantly associated with atopic dermatitis or disease severity in a single-center study of more than 600 children and adolescents.

However, “we did observe a strong correlation between average serum vitamin D levels and skin type, as well as body mass index,” said Kavita Darji, a medical student at Saint Louis (Mo.) University, who presented the findings in a poster at the annual meeting of the Society for Investigative Dermatology. Those findings challenge the logic of following universal definitions of vitamin D deficiency, especially given the phenotypic heterogeneity of patients in the United States, she added in an interview.

Amy Karon/Frontline Medical News

Serum vitamin D testing is one of most common laboratory assays in this country, but clinicians still debate the risks and benefits of supplementing children and adolescents who test below the Endocrine Society’s threshold for sufficiency (30.0 ng/mL).

To identify factors affecting vitamin D levels, Ms. Darji and her associates reviewed electronic medical charts for patients under age 22 years at Saint Louis University medical centers between 2009 and 2014. The cohort of 655 patients was primarily white (64%) or black (29%), and was nearly equally balanced by gender; their average age was 10 years. The researchers analyzed only the first vitamin D serum measurement for each patient, and defined deficiency as a level under 20 ng/mL, insufficiency as a level between 20 and 29.9 ng/mL, and sufficiency as a level of at least 30 ng/mL.

Serum vitamin D levels were slightly lower among atopic patients, compared with those without atopy, but the difference did not reach statistical significance (about 25 ng/mL vs. about 38 ng/mL; P greater than .05). “We also did not find an association between AD severity and vitamin D level,” Ms. Darji reported. Instead, race and body mass index were the most significant predictors of vitamin D deficiency, probably because these factors directly affect cutaneous photo-induced vitamin D synthesis and the sequestration of fat-soluble vitamins in adipose tissue, she said.

Using the standard definitions, more than 50% of black patients were vitamin D deficient, while less than 30% had sufficient vitamin D levels. In contrast, about 25% of white patients were vitamin D deficient, while nearly 40% had sufficient vitamin D levels (P less than .0001 for proportions of deficiency by race). Furthermore, only about 10% of obese children (those who exceeded the 99th percentile of BMI for age) had sufficient vitamin D levels, compared with more than 40% of underweight children and about 30% of normal-weight children (P less than .00001).

Since vitamin D deficiency was more common among black and obese patients, “maybe they could benefit from a different cut-off value than the standard 30 ng per mL that we used,” Ms. Darji said. “The question is, do they really require these supplements? It may be beneficial to look at the unique characteristics of each patient before supplementing, because the risks of supplementation are considerable in terms of bone health and cardiovascular disease.”

Vitamin D levels did not vary significantly by gender or by month or season measured, Ms. Darji noted. She reported no funding sources and had no disclosures.

SCOTTSDALE, ARIZ. – Serum vitamin D level was not significantly associated with atopic dermatitis or disease severity in a single-center study of more than 600 children and adolescents.

However, “we did observe a strong correlation between average serum vitamin D levels and skin type, as well as body mass index,” said Kavita Darji, a medical student at Saint Louis (Mo.) University, who presented the findings in a poster at the annual meeting of the Society for Investigative Dermatology. Those findings challenge the logic of following universal definitions of vitamin D deficiency, especially given the phenotypic heterogeneity of patients in the United States, she added in an interview.

Amy Karon/Frontline Medical News

Serum vitamin D testing is one of most common laboratory assays in this country, but clinicians still debate the risks and benefits of supplementing children and adolescents who test below the Endocrine Society’s threshold for sufficiency (30.0 ng/mL).

To identify factors affecting vitamin D levels, Ms. Darji and her associates reviewed electronic medical charts for patients under age 22 years at Saint Louis University medical centers between 2009 and 2014. The cohort of 655 patients was primarily white (64%) or black (29%), and was nearly equally balanced by gender; their average age was 10 years. The researchers analyzed only the first vitamin D serum measurement for each patient, and defined deficiency as a level under 20 ng/mL, insufficiency as a level between 20 and 29.9 ng/mL, and sufficiency as a level of at least 30 ng/mL.

