Header Tag Line

Laboratory Compliance Question of the Week


Archive

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

January 23, 2012

Question:

We currently order HIV-1 and HIV-2 AB, EIA, with reflex to WB CPT code 86703. How do the new CPT codes for HIV affect this test order?

Answer:

Codes 86701, 86702 and 86703 represent a rapid point of care platform for antibody detection that are confirmed by another method such as the Western blot (86689). The revised description of 86703 will not affect the current test-order process. The addition of CPT 87389 now provides a coding option for HIV-1 Ag, HIV-1 Ab, or HIV-2 Ab by EIA, yielding a reactive result if one or multiple analytes are present or a non-reactive result if none of the analytes are present. Education of physicians and notification of this testing option should occur if your laboratory offers this test platform.

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

 

January 16, 2012

Question:

Are non-Medicare payers implementing the new CPT 81200–81383 and 81400–81408 in 2012? Do charges need to be set up in chargemaster based on payer?

Answer:

The acceptance of the new molecular pathology CPT codes by non-Medicare / commercial payers will most likely vary from one to the next. The laboratory must monitor billing and payment guidelines and updated CDM as indicated for proper claims submission.

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

January 9, 2012

Question:

Did the specimen-collection fee for going to nursing homes change for 2012?

Answer:

The specimen-collection fee for nursing home or homebound patients remains at $3, and, according to MM7526, the travel allowance is either a minimum of $1.01 per mile (for code P9603) or the flat rate of $10.05 (for code P9604). Medicare contractors implemented these fees on November 29, 2011, but their effective date is July 1, 2011. In R2365CP, the Centers for Medicare & Medicaid Services did say that it would issue an update at some point in the future.

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

January 2, 2012

Question:

Last week you said that labs would not receive payment for the new molecular pathology codes. Does this mean that we should not bill them?

Answer:

According to the Centers for Medicare & Medicaid Services, these tests may be billed to Medicare. When that occurs, CMS acknowledged that existing CPT test codes are “stacked” to represent a given test. For example, Laboratory A has a genetic test that is generally billed to Medicare as follows in order to represent the performance of the entire test: 83891 (one time) + 83898 (multiple times) + 83904 (multiple times) + 83909 (multiple times) + 83912 (one time).

If the new CPT test coding structure were active, Laboratory A would bill Medicare the new, single CPT test code that corresponds to the test represented by the “stacked” codes in the example above rather than billing each component of the test separately.

If fact, beginning with claims with dates of service on and after January 1, 2012, CMS requests that Medicare claims for molecular pathology procedures reflect both the existing CPT “stacked” test codes that are required for payment and the new single CPT test code that would be used for payment purposes if the new CPT test codes were active.
While the allowed charge amount will be $0.00 for the new molecular pathology procedure test codes that carry the “B” indicator, CMS requests that Medicare claims also reflect a charge for the non-payable service.

For the memo that includes the above, go to
http://www.cms.gov/transmittals/downloads/R2365CP.pdf.

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

December 26, 2011

Question:

How will the new molecular pathology codes be paid?

Answer:

Under the clinical laboratory fee schedule, the Centers for Medicare & Medicaid Services have assigned a “B” indicator to these codes, which identifies that payment for covered services always will be bundled into payment for other services not specified. These codes will have no relative value units (RVUs) or payment amounts, and they will not receive separate payments.

As CMS explains, “When these services are covered, payment for them is subsumed by the payment for the services to which they are incident…”

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


December 19, 2011

Question:

Has CMS released any instructions related to billing the new molecular pathology codes?

Answer:

Yes, it has and they can be found in transmittal R2365CP at http://www.cms.gov/transmittals/downloads/R2365CP.pdf. This transmittal also includes information about the 2012 update to the clinical laboratory fee schedule.

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

December 12, 2011

Question:

Last week you indicated that independent labs may not bill for the TC of physician pathology services after December 31. I do not understand the rationale behind not allowing this billing. Can you help with this?

