1 Bella English, A Woman's Fear and the Remedy, Boston Globe, Aug. 25, 1993, at 21. In 1992, an estimated 180,000 women developed Breast Cancer and 46,000 died as a result. Senate Comm. on Labor and Human Resources, S. Rep. NO. 448, 102d Cong., 2d Sess., pt. II, at 3 (1992) [hereinafter S. 1777 Report with Amendment]. It is difficult to determine how much of the increase is “real” since it may also reflect improvements in Breast Cancer detection practices. General Accounting Office, Breast Cancer 1971-91: PRevention, Treatment, and Research 18-19 (Dec. 1991) (on file with author) [hereinafter Breast Cancer 1971-91]. “Widespread mammography screening may explain, in part, the increasing breast-cancer incidence in the United States; however, this increase also occurred among population groups not covered by screening and among industrialized countries before mammographic screening had been widely implemented.” A. Elixhauser, Public Health Focus: Mammography, 268 JAMA 452, 453 (1992) (CDC Editorial Note).

2 See Susan M. Love, DR. Susan Love's Breast Book 143-44 (1990) (“[B]reast cancer is what is known as a ‘multifactional disease’ — that is, it has many causes which interact with each other in ways we don't understand yet.“).

3 Between.1955 and 1957, the age-adjusted Breast Cancer mortality rate per 100,000 women was 26.3%, whereas that between 1985 and 1987 was 27.2%, thereby reflecting no significant change. American Cancer Society, Cancer Facts & Figures - 1991 4 (1991) (on file with author) [hereinafter Cancer Facts & Figures]; see also Breast Cancer 1971-91, supra note 1, at 2.

4 Shari Roan, A First Step — At Last, L.A. Times, Oct. 19, 1993, at El.

5 See generally Breast Cancer 1971-91, supra note 1, at 37-43; Love, supra note 2, at 135-69.

6 Council on Scientific Affairs et al., Mammographic Screening in Asymptomatic Women Aged 40 Years and Older, 261 JAMA 2535, 2535 (1989) [hereinafter Mammographic Screening in Asymptomatic Women]; General Accounting Office, Breast Cancer: Progress to Date and Directions for the Future 2 (Dec. 1991) (on file with author) [hereinafter Progress and Future].

7 For instance, the Breast Cancer Prevention Trial (BCPT), a $68 million federal study, will follow 16,000 American and Canadian women every day for the next five years to determine whether the drug tamoxifen lowers the risk of Breast Cancer. Shari Roan, Cancer Prevention Trials Open New Era In Medicine, L.A. TIMES, Sept. 7, 1992, at Al. In addition, Massachusetts General Hospital plans to build a “library” of genes from 400 young women with Breast Cancer in order to research factors that predispose women to Breast Cancer. Richard A. Knox, MGH To Put Focus On Breast Cancer, Boston Globe, Oct. 20, 1992, at 40.

8 Love, supra note 2, at 175-76; National Cancer Institute, Breast Exams: what you Should Know 1 (1988) (on file with author) [hereinafter Breast Exams]; Jerome F. Levy, your Breasts 4 (1990); General Accounting Office, Screening Mammography: Low-Cost Services do not Compromise Quality 10-11 (Jan. 1990) (on file with author) [hereinafter Screening Mammography]; Mammographic Screening in Asymptomatic Women, supra note 6, at 2535-36.

9 National Cancer Institute, Questions and Answers About Breast Lumps 1 (1989) (on file with author); Cancer Facts & Figures, supra note 3, at 9.

10 Breast Cancer, 1971-91, supra note 1, at 20.

11 Levy, supra note 8, at 52; Breast Exams, supra note 8, at 7; Progress and Future, supra note 6, at 3.

12 Ultrasound produces “an X-ray-like image by sending sound waves into the body and ‘reading’ them as they bounce back off body structures.” Levy, supra note 8, at 53.

13 Thermography “evaluates changes in the breasts’ skin temperature.” Id. at 52.

14 Transillumination, which remains experimental, involves “shining strong light through the breast to highlight internal structures.” Id. at 52-53.

15 See generally American Cancer Society, Breast Cancer: your Best Protection … Early Detection 2 (1991) (on file with author) [hereinafter your Best Protection]. There has been general agreement among major cancer groups and medical associations as to the efficacy of screening mammography for women 50 years of age and older. As of late, the debate among these groups has intensified as some have questioned the benefits of screening mammography for women between the ages of 40 and 49. See Anita Manning & Tim Friend, Mammogram Before 50 of “Margina” Use, USA Today, Oct. 20, 1993, at lA;Judy Foreman, U.S. Unit Plans to Change Its Guidelines on Mammograms, Boston Globe, Oct. 20, 1993, at 1 [hereinafter Foreman, U.S. Unit Plans to Change Its Guidelines]. For further analysis of this heated and divisive debate, see infra notes 67-78 and accompanying text.

One must distinguish between the two types of mammography services available to women: screening and diagnostic. Screening mammography is performed on women exhibiting no symptoms of Breast Cancer (asymptomatic), whereas diagnostic mammography is reserved for those women exhibiting such symptoms (symptomatic). Levy, supra note 8, at 20-22. Although this Note focuses on screening mammography services only (unless otherwise specified), the Mammography Quality Standards Act of 1992 covers both types of mammography. See infra note 178.

