Lynne Fairobent. Manager of Legislative and Regulatory Affairs AAMP. ACMP - May 24, 2010

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1 External Factors Impacting the Practice of Medical Physics Lynne Fairobent Manager of Legislative and Regulatory Affairs AAMP ACMP - May 24, 2010

2 Regulatory Nuclear Regulatory Commission Department of Energy Consulting Career Experience Science Applications International Corporation, Inc. Lamb Associates, Inc. Advanced Technology and Laboratories, Inc. The Environmental Company, Inc. Association/Non-Profit Nuclear Energy Institute National Council on Radiation Protections and Measurements American College of Radiology AAPM Member Advisory Board School of Health Sciences Purdue University Member of the Annual Review Team for DOE/NNSA on US medical isotope production capability

3 Outline The national (and international) focus on medical errors and quality in health care Federal legislative initiatives State regulatory changes / legislation Private insurance companies Where do we go from here?

4 The national/international focus Past 2 decades focus on medical errors and healthcare quality (adverse incidents, studies by US and European government- supported groups). Result: increased concern with verifying i the quality of healthcare delivery and healthcare professionals competence.

5 The Institute of Medicine In 2000, the National Academy of Science- sponsored Institute of Medicine published its first book in a series on healthcare quality, titled To err is human.

6 The Institute of Medicine Concluded that 98,000 patients die each year as a result of medical errors. Two key recommendations: 1. Standardize procedures 2. Regularly validate professional competence.

7 The Institute of Medicine Report Recommendation 7.2: Performance standards and expectations for health professionals should focus greater attention on patient safety. Health professional licensing bodies should: (1) Implement periodic reexamination and relicensing of fd doctors, nurses and other key providers, based on both competence and knowledge of safety procedures, and (2) Work with certifying and credentialing organizations to develop more effective methods to identify unsafe providers and take action.

8 Technology = Safety??

9 The IAEA

10 Canada Focus on learning from incidents and potential incidents taxonomy to categorize incidents for analysis.

11 Errors & the AAPM

12 Media Influence

15 Increased media focus While new technology saves While new technology saves the lives of countless cancer patients, errors can lead to unspeakable pain and death. January 24, 2010

16 Recent NY Times Articles THEY CHECK THE MEDICAL EQUIPMENT, BUT WHO IS CHECKING UP ON THEM? Loose regulation of medical physicists i has allowed problems to enter a part of the process meant to make health care safer. January 27, 2010.

17 Recent NY Times Articles RADIATION THERAPY S HARMFUL SIDE While radiation therapy has saved countless lives, the dark side of the treatments is hugely underreported. January 27, CASE STUDIES: WHEN MEDICAL RADIATION GOES AWRY Patients often know little about the harm that can result when safety rules are violated and ever more powerful and technologically complex machines go awry. January 27, 2010.

18 Recent NY Times Articles AS TECHNOLOGY SURGES, RADIATION SAFEGUARDS LAG While new treatments are more accurate, errors in software and operation are more difficult to detect. January 27, MEDICAL GROUP URGES NEW RULES ON RADIATION The American Society for Radiation Oncology issued a six-point plan that it said would improve safety and quality and reduce the chances of errors in medical radiation. February 5, 2010.

19 Recent NY Times Articles FDA TO INCREASE OVERSIGHT OF MEDICAL RADIATION The agency said it would move to more stringently regulate the most potent sources, including CT scans. February 10, RADIATION ERRORS REPORTED IN MISSOURI CoxHealth in Springfield, Mo., said 76 patients over five years were overdosed because powerful new equipment had been set up incorrectly. February 25, 2010.

20 Increased media focus St Louis Today: Rural Missouri

21 Recent NY Times Articles RADIATION BILLS RAISE QUESTION OF SUPERVISION Officials are investigating billing practices at a Florida cancer center, a case that points up oversight concerns. February 26, AT HEARING ON RADIATION, CALLS FOR BETTER OVERSIGHT A dozen witnesses told a House subcommittee that more needed to be done to assure that radiation continues to help, not harm, patients. February 27, 2010.

22 Congressional Focus

23 Last summer

24 Last fall

25 Congressional focus

AAPM Testifies Before Congress As many of you know, there have been a number of

This combined with the recent publicity on CT perfusion dose problems has

guide direction for improving patient safety in the medical use of radiation.