Answer:

In the final rule, the Centers for Medicare & Medicaid Services (CMS) explained that payment for the costs of furnishing the pathology service (but not its interpretation) is already included in the bundled inpatient stay payment to the hospital. It believes that allowing technical component (TC) billing by independent labs represents a duplicate payment for the TC service in the following ways:

Generally, says CMS, there is no duplicate payment for outpatient services because the hospital does not bill Medicare when the independent laboratory bills Medicare.

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

December 5, 2011

Question:

When January 1, 2012, comes around, can independent labs still bill for the TC of physician path services?

Answer:

No, for services furnished after December 31, 2011, an independent laboratory may not bill a Medicare contractor for the technical component (TC) of physician pathology services for fee-for service Medicare beneficiaries who are inpatients or outpatients of a covered hospital. The Centers for Medicare & Medicaid Services published this policy in the 2012 Medicare physician fee schedule final rule, and it takes effect on January 1 “absent additional legislation” said the agency.

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

November 28, 2011

Question:

The code you gave in the answer last week (87389) is not in the 2011 AMA book. Was this a typo?

Answer:

Thank you so much for catching this, and you are right that 87389 is not in the 2011 CPT book. It is a new code in the 2012 CPT code book. The full description for 87389 is “HIV-1 antigen(s), with HIV-1 and HIV-2 antibodies, single result.”

For 2012, AMA also revised the other code mentioned last week. In 2011, the code descriptor for 86703 read as “HIV-1 and HIV-2, single assay.” For 2012, the American Medical Association (AMA( revised the 86703 descriptor to read as follows: “HIV-1 and HIV-2, single result.” (The boldface type is for emphasis in the code descriptors.)

We will revise last week’s answer in our archives.

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

November 21, 2011

Question:

Should revised CPT code 86703 be used to report HIV-1 antigens with HIV-1 and HIV-2 antibodies, single result?

Answer:

In the 2012 code book, the descriptor for 86703 has been revised. A guideline under that code indicates that new code 87389 (HIV-1 antigen(s), with HIV-1 and HIV-2 antibodies, single result) should be assigned.

Note also that the AMA revised 86703 for 2012. In 2011, this descriptor for 86703 read as “HIV-1 and HIV-2, single assay.” For 2012, the American Medical Association (AMA) revised the 86703 descriptor to read as follows: “HIV-1 and HIV-2, single result.”

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

November 14, 2011

Question:

What is the latest update from CMS on rescinding the physician signature requirement on outpatient requisitions?

Answer:

In the 2012 Medicare physician fee schedule (MPFS) final rule, the Centers for Medicare & Medicaid Services said it was retracting the policy that required a physician's or non-physician practitioner’s signature on a requisition for clinical diagnostic laboratory tests paid under the clinical laboratory fee schedule. It is reinstating its previous policy that the signature of the physician or NPP is not required on a requisition for a clinical diagnostic laboratory test paid under the CLFS for Medicare purposes.

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

November 7, 2011

Question:

Can you describe what the technical component (TC) of physician pathology services includes?

Answer:

For pathologists, the TC refers to the preparation of the slide involving tissue or cells that they will interpret. (In contrast, the pathologist’s interpretation of the slide is the professional component [PC] services.) If the hospital pathologist furnishes this service 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.

For more on this, see http://www.cms.hhs.gov/transmittal/downloads/R1148CP.pdf and http://www.cms.hhs.gov/mlnmattersarticles/downloads/MM5468.pdf.

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


October 31, 2011

Question:

On the topic of “meaningful use,” what are the responsibilities for laboratory managers?

Answer:

The best place to learn about meaningful use and the electronic health record (EHR) is at the website of the Centers for Medicare & Medicaid Services: https://www.cms.gov/ehrincentiveprograms/30_Meaningful_Use.asp. According to the College of American Pathology (CAP), lab managers will need to check with their laboratory information system (LIS) vendors to see that the system is CMS-certified and uses the appropriate version of the HL7 standard.

Many laboratories need to upgrade to the meaningful use certified version of their LIS or to an HL7 2.5.1 format, in addition LOINC encoding the reportable results in their data dictionary.  LOINC encoding is the most challenging in terms of time, resources, and expertise. LOINC, a universal set of identifiers for lab observations, facilitates the exchange of meaningful information between the LIS and the care provider.