16 A recent study indicates that the effectiveness of magnetic resonance imaging (MRI), which uses magnetic fields and radio frequencies instead of X-rays, surpasses that of mammography. Jon Van, Xew Technology Shedding Light On Cancer Darkness, Cm. Trib., Dec. 3, 1991, § 3, at 1. These results are limited because of the study's small sample size and sample bias in that all 57 women were thought to have Breast Cancer. Id. Cost effectiveness is also an issue. An MRI scan costs $1,000, as compared to $55 for a standard screening mammogram, and there are no plans for performing screening magnetic resonance at this time. See Sally Squires, MRI Tests vs. Mammography in Detecting Breast Cancer, Wash. POST, Dec. 17, 1991, Health Section, at 5. Therefore, screening mammography remains the only viable screening option for women.

17 Linda, F. anderson, Researchers Push to Improve Breast Imaging, 83 J. Nat'L Cancer Inst. 1444 (1991)Google Scholar; Screening Mammography, supra note 8, at 35; see also Staff of Senator Brock Adams, Mammography Facts (1992) (on file with author) [hereinafter Mammography facts]; The Failure and Success of Current Mammography Practice: The Weed for Strong Federal Quality Standards: Hearing on S. 1777 Before the Subcomm. on Aging of the Senate Comm. on Labor and Human Resources, 102d Cong., 1st Sess. 6-7 (1992) [hereinafter S. 1777 Hearings].

18 PrimeTime Live (ABC television broadcast, Feb. 27, 1992 & Mar. 5, 1992); see also S. 1777 Hearings, supra note 17, at 16-20, 21-25 (statements of Mary P. Stupp and Marie-Anne Domsalla, victims of these “errors“); Judy Foreman, A Cancer Unseen, Boston Globe, Feb. 7, 1993, at 1 (story of Diane Walker, whose Breast Cancer was misdiagnosed over a four-year period) [hereinafter Foreman, A Cancer Unseen]; Judy Foreman, Breast Cancer a Special Tenor, Boston Globe, Nov. 4, 1991, at 26 [hereinafter Foreman, Breast Cancer a Special Terror]; James, F. Newsome & Robert, McClelland, A Word of Caution Concerning Mammography, 255 JAMA 528 (1986)Google Scholar [hereinafter Newsome & McClelland, A Word of Caution].

19 Public awareness of Breast Cancer has soared, prompting an increase in the number of women seeking screening mammograms and the amount of money allocated for the provision of mammograms and education about Breast Cancer screening. See Sally Squires, Mammograms Increase by 10 Percent in U.S., WASH. POST, Aug. 25, 1992, Health Section, at 5; see also Toni Locy, Bay Stale Declares Breast Cancer Rate At Epidemic Level, Boston Globe, May 21, 1992, at 1. But see Betsy A. Lehman, Mammogram Advice Sows Confusion, Boston Globe, Sept. 13, 1993, at 25, 26 (describing various “barriers” that affect demand and access). As will be discussed, coverage for screening mammography through Medicare and private insurers, and increased access to services through office-based equipment and mobile units, may create supply-induced demand. See infra notes 141-42, 244 and accompanying text.

20 Felicity Barringer, Screening for Breast Cancer: Questions of Cost and Quality, N.Y. Times, Aug. 19, 1991, at Al, A13. But see Screening Mammography, supra note 8, at 32 (noting a strong relationship between high volume, adherence to quality standards, and low costs).

21 Telephone Interview with spokesperson for the American College of Radiology (Feb. 1992).

22 See S. 1777 Report with Amendment, supra note 1, at 4-5.

23 The American College of Radiology is a professional and educational association of 20,000 board-certified radiologists and radiological physicists. 5. 17 7 7 Hearings, supra note 17, at 57-69 (statement of Dr. Larry Basset, American College of Radiology).

24 Robert, McClelland et al., The American College of Radiology Mammography Accreditation Program, 157 Am. J. Radiology 473, 474 (1991)Google Scholar [hereinafter McClelland et al., ACR Mammography Accreditation Program].

25 Although these statutes are not identical, they set quality standards in the key areas of equipment, personnel, and quality assurance. Mammography Facts, supra note 17, at 7.

26 See Screening Mammography, supra note 8, at 35-38.

27 Pub. L. No. 101-508, 104 Stat. 1388 (1990).

28 S. 17 7 7 Hearings, supra note 17, at 30-31 (statement of Janet L. Shikles, Director, Health Financing and Policy Issues, U.S. General Accounting Office).

29 9 S. 1777 Report with Amendment, supra note 1, at 7-8.

30 Id. at 8.

31 42 U.S.C. § 263b (West Supp. 1993).

32 See World and National News, Star Trib., Oct. 28, 1992, at 4A; Telephone Interview with Lucia Giudice, Health Fellow, Office of Senator Brock Adams (Oct. 27, 1992).

33 Foreman, Breast Cancer a Special Terror, supra note 18, at 26.

34 Breast Cancer 1971-91, supra note 1, at 36; see Love, supra note 2, at 137-51.

35 See Love, supra note 2, at 137-51.

36 “The risk of radiation-induced Breast Cancer from modern mammography is generally estimated to be small in relation to its benefits.” Breast Cancer 1971-91, supra note 1, at 42. Further, the contribution of radiation from screening to Breast Cancer risk among asymptomatic women is not much of an issue. Id.

37 Hormone replacement therapy involves the prescription of estrogen to treat menopausal symptoms and adjust the estrogen levels of women who have undergone surgical removal of the ovaries. Id. at 40; see also Laurie Garrett, The Estrogen Decision, Newsday, May 12, 1992, at 48 (discussing the risks and benefits of estrogen); Dolores Kong, Fetal Exposure to Estrogen May Indicate Breast Cancer Risk, Boston Globe, Oct. 23, 1992, at 3 (reporting that daughters of women with low estrogen levels during pregnancy are at lower risk of developing Breast Cancer).

38 See Love, supra note 2, at 152-69. But see Dolores Kong, Diet's Link to Breast Cancer Is Downplayed, Boston Globe, Oct. 21, 1992, at 1, 10 (study of 90,000 nurses found no evidence that reducing fat or increasing fiber lowers the risk of Breast Cancer).

