Education & Workforce Development

2007 Statement from Partners Office of the General Counsel

You have asked for information on the Federal regulatory requirements for Radiology Assistants (“RAs”) and Radiology Practitioner Assistant (“RPAs”). RAs and RPAs represent two relatively new certification designations for individuals who work under the supervision of a radiologist. To address the relevant Federal requirements, we have reviewed the Medicare coverage and billing rules which establish the Federal regulatory requirements for the majority of healthcare services. These rules are separate from the pertinent state regulatory requirements on which Carl Rosenfield is working. We note, however, that many private payers follow the Medicare coverage and billing rules.

Certification of RAs and RPAs

An RA is an individual who is certified by the American Registry of Radiologic Technologist (“ARRT”) as an advanced-level radiologic technologist who works under the supervision of a radiologist. Under the ARRT definition, an RA is defined as:

Radiologist assistants are experienced, registered radiographers who have completed an RA educational program and passed the RA certification examination offered by the American Registry of Radiologic Technologists. They work under the supervision of a radiologist to provide patient care.

As a radiologist extender in the diagnostic imaging environment, the RA has three major areas of responsibility. First, the RA takes a leading role in patient management and assessment. Duties in this area might include determining whether a patient has been appropriately prepared for a procedure, obtaining patient consent prior to beginning the procedure, answering questions from the patient and his or her family, and adopting exam protocols to improve diagnostic quality. The radiologist assistant also is expected to serve as a patient advocate, ensuring that each patient receives quality care while in the radiology department or clinic.

Second, the radiologist assistant performs selected radiology examinations and procedures under the supervision of a radiologist. Although each RA’s responsibilities will vary, a few of the procedures include assisting radiologists with invasive procedures, performing fluoroscopy for noninvasive procedures under direct supervision of the radiologist, placing nasoemteric and oroenteric feeding tubes in uncomplicated patients, and performing selected peripheral venous diagnostic procedures. The level of radiologist supervision varies, depending on the type of examination.

And third, the RA may be responsible for evaluating image quality, making initial image observations and forwarding those observations to the supervising radiologist. The supervising radiologist remains responsible for providing a final written report, an interpretation or a diagnosis.

An RPA is a mid-level healthcare professional who works under the supervision of a radiologist. To be a certified RPA, an individual must initially be certified as a registered radiological technologist (RRT) by the ARRT, hold a current, active registration with the ARRT, and completed a certified educational program recognized by the Certification Board for Radiology Practitioner Assistants.

We did not undertake an independent study of the roles for RAs and RPAs beyond that described above. If you would like additional details, please let us know.

Billing and Reimbursement Rules

As noted above, RAs and RPAs work under the supervision of a radiologist. Consequently, most services associated with the work of an RA and RPA are billed under the radiologist’s name for all payors. In the hospital inpatient and outpatient settings, the RA and RPA services are generally bundled into the Medicare prospective payment system and are not separately billed.

Radiology services include both procedural services and diagnostic testing services. The Medicare billing and reimbursement rules (as well as the requirements for non-physician practitioners) differ depending on the type of service. However, some of the principles apply equally in both contexts when RAs and RPAs are involved. The following sections address these requirements.

A. RAs and RPAs Are Not Independent Non-Physician Practitioners

As a preliminary matter, Medicare treats certain practitioners as “independent non-physician practitioners,” such as physician assistants and nurse practitioners, who can bill independently for their services. Medicare does not consider RAs and RPAs to be such independent practitioners. Therefore, RAs and RPAs cannot bill Medicare independently for their services.

B. “Incident To” Billing Rules

  • The Medicare “incident to” rules apply when a service is furnished in a physician’s office by a staff member and it is not considered a physician’s service. In this circumstance, the Medicare rules permit the service to be billed “incident to” the physician’s professional service subject to certain requirements. Most significant, all “incident to” services must be furnished under a physician’s direct supervision. See Medicare Benefit Policy Manual (CMS Pub. 100-02), Ch. 15, § 60. However, the physician office “incident to” rules generally apply only to professional services and, therefore, do not apply to most diagnostic tests.

It should be noted that, as described in greater detail below, a separate charge for the services of a physicist assisting a radiologist in the provision of X-ray, radium and radioactive therapy may be covered under the “incident to” provision, although the RPA or RA is unlikely to also qualify as a physicist. See Medicare Benefit Policy Manual, Ch. 15, § 90.

