Medicolegal Issues

Case

While placing a central line, you sustain a needlestick. You’ve washed the area thoroughly with soap and water, but you are concerned about contracting a bloodborne pathogen. What is the risk of contracting such a pathogen, and what can be done to reduce this risk?

Overview

Needlestick injuries are a common occupational hazard in the hospital setting. According to the International Health Care Worker Safety Center (IHCWSC), approximately 295,000 hospital-based healthcare workers experience occupational percutaneous injuries annually. In 1991, Mangione et al surveyed internal-medicine house staff and found an annual incidence of 674 needlestick injuries per 1,000 participants.¹ Other retrospective data estimate this risk to be as high as 839 per 1,000 healthcare workers annually.² Evidence from the Centers for Disease Control and Prevention (CDC) in 2004 suggests that because these are only self-reported injuries, the annual incidence of such injuries is in fact much higher than the current estimates suggest.^2,3,4

click for large version

More than 20 bloodborne pathogens (see Table 1, right) might be transmitted from contaminated needles or sharps, including human immunodeficiency virus (HIV), hepatitis B virus (HBV), and hepatitis C virus (HCV). A quick and appropriate response to a needlestick injury can greatly decrease the risk of disease transmission following an occupational exposure to potentially infectious materials.

Review of the Data

After any needlestick injury, an affected healthcare worker should wash the area with soap and water immediately. There is no contraindication to using antiseptic solutions, but there is also no evidence to suggest that this reduces the rates of disease transmission.

As decisions for post-exposure prophylaxis often need to be made within hours, a healthcare worker should seek care in the facility areas responsible for managing occupational exposures. Healthcare providers should always be encouraged and supported to report all sharps-related injuries to such departments.

The source patient should be identified and evaluated for potentially transmissible diseases, including HIV, HBV, and HCV. If indicated, the source patient should then undergo appropriate serological testing, and any indicated antiviral prophylaxis should be initiated (see Table 2, p. 19).

Risk of Seroconversion

For all bloodborne pathogens, a needlestick injury carries a greater risk for transmission than other occupational exposures (e.g. mucous membrane exposure). If a needlestick injury occurs in the setting of an infected patient source, the risk of disease transmission varies for HIV, HBV, and HCV (see Table 3, p. 19). In general, risk for seroconversion is increased with a deep injury, an injury with a device visibly contaminated with the source patient’s blood, or an injury involving a needle placed in the source patient’s artery or vein.^3,5,6

Human immunodeficiency virus. Contracting HIV after needlestick injury is rare. From 1981 to 2006, the CDC documented only 57 cases of HIV/AIDS in healthcare workers following occupational exposure and identified an additional “possible” 140 cases post-exposure.5,6 Of the 57 documented cases, 48 sustained a percutaneous injury.

Following needlestick injury involving a known HIV-positive source, the one-year risk of seroconversion has been estimated to be 0.3%.5,6 In 1997, Cardo and colleagues identified four factors associated with increased risk for seroconversion after a needlestick/sharps injury from a known positive-HIV source:

• Deep injury;
• Injury with a device visibly contaminated with the source patient’s blood;
• A procedure involving a needle placed in the source patient’s artery or vein; and
• Exposure to a source patient who died of AIDS in the two months following the occupational exposure.⁵

Hepatitis B virus. Wides-pread immunization of healthcare workers has led to a dramatic decline in occupationally acquired HBV. The CDC estimated that in 1985, approximately 12,500 new HBV infections occurred in healthcare workers.³ This estimate plummeted to approximately 500 new occupationally acquired HBV infections in 1997.³

Despite this, hospital-based healthcare personnel remain at risk for HBV transmission after a needlestick injury from a known positive patient source. Few studies have evaluated the occupational risk of HBV transmission after a needlestick injury. Buergler et al reported that following a needlestick injury involving a known HBV-positive source, the one-year risk of seroconversion was 0.76% to 7.35% for nonimmunized surgeons, and 0.23% to 2.28% for nonimmunized anesthesiologists.⁷

In the absence of post-exposure prophylaxis, an exposed healthcare worker has a 6% to 30% risk of becoming infected with HBV.^3,8 The risk is greatest if the patient source is known to be hepatitis B e antigen-positive, a marker for greater disease infectivity. When given within one week of injury, post-exposure prophylaxis (PEP) with multiple doses of hepatitis B immune globulin (HBIG) provides an estimated 75% protection from transmission.

Healthcare workers who have received the hepatitis B vaccine and developed immunity have virtually no risk for infection.^6,7

Hepatitis C virus. Prospective evaluation has demonstrated that the average risk of HCV transmission after percutaneous exposure to a known HCV-positive source is from 0% to 7%.3 The Italian Study Group on Occupational Risk of HIV and Other Bloodborne Infections evaluated HCV seroconversion within six months of a reported exposure with enzyme immunoassay and immunoblot assay. In this study, the authors found a seroconversion rate of 1.2%.⁹

Further, they suggested that HCV seroconversion only occurred from hollow-bore needles, as no seroconversions were noted in healthcare workers who sustained injuries with solid sharp objects.

Post-Exposure Management

The CDC does not recommend prophylaxis when source fluids make contact with intact skin. However, if a percutaneous occupational exposure has occurred, PEPs exist for HIV and HBV but not for HCV.^3,6 If a source patient’s HIV, HBV, and HCV statuses are unknown, occupational-health personnel can interview the patient to evaluate his or her risks and initiate testing. Specific information about the time and nature of exposure should be documented.

When testing is indicated, it should be done following institutional and state-specific exposure-control policies and informed consent guidelines. In all situations, the decision to begin antiviral PEP should be carefully considered, weighing benefits of PEP versus the risks and toxicity of treatment.

Human immunodeficiency virus. If a source patient is known to be HIV-positive, has a positive rapid HIV test, or if HIV status cannot be quickly determined, PEP is indicated. Healthcare providers should be aware of rare cases in which the source patient initially tested HIV-seronegative but was subsequently found to have primary HIV infection.

Per 2004 CDC recommendations, PEP is indicated for all healthcare workers who sustain a percuanteous injury from a known HIV-positive source.^3,8 For a less severe injury (e.g. solid needle or superficial injury), PEP with either a basic two-drug or three-drug regimen is indicated, depending on the source patient’s viral load.^3,5,6,8

If the source patient has unknown HIV status, two-drug PEP is indicated based on the source patient’s HIV risk factors. In such patients, rapid HIV testing also is indicated to aid in determining the need for PEP. When the source HIV status is unknown, PEP is indicated in settings where exposure to HIV-infected persons is likely.

If PEP is indicated, it should be started as quickly as possible. The 2005 U.S. Public Health Service Recommendations for PEP recommend initiating two nucleosides for low-risk exposures and two nucleosides plus a boosted protease inhibitor for high-risk exposures.

Examples of commonly used dual nucleoside regimens are Zidovudine plus Lamivudine (coformulated as Combivir) or Tenofovir plus Emtricitabine (coformulated as Truvada). Current recommendations indicate that PEP should be continued for four weeks, with concurrent clinical and laboratory evaluation for drug toxicity.

Hepatitis B virus. Numerous prospective studies have evaluated the post-exposure effectiveness of HBIG. When administered within 24 hours of exposure, HBIG might offer immediate passive protection against HBV infection. Additionally, if initiated within one week of percutaneous injury with a known HBV-positive source, multiple doses of HGIB provide an estimated 75% protection from transmission.

Although the combination of HBIG and the hepatitis vaccine B series has not been evaluated as PEP in the occupational setting, evidence in the perinatal setting suggests this regimen is more effective than HBIG alone.^3,6,8

Hepatitis C virus. No PEP exists for HCV, and current recommendations for post-exposure management focus on early identification and treatment of chronic disease. There are insufficient data for a treatment recommendation for patients with acute HCV infection with no evidence of disease; the appropriate dosing of such a regimen is unknown. Further, evidence suggests that treatment started early in the course of chronic infection could be just as effective and might eliminate the need to treat persons whose infection will spontaneously resolve.⁷

click for large version

Back to the Case

Your needlestick occurred while using a hollow-bore needle to cannulate a source patient’s vein, placing you at higher risk for seroconversion. You immediately reported the exposure to the department of occupational health at your hospital. The source patient’s HIV, HBV, and HCV serological statuses were tested, and the patient was found to be HBV-positive. After appropriate counseling, you decide to receive HGIB prophylaxis to reduce your chances of becoming infected with HBV infection.

Bottom Line

Healthcare workers who suffer occupational needlestick injuries require immediate identification and attention to avoid transmission of such infectious diseases as HIV, HBV, and HCV. Source patients should undergo rapid serological testing to determine appropriate PEP. TH

Dr. Zehnder is a hospitalist in the Section of Hospital Medicine at the University of Colorado Denver.

References

1. Mangione CM, Gerberding JL, Cummings, SR. Occupational exposure to HIV: Frequency and rates of underreporting of percutaneous and mucocutaneous exposures by medical housestaff. Am J Med. 1991;90(1):85-90.
2. Lee JM, Botteman MF, Nicklasson L, et al. Needlestick injury in acute care nurses caring for patients with diabetes mellitus: a retrospective study. Curr Med Res Opinion. 2005;21(5):741-747.
3. Workbook for designing, implementing, and evaluating a sharps injury prevention program. Centers for Disease Control and Prevention website. Available at: www.cdc.gov/sharpssafety/pdf/WorkbookComplete.pdf. Accessed Sept. 13, 2010.
4. Lee JM, Botteman MF, Xanthakos N, Nicklasson L. Needlestick injuries in the United States. Epidemiologic, economic, and quality of life issues. AAOHN J. 2005;53(3):117-133.
5. Cardo DM, Culver DH, Ciesielski CA, et al. A case-control study of HIV seroconversion in health care workers after percutaneous exposure. Centers for Disease Control and Prevention Needlestick Surveillance Group. N Engl J Med. 1997;337(21):1485-1490.
6. Exposure to blood: What healthcare personnel need to know. CDC website. Available at: www.cdc.gov/ncidod /dhqp/pdf/bbp/Exp_to_Blood.pdf. Accessed Aug. 31, 2010.
7. Buergler JM, Kim R, Thisted RA, Cohn SJ, Lichtor JL, Roizen MF. Risk of human immunodeficiency virus in surgeons, anesthesiologists, and medical students. Anesth Analg. 1992;75(1):118-124.
8. Updated U.S. Public Health Service guidelines for the management of occupational exposures to HBV, HCV, and HIV and recommendations for postexposure prophylaxis. CDC website. Available at: www.cdc.gov/mmwr/preview/mmwrhtml/rr5011a1.htm. Accessed Aug. 31, 2010.
9. Puro V, Petrosillo N, Ippolito G. Risk of hepatitis C seroconversion after occupational exposure in health care workers. Italian Study Group on Occupational Risk of HIV and Other Bloodborne Infections. Am J Infect Control. 1995;23(5):273-277.

Case

While placing a central line, you sustain a needlestick. You’ve washed the area thoroughly with soap and water, but you are concerned about contracting a bloodborne pathogen. What is the risk of contracting such a pathogen, and what can be done to reduce this risk?

Overview

Needlestick injuries are a common occupational hazard in the hospital setting. According to the International Health Care Worker Safety Center (IHCWSC), approximately 295,000 hospital-based healthcare workers experience occupational percutaneous injuries annually. In 1991, Mangione et al surveyed internal-medicine house staff and found an annual incidence of 674 needlestick injuries per 1,000 participants.¹ Other retrospective data estimate this risk to be as high as 839 per 1,000 healthcare workers annually.² Evidence from the Centers for Disease Control and Prevention (CDC) in 2004 suggests that because these are only self-reported injuries, the annual incidence of such injuries is in fact much higher than the current estimates suggest.^2,3,4

click for large version

More than 20 bloodborne pathogens (see Table 1, right) might be transmitted from contaminated needles or sharps, including human immunodeficiency virus (HIV), hepatitis B virus (HBV), and hepatitis C virus (HCV). A quick and appropriate response to a needlestick injury can greatly decrease the risk of disease transmission following an occupational exposure to potentially infectious materials.

Review of the Data

After any needlestick injury, an affected healthcare worker should wash the area with soap and water immediately. There is no contraindication to using antiseptic solutions, but there is also no evidence to suggest that this reduces the rates of disease transmission.

As decisions for post-exposure prophylaxis often need to be made within hours, a healthcare worker should seek care in the facility areas responsible for managing occupational exposures. Healthcare providers should always be encouraged and supported to report all sharps-related injuries to such departments.

