external factors impacting the pti fmdilphipractice of ... · external factors impacting the pti...

External Factors Impacting the External Factors Impacting the P ti f M di l Ph iP ti f M di l Ph iPractice of Medical PhysicsPractice of Medical Physics

Lynne Fairobent

Manager of Legislative and Regulatory AffairsAAMP

ACMP - May 24, 2010

Career ExperienceCareer ExperienceCareer ExperienceCareer Experience RegulatoryRegulatory

Nuclear Regulatory Commission Department of Energy

C ltiC lti ConsultingConsulting Science Applications International

Corporation, Inc. Lamb Associates, Inc. Advanced Technology and

L b t i ILaboratories, Inc. The Environmental Company, Inc.

Association/NonAssociation/Non--ProfitProfit Nuclear Energy Institute National Council on Radiation National Council on Radiation

Protections and Measurements American College of Radiology AAPM

Member Advisory Board School Member Advisory Board School of Health Sciences of Health Sciences –– Purdue Purdue UniversityUniversity

•• Member of the Annual Review Member of the Annual Review Team for DOE/NNSA on US medical Team for DOE/NNSA on US medical i t d ti biliti t d ti bilitisotope production capabilityisotope production capability

OutlineOutlineOutlineOutline

The national (and international) focus on The national (and international) focus on medical errors and quality in health caremedical errors and quality in health care

Federal legislative initiativesFederal legislative initiatives

State regulatory changes / legislationState regulatory changes / legislation State regulatory changes / legislationState regulatory changes / legislation

Private insurance companiesPrivate insurance companies

Where do we go from here?Where do we go from here?

The national/international focusThe national/international focusThe national/international focusThe national/international focus

Past 2 decades Past 2 decades focus on medical errors focus on medical errors and healthcare quality (adverse incidents, and healthcare quality (adverse incidents, studies by US and European governmentstudies by US and European governmentstudies by US and European governmentstudies by US and European government--supported groups).supported groups).

R lt i d ith if i thR lt i d ith if i th Result: increased concern with verifying the Result: increased concern with verifying the quality of healthcare delivery and healthcare quality of healthcare delivery and healthcare professionals’ competence.professionals’ competence.p pp p

The Institute of MedicineThe Institute of MedicineThe Institute of MedicineThe Institute of Medicine

In 2000, theIn 2000, the NationalNationalIn 2000, the In 2000, the National National Academy of ScienceAcademy of Science--sponsored Institute of sponsored Institute of Medicine published its Medicine published its first book in a series on first book in a series on h lth lit titl dh lth lit titl dhealthcare quality, titled healthcare quality, titled “To err is human”. “To err is human”.

The Institute of MedicineThe Institute of MedicineThe Institute of MedicineThe Institute of Medicine

Concluded that Concluded that 98,000 patients die each 98,000 patients die each year as a result of medical errors.year as a result of medical errors.

Two key recommendations: Two key recommendations: 1 Standardize procedures1. Standardize procedures2. Regularly validate professional competence.

The Institute of Medicine ReportThe Institute of Medicine ReportThe Institute of Medicine ReportThe Institute of Medicine Report“Recommendation 7.2:“Recommendation 7.2:Performance standards and expectations for health Performance standards and expectations for health

professionals professionals should focus greater attention on should focus greater attention on patient safety.patient safety.

Health professional licensing bodies should:Health professional licensing bodies should:(1) Implement (1) Implement periodic reexamination and relicensing periodic reexamination and relicensing

f d d h k id b df d d h k id b dof doctors, nurses and other key providers, based of doctors, nurses and other key providers, based on both competence and knowledge of safety on both competence and knowledge of safety procedures, and procedures, and

(2) Work (2) Work with certifying and credentialing with certifying and credentialing organizations to develop more effective methods to organizations to develop more effective methods to identify unsafe providers and take action.”identify unsafe providers and take action.”yy

Technology Technology = Safety ??= Safety ??= Safety ??= Safety ??