39 Mammographic Screening in Asymptomatic Women, supra note 6; Love, supra note 2, at 143; Breast Cancer 1971-91, supra note 1, at 35.

40 Mammographic Screening in Asymptomatic Women, supra note 6, at 2535.

41 See supra note 2.

42 Breast Cancer 1971-91, supra note 1, at 35.

43 Mammographic Screening in Asymptomatic Women, supra note 6, at 2535.

44 See supra note 8 and accompanying text.

45 Mammographic Screening in Asymptomatic Women, supra note 6, at 2535; your Best Protection, supra note 15, at 3; Breast Exams, supra note 8, at 2-6; see also Kathryn, M. Kash, Breast Cancer Detection Methods: Debate Continues, 84 J. NAT'L Cancer Inst. 725, 726 (1992)Google Scholar (“Guidelines for the early detection of Breast Cancer include all three methods, not one alone.“).

46 Levy, supra note 8, at 28-33.

47 Id. at 28; Breast Exams, supra note 8, at 4.

48 Levy, supra note 8, at 26-27; Breast Exams, supra note 8, at 5.

49 Researchers argue that BSE is cost-effective, reduces mortality, and detects 90% of lumps in women's breasts. These findings are particularly important for younger women. Kash, supra note 45, at 726.

50 Levy, supra note 8, at 24; Breast Exams, supra note 8, at 10.

Breast Cancer: A Feminist Issue, Radcliffe News, Winter 1992, at 4 (quoting Dr. Susan Love).

51 Love, supra note 2, at 21-23.

52 Levy, supra note 8, at 23; see also Mammographic Screening in Asymptomatic Women, supra note 6; Screening Mammography, supra note 8, at 11. For discussion of the cost effectiveness of MRI, see supra note 16. For a discussion of the debate within the medical community regarding the effectiveness of mammography for women under 50 years of age, see infra notes 66-78 and accompanying text.

53 Breast Cancer 1971-91, supra note 1, at 20.

54 Ann Landi, Mammograms Made Easy, SELF, Oct. 1991, at 139.

55 Breast Exams, supra note 8, at 2. As will be discussed, even under ideal screening circumstances, mammograms will not be completely accurate. The mammogram can only take a picture of the protruding part of the breast. The periphery of the breast will not get into the picture at all. Therefore, as Dr. Susan Love aptly points out, “[p]hysical exams and mammograms are complementary, not substitutions for each other: you can see some lumps on a mammogram that you can't feel, and you can feel some lumps through palpation that you can't see on an x-ray.” Love, supra note 2, at 176. As will be shown, this built-in limitation is one of many factors that illustrates the need for quality assurance for mammography services. It also points to the advantage of Mri, which produces a three-dimensional image. See infra note 62.

56 Love, supra note 2, at 176.

57 Your Best Protection, supra note 15, at 2.

58 See supra note 13.

59 CT imaging is a new type of X-ray that may require an injection of intravenous contrast material, but fails to distinguish between fibrocystic and cancerous breast changes. Levy, supra note 8, at 52.

60 See supra note 14.

61 See supra note 12.

62 Mri uses no irradiation and produces a three dimensional image that can be examined in cross section detail. Squires, supra note 16. Although it can detect lumps in dense breast tissue, it remains both experimental and expensive. Id.; Van, supra note 16; Levy, supra note 8, at 53.

63 Levy, supra note 8, at 52. But see supra notes 16, 62 and accompanying text.

64 See Manning & Friend, supra note 15, at 1A; Foreman, U.S. Unit Plans to Change its Guidelines, supra note 15, at 1; Richard, G. Wyatt, Benefits of Mammography Confirmed, 261 JAMA 1260 (1989)Google Scholar; Kenneth, C. Chu et al., Analysis of Breast Cancer Mortality and Stage Distribution by Age for the Health Insurance Plan Clinical Trial, 80 J. Nat'l Cancer Inst. 1125 (1988)Google Scholar; Michael, D. Wertheimer et al., Increasing the Effort Toward Breast Cancer Detection, 255 JAMA 1311 (1986)Google Scholar.

65 Love, supra note 2, at 173-75. In a study conducted in New York beginning in 1962, the HIP (an HMO) randomly assigned 62,000 women to one of two groups. One group underwent Breast Cancer screening (including both mammograms and physical examinations), while the other used the woman's “usual care.” In a similar study conducted in Sweden during the 1970s and 1980s, the experimental group underwent mammography only, yet confirmed the results of the HIP study. Results as they pertain to women below the age of 50 are unclear since it is still too early to follow up. In comparing the two studies, Dr. Love mentions that physical examinations in the HIP study were less effective for older women (50 years and older) than for younger women, whereas mammography was more effective. Id. at 174.

66 Levy, supra note 8, at 14-15.

67 See Love, supra note 2, at 175. But see Chu et al., supra note 64 (based on an 18-year followup, the study revealed a statistically significant mortality reduction for two female cohorts [40 to 49 and 50 to 64 years of age at entry] using screening mammography, as compared to unscreened control groups).

68 Mammographic Screening in Asymptomatic Women, supra note 6, at 2535; D.M., Eddy et al., The Value of Mammography Screening in Women Under Age 50 Years, 259 JAMA 1512 (1988)Google Scholar; see also Letters to Editor, Mammography Screening in Women Under Age 50 Years, 269 JAMA 473, 473-76 (1988) (presenting different views on this issue).

69 Asymptomatic women exhibit no symptoms of Breast Cancer. See supra note 15.

70 Christine, Gordillo, Breast Cancer Screening Guidelines Agreed on by Ama, Other Medically Related Organizations, 262 JAMA 1155 (1989)Google Scholar.

