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Ask the Expert
| Author: Dr. Sheila Dunn |
| Article Date: 10/1/2007 |
POLs Exempt from Competitive Bidding
Q. You mentioned that any lab with revenues over $100,000 would have to participate in the new Competitive Bidding trials. Is this net or gross revenues? Our POL business is at stake.
A. All testing that occurs in a setting where patients are seen (e.g., all POLs) are exempt from the competitive bidding demonstration project. If you own a laboratory located where patients are not seen, then the stipulation for labs with $100,000 in gross revenues would apply. In any case, I still strongly believe that the concept of competitive bidding will never materialize, since its basic premise is flawed. Essentially, competitive bidding says that lab testing is a commodity product, and we all know that laboratories and test results differ from location to location in terms of their ability to deliver results in a timely fashion as well as offer interpretive information about their tests.
Cardiac Risk Testing for Primary Care Settings
Q. What exact tests do you recommend for cardiac risk in a primary care setting?
A. Total and HDL cholesterol are absolutely necessary and triglycerides adds the icing on the cake for detecting patients with cardiac risk. I think the megabuck tests offered by some labs (e.g., Berkeley HeartLabs) for LDL and HDL subfractions and tests such as apolipoprotein A and A-1 might be great for cardiologists who are following people with complicated cardiac problems, but are overkill for primary care practitioners who will refer these types of patients.
In the August 15 JAMA, the authors suggest that 'Measuring other types of fatty substances in the blood such as apolipoprotein B and A-I does not substantially improve the accuracy of the prediction for heart disease over the total cholesterol to HDL ratio.
Non-invasive Cholesterol Test
Q. Is there a lipid test on the market that doesnÕt require a blood draw (fingerstick) like there is for glucose?
A. In 2008, AstraZeneca plans to market PreMDÕs Skin Cholesterol Test called PREVU, to physician offices, hospitals and retail chains. AstraZeneca also plans to target the life insurance market. The noninvasive CLIA-waived test measures skin tissue cholesterol, a novel risk factor for coronary artery disease, and requires no patient fasting. Two drops of a cholesterol binding agent and an enzymatic substrate are placed directly onto the patientÕs skin and skin cholesterol levels are quantified by reading the color change with a palm-sized spectrophotometer. If you are aware of studies comparing the efficacy of skin cholesterol with the total cholesterol/HDL ratio, please respond to this column.
INCLUDEPICTURE 'http://www.ioma.com/newspics/0708DTTR3g1.jpg' \* MERGEFORMATINET PreMD's PREVU POC skin cholesterol test
Non-Physician Office Visits
Q. Our physicians are considering starting a coagulation clinic. Can we also bill for an office visit when patients come in for their PT/INR test?
A. Not if the patient just comes in for a test and leaves, but this scenario should be as rare as henÕs teeth. Patients visiting the doctor pretty much figure that if they drove all the way to the office, they darn well better get their moneyÕs worth (even if itÕs a $5 copay) and Š what the heck Š get at least a cursory assessment. For patients coming in regularly for INR tests, your program should include a patient checklist for each visit, which includes BP, temp, visual exam for petechiae and bruising, etc. This is usually done by a nurse or other non-physician provider.
Just so you know, hereÕs how office visits are billed for established patients, followed by the approximate reimbursement:
É.Warning!! Do not read the following if you do not have a sense of humor!!!
99211 Š a non-physician office visit ($22)
99212 Š a minor complaint; probably just trying to get a day off work or some good pain killers ($38)
99213 Š a mid-level visit lasting about 15 minutes ($52)
99214 Š patient really messed up; probably looking for a disability claim so they can retire ($82)
99215 Š patient should just be taken out behind the barn and shot ($118)
Most physician offices that maintain a Coumadin clinic bill the code for the test plus a 99211 (non-physician visit).
Refilling Lotion and Soap Bottles
Q. A new employee saw us topping off our hand lotion and soap dispensers and went ballistic. She said there was a regulation against this. Is there?
A. Topping off is an invitation to infection according to the CDC, which advises to replace expired containers or those with low levels with a new bottle or container.
