Header Tag Line

Laboratory Compliance Question of the Week


Archive

To return to the current Laboratory Compliance Question of the Week, click here

September 29, 2008

Question:

We have a question about using standing orders or protocols for urine cultures (UC) when the urinalysis (UA) was abnormal. We are getting some denials on UC because we do not have diagnoses that cover it

For example, the physician orders a UA that comes back abnormal, and the lab automatically completes the UC per protocol. The order has a diagnosis that covers the UA but no UC diagnosis. Another example: The physician orders a UA/UC with only a diagnosis that will cover the UA.

Is it appropriate to use abnormal findings code? How are other facilities handling this?

Answer:

The use of urine protocols for automatic ordering of urine cultures is not recommended. You will need the treating physician's indication for the urine culture and the diagnosis provided by the physician for billing of the urine culture.

During the development stage of the NCDs for laboratory, CMS commented that the urine culture had been added to the NCD based on the high utilization of the CPT codes with lack of supporting documentation for medical necessity.

The laboratory may establish a protocol by which it is triggered to notify the physician of the results of the urinalysis and request additional direction as to whether a urine culture is needed. This would then need to be immediately followed by a documented order from the physician. The order should include a diagnosis to support the addition of the culture. Laboratory personnel and / or nursing personnel are not approved ordering / diagnosing professionals; therefore, the laboratory staff would not be able to add a diagnosis of UTI or abnormal urine constituent in order to support medical necessity.

When the diagnosis provided for the urinalysis does not support the billing of the urine culture, this must be communicated to the physician as the patient is most likely not present to sign an ABN. Without adequate diagnosis the procedure will trigger a "medical necessity write-off lacking ABN issuance."

-------------------------------------------------------------------------------

September 22, 2008

Question:

I would like you to clarify your comment on the confirmation of verbal orders covered in the August 11 Compliance Question of the Week. You state that for hospital inpatients and outpatients, Medicare requires written confirmation within 48 hours. This is significantly different than the CLIA requirement that states within 30 days. This is very confusing for the clinical laboratory.

Answer:

As stated in the answer to that question, the revised hospital conditions of participation for medical record services requires that verbal orders be subsequently authenticated in the medical record within 48 hours (the federal standard) for inpatients and outpatients, unless there is a state law that specifies a different time frame. If there is a state law different from 48 hours, then providers would follow that. As you stated, however, CLIA allows 30 days.

The Centers for Medicare & Medicaid Services (CMS) states that it does not believe that CLIA's 30-day timeframe for authentication is consistent with the intent to intercept an error as soon as possible. Given the lack of data to support a specific timeframe, CMS says it will continue to defer to state law, when there is one establishing an authentication timeframe for the verbal order.

Note that It is possible that a hospital verbal order for a laboratory test could be authenticated in compliance with the CLIA regulatory standard of authentication (i.e., within 30 days), but nonetheless be out of compliance with the hospital medical records' services requirement. Because CLIA laboratories, even those physically situated in a hospital, are surveyed for compliance only with CLIA regulations, the laboratory would not be cited for a deficiency by a CLIA survey team.

However, hospital surveyors would cite the hospital's inpatient or outpatient recordkeeping for deficiencies under the medical record services conditions of participation if the lab order originated for a patient during a hospital inpatient stay or hospital outpatient clinic visit and no state law otherwise permitted a delay of that length.

See the following sources for more on this:
· State Operations Manual (Publication 100-07), at http://www.cms.hhs.gov/Manuals/IOM/list.asp
· Chapter 6-Special Procedures for Laboratories-of the SOM can be located at http://www.cms.hhs.gov/manuals/downloads/som107c06.pdf.

-------------------------------------------------------------------------------

September 15, 2008

Question:

We sometimes receive test requests do not include a sign, symptom or diagnosis. What steps must we take to get one?

Answer:

The laboratory must contact the physician for this information. When medical documentation is obtained from a physician or other authorized individual after receipt of the specimen and the requisition form, it should be maintained as part of the patient record. If contact is made by phone, this documentation must include notation of the identification of the person who contacted the physician, who they spoke with, the date and the time of the conversation. If documentation is received electronically or by fax, place the document into the record as long as it contains identification of the physician or person authorized to provide that diagnosis.

-------------------------------------------------------------------------------

September 8, 2008

Question:

In last week's answer you referred to a change for 2009 to the coding of prostate saturation biopsies. Can you provide more details and a resource?

Answer:

In the 2009 proposed rule for the Medicare physician fee schedule (MPFS), the Centers for Medicare & Medicaid Services (CMS) states that it believes that paying individually for review of each core sample submitted grossly overpays for the pathological interpretation and report for this service. So, it has proposed the four G codes below to more accurately represent the pathologic evaluation, interpretation, and report for this service, which would be carrier priced.

GXXX1 Surgical pathology, gross and microscopic examination for prostate needle saturation biopsy sampling, 1-20 specimens
GXXX2 Surgical pathology, gross and microscopic examination for prostate needle saturation biopsy sampling, 21-40 specimens
GXXX3 Surgical pathology, gross and microscopic examination for prostate needle saturation biopsy sampling, 41-60 specimens
GXXX4 Surgical pathology, gross and microscopic examination for prostate needle saturation biopsy sampling, greater than 60 specimens

This information can be found in CMS-1403-P (2009 proposed MPFS) under "Spotlights" at http://www.cms.hhs.gov/center/physician.asp.

-------------------------------------------------------------------------------

September 1, 2008

Question:

What is the correct coding for a prostate saturation biopsy?

Answer:

A prostate saturation biopsy is a technique currently described by the following Category III CPT code:

0137T Biopsy, prostate, needle, saturation sampling for prostate mapping

Typically, this service entails 40 to 80 core samples taken from the prostate under general anesthesia. Currently, the biopsies are reviewed by a pathologist, and this service is captured under CPT code 88305 (surgical pathology, gross and microscopic examination), which is separately billed by the physician for each core sample taken. However, the 2009 proposed rule for the Medicare physician fee schedule (MPFS) contains changes to the coding.

For the MPFS proposed rule, go to http://edocket.access.gpo.gov/2008/pdf/E8-14949.pdf.

-------------------------------------------------------------------------------

August 25, 2008

Question:

A patient signs an ABN to agree to pay for a lab test. When she got the bill, she wanted us to request additional codes from the doctor and re-file the claim with Medicare. Can we re-file the claim with Medicare if the patient has signed an ABN and the physician does provide a code that meets medical necessity?

Answer:

Remember: Medical necessity of an outpatient procedure is determined by the highest level of known diagnosis, sign or symptom prior to the procedure being performed. The advance beneficiary notice (ABN) is just that-an advance notice of non-coverage based on lack of documentation validating medical necessity.

If a covered diagnosis is not available from the treating physician prior to a test being ordered and performed, he or she should supply the most definitive diagnosis known at the time. This is often a sign or symptom prompting the need for the test.

If the patient requests that the physician supplies additional information before he/she signs the ABN, then the information should be obtained by either the patient or the treating/performing facility prior to initiating the procedure. The patient may appeal the decision of financial liability with the fiscal intermediary (FI) after the claim is denied.

In the instance where the beneficiary appeals the financial liability, he/she will be asked to provide a copy of the signed ABN to the FI/Part A Medicare administrative contractor (MAC). The FI/Part A MAC may also request a copy of the signed ABN and physician order from the facility.

-------------------------------------------------------------------------------

August 18, 2008

Question:

You previously provided information about the new law that allows independent laboratories to continue to bill for the TC of physician pathology services furnished to hospital patients. Does the law include any other provisions relating to laboratories?

Answer:

Yes, the Medicare Improvements for Patients and Providers Act (MIPPA) of 2008 (HR 6331) repeals the Medicare competitive bidding demonstration project for clinical laboratory services. It also includes a provision to apply a 4.5 percent update to the procedures covered under the 2009 clinical laboratory fee schedule and a provision related to reference lab services paid to critical access hospitals (CAHs). Beginning July 1, 2009, CAH reference lab services can be billed as outpatient services and will be paid under the cost reimbursement methodology. .

Another key change is that MIPPA repeals the statutorily mandated 10.6 percent cut to payments made under the Medicare physician fee schedule (MPFS) that took effect July 1 (as required by previous law). That reduction was replaced with a 0.5 percent increase, retroactive to July 1, 2008, for the rest of this year. For 2009, a 1.1 percent update will be made to MPFS rates.

HR 6331 can be found at http://thomas.loc.gov/. Under "Search Bill Text," type HR 6331, and select "Bill Number" under that entry.

-------------------------------------------------------------------------------

August 11, 2008

Question:

Can you tell me whether the laboratory compliance question posted on July 21 re: the authentication of verbal orders pertains to inpatient orders, outpatient orders or both?