71 Id.

72 Id. The Ama adds, “the frequency and type of examination for symptomatic women will vary individually and should be determined by the responsible physician.” Id.

73 These organizations include the American Cancer Society, the American Medical Association, the American Society of Internal Medicine, the National Medical Association, the American Academy of Family Physicians, the American College of Radiology, the American Society for Therapeutic Radiology and Oncology, the American Osteopathic College of Radiology, the American Association of Women Radiologists, the College of American Pathologists, the American Society of Clinical Oncology, and the American College of Obstetrics and Gynecology. Mammography Facts, supra note 17, at 12.

74 Gina Kolata, Studies Say Mammograms Fail to Help Many Women, N.Y. Times, Feb. 26, 1993, at 1; Judy Foreman, Disputed Study May Downplay Mammogram Effectiveness, Boston Globe, May 5, 1992, at 1; see A.B., Miller, Re: “Author of Canadian Breast Cancer Study Retracts Warnings”, 84 J. Nat'l Cancer Inst. 1365 (1992)Google Scholar (author of Canadian study, and its critics, address preliminary results).

75 Foreman, U.S. Unit Plans to Change Its Guidelines, supra note 15, at 1; Ridgely Ochs, Mammographies Reconsidered, Newsday, Oct. 20, 1993, at 3.

76 Ochs, supra note 75.

77 Foreman, U.S. Unit Plans to Change Its Guidelines, supra note 15, at 1; Manning & Friend, supra note 15, at 1A; Ochs, supra note 75. “None of the studies are large enough or have been followed long enough to demonstrate that [screening mammography] is not a benefit.” Ochs, supra note 75 (quoting Dr. Harmon Eyre, Deputy Executive Vice President for Medical Affairs and Research, American Cancer Society).

It is interesting to note that the revisions by NCI (whose parent agency is the National Institutes of Health) are consistent with President Clinton's Health Care Plan, which will cover biannual screening mammograms for women over 50 years of age unless they have a family history of Breast Cancer or are deemed at risk for other reasons. See Foreman, U.S. Unit Plans to Change Its Guidelines, supra note 15, at 1; Ochs, supra note 75, at 3; see also Robert Pear, President to Limit Federal Subsidies in Health Program, N.Y. Times, Oct. 27, 1993, at 1.

78 For an instructive summary of arguments from those supporting and opposing mammograms for women between the ages of 40 and 49, see Carey Q, Gelemter, Mammogram Mixup, Chi. Trib., Aug. 15, 1993, at 12.

79 See Joan Beck, Activism Could Get Breast Cancer the Attention It Deserves, Cm. Trib., May 21, 1992, § 1, at 23; see also Sabin Russell, Women Battle Breast Cancer and the Health Care System, S.F. Chron., Dec. 3, 1991, at Al; Breast Cancer 1971-91, supra note 1, at 20-25.

80 David Zinman, Testing the Test: Effectiveness of Mammograms Is In Question, Newsday, Feb. 12, 1991, at 63 (quoting Dr. Charles Smart of the National Cancer Institute).

81 See Valerie, McManus et al., Enhancement of True-Positive Rates for Xonpalpable Carcinoma of the Breast Through Mammographic Selection, 175 Surgery, Gynecology and Obstetrics 212 (1992)Google Scholar; L., Ma et al., Case-Control Study of Factors Associated with Failure to Detect Breast Cancer by Mammography, 84 J. Nat'l Cancer Inst. 781 (1992)Google Scholar; Newsome & McClelland, A Word of Caution, supra note 18, at 528.

82 A dedicated mammographic unit is a piece of mammography equipment that is specifically designed and used for performing mammography services. Screening Mammography, supra note 8, at 23.

83 McClelland et al., ACR Mammography Accreditation Program, supra note 24, at 473.

84 See supra note 18 and accompanying text.

85 S. 1777 Report with Amendment, supra note 1, at 5-6; see also Newsome & McClelland, A Word of Caution, supra note 18, at 528 (authors believe that false-negative rate for mammography should not exceed 10%).

86 anderson, supra note 17, at 1444 (quoting Dr. Robert McLelland of the University of North Carolina at Chapel Hill).

87 McClelland et al., ACR Mammography Accreditation Program, supra note 24, at 473.

88 Id.; see also Mary, E. Costanza et al., Feasibility of Universal Screening Mammography: Lessons from a Community Intervention, 151 Archives Internal Med. 1851 (1991)Google Scholar.

89 For testimony from two such women, see S. 17 7 7 Hearings, supra note 17, at 16-20, 21-25 (statements of Mary P. Stupp and Marie-Anne Domsalla). Mary Stupp died during the summer of 1992. 138 Cong. Rec. S17.241 (daily ed. Oct. 7, 1992) (statement of Sen. Adams); see also Foreman, A Cancer Unseen, supra note 18, at 1 (Diane Walker died on January 6, 1993).

90 Tearle Meyer et al., The American College of Radiology Mammography Accreditation Program, Admin. Radiology, Aug. 1990, at 28.

91 Id.

92 Id.; Sandra Friedland, Mammography Laic's Daunting Task, N.Y. Times, Sept. 22, 1991, at NJ1; Office OF Cancer Communications, National Cancer Institute, Choosing A Mammography Facility (1991) (on file with author); 5. 17 7 7 Hearings, supra note 17, at 46-47 (statement of Dr. Gerald D. Dodd, President, American Cancer Society).

93 See generally Mammography Facts, supra note 17, at 8-9; McClelland et al., ACR Mammography Accreditation Program, supra note 24, at 473-75.