C. Diagnostic Radiology Tests

  • Diagnostic tests are a specific Medicare benefit, distinct from procedures, and are not performed “incident to” a physician’s professional services, but rather under specific supervision levels defined nationally by Medicare. See 42 U.S.C. § 1395x(s)(3). Thus, the “incident to” requirements do not have to be met for these diagnostic tests. Dr. Patti provides as an example the proposition that the work of performing an arthrogram is defined as a procedure but the work of imaging guidance and interpretation of that arthrogram is defined as a diagnostic test.
  • Similarly, X-ray, radium and radioactive isotope therapy is also a specific Medicare benefit and is not performed “incident to” a physician’s professional services. See 42 U.S.C. § 1395x(s)(4). Thus, the “incident to” requirements do not have to be met for these type of diagnostic services. However, the supervision requirements for diagnostic tests must be met. These supervision requirements are discussed in Part III of this memorandum.
  • Carriers will pay for the professional (“PC”) and technical (“TC”) components of diagnostic tests when furnished in physician offices, and other non-provider settings, so long as coverage and supervision requirements are met.  See Medicare Claims Processing Manual Ch. 13, §20.2.2.  CPT coding compliance rules require that a –52 modifier (reduced services) be attached to any claim for which the RA or RPA provides a portion of the professional component (PC) (e.g., UGI Series).  Additionally, Carriers will pay for the PC of a diagnostic test personally performed by the physician for a hospitalized patient if the services contribute directly to the diagnosis or treatment of the beneficiary, and require the services of a physician. See 452 CFR 415.102. However, the TC of a diagnostic test may not be billed by the physician to the Carrier when performed on a hospital inpatient or outpatient.  See Medicare Claims Processing Manual Ch. 13, §20.2.1. These services are included within the inpatient or outpatient payments to the hospital. See Id. Specifically, such diagnostic radiology services are bundled within the inpatient prospective payment to the hospital for inpatients, and separately payable to the hospital under the outpatient prospective payment system for outpatients.  See Id.
  • In the case of a patient who is not registered as an inpatient or an outpatient who is referred to a leased hospital radiology department by an outside physician, both the PC and the TC of the service may be paid by the Carrier under the fee schedule. See Medicare Claims Processing Manual, (CMS Pub. 100-04), Ch. 13, §20.2.3.

D. Purchased Diagnostic Test Rule.

  • Though beyond the scope of this memorandum, care should be taken that any billing for the services of RAs and RPAs under diagnostic test benefits comply with any other Medicare billing requirements. The Purchased Diagnostic Test Rule is one such requirement that may be implicated by complex relationships relating to RAs and RPAs.
  • What is a purchased diagnostic test? (See Medicare Claims Processing Manual, (CMS Pub. 100-04), Ch 13, § 20.2.4.1). Purchased diagnostic tests are the technical components (“TCs”) of tests billed by a physician but performed by an outside supplier. These tests include, but are not limited to, such tests as x-rays, EKGs, EEGs, cardiac monitoring, ultrasound, and the technical component of physician pathology services. If a physician purchases the TC of a diagnostic test, he or she can bill Medicare for the test if he or she performs the interpretation. In that case, the Purchased Diagnostic Test Rule applies. If the TC of the test is performed by a physician or supervised by a physician, such physician may bill under the normal physician fee schedule rules, and the purchased diagnostic test rule does not apply. The supervision requirement for physician billing is not met when the test is administered by outside supplier personnel even if the test is performed in the physician’s office.
  • Please note that the 2008 physician fee schedule proposed rule included (among other far-reaching changes to the Stark Law and reassignment provisions) the proposition that not only the technical component but perhaps also the professional component (the interpretation) of a diagnostic test should be subject to an anti-mark up requirement such as under the Purchased Diagnostic Test Rule. 72 Fed. Reg. 38122, 38179 (July 12, 2007). This principle is not yet included in Medicare regulations.
  • If the Purchased Diagnostic Test Rule (under its current regulatory formulation) applies, then the physician may not mark up the test. This means that the physician is limited in the amount they can receive from Medicare to the amount they paid the outside supplier for the test. The billing physician must identify the name of the supplier, address, zip code and supplier’s provider number (PIN in Item 32) on the claim form, and the amount the supplier charged the physician. If the physician fails to do so, no payment is allowed, and the physician may not bill the beneficiary for any amount. If the physician accepts assignment, the physician may bill the beneficiary for the deductible and copay for the purchased test.
  • The practical effect of the Purchased Diagnostic Test Rule is that if the rule applies, then the physicians will be limited in the amount they can collect from Medicare. Whether the rule applies is more complicated, but if the RA or RPA is leased from a supplier that also provides other aspects of the test, then the rule may apply. Care must be taken to assure that any employment arrangements, discussed in Section V, below, do not trigger the rule.