Answer:

The requirement to authenticate a verbal order applies to both inpatients and outpatients. According to a September 14, 2007, memo from the Survey and Certification Group to state survey agency directors, hospital surveyors assess compliance with the hospital conditions of participation (CoPs) by looking at the hospitals' standard operating procedures. The revised CoP for medical record services requires that verbal orders be subsequently authenticated in the medical record within 48 hours, unless there is a state law that specifies a different time frame.

For more information about this see, see http://www.cms.hhs.gov/SurveyCertificationGenInfo/Downloads/SCLetter07-37.pdf.

-------------------------------------------------------------------------------

August 4, 2008

Question:

What is happening regarding independent labs and the billing of the technical component (TC) of pathology services? I know that something was supposed to change about this policy on June 31. Did it?

Answer:

On July 16, Congress passed the Medicare Improvements for Patients and Providers Act (MIPPA) of 2008. This legislation (HR 6331) brings welcomed news to laboratories, including the reinstatement of the moratorium that allows independent laboratories to bill for the TC of physician pathology services furnished to hospital patients. For details, see Transmittal 1561 at http://www.cms.hhs.gov/transmittals/downloads/R1561CP.pdf and provider-information memo MM6042 at http://www.cms.hhs.gov/MLNMattersArticles/downloads/MM6042.pdf.

-------------------------------------------------------------------------------

July 28, 2008

Question:

When charging for laboratory tests, is it a requirement to charge upon result, or is it acceptable to charge upon receipt of the specimen?

Answer:

The date of service associated with the charge is the important element, regardless of whether the laboratory generates the charge at collection, accession or result. The date that transfers to the claim with the charge must represent the date of specimen collection with the few exceptions being defined by CMS as those tests collected over multiple days (24-hour urine), procedures performed on archived specimens or those tests related to chemotherapy sensitivity.

-------------------------------------------------------------------------------

July 21, 2008

Question:

Can you provide hospital guidelines related to authenticating verbal orders?

Answer:

Authentication of a verbal order may be written, electronic, or faxed. The hospital's policies and procedures' manual must outline the accepted method for establishing the identity of the practitioner who has given a verbal order, including verification of the author of faxed verbal orders or computer entries. Anyone who is authorized to accept a verbal order must be aware of the requirement to document the date and the time of the order in the record and to sign the verbal order in accordance with hospital policy.

CMS expects hospital policies and procedures for verbal orders to include a read-back and verification process. The prescribing practitioner must verify, sign, date and time the order as soon as possible after issuing it, in accordance with hospital policy, and state and federal requirements. Using the Merriam-Webster dictionary definition of "prompt" CMS has defined the time frame for verification of verbal orders as "performed readily or immediately."

-------------------------------------------------------------------------------

July 14, 2008

Question:

Any news about whether CMS will continue on with the laboratory bidding demonstration project?

Answer:

According to a press release from the American Clinical Laboratory Association, Congress passed by unanimous consent "The Medicare Improvement for Patients and Providers Act of 2008" (HR 6331). The bill now goes to the President.

The ACLA reports that this legislation repeals the laboratory competitive bidding demonstration project and extends the so-called technical component "grandfather clause" for 18 months and reverses the 10.6 percent cut in physician reimbursements that took effect on July 1. For more details, see http://www.clinical-labs.org/documents/FORIMMEDIATERELEASE.pdf.

-------------------------------------------------------------------------------

July 7, 2008

Question:

Regarding the latest update of the lab NCDs, what kind of changes have been made?

Answer:

The quarterly revisions to the laboratory national coverage determinations (NCDs) include the following:

- Updating descriptions for CPT codes;
- Updating descriptions for ICD-9-CM codes;
- Adding or deleting ICD-9-CM codes in the list of those covered by Medicare; and
- Adding or deleting ICD-9-CM codes in the list of those that do not support medical necessity.

Many of the ICD-9-CM diagnosis code changes are significant for reimbursement, because they involve the addition of certain codes with fifth-digit specificity, and the corresponding deletion of four-digit codes that are no longer sufficient to support medical necessity.

All of the diagnosis codes and other changes are listed in Transmittal 1531 at
http://www.cms.hhs.gov/Transmittals/downloads/R1531CP.pdf.

-------------------------------------------------------------------------------

June 30, 2008

Question:

I thought CMS was supposed is update the lab NCDs on a quarterly basis but I haven't seen any updates recently. Can you point me in the right direction to find these?

Answer:

It's true that the Centers for Medicare & Medicaid Services (CMS) has not updated the edit module for the laboratory national coverage determinations (NCDs) since April 2007. It is supposed to issues these updates on a quarterly basis. However, in Transmittal 1531, CMS does provide all changes that should have been made since April 2007 to the present. These changes take effect July 1. You can find all you need to know about this update at http://www.cms.hhs.gov/Transmittals/downloads/R1531CP.pdf.

-------------------------------------------------------------------------------

June 23, 2008

Question:

Where can I find help for meeting the 2003 requirements outlined by CMS and CDC guidelines related to quality and personnel rules for CLIA labs?

Answer:

The Centers for Medicare & Medicaid Services (CMS) provides assistance for meeting these requirements in the Survey Procedures and Interpretative Guidelines, which are included as Appendix C of the Medicare State Operations Manual. This manual reflects the current federal regulations related to facility administration and day-to-day laboratory operations. The information in that appendix is the same guidance that CLIA surveyors use when they assess a laboratory's performance. You can obtain a current copy from the CLIA web site at http://cms.hhs.gov/manuals/Downloads/som107ap_c_lab.pdf.

-------------------------------------------------------------------------------

June 16, 2008

Question:

What revenue codes must be reported for the Medicare blood deductible?

Answer:

To ensure correct application of the Medicare blood deductible, providers should use revenue code 381 (packed red cells) to report charges for whole units of packed red cells. For charges for whole units of whole blood, use revenue code 382 (whole blood). Not reporting the correct revenue code will cause your claim to be returned. (Note: Revenue code 380 is not a valid revenue code for Medicare.)

CMS also provided a few other revenue code guidelines in Transmittal 1495 (http://www.cms.hhs.gov/transmittals/downloads/R1495CP.pdf). Providers should bill split units of packed red cells and whole blood using revenue code 389 (other blood) and should not use revenue codes 381 or 382. Providers should bill split units of other blood products using the applicable revenue codes for the blood product type, such as 383 (plasma) or 384 (platelets), rather than 389.

-------------------------------------------------------------------------------

June 9, 2008

Question:

To what does the Part A blood deductible apply in regard to billing blood and blood products for hospital inpatients?

Answer:

The Part A blood deductible provision applies to whole blood and red blood cells, and reporting of the number of pints is applicable to both prospective payment system (PPS) and non-PPS hospitals. Hospitals should report charges for red blood cells using revenue code 381, and charges for whole blood using revenue code 382.

This information and more about billing blood and blood products can be found in transmittal 1495 at http://www.cms.hhs.gov/transmittals/downloads/R1495CP.pdf.

-------------------------------------------------------------------------------

June 2, 2008

Question:

Our vendor has given us coding instructions for its test kits. Does Medicare accept these as valid instructions?

Answer:

Be wary of vendor recommendations or communications that provide coding instruction for test kits. Compare all such communications against the CPT descriptions as well as billing guidance issued by the American Medical Association and the Centers for Medicare & Medicaid Services (CMS). Most test kits that have been cleared for waived and / or moderate complexity testing will have the approved CPT listed in the CMS listing of waived procedures.

In addition, information as to the defined methodology may be found in the CLIA database housed at the Food & Drug Administration's website at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCLIA/clia.cfm

-------------------------------------------------------------------------------

May 26, 2008

Question:

Last week you mentioned that Medicare does pay for non-hospital patients but didn't mention the policy for critical access hospitals (CAHs). Can you please address this?

Answer:

For CAHs, payment for clinical diagnostic laboratory tests is made at 101 percent of reasonable cost but only if the individuals are outpatients of the CAH and are physically present when the specimens are collected. Payment for non-patients (specimen only, TOB 14X) who are not registered outpatients at the time of specimen collection will be made on the clinical diagnostic laboratory fee schedule. Such services are covered to the extent appropriate, says the Centers for Medicare & Medicaid Services in Transmittal 82 at http://www.cms.hhs.gov/transmittals/downloads/R82BP.pdf.

-------------------------------------------------------------------------------

May 19, 2008

Question:

What is a "nonhospital patient," and how does being one affect billing in a hospital?

Answer:

The Centers for Medicare & Medicaid Services (CMS) defines a nonhospital patient as an individual who is neither an inpatient nor outpatient of the hospital furnishing the service. Primarily, they are individuals from whom a specimen has been taken and sent to the hospital for analysis, and the patient does not receive hospital outpatient services on the same day.

