(Medicare Claims Processing Manual)

for details on RHC billing.)  30.2 - Deductible and Coinsurance Application for Laboratory Tests  (Rev. 2581, Issued: 11- 02-12, Effective: 04-01-13, Implementation: 04-01-13)   Neither the annual cash deductible nor the 20 percent coinsurance apply to:    Clinical laboratory tests performed by a physician, laboratory, or other entity paid on an assigned basis;    Specimen collection fees; or    Travel allowance related to laboratory tests (e.g., collecting specimen).   Codes on the physician fee schedule are generally subject to the Part B deductible and coinsurance, although exceptions may be noted for a given code in the MPFS or through formal Medicare instructions such as temporary instructions and requirements for specific services noted in this manual.   Any laboratory code paid at reasonable charge is subject to the Part B deductible and coinsurance, unless otherwise specified in the description of coverage and payment rules.   30.3 - Method of Payment for Clinical Laboratory Tests - Place of Service Variation  (Rev. 3685, Issued: 12- 22-16, Effective: 01 -01-17, Implementation: 01 -03-17)  The following apply in determining the amount of Part B payment for clinical laboratory tests:   Laboratory tests not payable on the Clinical Diagnostic Laboratory Fee Schedule (CLFS) will be based on OPPS (for hospitals subject to OPPS) and current methodology for hospitals not subject to OPPS.   Independent laboratory or a physician or medical group -  Payment to an independent laboratory or a physician or medical group is the lesser of the actual charge, the fee schedule amount or the national limitation amount.  Part B deductible and coinsurance do not apply.  Reference laboratory - For tests performed by a reference laboratory, the payment is the lesser of the actual charge by the billing laboratory, the fee schedule amount, or the national limitation amount (NLA).  (See 50.5 for A/B MAC (B) jurisdiction detai ls.) Part B deductible and coinsurance do not apply.   Outpatient of OPPS hospital -  For hospitals paid under the OPPS, beginning January 1, 2014 outpatient laboratory tests are generally packaged as ancillary services and do not receive separate payment.  Only in the following circumstance are lab tests eligible for separate pa yment under the CLFS.  (1) Outpatient lab tests only -  If the hospital only provides outpatient laboratory tests to the patient (directly or under arrangement) and the patient does not also receive other hospital outpatient services on that day.  Payment to a hospital for laboratory tests payable on the Clinical Diagnostic Laboratory Fee Schedule, furnished to an outpatient of the hospital, is the lesser of the actual charge, fee schedule amount, or the NLA. Part B deductible and coinsurance do not  apply.  Laboratory tests not payable on the Clinical Diagnostic Laboratory Fee Schedule will be based on OPPS (for hospitals subject to OPPS) and current methodology for hospitals not subject to OPPS.   Exception: Reasonable cost reimbursement has been provided for outpatient clinical laboratory tests furnished by hospitals with fewer than 50 beds in qualified rural areas for cost reporting periods beginning on July 1, 2004 through 2008 (per the following legislation:  Section 416 of the Medicare Modernization Act (MMA) of 2003, Section 105 of the Tax Relief and Health Care Act (TRHCA) of 2006, and Section 107 of the Medicare, Medicaid and State Childrens Health Insurance Program (SCHIP) Extension Act of 2007).  Section 3122 of the Patient Protection and Affordable Care Act re -institutes the above reasonable cost provisions for cost reporting periods beginning on or after July 1, 2010, through June 30, 2011.  Section 109 of the Medicare and Medicaid Extend ers Act extends the above reasonable cost provisions for cost reporting periods beginning on or after July 1, 2011, through June 30, 2012.  Non-Patient (Referred) Laboratory Specimen - A non -patient is defined as a beneficiary that is neither an inpatient nor an outpatient of a hospital, but that has a specimen that is submitted for analysis to a hospital and the beneficiary is not physically present at the hospital.  All hospitals (including Maryland waiver hospitals and CAHs) bill non- patient lab tests on TOB 14X.  They are paid under the clinical laboratory fee schedule at the lesser of the actual charge, the fee schedule amount, or the NLA ( including CAH and MD Waiver hospitals).  Part B deductible and coinsurance do not apply.  Inpatient without Part A  Payment to a hospital for laboratory tests payable on the Clinical Diagnostic Laboratory Fee Schedule, is the lesser of the actual charge, fee schedule amount, or the NLA.  Part B deductible and coinsurance do not apply.  Laboratory tests not payable on the Clinical Diagnostic Laboratory Fee Schedule will be based on OPPS (for hospitals subject to OPPS) and current methodology for hospitals not subject to OPPS.  For hospitals subject to the OPPS, beginning January 1, 2014 Part B inpatient laboratory tests are packaged as ancillary services and do not receive separate payment unless the service with which the labs would otherwise be packaged is not a payable Part B inpatient service (see Chapter 6, Section 10 of the Medicare Benefit  Policy Manual, Pub. 100-02).  Payment to a SNF inpatient without Part A coverage is made under the laboratory fee schedule.  Inpatient or SNF patient with Part A - Payment to a hospital for laboratory tests furnished to an inpatient, whose stay is covered under Part A, is included in the PPS rate for PPS facilities or is made on a reasonable cost basis for non-PPS hospitals and is made at 101 percent of reasonable cost for CAHs.  Payments for lab services for beneficiaries in a Part A stay in a SNF, other than a swing bed in a CAH are included in the SNF PPS rate.  For such services provided in a swing bed of a CAH, payment is made at 101 percent of reasonable cost.  Sole community hospital  Sole community hospitals are subject to the OPPS, therefore OPPS packaging rules apply.  When the OPPS exception for separate payment of outpatient laboratory tests under the CLFS applies, a sole community hospital with a qualifie d hospital laboratory identified on the hospitals certification in the Provider Specific File is paid the least of the actual charge, the 62 percent fee schedule amount, or the 62 percent NLA.  