Serum vitamin D levels were slightly lower among atopic patients, compared with those without atopy, but the difference did not reach statistical significance (about 25 ng/mL vs. about 38 ng/mL; P greater than .05). “We also did not find an association between AD severity and vitamin D level,” Ms. Darji reported. Instead, race and body mass index were the most significant predictors of vitamin D deficiency, probably because these factors directly affect cutaneous photo-induced vitamin D synthesis and the sequestration of fat-soluble vitamins in adipose tissue, she said.

Using the standard definitions, more than 50% of black patients were vitamin D deficient, while less than 30% had sufficient vitamin D levels. In contrast, about 25% of white patients were vitamin D deficient, while nearly 40% had sufficient vitamin D levels (P less than .0001 for proportions of deficiency by race). Furthermore, only about 10% of obese children (those who exceeded the 99th percentile of BMI for age) had sufficient vitamin D levels, compared with more than 40% of underweight children and about 30% of normal-weight children (P less than .00001).

Since vitamin D deficiency was more common among black and obese patients, “maybe they could benefit from a different cut-off value than the standard 30 ng per mL that we used,” Ms. Darji said. “The question is, do they really require these supplements? It may be beneficial to look at the unique characteristics of each patient before supplementing, because the risks of supplementation are considerable in terms of bone health and cardiovascular disease.”

Vitamin D levels did not vary significantly by gender or by month or season measured, Ms. Darji noted. She reported no funding sources and had no disclosures.

SCOTTSDALE, ARIZ. – Serum vitamin D level was not significantly associated with atopic dermatitis or disease severity in a single-center study of more than 600 children and adolescents.

However, “we did observe a strong correlation between average serum vitamin D levels and skin type, as well as body mass index,” said Kavita Darji, a medical student at Saint Louis (Mo.) University, who presented the findings in a poster at the annual meeting of the Society for Investigative Dermatology. Those findings challenge the logic of following universal definitions of vitamin D deficiency, especially given the phenotypic heterogeneity of patients in the United States, she added in an interview.

Amy Karon/Frontline Medical News

Serum vitamin D testing is one of most common laboratory assays in this country, but clinicians still debate the risks and benefits of supplementing children and adolescents who test below the Endocrine Society’s threshold for sufficiency (30.0 ng/mL).

To identify factors affecting vitamin D levels, Ms. Darji and her associates reviewed electronic medical charts for patients under age 22 years at Saint Louis University medical centers between 2009 and 2014. The cohort of 655 patients was primarily white (64%) or black (29%), and was nearly equally balanced by gender; their average age was 10 years. The researchers analyzed only the first vitamin D serum measurement for each patient, and defined deficiency as a level under 20 ng/mL, insufficiency as a level between 20 and 29.9 ng/mL, and sufficiency as a level of at least 30 ng/mL.

Serum vitamin D levels were slightly lower among atopic patients, compared with those without atopy, but the difference did not reach statistical significance (about 25 ng/mL vs. about 38 ng/mL; P greater than .05). “We also did not find an association between AD severity and vitamin D level,” Ms. Darji reported. Instead, race and body mass index were the most significant predictors of vitamin D deficiency, probably because these factors directly affect cutaneous photo-induced vitamin D synthesis and the sequestration of fat-soluble vitamins in adipose tissue, she said.

Using the standard definitions, more than 50% of black patients were vitamin D deficient, while less than 30% had sufficient vitamin D levels. In contrast, about 25% of white patients were vitamin D deficient, while nearly 40% had sufficient vitamin D levels (P less than .0001 for proportions of deficiency by race). Furthermore, only about 10% of obese children (those who exceeded the 99th percentile of BMI for age) had sufficient vitamin D levels, compared with more than 40% of underweight children and about 30% of normal-weight children (P less than .00001).

Since vitamin D deficiency was more common among black and obese patients, “maybe they could benefit from a different cut-off value than the standard 30 ng per mL that we used,” Ms. Darji said. “The question is, do they really require these supplements? It may be beneficial to look at the unique characteristics of each patient before supplementing, because the risks of supplementation are considerable in terms of bone health and cardiovascular disease.”