In Chapter 6, Section 70.5, of the Medicare Benefit Policy Manual, CMS states that the following applies to all hospitals except critical access hospitals (CAHs) and Maryland-waiver hospitals. If a beneficiary receives hospital outpatient services on the same day as a specimen collection and laboratory test, then the patient is considered to be a registered hospital outpatient and cannot be considered to be a non-patient on that day for purposes of the specimen collection and laboratory test. However, if the non-CAH or Maryland-waiver hospital only collects or draws a specimen from the beneficiary, and the beneficiary does not also receive hospital outpatient services on that day, the hospital may choose to register the beneficiary as an outpatient for the specimen collection or bill for these services as non-patient on the 14X bill type.

For this information and more, see Transmittal 82 at http://www.cms.hhs.gov/transmittals/downloads/R82BP.pdf.

-------------------------------------------------------------------------------

May 12, 2008

Question:

How is a hospital paid when it hires an independent lab to perform its tests?

Answer:

When the hospital makes arrangements with others for diagnostic services, such services are covered under Part B as diagnostic tests whether furnished in the hospital or in other facilities. According to Chapter 6, Section 20.4.5 of the Medicare Benefit Policy Manual, independent lab services furnished to an outpatient under arrangements with the hospital are covered only under the "diagnostic laboratory tests" provisions of Part B but are to be billed along with other services to outpatients. For more details about this, see Transmittal 82 at http://www.cms.hhs.gov/transmittals/downloads/R82BP.pdf.

-------------------------------------------------------------------------------

May 5, 2008

Question:

Can you provide a definition of "group tests"?

Answer:

Group tests are panels or profiles (sometimes referred to as order-entry panels) that result in the billing of multiple CPT codes. Generally, reference labs have all components of panels and profiles listed in their catalogs. Unfortunately, the catalogs can become outdated quickly, so be sure to check with your reference lab to validate the codes. If you bill Medicare for a code, then you are liable-not the reference lab, even if it had the incorrect code printed in its catalog.

-------------------------------------------------------------------------------

April 28, 2008

Question:

How does the Centers for Medicare & Medicaid Services (CMS) determine the units of service for its medically unlikely edits (MUEs)?

Answer:

The basis for the edit is the unit of service most commonly reported for a particular code on the vast majority of claims processed by CMS; this becomes the maximum allowed line item limit. Through the claims processing systems, CMS will then evaluate each line item submitted by a single provider for a single beneficiary on a single date of service and will either return to provider (RTP) or deny units in excess of the allowable.

Because this is a per-line edit, laboratories must, where appropriate, line-item bill and apply modifiers as indicated to identify duplicate testing performed on subsequently collected specimens (modifier 91) or specimens collected from separate and distinct anatomical sites (modifier 59).

-------------------------------------------------------------------------------

April 21, 2008

Question:

When codes 87206 and 87260 are reported, will Medicare pay for both?

Answer:

According to the national correct coding initiative (NCCI) policies, the two codes you mention (see descriptors below) are bundled. Code 87206 is a component code of 87260-the comprehensive code. Laboratories would report only the comprehensive procedure and bundle the component code.

87206 Smear, primary source with interpretation; fluorescent and/or acid fast stain for bacteria, fungi, parasites, viruses or cell types
87260 Infectious agent antigen detection by immunofluorescent technique; adenovirus

An instruction note in the CPT manual states the following: 'Infectious agents by antigen detection, direct fluorescence microscopy, or nucleic acid probe techniques should be reported as precisely as possible. The most specific code possible should be reported. Therefore, code 87206 is included in code 87260 based on this CPT manual guideline."

-------------------------------------------------------------------------------

April 14, 2008

Question:

Is there any news about the revised ABN?

Answer:

Yes, on September 1, 2008, healthcare providers must begin using the revised Advance Beneficiary Notice (ABN) of Noncoverage (i.e., the CMS-R-131 form). This form replaces the general-use ABN (CMS-R-131-G) and the laboratory ABN (CMS-R-131-L) for physician-ordered lab tests, which are now being used.

Providers (including independent laboratories), physicians, practitioners, and suppliers may now begin using the revised ABN for all situations where Medicare payment is expected to be denied. However, during the six-month transition period, the current ABN is acceptable. CMS says that the new form also may be used for voluntary notifications, in place of the Notice of Exclusion from Medicare Benefits (NEMB). For the revised form and instructions, go to http://www.cms.hhs.gov/BNI/02_ABNGABNL.asp.

-------------------------------------------------------------------------------

April 7, 2008

Question:

When does CMS reimburse blood glucose testing?

Answer:

In Transmittal 258 (issue December 22, 2006), the Centers for Medicare & Medicaid Services stated the following: "Medicare separately pays for a blood glucose test only when the service meets all of the conditions of payment for a test payable under the clinical laboratory fee schedule including that the test must be ordered by the physician who is treating the beneficiary and the physician must use the results in the management of the beneficiary's specific medical condition. Our regulation states that for payment to be made for a blood glucose test under Medicare Part B, a physician must certify that each test is medically necessary and that a standing order for many tests over a time period is not sufficient documentation. Payment for nursing care glucose monitoring is encompassed under Medicare Part A and other payment methods."

Payment of lab tests provided under a standing order for a recurring or serial evaluation is, of course, subject to medical necessity review. All such orders must be written for a specific patient, and each instance of the test must be necessary. Each result must be reviewed with appropriate action taken by the treating physician including any appropriate change in the frequency or duration of testing.

-------------------------------------------------------------------------------

March 31, 2008

Question:

What requirements must be met to be paid for a recurring lab test specific to the needs of an individual patient?

Answer:

Standing orders for recurring diagnostic tests may be appropriate when all of the following conditions are met:

- Each ordered test must be appropriate for the 1) known or suspected diagnosis and 2) individual patient's clinical circumstances.
- Each test performed must be necessary for the individual patient's management.
- The frequency of repeated testing and the number of repeated studies must not be greater than medically necessary.
- The diagnosis must be indicated for each test with sufficient clarity to permit accurate ICD-9-CM coding to the highest level of specificity.
- The order for the recurring test must be renewed at least annually or sooner if required by state law or the patient's clinical circumstances.
- The treating physician must review each test's result, making any indicated adjustments in frequency and number of repeated studies.
- Documentation must demonstrate that all lab tests were reviewed and appropriate clinical action taken.

Appropriate, recurring diagnostic tests under the Medicare program include serial studies, says Noridian Administrative Services (NAS). For example, serial studies necessary to establish or characterize a diagnosis (e.g., repeated cardiac enzymes necessary for a patient with presenting symptoms suggestive of acute ischemia) would be appropriate.

-------------------------------------------------------------------------------

March 24, 2008

Question:

In last week's answer, you said that Medicare does not allow any generic standing orders. What about repeat tests for individual patients? Would these be an exception?

Answer:

According to the article posted by Noridian Administrative Services article mentioned last week, in some circumstances, a standing order for a recurring lab test that is specific to the needs of an individual patient may be reimbursable. (Certain requirements must be met.) Preprinted or electronic lists of potential orders also are permitted if the provider individually affirms, defines, or otherwise modifies each component as appropriate for an individual patient's clinical circumstances.

-------------------------------------------------------------------------------

March 17, 2008

Question:

Does Medicare allow labs to use generic, preprinted standing orders for lab tests?

Answer:

On December 5, 2007, Noridian Administrative Services (NAS) posted a document on its web site (https://www.noridianmedicare.com/ ) entitled "Medicare Part A Standing Orders." In that article, NAS stated that Medicare requires that lab tests be individually and specifically ordered for the patient, reviewed, and action taken by the treating physician. Automatic, routine, or generic standing orders for lab tests, such as those pre-printed for use with patients undergoing a procedure or admission (whether for all such patients or all those treated by a specific practitioner) are not allowed under Medicare.

-------------------------------------------------------------------------------

March 10, 2008

Question:

Did CMS increase the rates for the travel codes P9603 and P9604 for 2008?

Answer:

For dates of service January 1, 2008, through December 2008, the fee for clinical laboratory travel code P9603 is $0.935 per mile and for code P9604 is $9.35 per flat rate trip basis. (These are the same rates as 2007.) Codes P9603 and P9604 are billable only for travel to perform a specimen collection for either a nursing home or homebound patient.

The standard mileage rate for transportation costs is 48.5 cents a mile, which is incorporated into the fees for the travel codes. For 2008, CMS noted that it would issue a separate instruction if the standard mileage rates are revised.

-------------------------------------------------------------------------------

March 3, 2008

Question:

How much does Medicare pay for the Pap smear codes?