Emergency Showers
Q. WeÕre setting up a large lab from scratch in our multispecialty practice. The med tech they hired asked me where the emergency shower would be. I previously worked in another practice with a lab that didnÕt have such a shower. Is it required or does this person just want a place to freshen up after her lunchtime jog?
A. To my knowledge (and I live, sleep, eat and breathe OSHA and CLIA regulations!), OSHA has no such requirement for typical POLs. Large laboratories, such as hospital labs and independent labs, do need to have a shower, but that's because they use huge quantities of bulk chemicals and come under OSHA's Chemical Hygiene Standard. Because physician office labs donÕt keep bulk chemicals, they come under OSHA's Hazard Communication Standard, which does not require showers (only eyewashes). Bottom line, if your POL will perform sophisticated tests, such as RIA, or will use bulk quantities of chemicals (hematology reagents don't apply here), then you would also come under the Chemical Hygiene Standard and need a shower.
CLIA-waived Hepatitis C and Blood Gases
Q. Is there an easy hepatitis C test kit that doctors can do in their offices? How about analyzers to do blood gases that are CLIA-waived?
A. No to both, sorry! At this point, if you want to do either test, you have to bite the bullet and become moderately complex under CLIA. If your facility is now currently waived, an upgrade would mean larger fees, inspections every 2 years and proficiency testing, amongst other requirements for recordkeeping and Quality Assessment.
Billing for Sample Kits
Q. If a doctorÕs office receives free samples of test kits and run patient tests with them, can they bill Medicare for these tests?
A. I strongly recommend against doing this. IÕm no attorney, but judging from another high-profile case, doctors and the company who gave them the free goods, could get into hot water for doing this. In 2001, TAP pharmaceuticals ended up paying $875 million to settle charges for helping doctors bill Medicare for free cancer drugs. For more information about this case, see http://www.usdoj.gov/opa/pr/2001/October/513civ.htm.
Mercury Spills Raise Blood Pressure in Medical Facilities
Q. Our local newspaper ran a story about a ban on mercury thermometers in our city. Where can I find out if medical practices have to comply with this requirement? Also, what about blood pressure equipment?
A. Remember when, as kids, weÕd roll those fun, shiny beads of mercury around in our tiny hands, and then try stuffing them up our little brotherÕs nose? Well, scientists now inform us, in no uncertain terms, that mercury is dangerous! Could that explain an entire generation? But I digressÉÉ
In a medical setting, mercury is dangerous when itÕs breathed in - like when an employee has to clean up a broken mercury sphygmomanometer or thermometer from the doctorÕs carpeted exam room.
And because of that, clinics in places like McAllen, Tex., Marquette, Mich., College Park, Md., have been forced to evacuate recently because of mercury spills from a sphygmomanometer. While most thermometers contain only 0.5 grams of mercury, blood pressure units (the major culprit in mercury spills) contain a whopping 70 to 90 grams of mercury, costing an average of $1,539 to clean up. (And that doesnÕt include treatment for exposures, the cost of involvement by EPA, or dealing with the PR nightmare.)
The other reason that mercury is front-page news is that seafood-loving Americans are voraciously eating it. Discarded or spilled mercury has a propensity to slither right down into our wastewater stream and become food for little fish that get eaten by big fish, which get eaten by humans. Warnings on the evening news urge people, especially pregnant women, to avoid eating fresh water fish.
To finally answer your question, a list of certain states and localities that have banned mercury is available at HYPERLINK 'http://www.noharm.org/mercury/ordinances'http://www.noharm.org/mercury/ordinances, but the last action taken on this site was in 2003. I know for sure that MichiganÕs law banning the sale and use of mercury-containing sphygmomanometers and the sale of mercury-containing gastrointestinal devices begins Jan 1, 2008, so I suspect that list is not up to date. Perhaps itÕs best to call your local EPA for the specifics about your particular laws.
Struggling to eliminate mercury-containing products? Check out Quality AmericaÕs Resource Center at HYPERLINK 'http://www.quality-america.com/resource-center/osha-resources' http://www.quality-america.com/resource-center/osha-resources to download EPAÕs Eliminating Mercury- Environmental Best Practice. Look under ŅOSHA Watch Newsletter Resources.Ó
Q. You mentioned that any lab with revenues over $100,000 would have to participate in the new Competitive Bidding trials. Is this net or gross revenues? Our POL business is at stake.