Vitamin D levels did not vary significantly by gender or by month or season measured, Ms. Darji noted. She reported no funding sources and had no disclosures.

SCOTTSDALE, ARIZ. – Serum vitamin D level was not significantly associated with atopic dermatitis or disease severity in a single-center study of more than 600 children and adolescents.

However, “we did observe a strong correlation between average serum vitamin D levels and skin type, as well as body mass index,” said Kavita Darji, a medical student at Saint Louis (Mo.) University, who presented the findings in a poster at the annual meeting of the Society for Investigative Dermatology. Those findings challenge the logic of following universal definitions of vitamin D deficiency, especially given the phenotypic heterogeneity of patients in the United States, she added in an interview.

Amy Karon/Frontline Medical News

Serum vitamin D testing is one of most common laboratory assays in this country, but clinicians still debate the risks and benefits of supplementing children and adolescents who test below the Endocrine Society’s threshold for sufficiency (30.0 ng/mL).

To identify factors affecting vitamin D levels, Ms. Darji and her associates reviewed electronic medical charts for patients under age 22 years at Saint Louis University medical centers between 2009 and 2014. The cohort of 655 patients was primarily white (64%) or black (29%), and was nearly equally balanced by gender; their average age was 10 years. The researchers analyzed only the first vitamin D serum measurement for each patient, and defined deficiency as a level under 20 ng/mL, insufficiency as a level between 20 and 29.9 ng/mL, and sufficiency as a level of at least 30 ng/mL.

Serum vitamin D levels were slightly lower among atopic patients, compared with those without atopy, but the difference did not reach statistical significance (about 25 ng/mL vs. about 38 ng/mL; P greater than .05). “We also did not find an association between AD severity and vitamin D level,” Ms. Darji reported. Instead, race and body mass index were the most significant predictors of vitamin D deficiency, probably because these factors directly affect cutaneous photo-induced vitamin D synthesis and the sequestration of fat-soluble vitamins in adipose tissue, she said.

Using the standard definitions, more than 50% of black patients were vitamin D deficient, while less than 30% had sufficient vitamin D levels. In contrast, about 25% of white patients were vitamin D deficient, while nearly 40% had sufficient vitamin D levels (P less than .0001 for proportions of deficiency by race). Furthermore, only about 10% of obese children (those who exceeded the 99th percentile of BMI for age) had sufficient vitamin D levels, compared with more than 40% of underweight children and about 30% of normal-weight children (P less than .00001).

Since vitamin D deficiency was more common among black and obese patients, “maybe they could benefit from a different cut-off value than the standard 30 ng per mL that we used,” Ms. Darji said. “The question is, do they really require these supplements? It may be beneficial to look at the unique characteristics of each patient before supplementing, because the risks of supplementation are considerable in terms of bone health and cardiovascular disease.”

Vitamin D levels did not vary significantly by gender or by month or season measured, Ms. Darji noted. She reported no funding sources and had no disclosures.

While most Americans were still reacting in horror and disbelief to news of a mass shooting at the Pulse nightclub in Orlando, Florida in the early morning hours of June 12, 2016, the thoughts of most emergency physicians (EPs) were probably focused on the ongoing efforts to save as many victims as possible: What was the closest Level 1 trauma center, and how deep was the ED staffing there that night? Was there a need for additional resources, and perhaps even, could they get there in time to help? In this issue of Emergency Medicine (EM), Residency Program Director Salvatore Silvestri, MD, and his emergency medicine colleagues masterfully recount events from that night as they unfolded, both at the scene and two blocks away at the Orlando Regional Medical Center (ORMC) ED, in the minutes and hours following the first reported shootings.

Being prepared for a mass-casualty incident (MCI) is an extraordinarily expensive requirement of a hospital: It must acquire and maintain adequate resources and communication capabilities; periodically perform unannounced drills that disrupt other hospital activities; and ensure that all EPs and staff are not only able to perform their own day-to-day roles as attending physicians, residents, nurses, etc, but are also capable of taking on even greater responsibilities during an MCI—depending on the day and time it occurs. As you will read in the pages that follow, in the early morning hours of June 12, many of the practiced exercises and rehearsed procedures proved useful, even life-saving, while others had to be discarded or ignored in favor of improvised solutions to rapidly transport and treat the large number of victims with unanticipated needs, under unique conditions. 