Answer:

Like 2007, the 2008 lab fee schedule includes the following specimen-collection methods: 36415, P9612, and P9615. The 2008 mid-point payment listed for these codes is $3.

-------------------------------------------------------------------------------

February 25, 2008

Question:

I am looking for a list of the codes for which there will be a reasonable-charge payment under Medicare. Can you help?

Answer:

Many codes related to blood products, transfusion medicine, and reproductive medicine procedures are paid under a reasonable-charge basis for outpatients. By law, the reasonable charge may not exceed the lowest of the actual charge or the customary or prevailing charge for the previous 12-month period ending June 30, updated by the inflation-indexed update of 2.7 percent for 2008.

There are only two code additions to the 2007 list of blood product codes that will be paid under the reasonable charge method. These code additions are listed below:
P9043 Infusion, plasma protein fraction (human), 5%, 50 ml
P9048 Infusion, plasma protein fraction (human), 5%, 250ml

Aside from these two code additions, no changes have been made to the list of transfusion medicine codes or to the list of reproductive medicine procedure codes that will be paid via the reasonable charge method.

The transmittal summarized above can be found at http://www.cms.hhs.gov/transmittals/downloads/R1400CP.pdf.

-------------------------------------------------------------------------------

February 18, 2008

Question:

Does the recently introduced Medicare legislation (the one that delayed the 10 percent to physician payments) include any extension of reasonable cost payment for small hospitals?

Answer:

Yes, Senate Bill (SB) 2499--The Medicare, Medicaid and SCHIP Extension Act of 2007--addresses this topic. Specifically, clinical lab tests performed by small rural hospitals with fewer than 50 beds will receive reasonable-cost payments as part of their outpatient services through June 30, 2008.

-------------------------------------------------------------------------------

February 11, 2008

Question:

Does Medicare still allow independent labs to bill for technical component of pathology services?

Answer:

Yes, in certain situations, independent laboratories can continue to bill Medicare directly for the technical component of inpatient and outpatient surgical pathology services provided to hospitals. However, this provision extends only through June 30, 2008.

-------------------------------------------------------------------------------

February 4, 2008

Question:

For 2008, will labs get paid separately for new code 36592?

Answer:

Effective January 1, 2008, CPT code 36592-collection of blood specimen using established central or peripheral catheter, venous, not otherwise specified-is packaged under the hospital outpatient prospective payment system (OPPS). Hospitals are encouraged to bill for all packaged procedures so that Medicare can gather utilization data that will aid in the calculation of future payment data.

-------------------------------------------------------------------------------

January 28, 2008

Question:

The question you posted on January 14 regarding the new CPT code for VAD draws 36591 raises a question for me. Which revenue code do you recommend reporting?

Answer:

The revenue code assignment for 36591 should most accurately reflect the setting in which the procedure is performed. If the blood draw occurs in the emergency department, then 450 would be assigned; a treatment room procedure would map to 761, etc. In some instances, the most appropriate revenue code may be 300 to represent a specimen collection for laboratory. The intermediary would be the best point of contact to confirm the acceptance of 300 or other department-specific revenue code assignment.

-------------------------------------------------------------------------------

January 21, 2008

Question:

Does the new Medicare legislation include a provision to halt the competitive bidding project for clinical laboratories?

Answer:

No, Senate Bill (SB) 2499--The Medicare, Medicaid and SCHIP Extension Act of 2007- does not include any provision to repeal this project. It does delay for six months, from January 1, 2008, through June 30, 2008, the following:

- Billing of physician pathology services: Independent labs may, in certain situations, continue to bill Medicare directly for the technical component of inpatient and outpatient surgical pathology services provided to hospitals.
- Reasonable-cost payments. Clinical lab tests performed by small rural hospitals with fewer than 50 beds will receive reasonable-cost payments as part of their outpatient services.
- Diabetes laboratory tests. Certain tests that are approved for home use will be reimbursed at the same rate as other glycated hemoglobin tests beginning April 1, 2008.

For the complete text of SB 2499, go to http://www.govtrack.us/congress/billtext.xpd?bill=s110-2499.

-------------------------------------------------------------------------------

January 14, 2008

Question:

What code should be used to report a VAD blood draw?

Answer:

For 2008, the code 36540 for venous access device (VAD) blood draw was deleted and replaced by code 36591. New code
36592 was introduced for blood draw from a PICC.

36591 Collection of blood specimen from a completely implantable venous access device
36592 Collection of blood specimen using established central or peripheral catheter, venous, not otherwise specified.

-------------------------------------------------------------------------------

January 7, 2008

Question:

What codes should be assigned for antinuclear antibody (ANA) testing?

Answer:

The CPT book provides specific codes for ANA (86038) and ANA titers (86039). Even though the methodology is also described in codes 86255 (fluorescent noninfectious agent antibody; screen, each antibody) and 86256 (titer, each antibody), the correct coding is the specific codes 86038 and/or 86039. ANA testing is also one of those commonly "reflexed" tests, with laboratories automatically ordering (and billing) the titer if the screen is positive.

-------------------------------------------------------------------------------

December 31, 2007

Question:

For the competitive bidding demonstration project, what kind of measures or standards will be used?

Answer:

In addition to the quality standards required by the Clinical Laboratory Improvement Amendments (which apply to all clinical laboratories), terms and conditions for participation in the demonstration will include performance measurement. Performance measures that the Centers for Medicare & Medicaid Services (CMS) plan to collect throughout the demonstration include the following:

- Total, transport, and processing turnaround times;
- Total turnaround time for STAT tests;
- Reporting turnaround time for critical values and for public health notification;
- Log-in error rates; and
- Rates of lost specimens.

-------------------------------------------------------------------------------

December 24, 2007

Question:

What's the status of Medicare's competitive bidding project for labs?

Answer:

In spite of protests from all segments of the laboratory industry, the Centers for Medicare & Medicaid Services (CMS) are proceeding with implementation of the project. It selected the San Diego-Carlsbad-San Marcos, California metropolitan area as the first of two locations for a competitive bidding demonstration for clinical laboratory services provided to fee-for-service Medicare beneficiaries. The second demonstration site (to be announced later) will begin about one year after the first site begins. Each demonstration will last three years. That's the latest word from the Centers for Medicare & Medicaid Services (CMS) in an October 17 notice in the Federal Register (http://www.access.gpo.gov/su_docs/fedreg/a071017c.html). Scroll down to Centers for Medicare & Medicaid Services, Notices.

-------------------------------------------------------------------------------

December 17, 2007

Question:

Does Medicare ever take exception to the date of service (DOS) rule you described in last week's answer? Specifically, what DOS would be billed for the following example?

A patient presents with a lump in her left breast. She has a history of right partial mastectomy that had been diagnosed two years prior. The oncologist orders a quantitative tumor immunohistochemistry (88361) times three for estrogen receptor, progesterone receptor, and Her-2/neu on the archived specimen.

Answer:

Yes, special circumstances can warrant exceptions to this rule. Archived specimens are often used for additional procedures. Paraffin blocks are often used months or years later for additional special stains or to perform new technology procedures unavailable at the collection time. For lab tests that require retrieval of an archived specimen from storage, the DOS should be defined as the date the specimen was obtained from archives. In the example you give above, the DOS would be the present date when the specimen was obtained from storage or archives.

-------------------------------------------------------------------------------

December 10, 2007

Question:

What would be the date of service (DOS) for the following scenarios? A radical mastectomy with lymph nodes was performed on a right breast on January 10. Routine gross and microscopic exam was performed, and Level VI tissue exam (88309) was billed. Malignant cells were identified and reported. To predict therapy outcomes, the pathologist ordered hormone receptor studies on January 12. Estrogen and progesterone hormone receptors were performed, and two immunohistochemistry antibodies (88342) were billed.

Answer:

All three of these procedures would be billed using January 10 as the DOS. The date a cytopathology or pathology specimen is collected is considered to be the billing DOS. The date of collection most often corresponds to the date the test was ordered. However, in surgical-specimen processing, special stains are often ordered several days after the collection date. The DOS for any given specimen that requires add-on procedures remains the collection date regardless of the date the pathologist ordered additional diagnostic tests.

-------------------------------------------------------------------------------

December 3, 2007

Question:

What is the main reason laboratory claims are denied?

Answer:

Duplicate claims' submissions are the number one reason for denials or rejections of laboratory and pathology claims, according to Trailblazer Health Enterprises, a Medicare contractor. In a report covering claims processed between April and June 2007, the payer states that claims often deny as a duplicate for the following reasons:

- The claim previously processed (e.g., no payment made, allowed amount applied to the deductible on the initial claim, provider refiles a claim to correct initial claim, claim submitted again in error).
- Provider automatically refiles a claim to seek payment if the initial claim has not paid within 30 days.