The IAEAThe IAEAThe IAEAThe IAEA

CanadaCanadaCanadaCanada

Focus on learning Focus on learning from incidents from incidents and and potential incidentspotential incidents ––taxonomy to taxonomy to categorize incidentscategorize incidentscategorize incidents categorize incidents for analysis.for analysis.

Errors & the AAPMErrors & the AAPMErrors & the AAPMErrors & the AAPM

Media InfluenceMedia Influence

Increased media focusIncreased media focusIncreased media focusIncreased 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

Recent NY Times ArticlesRecent NY Times ArticlesRecent NY Times ArticlesRecent NY Times Articles

THEY CHECK THE MEDICAL THEY CHECK THE MEDICAL EQUIPMENT, BUT WHO IS CHECKING UP EQUIPMENT, BUT WHO IS CHECKING UP ON THEM?ON THEM?

L l ti f di l h i i t hLoose regulation of medical physicists has allowed problems to enter a part of the process meant to make health care saferprocess meant to make health care safer. January 27, 2010.


RADIATION THERAPY’S HARMFUL SIDERADIATION THERAPY’S HARMFUL SIDE While radiation therapy has saved countless

lives, the dark side of the treatments is hugely underreported January 27 2010hugely underreported. January 27, 2010.

CASE STUDIES: WHEN MEDICAL RADIATION CASE STUDIES: WHEN MEDICAL RADIATION GOES AWRYGOES AWRY Patients often know little about the harm that

can result when safety rules are violated andcan result when safety rules are violated and ever more powerful and technologically complex machines go awry. January 27, 2010.

Recent NY Times ArticlesRecent NY Times ArticlesRecent NY Times ArticlesRecent NY Times Articles AS TECHNOLOGY SURGES, RADIATION AS TECHNOLOGY SURGES, RADIATION

SAFEGUARDS LAGSAFEGUARDS LAGSAFEGUARDS LAGSAFEGUARDS LAG While new treatments are more accurate, errors

in software and operation are more difficult to detect. January 27, 2010.

MEDICAL GROUP URGES NEW RULES ONMEDICAL GROUP URGES NEW RULES ON MEDICAL GROUP URGES NEW RULES ON MEDICAL GROUP URGES NEW RULES ON RADIATIONRADIATION 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.errors in medical radiation. February 5, 2010.


FDA TO INCREASE OVERSIGHT OF MEDICAL FDA TO INCREASE OVERSIGHT OF MEDICAL RADIATIONRADIATION The agency said it would move to more

stringently regulate the most potent sources,stringently regulate the most potent sources, including CT scans. February 10, 2010.

RADIATION ERRORS REPORTED IN MISSOURIRADIATION ERRORS REPORTED IN MISSOURI RADIATION ERRORS REPORTED IN MISSOURIRADIATION ERRORS REPORTED IN MISSOURI CoxHealth in Springfield, Mo., said 76 patients

over five years were overdosed because ypowerful new equipment had been set up incorrectly. February 25, 2010.

Increased media focusIncreased media focus

St L i T dSt Louis Today:

Rural Missouri

Recent NY Times ArticlesRecent NY Times ArticlesRecent NY Times ArticlesRecent NY Times Articles RADIATION BILLS RAISE QUESTION OF RADIATION BILLS RAISE QUESTION OF

SUPERVISIONSUPERVISIONSUPERVISIONSUPERVISION Officials are investigating billing practices at a

Florida cancer center, a case that points up p poversight concerns. February 26, 2010.

AT HEARING ON RADIATION CALLS FORAT HEARING ON RADIATION CALLS FOR AT HEARING ON RADIATION, CALLS FOR AT HEARING ON RADIATION, CALLS FOR BETTER OVERSIGHTBETTER 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.harm, patients. February 27, 2010.

