Exerpts from http://www.medmarket.com/tenants/rainfo/fr/1997/9710/971031c.txt which pertain to the improved reimbursement of medical diagnostics. Part III Department of Health and Human Services Health Care Financing Administration 42 CFR Part 400, et al. SUMMARY: This final rule makes several policy changes affecting Medicare Part B payment. The changes relate to physician services, including geographic practice cost index changes, clinical psychologist services, physician supervision of diagnostic tests, establishment of independent diagnostic testing facilities, the methodology used to develop reasonable compensation equivalent limits, payment to participating and nonparticipating suppliers, global surgical services, caloric vestibular testing, and clinical consultations. This rule also implements provisions in the Balanced Budget Act of 1997 relating to practice expense relative value units, screening mammography, colorectal cancer screening, screening pelvic examinations, and EKG transportation. In addition, we are finalizing the 1997 interim work relative value units and are issuing interim work relative value units for new and revised codes for 1998. DATES: Effective Date: This rule is effective January 1, 1998. ***** Pertinent Contents ***** Section III. Implementation of the Balanced Budget Act of 1997 Subsections: B. Coverage of Screening Mammography and Related Payment Changes C. Colorectal Cancer Screening 1. Coverage Determination in Screening Barium Enemas 2. Provisions of the Final Rule 3. Frequency Limits and Conditions of Coverage 4. Payment Limits 5. Screening Colonoscopy in an Ambulatory Surgical Center D. Coverage of Screening Pelvic Examination (Including a Clinical Breast Examination) and Related Payment Changes Subsection B ****************************** Following is text exerpted from Federal Register [Federal Register: October 31, 1997 (Volume 62, Number 211)] [Rules and Regulations] [Page 59047-59097] ********** III. Implementation of the Balanced Budget Act of 1997 In addition to the physician fee schedule provisions of the Balanced Budget Act of 1997, the new legislation expands the previously enacted Medicare screening mammography benefit and adds several new screening benefits to the law--the colorectal cancer screening benefit and the screening pelvic examination benefit effective January 1, 1998. For many years physicians have understood the value of prevention and early detection measures in dealing with medical problems. Preventive services for the early detection of disease have also been associated with substantial reductions in morbidity. For example, dramatic reductions in the incidence of invasive cervical cancer and in cervical cancer mortality have occurred following the implementation of screening programs using Papanicolaou testing to detect cervical dysplasia. Although sound clinical reasons exist for emphasizing prevention in medicine, studies have shown that clinicians often fail to provide recommended clinical preventive services. This is due to a variety of factors, including inadequate reimbursement for preventive services, fragmentation of health care delivery, and insufficient time with patients to deliver the range of preventive services that are recommended. It is our expectation that implementation of the recently enacted new Medicare benefit provisions should help to overcome at least some of the barriers to the use of preventive services, and may lead to substantial reductions in morbidity and mortality. B. Coverage of Screening Mammography and Related Payment Changes Before the enactment of the BBA 1997, section 1834(c)(2) of the Act prescribed certain limitations on the frequency of coverage of mammography screenings for women over 39 years of age with no waiver of the yearly Part B deductible requirement. Specifically, for a woman over age 39 but under 50 years of age, the law provided for coverage of screening mammography either once a year or twice a year depending upon whether the woman was considered to be at high risk of developing breast cancer, as determined pursuant to factors identified by the Secretary and specified in regulations. In the case of a woman over 49 years of age but under 65 years of age, the law specified that payment could be made for a screening mammography once a year (that is, if at least 11 months had passed following the month in which the last screening mammography was performed). Finally, in the case of a woman over 64 years of age, the law provided that payment could be made for a screening mammography once every 2 years following the month in which the last screening mammography was performed. Section 4101(a) of the BBA 1997 amends section 1834(c)(2)(A) of the Act effective January 1, 1998 to simply provide that in the case of any woman over 39 years of age, payment may be made for a screening mammography if at least 11 months have passed following the month in which the last screening mammography was performed. Section 4101(b) of the BBA 1997 amends sections 1833(b) and 1834(c)(1)(C) of the Act to waive the Part B deductible requirement. In view of the statutory changes in the (1) limitations on the frequency of coverage of screening mammographies for all women over 39 years of age and (2) the Part B deductible requirement as [[Page 59079]] it relates