-------------------------------------------------------------------------------

November 26, 2007

Question:

We develop chemistry profiles and wonder if there are there any compliance issues of which we should be aware?

Answer:

Chemistry profiles are developed to facilitate ordering and increase convenience for the ordering physician. As always, performing profiles and panels that result in the billing of multiple CPT codes is a vulnerable workplace practice that should be carefully monitored.

Monitoring should be implemented to prevent double billing when multiple panels are ordered on the same date of service. There is also a potential for double billing if a single panel is ordered along with one or more individual tests. Examples include the ordering of glucose along with a basic metabolic panel, or a comprehensive panel along with a custom panel that includes tests already in the comprehensive.

-------------------------------------------------------------------------------

November 19, 2007

Question:

What should a microbiology chargemaster include?

Answer:

A microbiology chargemaster includes line items for each of the primary culture CPT codes, identification, culture typing, drug-sensitivity testing, and the various microscopic exams. While follow-up testing for positive cultures is more of a standard of practice than reflex testing, ensure that physicians are aware of the follow-up policies and procedures at your facility.

-------------------------------------------------------------------------------

November 12, 2007

Question:

I am confused about how to code 24-hour urine samples. Can you provide guidance?

Answer:

Twenty-four-hour urine samples are a fact of life in the clinical laboratory, and the measurement of that total volume is reimbursable for collection times of less than 24 hours with code 81050 (volume measurement for timed collection). Be sure not to link this code with lab tests performed on the 24-hour urine sample. Often multiple tests are performed on one sample, and linking the charges could result in double billing. Be sure to assign code 81050 only once per specimen. It can be used with any timed sample (2-hour, 12-hour, etc.).

-------------------------------------------------------------------------------

November 5, 2007

Question:

Please provide guidance for the following scenario: A physician submits prescription pad orders for outpatients and writes "CBC," but no signs or symptoms are provided.

Answer:

Outpatient orders such as you describe and those also without ICD-9 information do present a quandary for admitting clerks. Which test should they select? What should they do about medical necessity? Does the doctor want a differential? Should the clerk ask the patient for diagnostic information?

The correct step in such a case would be to contact the ordering physician for clarification. Let the physician select the extent of service and provide the reason for the test. The lesson here is to keep it simple. Using check-off style outpatient requisitions will remove your admitting staff from the decision-making process, and it will restrict the use of prescription pad orders.

-------------------------------------------------------------------------------

October 29, 2007

Question:

What steps can labs take to ensure that claims submitted are medically necessary?

Answer:

First check the appropriate national coverage determination (NCD) for clinical diagnostic lab tests issued and regularly updated by the Centers for Medicare & Medicaid Services (CMS). The 23 NCDs, which took effect back on November 25, 2002, include the covered and non-covered ICD-9-CMs. Go to www.cms.hhs.gov/mcd/index_section.asp?ncd_sections=40#B.

If there is no NCD for the service you're billing, check your payer's local coverage determinations (LCDs) for procedure-to-diagnosis code editing. The LCD should tell you whether a patient's diagnosis or condition meets the medical necessity requirements. If not, let the patient know that Medicare may not cover the service due to coverage limitations. If the patient wants to proceed with the test or service, request that he or she sign an advance beneficiary notice (ABN). In all cases, documentation must support the diagnosis submitted.

-------------------------------------------------------------------------------

October 22, 2007

Question:

What revenue code should be assigned for code 80299-quantitation of drug, not elsewhere specified?

Answer:

The proper revenue code for therapeutic drug testing (80150-80299) is either 300 or 301. Most fiscal intermediaries (FIs) do not require third-digit specificity for lab testing. Your business office should check with the FI in your state to determine its policy and requirements.

-------------------------------------------------------------------------------

October 15, 2007

Question:

Does Medicare pay for code 80299-quantitation of drug, not elsewhere specified?

Answer:

Many lab personnel avoid using code 80209 because they believe, incorrectly, that Medicare will not pay for it. That is not the case as Medicare will pay for it. However, you should use caution in reporting it rather than a specific test-methodology code because 80299 may reimburse at a higher rate than the correct method code.

-------------------------------------------------------------------------------

October 8, 2007

Question:

Does the term "standing order" mean the same as "recurring order"?

Answer:

No, the two terms have different meanings, according to Medicare guidelines. The following examples may help to clarify the different meanings.

A hospital may have the following policy in place. When a surgical procedure is scheduled for a female patient over 45, a series of tests will automatically be done to screen for risk. The tests have nothing to do with the individual's personal health history or the physician's request for the tests. This is a standing order.

A patient visits her physician, who determines that, because of her personal health history, she should have a glucose test every three months. He writes an order to request that recurring order, which is specific to this individual patient's needs.

On June 26, Noridian Administrative Services, LLC clarified the use of standing orders for laboratory tests. The document entitled "Medicare Part B: Standing Orders and Serial Diagnostic Tests" can be found at https://www.noridianmedicare.com/provider/updates/docs/standing_orders_fina_%206-25-07_acro.pdf

-------------------------------------------------------------------------------

October 1, 2007

Question:

How much would Medicare reimburse a lab for running two or three tests out of an automated test panel (ATP)?

Answer:

If the component tests are medically necessary, Medicare should pay for them. For 2007, the fees in the following table apply. For example, ATP02 indicates payment for one or two chemistry analytes; ATP03 indicates payment for three chemistry analytes and so on until you reach ATP16, which includes 13 through 16 tests and ATP 18, which includes 17 and 18 tests. (NLA indicates the national limitation amount.)

---------- NLA---- 2007 Mid Point
ATP02 - $7.28 -- $9.84
ATP03 - $9.29 -- $12.55
ATP04 - $9.80 -- $13.24
ATP05 - $10.93 - $14.77
ATP06 - $10.96 - $14.81
ATP07 - $11.42 - $15.43
ATP08 - $11.83 - $15.98
ATP09 - $12.13 - $16.39
ATP10 - $12.13 - $16.39
ATP11 - $12.34 - $16.68
ATP12 - $12.62 - $17.05
ATP16 - $14.77 - $19.96
ATP18 - $14.87 - $20.10
ATP19 - $15.45 - $20.88
ATP20 - $15.95 - $21.55
ATP21 - $16.45 - $22.23
ATP22 - $16.95 - $22.91

-------------------------------------------------------------------------------

September 24, 2007

Question:

Occasionally, when a panel is ordered, we can't run all of the tests (due to faulty instrumentation or reagents, etc.) and can't report all of the results. Can we bill the components that we did run, and, if so, will we receive payment for each?

Answer:

If you don't have a backup system, and you perform and report only some of the components, the answer to your first question is "yes," each component may be billed.

However, although you may bill separately, the system will limit the total paid to the amount for the entire automated test panel (ATP), rather than on a separate payment for each analyte identified by a CPT code. Payment is based on the national limitation amounts (NLA) listed in the clinical laboratory fee schedule.

-------------------------------------------------------------------------------

September 17, 2007

Question:

I just read the laboratory Q&A dated 9/10/2007 and would like confirmation about signs and symptoms for lab tests. If the results of the lab test confirm a diagnosis, isn't it appropriate to include the results on the claim being submitted to Medicare? (See ICD-9-CM Official Guidelines for Coding and Reporting Effective November 15, 2006 Page 89 of 102).

Answer:

Medical necessity of an outpatient encounter for laboratory testing should be supported by the sign, symptom or diagnosis that prompted the treating physician or practitioner to refer the patient to the laboratory. This documentation should be present in the physician order.

The results of a clinical diagnostic laboratory procedure are not, typically, reviewed and interpreted by the pathologist or a physician prior to the laboratory billing of that procedure. Test results may not be interpreted by non-physician personnel for the purpose of appending a diagnosis to the claim. (For example, a positive urine culture may not be interpreted by laboratory, billing or coding staff for the purpose of appending 599.0-urinary tract infection.) However, some procedures require an interpretation (e.g., surgical pathology, flow cytometry) by the pathologist/physician. If the interpretation is available at the time the claim is being coded, then, yes, the coding staff may append the appropriate diagnosis.

-------------------------------------------------------------------------------

September 10, 2007

Question:

I am looking for some lab-specific guidelines re: medical necessity and chemistry tests. Can you help with this?

Answer:

First, lab tests must be documented with signs and symptoms or ICD-9 information concerning the reason the test has been performed, not the post-test diagnosis. Many of the chemistry tests require specific signs, symptoms, and diagnoses for coverage. In general, if a patient has an existing diagnosis and is being monitored, medical necessity is met and claims up to frequency limits will be reimbursed. If a patient has signs and symptoms of a disease and appropriate tests are ordered, the tests will be covered.

