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Statement of the New York State Radiological Society, Inc

to: New York State Medicaid Evidence Based Benefit Review Advisory Committee Meeting December 15, 2016

The New York State Radiological Society (NYSRS) is the New York State chapter of the American College of Radiology (ACR) and represents 1523 diagnostic radiologist and radiation oncologists practicing in NY state. The NYSRS is committed to reducing breast cancer mortality by optimizing women’s access to effective breast cancer screening. Regular mammography is the mainstay of breast cancer screening, with ample data to support its efficacy in reducing breast cancer deaths [1]. Full‐field digital mammography (FFDM) became widely utilized over the last decade as studies showed its improved accuracy over traditional film‐screen mammography [2].

The NYSRS strongly recommends that the Medical Evidence Based Benefit Review Advisory Committee (EBBRAC) support and recommend Medicaid coverage of Digital Breast Tomosynthesis (DBT).
Digital Breast Tomosynthesis is an application of digital mammography that allows for 3‐dimensional (3D) imaging of the breast. Multiple studies performed over the last three years show that DBT has significant advantages over conventional mammography (FFDM or film‐screen) including improved accuracy, increased cancer detection rates, and a decrease in false positive results. The decrease in false positive rates results in fewer patient recalls for additional testing in women who do not have breast cancer [3‐11]. Thus, DBT has the potential to decrease both breast cancer mortality and the anxiety and costs associated with known limitations of traditional 2‐dimensional (2‐D) mammography,

Conventional mammography produces planar images in which overlapping tissue can result in both patient recalls from false positive studies and in missed cancers from false negative studies. Approximately 10% to 20% of the cases in which a woman must be recalled from screening mammography are due to superimposed normal tissue simulating a lesion [12]. In addition, overlying tissue can obscure cancers, with as many as 20% to 30% of cancers missed by conventional mammography [13, 14). DBT helps address the problem of overlapping tissues in planar FFDM and reduces interpretation inaccuracy.

The largest study to date published in the Journal of the American Medical Association in 2014 [7] which compared 281,187 conventional mammograms to 173,663 DBT exams reported the following statistically significant findings for DBT exams:

  • A 41% increase in the detection of invasive breast cancers.
  • A 29% increase in the detection of all breast cancers.
  • A 15% decrease in women recalled for additional imaging.
  • A 49% increase in positive predictive value for recall.
  • A 21% increase in positive predictive value for biopsy.

A study published online on February 18, 2016 by JAMA Oncology reaffirmed that 3‐D mammography is a better test for breast cancer screening. It found lower recall rates and the detection of more cancers than 2‐D mammograms. The authors of the study said that it is the first longitudinal evidence that the benefits of initial 3‐D mammograms can be sustained and improved over time with consecutive 3‐D mammogram screening [15].

A 2015 study showed that wider adoption of DBT presents an opportunity to deliver value‐based care. The study reported a $28.53 savings per woman screened due to the reduction in the number of women recalled for additional follow‐up imaging and the ability of DBT to facilitate earlier diagnosis at less invasive stages where treatment costs are lower [16].

The US Food & Drug Administration (FDA) approved DBT in 2011 for the same indications as traditional 2‐D mammography including breast cancer screening, diagnosis, and intervention. On August 26, 2014, a second vendor received FDA approval for DBT. Other vendors are expected to apply for approval. In the State of New York there are 111 sites that have implemented DBT.

It is important to note that DBT is not investigational. The term investigational implies that studies have not been performed demonstrating improved performance compared with FFDM. Numerous large‐scale studies of DBT have already demonstrated this benefit.

For all of the above reasons, the NYSRS strongly recommends that this Committee recommend Medicaid coverage of digital breast tomosynthesis.

Thank you for the opportunity to present this information.