to all screening mammography services, we are amending Sec. 410.34(d) (relating to limitations on coverage of screening mammography) and are adding a new exception as paragraph (5) in Sec. 410.160(b) (relating to exceptions to the Part B annual deductible) to reflect these changes in the regulations. C. Colorectal Cancer Screening Section 4104 of the BBA 1997 provides for Medicare coverage of colorectal cancer screening tests effective for services provided on or after January 1, 1998. The law provides for coverage for screening fecal-occult blood tests, screening flexible sigmoidoscopy, screening colonoscopy, and other tests we determined to be appropriate, subject to certain frequency and payment limits. Present Medicare coverage policy allows payment for diagnostic tests to diagnose colorectal cancer and related medically necessary services that are furnished to beneficiaries. Under this policy, diagnostic colorectal cancer tests are covered if they are medically necessary to evaluate a specific complaint from or monitor an existing medical condition of an individual who has had a history of colon cancer or inflammatory bowel disease. This coverage is based, in part, on section 1861(s)(3) of the Act, which provides general Medicare coverage for diagnostic x-ray, clinical laboratory, and other diagnostic tests. However, prior to the enactment of the BBA 1997, screening colorectal cancer tests have been excluded from coverage based on section 1862(a)(7) of the Act, which states that routine physical checkups are excluded services. This exclusion is described in Medicare regulations in Sec. 411.15(a). 1. Coverage Determination in Screening Barium Enemas Section 4104(a)(2) of the BBA 1997 requires us to publish a notice in the Federal Register related to the coverage of screening barium enema as a colorectal cancer screening test. As provided by section 4104(a)(2) of the BBA 1997, this notice is to be published in the Federal Register by November 3, 1997, within 90 days after the date of enactment. To the three colorectal cancer screening tests specifically designated as covered under sections 1861(pp)(1)(A), (B), and (C) of the Act, section 4104(a)(2) of the BBA 1997 added a new section 1861(pp)(1)(D) to the Act to provide that colorectal cancer screening tests may also include coverage of other tests or procedures the Secretary determines to be appropriate based on consultation with appropriate organizations. As required by section 1861(pp)(1)(D) of the Act, we, acting on behalf of the Secretary, consulted with appropriate Federal government organizations and other organizations regarding the efficacy of a barium enema examination for detecting colorectal cancer. We also inquired about how this coverage should be included under Medicare. We contacted representatives of various Federal agencies, including the Agency for Health Care Policy and Research, the Centers for Disease Control and Prevention, the Food and Drug Administration, and the National Cancer Institute, knowledgeable about using a barium enema as a screening test to detect colorectal cancer. We also consulted with staff from the American Cancer Society. In addition, the American Medical Association convened a preventive medicine expert panel that included representatives from the United States Preventive Services Task Force and various medical specialty organizations, such as the American Medical Association Council on Scientific Affairs, the American Medical Association Council on Medical Services, the American Academy of Family Physicians, the American College of Physicians, the American College of Preventive Medicine, the American College of Radiology, and the American Society of Colon and Rectal Surgeons. Based on our review of this information and our evaluation of other data, we concluded that while there is not a consensus in the medical community regarding the specific role of a barium enema examination under the Medicare colorectal cancer screening benefit when compared to the use of the flexible sigmoidoscopy and colonoscopy examinations, there is a sufficient basis for us to include the use of barium enema as part of the new national Medicare coverage for colorectal screening. In its Executive Summary, (AHCPR Publication Number 97-0302) Evidence Report No. 1: Colorectal Cancer Screening, the Agency for Health Care Policy and Research concluded that there is indirect evidence that supports the use of double contrast barium enema in screening for colorectal cancer. They also noted that the double contrast barium enema can image the entire colon and detect cancers and large polyps. (Medicare policy already allows payment for diagnostic barium enemas that are performed to evaluate a beneficiary's specific complaint or to monitor an existing medical condition for an individual with a history of colon cancer.) Additionally, the role of the barium enema examination as a colorectal cancer screening examination has recently been studied by several multi-disciplinary expert panels and, as a result of those studies, it appears that the usefulness of the examination is becoming widely accepted in the United States. First, the American Gastroenterological Association initially in conjunction with the Agency for Health Care Policy and Research, completed their report earlier this