(Medicare Claims Processing Manual)

Jurisdiction:  The Pennsylvania A/B MAC (B) may retain jurisdiction for processing the claim for all of the services.  The A/B MAC (B) servicing Boston and/or Millville may have jurisdiction for processing their claims if those laboratories bill for the services they perform, but the Philadelphia laboratory is barred from bill ing for the services that Boston and Millville submit for payment.  EXAMPLE 3:   Scenario 3:  Same relationships as in Example 2.  American Laboratories, Inc., is an independent laboratory company with branch laboratories located in Philadelphia, PA and Wilmington, DE, as well as regional laboratories located in Millville, NJ and Boston, MA.  This time the Wilmington laboratory draws a blood specimen from a patient whose physician has ordered a blood culture.  The Wilmington laboratory then sends the specimen to the Boston laboratory, which performs the required test.   Jurisdiction:  The A/B MAC (B) processing claims for providers/suppliers located in Delaware may retain jurisdiction for processing the claim.  If the laboratory in Boston chooses to bill for the service to the Massachusetts A/B MAC (B), then the Wilmington laboratory may not bill for the service.   60 - Specimen Collection Fee and Travel Allowance  (Rev. 1, 10- 01-03) B3-5114.1  60.1 - Specimen Collection Fee  (Rev. 12443, Issued:  01-04-24; Effective:  01-01-24; Implementation:  02-07-24)  Section 1833(h)(3) of the Act specifies that the Secretary shall provide for and establish a nominal fee in addition to the payment amounts for CDLTs on the CLFS to cover the appropriate costs of collecting the sample on which a clinical diagnostic laboratory test (CDLT) was performed and for which payment is made with respect to samples collected in the same encounter. The nominal fee is intended to cover the  appropriate  costs  in collecting  the sample,  which  could include  the costs  related  to drawing, collecting,  or handling a specimen.   Specimen  Collection  Fee Eligibility   To be eligible  for a specimen  collection  fee, the specimen  must  be:  used to perform  a CDLT  paid  under  the CLFS  regulations  at 42 CFR  part 414, subpart  G,  414.523;   collected by a trained technician from a Medicare beneficiary who is homebound, as described in  424.22(a)(1)(ii), or is a non-hospital  inpatient, but only when  no qualified  personnel  are available at the facility to collect the specimen; and ,  of the following typea blood specimen  collected  through venipuncture  or a urine  sample  collected by catheterization.   Trained  Technician   The phrase  trained  technician refers  to those  staff providing specimen  collection  services.  However, trained technician does not mandate certain educational requirements and, for the purposes of the specimen collection provisions, the term includes a phlebotomist.  Specimen  Collection  Type   A specimen  collection  fee is  allowed  in two circumstances:  (1) drawing a blood sample  through venipuncture  (i.e., inserting  into a vein a needle with syringe  or vacutainer to draw the specimen) or  (2) collecting  a urine  sample by catheterization.   A specimen collection fee is not payable for any other specimen types, including blood samples where the cost of collecting the specimen is minimal (such as a throat culture or a routine capillary puncture for clotting or bleeding time). This fee will not be paid to anyone who has not extracted the specimen. Only one  collection  fee is allowed  for each type of specimen  for each patient  encounter,  regardless  of the number of specimens drawn. This means that, if different types or multiple specimens are drawn from one patient, only one specimen collection fee would be allowed. Additionally, when a series of specimens is required to complete a single test (e.g., glucose tolerance test), the series is treated as a single encounter.   Specimen  Collection  Fee Rate   Effective  January 1, 2024, CMS  pays a general  specimen  collection  fee of $8.83 for all specimens  collected in one patient encounter. This fee is increased by $2 ($10.83)  for specimen collection from a Medicare beneficiary in a skilled nursing facility (SNF) or on behalf of a  home health agency (HHA) for all specimens collected in one patient encounter.  Specimen  Collection  Fee Annual  Update   Beginning January  1, 2024, the specimen collection  fee amount will update for each calendar year (CY)  by the percent change in the Consumer Price Index for All Urban Consumers (CPI-U) (U.S city average) for the 12-month period ending June 30th of the year preceding the update year. CMS issues these updates to the specimen  collection  fee amounts through subregulatory guidance, specifically  the existing  CMS  change request process, on an annual basis.  60.1.1 - Independent Laboratory Specimen Drawing  (Rev.  11778, Issued:01-06- 23; Effective:01 -01-23; Implementation:01 -23-23)  Medicare allows separate charges made by laboratories for drawing or collecting specimens whether or not the specimens are referred to hospitals or independent laboratories.  The laboratory does not bill for routine handling charges where a specimen is referred by one laboratory to another.  Payment for the specimen collection fee is made based on the clinical laboratory fee schedule.    Medicare allows payment for a specimen collection fee when it is medically necessary for a trained technician to draw a specimen from either a nursing home patient, a non-hospital inpatient or homebound patient.    The trained technician must personally draw the specimen, i.e., venipuncture or urine sample by catheterization.  Medicare does not allow a specimen collection fee to the visiting technician if a patient in a facility is (a) not confined to the facility, o r (b) the facility has personnel on duty qualified to perform the specimen collection.  Medical necessity for such services exists, for example, where a trained technician draws a blood specimen from a homebound or an institutionalized patient.  A patient need not be bedridden to be homebound.    However, where the specimen is a type that would require only the services of a messenger and would not require the skills of a trained technician, e.g., urine or sputum, a specimen pickup service would not be considered medically necessary.  (See Chapters 7 and 15 of Pub. 100-02, the Medicare Benefit Policy Manual for a discussion of homebound and a more complete definition of a medically necessary laboratory service to a homebound or an institutional patient.)  Claims Annotation  In addition to the usual information required on claim forms (including the name of the prescribing physician), all independent laboratory claims for such specimen drawing prescribed by a physician should be appropriately annotated, e.g., patient confined to home, patient homebound, or patient in nursing home, no qualified person on duty to draw specimen.  A/B MACs (B) must assure the validity of the annotation through scientific claims samples as well as through regular bill review techniques.  (This cou ld be done by use of the information in A/B MAC (B) files, and where necessary, contact with the prescribing physician.)  Medical Necessity Requirement   If a physician requests an independent laboratory to obtain specimens in situations which do not meet, or without regard to whether they meet, the medical necessity criteria in Chapter 15 of the Medicare Benefit Policy Manual, an educational contact with t he prescribing physician is warranted and, where necessary, corroborating documentation should be obtained on claims until the A/B MAC (B) is assured that the physician prescribes such services only when the criteria are met.   The specimen collection fee is paid based on the location of the independent laboratory where the test is performed and is billed in conjunction with a covered laboratory test.  60.1.2 - Coding Requirements for Specimen Collection  (Rev.  11778, Issued:01-06- 23; Effective:01 -01-23, Implementation:01-23-23)   The following HCPCS codes and terminology must be used:   36415 - Collection of venous blood by venipuncture.  G0471 - Collection of venous blood by venipuncture or urine sample by catheterization from an individual in a skilled nursing facility (SNF) or by a laboratory on behalf of a home health agency (HHA)  P9612 - Catheterization for collection of specimen(s), (single patient), all places of services   P96l5 - Catheterization for collection of specimen(s), (multiple patients)   The allowed amount for specimen collection in each of the above circumstances is included in the laboratory fee schedule distributed annually by CMS via a Recurring Update Notification (RUN) change request.  Neither the annual deductible nor the 20 percent coinsurance for Medicare apply to the specimen collection fees.   60.1.3 - Specimen Drawing for Dialysis Patients  (Rev. 3056, Issued: 08- 29-14, Effective: 04-01-14, Implementation: 12-01-14)   See the Medicare Benefit Policy Manual, Chapter 11, for a description of laboratory services included in the composite rate.  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.   Clinical laboratory tests can be performed individually or in predetermined groups on automated profile equipment.  A specimen collection fee determined by CMS will be allowed only in the following circumstances:    Drawing a blood sample through venipuncture (i.e., inserting into a vein a needle with a syringe or vacutainer to draw the specimen).   Collecting a urine sample by catheterization.   Special rules apply when such services are furnished to dialysis patients.  The specimen collection fee is not separately payable for patients dialyzed in the facility or for patients dialyzed at home under reimbursement Method I.  A specimen collection fe e is also not separately payable when an ESRD facility is collecting a specimen for transplant eligibility or other transplant requirements.  Payment for specimen collection is included under the ESRD PPS, regardless of whether the laboratory test itself i s included in the ESRD PPS or is separately billable with the AY modifier (see 40.6 of this chapter).   Fees for taking specimens in the hospital setting, but outside of the dialysis unit, for use in performing laboratory tests not included in the ESRD composite rate may be paid separately.   60.1.4 - Coding Requirements for Specimen Collection  (Rev. 3056, Issued: 08- 29-14, Effective: 04 -01-14, Implementation: 12- 01-14)  The following HCPCS codes and terminology must be used:    36415 -  Collection of venous blood by venipuncture.    G0471 -  Collection of venous blood by venipuncture or urine sample by catheterization from an individual in a skilled nursing facility (SNF) or by a laboratory on behalf of a home health agency (HHA)    P96l5 -  Catheterization for collection of specimen(s).   The allowed amount for specimen collection in each of the above circumstances is included in the laboratory fee schedule distributed annually by CMS.  60.2 - Travel Allowance  (Rev. 12443, Issued:  01-04-24; Effective:  01-01-24; Implementation:  02-07-24)  Section  1833(h)(3)(B)  of the  Act states  that the Secretary  shall  provide  for and  establish  a fee in addition to the payment amounts for CDLTs on the CLFS to cover the transportation and personnel expenses for trained personnel to travel to the location of an individual to collect the sample.   Travel  Allowance  Eligibility   CMS pays a travel allowance when the specimen collection fee is paid.  Requirements regarding payment for  specimen  collection  are described  in Section  60.1 above  and CFR   414.523(a)(1). These requirements must be met for the travel allowance to be payable.   Travel for simple pickup of specimens or for specimen collection that does not require the services of trained  technicians  should not be considered  in the calculation  of the travel  allowance.  This means  that the travel allowance amount may be paid only if a specimen collection fee is also payable; for example, no travel allowance would be paid if a trained technician merely performs a messenger service to pick up a specimen drawn by other technicians.   The travel allowance may be provided only with respect to an individual who is homebound or an inpatient in an inpatient facility (other than a hospital), such that travel allowance may only be paid when a trained technician  draws  a specimen  from  a patient  who either  is in an inpatient  facility  that is not a hospital  or is a homebound patient.  Only  one travel  allowance payment  may be made for specimen  collection  for a Medicare beneficiary  based on the beneficiarys location, and only when a Medicare beneficiary requires the collection of a specimen necessary for performance of CDLTs.