26 AAPM Testifies Before Congress As many of you know, there have been a number of recent articles in the press related to tragic errors in radiation therapy. This combined with the recent publicity on CT perfusion dose problems has prompted Congress to call a hearing entitled "Medical Radiation: an Overview of the Issues". AAPM, along with ASTRO, ACR, ASRT and MITA have been asked to testify to help guide direction for improving patient safety in the medical use of radiation. We sincerely believe that working together with all stakeholders that we can improve safety and quality in the medical use of radiation. Mike Herman, AAPM President

27 Congressional Hearing Transcript _content&view=article&id=1910:medical-radiation-an- overview-of-the-issues&catid=132:subcommittee-on- health&itemid=72

28 AAPM Statement In summary, the AAPM believes that patient safety in the use of medical radiation will be increased through: consistent education and certification of medical team members, whose qualifications are recognized nationally, and who follow consensus practice guidelines that meet established national accrediting standards. d We must also learn from our mistakes by collecting and evaluating them at the national level. AAPM has been working directly and in cooperation with other stakeholders for years on some of these issues and we are saddened that some people are injured during what should be beneficial procedures. We believe that more effort on all seven areas of focus, by all of us, working cooperatively, will continue to make the use of medical radiation safer and more effective for the people p that need it.

29 Legislation

30 Why Should You Care? Regulations and/or Legislation can greatly impact your day-to-day practice Dictate what you must do. Dictate what you can bill and how much. Frustrate you when professional judgment and regulation conflict!!

31 Legislative Interactions Federal/State Interacting with Congress or State Legislature Need to monitor legislation l First introduced When in committee On the Floor Write letters urging support of draft legislation Know your representatives both home and business addresses

32 Who Can Draft a Bill? Anyone can draft a piece of legislation Members of Congress Individuals id Special Interest Groups Organizations Associations

33 Who Can Introduce a Bill? Only members of Congress can introduce legislation The member that introduces the bill is known as the sponsor and all members that sign-on to the bill are called co- sponsors

34 The CARE Legislation

35 Who is the Alliance for Quality Medical Imaging and Radiation Therapy, referred to as The Alliance?

36 ASRT & the Alliance In July 1998, the ASRT and the SNM Technologists Section (SNMTs) recognized the importance of collaborating with other organizations and they founded the Alliance for Quality medical Imaging and Radiation Therapy

37 Members of the Alliance American Association of Medical Assistants American Association of Medical Dosimetrists American Association of Physicists in Medicine American College of Medical Physics American Registry of Radiologic Technologists American Society of Radiologic Technologists Association of Educators in Imaging and Radiologic Sciences Association of Vascular and Interventional Radiographers Cardiovascular Credentialing International Joint Review Committee on Education in Cardiovascular Technology Joint Review Committee on Education in Diagnostic Medical Sonography Joint Review Committee on Education in Radiologic Technology Joint Review Committee on Education Programs in Nuclear Medicine Technology Nuclear Medicine Technology Certification Board Section for Magnetic Resonance Technologists of International ti Society of Magnetic Resonance in Medicine Society of Nuclear Medicine- Technologist Section Society for Radiation Oncology Administrators Society for Vascular Ultrasound Society of Diagnostic Medical Sonography Society of Invasive Cardiovascular Professionals

38 Members of the Alliance Consulting Organizations: American College of Radiology American Healthcare Radiology Administrators American Society for Therapeutic Radiation and Oncology Conference of Radiation Control Program Directors Other Supporters American Cancer Society American Heart Association Council on Cardiovascular Radiology American Organization of Nurse Executives American Osteopathic College of Radiology Cancer Research Foundation of America Help Disabled War Veterans/Help Hospitalized Veterans International Society of Radiographers and Radiological Technologists National Coalition of Cancer Survivorship Medical Imaging Consultants, Inc. Philips Medical Systems, Inc.

39 CARE Bill CARE stands for: Consistency, Accuracy, Responsibility, and Excellence in Medical Imaging and Radiation Therapy Act of 2010

40 Brief Legislative History In 2000, a CARE bill was first introduced late in the 106 th Congressional year by Rep. Rick Lazio (R-NY). The bill died when Congress adjourned. A new CARE bill was introduced in the House on March 13, 2001 by Rep. Heather Wilson (R-NM) 107 th Congressional year. The bill died when Congress adjourned.

41 Brief Legislative History The 108 th Congress Jump ahead to th Congress House bill had 112 cosponsors 73 Democrats 39 Republicans New Senate bill had 18 co-sponsors 15 Democrats 2 Republicans 1 Independent Bill died d when Congress adjourned! d!