94 McClelland et al., ACR Mammography Accreditation Program, supra note 24, at 474.

95 For these specific criteria, see id. at 475.

96 Id. at 474.

97 A breast phantom contains test objects simulating masses, spicules, and calcifications of different shapes and sizes. Id.

98 In this procedure, a thermoluminescent dosimeter rests on the breast phantom and measures radiation exposure. Id.

99 McClelland et al., ACR Mammography Accreditation Program, supra note 24, at 474.

100 Id.

101 Id.

102 Id.; see also Screening Mammography, supra note 8, at 24.

103 McClelland et al., ACR Mammography Accreditation Program, supra note 24, at 474.

104 Id.

105 Id. at 474-75.

106 Id. at 475; see also American Collece of Radiology, ACR Standards for the Performance of Screeninc Mammography 3-4 (1990) (required checks apply to technologists and physicists).

107 McClelland et al., ACR Mammography Accreditation Program, supra note 24, at 475.

108 Mammography Facts, supra note 17, at 9. “These include both the technologists ‘tests (i.e., darkroom cleanliness, screen cleanliness, viewboxes and viewing condition) and medical physicists’ tests (i.e., beam quality assessment, focal spot size measurement.“). Id.

109 Id.

110 Id. Sites that fail obtain comments on the most likely causes of deficiencies and, after correcting them, may resubmit the portion of the evaluation that did not meet the criteria. Meyer et al., supra note 90, at 33. Any site that fails this second application must submit an entirely new application form and fees, with documentation that it has taken action to correct deficiencies. Mammography Facts, supra note 17, at 9.

To announce the accreditation of a facility, the ACR sends out a press release. An interesting side effect of this program is that the number of facilities in a given locale requesting accreditation materials increases whenever a facility in that locale announces its accreditation publicly. Meyer et al., supra note 90, at 36.

111 McClelland et al., ACR Mammography Accreditation Progiam, supra note 24, at 475.

112 Id.

113 Mammography Facts, supra note 17, at 9.

114 Id.

115 Id. at 9-10.

116 Id. at 10.

117 S. 1777 Report with Amendment, supra note l, at 11. More recent findings indicate that, as of early March 1993, 7,720 of the nation's estimated 9,500 mammography facilities applied for accreditation from ACR and 5,228 won accreditation. Kathleen Best, Mammogram Reform is Off to Slow Start, ST. Louis Post-Dispatch, Mar. 17, 1993, at 1A.

118 McClelland et al., ACR Mammography Accreditation Program, supra note 24, at 476-77.

119 Id. at 477.

120 Id.

121 Id.

122 Id.

123 McClelland et al., ACR Mammography Accreditation Program, supra note 24, at 477. The case of mobile units represents the exception. Their failure rate was 24% as compared to an average of 13.5% among other settings (such as hospitals, private offices, and multi-specialty clinics). Id. But see Screening Mammography, supra note 8, at 26.

124 McClelland et al., ACR Mammography Accreditation Program, supra note 24, at 477.

125 Id.

126 S. 1777 Report with Amendment, supra note 1, pt. X, at 28.

127 S. 17 7 7 Hearings, supra note 17, at 30 (statement of Janet L. Shikles, Director, Health Financing and Policy Issues, General Accounting Office).

128 Screening Mammography, supra note 8, at 32.

129 Id.

130 Id.

131 Meyer et al., supra note 90, at 28. Other segments of the medical community share this belief, as evidenced by the American Cancer Society's and the National Cancer Institute's recommending only ACR-accredited facilities to women seeking mammography screening services. See American Cancer Society, ACR Accredited Mammography Facilities (1992) (on file with author); Office of Cancer Communications, National Cancer Institute, Choosing A Mammography Facility (1991).

132 See supra note 117 and accompanying text.

133 See supra notes 85-87 and accompanying text.

134 See supra notes 1-4 & 33 and accompanying text.

135 See supra notes 5-6 & 34-43 and accompanying text.

136 Foreman, Breast Cancer a Special Terror, supra note 18, at 26. For the current fiscal year, which began October 1, 1993, these advocates seem to have found “that rock.” President Clinton designated an estimated $262.9 million for Breast Cancer research, up from $197 million in 1993 (a 33.5% increase). Gina Kolata, Weighing Spending on Breast Cancer, N.Y. Times, Oct. 20, 1993, at 14. The Department of Defense has an additional $210 million for research over the next five years. Breast Cancer Fight Underfunded, Chi. Trib., Oct. 28, 1993, at 5.

137 Reducing Risk of Faulty Mammograms, L.A. Times, Oct. 28, 1991, at B4.

138 Barringer, supra note 20, at A13 (quoting Helene Toiy, General Accounting Office).

139 Id. For examples of mammography quality assurance legislation, see Mammography Quality Standards Act of 1992, 42 U.S.C. § 263b (West Supp. 1993)); Cal. Health & Safety Code § 25827 (West 1993); Colo. Rev. Stat. § 25-11-105.5 (1993); Mass. Gen. L. CH. III, § 5Q (1992); R.I. Gen. Laws § 5-37-31 (1992).

140 See infra notes 142-43 and accompanying text.

141 S. 1777 Report with Amendment, supra note 1, at 10.

142 Breast Cancer 1971-91, supra note 1, at 22; see also S. 1777 Report with Amendment, supra note 1, at 10.

143 This group includes Arkansas, Indiana, Kentucky, Maryland, Michigan, New Mexico, North Carolina, Ohio, Rhode Island and Vermont. Massachusetts is a recent addition. Mammography Facts, supra note 17, at 7-8.