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

October 24, 2011

Question:

Can you provide a source for the recent rule related to direct access of lab test results?

Answer:

Under a recently proposed rule, patients (and their authorized representatives) would have direct electronic access to their own laboratory test-result reports. Labs could charge reasonable cost-based fees reflecting the labor costs for creating an electronic copy of the information and supplies. Before giving patients access, lab staff would have to verify the identity of the requesting individual. No access would be required if the test order is accompanied only by anonymous identifiers. For more on the proposal, see http://www.hhs.gov/news/press/2011pres/09/20110912a.html.

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

October 17, 2011

Question:

What is the allowed frequency for the glycated hemoglobin test when it’s given for Medicare patients?

Answer:

According to the Medicare laboratory National Coverage Determination (NCD) policy 190.21, unless documentation supports the medical necessity of testing, a glycated hemoglobin test is not considered reasonable and necessary more often than every three months on a controlled diabetic patient. The test is given to determine whether the patient’s metabolic control has been on average within the target range.

This test also is not considered reasonable and necessary more frequently than once a month for diabetic pregnant women. Testing for uncontrolled type one or two diabetes mellitus may require testing more than four times a year.

For details about the above policy, review the lab NCD, which can be found at http://www.cms.gov/manuals/downloads/ncd103c1_Part3.pdf. Scroll down to Section 190.21.

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

October 10, 2011

Question:

Do you have any information on the 2012 CPT code changes?

Answer:

Yes, the electronic file of next year’s CPT codes has been issued by the American Medical Association. It shows the addition of 75 new molecular pathology codes, ranging from 81200–81408. A College of American Pathology (CAP) spokesperson called the AMA’s intent “the biggest change in pathology and laboratory CPT coding in the last 20 years…” (March 17 issue of CAP’s Statline).

There also are eight changes in other sections. In the immunology section there is one new code and one revised code. The surgical pathology section contains six changes: CPT codes 88107 and 88318 will be deleted, and the AMA has revised codes 88312, 88313, 88314, and 88319.

Now is the time for all providers to purchase the 2012 CPT Code book (or electronic file), which is available at the AMA’s bookstore at http://www.amaassn.org/. Click on the Bookstore in the second level of tabs.

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

October 3, 2011

Question:

Has CMS updated the travel allowance for specimen collection recently?

Answer:

On August 26, the Centers for Medicare & Medicaid Services recently announced the second payment “raise” in 2011 for the travel allowance related to specimen-collection services provided to beneficiaries. (For the official memos, go to transmittal R2283CP at http://www.cms.gov/transmittals/downloads/R2283CP.pdf or MM7526 at https://www.cms.gov/MLNMattersArticles/downloads/MM7526.pdf.

The implementation date for the new rates is not until November 29, although the effective date is retroactive to July 1, 2011. As long as it is acceptable to the specific Medicare contractor, labs may choose to bill in one of two ways:

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

September 26, 2011

Question:

Will claims for tests related to the lab demonstration have to meet the requirements for medical necessity policy?

Answer:

Yes. All Medicare rules for adjudicating laboratory claims including medical necessity continue to apply under the demonstration.

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

September 19, 2011

Question:

Where can we find the latest NCD edits?

Answer:

In Transmittal R2257CP (issued July 22), the Centers for Medicare & Medicaid Services provide the numerous ICD-9-CM diagnosis codes that will be added to, and deleted from, the October 2011 release of Medicare’s edit module for clinical diagnostic laboratory national coverage determinations (NCDs). CMS issued the last update to this module in April. These changes become effective for services furnished on or after October 1, 2011.

Go to the following websites to view or download the memos that contain them: http://www.cms.gov/transmittals/downloads/R2257CP.pdf and https://www.cms.gov/MLNMattersArticles/downloads/MM7507.pdf.

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

September 12, 2011

Question:

What code is reported when it is medically necessary to evaluate both bone structure and bone marrow from a single biopsy, should 38221 or 20220 be reported?