  1. Feig, S.A., Current status of screening mammography. Obstet Gynecol Clin North Am, 2002. 29(1): p. 123‐36.
  2. Pisano, E.D., et al., Diagnostic Performance of Digital versus Film Mammography for Breast‐Cancer Screening. New England Journal of Medicine, 2005. 353(17): p. 1773‐1783.
  3. Skaane, P., et al., Comparison of digital mammography alone and digital mammography plus tomosynthesis in a population‐based screening program. Radiology, 2013. 267(1): p. 47‐56.
  4. Ciatto, S., et al., Integration of 3D digital mammography with tomosynthesis for population breast‐cancer screening (STORM): a prospective comparison study. Lancet Oncol, 2013. 14(7): p. 583‐9.
  5. Haas, B.M., et al., Comparison of tomosynthesis plus digital mammography and digital mammography alone for breast cancer screening. Radiology, 2013. 269(3): p. 694‐700.
  6. Rose, S.L., et al., Implementation of breast tomosynthesis in a routine screening practice: an observational study. AJR Am J Roentgenol, 2013. 200(6): p. 1401‐8.
  7. Friedewald, S.M., et al., Breast cancer screening using tomosynthesis in combination with digital mammography. JAMA, 2014. 311(24): p. 2499‐507.
  8. Greenberg, J.S., et al., Clinical performance metrics of 3D digital breast tomosynthesis compared with 2D digital mammography for breast cancer screening in community practice. AJR Am J Roentgenol, 2014. 203(3): p. 687‐93.
  9. Lourenco, A.P., et al., Changes in Recall Type and Patient Treatment Following Implementation of Screening Digital Breast Tomosynthesis. Radiology, 2014: p. 140317.
  10. Lee, C.I., et al., Comparative Effectiveness of Combined Digital Mammography and Tomosynthesis Screening for Women with Dense Breasts. Radiology, 2014: p. 141237.
  11. McCarthy, A.M., et al., Screening outcomes following implementation of digital breast tomosynthesis in a general‐population screening program. J Natl Cancer Ins
  12. Rosenberg R.D., et al., Performance benchmarks for screening mammography. Radiology. 2006 Oct; 241 (1): 55‐66. Erratum in: Radiology. 2014 May: 271(2):620.
  13. Schell MJ et al. Evidence‐based target recall rates for screening mammography. Radiology. June 2007: 243: 681‐689.
  14. Holland R, Mravunac M, Hendriks JH, Bekker BV. So‐called interval cancers of the breast: pathologic and radiologic analysis of sixtyfour cases. Cancer 1982;49(12):2527‐2533.
  15. McDonald, E, et al., Effectiveness of Digital Breast Tomosynthesis Compared With Digital Mammography: Outcomes Analysis From 3 Years of Breast Cancer Screening. JAMA Oncology Online. February 18, 2016.
  16. Bonafede M, et al., Value analysis of digital breast tomosynthesis for breast cancer screening in a commercially‐insured US population. ClincioEconomics and Outcomes Research. 2015: 7 53‐63,
By |2016-12-15T14:46:16+00:00December 15, 2016|News|Comments Off on Statement of the New York State Radiological Society, Inc

MAMMOGRAPHY REGULATIONS

Regulations proposed by Governor Andrew M. Cuomo to require hospitals and extension clinics certified to offer mammography services under the Mammography Quality Standards Act to provide extended hours for mammography services are effective May 18, 2016.

At the request of the New York State Radiological Society, the final rule was amended to: 1) change the term “mammography services” to “screening mammography” to clarify that the requirement does not include diagnostic or other procedures; and 2) eliminate the requirement that the screening hours provided must be consecutive.

The final regulation provides that extended hours must be offered for at least 2 days each week, for at least 2 hours each day offered, for a total of at least 4 hours per week. Appointment times must offered during the following times:

  • * Monday-Friday, between 7 a.m. and 9 a.m. or 5 p.m. and 7 p.m.; or
  • * Saturday or Sunday, between 9 a.m. and 5 p.m.

The regulation includes a waiver provision that would allow a facility to be exempt from the requirements for up to 90 days if it does not have sufficient staff to provide the expanded hours, if the center is in the process of discontinuing mammography services, or such other hardships as the Department of Health (DOH) deems appropriate.

The Department of Health has advised us that if a facility cannot comply with the regulations as of May 18, 2016, that they can apply for a waiver.

By |2016-09-19T14:45:29+00:00September 19, 2016|News|Comments Off on MAMMOGRAPHY REGULATIONS

ACR 2016

ACR The Crossroads of Radiology 2016

 ACR The Crossroads of Radiology 2016ACR The Crossroads of Radiology 2016

Dr. Robert Rapaport accepts the Government Relations Award for our stateDr. Robert Rapaport accepts the Government Relations Award for our state

Capitol Hill Lobby Day with Dr. Litvack, Dr. Surapaneni, Dr. Danahy and Rep. Chris Collins Capitol Hill Lobby Day with Dr. Litvack, Dr. Surapaneni, Dr. Danahy and Rep. Chris Collins

By |2016-08-19T14:42:34+00:00August 19, 2016|News|Comments Off on ACR 2016

NEW YORK STATE COURT OF APPEALS DECISION

NEW YORK STATE COURT OF APPEALS DECISION EXPOSES PHYSICIANS AND OTHER HEALTH CARE PROFESSIONS TO LIABILITY TO NON-PATIENT MEMBERS OF THE GENERAL COMMUNITY

The majority decision in Davis v. South Nassau Communities Hospital must be viewed as alarming to physicians and other health care professions. Physicians who administer or prescribe medication to patients must be prepared to document that they advised the patient of the foreseeable side effects of the medication, and, in particular, if the medication could foreseeably impair the patient’s ability to safely operate an automobile. Physicians must be prepared to document that they advised the patient not to drive while taking the medication.