Congressional FocusCongressional FocusCongressional FocusCongressional Focus

Last summerLast summerLast summerLast summer

Last fallLast fallLast fallLast fall

Congressional focusCongressional focus

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

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

Mike Herman, AAPM PresidentMike Herman, AAPM President

Congressional Hearing TranscriptCongressional Hearing TranscriptCongressional Hearing TranscriptCongressional Hearing Transcript

http://energycommerce.house.gov/index.php?option=comhttp://energycommerce.house.gov/index.php?option=com_content&view=article&id=1910:medical_content&view=article&id=1910:medical--radiationradiation--anan--overviewoverview--ofof--thethe--issues&catid=132:subcommitteeissues&catid=132:subcommittee--onon--health&Itemid=72health&Itemid=72

AAPM StatementAAPM StatementAAPM StatementAAPM Statement In summary, the AAPM believes that patient safety in the In summary, the AAPM believes that patient safety in the

use of medical radiation will be increased through: use of medical radiation will be increased through: consistent education and certification of medical team consistent education and certification of medical team members, whose qualifications are recognized nationally, members, whose qualifications are recognized nationally, and who follow consensus practice guidelines that meet and who follow consensus practice guidelines that meet

t bli h d ti l diti t d d W t lt bli h d ti l diti t d d W t lestablished national accrediting standards. We must also established national accrediting standards. We must also learn from our mistakes by collecting and evaluating them learn from our mistakes by collecting and evaluating them at the national level. AAPM has been working directly and at the national level. AAPM has been working directly and in cooperation with other stakeholders for years on somein cooperation with other stakeholders for years on somein cooperation with other stakeholders for years on some in cooperation with other stakeholders for years on some of these issues and we are saddened that some people of these issues and we are saddened that some people are injured during what should be beneficial procedures. are injured during what should be beneficial procedures. We believe that more effort on all seven areas of focus byWe believe that more effort on all seven areas of focus byWe believe that more effort on all seven areas of focus, by We believe that more effort on all seven areas of focus, by all of us, working cooperatively, will continue to make the all of us, working cooperatively, will continue to make the use of medical radiation safer and more effective for the use of medical radiation safer and more effective for the people that need it.people that need it.p pp p

LegislationLegislation

Why Should You Care?Why Should You Care?Why Should You Care?Why Should You Care?

Regulations and/or Legislation can Regulations and/or Legislation can greatly impact your daygreatly impact your day--toto--day practiceday practice

Dictate what you must do. Dictate what you can bill and how much Dictate what you can bill and how much. Frustrate you when professional judgment

and regulation conflict!!

Legislative InteractionsLegislative InteractionsLegislative InteractionsLegislative Interactions

Federal/StateFederal/State Interacting with Congress or State Legislature

N d t it l i l ti Need to monitor legislation First introduced When in committee On the Floor Write letters urging support of draft

legislationlegislation Know your representatives – both home and

business addresses

Who Can Draft a Bill?Who Can Draft a Bill?Who Can Draft a Bill?Who Can Draft a Bill?

Anyone can draft a piece of legislationAnyone can draft a piece of legislation Members of Congress

I di id l Individuals Special Interest Groups Organizations Associations

Who Can Introduce a Bill?Who Can Introduce a Bill?Who Can Introduce a Bill?Who Can Introduce a Bill?

Only members of Congress can Only members of Congress can introduce legislationintroduce legislation

The member that introduces the bill is The member that introduces the bill is known as the sponsor and all members known as the sponsor and all members that signthat sign--on to the bill are called coon to the bill are called co--sponsorssponsors

The CARE LegislationThe CARE Legislation

Who is the Alliance for QualityWho is the Alliance for QualityMedical Imaging and RadiationMedical Imaging and RadiationTherapy referred to asTherapy referred to asTherapy, referred to asTherapy, referred to as

“The Alliance”?“The Alliance”?