In any MCI, saving the largest number of victims invariably depends on rapidly instituting some deviations from standard operating procedures (SOPs) and standards of care (SOCs). As described by the ORMC EP authors, “...law enforcement vehicles and ambulances would make the two-block drive from the scene to ORMC carrying as many patients as they safely could, and return immediately after offload….minimal interventions were performed and unlike standard procedure, EMS could offer no prearrival report to the hospital.”

Deviations from SOPs and SOCs during an MCI are not confined to prehospital care, but often extend into the ED and beyond. Most difficult for an EP participating in an MCI is the moment of realization that the sheer number of seriously injured and dying patients arriving en masse mandates a change from “ED triage” to “battlefield triage.” As Dr Ponder recalled, “One of the first few patients I saw was pulse­less, and as I went to start chest compressions, I was stopped by a trauma surgeon who said, ‘He’s gone, focus on the ones we can help.’”

In EDs, dying patients are attended to first with extensive staff and resources, while, as a result, less seriously ill patients must sometimes wait longer for care. The opposite is true on the battlefield, where near-death victims of lethal injuries are provided only with comfort care, at most, in order to save those who have a chance of surviving their extensive or serious injuries. 

For hospitals and staff, the costs incurred by disaster preparedness are great and invariably exceed government funding provided for these efforts, but how much greater would be the human toll from an MCI without such efforts? All EPs should be proud of what our colleagues at ORMC accomplished on June 12. Though most EPs may never have to deal directly with an MCI, the Orlando nightclub shooting incident was only one of the latest MCIs, certainly not one of the last.

Previous editorials on MCIs may be found in EM September 2006 (9/11), June 2011 (first responders), September 2011 (9/11), November 2011 (surge capacity), and September 2012 (surge capacity/Hurricane Sandy).

While most Americans were still reacting in horror and disbelief to news of a mass shooting at the Pulse nightclub in Orlando, Florida in the early morning hours of June 12, 2016, the thoughts of most emergency physicians (EPs) were probably focused on the ongoing efforts to save as many victims as possible: What was the closest Level 1 trauma center, and how deep was the ED staffing there that night? Was there a need for additional resources, and perhaps even, could they get there in time to help? In this issue of Emergency Medicine (EM), Residency Program Director Salvatore Silvestri, MD, and his emergency medicine colleagues masterfully recount events from that night as they unfolded, both at the scene and two blocks away at the Orlando Regional Medical Center (ORMC) ED, in the minutes and hours following the first reported shootings.

Being prepared for a mass-casualty incident (MCI) is an extraordinarily expensive requirement of a hospital: It must acquire and maintain adequate resources and communication capabilities; periodically perform unannounced drills that disrupt other hospital activities; and ensure that all EPs and staff are not only able to perform their own day-to-day roles as attending physicians, residents, nurses, etc, but are also capable of taking on even greater responsibilities during an MCI—depending on the day and time it occurs. As you will read in the pages that follow, in the early morning hours of June 12, many of the practiced exercises and rehearsed procedures proved useful, even life-saving, while others had to be discarded or ignored in favor of improvised solutions to rapidly transport and treat the large number of victims with unanticipated needs, under unique conditions. 

In any MCI, saving the largest number of victims invariably depends on rapidly instituting some deviations from standard operating procedures (SOPs) and standards of care (SOCs). As described by the ORMC EP authors, “...law enforcement vehicles and ambulances would make the two-block drive from the scene to ORMC carrying as many patients as they safely could, and return immediately after offload….minimal interventions were performed and unlike standard procedure, EMS could offer no prearrival report to the hospital.”

Deviations from SOPs and SOCs during an MCI are not confined to prehospital care, but often extend into the ED and beyond. Most difficult for an EP participating in an MCI is the moment of realization that the sheer number of seriously injured and dying patients arriving en masse mandates a change from “ED triage” to “battlefield triage.” As Dr Ponder recalled, “One of the first few patients I saw was pulse­less, and as I went to start chest compressions, I was stopped by a trauma surgeon who said, ‘He’s gone, focus on the ones we can help.’”