144 S. 1777 Report with Amendment, supra note 1, at 10.

145 Act of June 16, 1989, 1989 Mich. Pub. Acts § 13523(2)(g).

146 Id. § 13523(l)-(2)(f).

147 S. 1777 Report with Amendment, supra note 1, at 11.

148 See generally Mammography Facts, supra note 17, at 7-8 (Rhode Island and Kentucky have such requirements).

149 Reducing Risk of Faulty Mammograms, supra note 137, at 4; see also Screening Mammography, supra note 8, at 35-39.

150 S. 1777 Report with Amendment, supra note 1, at 11; American Cancer Society Holds News Conference on Mammography Quality Assurance in Michigan, PR Newswire, Feb. 27, 1992, available in Lexis, Nexis Library, PR News file [hereinafter ACS Xews Conference].

151 ACS News Conference, supra note 150.

152 S. 1777 Report with Amendment, supra note 1, at 11.

153 See supra notes 113-22 and accompanying text; see also Screening Mammography, supra note 8, at 35-39.

154 See Richard, E. Leahy, Rational Health Policy and the Legal Standard of Care: A Call for Judicial Deference to Medical Practice Guidelines, 77 Cal. L. Rev. 1483 (1989)Google Scholar.

155 Id. at 1509-11.

156 Mammography Facts, supra note 17, at 2.

157 Screening Mammography, supra note 8, at 39.

158 Mammography Facts, supra note 17, at 2.

159 Id.

160 S. 1777 Report with Amendment, supra note 1, at 7.

161 Id.

162 Id.

163 Id.

164 Id. at 8.

165 Pub. L. No. 101-508, 104 Stat. 1388 (1990).

166 S. 17 7 7 Hearings, supra note 17, at 30 (statement of Janet L. Shikles, Director, Health Financing and Policy Issues, General Accounting Office). Before January 1, 1991, Medicare covered only diagnostic mammography. Id. at 31.

167 Id.

168 Mammography Facts, supra note 17, at 3.

169 Id.

170 Id. at 4.

171 Sandra Boodman, How Accurate are Medical Lab Tests?: New Law to Protect Patients Has Been Diluted and Delayed, Wash. post, Sept. 1, 1992, at 10. A Pap smear is part of a routine gynecological exam and entails smearing cells from a woman's cervix on a slide for examination under a microscope. If performed properly, the procedure can detect precancerous abnormalities or cervical cancer in the disease's earliest stages. Id. However, a prize-winning series of Wall Street Journal articles published in 1987 revealed an error rate of 20 to 40% for this procedure, due mainly to “the proliferation of ‘Pap mills, cut-rate high-volume labs staffed by poorly trained, underpaid workers who were pushed to read hundreds of slides per day.” Id.

172 H.R. REP. NO. 899, 100th Cong., 2d Sess. (1988).

173 See Diane M. Gianelli, Gentler Lab Regulations, Am. Med. News, Sept. 14, 1992, at 1, 14-15 [hereinafter Gianelli, Gentler Lab Regulations]; Sandra G. Boodman, What the Law Provides, Wash. POST, Sept. 1, 1992, Health Section, at 12.

174 Boodman, supra note 171.

175 Id.

176 Gianelli, Gentler Lab Regulations, supra note 173, at 1. This does not include a 90-day grace period later granted by federal health officials. Id.

177 Id. at 14. For a discussion about Clia's treacherous history, see infra notes 253-63 and accompanying text.

178 42 U.S.C. § 263b(b)-(c) (West Supp. 1993). This legislation covers both screening and diagnostic mammography services, and will apply to Medicare facilities. Id. § 263b(a)(5).

179 Id. § 263b(c)(l).

180 Id. § 263b(c)(2). The facility must demonstrate that a geographic area's access to mammography would be significantly reduced, and document steps that will be taken to meet certification requirements. Id.

181 Id. §263b(d)(l).

182 Id. § 263b(d)(2)-(3).

183 Id. § 263b(d).

184 See id. § 263b(q).

185 Id. § 263b(e)(l)(A). These standards pertain to clinical image reviews by qualified practicing physicians, annual surveys by a qualified medical physicist, accreditation fees, and financial relationships that may represent conflicts of interest. Id. § 263b(e)(l)(B).

186 Id. § 263b(e)(l)(D).

187 Id. § 263b(e)(l)(C).

188 Id. § 263b(e)(4). Facilities are given notice before such visits. Id.

189 Id. § 263b(e)(6). Part of this review process includes the Secretary's inspection of a percentage of facilities that the body accredits. Id. § 263b(g)(2). Evaluations are submitted to the appropriate Congressional committees. Id. § 263b(e)(6).

190 Id. § 263b(f)(l)(A).

191 Id. § 263b(f)(l)(B).

192 Id. § 263b(f)(l)(C).

193 Id. § 263b(f)(l)(D).

194 Id. § 263b(f)(l)(E).

195 Id. § 263b(f)(l)(F).

196 Id. § 263b(f)(l)(G).

197 Id. § 263b(f)(l)(H).

198 Id. § 263b(f)(2)(A).

199 Id. § 263b(f)(2)(B)-(C).

200 Id. § 263b(f)(2)(D).

201 The Secretary or state agency must conduct inspections “not less often than annually.” Id. § 263b(g)(l)(E).

202 Id. § 263b(g)(l)(A).

203 Id. § 263b(g)(l)(D).

204 Id. § 263b(g)(l)(C).

205 Id. § 263b(g)(l)(F).

206 Id.

207 Id. § 263b(g)(3). For all inspections, facilities will receive prior notice, though the Secretary may waive this requirement if the facility's continued performance threatens the public health. Id. § 263b(g)(4).

208 Id. §263b(h)(l).

209 Id. §263b(h)(2).

210 Id. §263b(h)(3).

211 Id. § 263b(i)(l). No person who owned or operated a facility that had its certificate revoked may own or operate a facility that requires similar certification within two years of the revocation. Id. § 263b(i)(3).