The source patient should be identified and evaluated for potentially transmissible diseases, including HIV, HBV, and HCV. If indicated, the source patient should then undergo appropriate serological testing, and any indicated antiviral prophylaxis should be initiated (see Table 2, p. 19).

Risk of Seroconversion

For all bloodborne pathogens, a needlestick injury carries a greater risk for transmission than other occupational exposures (e.g. mucous membrane exposure). If a needlestick injury occurs in the setting of an infected patient source, the risk of disease transmission varies for HIV, HBV, and HCV (see Table 3, p. 19). In general, risk for seroconversion is increased with a deep injury, an injury with a device visibly contaminated with the source patient’s blood, or an injury involving a needle placed in the source patient’s artery or vein.^3,5,6

Human immunodeficiency virus. Contracting HIV after needlestick injury is rare. From 1981 to 2006, the CDC documented only 57 cases of HIV/AIDS in healthcare workers following occupational exposure and identified an additional “possible” 140 cases post-exposure.5,6 Of the 57 documented cases, 48 sustained a percutaneous injury.

Following needlestick injury involving a known HIV-positive source, the one-year risk of seroconversion has been estimated to be 0.3%.5,6 In 1997, Cardo and colleagues identified four factors associated with increased risk for seroconversion after a needlestick/sharps injury from a known positive-HIV source:

• Deep injury;
• Injury with a device visibly contaminated with the source patient’s blood;
• A procedure involving a needle placed in the source patient’s artery or vein; and
• Exposure to a source patient who died of AIDS in the two months following the occupational exposure.⁵

Hepatitis B virus. Wides-pread immunization of healthcare workers has led to a dramatic decline in occupationally acquired HBV. The CDC estimated that in 1985, approximately 12,500 new HBV infections occurred in healthcare workers.³ This estimate plummeted to approximately 500 new occupationally acquired HBV infections in 1997.³

Despite this, hospital-based healthcare personnel remain at risk for HBV transmission after a needlestick injury from a known positive patient source. Few studies have evaluated the occupational risk of HBV transmission after a needlestick injury. Buergler et al reported that following a needlestick injury involving a known HBV-positive source, the one-year risk of seroconversion was 0.76% to 7.35% for nonimmunized surgeons, and 0.23% to 2.28% for nonimmunized anesthesiologists.⁷

In the absence of post-exposure prophylaxis, an exposed healthcare worker has a 6% to 30% risk of becoming infected with HBV.^3,8 The risk is greatest if the patient source is known to be hepatitis B e antigen-positive, a marker for greater disease infectivity. When given within one week of injury, post-exposure prophylaxis (PEP) with multiple doses of hepatitis B immune globulin (HBIG) provides an estimated 75% protection from transmission.

Healthcare workers who have received the hepatitis B vaccine and developed immunity have virtually no risk for infection.^6,7

Hepatitis C virus. Prospective evaluation has demonstrated that the average risk of HCV transmission after percutaneous exposure to a known HCV-positive source is from 0% to 7%.3 The Italian Study Group on Occupational Risk of HIV and Other Bloodborne Infections evaluated HCV seroconversion within six months of a reported exposure with enzyme immunoassay and immunoblot assay. In this study, the authors found a seroconversion rate of 1.2%.⁹

Further, they suggested that HCV seroconversion only occurred from hollow-bore needles, as no seroconversions were noted in healthcare workers who sustained injuries with solid sharp objects.

Post-Exposure Management

The CDC does not recommend prophylaxis when source fluids make contact with intact skin. However, if a percutaneous occupational exposure has occurred, PEPs exist for HIV and HBV but not for HCV.^3,6 If a source patient’s HIV, HBV, and HCV statuses are unknown, occupational-health personnel can interview the patient to evaluate his or her risks and initiate testing. Specific information about the time and nature of exposure should be documented.

When testing is indicated, it should be done following institutional and state-specific exposure-control policies and informed consent guidelines. In all situations, the decision to begin antiviral PEP should be carefully considered, weighing benefits of PEP versus the risks and toxicity of treatment.

Human immunodeficiency virus. If a source patient is known to be HIV-positive, has a positive rapid HIV test, or if HIV status cannot be quickly determined, PEP is indicated. Healthcare providers should be aware of rare cases in which the source patient initially tested HIV-seronegative but was subsequently found to have primary HIV infection.

Per 2004 CDC recommendations, PEP is indicated for all healthcare workers who sustain a percuanteous injury from a known HIV-positive source.^3,8 For a less severe injury (e.g. solid needle or superficial injury), PEP with either a basic two-drug or three-drug regimen is indicated, depending on the source patient’s viral load.^3,5,6,8

If the source patient has unknown HIV status, two-drug PEP is indicated based on the source patient’s HIV risk factors. In such patients, rapid HIV testing also is indicated to aid in determining the need for PEP. When the source HIV status is unknown, PEP is indicated in settings where exposure to HIV-infected persons is likely.

If PEP is indicated, it should be started as quickly as possible. The 2005 U.S. Public Health Service Recommendations for PEP recommend initiating two nucleosides for low-risk exposures and two nucleosides plus a boosted protease inhibitor for high-risk exposures.

Examples of commonly used dual nucleoside regimens are Zidovudine plus Lamivudine (coformulated as Combivir) or Tenofovir plus Emtricitabine (coformulated as Truvada). Current recommendations indicate that PEP should be continued for four weeks, with concurrent clinical and laboratory evaluation for drug toxicity.

Hepatitis B virus. Numerous prospective studies have evaluated the post-exposure effectiveness of HBIG. When administered within 24 hours of exposure, HBIG might offer immediate passive protection against HBV infection. Additionally, if initiated within one week of percutaneous injury with a known HBV-positive source, multiple doses of HGIB provide an estimated 75% protection from transmission.

Although the combination of HBIG and the hepatitis vaccine B series has not been evaluated as PEP in the occupational setting, evidence in the perinatal setting suggests this regimen is more effective than HBIG alone.^3,6,8

Hepatitis C virus. No PEP exists for HCV, and current recommendations for post-exposure management focus on early identification and treatment of chronic disease. There are insufficient data for a treatment recommendation for patients with acute HCV infection with no evidence of disease; the appropriate dosing of such a regimen is unknown. Further, evidence suggests that treatment started early in the course of chronic infection could be just as effective and might eliminate the need to treat persons whose infection will spontaneously resolve.⁷

click for large version

Back to the Case

Your needlestick occurred while using a hollow-bore needle to cannulate a source patient’s vein, placing you at higher risk for seroconversion. You immediately reported the exposure to the department of occupational health at your hospital. The source patient’s HIV, HBV, and HCV serological statuses were tested, and the patient was found to be HBV-positive. After appropriate counseling, you decide to receive HGIB prophylaxis to reduce your chances of becoming infected with HBV infection.

Bottom Line

Healthcare workers who suffer occupational needlestick injuries require immediate identification and attention to avoid transmission of such infectious diseases as HIV, HBV, and HCV. Source patients should undergo rapid serological testing to determine appropriate PEP. TH

Dr. Zehnder is a hospitalist in the Section of Hospital Medicine at the University of Colorado Denver.

References

1. Mangione CM, Gerberding JL, Cummings, SR. Occupational exposure to HIV: Frequency and rates of underreporting of percutaneous and mucocutaneous exposures by medical housestaff. Am J Med. 1991;90(1):85-90.
2. Lee JM, Botteman MF, Nicklasson L, et al. Needlestick injury in acute care nurses caring for patients with diabetes mellitus: a retrospective study. Curr Med Res Opinion. 2005;21(5):741-747.
3. Workbook for designing, implementing, and evaluating a sharps injury prevention program. Centers for Disease Control and Prevention website. Available at: www.cdc.gov/sharpssafety/pdf/WorkbookComplete.pdf. Accessed Sept. 13, 2010.
4. Lee JM, Botteman MF, Xanthakos N, Nicklasson L. Needlestick injuries in the United States. Epidemiologic, economic, and quality of life issues. AAOHN J. 2005;53(3):117-133.
5. Cardo DM, Culver DH, Ciesielski CA, et al. A case-control study of HIV seroconversion in health care workers after percutaneous exposure. Centers for Disease Control and Prevention Needlestick Surveillance Group. N Engl J Med. 1997;337(21):1485-1490.
6. Exposure to blood: What healthcare personnel need to know. CDC website. Available at: www.cdc.gov/ncidod /dhqp/pdf/bbp/Exp_to_Blood.pdf. Accessed Aug. 31, 2010.
7. Buergler JM, Kim R, Thisted RA, Cohn SJ, Lichtor JL, Roizen MF. Risk of human immunodeficiency virus in surgeons, anesthesiologists, and medical students. Anesth Analg. 1992;75(1):118-124.
8. Updated U.S. Public Health Service guidelines for the management of occupational exposures to HBV, HCV, and HIV and recommendations for postexposure prophylaxis. CDC website. Available at: www.cdc.gov/mmwr/preview/mmwrhtml/rr5011a1.htm. Accessed Aug. 31, 2010.
9. Puro V, Petrosillo N, Ippolito G. Risk of hepatitis C seroconversion after occupational exposure in health care workers. Italian Study Group on Occupational Risk of HIV and Other Bloodborne Infections. Am J Infect Control. 1995;23(5):273-277.

Case

While placing a central line, you sustain a needlestick. You’ve washed the area thoroughly with soap and water, but you are concerned about contracting a bloodborne pathogen. What is the risk of contracting such a pathogen, and what can be done to reduce this risk?

Overview

Needlestick injuries are a common occupational hazard in the hospital setting. According to the International Health Care Worker Safety Center (IHCWSC), approximately 295,000 hospital-based healthcare workers experience occupational percutaneous injuries annually. In 1991, Mangione et al surveyed internal-medicine house staff and found an annual incidence of 674 needlestick injuries per 1,000 participants.¹ Other retrospective data estimate this risk to be as high as 839 per 1,000 healthcare workers annually.² Evidence from the Centers for Disease Control and Prevention (CDC) in 2004 suggests that because these are only self-reported injuries, the annual incidence of such injuries is in fact much higher than the current estimates suggest.^2,3,4

click for large version

More than 20 bloodborne pathogens (see Table 1, right) might be transmitted from contaminated needles or sharps, including human immunodeficiency virus (HIV), hepatitis B virus (HBV), and hepatitis C virus (HCV). A quick and appropriate response to a needlestick injury can greatly decrease the risk of disease transmission following an occupational exposure to potentially infectious materials.

Review of the Data

After any needlestick injury, an affected healthcare worker should wash the area with soap and water immediately. There is no contraindication to using antiseptic solutions, but there is also no evidence to suggest that this reduces the rates of disease transmission.

As decisions for post-exposure prophylaxis often need to be made within hours, a healthcare worker should seek care in the facility areas responsible for managing occupational exposures. Healthcare providers should always be encouraged and supported to report all sharps-related injuries to such departments.

The source patient should be identified and evaluated for potentially transmissible diseases, including HIV, HBV, and HCV. If indicated, the source patient should then undergo appropriate serological testing, and any indicated antiviral prophylaxis should be initiated (see Table 2, p. 19).

Risk of Seroconversion

For all bloodborne pathogens, a needlestick injury carries a greater risk for transmission than other occupational exposures (e.g. mucous membrane exposure). If a needlestick injury occurs in the setting of an infected patient source, the risk of disease transmission varies for HIV, HBV, and HCV (see Table 3, p. 19). In general, risk for seroconversion is increased with a deep injury, an injury with a device visibly contaminated with the source patient’s blood, or an injury involving a needle placed in the source patient’s artery or vein.^3,5,6

Human immunodeficiency virus. Contracting HIV after needlestick injury is rare. From 1981 to 2006, the CDC documented only 57 cases of HIV/AIDS in healthcare workers following occupational exposure and identified an additional “possible” 140 cases post-exposure.5,6 Of the 57 documented cases, 48 sustained a percutaneous injury.