However, unless the test is one of the tests approved for screening (PAP smears, prostate specific antigen, fecal occult blood, cardiovascular risk, diabetes, and prediabetes), and if no signs or symptoms are evident, the testing is considered screening and will not be paid.

Note: More information on this topic and others can be found in MedLearn's 2007 edition of Coding Essentials for Laboratory

-------------------------------------------------------------------------------

September 3, 2007

Question:

I am confused about the test for blood gases. Can you provide any billing tips?

Answer:

The test for blood gases is a notable example of a comprehensive code in the chemistry section that seems to cause a lot of confusion. Any two or more of the analytes listed in the test description may be performed in any combination to qualify that code for use. It is not permissible to bill for individual components of 82803 in addition to code 82803.

82803 Gases, blood, any combination of pH, pCO2, pO2, CO2, HCO3 (including calculated O2 saturation);

Note: More information on this topic and others can be found in MedLearn's 2007 edition of Coding Essentials for Laboratory

-------------------------------------------------------------------------------

August 27, 2007

Question:

What revenue code should be used for the urinalysis codes?

Answer:

The revenue code for the urinalysis series is either 300 or 307. However, many fiscal intermediaries (FIs) do not require third-digit specificity for laboratory testing. Check with FI to determine the revenue code policy in your state.

Note: More information on this topic and others can be found in MedLearn's 2007 edition of Coding Essentials for Laboratory

-------------------------------------------------------------------------------

August 20, 2007

Question:

From Medicare's perspective, is it appropriate for a facility to create its own organ and disease panels?

Answer:

Any grouping of multiple tests other than those described in the organ and disease panel section of the CPT manual is considered a custom panel, and it must be ordered and billed at the component level. There are also annual physician notices that must acknowledge the composition of all custom panels. Medicare only pays for tests that are ordered by a physician or authorized practitioner.

Note: More information on this topic and others can be found in MedLearn's 2007 edition of Coding Essentials for Laboratory

-------------------------------------------------------------------------------

August 13, 2007

Question:

Does the term "standing order" mean the same as "recurring order"?

Answer:

No, the two terms have different meanings, according to Medicare guidelines. Oftentimes, laboratory staff uses the term "standing order" when, in actuality, they are talking about a "recurring order." The following examples may help to clarify the different meanings.

A hospital may have the following policy in place. When a surgical procedure is scheduled for a female patient over 45, a series of tests will automatically be done to screen for risk. The tests have nothing to do with the individual's personal health history or the physician's request for the tests. This is a standing order.

A patient visits her physician, who determines that, because of her personal health history, that she should have a glucose test every three months. He writes an order to request that recurring order, which is specific to this individual patient's needs.
On June 26, Noridian Administrative Services, LLC clarified the use of standing orders for laboratory tests. The document entitled "Medicare Part B:

Standing Orders and Serial Diagnostic Tests" can be found at https://www.noridianmedicare.com/provider/updates/docs/standing_orders_fina_%206-25-07_acro.pdf.

-------------------------------------------------------------------------------

August 6, 2007

Question:

In the Q&A for the week of July 23, you mention "patient encounter." How does CMS define this term?

Answer:

The following is taken from the Medicare Claims Processing Manual, Chapter 2--Admission and Registration Requirements, Section 90.6.

"The term "encounter" means a direct personal contact in the hospital between a patient and a physician, or other person who is authorized by State law and, if applicable, by hospital staff bylaws to order or furnish services for diagnosis or treatment of the patient. Direct personal contact does not include telephone contacts between a patient and physician. Nor is the compensation arrangement between the physician and the hospital relevant to whether an encounter has occurred. Patients will be treated as hospital outpatients for purposes of billing for certain diagnostic services that are ordered during or as a result of an encounter that occurred while such patients are in an outpatient status at the hospital. If a Medicare outpatient is referred to another provider or supplier for further diagnostic testing or other diagnostic services as a result of an encounter that occurs in this hospital, the hospital is responsible for arranging with the other entity for the furnishing of services. Hospitals are not required to verify that all ordered services are furnished but only to assure that, when it is necessary to refer a patient to an outside entity, the referral is made to a provider or supplier with which the referring hospital an arrangement. This requirement is necessary to assure that billing for services that are furnished is processed through the servicing hospital.

When a patient has follow-up visits with a physician in the hospital following an initial encounter, each subsequent visit to the physician will be treated as a separate encounter for billing."

-------------------------------------------------------------------------------

July 30, 2007

Question:

Does Medicare pay for code 36416 and/or code 36540?

Answer:

Code 36416 is not paid by Medicare as a separate service when is used to report a capillary-specimen collection. Code 36540 is used to report specimens collected from pre-existing implantable venous access devices. The code is reportable to Medicare as an incidental procedure and, therefore, has no additional reimbursement. However, this does provide a code that represents the often performed specimen-collection procedures involving an implanted access device sometimes referred to as "port draws."

-------------------------------------------------------------------------------

July 23, 2007

Question:

Will Medicare pay for more than one venipuncture per patient encounter? What is the correct code to report?

Answer:

For 2007, facilities continue to report CPT code 36415-collection of venous blood by venipuncture. The code is reportable once per encounter.

-------------------------------------------------------------------------------

July 16, 2007

Question:

For the past few months, our claims that contain code G0107 (screening fecal occult blood test [FOBT]) have been rejected. Has there been a change in coverage or coding?

Answer:

Until December 31, 2006, providers used codes G0107 and G0328 to bill screening FOBT. However, in the 2007 hospital outpatient prospective payment system final rule, CMS announced that G0107 would be retired from the clinical diagnostic laboratory fee schedule effective January 1, 2007. It instructed providers to report the CPT code 82270 in its place when billing for screening FOBT. Code G0328 is still an active and appropriate code.

-------------------------------------------------------------------------------

July 9, 2007

Question:

Does Medicare cover the PSA screening test?

Answer:

The Balanced Budget Act of 1997 provides for Medicare Part B coverage of certain prostate cancer screening tests, including the prostate specific antigen (PSA) test, which is reported with code G0103. Like the other prostate tests, they are subject to certain coverage, frequency, and payment limitations and must be billed with diagnosis code
V76.44--special screening for malignant neoplasms, prostate. The PSA screening procedure may be paid at a frequency of once every 12 months for men who have attained age 50 (i.e., starting at least one day after they have attained age 50).

-------------------------------------------------------------------------------

July 2, 2007

Question:

Has CMS issued any updates on the new, merged ABN?

Answer:

The Centers for Medicare & Medicaid Services (CMS) may go back to the drawing board with its proposal to merge the two advance beneficiary notices (ABN) into one (February 23 issue of the Federal Register notice). In response to that proposal, it received an onslaught of comments about the change. Numerous industry organizations, including the American Clinical Laboratory Association (ACLA), asked CMS to reconsider its proposal.

In the April issue of its Results newsletter, the ACLA argued that "CMS had presented no rationale for the consolidation" and the change would result in "unnecessary burden and confusion to beneficiaries, physicians and laboratories." It also stated, "Changing the form would require labs to reeducate physicians and beneficiaries and incur considerable new costs in reprogramming software and systems."

-------------------------------------------------------------------------------

June 25, 2007

Question:

The clinical lab fee schedule does not include payment amounts for unlisted codes 81099, 84999, 85999, 86849, and 87999. How does Medicare pay for these?

Answer:

It's up to Medicare carriers to price them. Fiscal intermediaries (FIs) review the narrative description of the tests that hospitals submit to determine if a specific HCPCS code is available to describe it. If there is, hospitals should report this code instead of the unlisted lab code.

If there is no appropriate specific code, the FI will contact the carrier in the hospital's jurisdiction to obtain an appropriate payment amount. If that carrier cannot provide a payment, the FI contacts the carrier in the jurisdiction of the reference laboratory that performed the test. If neither has a payment and the FI determines that the service is covered, it will determine the payment amount. However, FIs will not search their files to adjust previously processed claims, so it's up to labs to bring such claims to their attention.

-------------------------------------------------------------------------------

June 18, 2007

Question:

Can you provide the official definitions of presumptive vs. definitive identification as they relate to microbiology?

Answer:

According to the American Medical Association (AMA), a presumptive identification is one by colony morphology, growth on selective media, Gram stains, or up to three tests (e.g., catalase, oxidase, indole, urease). Definitive identification of microorganisms is defined as identification to the genus or species level that requires additional tests (e.g., biochemical panels, slide cultures).

The CPT manual instructs providers to report code 87076 or 87077 for the definitive identification of culture isolates. This wording differentiates this work as distinct from that involved in the isolation and presumptive identification of a microorganism. The CPT manual also states the following: If additional studies that involve molecular probes, chromatography, or immunologic techniques are required beyond the definitive identification code, report the code representing the testing methodology from the code range 87140-87158 in addition to the definitive identification code.