A. All testing that occurs in a setting where patients are seen (e.g., all POLs) are exempt from the competitive bidding demonstration project. If you own a laboratory located where patients are not seen, then the stipulation for labs with $100,000 in gross revenues would apply. In any case, I still strongly believe that the concept of competitive bidding will never materialize, since its basic premise is flawed. Essentially, competitive bidding says that lab testing is a commodity product, and we all know that laboratories and test results differ from location to location in terms of their ability to deliver results in a timely fashion as well as offer interpretive information about their tests.
Cardiac Risk Testing for Primary Care Settings
Q. What exact tests do you recommend for cardiac risk in a primary care setting?
A. Total and HDL cholesterol are absolutely necessary and triglycerides adds the icing on the cake for detecting patients with cardiac risk. I think the megabuck tests offered by some labs (e.g., Berkeley HeartLabs) for LDL and HDL subfractions and tests such as apolipoprotein A and A-1 might be great for cardiologists who are following people with complicated cardiac problems, but are overkill for primary care practitioners who will refer these types of patients.
In the August 15 JAMA, the authors suggest that 'Measuring other types of fatty substances in the blood such as apolipoprotein B and A-I does not substantially improve the accuracy of the prediction for heart disease over the total cholesterol to HDL ratio.
Non-invasive Cholesterol Test
Q. Is there a lipid test on the market that doesnÕt require a blood draw (fingerstick) like there is for glucose?
A. In 2008, AstraZeneca plans to market PreMDÕs Skin Cholesterol Test called PREVU, to physician offices, hospitals and retail chains. AstraZeneca also plans to target the life insurance market. The noninvasive CLIA-waived test measures skin tissue cholesterol, a novel risk factor for coronary artery disease, and requires no patient fasting. Two drops of a cholesterol binding agent and an enzymatic substrate are placed directly onto the patientÕs skin and skin cholesterol levels are quantified by reading the color change with a palm-sized spectrophotometer. If you are aware of studies comparing the efficacy of skin cholesterol with the total cholesterol/HDL ratio, please respond to this column.
INCLUDEPICTURE 'http://www.ioma.com/newspics/0708DTTR3g1.jpg' \* MERGEFORMATINET PreMD's PREVU POC skin cholesterol test
Non-Physician Office Visits
Q. Our physicians are considering starting a coagulation clinic. Can we also bill for an office visit when patients come in for their PT/INR test?
A. Not if the patient just comes in for a test and leaves, but this scenario should be as rare as henÕs teeth. Patients visiting the doctor pretty much figure that if they drove all the way to the office, they darn well better get their moneyÕs worth (even if itÕs a $5 copay) and Š what the heck Š get at least a cursory assessment. For patients coming in regularly for INR tests, your program should include a patient checklist for each visit, which includes BP, temp, visual exam for petechiae and bruising, etc. This is usually done by a nurse or other non-physician provider.
Just so you know, hereÕs how office visits are billed for established patients, followed by the approximate reimbursement:
É.Warning!! Do not read the following if you do not have a sense of humor!!!
99211 Š a non-physician office visit ($22)
99212 Š a minor complaint; probably just trying to get a day off work or some good pain killers ($38)
99213 Š a mid-level visit lasting about 15 minutes ($52)
99214 Š patient really messed up; probably looking for a disability claim so they can retire ($82)
99215 Š patient should just be taken out behind the barn and shot ($118)
Most physician offices that maintain a Coumadin clinic bill the code for the test plus a 99211 (non-physician visit).
Refilling Lotion and Soap Bottles
Q. A new employee saw us topping off our hand lotion and soap dispensers and went ballistic. She said there was a regulation against this. Is there?
A. Topping off is an invitation to infection according to the CDC, which advises to replace expired containers or those with low levels with a new bottle or container.