212 Id. § 263b(j). Judicial review of the suspension or revocation of a facility's certificate, or the imposition of a sanction, is possible. Id. § 263b(k).

213 Id. §263b(l)(l).

214 Id.

215 Id. § 263b(n)(l)-(2). The Committee will meet at least quarterly for the first three years of the program and at least biannually thereafter. Id. § 263b(n)(4).

216 Id. § 263b(n)(3)(A)-(C).

217 Id. § 263b(n)(3)(D)-(E).

218 Id. § 263b(n)(3)(F).

219 Id. § 263b(n)(3)(G)-(I).

220 Id. §263b(o).

221 Id. § 263b(p)(l)(A). Grants may be used to study relationships between Breast Cancer screening and population-based cancer registry data, to provide diagnostic outcome data to radiology facilities for their evaluation of patterns of mammography interpretation, and to enhance the confidentiality of all stored data. Id. § 263b(p)(l)(B).

222 Id. § 263b(p)(l)(D).

223 Id. § 263b(p)(2)-(3).

224 Id. §263b(p)(4).

225 Id. § 263b(m).

226 id. § 263b(q)(l).

227 Id. §263b(q)(2).

228 Id. § 263b(q)(3)(C).

229 Id. § 263b(q)(3)(B).

230 Id. § 263b(q)(3)(A). If a state does not meet federal requirements, the Secretary may withdraw its approval of the state's authority; facilities certified by that state may operate during a reasonable period for the facility to obtain certification from the Secretary. Id. § 263b(q)(4).

231 Id. § 263b(r)(l). Fees must be assessed and collected so as to yield an amount equal to total inspection costs; a person's liability for fees will be reasonably based on that person's proportion of the inspection costs. Id.

232 Staff of Senator Brock Adams, Analysis of the Mammography Quality Standards Act, H.R. 6182, at 3 (undated) (on file with author).

233 42 U.S.C. §263b(r)(2).

234 Mammography Quality Standards Act of 1992, 42 U.S.C. § 263b. The Comptroller General will complete an interim Report no later than three years from the enactment of this legislation, and a final Report no later than five years from that date; the appropriate Congressional committees will receive each Report. Id. § 263b(r) note.

235 Paul, M. Ellwood, Shattuck Lecture — Outcome Management: Technology of Patient Experience, 318 New Eng. J. Med. 1549, 1550 (1988)Google Scholar.

236 See 42 U.S.C. § 263b(r). See infra note 239 regarding Congress's failure to allocate appropriate funding for the Act's implementation.

237 S. 1777, 102d Cong., 1st Sess. § 354A(e) (1991).

238 H.R. 5938, 102d Cong., 2d Sess. § 354(r) (1992).

239 In fact, sources indicate that upon Congress's passage of the Act, Congress failed to allocate the $10 million needed to implement the Act. Best, supra note 117, at 1A. This represents one of many glitches that could push back the Act's October 1994 deadline. See id. Congress has since responded in an attempt to remedy this problem. See Pub. L. No. 103-50, 107 Stat. 241 (1993) (for the fiscal year ending September 30, 1993, Congress appropriated $3 million for carrying out the Act).

240 See supra notes 128-29; infra notes 243-50 and accompanying text.

241 See infra notes 251-52 and accompanying text.

242 Russell, supra note 79, at Al (quoting Uwe Reinhardt, a Princeton medical economist).

243 See supra notes 141-42 & 163-66 and accompanying text.

244 See Barringer, supra note 20, at Al, A13. Profit motive has attracted those who build an entire business around mammography, particularly in areas where low-cost, high-volume screening mammography is feasible. For example, appearing in New Jersey are portable units and developers that can be moved into an employee lounge or rest room to screen women in their work place. According to the providers, neither they nor the units were accredited. Friedland, supra note 92, at 1. In Seattle, a mobile van travelled to selected grocery store sites and provided lowcost mammograms to customers. Low-Cost Mammograms Offered al Safeway-Store Sites, Seattle Times, Oct. 9, 1991, at G5. Testing procedures reportedly met or exceeded state and professional standards.

245 Screening Mammography, supra note 8, at 17-22.

246 Id. at 20-21. Procedural efficiencies include batch-reading of films, maintaining a large volume of patients, and requiring payment at time of service.

247 Id. at 20. In this survey, the average charge for screening was $53, as compared to $113 for diagnostic.

248 Id. at 21-22.

249 Id. at 22.

250 Id. Some would argue that high-volume facilities fare better simply because those interpreting a large number of mammograms have a better opportunity to sharpen their skills over time than would those interpreting mammograms less frequently. Id.

251 Telephone Interview with ACR spokesperson (Feb. 1992). One cannot ignore the appeal of mammography as a money-making extension of a physician's practice that would preclude referrals to outside clinics, thereby keeping patients (and their fees) in-house. For example, Dr. Richard Jones, president of the American College of Obstetrics and Gynecology, has reportedly leased mammography equipment for use in his office: “ ‘I say, You need a mammogram. Would you like to have it here today? Compliance has gone to 80 percent.’ The films taken in his office are read by a local radiologist. The total charge is $ 125.” Barringer, supra note 20, at A13. Dr. Jones, whose services are ACR-accredited, did not Report his profit margin.

252 Friedland, supra note 92, at 1.

253 See Boodman, supra note 171, at 10.

254 Id.

255 Id.

256 Id.; Robert Pear, 19 8 8 Standards for Medical Labs Go Unenforced by Administration, N.Y. Times, Mar. 20, 1991, at 1.