Following needlestick injury involving a known HIV-positive source, the one-year risk of seroconversion has been estimated to be 0.3%.5,6 In 1997, Cardo and colleagues identified four factors associated with increased risk for seroconversion after a needlestick/sharps injury from a known positive-HIV source:

• Deep injury;
• Injury with a device visibly contaminated with the source patient’s blood;
• A procedure involving a needle placed in the source patient’s artery or vein; and
• Exposure to a source patient who died of AIDS in the two months following the occupational exposure.⁵

Hepatitis B virus. Wides-pread immunization of healthcare workers has led to a dramatic decline in occupationally acquired HBV. The CDC estimated that in 1985, approximately 12,500 new HBV infections occurred in healthcare workers.³ This estimate plummeted to approximately 500 new occupationally acquired HBV infections in 1997.³

Despite this, hospital-based healthcare personnel remain at risk for HBV transmission after a needlestick injury from a known positive patient source. Few studies have evaluated the occupational risk of HBV transmission after a needlestick injury. Buergler et al reported that following a needlestick injury involving a known HBV-positive source, the one-year risk of seroconversion was 0.76% to 7.35% for nonimmunized surgeons, and 0.23% to 2.28% for nonimmunized anesthesiologists.⁷

In the absence of post-exposure prophylaxis, an exposed healthcare worker has a 6% to 30% risk of becoming infected with HBV.^3,8 The risk is greatest if the patient source is known to be hepatitis B e antigen-positive, a marker for greater disease infectivity. When given within one week of injury, post-exposure prophylaxis (PEP) with multiple doses of hepatitis B immune globulin (HBIG) provides an estimated 75% protection from transmission.

Healthcare workers who have received the hepatitis B vaccine and developed immunity have virtually no risk for infection.^6,7

Hepatitis C virus. Prospective evaluation has demonstrated that the average risk of HCV transmission after percutaneous exposure to a known HCV-positive source is from 0% to 7%.3 The Italian Study Group on Occupational Risk of HIV and Other Bloodborne Infections evaluated HCV seroconversion within six months of a reported exposure with enzyme immunoassay and immunoblot assay. In this study, the authors found a seroconversion rate of 1.2%.⁹

Further, they suggested that HCV seroconversion only occurred from hollow-bore needles, as no seroconversions were noted in healthcare workers who sustained injuries with solid sharp objects.

Post-Exposure Management

The CDC does not recommend prophylaxis when source fluids make contact with intact skin. However, if a percutaneous occupational exposure has occurred, PEPs exist for HIV and HBV but not for HCV.^3,6 If a source patient’s HIV, HBV, and HCV statuses are unknown, occupational-health personnel can interview the patient to evaluate his or her risks and initiate testing. Specific information about the time and nature of exposure should be documented.

When testing is indicated, it should be done following institutional and state-specific exposure-control policies and informed consent guidelines. In all situations, the decision to begin antiviral PEP should be carefully considered, weighing benefits of PEP versus the risks and toxicity of treatment.

Human immunodeficiency virus. If a source patient is known to be HIV-positive, has a positive rapid HIV test, or if HIV status cannot be quickly determined, PEP is indicated. Healthcare providers should be aware of rare cases in which the source patient initially tested HIV-seronegative but was subsequently found to have primary HIV infection.

Per 2004 CDC recommendations, PEP is indicated for all healthcare workers who sustain a percuanteous injury from a known HIV-positive source.^3,8 For a less severe injury (e.g. solid needle or superficial injury), PEP with either a basic two-drug or three-drug regimen is indicated, depending on the source patient’s viral load.^3,5,6,8

If the source patient has unknown HIV status, two-drug PEP is indicated based on the source patient’s HIV risk factors. In such patients, rapid HIV testing also is indicated to aid in determining the need for PEP. When the source HIV status is unknown, PEP is indicated in settings where exposure to HIV-infected persons is likely.

If PEP is indicated, it should be started as quickly as possible. The 2005 U.S. Public Health Service Recommendations for PEP recommend initiating two nucleosides for low-risk exposures and two nucleosides plus a boosted protease inhibitor for high-risk exposures.

Examples of commonly used dual nucleoside regimens are Zidovudine plus Lamivudine (coformulated as Combivir) or Tenofovir plus Emtricitabine (coformulated as Truvada). Current recommendations indicate that PEP should be continued for four weeks, with concurrent clinical and laboratory evaluation for drug toxicity.

Hepatitis B virus. Numerous prospective studies have evaluated the post-exposure effectiveness of HBIG. When administered within 24 hours of exposure, HBIG might offer immediate passive protection against HBV infection. Additionally, if initiated within one week of percutaneous injury with a known HBV-positive source, multiple doses of HGIB provide an estimated 75% protection from transmission.

Although the combination of HBIG and the hepatitis vaccine B series has not been evaluated as PEP in the occupational setting, evidence in the perinatal setting suggests this regimen is more effective than HBIG alone.^3,6,8

Hepatitis C virus. No PEP exists for HCV, and current recommendations for post-exposure management focus on early identification and treatment of chronic disease. There are insufficient data for a treatment recommendation for patients with acute HCV infection with no evidence of disease; the appropriate dosing of such a regimen is unknown. Further, evidence suggests that treatment started early in the course of chronic infection could be just as effective and might eliminate the need to treat persons whose infection will spontaneously resolve.⁷

click for large version

Back to the Case

Your needlestick occurred while using a hollow-bore needle to cannulate a source patient’s vein, placing you at higher risk for seroconversion. You immediately reported the exposure to the department of occupational health at your hospital. The source patient’s HIV, HBV, and HCV serological statuses were tested, and the patient was found to be HBV-positive. After appropriate counseling, you decide to receive HGIB prophylaxis to reduce your chances of becoming infected with HBV infection.

Bottom Line

Healthcare workers who suffer occupational needlestick injuries require immediate identification and attention to avoid transmission of such infectious diseases as HIV, HBV, and HCV. Source patients should undergo rapid serological testing to determine appropriate PEP. TH

Dr. Zehnder is a hospitalist in the Section of Hospital Medicine at the University of Colorado Denver.

References

1. Mangione CM, Gerberding JL, Cummings, SR. Occupational exposure to HIV: Frequency and rates of underreporting of percutaneous and mucocutaneous exposures by medical housestaff. Am J Med. 1991;90(1):85-90.
2. Lee JM, Botteman MF, Nicklasson L, et al. Needlestick injury in acute care nurses caring for patients with diabetes mellitus: a retrospective study. Curr Med Res Opinion. 2005;21(5):741-747.
3. Workbook for designing, implementing, and evaluating a sharps injury prevention program. Centers for Disease Control and Prevention website. Available at: www.cdc.gov/sharpssafety/pdf/WorkbookComplete.pdf. Accessed Sept. 13, 2010.
4. Lee JM, Botteman MF, Xanthakos N, Nicklasson L. Needlestick injuries in the United States. Epidemiologic, economic, and quality of life issues. AAOHN J. 2005;53(3):117-133.
5. Cardo DM, Culver DH, Ciesielski CA, et al. A case-control study of HIV seroconversion in health care workers after percutaneous exposure. Centers for Disease Control and Prevention Needlestick Surveillance Group. N Engl J Med. 1997;337(21):1485-1490.
6. Exposure to blood: What healthcare personnel need to know. CDC website. Available at: www.cdc.gov/ncidod /dhqp/pdf/bbp/Exp_to_Blood.pdf. Accessed Aug. 31, 2010.
7. Buergler JM, Kim R, Thisted RA, Cohn SJ, Lichtor JL, Roizen MF. Risk of human immunodeficiency virus in surgeons, anesthesiologists, and medical students. Anesth Analg. 1992;75(1):118-124.
8. Updated U.S. Public Health Service guidelines for the management of occupational exposures to HBV, HCV, and HIV and recommendations for postexposure prophylaxis. CDC website. Available at: www.cdc.gov/mmwr/preview/mmwrhtml/rr5011a1.htm. Accessed Aug. 31, 2010.
9. Puro V, Petrosillo N, Ippolito G. Risk of hepatitis C seroconversion after occupational exposure in health care workers. Italian Study Group on Occupational Risk of HIV and Other Bloodborne Infections. Am J Infect Control. 1995;23(5):273-277.

Baseball, kick the can, Russian roulette—pick your game. Chances are good that it has worked its way into a metaphor to illustrate the infuriating, perplexing, and altogether frustrating inability of Congress to step up to the plate and pass a long-term fix to the broken sustainable growth rate (SGR) formula used to determine Medicare reimbursement rates.

On June 24, legislators avoided catastrophe by temporarily rescinding a 21.3% rate cut that went into effect June 1. The after-the-fact patch meant that some Medicare claims had to be reprocessed to recoup the full value, creating an administrative mess. The accompanying 2.2% rate increase expires Nov. 30. The reimbursement cut could reach nearly 30% next year unless Congress intervenes again.

“Obviously, there’s a lot of frustration around the issue, especially on the membership side,” says Ron Greeno, MD, FACP, SFHM, a member of SHM’s Public Policy and Leadership committees, and chief medical officer for Brentwood, Tenn.-based Cogent Healthcare. For hospitalists in many small private practices, he says, a major percentage of income comes from Medicare. “It’s a tremendous headache,” he says of the uncertainty. “It’s very hard to plan for. You’re trying to budget and you don’t know what the policy is going to be literally from week to week.”

The Blame Game

Despite the widespread sentiment among doctors that a permanent reimbursement rate fix should have been included in the healthcare reform legislation, skittishness over the price tag led legislators to drop it from the package. Based on last fall’s estimates, the total cost of a reform bill that scrapped the SGR would have ballooned by roughly $250 billion over 10 years, which would have threatened the bill’s passage.

But Congress has since been unable to pass a permanent fix as standalone legislation amid mounting concern over the national debt, and the price of inaction continues to rise. On April 30, the Congressional Budget Office (CBO) estimated that the cost of jettisoning the SGR formula and freezing rates at current levels had grown to $276 billion over 10 years.

Any serious consideration of lasting alternatives has now been pushed back to the lame-duck session, after the midterm elections. The can has been kicked down the road so many times, Dr. Greeno and others say, that most Congressional members have boot marks all over them. “So now you have a bigger problem at a more crucial time, when money is tighter than ever in a poor economy,” Dr. Greeno says. “And I just think it’s been a failure of our politicians.”

Other healthcare industry leaders have been just as critical. “Delaying the problem is not a solution,” said AMA President Cecil B. Wilson, MD, in a prepared statement after Congress passed the latest six-month reprieve in June. “It doesn’t solve the Medicare mess Congress has created with a long series of short-term Medicare patches over the last decade—including four to avert the 2010 cut alone.”

AMA-sponsored print ads have reminded legislators that delaying a fix until 2013 will again increase its cost, to $396 billion over 10 years. And the association’s June press release asserted that “Congress is playing a dangerous game of Russian roulette with seniors’ healthcare.”

Perhaps a game of “chicken” would be more apt.

Republicans have dared Democrats to spend the billions for a more lasting solution—in the absence of any cuts elsewhere in the healthcare delivery system—and be labeled as fiscally irresponsible. In turn, Democrats have dared Republicans to let the rate cut take effect and be labeled heartless as Medicare beneficiaries lose access to their healthcare providers.

Both parties blinked, resorting to almost unanimous short-term fixes that have allowed legislators to save face while putting off politically risky votes until after the November elections.

Lynne M. Allen, MN, ARNP, who works as a part-time hospitalist in hematology-oncology at 188-bed Kadlec Regional Medical Center in Richland, Wash., says she and other colleagues were initially hopeful that the Obama administration would make Congress work together to find a lasting solution. “There’s a sense of frustration because instead of that happening from our legislators, they’re playing a lot of games with the funding,” says Allen, a member of Team Hospitalist. “They’re not willing to step up to the plate, as they say, and make a decision that will allow us to go forward smoothly.”

The result, Allen says, has been a “roller-coaster ride” of uncertainty over reimbursements. Because Washington’s Tri-Cities region has a relatively high percentage of patients with private insurance, her hospital is somewhat cushioned from a precipitous drop in Medicare fees. But if CMS is ever forced to cut back on its rates, she fully expects private insurers to follow the same downward track.

Practical Concerns

Barbara Hartley, MD, a part-time hospitalist at 22-bed Benson Hospital in Benson, Ariz., says the town’s healthcare facility is somewhat protected from potential Medicare rate cuts through its official status as a Critical Access Hospital. Instead of being reimbursed through diagnosis-related group (DRG) codes, the rural hospital is repaid by Medicare for its total cost per day per patient.

The arrangement is a stable one at the moment, but not enough to dispel Dr. Hartley’s uneasy question: If the economy worsens, will Medicare be able to retain its commitment to rural hospitals? If not, the pain might be felt acutely in communities like Benson, where Dr. Hartley estimates that as much as 75% of the hospital’s in-patient business is through either Medicare or a Medicare Advantage plan.