ASRT & the AllianceASRT & the AllianceASRT & the AllianceASRT & the Alliance

In July 1998, the ASRT and the SNM In July 1998, the ASRT and the SNM Technologists Section (SNMTs) recognized Technologists Section (SNMTs) recognized g ( ) gg ( ) gthe importance of collaborating with other the importance of collaborating with other organizations and they founded the Alliance organizations and they founded the Alliance f Q lit di l I i d R di tif Q lit di l I i d R di tifor Quality medical Imaging and Radiation for Quality medical Imaging and Radiation TherapyTherapy

Members of the AllianceMembers of the AllianceMembers of the AllianceMembers of the Alliance American Association of Medical American Association of Medical

AssistantsAssistantsAssistantsAssistants American Association of Medical American Association of Medical

DosimetristsDosimetrists American Association of Physicists in American Association of Physicists in

MedicineMedicine

Joint Review Committee on Education Joint Review Committee on Education in Radiologic Technologyin Radiologic Technology

Joint Review Committee on Education Joint Review Committee on Education Programs in Nuclear Medicine Programs in Nuclear Medicine MedicineMedicine

American College of Medical PhysicsAmerican College of Medical Physics American Registry of Radiologic American Registry of Radiologic

TechnologistsTechnologists American Society of RadiologicAmerican Society of Radiologic

TechnologyTechnology Nuclear Medicine Technology Nuclear Medicine Technology

Certification BoardCertification Board Section for Magnetic Resonance Section for Magnetic Resonance

T h l i t f I t ti l S i tT h l i t f I t ti l S i t American Society of Radiologic American Society of Radiologic TechnologistsTechnologists

Association of Educators in Imaging and Association of Educators in Imaging and Radiologic SciencesRadiologic Sciences

Association of Vascular and Interventional Association of Vascular and Interventional

Technologists of International Society Technologists of International Society of Magnetic Resonance in Medicineof Magnetic Resonance in Medicine

Society of Nuclear MedicineSociety of Nuclear Medicine--Technologist SectionTechnologist Section

Society for Radiation OncologySociety for Radiation OncologyRadiographersRadiographers

Cardiovascular Credentialing InternationalCardiovascular Credentialing International Joint Review Committee on Education in Joint Review Committee on Education in

Cardiovascular TechnologyCardiovascular Technology

Society for Radiation Oncology Society for Radiation Oncology Administrators Administrators

Society for Vascular UltrasoundSociety for Vascular Ultrasound Society of Diagnostic Medical Society of Diagnostic Medical

SonographySonography Joint Review Committee on Education in Joint Review Committee on Education in

Diagnostic Medical SonographyDiagnostic Medical Sonography

SonographySonography Society of Invasive Cardiovascular Society of Invasive Cardiovascular

ProfessionalsProfessionals

Members of the AllianceMembers of the Alliance Consulting Organizations:Consulting Organizations: American College of RadiologyAmerican College of Radiology American Healthcare RadiologyAmerican Healthcare Radiology

Other SupportersOther Supporters American Cancer SocietyAmerican Cancer Society American Heart Association Council American Heart Association Council

on Cardiovascular Radiologyon Cardiovascular Radiology American Healthcare Radiology American Healthcare Radiology AdministratorsAdministrators

American Society for American Society for Therapeutic Radiation and Therapeutic Radiation and

on Cardiovascular Radiologyon Cardiovascular Radiology American Organization of Nurse American Organization of Nurse

ExecutivesExecutives American Osteopathic College of American Osteopathic College of

OncologyOncology Conference of Radiation Conference of Radiation

Control Program DirectorsControl Program Directors

RadiologyRadiology Cancer Research Foundation of Cancer Research Foundation of

AmericaAmerica Help Disabled War Veterans/HelpHelp Disabled War Veterans/Help Help Disabled War Veterans/Help Help Disabled War Veterans/Help

Hospitalized VeteransHospitalized Veterans International Society of International Society of

Radiographers and Radiological Radiographers and Radiological TechnologistsTechnologistsTechnologistsTechnologists

National Coalition of Cancer National Coalition of Cancer SurvivorshipSurvivorship

Medical Imaging Consultants, Inc.Medical Imaging Consultants, Inc. Philips Medical Systems, Inc.Philips Medical Systems, Inc.