Emergency Showers
Q. WeÕre setting up a large lab from scratch in our multispecialty practice. The med tech they hired asked me where the emergency shower would be. I previously worked in another practice with a lab that didnÕt have such a shower. Is it required or does this person just want a place to freshen up after her lunchtime jog?
A. To my knowledge (and I live, sleep, eat and breathe OSHA and CLIA regulations!), OSHA has no such requirement for typical POLs. Large laboratories, such as hospital labs and independent labs, do need to have a shower, but that's because they use huge quantities of bulk chemicals and come under OSHA's Chemical Hygiene Standard. Because physician office labs donÕt keep bulk chemicals, they come under OSHA's Hazard Communication Standard, which does not require showers (only eyewashes). Bottom line, if your POL will perform sophisticated tests, such as RIA, or will use bulk quantities of chemicals (hematology reagents don't apply here), then you would also come under the Chemical Hygiene Standard and need a shower.
CLIA-waived Hepatitis C and Blood Gases
Q. Is there an easy hepatitis C test kit that doctors can do in their offices? How about analyzers to do blood gases that are CLIA-waived?
A. No to both, sorry! At this point, if you want to do either test, you have to bite the bullet and become moderately complex under CLIA. If your facility is now currently waived, an upgrade would mean larger fees, inspections every 2 years and proficiency testing, amongst other requirements for recordkeeping and Quality Assessment.
Billing for Sample Kits
Q. If a doctorÕs office receives free samples of test kits and run patient tests with them, can they bill Medicare for these tests?
A. I strongly recommend against doing this. IÕm no attorney, but judging from another high-profile case, doctors and the company who gave them the free goods, could get into hot water for doing this. In 2001, TAP pharmaceuticals ended up paying $875 million to settle charges for helping doctors bill Medicare for free cancer drugs. For more information about this case, see http://www.usdoj.gov/opa/pr/2001/October/513civ.htm.
Mercury Spills Raise Blood Pressure in Medical Facilities
Q. Our local newspaper ran a story about a ban on mercury thermometers in our city. Where can I find out if medical practices have to comply with this requirement? Also, what about blood pressure equipment?
A. Remember when, as kids, weÕd roll those fun, shiny beads of mercury around in our tiny hands, and then try stuffing them up our little brotherÕs nose? Well, scientists now inform us, in no uncertain terms, that mercury is dangerous! Could that explain an entire generation? But I digressÉÉ
In a medical setting, mercury is dangerous when itÕs breathed in - like when an employee has to clean up a broken mercury sphygmomanometer or thermometer from the doctorÕs carpeted exam room.
And because of that, clinics in places like McAllen, Tex., Marquette, Mich., College Park, Md., have been forced to evacuate recently because of mercury spills from a sphygmomanometer. While most thermometers contain only 0.5 grams of mercury, blood pressure units (the major culprit in mercury spills) contain a whopping 70 to 90 grams of mercury, costing an average of $1,539 to clean up. (And that doesnÕt include treatment for exposures, the cost of involvement by EPA, or dealing with the PR nightmare.)
The other reason that mercury is front-page news is that seafood-loving Americans are voraciously eating it. Discarded or spilled mercury has a propensity to slither right down into our wastewater stream and become food for little fish that get eaten by big fish, which get eaten by humans. Warnings on the evening news urge people, especially pregnant women, to avoid eating fresh water fish.
To finally answer your question, a list of certain states and localities that have banned mercury is available at HYPERLINK 'http://www.noharm.org/mercury/ordinances'http://www.noharm.org/mercury/ordinances, but the last action taken on this site was in 2003. I know for sure that MichiganÕs law banning the sale and use of mercury-containing sphygmomanometers and the sale of mercury-containing gastrointestinal devices begins Jan 1, 2008, so I suspect that list is not up to date. Perhaps itÕs best to call your local EPA for the specifics about your particular laws.
Struggling to eliminate mercury-containing products? Check out Quality AmericaÕs Resource Center at HYPERLINK 'http://www.quality-america.com/resource-center/osha-resources' http://www.quality-america.com/resource-center/osha-resources to download EPAÕs Eliminating Mercury- Environmental Best Practice. Look under ŅOSHA Watch Newsletter Resources.Ó