Kirk Mathews, CEO of St. Louis-based Inpatient Management Inc. and a member of SHM’s Public Policy and Practice Management committees, says Medicare rate cuts also could significantly reduce the leverage of hospitalists during contract negotiations.

“Even if we’re employed by the hospital, but our professional fees that the hospital can recoup for our services are dramatically affected, it will affect how those future contracts go,” Mathews says. “We might be insulated temporarily by the strength of our current contract. But if the formula—however that works out—dramatically impacts the hospitalist reimbursement on the professional fee side, the hospital will feel that, and then hospitalists will eventually feel that as well.” In other words, it could strengthen the bargaining hand of the hospital at the expense of the hospitalist. “Therein lies the long-term threat,” he points out.

Independent Solution?

Some of the authority over physician payments might eventually be depoliticized via language in the reform legislation that empowers a new entity, the Independent Payment Advisory Board, to create policy on such critical monetary issues as reimbursement rates. Congress could still override the board’s policy decisions, but only if the Congressional alternative saves just as much money.

In the meantime, the money for a fix still has to come from somewhere, and no consensus has emerged. Advocates likewise refuse to coalesce around any single alternative. Some experts favor a new formula based on the Medicare economic index, which measures inflation in healthcare delivery costs. But the CBO estimates that per-beneficiary spending under such a formula would be 30% more by 2016 than under the current formula. Other proposals call for temporarily increasing rates, then reverting to annual GDP growth, plus a bit more to cover physician costs.

No matter how the crisis is resolved, experts say, doctors almost certainly will have to make do with less. “When healthcare reform is finally fully implemented, there are going to be less dollars to pay for more services. It’s inevitable,” Mathews says. “And whether it takes the form of SGR or some other form, I’m afraid physicians are going to have to get used to having less money in the pool of money that’s allocated to pay providers.”

It could be a whole new ballgame. TH

Bryn Nelson, PhD, is a freelance medical writer based in Seattle.

Baseball, kick the can, Russian roulette—pick your game. Chances are good that it has worked its way into a metaphor to illustrate the infuriating, perplexing, and altogether frustrating inability of Congress to step up to the plate and pass a long-term fix to the broken sustainable growth rate (SGR) formula used to determine Medicare reimbursement rates.

On June 24, legislators avoided catastrophe by temporarily rescinding a 21.3% rate cut that went into effect June 1. The after-the-fact patch meant that some Medicare claims had to be reprocessed to recoup the full value, creating an administrative mess. The accompanying 2.2% rate increase expires Nov. 30. The reimbursement cut could reach nearly 30% next year unless Congress intervenes again.

“Obviously, there’s a lot of frustration around the issue, especially on the membership side,” says Ron Greeno, MD, FACP, SFHM, a member of SHM’s Public Policy and Leadership committees, and chief medical officer for Brentwood, Tenn.-based Cogent Healthcare. For hospitalists in many small private practices, he says, a major percentage of income comes from Medicare. “It’s a tremendous headache,” he says of the uncertainty. “It’s very hard to plan for. You’re trying to budget and you don’t know what the policy is going to be literally from week to week.”

The Blame Game

Despite the widespread sentiment among doctors that a permanent reimbursement rate fix should have been included in the healthcare reform legislation, skittishness over the price tag led legislators to drop it from the package. Based on last fall’s estimates, the total cost of a reform bill that scrapped the SGR would have ballooned by roughly $250 billion over 10 years, which would have threatened the bill’s passage.

But Congress has since been unable to pass a permanent fix as standalone legislation amid mounting concern over the national debt, and the price of inaction continues to rise. On April 30, the Congressional Budget Office (CBO) estimated that the cost of jettisoning the SGR formula and freezing rates at current levels had grown to $276 billion over 10 years.

Any serious consideration of lasting alternatives has now been pushed back to the lame-duck session, after the midterm elections. The can has been kicked down the road so many times, Dr. Greeno and others say, that most Congressional members have boot marks all over them. “So now you have a bigger problem at a more crucial time, when money is tighter than ever in a poor economy,” Dr. Greeno says. “And I just think it’s been a failure of our politicians.”

Other healthcare industry leaders have been just as critical. “Delaying the problem is not a solution,” said AMA President Cecil B. Wilson, MD, in a prepared statement after Congress passed the latest six-month reprieve in June. “It doesn’t solve the Medicare mess Congress has created with a long series of short-term Medicare patches over the last decade—including four to avert the 2010 cut alone.”

AMA-sponsored print ads have reminded legislators that delaying a fix until 2013 will again increase its cost, to $396 billion over 10 years. And the association’s June press release asserted that “Congress is playing a dangerous game of Russian roulette with seniors’ healthcare.”

Perhaps a game of “chicken” would be more apt.

Republicans have dared Democrats to spend the billions for a more lasting solution—in the absence of any cuts elsewhere in the healthcare delivery system—and be labeled as fiscally irresponsible. In turn, Democrats have dared Republicans to let the rate cut take effect and be labeled heartless as Medicare beneficiaries lose access to their healthcare providers.

Both parties blinked, resorting to almost unanimous short-term fixes that have allowed legislators to save face while putting off politically risky votes until after the November elections.

Lynne M. Allen, MN, ARNP, who works as a part-time hospitalist in hematology-oncology at 188-bed Kadlec Regional Medical Center in Richland, Wash., says she and other colleagues were initially hopeful that the Obama administration would make Congress work together to find a lasting solution. “There’s a sense of frustration because instead of that happening from our legislators, they’re playing a lot of games with the funding,” says Allen, a member of Team Hospitalist. “They’re not willing to step up to the plate, as they say, and make a decision that will allow us to go forward smoothly.”

The result, Allen says, has been a “roller-coaster ride” of uncertainty over reimbursements. Because Washington’s Tri-Cities region has a relatively high percentage of patients with private insurance, her hospital is somewhat cushioned from a precipitous drop in Medicare fees. But if CMS is ever forced to cut back on its rates, she fully expects private insurers to follow the same downward track.

Practical Concerns

Barbara Hartley, MD, a part-time hospitalist at 22-bed Benson Hospital in Benson, Ariz., says the town’s healthcare facility is somewhat protected from potential Medicare rate cuts through its official status as a Critical Access Hospital. Instead of being reimbursed through diagnosis-related group (DRG) codes, the rural hospital is repaid by Medicare for its total cost per day per patient.

The arrangement is a stable one at the moment, but not enough to dispel Dr. Hartley’s uneasy question: If the economy worsens, will Medicare be able to retain its commitment to rural hospitals? If not, the pain might be felt acutely in communities like Benson, where Dr. Hartley estimates that as much as 75% of the hospital’s in-patient business is through either Medicare or a Medicare Advantage plan.

Kirk Mathews, CEO of St. Louis-based Inpatient Management Inc. and a member of SHM’s Public Policy and Practice Management committees, says Medicare rate cuts also could significantly reduce the leverage of hospitalists during contract negotiations.

“Even if we’re employed by the hospital, but our professional fees that the hospital can recoup for our services are dramatically affected, it will affect how those future contracts go,” Mathews says. “We might be insulated temporarily by the strength of our current contract. But if the formula—however that works out—dramatically impacts the hospitalist reimbursement on the professional fee side, the hospital will feel that, and then hospitalists will eventually feel that as well.” In other words, it could strengthen the bargaining hand of the hospital at the expense of the hospitalist. “Therein lies the long-term threat,” he points out.

Independent Solution?

Some of the authority over physician payments might eventually be depoliticized via language in the reform legislation that empowers a new entity, the Independent Payment Advisory Board, to create policy on such critical monetary issues as reimbursement rates. Congress could still override the board’s policy decisions, but only if the Congressional alternative saves just as much money.

In the meantime, the money for a fix still has to come from somewhere, and no consensus has emerged. Advocates likewise refuse to coalesce around any single alternative. Some experts favor a new formula based on the Medicare economic index, which measures inflation in healthcare delivery costs. But the CBO estimates that per-beneficiary spending under such a formula would be 30% more by 2016 than under the current formula. Other proposals call for temporarily increasing rates, then reverting to annual GDP growth, plus a bit more to cover physician costs.

No matter how the crisis is resolved, experts say, doctors almost certainly will have to make do with less. “When healthcare reform is finally fully implemented, there are going to be less dollars to pay for more services. It’s inevitable,” Mathews says. “And whether it takes the form of SGR or some other form, I’m afraid physicians are going to have to get used to having less money in the pool of money that’s allocated to pay providers.”

It could be a whole new ballgame. TH

Bryn Nelson, PhD, is a freelance medical writer based in Seattle.

Baseball, kick the can, Russian roulette—pick your game. Chances are good that it has worked its way into a metaphor to illustrate the infuriating, perplexing, and altogether frustrating inability of Congress to step up to the plate and pass a long-term fix to the broken sustainable growth rate (SGR) formula used to determine Medicare reimbursement rates.

On June 24, legislators avoided catastrophe by temporarily rescinding a 21.3% rate cut that went into effect June 1. The after-the-fact patch meant that some Medicare claims had to be reprocessed to recoup the full value, creating an administrative mess. The accompanying 2.2% rate increase expires Nov. 30. The reimbursement cut could reach nearly 30% next year unless Congress intervenes again.

“Obviously, there’s a lot of frustration around the issue, especially on the membership side,” says Ron Greeno, MD, FACP, SFHM, a member of SHM’s Public Policy and Leadership committees, and chief medical officer for Brentwood, Tenn.-based Cogent Healthcare. For hospitalists in many small private practices, he says, a major percentage of income comes from Medicare. “It’s a tremendous headache,” he says of the uncertainty. “It’s very hard to plan for. You’re trying to budget and you don’t know what the policy is going to be literally from week to week.”

The Blame Game

Despite the widespread sentiment among doctors that a permanent reimbursement rate fix should have been included in the healthcare reform legislation, skittishness over the price tag led legislators to drop it from the package. Based on last fall’s estimates, the total cost of a reform bill that scrapped the SGR would have ballooned by roughly $250 billion over 10 years, which would have threatened the bill’s passage.

But Congress has since been unable to pass a permanent fix as standalone legislation amid mounting concern over the national debt, and the price of inaction continues to rise. On April 30, the Congressional Budget Office (CBO) estimated that the cost of jettisoning the SGR formula and freezing rates at current levels had grown to $276 billion over 10 years.

Any serious consideration of lasting alternatives has now been pushed back to the lame-duck session, after the midterm elections. The can has been kicked down the road so many times, Dr. Greeno and others say, that most Congressional members have boot marks all over them. “So now you have a bigger problem at a more crucial time, when money is tighter than ever in a poor economy,” Dr. Greeno says. “And I just think it’s been a failure of our politicians.”

Other healthcare industry leaders have been just as critical. “Delaying the problem is not a solution,” said AMA President Cecil B. Wilson, MD, in a prepared statement after Congress passed the latest six-month reprieve in June. “It doesn’t solve the Medicare mess Congress has created with a long series of short-term Medicare patches over the last decade—including four to avert the 2010 cut alone.”

AMA-sponsored print ads have reminded legislators that delaying a fix until 2013 will again increase its cost, to $396 billion over 10 years. And the association’s June press release asserted that “Congress is playing a dangerous game of Russian roulette with seniors’ healthcare.”

Perhaps a game of “chicken” would be more apt.

Republicans have dared Democrats to spend the billions for a more lasting solution—in the absence of any cuts elsewhere in the healthcare delivery system—and be labeled as fiscally irresponsible. In turn, Democrats have dared Republicans to let the rate cut take effect and be labeled heartless as Medicare beneficiaries lose access to their healthcare providers.

Both parties blinked, resorting to almost unanimous short-term fixes that have allowed legislators to save face while putting off politically risky votes until after the November elections.

Lynne M. Allen, MN, ARNP, who works as a part-time hospitalist in hematology-oncology at 188-bed Kadlec Regional Medical Center in Richland, Wash., says she and other colleagues were initially hopeful that the Obama administration would make Congress work together to find a lasting solution. “There’s a sense of frustration because instead of that happening from our legislators, they’re playing a lot of games with the funding,” says Allen, a member of Team Hospitalist. “They’re not willing to step up to the plate, as they say, and make a decision that will allow us to go forward smoothly.”

The result, Allen says, has been a “roller-coaster ride” of uncertainty over reimbursements. Because Washington’s Tri-Cities region has a relatively high percentage of patients with private insurance, her hospital is somewhat cushioned from a precipitous drop in Medicare fees. But if CMS is ever forced to cut back on its rates, she fully expects private insurers to follow the same downward track.