year. The double contrast barium enema was recommended as a screening option for all average risk patients (those with no predisposing factors) and selected groups of high risk patients (those with a history of prior polyps, or those with a first degree relative with colorectal cancer). Only in the case of the subset of patients at high risk with a family history of familial adenomatous polyposis, hereditary non-polyposis colorectal cancer, and inflammatory bowel disease was a colonoscopy recommended as the only screening modality. (This subset of patients represents a minority of the high risk population as defined by statute.) Second, earlier this year the American Cancer Society recently revised their guidelines to include the double contrast barium enema as an option for patients at average and moderate risk (nearly identical to the above described American Gastroenterological Association guidelines). The American Gastroenterological Association and the National Cancer Institute studies have indicated that one of the major advantages of the barium enema examination is that it permits the imaging of the entire colorectum and it appears to have the ability to detect precursor adenomas as well as colorectal cancers. Anatomic visualization of the entire colorectum is believed to be highly desirable and is widely considered optimum for evaluating the colon. (It is generally acknowledged that one limitation of the flexible sigmoidoscopy examination is that it only allows for direct examination of the lower third to one-half of the colorectum.) There is also some evidence that racial differences exist in the distribution of colorectal cancers, with African-Americans having a higher proportion of cancers in the right side of the colon than Caucasians. Thus, tests that allow full structural coverage of the entire colorectum are needed as a choice for certain segments of the population. Furthermore, on the basis of the information we have reviewed, the barium enema screening examination appears to have a superior safety profile [[Page 59080]] when compared to the screening flexible sigmoidoscopy and colonoscopy examinations, and it does not require sedation as is the case with colonoscopy examinations. Our information indicates that patients are typically exposed to 300 to 500 mrad of radiation during a barium enema examination, which is about equivalent to the dose of radiation that results from a single screening mammography examination. Considering the age and frequency at which screening is recommended for a barium enema examination, it is estimated by the American College of Radiology that a screening strategy using a barium enema x-ray every 2 or 4 years would deliver a lifetime dose of radiation that is lower than the radiation that would result from use of the annual Medicare screening mammography benefit. Specifically, in view of the information summarized above, we have determined that a barium enema is a reasonable and necessary screening test for colorectal cancer, and have decided to cover screening barium enema examinations in the following manner: First, such a screening examination may be covered as an alternative to a flexible sigmoidoscopy examination (that is, as a substitute for, and not as an added optional benefit) for an individual attaining age 50 and not at high risk for colorectal cancer, if the individual's attending physician orders the test in writing after a determination that the test is the appropriate screening test. That is, the attending physician must determine that, in the case of a particular individual, the estimated screening potential for the barium enema is equal to or greater than the screening potential that has been estimated for a flexible sigmoidoscopy for that same individual. For example, in the case of an individual who is taking anti-coagulant medications, the individual's attending physician may decide to order a barium enema instead of a flexible sigmoidoscopy because it is less likely to produce bleeding and typically allows for a total inspection of the colon, while the flexible sigmoidoscopy does not. Second, we are establishing a frequency limitation for the coverage of the screening barium enema for an individual age 50 and over who is not at high risk for colorectal cancer at the same time interval that is specified in the statute for screening flexible sigmoidoscopy examination (that is, once every 48 months for the same individual.) Third, we are providing that a screening barium enema may be covered as an alternative to a screening colonoscopy (that is, as a substitute and not as an added optional benefit) for individuals at high risk for colorectal cancer, if the individual's attending physician orders the test in writing following a determination that the screening barium enema is the appropriate test for that particular individual. This means that the attending physician must determine, in the case of a particular individual, that the estimated screening potential for the barium enema examination is equal to or greater than the screening potential that has been estimated for the colonoscopy examination. For instance, in the case of an individual at high risk for colorectal cancer who may not be able to receive a complete colonoscopy due to a markedly long and twisting loop(s) of colon, the