(Medicare Claims Processing Manual)

The IL must perform at least one of the component services.  If they purchase both the PC and the TC services, only the physician or supplier that performed those services may bill.   40.3 - Hospital Billing Under Part B  (Rev. 3014, Issued: 08- 06-14, Effective: ICD - 10: Upon Implementation of ICD -10 ASC -X12: 01- 01-12, Implementation: ICD -10: Upon Implementation of ICD -10 ASC X12: 09- 08-14)  Hospital laboratories, billing for either outpatient or non- patient claims, bill the A/B MAC (A).   Neither deductible nor coinsurance applies to laboratory tests paid under the fee schedule.   Hospitals must follow requirements for submission of the ASC X12 837 institutional claim or the hardcopy Form CMS -1450.  (See Chapter 25 for a description of the data set, and for requirements for the paper form.  See the ASC X12 837 implementation guide f or billing requirements for the electronic claim,).   When the hospital obtains laboratory tests for outpatients under arrangements with clinical laboratories or other hospital laboratories, only the hospital can bill for the arranged services.   As discussed in section 30.3 (Place of Service Variation, Critical Access Hospitals) of this chapter, when the CAH bills a 14X bill type as a non- patient laboratory specimen, it is paid on the clinical laboratory fee schedule.  For CAHs, payment for clinical diagnostic laboratory tests is made at 101 percent of reasonable cost only if the beneficiary is an outpatient of the CAH (85X TOB), as defined in 42 CFR 410.2, and is physically present in the CAH at the time the specimen is collected, for dates of s ervice prior to July 1, 2009.  However, for dates of service on or after July 1, 2009, the beneficiary does not have to be physically present in the CAH at the time the specimen is collected as long as certain criteria are met, per Section 148 of the MIPPA  (i.e. other outpatient services are received by the beneficiary in the CAH on the same day the specimen is collected, or the specimen is collected by an employee of the CAH or of a facility provider -based to the CAH) (see Section 30.3 above, Critical Acce ss Hospital).  Clinical diagnostic laboratory tests performed for a beneficiary who is not physically present at the CAH when the specimen is collected, by a non- CAH employee or who are not receiving other outpatient services in the CAH on the same day the  specimen is collected, are paid are paid for under the clinical lab fee schedule.  Similarly, for Maryland waiver hospitals, the waiver is limited to services to inpatients and registered outpatients as defined in 42 CFR 410.2.  Therefore 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.   Section 416 of the Medicare Prescription, Drug, Improvement, and Modernization Act (MMA) of 2003 also eliminates the application of the clinical laboratory fee schedule for hospital outpatient laboratory testing by a hospital laboratory with fewer than 50 beds in a qualified rural area for cost reporting periods beginning during the 2- year period beginning on July 1, 2004.  Payment for these hospital outpatient laboratory tests will be reasonable costs without coinsurance and deductibles during the applicable time period.  A qualified rural area is one with a population density in the lowest quartile of all rural county populations.   The reasonable costs are determined using the ratio of costs to charges for the laboratory cost center multiplied by the PS&Rs billed charges for outpatient laboratory services for cost reporting periods beginning on or after July 1, 2004 but before July 1, 2006.   In determining whether clinical laboratory services are furnished as part of outpatient services of a hospital, the same rules that are used to determine whether clinical laboratory services are furnished as an outpatient critical access hospital service w ill apply.   40.3.1 - Critical Access Hospital (CAH) Outpatient Laboratory Service  (Rev. 2971, Issued:  05-23-14, Effective:  07-01-14, Implementation:  07-07-14)   Effective for services furnished on or after the enactment of the Balanced Budget Refinement Act of 1999 (BBRA), Medicare beneficiaries are not liable for any coinsurance, deductible, co -payment, or other cost sharing amount with respect to clinical laboratory services furnished as a CAH outpatient service.  This change is effect ive for claims with dates of service on or after November 29, 1999.  For CAH bill type 85X, the laboratory fees are paid at 101 percent of reasonable cost.  When the CAH bills a 14X bill type as a non-patient laboratory specimen, it is paid on the clinical laboratory fee schedule.  40.4 - Special Skilled Nursing Facility (SNF) Billing Exceptions for Laboratory Tests  (Rev. 1, 10-01-03) SNF 541, A3-3137.1, HO-437, B3-5114.1  When a SNF furnishes laboratory services directly, it must have a Clinical Laboratory Improvement Act (CLIA) number or a CLIA certificate of waiver, and the laboratory itself must be in the portion of the facility so certified.  Normally the A/B MAC (A) ma kes payment under Part B for clinical laboratory tests only to the entity that performed the test.  However, the law permits SNFs to submit a Part B claim to the A/B MAC (A) for laboratory tests that it makes arrangements for another entity to perform on the SNFs behalf.  Section 1833(h)(5) of the Act (as enacted by The Deficit Reduction Act of 1984, P.L. 98-369) requires the establishment of a fee schedule for clinical laboratory tests paid under Part B and also requires that, with certain exceptions, only the entity that performed the test may be paid.  The fee schedule applies to all SNF clinical laboratory services.   Where a SNF operates a laboratory that provides laboratory services to patients other than its own patients, it is functioning as a clinical laboratory.  