Practical Concerns

Barbara Hartley, MD, a part-time hospitalist at 22-bed Benson Hospital in Benson, Ariz., says the town’s healthcare facility is somewhat protected from potential Medicare rate cuts through its official status as a Critical Access Hospital. Instead of being reimbursed through diagnosis-related group (DRG) codes, the rural hospital is repaid by Medicare for its total cost per day per patient.

The arrangement is a stable one at the moment, but not enough to dispel Dr. Hartley’s uneasy question: If the economy worsens, will Medicare be able to retain its commitment to rural hospitals? If not, the pain might be felt acutely in communities like Benson, where Dr. Hartley estimates that as much as 75% of the hospital’s in-patient business is through either Medicare or a Medicare Advantage plan.

Kirk Mathews, CEO of St. Louis-based Inpatient Management Inc. and a member of SHM’s Public Policy and Practice Management committees, says Medicare rate cuts also could significantly reduce the leverage of hospitalists during contract negotiations.

“Even if we’re employed by the hospital, but our professional fees that the hospital can recoup for our services are dramatically affected, it will affect how those future contracts go,” Mathews says. “We might be insulated temporarily by the strength of our current contract. But if the formula—however that works out—dramatically impacts the hospitalist reimbursement on the professional fee side, the hospital will feel that, and then hospitalists will eventually feel that as well.” In other words, it could strengthen the bargaining hand of the hospital at the expense of the hospitalist. “Therein lies the long-term threat,” he points out.

Independent Solution?

Some of the authority over physician payments might eventually be depoliticized via language in the reform legislation that empowers a new entity, the Independent Payment Advisory Board, to create policy on such critical monetary issues as reimbursement rates. Congress could still override the board’s policy decisions, but only if the Congressional alternative saves just as much money.

In the meantime, the money for a fix still has to come from somewhere, and no consensus has emerged. Advocates likewise refuse to coalesce around any single alternative. Some experts favor a new formula based on the Medicare economic index, which measures inflation in healthcare delivery costs. But the CBO estimates that per-beneficiary spending under such a formula would be 30% more by 2016 than under the current formula. Other proposals call for temporarily increasing rates, then reverting to annual GDP growth, plus a bit more to cover physician costs.

No matter how the crisis is resolved, experts say, doctors almost certainly will have to make do with less. “When healthcare reform is finally fully implemented, there are going to be less dollars to pay for more services. It’s inevitable,” Mathews says. “And whether it takes the form of SGR or some other form, I’m afraid physicians are going to have to get used to having less money in the pool of money that’s allocated to pay providers.”

It could be a whole new ballgame. TH

Bryn Nelson, PhD, is a freelance medical writer based in Seattle.

Dear Dr. Mossman:
We often have to administer sedating medications to aggressive patients who pose an immediate threat of harm to themselves or others. But I am unsure about whether these “chemical restraints” create more liability problems than “physical restraints”—or vice versa. Does one type of restraint carry more legal risk than the other?—Submitted by “Dr. L”

Mental health professionals view “mechanical” or “physical” restraints in a way that really differs from how they felt 2 decades ago. In the 1980s, physical restraint use was a common response when patients seemed to be immediately dangerous to themselves or others. But recent practice guidelines say physical restraints are a “last resort,” to be used only when other treatment measures to prevent aggression fail to work.

What should psychiatrists do? Is use of physical restraints malpractice? Are “chemical” restraints better?

This article looks at:

• definitions of restraint
• medical risks of restraint
• evolution and status of restraint policy
• what you can do about legal risks of restraint.

Definitions

In medical contexts, restraint typically refers to “any device or medication used to restrict a patient’s movement.”¹ The longer, official US regulatory definitions of physical and chemical restraints appear in Table 1.² Two important notes:

• Neither regulatory definition of restraint is limited to psychiatric patients; both definitions and the accompanying regulations on restraint apply to any patient in a hospital eligible for federal reimbursement.
• The definition of physical restraint would include holding a patient still while administering an injection.

The detailed interpretive rules (“Conditions of Participation for Hospitals”)³ for these regulations require hospitals to document conditions surrounding and reasons related to restraint incidents and to make this documentation available to federal surveyors.

Table 1

Federal regulatory definitions of ‘restraint’

Medical risks of restraint

In 1998, the Hartford Courant investigative series “Deadly restraint”⁴ reported on 142 deaths of psychiatric patients and alerted the public to the potentially fatal consequences of physical restraint. Often, restraint deaths result from asphyxia when patients try to free themselves and get caught in positions that restrict breathing.⁵ Other injuries—particularly those produced by falls—can result from well-intentioned efforts to protect confused patients by restraining them.⁶

Evolution of restraint policy

Although restraining patients might inadvertently cause harm, isn’t it better to restrain someone, which prevents harm from aggression and accidents? Mental health professionals once thought the answer to this question was, “Of course!” But scientific data say, “Often not.”

Studies conducted when physical restraint was more common found order-of-magnitude disparities in restraint rates at sites with similar patient populations. This suggested that institutional norms and practice styles—not patients’ problems or dangerousness—explained why much restraint occurred.^7-9

Reacting to these kinds of findings, psychiatric hospitals in the United States and abroad implemented various methods and policy changes to reduce restraint. Follow-up studies typically showed that episodes of restraint and total time spent in restraints could decrease markedly without any increase in events that harmed patients or staff members.¹⁰ In addition, mental health professionals now recognize that being restrained is psychologically traumatic for patients, even when restraint causes no physical injury.¹¹

Patients in psychiatric settings represent a minority of persons who get restrained. On inpatient medical/surgical units, patient confusion and wandering, fall prevention, and perceived medical necessity can lead to physical restraint use.¹² Yet physical restraints as innocent-seeming as bed rails can lead to deaths and injuries.¹³

Nursing homes are another environment where restraints may be common but sometimes detrimental. A recent study found that in all aspects of nursing home patients’ health and functioning—behavior, cognitive performance, falls, walking, activities of daily living, pressure sores, and contractures—physical restraints lead to worse outcomes than leaving patients unrestrained.¹⁴

For all these reasons, restraining patients is often viewed as “poor practice”¹⁴ and a response of last resort for behavioral problems.^15-17

Federal regulations

Publication of the Courant article spurred Congress to develop standards¹⁸ that, a decade later, permit restraint or seclusion only when less restrictive interventions will not prevent harm, only for limited periods, and only with careful medical monitoring. Restraint is permissible when no alternative exists, but facilities that use restraint must train staff members to recognize and avert situations that might lead to physical interventions and must generate proper documentation each time restraint is used.²

Federal regulations also apply to “chemical restraints” and aim to restrict their use. This doesn’t mean you can’t use drugs to treat patients, however. Regulations explicitly allow you to prescribe “standard treatment” (Table 2)³ to help your patients function or sleep better, to alleviate pain, or to reduce agitation—and such uses of medication are not “chemical restraint.” Rather, you’re using “chemical restraint” if you prescribe a drug to control bothersome behavior—for example, to “knock out” a patient with dementia whose “sundowning” bothers staff members.¹⁹ Psychiatrists should be familiar with the risks of medications used for behavioral control, particularly in elderly patients.²⁰

Table 2

Federal criteria for ‘standard treatment‘

Avoiding legal risks

No study or systematic data will ever tell us whether physical or chemical restraints create a greater liability risk. Obviously, the best way to avoid legal liability for restraints is to minimize use of physical restraints and to avoid using medications as chemical restraints. Psychiatrists who work in hospitals or other institutional settings can politely but firmly decline to prescribe medications or to order physical restraints when staff members request these measures for non-therapeutic reasons—ie, for a patient who has calmed down but whom staff members believe “needs to learn a lesson” or “get some consequences” for throwing a chair. When restraints are necessary, psychiatrists (along with other staff members) should document the reasons why, including what other interventions were tried first.

Many psychiatric facilities and care systems have reduced incidence of restraint and time spent by patients in restraint through programs that broadly address institutional practices. Such programs usually involve a multi-disciplinary, multi-strategy commitment to alternatives—to helping staff members see that restraints represent a failure in treatment rather than a form of treatment, and to developing other mechanisms for averting or responding to patients’ aggression before restraint becomes the only option.^10,21 Individual psychiatrists can play an important role in advocating and supporting institutional policies, practices, and training that help staff members minimize restraint use.

Dear Dr. Mossman:
We often have to administer sedating medications to aggressive patients who pose an immediate threat of harm to themselves or others. But I am unsure about whether these “chemical restraints” create more liability problems than “physical restraints”—or vice versa. Does one type of restraint carry more legal risk than the other?—Submitted by “Dr. L”

Mental health professionals view “mechanical” or “physical” restraints in a way that really differs from how they felt 2 decades ago. In the 1980s, physical restraint use was a common response when patients seemed to be immediately dangerous to themselves or others. But recent practice guidelines say physical restraints are a “last resort,” to be used only when other treatment measures to prevent aggression fail to work.

What should psychiatrists do? Is use of physical restraints malpractice? Are “chemical” restraints better?

This article looks at:

• definitions of restraint
• medical risks of restraint
• evolution and status of restraint policy
• what you can do about legal risks of restraint.

Definitions

In medical contexts, restraint typically refers to “any device or medication used to restrict a patient’s movement.”¹ The longer, official US regulatory definitions of physical and chemical restraints appear in Table 1.² Two important notes:

• Neither regulatory definition of restraint is limited to psychiatric patients; both definitions and the accompanying regulations on restraint apply to any patient in a hospital eligible for federal reimbursement.
• The definition of physical restraint would include holding a patient still while administering an injection.

The detailed interpretive rules (“Conditions of Participation for Hospitals”)³ for these regulations require hospitals to document conditions surrounding and reasons related to restraint incidents and to make this documentation available to federal surveyors.

Table 1

Federal regulatory definitions of ‘restraint’

Medical risks of restraint

In 1998, the Hartford Courant investigative series “Deadly restraint”⁴ reported on 142 deaths of psychiatric patients and alerted the public to the potentially fatal consequences of physical restraint. Often, restraint deaths result from asphyxia when patients try to free themselves and get caught in positions that restrict breathing.⁵ Other injuries—particularly those produced by falls—can result from well-intentioned efforts to protect confused patients by restraining them.⁶

Evolution of restraint policy

Although restraining patients might inadvertently cause harm, isn’t it better to restrain someone, which prevents harm from aggression and accidents? Mental health professionals once thought the answer to this question was, “Of course!” But scientific data say, “Often not.”

Studies conducted when physical restraint was more common found order-of-magnitude disparities in restraint rates at sites with similar patient populations. This suggested that institutional norms and practice styles—not patients’ problems or dangerousness—explained why much restraint occurred.^7-9

Reacting to these kinds of findings, psychiatric hospitals in the United States and abroad implemented various methods and policy changes to reduce restraint. Follow-up studies typically showed that episodes of restraint and total time spent in restraints could decrease markedly without any increase in events that harmed patients or staff members.¹⁰ In addition, mental health professionals now recognize that being restrained is psychologically traumatic for patients, even when restraint causes no physical injury.¹¹

Patients in psychiatric settings represent a minority of persons who get restrained. On inpatient medical/surgical units, patient confusion and wandering, fall prevention, and perceived medical necessity can lead to physical restraint use.¹² Yet physical restraints as innocent-seeming as bed rails can lead to deaths and injuries.¹³

Nursing homes are another environment where restraints may be common but sometimes detrimental. A recent study found that in all aspects of nursing home patients’ health and functioning—behavior, cognitive performance, falls, walking, activities of daily living, pressure sores, and contractures—physical restraints lead to worse outcomes than leaving patients unrestrained.¹⁴

For all these reasons, restraining patients is often viewed as “poor practice”¹⁴ and a response of last resort for behavioral problems.^15-17

Federal regulations

Publication of the Courant article spurred Congress to develop standards¹⁸ that, a decade later, permit restraint or seclusion only when less restrictive interventions will not prevent harm, only for limited periods, and only with careful medical monitoring. Restraint is permissible when no alternative exists, but facilities that use restraint must train staff members to recognize and avert situations that might lead to physical interventions and must generate proper documentation each time restraint is used.²

Federal regulations also apply to “chemical restraints” and aim to restrict their use. This doesn’t mean you can’t use drugs to treat patients, however. Regulations explicitly allow you to prescribe “standard treatment” (Table 2)³ to help your patients function or sleep better, to alleviate pain, or to reduce agitation—and such uses of medication are not “chemical restraint.” Rather, you’re using “chemical restraint” if you prescribe a drug to control bothersome behavior—for example, to “knock out” a patient with dementia whose “sundowning” bothers staff members.¹⁹ Psychiatrists should be familiar with the risks of medications used for behavioral control, particularly in elderly patients.²⁰

Table 2

Federal criteria for ‘standard treatment‘

Avoiding legal risks

No study or systematic data will ever tell us whether physical or chemical restraints create a greater liability risk. Obviously, the best way to avoid legal liability for restraints is to minimize use of physical restraints and to avoid using medications as chemical restraints. Psychiatrists who work in hospitals or other institutional settings can politely but firmly decline to prescribe medications or to order physical restraints when staff members request these measures for non-therapeutic reasons—ie, for a patient who has calmed down but whom staff members believe “needs to learn a lesson” or “get some consequences” for throwing a chair. When restraints are necessary, psychiatrists (along with other staff members) should document the reasons why, including what other interventions were tried first.