CARE BillCARE BillCARE BillCARE Bill

CARE stands for:CARE stands for:

Consistency, Accuracy, Responsibility, and Excellence in Medical Imaging and Radiation Therapy Act of 2010Radiation Therapy Act of 2010

Brief Legislative HistoryBrief Legislative HistoryBrief Legislative HistoryBrief Legislative History

In 2000 a CARE bill was first introduced late in theIn 2000 a CARE bill was first introduced late in the In 2000, a CARE bill was first introduced late in the In 2000, a CARE bill was first introduced late in the 106106thth Congressional year Congressional year by Rep. Rick Lazio (Rby Rep. Rick Lazio (R--NY). NY). The bill died when Congress adjourned.The bill died when Congress adjourned.

A “new” CARE bill was introduced in the House on A “new” CARE bill was introduced in the House on March 13 2001 by Rep Heather Wilson (RMarch 13 2001 by Rep Heather Wilson (R NM)NM) 107107ththMarch 13, 2001 by Rep. Heather Wilson (RMarch 13, 2001 by Rep. Heather Wilson (R--NM) NM) 107107thth

Congressional yearCongressional year. The bill died when Congress . The bill died when Congress adjourned.adjourned.

Brief Legislative History Brief Legislative History ––Th 108Th 108thth CCThe 108The 108thth CongressCongress

J h d t 2004J h d t 2004 108108thth CC Jump ahead to 2004 Jump ahead to 2004 –– 108108thth CongressCongress

House bill had 112 cosponsors House bill had 112 cosponsors 73 Democrats 39 Republicans

New Senate bill had 18 co-sponsors 15 Democrats 2 Republicans 2 Republicans 1 Independent

Bill di d h C dj d!Bill di d h C dj d! Bill died when Congress adjourned!Bill died when Congress adjourned!

Brief Legislative History Brief Legislative History ––TTh 109th CTThe 109th Congress

Bills in both Houses of Congress Bills in both Houses of Congress ––however language is not identicalhowever language is not identicalhowever language is not identicalhowever language is not identical

Passed unanimously in Senate howeverPassed unanimously in Senate however Passed unanimously in Senate however, Passed unanimously in Senate however, no time left in Session to pass the House. no time left in Session to pass the House.

Bill died!!!!!! Bill died!!!!!!


Hit a jurisdiction issue between Senate Health, j ,Education, Labor and Pension (HELP) and Finance committees

Interference from imaging provisions of State State Children's Health Insurance Program (Children's Health Insurance Program (SCHIP)Children s Health Insurance Program (Children s Health Insurance Program (SCHIP) and Medicare Improvements for Patients and Medicare Improvements for Patients and Providers Act (Providers Act (MIPPA)


House introduced H.R. 583House introduced H.R. 583 –– Rep. Doyle [PARep. Doyle [PA--14]14]House introduced H.R. 583 House introduced H.R. 583 Rep. Doyle [PARep. Doyle [PA 14]14] 150 co-sponsors (including sponsor)*

97 Democrats 53 Republicans

Senate introduced S. 1042 Senate introduced S. 1042 –– Sen. Enzi [WY]Sen. Enzi [WY] 26 co-sponsors (including sponsor)*

8 Democrats 8 Democrats 17 Republicans 2 Independents

Both Bills were identical!Both Bills were identical!

(*A f O t b 24 2008)(*As of October 24, 2008)

Challenges to CARE in 110th CongressChallenges to CARE in 110 Congress For the first time challenges were raised by the For the first time challenges were raised by the

E i t f t 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 useinclusion of ultrasound; nurses use ultrasound in the crisis pregnancy centers to verify or check pregnancy statusI f i Infusion nurses

Sonography concerns, coupled with presidential Sonography concerns, coupled with presidential election year politics brought the CARE bill’selection year politics brought the CARE bill’selection year politics brought the CARE bill s election year politics brought the CARE bill s process to a standstill. It DIED!!!!process to a standstill. It DIED!!!!

Current Status Current Status ––Th 111Th 111thth CCThe 111The 111thth CongressCongress

Introduced by Rep. John Barrow, [GAIntroduced by Rep. John Barrow, [GA--12] 12] on September 25, 2009on September 25, 2009R f d t th H W & M dR f d t th H W & M d Referred to the House Ways & Means and Referred to the House Ways & Means and Energy & Commerce committees.Energy & Commerce committees.