257 Boodman, supra note 171, at 10.

258 Id.

259 Id.; see Diane M. Gianelli, Clinical Lab Regulations Issued, Am. Med. News, Mar. 9, 1992, at 1, 57 [hereinafter Gianelli, Clinical Lab Regulations]. These regulations were less stringent than the first set. See Boodman, supra note 171, at 10.

260 “The intent of this law was to regulate the industry vigorously — not to legalize its worst practices, which is what these regulations do.” Boodman, supra note 171, at 10 (quoting Mark Cooper, Director of Research, Consumer Federation of America). “There was a terrible problem with clinical labs and there still is … The substantive situation that caused the enactment of Clia has not changed.” Id. (quoting Rep. John Dingell from Michigan).

261 Gianelli, Gentler Lab Regulations, supra note 173, at 1. Among Hcfa's concessions were a 90-day grace period (until December 1) to allow physicians to register their labs, the continuance of Medicare reimbursement during this period, the elimination of the unannounced inspections requirement, and the designation of the first office lab inspection as “educational,” with no penalties unless violations are egregious. Id.

262 See id. at 15. “Through combined efforts, Hcfa and organized medicine have very successfully managed to weaken it to the point — well, I'm not sure there's anything left to enforce frankly.” Id. (quoting House Energy and Commerce oversight and investigations subcommittee staff member); Letter from Blair M. Eng, Laboratory Advisory Committee, State of Maryland, Wash. Post, Sept. 29, 1992, Health Section, at 4 (“Clia ‘88 regulations muddle along under the federal government's guidance.“).

263 Edwin Chen, Rules for Doctors'Office Labs May Ease, L.A. Times, June 16, 1993, at 20. Overall, quality assurance standards would be “simplified,” but the stringent Pap smear requirements would be retained. Id.

264 Because the Mammography Quality Standards Act will cover facilities receiving Medicare reimbursement, the Medicare standards will no longer control. H.R. 6182, 102d Cong., 2d Sess., at 3, 1992.

265 Mammography Facts, supra note 17, at 5-6.

266 Id.

267 Id. at 6.

268 138 Cong. Rec. S17.240-41 (daily ed. Oct. 7, 1992) (statement of Sen. Adams).

269 Id.

270 42 U.S.C § 263b(c), (e) & (f). The Act does not otherwise specify the agency within the Department of Health and Human Services that will enforce the provisions.

271 Id. § 263b(e)(l)(D).

272 Best, supra note 117, at 1A.

273 Id. Unless Congress changes the October 1994 deadline, all uncertified centers will be forced to close. Id.

274 A previous version of the bill listed the factors that the Secretary had to consider in formulating quality standards. Among them were the ACR standards. S. 1777, 101st Cong., 1st Sess. § 354(f)(2) (1991).

275 42 U.S.C. § 263b(o).

276 Id. §263b(n).

277 McClelland et al„ ACR Mammography Accreditation Program, supra note 24, at 478.

278 S. 1777 Hearings, supra note 17, at 68 (statement of Dr. R. Edward Hendrick, American College of Radiology).

279 S. 1777 Report with Amendment, supra note 1, pt. X, at 28-29 (additional views of Sens. Hatch, Thurmond, Kassebaum, and Cochran).

280 Meyer et al., supra note 90, at 28.

281 Id.; McLelland et al., ACR Mammography Accreditation Program, supra note 24, at 474.

282 42 U.S.C. §263b(a)(3).

283 McClelland et al., ACR Mammography Accreditation Program, supra note 24, at 478.

284 See supra notes 66-78 and accompanying text.

285 McClelland et al., ACR Mammography Accreditation Program, supra note 24, at 478.

286 See supra notes 94, 100-03. The ACR requires that a physician supervising and/or interpreting mammograms meet one of two criteria: completion of at least two months of documented, formal training in reading mammograms with instruction in medical radiation physics, radiation effects, and radiation protection; or certification in diagnostic radiology by the American Board of Radiology or the American Osteopathic Board of Radiology. This physician must also read at least 480 mammograms per year, maintain records containing outcome data for correlations of positive mammograms to biopsies performed and cancers detected, and document a minimum number of Continuing Medical Education Credits in Mammography [40 hours upon initial accreditation and 15 upon re-accreditation]. McClelland et al., ACR Mammography Accreditation Program, supra note 24, at 475.

287 McCellland et al., ACR Mammography Accreditation Program, supra note 24, at 474.

288 “No one knows how much difficulty will be encountered by rural and inner city facilities in meeting the requirements of this Act. Nor do we know, if these facilities were to close, what the effect on access would be for the vulnerable populations that these facilities serve.” S. 1777 Report with Amendment, supra note 1, pt. X, at 28 (additional views of Sens. Hatch, Thurmond, Kassebaum, and Cochran).

289 42 U.S.C. § 263b(c)(2).

290 Id. § 263b(n)(3)(E)-(G).

291 Id. § 263b(n)(3).

292 Id. Delays in the implementation of the Act will likely change this time frame. See supra notes 239, 272-73 and accompanying text.

293 Id. § 263b note.

294 S. 1777 Report with Amendment, supra note 1, pt. X, at 29 (additional views of Sens. Hatch, Thurmond, Kassebaum, and Cochran).

295 138 Cong. Rec. H9104 (daily ed. Sept. 22, 1992) (statement of Rep. Dannemeyer).

296 Unfortunately, the analogy gains some strength when one considers the potential delays and funding concerns that impacted CLIA and that seem to have already beset the Act. See supra notes 239, 272-73 and accompanying text.

297 42 U.S.C. § 263b(m).

298 Id. § 263b(g)(l)(A).

299 Id. §263b(q).

300 McLelland et al., ACR Mammography Accreditation Program, supra note 24, at 476-77.