In EDs, dying patients are attended to first with extensive staff and resources, while, as a result, less seriously ill patients must sometimes wait longer for care. The opposite is true on the battlefield, where near-death victims of lethal injuries are provided only with comfort care, at most, in order to save those who have a chance of surviving their extensive or serious injuries. 

For hospitals and staff, the costs incurred by disaster preparedness are great and invariably exceed government funding provided for these efforts, but how much greater would be the human toll from an MCI without such efforts? All EPs should be proud of what our colleagues at ORMC accomplished on June 12. Though most EPs may never have to deal directly with an MCI, the Orlando nightclub shooting incident was only one of the latest MCIs, certainly not one of the last.

Previous editorials on MCIs may be found in EM September 2006 (9/11), June 2011 (first responders), September 2011 (9/11), November 2011 (surge capacity), and September 2012 (surge capacity/Hurricane Sandy).

While most Americans were still reacting in horror and disbelief to news of a mass shooting at the Pulse nightclub in Orlando, Florida in the early morning hours of June 12, 2016, the thoughts of most emergency physicians (EPs) were probably focused on the ongoing efforts to save as many victims as possible: What was the closest Level 1 trauma center, and how deep was the ED staffing there that night? Was there a need for additional resources, and perhaps even, could they get there in time to help? In this issue of Emergency Medicine (EM), Residency Program Director Salvatore Silvestri, MD, and his emergency medicine colleagues masterfully recount events from that night as they unfolded, both at the scene and two blocks away at the Orlando Regional Medical Center (ORMC) ED, in the minutes and hours following the first reported shootings.

Being prepared for a mass-casualty incident (MCI) is an extraordinarily expensive requirement of a hospital: It must acquire and maintain adequate resources and communication capabilities; periodically perform unannounced drills that disrupt other hospital activities; and ensure that all EPs and staff are not only able to perform their own day-to-day roles as attending physicians, residents, nurses, etc, but are also capable of taking on even greater responsibilities during an MCI—depending on the day and time it occurs. As you will read in the pages that follow, in the early morning hours of June 12, many of the practiced exercises and rehearsed procedures proved useful, even life-saving, while others had to be discarded or ignored in favor of improvised solutions to rapidly transport and treat the large number of victims with unanticipated needs, under unique conditions. 

In any MCI, saving the largest number of victims invariably depends on rapidly instituting some deviations from standard operating procedures (SOPs) and standards of care (SOCs). As described by the ORMC EP authors, “...law enforcement vehicles and ambulances would make the two-block drive from the scene to ORMC carrying as many patients as they safely could, and return immediately after offload….minimal interventions were performed and unlike standard procedure, EMS could offer no prearrival report to the hospital.”

Deviations from SOPs and SOCs during an MCI are not confined to prehospital care, but often extend into the ED and beyond. Most difficult for an EP participating in an MCI is the moment of realization that the sheer number of seriously injured and dying patients arriving en masse mandates a change from “ED triage” to “battlefield triage.” As Dr Ponder recalled, “One of the first few patients I saw was pulse­less, and as I went to start chest compressions, I was stopped by a trauma surgeon who said, ‘He’s gone, focus on the ones we can help.’”

In EDs, dying patients are attended to first with extensive staff and resources, while, as a result, less seriously ill patients must sometimes wait longer for care. The opposite is true on the battlefield, where near-death victims of lethal injuries are provided only with comfort care, at most, in order to save those who have a chance of surviving their extensive or serious injuries. 

For hospitals and staff, the costs incurred by disaster preparedness are great and invariably exceed government funding provided for these efforts, but how much greater would be the human toll from an MCI without such efforts? All EPs should be proud of what our colleagues at ORMC accomplished on June 12. Though most EPs may never have to deal directly with an MCI, the Orlando nightclub shooting incident was only one of the latest MCIs, certainly not one of the last.

Previous editorials on MCIs may be found in EM September 2006 (9/11), June 2011 (first responders), September 2011 (9/11), November 2011 (surge capacity), and September 2012 (surge capacity/Hurricane Sandy).