Answer:

When it is medically necessary to evaluate both structure and marrow, report either one of these codes for the surgical procedure. If two separate biopsies are medically necessary, report both and append modifier 59 to one of the codes. If only one specimen is submitted for surgical pathology, report only CPT code 88305 or 88307 (as appropriate)—even if the report includes evaluation of both bone structure and bone marrow morphology.

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

September 5, 2011

Question:

The laboratory services we furnish to end-stage renal disease (ESRD) patients in the emergency room/department are being denied. Is there any Medicare policy about why this would happen?

Answer:

Without more details, it is difficult to answer your question. But in the ESRD prospective payment system (PPS) final rule, CMS discussed the consolidated billing rules and edits that are currently in place to prevent renal dialysis services from getting paid outside of the bundled payment. All outpatient claims are subject to these edits, which means there are some edits included for ESRD-related laboratory services. CMS acknowledged that providers are confused about whether certain renal dialysis services furnished in an ED are covered under the ESRD PPS, and your situation may well fall into this category.

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

August 29, 2011

Question:

Are clinical laboratory tests part of Medicare’s initial preventive physical examination (IPPE) or its annual wellness visit (AWV)?

Answer:

Neither the IPPE nor the AWV include any clinical laboratory tests, but providers still may want to make referrals for such tests as part of them.

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

August 22, 2011

Question:

In the case of PT, do you know whether Medicare covers the diagnosis code for chest pain?

Answer:

The Centers for Medicare & Medicaid Services recently released its decision about coverage of the following two ICD-9-CM diagnosis codes listed below for the national coverage determination (NCD) for prothrombin time (PT): 786.50 (chest pain, unspecified) and 786.51 (precordial pain).

In its announcement, CMS noted that a PT test may be used to assess the following types of patients:

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

August 15, 2011

Question:

My question relates to the upcoming laboratory demonstration project, which had an August 1 deadline to apply to participate. Do you know whether CMS would accept late applications?

Answer:

September 6, instead of the previously announced August 1, is the new deadline for submitting supporting information to request a temporary code for the demonstration project for complex diagnostic laboratory tests being planned by the Centers for Medicare & Medicaid Services, according to a list serve announcement. For more information, go to http://www.cms.gov/DemoProjectsEvalRpts/MD/itemdetail.asp?itemID=CMS1240611.

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

August 8, 2011

Question:

Why are laboratory services furnished to ESRD patients in the emergency room/department setting being denied?

Answer:

In the end-stage renal disease (ESRD) prospective payment system (PPS) final rule, CMS discussed the consolidated billing rules and edits that are currently in place to prevent renal dialysis services from getting paid outside of the bundled payment. Included in the consolidated billing requirements are edits for ESRD-related laboratory services. All outpatient claims are subject to these edits. However, CMS has said that there is confusion as to whether certain renal dialysis services furnished in an ED or ED are considered to be renal dialysis services covered under the ESRD PPS.

In emergency situations diagnostic laboratory testing is ordered according to the illness the patient is presenting and that it may not be feasible for the ordering physician to know at the time the laboratory test is being ordered for reasons of treating the patient's ESRD.
CMS says that it will need to make a change in claims processing in order to address this problem, but it cannot create an immediate fix. Hospital providers billing for ED or ER services will need to bill non-ESRD related laboratory tests using the AY modifier to receive separate payment. According to CMS, it will address the problem in future guidance that will be implemented January 1, 2012.

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


August 1, 2011

Question:

A lab does manual differentials off of flags rather than physician order. The reflex test goes through our executive committee—a medical review board of physicians, which approves the flags used. Can the executive committee’s reflex-testing decisions be considered a physician order?

Answer:

No.  The executive committee has approved the components of the laboratory’s protocols for reflex procedures, which does not make the manual diff separately billable in addition to the CBC. A physician’s “patient-specific order” is required for billing and would be based on the parameters for that patient’s blood sample. The physician has the option to indicate on the order to apply or disregard reflex protocol (refer to the OIG Compliance Program Guidance for Clinical Laboratories at http://oig.hhs.gov/authorities/docs/cpglab.pdf. 