The Part B deductible and coinsurance do not apply.  Waived Hospitals - Payment for outpatient (bill type13X), to a hospital which has been granted a waiver of Medicare payment principles for outpatient services is subject to Part B deductible and coinsurance unless otherwise waived as part of an approved waiver.  Specifically , laboratory fee schedules do not apply to laboratory tests furnished by hospitals in States or areas that have been granted waivers of Medicare reimbursement principles for outpatient services.  The State of Maryland has been granted such a waiver. Paymen t for non-patient laboratory specimens (bill type14X) is based on the fee schedule.  Laboratory tests not payable on the Clinical Diagnostic Laboratory Fee Schedule will be paid based on current methodology.  Critical Access Hospital - When the CAH bills a 14X bill type as a non-patient laboratory specimen, it is paid on the laboratory fee schedule.  If the beneficiary is an outpatient of the CAH, the CAH bills using an 85x bill type and is paid based on 101 pe rcent of reasonable cost.   Beneficiaries are not liable for any coinsurance, deductible, co -payment, or other cost sharing amount with respect to CAH clinical laboratory services.   Section 148 of the Medicare Improvements for Patients and Providers Act (MIPPA)  Effective for services furnished on or after July 1, 2009, the beneficiary is no longer required to be physically present in a CAH at the time the specimen is collected in order for the CAH to be paid based on 101 percent of reasonable cost.  However, the beneficiary must be an outpatient of the CAH, as defined at 42 CFR 410.2 and be receiving services directly from the CAH.  In order for the beneficiary to be receiving services directly from the CAH if he/she is not present in the CAH when the specimen is collected, the beneficiary must either be receiving outpatient services in the CAH on the same day the specimen is collected, or the specimen must be collected by an employee of the CAH or of a facility provider-based to the CAH.  Dialysis facility - Effective for items and services furnished on or after January 1, 2011 Section 153b of the Medicare Improvements for Patients and Providers Act (MIPPA) requires that all ESRD -related laboratory tests be reported by the ESRD facility whether provided directly or under arrangements with an independent laboratory.  When laboratory services are billed by a laboratory other than the ESRD facility and the laboratory service furnished is designated as a laboratory test that is included in the E SRD PPS (i.e., ESRD -related), the claim will be rejected or denied.  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 rout inely performed for the treatment of ESRD.  In the event that an ESRD -related laboratory service was furnished to an ESRD beneficiary for reasons other than for the treatment of ESRD, the supplier may submit a claim for separate payment using modifier AY.  See Pub.100-04, Chapter 8 for more information regarding Outpatient ESRD Hospital, Independent Facility, and Physician/Supplier Claims.   Rural Health Clinic (RHC)/Federally Qualified Health Center (FQHC) - Payment to a RHC/FQHC for laboratory tests performed for a patient of that clinic/center is not included in the all- inclusive rate and may be billed separately by either the base provider for a provider-based RHC/FQHC, or by the physician for an independent or free-standing RHC/FQHC.  Payment for the laboratory service is not subject to Part B deductible and coinsurance.  If the RHC/FQHC is provider-based, payment for lab tests is to the base provider (i.e., hospital).  If the RHC/FQHC is independent or freestanding, payment for lab tests is made to the practitioner (physician) via the clinical lab fee schedule.   (See Sections 30.1.1 and 40.5 for details on RHC/FQHC billing.)   Enrolled in Managed Care - Payment to a participating health maintenance organization (HMO) or health care prepayment plan (HCPP) for laboratory tests provided to a Medicare beneficiary who is an enrolled member is included in the monthly capitation amount.  Non-enrolled Managed Care - Payment to a participating HMO or HCPP for laboratory tests performed for a patient who is not a member is the lesser of the actual charge, or the fee schedule, or the NLA.  The Part B deductible and coinsurance do not apply.  Hospice - Payment to a hospice for laboratory tests performed by the hospice is included in the hospice rate.  30.4 - Payment for Review of Laboratory Test Results by Physician  (Rev. 1, 10-01-03) B3-5114.2  Reviewing results of laboratory tests, phoning results to patients, filing such results, etc., are Medicare covered services.  Payment is included in the physician fee schedule payment for the evaluation and management (E and M) services to the patient.  V isit services entail a wide range of components and activities that may vary somewhat from patient to patient.  The CPT lists different levels of E and M services for both new and established patients and describes services that are included as E and M ser vices.  Such activities include obtaining, reviewing, and analyzing appropriate diagnostic tests.  40 - Billing for Clinical Laboratory Tests  (Rev. 1, 10-01-03)  40.1 - Laboratories Billing for Referred Tests  (Rev. 85, 02-06-04) B3-5114.1.E,   Section 1833(h)(5)(A) of the Act provides that a referring laboratory may bill for clinical laboratory diagnostic tests on the clinical laboratory fee schedule for Medicare beneficiaries performed by a reference laboratory only if the referring laboratory meets certain conditions.  Payment may be made to the referring laboratory but only if one of the following conditions is met:   the referring laboratory is located in, or is part of, a rural hospital;   the referring laboratory is wholly owned by the entity performing such test, the referring laboratory wholly owns the entity performing such test, or both the referring laboratory and the entity performing such test are wholly -owned by a third entity; or   the referring laboratory does not refer more than 30 percent of the clinical laboratory tests for which it receives requests for testing during the year (not counting referrals made under the wholly-owned condition described above).  In the case of a clinical laboratory test provided under an arrangement (as defined in 1861(w)(1)) made by a hospital, CAH or SNF, payment is made to the hospital or SNF.