individual's attending physician may decide to order a barium enema in lieu of a screening colonoscopy because it is more likely to permit a complete view of the entire colon. Fourth, we are establishing the frequency limitation for coverage of the screening barium enema for an individual who is at high risk for colorectal cancer at the same time interval that is specified in the statute for screening colorectal examinations (that is, once every 24 months for the same individual.) Fifth, we are establishing the double contrast barium enema as the standard type of screening barium enema that will be covered under the Medicare program because, based on information obtained from the American College of Radiology, we understand that it is regarded as the most sensitive for small colonic lesions in patients who are adequately prepared and optimally imaged. In the case of some patients who are infirm, immobile, or debilitated, however, a technically optimal double contrast examination may not be possible. In these patients a single contrast barium examination may be performed with high quality results despite the limitations of the patient's condition. In these situations, we are covering the single contrast method if it would satisfy the test described above for allowing coverage of the barium enema examination as an alternative to one of the other two colorectal cancer screening tests. That is, the individual's attending physician would have to determine that the estimated screening potential from the use of the single contrast barium enema is equal to or exceeds the estimated screening potential that would result from the use of the flexible sigmoidoscopy and the colonoscopy examinations. In summary, effective January 1, 1998, we will pay for screening barium enemas as an alternative to either a screening flexible sigmoidoscopy or a screening colonoscopy, in accordance with the same frequency parameters specified in the law for the other two colorectal screening services identified. 2. Provisions of the Final Rule We are specifying an exception to the list of examples of routine physical checkups excluded from coverage in Sec. 411.15(a)(1) (Particular services excluded from coverage). The exception is for colorectal cancer screening tests that meet the frequency limitations and the conditions for coverage that we are specifying under Sec. 410.37. Coverage of colorectal cancer screening tests is provided under Medicare Part B only. 3. Frequency Limits and Conditions of Coverage Section 4104 of the BBA 1997 adds new subparagraph (R) to section 1861(s)(2) of the Act authorizing Medicare coverage of certain colorectal screening services as defined in section 1861(pp) that are furnished on or after January 1, 1998. These statutorily mandated colorectal services include screening fecal-occult blood tests, screening flexible sigmoidoscopy examinations, and screening colonoscopy examinations. Section 4104(b) of the BBA 1997 also establishes frequency of coverage limitations for all three of these colorectal screening services. The frequency of coverage limitations specified for fecal-occult blood tests is that payment may be made only for an individual 50 years of age or over, if the test has not been performed within the 11 months that have passed following the month in which the last screening fecal-occult blood test was performed. The frequency of coverage limitation indicated for screening flexible sigmoidoscopy examinations is that payment may be made only for an individual age 50 years of age or over, if the procedure has not been performed within the 47 months that have passed following the month in which the last screening flexible sigmoidoscopy examination was performed. In the case of screening colonoscopy examinations, section 4104 of the BBA 1997 provides for coverage of screening colonoscopies for individuals at high risk for developing colorectal cancer (as now defined in section 1861(pp)(2) of the Act), if the screening examination has not been performed within the 23 months that have passed following the month in which the last screening colonoscopy was performed. [[Page 59081]] We have added Sec. 410.37 to provide for coverage of four types of colorectal cancer screening tests. First, we are specifying several definitions of terms that are included to implement the statutory provisions and to help the reader in understanding the regulation provisions. These include definitions of the terms (1) colorectal cancer screening tests, (2) fecal-occult blood test, (3) individual at high risk for colorectal cancer, (4) screening barium enema, and (5) attending physician. Second, we are establishing conditions of coverage for all four of the colorectal cancer screening tests that we will be paying for, effective January 1, 1998. Under our authority under the ``reasonable and necesary'' clause of the Act, section 1862(a)(1)(A), we are establishing conditions under which we would cover colorectal screening services. In Sec. 410.37(b) (Conditions for coverage of screening fecal-occult blood tests) and Sec. 410.37 (h) (Conditions for coverage of screening barium enemas) we are specifying that coverage is available for screening fecal-occult blood tests and screening barium enema examinations only if they are ordered in writing by the beneficiary's