Many psychiatric facilities and care systems have reduced incidence of restraint and time spent by patients in restraint through programs that broadly address institutional practices. Such programs usually involve a multi-disciplinary, multi-strategy commitment to alternatives—to helping staff members see that restraints represent a failure in treatment rather than a form of treatment, and to developing other mechanisms for averting or responding to patients’ aggression before restraint becomes the only option.^10,21 Individual psychiatrists can play an important role in advocating and supporting institutional policies, practices, and training that help staff members minimize restraint use.

Dear Dr. Mossman:
We often have to administer sedating medications to aggressive patients who pose an immediate threat of harm to themselves or others. But I am unsure about whether these “chemical restraints” create more liability problems than “physical restraints”—or vice versa. Does one type of restraint carry more legal risk than the other?—Submitted by “Dr. L”

Mental health professionals view “mechanical” or “physical” restraints in a way that really differs from how they felt 2 decades ago. In the 1980s, physical restraint use was a common response when patients seemed to be immediately dangerous to themselves or others. But recent practice guidelines say physical restraints are a “last resort,” to be used only when other treatment measures to prevent aggression fail to work.

What should psychiatrists do? Is use of physical restraints malpractice? Are “chemical” restraints better?

This article looks at:

• definitions of restraint
• medical risks of restraint
• evolution and status of restraint policy
• what you can do about legal risks of restraint.

Definitions

In medical contexts, restraint typically refers to “any device or medication used to restrict a patient’s movement.”¹ The longer, official US regulatory definitions of physical and chemical restraints appear in Table 1.² Two important notes:

• Neither regulatory definition of restraint is limited to psychiatric patients; both definitions and the accompanying regulations on restraint apply to any patient in a hospital eligible for federal reimbursement.
• The definition of physical restraint would include holding a patient still while administering an injection.

The detailed interpretive rules (“Conditions of Participation for Hospitals”)³ for these regulations require hospitals to document conditions surrounding and reasons related to restraint incidents and to make this documentation available to federal surveyors.

Table 1

Federal regulatory definitions of ‘restraint’

Medical risks of restraint

In 1998, the Hartford Courant investigative series “Deadly restraint”⁴ reported on 142 deaths of psychiatric patients and alerted the public to the potentially fatal consequences of physical restraint. Often, restraint deaths result from asphyxia when patients try to free themselves and get caught in positions that restrict breathing.⁵ Other injuries—particularly those produced by falls—can result from well-intentioned efforts to protect confused patients by restraining them.⁶

Evolution of restraint policy

Although restraining patients might inadvertently cause harm, isn’t it better to restrain someone, which prevents harm from aggression and accidents? Mental health professionals once thought the answer to this question was, “Of course!” But scientific data say, “Often not.”

Studies conducted when physical restraint was more common found order-of-magnitude disparities in restraint rates at sites with similar patient populations. This suggested that institutional norms and practice styles—not patients’ problems or dangerousness—explained why much restraint occurred.^7-9

Reacting to these kinds of findings, psychiatric hospitals in the United States and abroad implemented various methods and policy changes to reduce restraint. Follow-up studies typically showed that episodes of restraint and total time spent in restraints could decrease markedly without any increase in events that harmed patients or staff members.¹⁰ In addition, mental health professionals now recognize that being restrained is psychologically traumatic for patients, even when restraint causes no physical injury.¹¹

Patients in psychiatric settings represent a minority of persons who get restrained. On inpatient medical/surgical units, patient confusion and wandering, fall prevention, and perceived medical necessity can lead to physical restraint use.¹² Yet physical restraints as innocent-seeming as bed rails can lead to deaths and injuries.¹³

Nursing homes are another environment where restraints may be common but sometimes detrimental. A recent study found that in all aspects of nursing home patients’ health and functioning—behavior, cognitive performance, falls, walking, activities of daily living, pressure sores, and contractures—physical restraints lead to worse outcomes than leaving patients unrestrained.¹⁴

For all these reasons, restraining patients is often viewed as “poor practice”¹⁴ and a response of last resort for behavioral problems.^15-17

Federal regulations

Publication of the Courant article spurred Congress to develop standards¹⁸ that, a decade later, permit restraint or seclusion only when less restrictive interventions will not prevent harm, only for limited periods, and only with careful medical monitoring. Restraint is permissible when no alternative exists, but facilities that use restraint must train staff members to recognize and avert situations that might lead to physical interventions and must generate proper documentation each time restraint is used.²

Federal regulations also apply to “chemical restraints” and aim to restrict their use. This doesn’t mean you can’t use drugs to treat patients, however. Regulations explicitly allow you to prescribe “standard treatment” (Table 2)³ to help your patients function or sleep better, to alleviate pain, or to reduce agitation—and such uses of medication are not “chemical restraint.” Rather, you’re using “chemical restraint” if you prescribe a drug to control bothersome behavior—for example, to “knock out” a patient with dementia whose “sundowning” bothers staff members.¹⁹ Psychiatrists should be familiar with the risks of medications used for behavioral control, particularly in elderly patients.²⁰

Table 2

Federal criteria for ‘standard treatment‘

Avoiding legal risks

No study or systematic data will ever tell us whether physical or chemical restraints create a greater liability risk. Obviously, the best way to avoid legal liability for restraints is to minimize use of physical restraints and to avoid using medications as chemical restraints. Psychiatrists who work in hospitals or other institutional settings can politely but firmly decline to prescribe medications or to order physical restraints when staff members request these measures for non-therapeutic reasons—ie, for a patient who has calmed down but whom staff members believe “needs to learn a lesson” or “get some consequences” for throwing a chair. When restraints are necessary, psychiatrists (along with other staff members) should document the reasons why, including what other interventions were tried first.

Many psychiatric facilities and care systems have reduced incidence of restraint and time spent by patients in restraint through programs that broadly address institutional practices. Such programs usually involve a multi-disciplinary, multi-strategy commitment to alternatives—to helping staff members see that restraints represent a failure in treatment rather than a form of treatment, and to developing other mechanisms for averting or responding to patients’ aggression before restraint becomes the only option.^10,21 Individual psychiatrists can play an important role in advocating and supporting institutional policies, practices, and training that help staff members minimize restraint use.

The Coming Challenges—and Opportunities—of Value-Based Purchasing

The Patient Protection and Affordable Care Act was signed into law in March, furthering the federal government’s commitment to increasing the efficiency of the U.S. healthcare system by decreasing cost and improving quality. An expansion of the “value-based purchasing” model, this law mandates that ratings and reimbursements to physicians and hospitals be increasingly tied to measured quality of care.

In this system, a physician’s quality profile will be determined by a variety of factors, including reported quality data, severity-adjusted clinical outcome measures, patient-safety indicators, and hospital-acquired conditions (HACs). Since all of these are, to a large extent, documentation issues, physicians are now forced to pay close attention to how they identify and describe diagnoses and procedures.

Medicare will, in effect, attempt to determine: “Did the clinical team correctly identify and appropriately treat all relevant patient conditions—without causing any adverse conditions—and do so safely, efficiently, and with good outcomes?”

The patient chart must “tell the story” of the episode of care in the hospital. It must accurately describe all of the patient’s conditions and demonstrate the complexity of medical decision-making and establishment of risk. Upon discharge, this risk must “match up” with the diagnoses that are being coded and the Medicare Severity Diagnostic Related Group (MS-DRGs) being assigned. Often, the information is present in the chart but is inconsistent from provider to provider, or documented in a way that is misunderstood by hospital coders.

If successful in improving our documentation skills, the reward will be a higher rating and increased reimbursement.

Medicare also is ramping up its claims denial and recovery business to help “clean up” the system. This includes the national rollout of the Recovery Audit Contactor (RAC) initiative (see “Attention to Detail,” April 2010, p. 1), as well as the new Medicare administrative contractors (MACs). Both rely on accurate documentation. The RACs will penalize hospitals and physicians financially for documentation lacking in specificity and accuracy; the MACs will deny payment for claims erroneously submitted (technical errors) or lacking documentation of medical necessity.

What makes many physicians even more uncomfortable in this new environment is that Medicare is striving to better align the priorities and financial incentives of hospitals and physicians. Alliances between the two are strongly encouraged through such programs as the Acute Care Episode (ACE) Demonstration Project (the precursor to hospital-physician bundled payments), and the establishment of accountable care organizations (ACOs).

This emerging environment presents a unique set of challenges and opportunities to HM groups. Hospitalists are historically more aligned with hospital administrations, as compared with most other specialties. Hospitalists also are asked to participate in the care of an increasingly large percentage of patients across all specialties. This could well be an opportunity to be rewarded for embracing both of these trends.

Hospitalists are uniquely positioned to function as the documentation improvement clinical team leaders, working closely with other physicians across all specialties and the administration to fulfill all documentation requirements—and to be rewarded for doing so. Though hospitalists should have a general understanding of the language and rules of documentation, a system must be in place that helps them identify and capture all the pertinent aspects of the medical record without the need to become coders themselves. To this end, a clinical documentation improvement (CDI) program is critical.

But it might not be enough.

What is needed is a clinical integration program, an enhancement of traditional CDI. This approach requires participation from ED physicians, along with clinical integration specialists, to document accurately and completely from the start. The clinical integration specialist ensures that medical necessity for inpatient admission and patient risk is being addressed and established, conditions are appropriately identified as being present on admission (POA), and all diagnoses are properly recognized and documented thoroughly and accurately. Clinical integration through collaborative documentation then continues throughout the hospitalization, with diagnostic authority and oversight from the hospitalist, all the way through discharge.

Hospitalists should welcome and champion this type of program. As documentation becomes the key to survival, a complete medical record will stand up to any and all scrutiny by Medicare or others.

As for the negatives, there are none.

Andrew H. Dombro, MD, national medical director, and Paul Weygandt, MD, JD, vice president of physician services, J.A. Thomas & Associates, Atlanta

The Coming Challenges—and Opportunities—of Value-Based Purchasing

The Patient Protection and Affordable Care Act was signed into law in March, furthering the federal government’s commitment to increasing the efficiency of the U.S. healthcare system by decreasing cost and improving quality. An expansion of the “value-based purchasing” model, this law mandates that ratings and reimbursements to physicians and hospitals be increasingly tied to measured quality of care.

In this system, a physician’s quality profile will be determined by a variety of factors, including reported quality data, severity-adjusted clinical outcome measures, patient-safety indicators, and hospital-acquired conditions (HACs). Since all of these are, to a large extent, documentation issues, physicians are now forced to pay close attention to how they identify and describe diagnoses and procedures.

Medicare will, in effect, attempt to determine: “Did the clinical team correctly identify and appropriately treat all relevant patient conditions—without causing any adverse conditions—and do so safely, efficiently, and with good outcomes?”

The patient chart must “tell the story” of the episode of care in the hospital. It must accurately describe all of the patient’s conditions and demonstrate the complexity of medical decision-making and establishment of risk. Upon discharge, this risk must “match up” with the diagnoses that are being coded and the Medicare Severity Diagnostic Related Group (MS-DRGs) being assigned. Often, the information is present in the chart but is inconsistent from provider to provider, or documented in a way that is misunderstood by hospital coders.

If successful in improving our documentation skills, the reward will be a higher rating and increased reimbursement.

Medicare also is ramping up its claims denial and recovery business to help “clean up” the system. This includes the national rollout of the Recovery Audit Contactor (RAC) initiative (see “Attention to Detail,” April 2010, p. 1), as well as the new Medicare administrative contractors (MACs). Both rely on accurate documentation. The RACs will penalize hospitals and physicians financially for documentation lacking in specificity and accuracy; the MACs will deny payment for claims erroneously submitted (technical errors) or lacking documentation of medical necessity.