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

July 25, 2011

Question:

Is any information yet available for lab code changes for 2012?

Answer:

At this point, at least, the laboratory section of CPT will include two new codes—one in immunology and one in microbiology, which are listed below. Note, however, that their code numbers are not yet final.

863XX Nuclear matrix protein 22 (NMP22), qualitative
873XX HIV-1 antigen(s), with HIV-1 and HIV-2 antibodies, single result

At its July 18 forum on lab-test code changes for 2012, the Centers for Medicare & Medicaid Services also accepted comments on the following codes: G0434, G0435, 83861, and 86481. These fall into the category of “reconsideration requests,” meaning that the codes and/or payments may change.

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

July 18, 2011

Question:

If the Medicare rule requiring a physician’s signature on a requisition does not take effect, would it be appropriate for a laboratory to set up a system like this on its own?

Answer:

Laboratories may still choose to require a physician's or non-physician practitioner’s (NPP) signature on the requisition. In fact, the Centers for Medicare & Medicaid Services urge laboratories to develop their own compliance procedures, such as those listed below, to ensure that they only furnish services in response to a physician or NPP order.

• Internal audits;
• Agreements with ordering physicians or NPPs to provide medical record evidence of the order in the event of an internal or external audit;
• Steps to confirm the existence of an order under certain circumstances; or
• Any other measures including the acceptance of risk (financial and compliance responsibility) by the clinical laboratory.

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

July 11, 2011

Question:

What should we do about this situation? We get physicians who submit prescription pad orders for outpatients and write “CBC” but do not include signs, symptoms, or ICD-9 information. The admitting clerks don’t know which test to select or what to do about medical necessity.

Answer:

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 checkoff-style outpatient requisitions will help your admitting staff by removing them from the decision-making process, and it will restrict the use of prescription pad orders.

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

July 4, 2011

Question:

I heard that CMS withdrew the physician signature requirements for lab claims. Can you provide a source for this information?

Answer:

The agency has, indeed, proposed rescinding the requirement that the ordering physician or practitioner sign requisitions for all clinical diagnostic laboratory tests paid under the clinical laboratory fee schedule. For the proposal, go to: http://www.ofr.gov/OFRUpload/OFRData/2011-16366_PI.pdf.

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

June 27, 2011

Question:

When a CPT code is not listed on the Clinical Laboratory Fee Schedule, how does one determine reimbursement?  This is the case, for example, with CPT code 88313—special stains; group II, all other (e.g., iron, trichrome), except immunocytochemistry and immunoperoxidase stains, including interpretation and report, each.

Answer:

Code 88313 is paid under the hospital outpatient prospective payment system (OPPS) at a rate of $17.07 (as of April 2011). Addendum B lists a status indicator of X, which means a separate payment will be made.

To locate this information, go to the following site: http://www.cms.gov/HospitalOutpatientPPS/AU/list.asp#TopOfPage. In the center, you will see a chart with the first column labeled Release Date. Click April 2011. In the center of the page, under Downloads, click Addendum B, updated 4/4/11. After accepting the AMA’s license agreement, you will see an Excel chart where the first column lists all codes. Scroll down until you hit the code you want to check.

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

June 20, 2011

Question:

The last two questions and answers have related to waived coinsurance and deductibles. Where can I find more information about this new process?

Answer:

Information about this waiver can be found in transmittal R864OTN (issued March 2, 2011) at http://www.cms.gov/transmittals/downloads/R864OTN.pdf.

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

June 13, 2011

Question:

In last week’s answer you provided the codes for screening Pap smears with waived coinsurance and deductible. Are there other lab codes that have this same waiver?

Answer:

Yes, several selected preventive services, including the laboratory tests listed below, fall into this category:

• Prostate cancer screening tests: G0103;
• Colorectal cancer screening tests: 82270, G0328;
• Cardiovascular screening blood test: 80061, 82465, 83718, and 84478;
• Diabetes screening tests: 82947, 82950, 82951; and
• Human immunodeficiency virus (HIV) testing: G0432, G0433, G0435.

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

June 6, 2011

Question:

What codes assigned to Pap smears can be waived for 2011?