42 Brief Legislative History The 109 th Congress Bills in both Houses of Congress however language is not identical Passed unanimously in Senate however, no time left in Session to pass the House. Bill died!!!!!!

43 Brief Legislative History The 110 th Congress Hit a jurisdiction issue between Senate Health, Education, Labor and Pension (HELP) and Finance committees Interference from imaging provisions of State Children's Health Insurance Program (SCHIP) and Medicare Improvements for Patients and Providers Act (MIPPA)

44 Brief Legislative History The 110 th Congress House introduced H.R. 583 Rep. Doyle [PA-14] 150 co-sponsors (including sponsor)* 97 Democrats 53 Republicans Senate introduced S Sen. Enzi [WY] 26 co-sponsors (including sponsor)* 8Democrats 17 Republicans 2 Independents Both Bills were identical! (*As of October 24, 2008)

45 Challenges to CARE in 110 th Congress For the first time challenges were raised by the Equipment manufacturers OB/GYN and ophthalmology organizations since ultrasound was included in the draft legislation for the first time Crisis pregnancy centers again due to the inclusion of ultrasound; nurses use ultrasound in the crisis pregnancy centers to verify or check pregnancy status Infusion nurses Sonography concerns, coupled with presidential election year politics brought the CARE bill s process to a standstill. It DIED!!!!

46 Current Status The 111 th Congress Introduced by Rep. John Barrow, [GA-12] on September 25, 2009 Referred dt to the House Ways &M Means and Energy & Commerce committees. Minor adjustments to tie enforcement more closely to Medicare. Currently has 89 Cosponsors No Senate bill

47 A Bill To amend the Public Health Service Act to make the provision of technical services for medical imaging examinations and radiation therapy treatments safer, more accurate, and less costly.

48 CARE Act Excludes physicians, physician assistants and nurse practioners Does not mandate licensure but does not preclude licensure Currently excludes Advanced Imaging Modalities covered by MIPPA PET, CT, MR, Nuclear Medicine i Requires Secretary of HHS to work with expert advisers to develop standards (e.g., regulations)

49 The CARE Bill will: Set uniform standards for personnel performing medical imaging i and radiation therapy services paid for by all health programs under the jurisdiction of HHS. Direct the Secretary to update federal certification standards for persons performing medical imaging, planning and delivering radiation therapy treatments.

50 The CARE Bill will: Recognize state licensure standards that meet or exceed the federal standard. Require HHS to examine each state s existing licensure program to ensure it meets the federal standard. Direct HHS to ensure that no later than 3 years after the date of enactment of the legislation, l all programs under HHS jurisdiction adhere to the standards including payment for medical imaging or radiation therapy procedures.

51 CARE bill

52 Senate Status Senators Enzi,,[ [WY] and Harkin [IA] poised to introduce bill once more co- sponsors are identified Language is slightly different that H.R Removes exclusion for MIPPA Tightens dates for enactment Discussions with Rep. Barrows, sponsor of H.R indicate he is willing to accept the changes when it comes to the floor of the House for a vote.

53 MIPPA

54 MIPPA Medicare Improvements for Patients and Providers Act of 2008 (Section 1834 of the Social Security Act, (e) (2) (A) Factors for Designation of Accreditation Organizations) signed into law in July 2008 Requires practice accreditation for the advanced imaging modalities which includes CT, MR, and Nuclear Medicine. Does not include x-ray, fluoroscopy, sonography, or anything in radiation oncology.

55 MIPPA facts: MIPPA [2] Only addressed the big ticket imaging g items They only impact 17% of Medicare diagnostic imaging expenditures Only accredits the facility, not the personnel performing the imaging The accrediting body can place requirements on the operators of imaging i equipment but these requirements can be very minimal such as completing a manufactures operators course Requires Centers for Medicare and Medicaid Services (CMS) to recognize accrediting bodies

56 Accrediting Bodies Recognized By CMS Under MIPPA American College of Radiology Intersocietal Accreditation Commission on Accreditation The Joint Commission The Problem/Concern All have different requirements for personnel, AAPM is on record indicating concern with not requiring board certification for medical physicists

57 American Medical Isotopes Production Act of 2010

58 American Medical Isotopes Production Act of 2010 Rep. Edward Markey, [MA-7] Passed House Pending in the Senate To promote the production of molybdenum-99 in the United States for medical isotope production, and to condition and phase out the export of highly enriched uranium for the production of medical isotopes.