Supervision of Diagnostic Radiology Tests

  • While diagnostic tests associated with RAs and RPAs do not have to meet the “incident to” requirements and, thus, the direct physician supervision requirement, the technical component must still be under a physician’s supervision when performed for a patient who is not a hospital inpatient or outpatient. The physician supervision requirement is set forth in the diagnostic test benefit rule, at 42 C.F.R. § 410.32, which applies to tests performed in facilities such as a single physician or medical group offices, laboratories, and independent diagnostic testing facilities (“IDTFs”). This rule specifies the appropriate level of physician supervision for the type of diagnostic tests that is performed. Diagnostic mammography procedures are excluded from this rule. The physician supervision rules do not apply to diagnostic tests furnished on hospital inpatients or outpatients – except that the supervision rules do apply at facilities that have been “designated” as having “provider-based status,” which includes many hospital outpatient departments. See 42 CFR § 410.28(e). This regulation is particularly difficult for providers to apply, and it may merit a separate discussion if you are interested.

Levels of Physician Supervision

Under the diagnostic test benefit, diagnostic tests may be subject to a general, direct or personal level of physician supervision. The levels of physician supervision required for furnishing the technical component of diagnostic tests are defined as follows:

General supervision means the procedure is furnished under the physician’s overall direction and control, but the physician’s presence is not required during the performance of the procedure. Under general supervision, the training of the non-physician personnel who actually perform the diagnostic procedure and the maintenance of the necessary equipment and supplies are the continuing responsibility of the physician.

Direct supervision in the office setting means the physician must be present in the office suite and immediately available to furnish assistance and direction throughout the performance of the procedure. It does not mean that the physician must be present in the room when the procedure is performed.
Personal supervision means a physician must be in attendance in the room during the performance of the procedure.

The requisite level of supervision is determined by the CPT code assigned to a particular diagnostic test. Medicare assigns a numerical level to the diagnostic test CPT codes in the Medicare Physician Fee Schedule Database.

Who Qualifies as a Supervising Physician

For purposes of the diagnostic test benefit rule, the individual who is supervising the test must meet the definition of “physician” as defined in the Social Security Act. See 42 U.S.C. § 1395x(r). This includes a doctor of medicine or osteopathy legally authorized to practice medicine and surgery in the State in which he performs such functions.

Nurse practitioners, clinical nurse specialists, and physician assistants are not defined as physicians under Section 1395x(r). Therefore, these non-physician practitioners may not function as supervisory physicians under the diagnostic test benefit rule. However, non-physician practitioners may order diagnostic tests if operating within the scope of their authority under State law and within the scope of their Medicare statutory benefit. 42 C.F.R. § 410.32(a)(3). As noted above, RPAs and RAs are not considered to be a non-physician practitioners under the Medicare rules, unless they also qualify as another type of practitioner, such as a physician assistant.

Supervision of X-ray, Radium and Radioactive Isotope Services

There are specific Medicare supervision rules with respect to X-ray, radium and radioactive isotope therapy furnished in a non-hospital facility. These types of tests must be furnished under the direct personal supervision of a physician. Medicare Benefit Policy Manual Ch. 15, § 90. The physician need not be in the same room, but must be in the area and immediately available to provide assistance and direction throughout the time the procedure is being performed. The supervision does not represent a physician’s service and cannot be billed as a Part B service.
With respect to the performance of X-ray procedures, they are subject to the supervision of a physician and one of the following requirements must be met:
The supervising physician owns the equipment and it is operated only by his employees; or

The supervising physician certifies annually that he or she periodically checks the procedural manuals and observes the operators' performance, that he or she has verified that equipment and personnel meet applicable Federal, State, and local licensure and registration requirements and that safe operating procedures are used.