The billing for these laboratory services depends upon the HCPCS code as defined in the CMS annual fee schedule releases (laboratory and MPFS), and the arrangements made for payment with the referring entity (e.g., does the SNF or the referring entity bill under the agreement between the two).  The SNF is responsible for ascertaining the necessary information for billing the A/B MAC (A).  Any questions must be referred to the A/B MAC (A).  40.4.1 - Which A/B MAC (A) or (B) to Bill for Laboratory Services Furnished to a Medicare Beneficiary in a Skilled Nursing Facility (SNF)  (Rev. 1, 10-01-03)  Inpatient Part A beneficiary  - SNF bills the A/B MAC (A) under Part A.  The service is included in SNF PPS payment.  Inpatient Part B beneficiary (benefits exhausted or no Part A entitlement)  - SNFs may provide the service and bill the A/B MAC (A), may obtain the service under arrangement and bill the A/B MAC (A) under Part B, or may have agreement with a reference laboratory for the reference laboratory to provide the service and have the ref erence laboratory bill the A/B MAC (B) under Part B.  Regardless of who bills, CMS policy requires that the service be paid under the fee schedule, whether or not the beneficiary is in a Medicare certified bed.   Outpatient Part B  - See inpatient Part B beneficiary (benefits exhausted or no Part A entitlement), immediately above.   40.5 - Rural Health Clinic (RHC) Billing  (Rev. 1, 10-01-03) B3-3628  For independent RHCs, laboratory services provided in the RHCs laboratory are not included in the all-inclusive rate payment to the RHC and may be billed separately to the A/B MAC (B).  This includes the six basic laboratory tests required for certification as well as any other laboratory tests provided in the RHC laboratory.  Note:  If the RHC sends laboratory services to an outside laboratory, the outside laboratory bills the A/B MAC (B) for the tests.   If the RHC laboratory becomes certified as a clinical laboratory, it bills all laboratory tests performed in its laboratory to the laboratorys A/B MAC (B).  Laboratory tests are not included as RHC costs nor as part of the RHC all -inclusive rate payment.  For provider based RHCs the rules in the preceding paragraph apply with the following exception.  The provider bills tests provided in its laboratory to the A/B MAC (A).  40.6 - Billing for End Stage Renal Disease (ESRD) Related Laboratory Tests  (Rev. 2487, Issued: 06- 08-12, Effective: 01-01-11, Implementation: 06-19-12)  With the implementation of the ESRD PPS, effective for claims with dates of service on or after January 1, 2011, all ESRD- related laboratory services are included in the ESRD PPS base rate and must be reported by the ESRD facility and are not separately paid.  For instructions on ESRD facility billing under ESRD PPS, see Publication 100-04, Chapter 8.  The list of items and services subject to consolidated billing located at http://www.cms.gov/ESRDPayment/50_Consolidated_Billing.asp#TopOfPage includes the list of ESRD -related laboratory tests that are routinely performed for the treatment of ESRD.   Laboratory services that are not related to the treatment of ESRD are separately billable under the ESRD PPS and may be billed by either the ESRD facility or the independent laboratory.  If the ESRD facility or independent laboratory bills a laboratory ser vice that was not related to the treatment of ESRD, the bill must include the modifier AY.  The AY modifier serves as an attestation that the item or service is medically necessary for the dialysis patient but is not being used for the treatment of ESRD.  40.6.1 - Automated Multi- Channel Chemistry (AMCC) Tests for ESRD Beneficiaries  Rev. 3116, Issued:  11- 06-14, Effective:  04-01-15, Implementation:  04-06-15)   Instructions for Services Provided on and After January 1, 2011  Section 153b of the MIPPA requires that all ESRD-related laboratory tests must be reported by the ESRD facility whether provided directly or under arrangements with an independent laboratory.  When laboratory services are billed by providers other than the ESRD facility and the laboratory test furnished is designated as a laboratory test that is included in the ESRD PPS (ES RD-related), the claim will be rejected or denied.  In the event that an ESRD -related laboratory test was furnished to an ESRD beneficiary for reasons other than for the treatment of ESRD, the provider may submit a claim for separate payment using modifier AY.  The AY modifier serves as an attestation that the item or service is medically necessary for the dialysis patient but is not being used for the treatment of ESRD.  The items and services subject to consolidated billing located on the CMS website incl udes the list of ESRD-related laboratory tests that are routinely performed for the treatment of ESRD.   For services provided on or after January 1, 2011, the 50/50 rule no longer applies to independent laboratory claims for AMCC tests furnished to ESRD beneficiaries.  The 50/50 rule modifiers (CD, CE, and CF) are no longer required for independent laboratories effective for dates of service on and after January 1, 2011.  However, for services provided between January 1, 2011 and March 31, 2015, the 50/50 rule modifiers are still required for use by ESRD facilities that are receiving the transitional blended payment amount (the transition ends in CY 2014).  For services provided on or after April 1, 2015, the 50/50 rule modifiers are no longer required for use by ESRD facilities.  Effective for dates of service on and after January 1, 2012, A/B MACs (B) shall allow organ disease panel codes (i.e., HCPCS codes 80047, 80048, 80051, 80053, 80061, 80069, and 80076) to be billed by independent laboratories for AMCC panel tests furnished to ESRD eligible beneficiaries if:   The beneficiary is not receiving dialysis treatment for any reason (e.g., post- transplant beneficiaries), or   The test is not related to the treatment of ESRD, in which case the supplier would append modifier AY.