(Medicare Benefit Policy Manual)

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.  Diagnostic services furnished under arrangement in on- campus hos pital locations, off -campus hospital locations, and in nonhospital locations must be furnished under the appropriate level of physician supervision according to the requirements of 42 CFR 410.28(e) and 410.32(b)(3), as discussed in the applicable sections above.   Independent laboratory services furnished to an outpatient under arrangements with the hospital are covered only under the "diagnostic laboratory tests" provisions of Part B (see Section 10, above), but are to be billed along with other services to outpati ents.  See Pub. 100-02, Medicare Benefit Policy Manual, Chapter 1, Inpatient Hospital Services, Section 50.3, for: (1) the definition of an independent clinical laboratory; (2) the requirements which such a laboratory must meet; and (3) instructions to t he A/B MAC (A) when it is not approved.  The cost to the hospital for diagnostic laboratory services for outpatients obtained under arrangements is the reasonable charge by the laboratory.   Laboratory services may also be furnished to a hospital outpatient under arrangements by:  1. The laboratory of another participating hospital; or   2. The laboratory of an emergency hospital or participating skilled nursing facility that meets the hospital conditions of participation relating to laboratory services.  20.5 - Outpatient Therapeutic Services  (Rev. 82; Issued:  02- 08-08; Effective:  01 -01-08; Implementation:  03 -10-08) Sources:  42 CFR 410.27; 65 FR 18536, April 7, 2000  20.5.1 - Coverage of Outpatient Therapeutic Services Incident to a Physicians Service Furnished on or After August 1, 2000, and Before January 1, 2010  (Rev. 128, Issued: 05- 28-10, Effective: 07 -01-10, Implementation: 07- 06-10)  Therapeutic services and supplies which hospitals provide on an outpatient basis are those services and supplies (including the use of hospital facilities) which are incident to the services of physicians and practitioners in the treatment of patients.  Al l hospital outpatient services that are not diagnostic are services that aid the physician or practitioner in the treatment of the patient.  Such therapeutic services include clinic services, emergency room services, and observation services.  Policies for  hospital services incident to physicians services rendered to outpatients differ in some respects from policies that pertain to incident to services furnished in office and physician-directed clinic settings.  See Chapter 15,Covered Medical and Other Health Services, section 60.  To be covered as incident to physicians services, the services and supplies must be furnished by the hospital or CAH or under arrangement made by the hospital or CAH (see section 20.1.1 of this chapter).  The services and supplies must be furnished as an integral, although incidental, part of the physician or nonphysician practitioners professional service in the course of treatment of an illness or injury.  The services and supplies must be furnished in the hospital or at a department of the hospital which has provider -based status in relation to the hospital under 42 CFR 413.65.  The services and supplies must be furnished under the order of a physician or other practitioner practicing within the extent of the Act, the Code of Federal Regulations, and State law, and furnished by hospital personnel under the direct supervision of a physician or clinical psychologist as defined at 42 CFR 410.32(b)(3)(ii) and 482.12.  This does not mean that each occasion of service by a nonphysician need also be the occasion of the actual rendition of a personal professional service by the physician responsible for care of the patient.  However, during any course of treatment re ndered by auxiliary personnel, the physician must personally see the patient periodically and sufficiently often to assess the course of treatment and the patients progress and, where necessary, to change the treatment regimen.  A hospital service or supply would not be considered incident to a physicians service if the attending physician merely wrote an order for the services or supplies and referred the patient to the hospital without being involved in the management of that course of treatment.   The physician or clinical psychologist that supervises the services need not be in the same department as the ordering physician.  For services furnished at a department of the hospital which has provider -based status in relation to the hospital under 42 C FR 413.65, direct supervision means the physician or clinical psychologist must be present and on the premises of the location ( the provider -based department of the hospital) and immediately available to furnish assistance and direction throughout the pe rformance of the procedure.  It does not mean that the physician must be present in the room when the procedure is performed.   If a hospital therapist, other than a physical, occupational or speech- language pathologist, goes to a patients home to give treatment unaccompanied by a physician, the therapists services would not be covered.  See Chapter 15, "Covered Medical and Other  Health Services," Sections 220 and 230, for outpatient physical therapy and speech- language pathology coverage conditions.   20.5.2 - Coverage of Outpatient Therapeutic Services Incident to a Physicians Service Furnished on January 1, 2010 through December 31, 2019  (Rev. 267, Issued: 02- 04-2020, Effective: 01- 01-2020, Implementation: 01- 06-2020)    Therapeutic services and supplies which hospitals provide on an outpatient basis are those services and supplies (including the use of hospital facilities and drugs and biologicals that cannot be self -administered) which are not diagnostic services, are furnished to outpatients incident to the services of physicians and practitioners and which aid them in the treatment of patients.  These services include clinic services, emergency room services, and observation services.  Policies for hospital outpatient t herapeutic services furnished incident to physicians services differ in some respects from policies that pertain to incident to services furnished in office and physician- directed clinic settings.  See Chapter 15, Covered Medical and Other Health Servi ces, Section 60.   To be covered as hospital outpatient therapeutic services, the services and supplies must be furnished by the hospital or CAH or under arrangement made by the hospital or CAH (see section 20.1.1 of this chapter).  The services and supplies must be furnishe d as an integral, although incidental, part of the physician or nonphysician practitioners professional service in the course of treatment of an illness or injury.  The services and supplies must be furnished in the hospital or at a department of the hospital that has provider -based status in relation to the hospital under 42 CFR 413.65.  