42 C.F.R. § 486.102; State Operations Provider Certification Manual (CMS-Pub. 100-07), App. D).

FDA Requirements for Mammography Procedures

In addition to the Medicare coverage and billing rule discussed above, there are also specific rules under the Food, Drug, and Cosmetic Act applicable to screening and diagnostic mammography services. The Mammography Quality Standards Act establishes procedures for the accreditation of facilities that perform screening or diagnostic mammography services as well as minimum national quality standards for mammography facilities. All mammographic services performed in a mammography facility approved by the Food and Drug Administration (“FDA”) must be performed by radiologic technologists who meet general requirements, mammography requirements, and continuing education and experience requirements as set forth in the FDA regulations. 21 C.F.R. § 900.12(a)(2).)
The radiologic technologist must be licensed to perform general radiographic procedures in a State or have general certification from one of the bodies determined by FDA to have procedures and requirements adequate to ensure that radiologic technologists certified by the body are competent to perform radiologic examinations. 21 C.F.R. § 900.12(a)(2)(i).

Employment Considerations for RAs and RPAs

The billing and supervision requirements for RAs and RPAs have ramifications for decisions about which entities will employ RAs and RPAs. The effect of the rules described in Parts II and III hereof is as follows. In the office, clinic and independent diagnostic testing facility (“IDTF”) settings, RAs and RPAs may perform diagnostic services (meeting appropriate supervision rules) and clinical services (meeting incident to requirements) within the scope of their practice. Once these rules are met, the employer of the RA or RPA (generally a physician group) may bill for the PC and TC of the service. (The payor will be the Medicare Carrier for the diagnostic test services performed in the office, clinic or IDTF). In the hospital setting, services performed by the RA or RPA may not be billed by a physician employer to Medicare. The TC of a diagnostic test performed by the RA or RPA in the hospital setting is included within the inpatient or outpatient prospective payment system payment to the hospital. Commercial insurance rules may produce different results.

These reimbursement conclusions drive certain decisions regarding employment. If the RA or RPA is working predominantly in a hospital setting, then it is logical that the hospital would be the employer. This is because the hospital (not any physicians) would be the entity economically benefiting from the RA or RPA’s services. In the reverse, if the RA or RPA is working predominantly in an office, clinic or IDTF setting, then it is logical that the physician group would be the employer. If the RA or RPA is performing services for both a hospital and a physician group, one of the entities would employ the RA/RPA, and the other could lease from the employer that portion of the RA/RPA’s time spent at the second site.

In situations where either the physician group or the hospital seeks to bill for the services of the RA or RPA, then the costs of the RA or RPA should be borne by that entity. This could be done by direct employment or employee leases meeting underlying billing requirements and Partners policies. The leased employee model is sufficient for incident to billing, so long as the employment relationship is recognized by state law. Partners has developed some form lease agreements that may be customized for purposes of these arrangements. Care should be taken to assure that any lease arrangements do not also trigger the purchased diagnostic test rule, described in Section III, above.

VI. Conclusion

In summary, billing and employment for RAs and RPAs will follow the following rules:

1. Physician employers may not bill for services (either procedural or the TC of diagnostic tests) of the RAs and RPAs in the hospital setting. However, physician employers may bill for the PC of diagnostic tests performed by the RAs or RPAs in a hospital, even if a portion of the PC (e.g., fluoroscopy) is provided by the RA or RPA, as long as a-52 modifier is attached to the claim;

2. Physician employers may bill for the procedural services of RAs and RPAs in the office, clinic or IDTF setting if such services meet all the “incident to” benefit requirements, including the physician supervision requirement;

3. Physician employers may bill for diagnostic tests performed by RAs and RPAs in the office, clinic or IDTF setting if they meet the diagnostic test supervision requirements; according to CPT coding compliance rules, the PC of such tests must also contain the -52 modifier;

4. Hospitals may include the charges for diagnostic services performed by RAs and RPAs under the inpatient and outpatient hospital prospective payment system benefit; and

5. The entity billing for the services of the RAs and RPAs should assume the expense of such individuals, under contractual arrangements that meet the various regulatory requirements including, inter alia, Stark, Anti-kickback and the Purchased Diagnostic Test Rule.

 I hope this material has been useful. Please let me know if you would like any additional information or material on this subject.

 

We are aware of very few colleges, perhaps only two, that offer RPA programs in the United States.

We note that an individual certified as an RPA or RA may also be a non-physician practitioner, such as a physician assistant, and be, for that reason, an independent biller.

 

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