attending physician. We are including these coverage requirements to make certain that beneficiaries receive appropriate preventive counseling about the implications and possible results of having these examinations performed. In addition, in the case of the screening barium enema, which we will cover as an alternative to either the screening flexible sigmoidoscopy or the colonoscopy examination, we want to ensure that the beneficiary's attending physician has made a determination that the screening potential of that exam is at least equal to or greater than the screening potential for the alternative examination. Third, in order to ensure that the screening flexible sigmoidoscopy and screening colonoscopy exams are performed as safely and accurately as possible, we are requiring in Sec. 410.37(d) (Conditions for coverage of screening flexible sigmoidoscopies) and Sec. 410.37(f) (Conditions for coverage of screening colonoscopies) that the examinations must be performed by a doctor of medicine or osteopathy (as defined in section 1861(r)(1) of the Act.) Additionally, in Secs. 410.37(c), 410.37(e), 410.37(g), and 410.37(i) (Limitations on coverage of screening fecal-occult blood tests, Limitations on coverage of screening flexible sigmoidoscopies, Limitations on coverage of screening colonoscopies, and limitations on coverage of screening barium enemas, respectively), we are setting forth the following frequency and payment restrictions for the four types of colorectal cancer screening test covered, which are mandated by sections 1834(d)(1)(B), 1834(d)(2)(E) and 1834(d)(3)(E) of the Act, except for those relating to screening barium enema examinations, which the law did not specifically address. Limits on Fecal-Occult Blood Tests Payment may not be made for a screening fecal-occult blood test performed for an individual under age 50. For an individual 50 years of age or over, payment may be made for a screening fecal-occult blood test performed after at least 11 months have passed following the month in which the last fecal- occult blood test was performed. Limits on Flexible Sigmoidoscopies Payment may not be made for a screening flexible sigmoidoscopy performed for an individual under age 50. For an individual 50 years of age or over, payment may be made for a screening flexible sigmoidoscopy performed after at least 47 months have passed following the month in which the last screening flexible sigmoidoscopy, or the last screening barium enema was performed. Limits on Colonoscopies Payment may not be made for a screening colonoscopy performed for an individual who is not at high risk for colorectal cancer. Payment may be made for a screening colonoscopy performed for an individual at high risk for colorectal cancer after at least 23 months have passed following the month in which the last screening colonoscopy or the last screening barium enema was performed. Limits for Barium Enemas In the case of an individual age 50 and over who is not at high risk for colorectal cancer, payment may be made for a screening barium enema after 47 months have passed following the month in which the last screening barium enema, or the last screening flexible sigmoidoscopy was performed. In the case of an individual who is at high risk for colorectal cancer, payment may be made for a screening barium enema after at least 23 months have passed following the month in which the last screening barium enema, or the last screening colonoscopy was performed. As indicated previously, in explaining our national coverage determination on screening barium enemas, we have decided to pay for this examination as an alternative to either the flexible sigmoidoscopy or the colonoscopy coverage provisions (that is, as a substitute for, and not as add-on coverage.) In reviewing the matter of the appropriate frequency limits for screening barium enemas, we did consider the possibility of providing for payment for these services as an add-on to the other two major screening coverage provisions. However, since the screening barium enema allows for a complete examination of the colon, we have not adopted this alternative because we believe it would be duplicative for us to permit coverage of both a screening barium enema and a screening flexible sigmoidoscopy (or a screening colonoscopy for an individual at high risk of colorectal cancer) during the same 2 or 4 year time period, respectively. In the case of a suspicious or equivocal examination, other tests would be necessary but would be considered diagnostic tests, not screening, and would be covered under Medicare. It is generally unnecessary to perform duplicate screening tests. 