For therapeutic services furnished during CY 2010, as specified at 42 CFR 410.27(g), "in the hospital or CAH" means areas in the main building(s) of the hospital or CAH that are under the ownership, financial, and administrative control of the hospital or CAH; that are operated as part of the hospital or CAH; and for which the hospita l or CAH bills the services furnished under the hospitals or CAHs CMS Certification Number.   Hospital outpatient therapeutic services and supplies must be furnished under the order of a physician or other practitioner practicing within the extent of the Act, the Code of Federal Regulations, and State law.  They must be furnished by hospital personnel under the appropriate supervision of a physician or nonphysician practitioner as required in this manual and by 42 CFR 410.27 and 482.12.  This does not mean that each occasion of service by a nonphysician need also be the occasion of the actual rendit ion of a personal professional service by the physician responsible for care of the patient.  However, during any course of treatment rendered by auxiliary personnel, the physician must personally see the patient periodically and sufficiently often to asse ss the course of treatment and the patients progress and, when necessary, to change the treatment regimen.  A hospital service or supply would not be considered incident to a physicians service if the attending physician merely wrote an order for the ser vices or supplies and referred the patient to the hospital without being involved in the management of that course of treatment.   CMS requires direct supervision (defined below) by an appropriate physician or non-physician practitioner in the provision of all therapeutic services to hospital outpatients, including CAH outpatients.  CMS may assign certain hospital outpatient therapeut ic services either general supervision or personal supervision.  When such assignment is made, general supervision means the definition specified at 42 CFR 410.32(b)(3)(i), that is, the procedure or service is furnished under the physician's overall direction and control, but the physician's presence is not required during the performance of the procedure.  Personal supervision means the definition specified at 42 CFR 410.32(b)(3)(iii), that is, the physician must be in attendance in the room during the performance of the service or procedure.   Effective January 1, 2011 through December 31, 2019, hospitals may change to general supervision for a portion of services defined as non-surgical extended duration therapeutic services (extended duration services) but only as specified in this manual for those services (see section 20.7).  Pulmonary rehabilitation, cardiac rehabilitation, and intensive cardiac rehabilitation services require direct supervision which must be furnished by a doctor of medicine or osteopathy, as specified at 42 CFR 410.47 and 410.49, respectively.  The list of services for the period of January 1, 2010 through December 31, 2019 that may be furnished under general supervision or that are defined as non- surgical extended duration therapeutic services is available on the OPPS Website at http://www.cms.gov/Medicare/Medicare- Fee-for-Service-Payment/HospitalOutpatientPPS/index.html.  Beginning January 1, 2010, according to 42 CFR 410.27, in addition to physicians and clinical psychologists, licensed clinical social workers, physician assistants, nurse practitioners, clinical nurse specialists, and certified nurse -midwives may furnish t he required supervision of hospital outpatient therapeutic services that they may personally furnish in accordance with State law and all additional rules governing the provision of their services, including those specified at 42 CFR Part 410.  These nonphysician practitioners are specified at 42 CFR 410.27(g).  Considering that hospitals furnish a wide array of very complex outpatient services and procedures, including surgical procedures, CMS would expect that hospitals already have the credentialing procedures, bylaws, and other policies in place to ensure that hospital outpatient services furnished to Medicare beneficiaries are being provided only by qualified practitioners in accordance with all applicable laws and regulations.  For services not furnished directly by a physician or nonphysician practitioner, CMS would expect that these hospital bylaws and policies would ensure that the therapeutic services are being supervised in a manner commensurate with their complexity, including personal supervision where appropriate.  For therapeutic services furnished during CY 2010 in the hospital or CAH or in an on-campus outpatient department of the hospital or CAH, as defined at 42 CFR 413.65, direct supervision means that the physician or nonphysician practitioner must be presen t on the same campus where the services are being furnished.  For services furnished in an off -campus provider based department as defined in 42 CFR 413.65, he or she must be present within the off -campus provider based department.  The physician or nonphysician practitioner must be immediately available to furnish assistance and direction throughout the performance of the procedure.  The physician or nonphysician practitioner does not have to be present in the room when the procedure is performed.   For therapeutic services furnished during CY 2011 and following, whether in the hospital or CAH or in an on- campus or off -campus outpatient department of the hospital or CAH as defined at 42 CFR 413.65, direct supervision means that the physician or nonphysician practitioner must be immediately available to furnish assistance and direction throughout the performance of the procedure.  As discussed below, the physician is not required to be present in the room where the procedure is performed or within any other physical boundary as long as he or she is immediately available.  Immediate availability requires the immediate physical presence of the supervisory physician or nonphysician practitioner.  CMS has not specifically defined the word immediate in terms of time or distance; however, an example of a lack of immediate avail ability would be situations where the supervisory physician or nonphysician practitioner is performing another procedure or service that he or she could not interrupt.  Also, for services furnished on- campus, the supervisory physician or nonphysician pract itioner may not be so physically distant on- campus from the location where hospital/CAH outpatient services are being furnished that he or she could not intervene right away.  The hospital or supervisory practitioner must judge the supervisory practitioner s relative location to ensure that he or she is immediately available.   For services furnished in CY 2011 and following, a supervisory practitioner may furnish direct supervision from a physician office or other nonhospital space that is not officially part of the hospital or CAH campus where the services are being furnished a s long as he or she remains immediately available.  Similarly, as of CY 2011, an allowed practitioner can furnish direct supervision from any location in or near an off -campus hospital or CAH building that houses multiple hospital provider -based department s where the services are being furnished as long as the supervisory practitioner is immediately available.