Answer:

As required by Section 4104 of The Affordable Care Act, Medicare will, for claims dated January 1, 2011, and after, waive any coinsurance or copayment for the following codes assigned for screening Pap smears: G0123, G0124, G0141–G0148, P3000, P3001, and Q0091.

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

May 30, 2011

Question:

Since the start of the year, our Medicare contractor has applied deductible and coinsurance to our outpatient claims containing Q0091. I thought there was a new policy stating that this would not occur after January 1. Do you know what’s going on with this?

Answer:

You are correct that there is a new policy. As required by Section 4104 of The Affordable Care Act, Medicare contractors must, for claims dated January 1, 2011, and after, waive any coinsurance or copayment for the initial preventive physical examination, the annual wellness visit, and for selected preventive services, including several laboratory-related services. (For more on this policy, see http://www.cms.gov/MLNMattersArticles/downloads/MM7012.pdf.)

However, in an April 7 memo to the outpatient prospective payment system list serve, the Centers for Medicare & Medicaid Services announced that Medicare contractors have been erroneously applying deductible and coinsurance to certain OPPS claims. Luckily, this processing error only applies to one lab-related preventive service when it is submitted on type of bill 13X with dates of service on or after January 1, 2011: Q0091—screening Papanicolaou smear; obtaining, preparing and conveyance of cervical or vaginal smear to laboratory.

As instructed, Medicare contractors will hold claims for the above and process after CMS makes a software correction on May 9, 2011. As corrections are made, contractors will release suspended claims and automatically reprocess them. Most reprocessing will be completed by May 31, 2011, says CMS.

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

May 23, 2011

Question:

Do you know what code should be assigned for a Clearview Complete HIV 1/2 test?

Answer:

In transmittal R2196CP (issued April 22), the Centers for Medicare & Medicaid Services indicated that code G0433 should be assigned (instead of 86703QW as previously announced). For the transmittal, go to go to https://www.cms.gov/transmittals/downloads/R2196CP.pdf. 

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

May 16, 2011

Question:

Has CMS posted any information about which transmission and communication standards work best for electronic exchange of lab data?

Answer:

The Centers for Medicare & Medicaid Services strongly encourages laboratories to use Health Level 7 (HL7) 2.5.1 as the transmission standard and logical observation identifiers, names and codes (LOINC) as the vocabulary standard. An important question to ask vendors is whether or not their products support these standards.

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

May 9, 2011

Question:

Are there any federal rules about showing patients their test results?

Answer:

CLIA permits patient access to tests results if state law does not prohibit it.  Some states allow patients to order and receive test results regardless of who ordered the test. According to survey guidance in Appendix C of the State Operations Manual, “In these states a laboratory may release directly to a patient as an ‘authorized person’ in accordance with state law.”

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

May 2, 2011

Question:

Will Medicare pay for code 80100 when performed for outpatients?

Answer:

In transmittal R2174CP (issued March 18, 2011), the Centers for Medicare & Medicaid Services (CMS) listed a change to the payment status indicator (SI) for code 80100 (drug screen, qualitative; multiple drug classes chromatographic method, each procedure) that took effect on January 1, 2011. The final hospital outpatient prospective payment system (OPPS) rule listed this code with a SI of “A” (services furnished to a hospital outpatient paid under a non-OPPS fee schedule or payment system, such as the clinical diagnostic laboratory). However, now the SI is “E” (not paid by Medicare when submitted on outpatient claims (any outpatient bill type).

For this information, go to http://www.cms.gov/Transmittals/downloads/R2174CP.pdf or https://www.cms.gov/MLNMattersArticles/downloads/MM7342.pdf.

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

April 25, 2011

Question:

I have heard that changes have been made to CLIA rules. What are these changes?

Answer:

As the federal government pushes adoption of electronic health records (EHRs) in healthcare, it has had to address a number of obstacles related to the Clinical Laboratory Improvement Amendments (CLIA).

Industry stakeholders have complained about perceived conflicts between CLIA provisions and the electronic exchange of lab data. In response, the Centers for Medicare and Medicaid Services (CMS) issued revised CLIA survey procedures and guidelines for laboratories on March 1, 2010. The guidelines are currently in effect and offer laboratories some direction in keeping pace with EHR initiatives.