-------------------------------------------------------------------------------

June 11, 2007

Question:

I have a question about coding immunology tests. When multiple tests are done to detect antibodies to organisms classified more precisely than the specificity allowed by available codes, it is appropriate to code each as a separate service?

Answer:

Yes, in the case you describe, it is appropriate to code separately. For example, Coxsackie viruses are enteroviruses, but there are no codes for the individual species of Enterovirus. If assays are performed for antibodies to Coxsackie A and B species, each assay should be separately coded.

-------------------------------------------------------------------------------

June 4, 2007

Question:

How many diagnosis codes can we put on our lab claims?

Answer:

For claims processed July 1, 2007, and later, Part B standard systems and carrier claims processing systems will capture and process up to eight diagnosis codes in the adjudication of paper and electronic claims. Historically, these systems have used only the first four diagnosis codes reported on the claim when processing the HIPAA format claims. Carriers have used a manual process to consider the remaining diagnosis codes in the Medicare payment determinations.

As described by the Centers for Medicare & Medicaid Systems (CMS) in Transmittal 1157 (January 19), the ANSI 837P 4010A allows a maximum of eight diagnosis codes to be reported for each claim. In processing the HIPAA format claim, the multi-carrier system (MCS) applies the first four diagnosis codes on the claim. The remaining diagnosis codes are not used in the payment determination for Medicare.

Information Source: The transmittal summarized above can be found at http://www.cms.hhs.gov/Transmittals/downloads/R1157CP.pdf.

-------------------------------------------------------------------------------

May 28, 2007

Question:

What colorectal screening tests does Medicare cover?

Answer:

Since January 1, 1998, Medicare has covered the following:

- Screening fecal-occult blood test (FOBT) (defined as a guaiac-based test for peroxidase activity, in which the Medicare patient completes the test by taking samples from two different sites of three consecutive stools)
- Screening fecal-occult blood test immunoassay, 1-3 determinations

For Medicare to cover these procedures and tests, the patient must be age 50 or older. A screening FOBT may be performed once every 12 months. A number of diagnosis codes are recognized for the coverage of high-risk screening; Contact your local Medicare contractor for additional guidance.

-------------------------------------------------------------------------------

May 21, 2007

Question:

Does Medicare allow a laboratory to perform screening services based upon a patient's request?

Answer:

No. Preventative screening procedures performed by the laboratory must be performed based on the request of the patient's physician or other authorized ordering practitioner. Note that some states may allow for direct access testing, which refers to a limited number of test procedures, usually waived status, to be performed at the request of the patient. Contact your fiscal intermediary to confirm the test-order requirements for your laboratory.

-------------------------------------------------------------------------------

May 14, 2007

Question:

I work for a critical access hospital with 45 beds. Up until now, we have been paid reasonable costs for lab tests. I have heard this will end. Can you tell me when?

Answer:

After July 1, 2007, critical access hospitals (CAHs) with fewer than 50 beds in qualified rural areas will continue to receive reasonable-cost payments for outpatient clinical laboratory tests. The Tax Relief and Health Care Act of 2006 extended the reasonable-cost payment from a two-year period to a three-year period. Reasonable cost payments will be made to those CAHs with cost-reporting periods that began between July 1, 2004 and July 1, 2007. For Transmittal 1180, which provides details related to this, go to http://www.cms.hhs.gov/transmittals/downloads/R1180CP.pdf.

-------------------------------------------------------------------------------

May 7, 2007

Question:

Is Medicare still making reasonable cost payments to small critical access hospitals for lab services?

Answer:

After July 1, 2007, critical access hospitals (CAHs) with fewer than 50 beds in qualified rural areas will continue to receive reasonable-cost payments for outpatient clinical laboratory tests. The Tax Relief and Health Care Act of 2006 extended the
reasonable-cost payment from a two-year period to a three-year period. Reasonable cost payments will be made to those CAHs with cost-reporting periods that began between July 1, 2004 and July 1, 2007.

More information about this topic can be found in Transmittal 1180 at http://www.cms.hhs.gov/transmittals/downloads/R1180CP.pdf. Related provider-information memo MM5493 is available at http://www.cms.hhs.gov/MLNMattersArticles/Downloads/mm5493.pdf.

-------------------------------------------------------------------------------

April 30, 2007

Question:

I recently heard about a piece of legislation called the Genomics and Personalized Medicine Act. What is it?

Answer:

On March 23, Senator Barack Obama (D-IL) and Senator Richard Burr (R-NC) introduced this bill, which, according to an American Clinical Laboratory Association (ACLA) press release, "provides a comprehensive, well-reasoned approach to improve access to and establish appropriate utilization of molecular genetic tests." According to ACLA, the bill goes beyond issues of regulatory oversight by recognizing the interlocking need to expand research, collect genomic data, and enhance training opportunities in this field.

-------------------------------------------------------------------------------

April 23, 2007

Question:

One of the criteria you listed last week that is used to establish the medically unlike edits was clinical judgment. Can you say more about this?

Answer:

According to Coding Solutions, LLC, the overseer of the MUEs as well as the correct coding initiative edits, about 40 percent of CPT and level II codes will be evaluated according to this category. Code 80053 (comprehensive metabolic panel) is one example. Rosen stated that although 14 individual tests can be billed if necessary, there's an exceedingly low chance that they would be performed on the same day of service.

-------------------------------------------------------------------------------

April 16, 2007

Question:

What criteria were used to establish the medically unlikely edits (MUEs), and how does they apply to lab services?

Answer:

A company called Coding Solutions, LLC, oversees the MUEs. According to the company's medical director, seven types of criteria are used to set the edits: anatomic consideration, code descriptor, coding instruction, CMS policies, nature of equipment, nature of analyte (testing procedure and specimen), and clinical judgment. Here are examples of how the nature of analyte criteria would relate to laboratory codes.

- Nature of testing procedure: The number of times some codes, such as 85557 (osmotic fragility, RBC; incubated), can be reported is sometimes limited by the very nature of their testing. For example, code 85557 requires a 24-hour incubation period, so more than one unit of service can never be reported.

- Nature of testing specimen: The MUEs for code 82575 (creatinine; clearance) are based on the type of specimen. The code requires a 24-hour urine specimen and, therefore, is only one unit of service.

-------------------------------------------------------------------------------

April 9, 2007

Question:

Last week you provided information about CMS merging the two advance beneficiary notices (ABNs) into one form but did not explain what would be changed? Can you address the details?

Answer:

As stated, the general-use ABN (CMS-R-131-G) and the ABN used specifically for physician-ordered laboratory tests (CMS-R-131-L) would be merged into a single general notice meeting both needs. The basic content of the ABN would remain the same, but the following are among the changes that may occur:

- Revised, more user-friendly language
- Addition of the 1-800-MEDICARE number to the notice
- More information about the beneficiary's right to demand that Medicare be billed.
- Increase the selection options to three from two to allow beneficiaries' the right to pay out of pocket when they desire.
- Allow a place for other insurance information to be recorded
- Describe the significance of the signature

The Federal Register notice can be found at http://www.access.gpo.gov/su_docs/fedreg/a070223c.html under the Centers for Medicare and Medicaid Services.

-------------------------------------------------------------------------------

April 2, 2007

Question:

Is it true that CMS plans to eliminate the lab-specific ABN?

Answer:

In late February, the Centers for Medicare & Medicaid Services (CMS) announced its proposal to merge the two current versions (one lab and one general) of the advanced beneficiary notice (ABN) into one form. According to CMS, the form will be modified to meet both general and lab-specific needs.

All providers and suppliers, including labs, already required to use ABNs should continue to use the currently approved ABN until the revised notice is finalized and approved.

-------------------------------------------------------------------------------

March 26, 2007

Question:

What's the start date of the laboratory competitive bidding demonstration? Are hospital labs participating in this demo?

Answer:

According to Transmittal 50 (Change Request 5359, November 1, 2006), implementation of the demonstration in the first competitive bidding area is April 1, 2007. The project will cover demonstration tests for all Medicare Part B beneficiaries who live in the demonstration sites, as determined by the zip code of the beneficiary's residence.

Hospital inpatient testing is covered by Medicare Part A and is, therefore, exempt from the demonstration. Physician office laboratory testing and hospital outpatient testing are not included in the demonstration, except where the physician office or hospital laboratory functions as an independent laboratory performing testing for a beneficiary who is not a patient of the physician or hospital outpatient department. More details can be found at http://www.cms.hhs.gov/transmittals/downloads/R50DEMO.pdf.

-------------------------------------------------------------------------------

March 19, 2007

Question:

I have heard and read about LOINC in relation to laboratory quality measures. Can you provide any information about this?