What makes many physicians even more uncomfortable in this new environment is that Medicare is striving to better align the priorities and financial incentives of hospitals and physicians. Alliances between the two are strongly encouraged through such programs as the Acute Care Episode (ACE) Demonstration Project (the precursor to hospital-physician bundled payments), and the establishment of accountable care organizations (ACOs).

This emerging environment presents a unique set of challenges and opportunities to HM groups. Hospitalists are historically more aligned with hospital administrations, as compared with most other specialties. Hospitalists also are asked to participate in the care of an increasingly large percentage of patients across all specialties. This could well be an opportunity to be rewarded for embracing both of these trends.

Hospitalists are uniquely positioned to function as the documentation improvement clinical team leaders, working closely with other physicians across all specialties and the administration to fulfill all documentation requirements—and to be rewarded for doing so. Though hospitalists should have a general understanding of the language and rules of documentation, a system must be in place that helps them identify and capture all the pertinent aspects of the medical record without the need to become coders themselves. To this end, a clinical documentation improvement (CDI) program is critical.

But it might not be enough.

What is needed is a clinical integration program, an enhancement of traditional CDI. This approach requires participation from ED physicians, along with clinical integration specialists, to document accurately and completely from the start. The clinical integration specialist ensures that medical necessity for inpatient admission and patient risk is being addressed and established, conditions are appropriately identified as being present on admission (POA), and all diagnoses are properly recognized and documented thoroughly and accurately. Clinical integration through collaborative documentation then continues throughout the hospitalization, with diagnostic authority and oversight from the hospitalist, all the way through discharge.

Hospitalists should welcome and champion this type of program. As documentation becomes the key to survival, a complete medical record will stand up to any and all scrutiny by Medicare or others.

As for the negatives, there are none.

Andrew H. Dombro, MD, national medical director, and Paul Weygandt, MD, JD, vice president of physician services, J.A. Thomas & Associates, Atlanta

The Coming Challenges—and Opportunities—of Value-Based Purchasing

The Patient Protection and Affordable Care Act was signed into law in March, furthering the federal government’s commitment to increasing the efficiency of the U.S. healthcare system by decreasing cost and improving quality. An expansion of the “value-based purchasing” model, this law mandates that ratings and reimbursements to physicians and hospitals be increasingly tied to measured quality of care.

In this system, a physician’s quality profile will be determined by a variety of factors, including reported quality data, severity-adjusted clinical outcome measures, patient-safety indicators, and hospital-acquired conditions (HACs). Since all of these are, to a large extent, documentation issues, physicians are now forced to pay close attention to how they identify and describe diagnoses and procedures.

Medicare will, in effect, attempt to determine: “Did the clinical team correctly identify and appropriately treat all relevant patient conditions—without causing any adverse conditions—and do so safely, efficiently, and with good outcomes?”

The patient chart must “tell the story” of the episode of care in the hospital. It must accurately describe all of the patient’s conditions and demonstrate the complexity of medical decision-making and establishment of risk. Upon discharge, this risk must “match up” with the diagnoses that are being coded and the Medicare Severity Diagnostic Related Group (MS-DRGs) being assigned. Often, the information is present in the chart but is inconsistent from provider to provider, or documented in a way that is misunderstood by hospital coders.

If successful in improving our documentation skills, the reward will be a higher rating and increased reimbursement.

Medicare also is ramping up its claims denial and recovery business to help “clean up” the system. This includes the national rollout of the Recovery Audit Contactor (RAC) initiative (see “Attention to Detail,” April 2010, p. 1), as well as the new Medicare administrative contractors (MACs). Both rely on accurate documentation. The RACs will penalize hospitals and physicians financially for documentation lacking in specificity and accuracy; the MACs will deny payment for claims erroneously submitted (technical errors) or lacking documentation of medical necessity.

What makes many physicians even more uncomfortable in this new environment is that Medicare is striving to better align the priorities and financial incentives of hospitals and physicians. Alliances between the two are strongly encouraged through such programs as the Acute Care Episode (ACE) Demonstration Project (the precursor to hospital-physician bundled payments), and the establishment of accountable care organizations (ACOs).

This emerging environment presents a unique set of challenges and opportunities to HM groups. Hospitalists are historically more aligned with hospital administrations, as compared with most other specialties. Hospitalists also are asked to participate in the care of an increasingly large percentage of patients across all specialties. This could well be an opportunity to be rewarded for embracing both of these trends.

Hospitalists are uniquely positioned to function as the documentation improvement clinical team leaders, working closely with other physicians across all specialties and the administration to fulfill all documentation requirements—and to be rewarded for doing so. Though hospitalists should have a general understanding of the language and rules of documentation, a system must be in place that helps them identify and capture all the pertinent aspects of the medical record without the need to become coders themselves. To this end, a clinical documentation improvement (CDI) program is critical.

But it might not be enough.

What is needed is a clinical integration program, an enhancement of traditional CDI. This approach requires participation from ED physicians, along with clinical integration specialists, to document accurately and completely from the start. The clinical integration specialist ensures that medical necessity for inpatient admission and patient risk is being addressed and established, conditions are appropriately identified as being present on admission (POA), and all diagnoses are properly recognized and documented thoroughly and accurately. Clinical integration through collaborative documentation then continues throughout the hospitalization, with diagnostic authority and oversight from the hospitalist, all the way through discharge.

Hospitalists should welcome and champion this type of program. As documentation becomes the key to survival, a complete medical record will stand up to any and all scrutiny by Medicare or others.

As for the negatives, there are none.

Andrew H. Dombro, MD, national medical director, and Paul Weygandt, MD, JD, vice president of physician services, J.A. Thomas & Associates, Atlanta

When I started writing this, Congress hadn’t settled the issue of the 21% cut in Medicare reimbursement for services called for by the sustainable growth rate (SGR) formula. Fortunately, Congress stepped up and passed another extension with a 2.2% pay increase; however, the quick fix only lasts until November.

The process is all too routine: The deadline for these reimbursement cuts looms, Medicare instructs its fiscal intermediaries (the organizations that actually write the checks to providers) to hold claims rather than pay at the lower rate, and, within a few days of the deadline passing, Congress decides to pass an extension, which allows Medicare to continue paying the historical (higher) rate for the time being.

Imagine Medicare reimbursement rates dropping 21% overnight. I suspect it would be cataclysmic. But I hear remarkably little chatter about this possibility. In fact, while with 2,500 other hospitalists for several days at HM10 in April, I didn’t hear a single person bring up the SGR issue.

One reason there isn’t more handwringing about the looming, draconian cuts is that we’ve been there before. In fact, reimbursement cuts required by the SGR have come up every year since 2001. Each time, Congress has chosen not to implement the cuts; and in some years it has approved reimbursement increases instead. So most in healthcare circles basically have come to expect Congress to pass last-minute legislation to avoid the drastic cuts. (SHM and most other medical societies want a repeal of the flawed SGR formula. Visit SHM’s Legislative Action Center, http://capwiz.com/hospitalmedicine/home/, to write your legislators and urge repeal of the SGR. It only takes about two minutes, and you don’t even need to remember who your representatives are; you just need to know your ZIP code.)

Don’t Be Too Smug

There is another reason many hospitalists, and other doctors who are employed and salaried by a large entity like a hospital, might not be more concerned about proposed cuts: They probably think their own salaries will be unaffected by decreases in reimbursement from Medicare and other payors. My experience is that a lot of hospitalists are so unconcerned about payor reimbursement rates that they aren’t even aware of the threatened Medicare cuts.

Their thinking goes something like this: “I’m paid mostly via a fixed annual salary with a small productivity and quality incentive. None of this is connected to the payor mix or collection rates from the patients I see. So if the portion of uninsured patients I see goes up, my compensation is unaffected. Or if payors decrease their rates, my compensation is unaffected. So I don’t need to sweat the possibility of a 21% decrease in Medicare rates. The hospital will have to make up the difference, so my salary is unaffected, and it will be up to bean counters at the hospital to get the numbers to work out.”

In fact, this is true, in theory, for the majority of hospitalists. But I think it is a mistake to assume your salary is untouchable. If Medicare were to cut rates by 21%, you’d better run to your hospital CEO’s office right away, because a long line will form immediately. Every doctor who sees patients at your hospital will be in that line asking the CEO to provide some money to offset the Medicare cuts, and I doubt any hospital will be able to satisfy their doctors without spending so much money that the hospital goes bankrupt or out of business.

Even if you have a valid contract that calls for your compensation to be paid independent of the amount of professional fee collections, a dire shortage of money could lead a hospital to lay off hospitalists or cancel the contract (most contracts would allow the hospital to do this simply by giving a 90-day notice).

I suggest that no hospitalist feel too smug about how well their employment contract protects the group from broader market forces like reimbursement rates. I doubt we’ll ever see an overnight 21% reduction in Medicare rates, but over time, we could see ever-increasing pressure to limit the growth in our incomes.

I believe every hospitalist should spend at least a little time following broader financial issues like this one, and get involved in the political process to let your legislators know your thoughts. For the record, I think the financial underpinnings of our healthcare system are disastrously messed up and something has to be done. And I don’t think anyone’s salary, including mine, is untouchable. But I also believe the SGR is an ineffective way to make the system more financially sound. That said, you don’t need to agree with me; I only recommend that you have a reasonably informed opinion.

One approach might be for your HM group to appoint a “political” or “marketplace” watchdog. This person could be charged with following issues closely and reporting back to the whole group during regular meetings.

“Marketplace” Risk

Medicare rates are only one part of the complex financial ecosystem on which we depend. It is awfully common, and I think pretty reasonable, for hospitalists to have a contractual arrangement with hospitals. The majority of the time, the hospital has most—or all—of the risk for the financial performance of the practice. In fact, most prospective hospitalists, especially those seeking their first jobs out after residency, say one of the most attractive reasons for choosing work as a hospitalist is that many practices provide a salary that is nearly fixed. Any variable components to the salary, such as those based on production or quality, are typically very small.

A hospitalist might think, “I want a practice that pays a fixed salary so I don’t have to worry about any business and financial issues other than when to show up to work.” In fact, a lot of recruitment ads trumpet this very idea (i.e., “you handle the doctoring and get to enjoy the wonderful recreational opportunities and schools our locale provides, and we’ll worry about all the business issues”). That may sound nice, but I worry it is a little short-sighted.

Here is another point of view, which is only slightly more complicated. In most cases, you should try to negotiate a contract that insulates you from “payor risk” (e.g., changes in payor mix and rates paid by payors don’t flow through to your compensation). But you should think twice before asking your employer to assume all the risk for staffing and scheduling decisions, such as whether you get the work done with 10 hospitalists or 11, or whether you have an evening admitter (“swing”) shift. If the employer holds all the risk, then the hospitalists give up nearly all their autonomy to decide how hard they want to work and how they want to schedule themselves. This causes problems for many practices, and is the No. 1 reason I’m called in as a consultant. Contrary to being very risky and stressful, many hospitalists find it liberating to assume financial risk for their staffing and workload decisions.

You should realize that if your employer pays you a fixed compensation, then someone has to ensure that you do enough work to justify that compensation. This can mean that the employer “issues decrees” (i.e., “we won’t add another provide to the practice until we’ve averaged ‘X’ encounters per month for 6 months”). A hospitalist might see this as unreasonable, yet the group has limited recourse since the employer has already guaranteed the compensation.

If you’d rather have more autonomy in your staffing and workload, then you will need to connect your paycheck to these decisions. Although it might sound terribly risky, those who make the switch often say they wouldn’t have it any other way. Most importantly, it ensures hospitalists have much more say in big decisions. TH

Dr. Nelson has been a practicing hospitalist since 1988 and is co-founder and past president of SHM. He is a principal in Nelson Flores Hospital Medicine Consultants, a national hospitalist practice management consulting firm (www.nelsonflores.com). He is also course co-director and faculty for SHM’s “Best Practices in Managing a Hospital Medicine Program” course. This column represents his views and is not intended to reflect an official position of SHM.

When I started writing this, Congress hadn’t settled the issue of the 21% cut in Medicare reimbursement for services called for by the sustainable growth rate (SGR) formula. Fortunately, Congress stepped up and passed another extension with a 2.2% pay increase; however, the quick fix only lasts until November.