Note that neither the CLIA regulations nor the survey process have changed. However, for certain regulations, CMS has updated the interpretive guidance found in Appendix C of the State Operations Manual. For this information, go to https://www.cms.gov/SurveyCertificationGenInfo/downloads/SCLetter10-12.pdf.

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

April 18, 2011

Question:

Is it true that CMS has canceled the requirement to have physicians sign lab requisitions?

Answer:

Yes, it’s true. A March 31 memo from the Centers for Medicare & Medicaid Services (CMS) directed Medicare contractors to not enforce the requirement to have the ordering physician or qualified non-physician practitioner signature on requisitions for clinical diagnostic laboratory tests paid under the clinical laboratory fee schedule. CMS asked Congress for permission to officially rescind the requirement, although at this moment that hasn’t occurred. Industry spokespersons believe CMS will address this in a future regulation.

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

April 11, 2011

Question:

If an end-stage renal disease (ESRD) facility has a CLIA certificate of waiver, does this change what it is allowed to bill for labs?

Answer:

Laboratory tests that are for the treatment of ESRD are renal dialysis services and included in the prospective payment system. The laboratory should bill the ESRD facility for those tests under arrangements when not performed by the facility. If the laboratory test is not for the treatment of ESRD, it does not meet the definition of a renal dialysis service and the independent laboratory should bill directly. However, if the laboratory test is a CLIA-waived test and is not for the treatment of ESRD then the facility could bill Medicare directly with an AY modifier.

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

April 4, 2011

Question:

What is the maximum number of units of service that can be billed with code G0434?

Answer:

Bill only one unit of service for this code per patient encounter regardless of the number of drug classes tested and irrespective of the use or presence of the QW modifier on claim lines.

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

March 28, 2011

Question:

Can code G0431 be reported for CLIA-waived tests?

Answer:

No. In transmittal SE1105, CMS states that the following code should be used for CLIA-waived tests and comparable non-waived tests:

G0434 - Drug screen, other than chromatographic; any number of drug classes, by CLIA waived test or moderate complexity test, per patient encounter

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

March 21, 2011

Question:

Has CMS ever issued billing guidelines for the drug-screening codes G0431 and G0434?

Answer:

Yes, that information can be found in SE1105 at http://www.cms.gov/MLNMattersArticles/Downloads/SE1105.pdf.

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

March 14, 2011

Question:

What tests will CMS include in the new laboratory demonstration project?

Answer:

According to transmittal R67DEMO, the following complex diagnostic laboratory tests will be included in the demonstration:

• An analysis of gene protein expression, topographic genotyping, or a cancer chemotherapy sensitivity assay;
• No alternative test is available with equivalent performance characteristics;
• Billed using a HCPCS code other than a not otherwise classified (NOC) code; and
• Approved or cleared by the Food and Drug Administration or covered under title XVIII of the Social Security Act.

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

March 7, 2011

Question:

If an independent laboratory bills a non-ESRD-related test included in the ESRD PPS bundle using modifier AY, must the ESRD facility report it on its claim?

Answer:

According to the Centers for Medicare & Medicaid Services, the answer is no. The ESRD facility should not report the diagnostic test on its claim because the test is not ESRD-related. There should be no instance where a diagnostic test is reported on an ESRD facility claim and billed by an independent laboratory.

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

February 28, 2011

Question:

Who bills for the ESRD-related diagnostic laboratory tests that are outside of the end-stage renal disease (ESRD) prospective payment system (PPS) bundle?

Answer:

According to the Centers for Medicare & Medicaid Services, all ESRD-related diagnostic laboratory tests are included in the ESRD PPS base rate and should be reported on ESRD facility claims. If an independent laboratory or an ESRD facility (with the appropriate clinical laboratory certification in accordance with Clinical Laboratory Improvement Act) furnishes a diagnostic test for an ESRD patient that is ESRD-related, the ESRD facility is responsible for the diagnostic test. Specifically, the ESRD facility is responsible for payment to a laboratory that furnished the renal dialysis service.

