Administrative Code

Virginia Administrative Code
1/27/2022

Part III. Radiation Therapy Services

Article 1
Radiation Therapy Services

12VAC5-230-280. Travel time.

Article 1
Radiation Therapy Services

Radiation therapy services should be available within 60 minutes driving time one way under normal conditions of 95% of the population of the health planning district using a mapping software as determined by the commissioner.

Statutory Authority

§ 32.1-102.2 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-230-290. Need for new service.

A. No new radiation therapy service should be approved unless:

1. Existing radiation therapy machines located in the health planning district performed an average of 8,000 procedures per existing and approved radiation therapy machine in the relevant reporting period; and

2. The new service will perform at least 5,000 procedures by the second year of operation without significantly reducing the utilization of existing providers in the health planning district.

B. The number of radiation therapy machines needed in a health planning district will be determined as follows:

Population x Cancer Incidence Rate x 60%

320

where:

1. The population is projected to be at least 150,000 people three years from the current year as reported in the most current projections of a demographic entity as determined by the commissioner;

2. The cancer incidence rate as determined by data from the Statewide Cancer Registry;

3. 60% is the estimated number of new cancer cases in a health planning district that are treatable with radiation therapy; and

4. 320 is 100% utilization of a radiation therapy machine based upon an anticipated average of 25 procedures per case.

C. Proposals for new radiation therapy services located less than 60 minutes driving time one way, under normal conditions, from any site that radiation therapy services are available shall demonstrate that the proposed new services will perform an average of 4,500 procedures annually by the second year of operation, without significantly reducing the utilization of existing services in the health planning district.

Statutory Authority

§ 32.1-102.2 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-230-300. Expansion of service.

Proposals to expand radiation therapy services should be approved only when all existing radiation therapy services operated by the applicant in the health planning district have performed an average of 8,000 procedures for the relevant reporting period and the proposed expansion would not significantly reduce the utilization of existing providers.

Statutory Authority

§ 32.1-102.2 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-230-310. Statewide Cancer Registry.

Facilities with radiation therapy services shall participate in the Statewide Cancer Registry as required by Article 9 (§ 32.1-70 et seq.) of Chapter 2 of Title 32.1 of the Code of Virginia.

Statutory Authority

§ 32.1-102.2 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-230-320. Staffing.

Radiation therapy services should be under the direction or supervision of one or more qualified physicians designated or authorized by the Nuclear Regulatory Commission or the Division of Radiologic Health of the Virginia Department of Health, as applicable.

Statutory Authority

§ 32.1-102.2 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

Article 2
Criteria and Standards for Stereotactic Radiosurgery

12VAC5-230-330. Travel time.

Article 2
Criteria and Standards for Stereotactic Radiosurgery

Stereotactic radiosurgery services should be available within 60 minutes driving time one way under normal conditions of 95% of the population of a health planning region using a mapping software as determined by the commissioner.

Statutory Authority

§ 32.1-102.2 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-230-340. Need for new service.

A. No new stereotactic radiosurgery services should be approved unless:

1. The number of procedures performed with existing units in the health planning region averaged more than 350 per year in the relevant reporting period; and

2. The proposed new service will perform at least 250 procedures in the second year of operation without significantly reducing the utilization of existing providers in the health planning region.

B. Preference may be given to a project that incorporates stereotactic radiosurgery service incorporated within an existing standard radiation therapy service using a linear accelerator when an average of 8,000 procedures during the relevant reporting period and utilization of existing services in the health planning region will not be significantly reduced.

C. Preference may be given to a project that incorporates a dedicated Gamma Knife® within an existing radiation therapy service when:

1. At least 350 Gamma Knife® appropriate cases were referred out of the region in the relevant reporting period; and

2. The applicant can demonstrate that:

a. An average of 250 procedures will be preformed in the second year of operation; and

b. Utilization of existing services in the health planning region will not be significantly reduced.

D. Preference may be given to a project that incorporates non-Gamma Knife® SRS technology within an existing radiation therapy service when:

1. The unit is not part of a linear accelerator;

2. An average of 8,000 radiation procedures per year were performed by the existing radiation therapy services;

3. At least 250 procedures will be performed within the second year of operation; and

4. Utilization of existing services in the health planning region will not be significantly reduced.

Statutory Authority

§ 32.1-102.2 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009; Errata, 25:11 VA.R. 2018 February 2, 2009.

12VAC5-230-350. Expansion of service.

Proposals to increase the number of stereotactic radiosurgery services should be approved only when all existing stereotactic radiosurgery machines in the health planning region have performed an average of 350 procedures per existing and approved unit for the relevant reporting period and the proposed expansion would not significantly reduce the utilization of existing providers in the health planning region.

Statutory Authority

§ 32.1-102.2 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-230-360. Statewide Cancer Registry.

Facilities with stereotactic radiosurgery services shall participate in the Statewide Cancer Registry as required by Article 9 (§ 32.1-70 et seq.) of Chapter 2 of Title 32.1 of the Code of Virginia.

Statutory Authority

§ 32.1-102.2 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-230-370. Staffing.

Stereotactic radiosurgery services should be under the direction or supervision of one or more qualified physicians.

Statutory Authority

§ 32.1-102.2 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

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