The process is all too routine: The deadline for these reimbursement cuts looms, Medicare instructs its fiscal intermediaries (the organizations that actually write the checks to providers) to hold claims rather than pay at the lower rate, and, within a few days of the deadline passing, Congress decides to pass an extension, which allows Medicare to continue paying the historical (higher) rate for the time being.

Imagine Medicare reimbursement rates dropping 21% overnight. I suspect it would be cataclysmic. But I hear remarkably little chatter about this possibility. In fact, while with 2,500 other hospitalists for several days at HM10 in April, I didn’t hear a single person bring up the SGR issue.

One reason there isn’t more handwringing about the looming, draconian cuts is that we’ve been there before. In fact, reimbursement cuts required by the SGR have come up every year since 2001. Each time, Congress has chosen not to implement the cuts; and in some years it has approved reimbursement increases instead. So most in healthcare circles basically have come to expect Congress to pass last-minute legislation to avoid the drastic cuts. (SHM and most other medical societies want a repeal of the flawed SGR formula. Visit SHM’s Legislative Action Center, http://capwiz.com/hospitalmedicine/home/, to write your legislators and urge repeal of the SGR. It only takes about two minutes, and you don’t even need to remember who your representatives are; you just need to know your ZIP code.)

Don’t Be Too Smug

There is another reason many hospitalists, and other doctors who are employed and salaried by a large entity like a hospital, might not be more concerned about proposed cuts: They probably think their own salaries will be unaffected by decreases in reimbursement from Medicare and other payors. My experience is that a lot of hospitalists are so unconcerned about payor reimbursement rates that they aren’t even aware of the threatened Medicare cuts.

Their thinking goes something like this: “I’m paid mostly via a fixed annual salary with a small productivity and quality incentive. None of this is connected to the payor mix or collection rates from the patients I see. So if the portion of uninsured patients I see goes up, my compensation is unaffected. Or if payors decrease their rates, my compensation is unaffected. So I don’t need to sweat the possibility of a 21% decrease in Medicare rates. The hospital will have to make up the difference, so my salary is unaffected, and it will be up to bean counters at the hospital to get the numbers to work out.”

In fact, this is true, in theory, for the majority of hospitalists. But I think it is a mistake to assume your salary is untouchable. If Medicare were to cut rates by 21%, you’d better run to your hospital CEO’s office right away, because a long line will form immediately. Every doctor who sees patients at your hospital will be in that line asking the CEO to provide some money to offset the Medicare cuts, and I doubt any hospital will be able to satisfy their doctors without spending so much money that the hospital goes bankrupt or out of business.

Even if you have a valid contract that calls for your compensation to be paid independent of the amount of professional fee collections, a dire shortage of money could lead a hospital to lay off hospitalists or cancel the contract (most contracts would allow the hospital to do this simply by giving a 90-day notice).

I suggest that no hospitalist feel too smug about how well their employment contract protects the group from broader market forces like reimbursement rates. I doubt we’ll ever see an overnight 21% reduction in Medicare rates, but over time, we could see ever-increasing pressure to limit the growth in our incomes.

I believe every hospitalist should spend at least a little time following broader financial issues like this one, and get involved in the political process to let your legislators know your thoughts. For the record, I think the financial underpinnings of our healthcare system are disastrously messed up and something has to be done. And I don’t think anyone’s salary, including mine, is untouchable. But I also believe the SGR is an ineffective way to make the system more financially sound. That said, you don’t need to agree with me; I only recommend that you have a reasonably informed opinion.

One approach might be for your HM group to appoint a “political” or “marketplace” watchdog. This person could be charged with following issues closely and reporting back to the whole group during regular meetings.

“Marketplace” Risk

Medicare rates are only one part of the complex financial ecosystem on which we depend. It is awfully common, and I think pretty reasonable, for hospitalists to have a contractual arrangement with hospitals. The majority of the time, the hospital has most—or all—of the risk for the financial performance of the practice. In fact, most prospective hospitalists, especially those seeking their first jobs out after residency, say one of the most attractive reasons for choosing work as a hospitalist is that many practices provide a salary that is nearly fixed. Any variable components to the salary, such as those based on production or quality, are typically very small.

A hospitalist might think, “I want a practice that pays a fixed salary so I don’t have to worry about any business and financial issues other than when to show up to work.” In fact, a lot of recruitment ads trumpet this very idea (i.e., “you handle the doctoring and get to enjoy the wonderful recreational opportunities and schools our locale provides, and we’ll worry about all the business issues”). That may sound nice, but I worry it is a little short-sighted.

Here is another point of view, which is only slightly more complicated. In most cases, you should try to negotiate a contract that insulates you from “payor risk” (e.g., changes in payor mix and rates paid by payors don’t flow through to your compensation). But you should think twice before asking your employer to assume all the risk for staffing and scheduling decisions, such as whether you get the work done with 10 hospitalists or 11, or whether you have an evening admitter (“swing”) shift. If the employer holds all the risk, then the hospitalists give up nearly all their autonomy to decide how hard they want to work and how they want to schedule themselves. This causes problems for many practices, and is the No. 1 reason I’m called in as a consultant. Contrary to being very risky and stressful, many hospitalists find it liberating to assume financial risk for their staffing and workload decisions.

You should realize that if your employer pays you a fixed compensation, then someone has to ensure that you do enough work to justify that compensation. This can mean that the employer “issues decrees” (i.e., “we won’t add another provide to the practice until we’ve averaged ‘X’ encounters per month for 6 months”). A hospitalist might see this as unreasonable, yet the group has limited recourse since the employer has already guaranteed the compensation.

If you’d rather have more autonomy in your staffing and workload, then you will need to connect your paycheck to these decisions. Although it might sound terribly risky, those who make the switch often say they wouldn’t have it any other way. Most importantly, it ensures hospitalists have much more say in big decisions. TH

Dr. Nelson has been a practicing hospitalist since 1988 and is co-founder and past president of SHM. He is a principal in Nelson Flores Hospital Medicine Consultants, a national hospitalist practice management consulting firm (www.nelsonflores.com). He is also course co-director and faculty for SHM’s “Best Practices in Managing a Hospital Medicine Program” course. This column represents his views and is not intended to reflect an official position of SHM.

When I started writing this, Congress hadn’t settled the issue of the 21% cut in Medicare reimbursement for services called for by the sustainable growth rate (SGR) formula. Fortunately, Congress stepped up and passed another extension with a 2.2% pay increase; however, the quick fix only lasts until November.

The process is all too routine: The deadline for these reimbursement cuts looms, Medicare instructs its fiscal intermediaries (the organizations that actually write the checks to providers) to hold claims rather than pay at the lower rate, and, within a few days of the deadline passing, Congress decides to pass an extension, which allows Medicare to continue paying the historical (higher) rate for the time being.

Imagine Medicare reimbursement rates dropping 21% overnight. I suspect it would be cataclysmic. But I hear remarkably little chatter about this possibility. In fact, while with 2,500 other hospitalists for several days at HM10 in April, I didn’t hear a single person bring up the SGR issue.

One reason there isn’t more handwringing about the looming, draconian cuts is that we’ve been there before. In fact, reimbursement cuts required by the SGR have come up every year since 2001. Each time, Congress has chosen not to implement the cuts; and in some years it has approved reimbursement increases instead. So most in healthcare circles basically have come to expect Congress to pass last-minute legislation to avoid the drastic cuts. (SHM and most other medical societies want a repeal of the flawed SGR formula. Visit SHM’s Legislative Action Center, http://capwiz.com/hospitalmedicine/home/, to write your legislators and urge repeal of the SGR. It only takes about two minutes, and you don’t even need to remember who your representatives are; you just need to know your ZIP code.)

Don’t Be Too Smug

There is another reason many hospitalists, and other doctors who are employed and salaried by a large entity like a hospital, might not be more concerned about proposed cuts: They probably think their own salaries will be unaffected by decreases in reimbursement from Medicare and other payors. My experience is that a lot of hospitalists are so unconcerned about payor reimbursement rates that they aren’t even aware of the threatened Medicare cuts.

Their thinking goes something like this: “I’m paid mostly via a fixed annual salary with a small productivity and quality incentive. None of this is connected to the payor mix or collection rates from the patients I see. So if the portion of uninsured patients I see goes up, my compensation is unaffected. Or if payors decrease their rates, my compensation is unaffected. So I don’t need to sweat the possibility of a 21% decrease in Medicare rates. The hospital will have to make up the difference, so my salary is unaffected, and it will be up to bean counters at the hospital to get the numbers to work out.”

In fact, this is true, in theory, for the majority of hospitalists. But I think it is a mistake to assume your salary is untouchable. If Medicare were to cut rates by 21%, you’d better run to your hospital CEO’s office right away, because a long line will form immediately. Every doctor who sees patients at your hospital will be in that line asking the CEO to provide some money to offset the Medicare cuts, and I doubt any hospital will be able to satisfy their doctors without spending so much money that the hospital goes bankrupt or out of business.

Even if you have a valid contract that calls for your compensation to be paid independent of the amount of professional fee collections, a dire shortage of money could lead a hospital to lay off hospitalists or cancel the contract (most contracts would allow the hospital to do this simply by giving a 90-day notice).

I suggest that no hospitalist feel too smug about how well their employment contract protects the group from broader market forces like reimbursement rates. I doubt we’ll ever see an overnight 21% reduction in Medicare rates, but over time, we could see ever-increasing pressure to limit the growth in our incomes.

I believe every hospitalist should spend at least a little time following broader financial issues like this one, and get involved in the political process to let your legislators know your thoughts. For the record, I think the financial underpinnings of our healthcare system are disastrously messed up and something has to be done. And I don’t think anyone’s salary, including mine, is untouchable. But I also believe the SGR is an ineffective way to make the system more financially sound. That said, you don’t need to agree with me; I only recommend that you have a reasonably informed opinion.

One approach might be for your HM group to appoint a “political” or “marketplace” watchdog. This person could be charged with following issues closely and reporting back to the whole group during regular meetings.

“Marketplace” Risk

Medicare rates are only one part of the complex financial ecosystem on which we depend. It is awfully common, and I think pretty reasonable, for hospitalists to have a contractual arrangement with hospitals. The majority of the time, the hospital has most—or all—of the risk for the financial performance of the practice. In fact, most prospective hospitalists, especially those seeking their first jobs out after residency, say one of the most attractive reasons for choosing work as a hospitalist is that many practices provide a salary that is nearly fixed. Any variable components to the salary, such as those based on production or quality, are typically very small.

A hospitalist might think, “I want a practice that pays a fixed salary so I don’t have to worry about any business and financial issues other than when to show up to work.” In fact, a lot of recruitment ads trumpet this very idea (i.e., “you handle the doctoring and get to enjoy the wonderful recreational opportunities and schools our locale provides, and we’ll worry about all the business issues”). That may sound nice, but I worry it is a little short-sighted.

Here is another point of view, which is only slightly more complicated. In most cases, you should try to negotiate a contract that insulates you from “payor risk” (e.g., changes in payor mix and rates paid by payors don’t flow through to your compensation). But you should think twice before asking your employer to assume all the risk for staffing and scheduling decisions, such as whether you get the work done with 10 hospitalists or 11, or whether you have an evening admitter (“swing”) shift. If the employer holds all the risk, then the hospitalists give up nearly all their autonomy to decide how hard they want to work and how they want to schedule themselves. This causes problems for many practices, and is the No. 1 reason I’m called in as a consultant. Contrary to being very risky and stressful, many hospitalists find it liberating to assume financial risk for their staffing and workload decisions.

You should realize that if your employer pays you a fixed compensation, then someone has to ensure that you do enough work to justify that compensation. This can mean that the employer “issues decrees” (i.e., “we won’t add another provide to the practice until we’ve averaged ‘X’ encounters per month for 6 months”). A hospitalist might see this as unreasonable, yet the group has limited recourse since the employer has already guaranteed the compensation.

If you’d rather have more autonomy in your staffing and workload, then you will need to connect your paycheck to these decisions. Although it might sound terribly risky, those who make the switch often say they wouldn’t have it any other way. Most importantly, it ensures hospitalists have much more say in big decisions. TH

Dr. Nelson has been a practicing hospitalist since 1988 and is co-founder and past president of SHM. He is a principal in Nelson Flores Hospital Medicine Consultants, a national hospitalist practice management consulting firm (www.nelsonflores.com). He is also course co-director and faculty for SHM’s “Best Practices in Managing a Hospital Medicine Program” course. This column represents his views and is not intended to reflect an official position of SHM.