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

February 21, 2011

Question:

Do the automated multi-channel chemistry (AMCC) lab tests billed by ESRD facilities continue to be reported by individual CPT codes rather than panel codes?

Answer:

Yes, the AMCC lab tests should be reported with individual lab codes rather than panel codes along with the appropriate modifier (i.e., CD, CE or CF).

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

February 14, 2011

Question:

In regard to your answer to the January 31 question: Are we allowed to use a modifier for the repeat protein, since it is part of the reference lab testing protocol?

Answer:

There is no medical necessity for the repeat protein. It is a duplicate test, and no modifier should be assigned.

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

February 7, 2011

Question:

My question relates to the new policy on signatures required on lab requisitions. In the 2011 Medicare fee schedule, one commenter requested that long-term-care (LTC) facilities be exempted from this policy because physicians who can actually sign these requisitions are rarely seen in the facility. CMS responded that, basically, the policy only affects requisitions and not orders. I am not sure how that answer helps.

For example, a nursing home is daily sending requisitions to a laboratory for testing that its patients need, and the facility’s medical director is only in one day a week or even less in some cases. How is it possible to get his/her signature on a requisition? What about STAT testing needs? If I am reading this correctly, then I must require that the physician signs all these requisitions prior to them being sent to my lab. Is that a correct interpretation?

Answer:

Both LTC facilities and laboratories will have to revise some practices in light of the CMS ruling regarding signatures. This new policy should be a topic of discussion among the laboratory director, director of compliance and/or hospital administrators sooner rather than later. The goal of the discussion(s) should be to develop a workable process for your laboratory that you might propose to your clients that will ensure compliance without compromising care. In your discussion, consider that CMS states that an order may be delivered via any of the following forms:

• A written document signed by the treating physician/practitioner, which is hand-delivered, mailed, or faxed to the testing facility;

• A telephone call by the treating physician/practitioner or his or her office to the testing facility; or

• An electronic mail, or other electronic means, by the treating physician/practitioner or his or her office to the testing facility.

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

January 31, 2011

Question:

Physicians often order a CMP and protein electrophoresis together. We do a CMP (CPT code 80053) here at our facility, and send the serum protein electrophoresis to our reference lab. A total protein (CPT 84155) is a component of the CMP we do here, but it is also a component of the serum protein electrophoresis that is done at the reference laboratory. What would be the correct way to handle this situation?

Answer:

Report CPT code 80053 (CMP) and CPT code 84165 (electrophoresis) only. Do not report CPT 84155. This would be double billing the serum protein test, which is a component of the CMP. Depending on your billing system capabilities and the type of claim you file (UB versus CMS-1500) this may be easier said than done. You may have to manually delete the charge.

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

January 24, 2011

Question:

Does reference testing billed on the CMS-1450 require modifier 90 and CLIA/laboratory address information?

Answer:

No.  The requirements to report modifier 90 and the CLIA/laboratory address are applicable to the  CMS- 1500 form, not the CMS-1450.    Modifier 90 is not allowed on the CMS-1450 form.  The only addresses reported on the CMS-1450 are those of the patient and the billing provider. No  CLIA information is entered on this form.

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

January 17, 2011

Question:

We use modifier 91 when we perform a repeat of the same lab test (separately ordered and warranted) on same day on the same patient. For certain codes like 86001 and 82787, the same CPT code applies, but you charge for each separate and specific antigen. This does not appear to be for the exact same test being repeated. Instead of modifier 91, should we use modifier 59, which refers to different parts or sites and not different antigens.

Answer:

When a code definition includes "each" or "per" indicating that the procedure code is intended to be reported multiple times (e.g., 86003—allergen specific IgE; quantitative or semiquantitative, each allergen), no modifier is required.

Please see Medicare Claims Processing Manual, Chapter 4, Section 20.6, Use of Modifiers on page 44 at http://www.cms.gov/manuals/downloads/clm104c04.pdf. CMS says, "Providers do not use a modifier if the narrative definition of a code indicates multiple occurrences."