4. Payment Limits Payment amounts for screening fecal-occult blood tests, screening sigmoidoscopies, screening colonoscopies, and barium enemas as follows: Screening fecal occult blood tests are covered at a frequency of once every 12 months for beneficiaries who have attained age 50. Section 1834(d)(1) of the Act provides that screening fecal occult blood tests are paid at the same rate as diagnostic fecal-occult blood tests (CPT code 82270) are paid under the clinical laboratory fee schedule. We have created a new HCPCS code G0107, colorectal cancer screening; fecal-occult blood test, one to three simultaneous determinations, to be used for screening fecal-occult blood tests. This code will be carrier-priced at the payment amount that the Medicare carrier pays for CPT code 82270 under the clinical laboratory fee schedule. Screening flexible sigmoidoscopy is covered at a frequency of once every 48 months for beneficiaries who have attained age 50. Section 1861(pp)(2) of the Act provides that payment for screening flexible sigmoidoscopies be paid at rates consistent with payment for similar or related services under the physician fee schedule, not to exceed the rates for a diagnostic flexible sigmoidoscopy (CPT code 45330). [[Page 59082]] We have created a new HCPCS code G0104, colorectal cancer screening; flexible sigmoidoscopy, to be used for screening flexible sigmoidoscopy. We believe that the work is the same whether the procedure is a screening or a diagnostic sigmoidoscopy and are, therefore, assigning the same RVUs to HCPCS code G0104 as those assigned to CPT code 45330 in Addendum B. If during the course of the screening flexible sigmoidoscopy a lesion or a growth is detected that results in a biopsy or removal of the growth, section 1834(d)(2)(D) of the Act provides that the physician should bill for a flexible sigmoidoscopy with biopsy or removal, rather than using the screening HCPCS code G0104. Screening colonoscopy is covered at a frequency of once every 24 months for beneficiaries at high risk for colorectal cancer under section 1834(d)(3)(E) of the Act. Section 1861(pp)(2) of the Act defines high risk as a person who, because of family history, prior experience of cancer or precursor neoplastic polyps, a history of chronic digestive disease condition (including inflammatory bowel disease, Crohn's disease, or ulcerative colitis), the presence of any appropriate recognized gene markers for colorectal cancer, or other predisposing factors, faces a high risk for colorectal cancer. The law provides that payment for screening colonoscopies be paid at rates consistent with payment for similar or related services under the physician fee schedule, not to exceed the rates for a diagnostic colonoscopy (CPT code 45378). We have created a new HCPCS code G0105, colorectal cancer screening; colonoscopy for an individual at high risk, to be used for screening colonoscopy. We believe that the work is the same whether the procedure is a screening or a diagnostic colonoscopy, and we are, therefore, assigning the same RVUs to HCPCS code G0105 as those assigned to CPT code 45378 in Addendum B. If during the course of the screening colonoscopy a lesion or growth is detected that results in a biopsy or removal of the growth, section 1834(d)(3)(D) of the Act provides that the physician should bill for a colonoscopy with biopsy or removal, rather than using the screening HCPCS code G0105. The frequency of payment limitations for the screening barium exams will be exactly the same as the frequency of payment limitations that would apply if the barium examination were not being substituted for the other screening service (that is, once every 4 years for a flexible sigmoidoscopy examination for individuals age 50 or over and once every 2 years for colonoscopy screening for individuals at high risk for colorectal cancer). We have created the following new HCPCS codes: ------------------------------------------------------------------------ HCPCS code Descriptor ------------------------------------------------------------------------ G0106............................. Colorectal cancer screening; alternative to G0104, screening sigmoidoscopy, barium enema. G0120............................. Colorectal cancer screening; alternative to G0105, screening colonoscopy, barium enema. G0121............................. Colorectal cancer screening; colonoscopy on individual not meeting criteria for high risk (non- covered). G0122............................. Colorectal cancer screening; barium enema (non-covered). ------------------------------------------------------------------------ The first two codes (G0106, and G0120) are to be used for the barium enema when the barium enema is being substituted for either the sigmoidoscopy or the colonoscopy, as indicated by the code nomenclature. The RVUs for these procedures will be the same as for the diagnostic barium enema procedure, CPT code 74280, and are shown in Addendum B. The second two codes are to be used when the high risk criteria are not met, or a barium enema is performed but not a substitute for either a sigmoidoscopy or colonoscopy. These are non-covered services. 5. Screening Colonoscopy in an Ambulatory Surgical Center CPT code 45378, which is used to code a diagnostic colonoscopy, is on the list of procedures approved by Medicare for payment of an ambulatory surgical center (ASC) facility fee under section 1833(I) of the Act. CPT code 45378 is currently assigned to ASC payment group 2. We propose to add the new HCPCS code G0105, colorectal cancer screening; colonoscopy on individual at high risk, to the ASC list. We believe that the facility services are the same whether the procedure is a screening or a diagnostic colonoscopy and are, therefore, assigning HCPCS code G0105 to payment group 2, which is the same payment rate assigned to CPT code 45378. If during the course of the screening colonoscopy performed at an ASC a lesion or growth is detected which