59 Increased regulation likely:

60 Learning from errors: Most are process failures resulting from inadequate SOPs, staffing, resources:

61 Advocacy How to get involved.

62 Grassroots Grassroots advocacy means promoting the profession s interests and issues by communicating with elected officials or regulators in an effective and efficient manner. Grassroots involvement rarely takes up much of your time yet a few moments spent could have a huge impact. If you have a phone or if you ve ever sent an , you can be an active part of the process.

63 When You re at Home Become active in state and local affiliate societies. Vote in state and local elections. Keep up to date on state and local news and current political l trends in your community. Serve as a resource for your state and local lawmakers on health care issues.

64 When You re Not on the Hill Some of the most effective lobbyists never step foot in the Capitol. Volunteer for campaigns. Make yourself a resource. Be a polite pest. Show and tell. Don t be a one issue advocate.

65 Up On The Hill Now that I m here, how do I make them listen? Understand your issue the pros and the cons. Play the numbers game. Make it personal. Make The Ask. FOLLOW UP! Be honest, gracious and courteous.

66 Regulatory Process

67 Key Agencies Regulatory Interactions Nuclear Regulatory Commission (NRC) Food and Drug Administration (FDA) Center for Radiological Devices and Health Center for Drugs Health and Human Services National Institutes of Health National Cancer Institute National Institute for Biomedical Imaging and Bioengineering Centers for Medicare and Medicaid Services (CMS) Department of Homeland Security (DHS) Department of Transportation (DOT)

68 The Nuclear Regulatory Commission (NRC) Created by the Energy Reorganization Act of 1974, recent amendment Energy Policy Act of 2005 Exercises authority through licensing, regulations, and enforcement Scope of authority includes commercial nuclear power plants; medical, academic, and industrial i use; transport, storage, and disposal of radioactive material May relinquish authority over radioactive materials to Agreement states

69 NRC Commissioners Chairman Gregory Jazcko Sworn In: 1/21/05 Term Ends: 6/30/13 Kristine L. Svinicki Sworn In: 3/28/08 Term Ends: 6/30/12 George Apostolakis Sworn In: 4/23/10 Term Ends: 6/30/14

70 NRC Commissioners Continued William Magwood Sworn In: 4/01/10 Term Ends: 6/30/15 William C. Ostendorff William C. Ostendorff Sworn In: 4/01/10 Term Ends: 6/30/11

71 NRC Web Addresses NRC Medical Uses Toolkit: NRC Part 35 Regulation: NUREG 1556, Volume 9, Revision 1; Specialty Board(s) Certification Recognized by NRC Under 10 CFR Part 35 reg initiatives/spec cert.html

72 Purpose of the ACMUI Advises NRC on policy and technical issues that arise in the regulation of the medical uses of radioactive material in diagnosis i and therapy. Evaluates certain non-routine uses of radioactive i material; provides technical assistance in licensing, inspection, and enforcement cases; and brings key issues to the attention of the Commission for appropriate action. Membership includes health care professionals from various disciplines who comment on changes to NRC regulations and guidance.

73 CRCPD Mission is to promote consistency in addressing and resolving radiation protection issues. Began with the agreement state initiatives in CRCPD established as a nonprofit, non- governmental organizations dedicated to radiation protection. Established a forum for states to discuss and talk about state t initiatives iti and to share resources. Is the only association that addresses all radiation protection issues. Responsible for developing suggested state regulations.

74 How Regulations Are Introduced Agency initiated Advanced Notice of Proposed Rulemaking Proposed Rule Final Rule Petition for Rulemaking Initiated by member of public Must include all elements of rulemaking package equal to those initiated iti t by an agency

75 Developing Regulations Rule Language Implementation and Interpretation

76 Recent USA Today Article March 17, 2010.

77 NRC s Patient Release Rule Questions 10 CFR In 2005 Peter Crane filed a Petition for Rulemaking questioning the regulation Most in the medical community requested NRC deny the Petition NRC denied the Petition but this did not end Mr. Cane s concerns

78 Rep. Markey Patient Release

79 State regulations Professional Licensure or registry. More states are implementing strong definitions of a QMP, with Board certification the only yp pathway. CRCPD SSRs incorporate QMP definition

80 Licensure & the AAPM/ACMP Joint subcommittee formed to promote minimum practice standards through licensure or registration regulations. The AAPM Board has approved significant funding to support this effort (new staff member, IT support, lobbying).