Answer:

The Centers for Medicare & Medicaid Services (CMS) is developing measures related to quality and efficiency of care for clinical lab fee schedule services. One aspect of that research involves the Logical Observation Identifiers Names and Codes (LOINC®) database.

According to the The Regenstrief Institute, Inc., which maintains the LOINC database and its supporting documentation, the purpose of the database is to "facilitate the exchange and pooling of results, such as blood hemoglobin, serum potassium, or vital signs, for clinical care, outcomes management, and research." LOINC offers universal identifiers for laboratory and other clinical observations that solve this problem.

Presently, most labs and other diagnostic services use HL7 to send their results electronically from their reporting systems to their care systems. However, HL7 can't fully "understand" and properly file the results received unless they either adopt the producer's lab codes or invest in the work to map each result producer's code system to their internal code system. More information about this and LOINC can be found at www.regenstrief.org.

-------------------------------------------------------------------------------

March 12, 2007

Question:

Can you recommend any reference to prepare for CLIA audits, specifically the pre-analytical phase of testing?

Answer:

According to the Centers for Medicare & Medicaid Services (CMS), studies indicate that most errors in the laboratory occur in the pre-analytical phase of testing. As a result, CLIA surveyors will review the laboratory's quality-assurance procedures in this area.

To prepare for this part of the survey, review the probes included in Appendix C of the CLIA rule, including those about training of front-office and phlebotomy staff. CLIA personnel guidelines do not address these positions, so the importance
of documenting education to staff may not have been noted in a prior survey. These staff members are very involved in the pre-analytic phase so managers need to take a close look at how they provide training and also follow-up, when necessary, with disciplinary action.

-------------------------------------------------------------------------------

March 5, 2007

Question:

Which codes are subject to CLIA edits in 2007, and which are excluded from them?

Answer:

The following codes are subject to CLIA edits this year: 82107, 83698, 83913, 86788, 86789, 87305, 87498, 87640, 87641, 87653, and 87808. From the Mohs micrographic surgery section of the CPT code book, the following also have been added to the edit list: 17311, 17312, 17313, 17314 and 17315. Discontinued codes include 17304, 17305, 17306, 17307, and 17310.

This information can be found in Transmittal 1165 (January 26) at http://www.cms.hhs.gov/transmittals/downloads/
R1165CP.pdf
.

-------------------------------------------------------------------------------

February 26, 2007

Question:

How will special packaged codes 36540 and 36600 be paid? Can you provide any billing tips about these codes?

Answer:

When two or more "special" packaged codes are reported on a single date of service (DOS), the PRICER will assign separate payment to the highest-paid code. The other special code listed will remain packaged and will not receive separate payment. If the only other procedure that appears on the claim is paid from the lab fee schedule then these codes should be paid rather than packaged.

When a code, such as 36540, is packaged, many labs generate venipuncture code 36415 instead. However, 36540 and 36600 pay significantly higher than 36415, so it is in the best interest of the facility to code and charge appropriately based on the procedure performed.

A word to the wise: Hospitals that autogenerate venipuncture charges will need to implement a process to not bill for both 36540 and 36415.

-------------------------------------------------------------------------------

February 19, 2007

Question:

I know that the 2007 hospital outpatient prospective payment system final rule included something about "special codes." What are they, and how do they affect lab code assignments?

Answer:

As you stated, in the 2007 hospital OPPS final rule, the Centers for Medicare & Medicaid Services (CMS) announced that it had created a new category of "special packaged codes" that took effect on January 1. The codes have a status indicator of H, which means that Medicare will make a separate payment when no other separately payable OPPS services are also reported for the same date of service (DOS).

The special payment is intended to compensate for all of the associated costs, when the hospital provides no other separately payable OPPS services to the patient on that day. Associated costs may include patient registration and establishment of a medical record. In all other circumstances, the above-listed codes will be treated as packaged services.

The following special packaged codes may be of interest to some labs.

- 36540 Collect blood, venous access device
- 36600 Arterial puncture; withdrawal of blood for diagnosis

The above information is item number 8 in Transmittal 1139 (Change Request 5438, December 22) at http://www.cms.hhs.gov/transmittals/downloads/R1139CP.pdf.

-------------------------------------------------------------------------------

February 12, 2007

Question:

Is it true that the per-mile rate paid to labs for travel hasn't changed this year?

Answer:

For dates of service January 1, 2007 through December 2007, the fee for clinical laboratory travel code P9603 is $0.935 per mile and for code P9604 is $9.35 per flat rate trip basis. (These are the same rates as 2006.) Codes P9603 and P9604 are billable only for travel to perform a specimen collection for either a nursing home or homebound patient. The standard mileage rate for transportation costs is 48.5 cents a mile, which is incorporated into the fees for the travel codes.

-------------------------------------------------------------------------------

February 5, 2007

Question:

What's Pap smear codes are paid by the NLA in 2007?

Answer:

By order of statute, payment for a cervical or vaginal Pap smear must be the lesser of the local fee or the national limitation amount (NLA), but not less than the national minimum payment amount. For 2007, the national minimum payment amount is $14.76 ($14.76 plus 0 percent update for 2007). Payment for a Pap smear also may not exceed the actual charge. The following codes are affected by the NLA: 88142-88154, 88164-88167, 88174, 88175, G0123, G0143-G0145, G0147, G0148, and P3000.

--------------------------------------------------------------------------------

January 29 , 2007

Question:

What is "reasonable charge payment," and what laboratory outpatient procedures are paid this way?

Answer:

Many codes related to blood products, transfusion medicine, and reproductive medicine procedures are paid under a reasonable charge basis for outpatients. By law, the reasonable charge may not exceed the lowest of the actual charge or the customary or prevailing charge for the previous 12-month period ending June 30, updated by the 2007 inflation-indexed update of 4.3 percent.

A list of the lab codes paid under this method can be found in Transmittal 1122 at http://www.cms.hhs.gov/transmittals/downloads/R1122CP.pdf. Related provider-information memo MM5362 can be found at http://www.cms.hhs.gov/MLNMattersArticles/downloads/MM5362.pdf.



--------------------------------------------------------------------------------

January 22, 2007

Question:

What does the technical component of physician pathology services include?

Answer:

The TC of physician pathology services refers to a slide preparation involving tissue or cells that a pathologist will interpret. In contrast, the pathologist's interpretation of the slide is the professional component (PC) service. If this service is furnished by the hospital pathologist for a hospital patient, it is separately billable. If the independent laboratory's pathologist furnishes the PC service, it is usually billed with the TC service as a combined service.

--------------------------------------------------------------------------------

January 15, 2007

Question:

Has CMS issued the 2007 clinical laboratory fee schedule yet? If so, what topics are included, and where can it be downloaded?

Answer:

Yes, the Centers for Medicare & Medicaid Services (CMS) has issued the lab fee schedule, which is available at http://www.cms.hhs.gov/ClinicalLabFeeSched/02_clinlab.asp#TopOfPage. The topics covered include fee schedule payments for new and revised 2007 codes as well as information about reasonable charge payments.

--------------------------------------------------------------------------------

January 8, 2007

Question:

What is the effective date for the new Medicare policy related to independent labs not billing for the TC of surgical pathology services?

Answer:

The implementation date for this policy has been extended until January 1, 2008. The Tax Relief and Health Care Act of 2006, which President Bush signed on December 20, 2006, extends the ability of independent clinical laboratories to bill Medicare directly for the technical component (TC) of surgical pathology services provided to hospital patients. The statute that required the Centers for Medicare and Medicaid Services (CMS) to permit such billing arrangements was set to expire on December 31, 2006. However, as just stated, the tax-relief legislation delays implementation of the existing regulation until January 1, 2008.

--------------------------------------------------------------------------------

January 1, 2007

Question:

Has CMS issued any recent diagnosis code changes for the laboratory NCDs?

Answer:

Right on its quarterly schedule, CMS updated the edit module for clinical diagnostic laboratory national coverage determinations (NCDs). The following ICD-9-CM codes, which have been added to the list of Medicare-covered codes, take effect on January 1, 2007:

- Prothrombin time NCD: Code V58.83 (encounter for therapeutic drug monitoring)
- Partial thromboplastin time NCD: Code V58.83 (encounter for therapeutic drug monitoring)
- Thyroid testing NCD: Codes 783.0 (anorexia) and 793.99 (other nonspecific abnormal findings on radiological and other examinations of body structure)
- Fecal occult blood test NCD. Code 995.20 (unspecified adverse effect of unspecified drug, medicinal and biological substance)

The above information can be found in Transmittal 1093 at http://www.cms.hhs.gov/transmittals/downloads/R1093CP.pdf.