results in a biopsy or removal of the growth, the appropriate procedure classified as a colonoscopy with biopsy or removal should be billed and paid rather than HCPCS code G0105. D. Coverage of Screening Pelvic Examination (Including a Clinical Breast Examination) and Related Payment Changes Section 4102 of the BBA 1997 provides for coverage of screening pelvic examinations (including a clinical breast examination) for all female beneficiaries, effective January 1, 1998, subject to certain frequency and other limitations. A screening pelvic examination (including a clinical breast examination) should include at least seven of the following eleven elements: Inspection and palpation of breasts for masses or lumps, tenderness, symmetry, or nipple discharge. Digital rectal examination including sphincter tone, presence of hemorrhoids, and rectal masses. Pelvic examination (with or without specimen collection for smears and cultures) including: External genitalia (for example, general appearance, hair distribution, or lesions). Urethral meatus (for example, size, location, lesions, or prolapse). Urethra (for example, masses, tenderness, or scarring). Bladder (for example, fullness, masses, or tenderness). Vagina (for example, general appearance, estrogen effect, discharge, lesions, pelvic support, cystocele, or rectocele). Cervix (for example, general appearance, lesions, or discharge). Uterus (for example, size, contour, position, mobility, tenderness, consistency, descent, or support). Adnexa/parametria (for example, masses, tenderness, organomegaly, or nodularity). Anus and perineum. This description is from Documentation Guidelines for Evaluation and Management Services, published in May 1997, and was developed by the Health Care Financing Administration and the American Medical Association. Section 1862(a)(1)(A) of the Act provides that Medicare cover only services that are reasonable and necessary for the diagnosis or treatment of illness or injury. We believe that a pelvic screening procedure should examine [[Page 59083]] various anatomical structures to avoid missing detection of as many potential disorders as practical. We will be including this description in instructions in the Medicare Carriers Manual. This coverage allows payment for one pelvic examination for every female beneficiary every 3 years but includes the allowance of payment once every year for certain women of childbearing age as well as certain women at high risk for cervical or vaginal cancer. Specifically, section 4102(a) of the BBA 1997 provides for the following frequency of coverage limitations: As reflected in the law, payment may be made for a screening pelvic examination on an annual basis if one of the following occurs: The woman is of childbearing age and has had an examination indicating the presence of cervical or vaginal cancer or other abnormality during any of the preceding 3 years. The woman is considered by her physician or other practitioner to be at high risk of developing cervical or vaginal cancer as we have defined in these regulations. We are adding Sec. 410.56 (Screening pelvic examinations) to include this new coverage. In Sec. 410.56(a) (Conditions for screening pelvic examinations), we are requiring that to be covered by Medicare Part B the screening pelvic examination must be performed by a doctor of medicine or osteopathy (as defined in section 1861(r)(1) of the Act), or by a certified nurse midwife (as defined in section 1861(gg) of the Act), or a physician assistant, nurse practitioner, or clinical nurse specialist (as defined in section 1861(aa) of the Act) who is authorized under State law to perform the examination. We have included this requirement to ensure that the screening exam is performed as safely and accurately as possible. To implement the statutory mandate that requires us to identify in regulations the high risk factors for cervical and vaginal cancer, we are specifying in Sec. 410.56(b)(2) (More frequent screening based on high-risk factors), the following factors that have been recommended to us by the National Cancer Institute and the Centers for Disease Prevention and Control. While other factors may have been identified such as low socioeconomic status, the lack of precise and verifiable definitions does not make them amenable to regulation at this time. 1. High Risk Factors for Cervical Cancer Early onset of sexual activity (under 16 years of age). Multiple sexual partners (five or more in a lifetime). History of a sexually transmitted disease (including the human immunodeficiency virus (HIV). Absence of three negative Pap smears or any Pap smears within the previous 7 years. 2. High Risk Factors for Vaginal Cancer Prenatal exposure to diethylstilbestrol. Based on consultation with representatives of the American College of Gynecologists and Obstetricians and others, we have defined a woman of childbearing age in Sec. 410.56(b)(3) (More frequent screening for women of childbearing age) to mean a woman who is premenopausal, and has been determined by her physician or other practitioner, as specified in Sec. 410.56(a), to be of childbearing age, based on her medical history or other findings. This new section also provides for a waiver of the Part B deductible requirement that would otherwise be applicable to these services.