81 State regulations

82 Licensure NY, FL, TX, HI. NY law:

83 NY Licensure 18-month phase-in period, then Board certification required.

84 Registration 20 states, with more drafting new regs. Many follow ACMP/AAPM QMP definition. Wide variation in professional standards and enforcement

85 MA Registry

86 CT: Proposed Registry

87 Accreditation: State laws

88 Accreditation - Private insurers: BCBS MA

89 The ABR, through MOC: TG-127 is working with the ABR to implement a peer review-based system to satisfy the PQI requirement.

90 Task Group 11 standards for solo practice physicists in RadOnc In 2003, recommended d peer review, practice accreditation, and standardized procedures.

91 Task Group 103 peer review In 2005, recommended d a specific process for peer review, provided tools for reviewers to ensure efficient use of time & consistent reviews.

92 TG 103 recommendations Regular review by an outside QMP Review includes on-site visit and written report Major components: Independent output verification Chart audit using a template QA/QC program and documentation (standard procedures for calibrations, dose calcs) Is physics coverage sufficient for services provided? Continued professional development & new technologies

93 TG 103 documents

94 Path forward? Minimum standards for practicing clinical medical physics will likely have the force of regulation in most states within a decade. Major components: Minimum education & training requirements Board certification Peer review at regular intervals Continuing professional development (MOC) Error prevention programs will gain more prominence.

95 How do we respond? If we (AAPM/ACMP) do not define our profession, others will do it for us. Current efforts: Licensure / registration with strong template ASTRO/ACR/IAC/TJC strong accreditation Develop Minimum Practice Standards Work with CRCPD (SSRs) & FDA (devices) Congress: CARE bill for Training & Education standards Tie Medicare funding to accreditation

96 Part 37 Intent to move orders into regulation Proposed rule to be issued mid-june day Comment Period Need input from members currently under orders HDR and Gamma Knife licenses Review against current order

97 Table 1 Radionuclides of Concern Radionuclide Cat 2 (TBq) 1 Cat 2 (Ci) 2 Am Am -241/BE Cf Co Cm Cs Gd Ir Pu Pu-239/BE Pm ,000 Ra Se Sr-90 (Y-90) Tm ,400 Yb Combinations of See footnote 4 radioactive materials listed above 3 1. The aggregate g activity of multiple, collocated sources of the same radionuclide should be included when the total activity equals or exceeds the quantity of concern. 2. The primary values used for compliance with this Order are TBq. The curie (Ci) values are rounded to two significant figures for informational purposes only. 3. Radioactive materials are to be considered aggregated or collocated if breaching a common physical security barrier (e.g., a locked door at the entrance to a storage room) would allow access to the radioactive material or devices containing the radioactive material. 4. f several radionuclides are aggregated, the sum of the ratios of the activity of each source, i of radionuclide, n, A(i,n), to the quantity of concern for radionuclide n, Q(n), listed for that radionuclide equals or exceeds one. [(aggregated g source activity for radionuclide A) (quantity of concern for radionuclide A)] + [(aggregated source activity for radionuclide B) (quantity of concern for radionuclide B)] + etc... 1.

98 Good Practice? Or how to get to know your local FBI or Homeland Security Agent!!!!! We have a Cs-137 brachytherapy sealed source '3M' type sources that we no longer use and would like to find a new home for them. There are 22 sources in the current inventory ranging in activity from 9.1 to 33.7 mg-ra Ra-eq. There is a storage safe, 'L-Block', wheeled transport pig and sturdy wheeled steel work table in the package. If you are interested please contact me at....!!!!! *From the medical physics list serve 9/13/07

Good Practice? Or how to get to know your local l FBI or Homeland Security Agent!!!!! We have Cesium 137 for LDR Brachytherapy procedures that we no longer do.

99 Good Practice? Or how to get to know your local l FBI or Homeland Security Agent!!!!! We have Cesium 137 for LDR Brachytherapy procedures that we no longer do. If anyone is interested in the Cesium please respond to this post. If you are interested please contact me at....!!!!! *From the medical physics list serve 9/25/07

100 Questions????????

Toward Minimum Practice Standards in Clinical Medical Physics:

Toward Minimum Practice Standards in Clinical Medical Physics: Response to an increasing focus on reducing medical errors and validating professional competence Per Halvorsen, MS, DABR, FACR, FAAPM October