By |2015-09-19T14:25:09+00:00September 19, 2015|News|Comments Off on NEW YORK STATE COURT OF APPEALS DECISION

ACR 2015: THE CROSSROADS OF RADIOLOGY

 Washington, D.C. May 2015

 Dr. S. Richard Cavoli at Lobby Day on Capitol Hill at Rep. Gibson's officeDr. S. Richard Cavoli at Lobby Day on Capitol Hill at Rep. Gibson’s office

Dr. Jacqueline Bello receives the RADPAC appreciation  award
Dr. Jacqueline Bello receives the RADPAC appreciation award

Gov Relations
Dr. Bonnie Litvack and Dr. S. Richard Cavoli with the ACR Government Relations Award for New York State

By |2015-05-25T13:48:53+00:00May 25, 2015|News|Comments Off on ACR 2015: THE CROSSROADS OF RADIOLOGY

NYSRS Statement on Digital Breast Tomosynthesis

THE NEW YORK STATE RADIOLOGICAL SOCIETY, INC.

A CHAPTER OF THE AMERICAN COLLEGE OF RADIOLOGY
www.nysrs.org

NYSRS Statement on Digital Breast Tomosynthesis

The New York State Radiological Society (NYSRS) is the New York State chapter of the American College of Radiology (ACR) and represents 1523 diagnostic radiologist and radiation oncologists practicing in NY state. The NYSRS is committed to reducing breast cancer mortality by optimizing women’s access to effective breast cancer screening. Regular mammography is the mainstay of breast cancer screening, with ample data to support its efficacy in reducing breast cancer deaths [1]. Full-field digital mammography became widely utilized over the last decade as studies showed its improved accuracy over traditional film-screen mammography [2].

Digital breast tomosynthesis (DBT) is an application of digital mammography that allows for 3-dimensional (3-D) imaging of the breast. Multiple studies performed over the last three years have shown that it has improved accuracy over full-field digital mammography, demonstrating both an increased cancer detection rate and a decrease in false positive results; that is, results that lead to additional testing in women who do not have breast cancer[3-11]. Thus, DBT has the potential to decrease both breast cancer mortality and the anxiety and costs associated with known limitations of traditional 2-dimensional (2-D) mammography.

Widespread availability of DBT will facilitate research assessing long term clinical outcomes and identification of subgroups of women most likely to benefit from the examinations. As with any medical examination, availability is greatly impacted by reimbursement for the service provided. Interoperability among different DBT and Radiology Picture Archiving and Communication System (PACS) vendors is another essential factor for optimizing patient access. In the state of NY, there are currently over 80 sites that have implemented DBT.

The US Food & Drug Administration (FDA) approved DBT in 2011 for the same indications as traditional 2-D mammography including breast cancer screening, diagnosis, and intervention. The Centers for Medicare and Medicaid Services (CMS) recently included payment codes and reimbursement rate values for DBT in its final 2015 Medicare Physician Fee Schedule (MPFS) and Hospital Outpatient Prospective Payment System (HOPPS) and will be covering DBT as of January 1, 2015. Along with the ACR, the NYSRS supports CMS’s decision and strongly urges private insurers to cover beneficiaries for DBT as a medically necessary alternative and supplement to 2-D mammography for screening and diagnosis of breast cancer and to ultimately facilitate women’s access to these important exams.

  1. Feig, S.A., Current status of screening mammography. Obstet Gynecol Clin North Am, 2002. 29(1): p. 123-36.
  2. Pisano, E.D., et al., Diagnostic Performance of Digital versus Film Mammography for Breast-Cancer Screening. New England Journal of Medicine, 2005. 353(17): p. 1773-1783.
  3. Skaane, P., et al., Comparison of digital mammography alone and digital mammography plus tomosynthesis in a population-based screening program. Radiology, 2013. 267(1): p. 47-56.
  4. Ciatto, S., et al., Integration of 3D digital mammography with tomosynthesis for population breast-cancer screening (STORM): a prospective comparison study. Lancet Oncol, 2013. 14(7): p. 583-9.
  5. Haas, B.M., et al., Comparison of tomosynthesis plus digital mammography and digital mammography alone for breast cancer screening. Radiology, 2013. 269(3): p. 694-700.
  6. Rose, S.L., et al., Implementation of breast tomosynthesis in a routine screening practice: an observational study. AJR Am J Roentgenol, 2013. 200(6): p. 1401-8.
  7. Friedewald, S.M., et al., Breast cancer screening using tomosynthesis in combination with digital mammography. JAMA, 2014. 311(24): p. 2499-507.
  8. Greenberg, J.S., et al., Clinical performance metrics of 3D digital breast tomosynthesis compared with 2D digital mammography for breast cancer screening in community practice. AJR Am J Roentgenol, 2014. 203(3): p. 687-93.
  9. Lourenco, A.P., et al., Changes in Recall Type and Patient Treatment Following Implementation of Screening Digital Breast Tomosynthesis. Radiology, 2014: p. 140317.
  10. Lee, C.I., et al., Comparative Effectiveness of Combined Digital Mammography and Tomosynthesis Screening for Women with Dense Breasts. Radiology, 2014: p. 141237.
  11. McCarthy, A.M., et al., Screening outcomes following implementation of digital breast tomosynthesis in a general-population screening program. J Natl Cancer Inst, 2014. 106(11).
By |2014-11-24T13:43:39+00:00November 24, 2014|News|Comments Off on NYSRS Statement on Digital Breast Tomosynthesis

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