Minor adjustments to tie enforcementMinor adjustments to tie enforcement Minor adjustments to tie enforcement Minor adjustments to tie enforcement more closely to Medicare.more closely to Medicare.

Currently has 89 CosponsorsCurrently has 89 Cosponsorsy py p No Senate billNo Senate bill http://www.thomas.gov/cgihttp://www.thomas.gov/cgi--bin/query/z?c111:H.R.3652: bin/query/z?c111:H.R.3652:

A BillA BillTo amend the Public Health Service Act to

make the provision of technical services for pmedical imaging examinations and radiation

therapy treatments safer, more accurate, and less costly and less costly.

CARE ActCARE Act Excludes physicians, physician assistants Excludes physicians, physician assistants

and nurse practionersand nurse practionersand nurse practionersand nurse practioners Does not mandate licensure but does not Does not mandate licensure but does not

preclude licensurepreclude licensurepp Currently Currently excludes excludes Advanced Imaging Advanced Imaging

Modalities covered by MIPPA Modalities covered by MIPPA –– PET, CT, PET, CT, MR N l M di iMR N l M di iMR, Nuclear MedicineMR, Nuclear Medicine

Requires Secretary of HHS to work with Requires Secretary of HHS to work with expert advisers to develop standards (e gexpert advisers to develop standards (e gexpert advisers to develop standards (e.g., expert advisers to develop standards (e.g., regulations)regulations)

The CARE Bill will:The CARE Bill will:The CARE Bill will:The CARE Bill will: Set uniform standards for personnel Set uniform standards for personnel

f i di l i i d di tif i di l i i d di tiperforming medical imaging and radiation performing medical imaging and radiation therapy services paid for by all health therapy services paid for by all health programs under the jurisdiction of HHS.programs under the jurisdiction of HHS.programs under the jurisdiction of HHS.programs under the jurisdiction of HHS.

Direct the Secretary to update federal Direct the Secretary to update federal y py pcertification standards for persons certification standards for persons performing medical imaging, planning and performing medical imaging, planning and delivering radiation therapy treatmentsdelivering radiation therapy treatmentsdelivering radiation therapy treatments.delivering radiation therapy treatments.

The CARE Bill will:The CARE Bill will:The CARE Bill will:The CARE Bill will: Recognize state licensure standards that Recognize state licensure standards that

meet or exceed the federal standardmeet or exceed the federal standardmeet or exceed the federal standard.meet or exceed the federal standard.

Require HHS to examine each state’s Require HHS to examine each state’s qqexisting licensure program to ensure it existing licensure program to ensure it meets the federal standard.meets the federal standard.

Direct HHS to ensure that no later than 3 Direct HHS to ensure that no later than 3 years after the date of enactment of the years after the date of enactment of the l i l ti ll d HHSl i l ti ll d HHSlegislation, all programs under HHS legislation, all programs under HHS jurisdiction adhere to the standards jurisdiction adhere to the standards including payment for medical imaging or including payment for medical imaging or

di ti th ddi ti th dradiation therapy procedures.radiation therapy procedures.

CARE billCARE billCARE billCARE bill

Senate StatusSenate StatusSenate StatusSenate Status

Senators Enzi, [WY] and Harkin [IA] Senators Enzi, [WY] and Harkin [IA] , [ ] [ ], [ ] [ ]poised to introduce bill once more copoised to introduce bill once more co--sponsors are identifiedsponsors are identified

Language is slightly different that H.R. Language is slightly different that H.R. 36523652 R l i f MIPPA Removes exclusion for MIPPA Tightens dates for enactment Discussions with Rep. Barrows, sponsor of

H.R. 3652 indicate he is willing to accept the changes when it comes to the floor of the House for a vote.House for a vote.

MIPPAMIPPA

MIPPAMIPPAMIPPAMIPPA Medicare Improvements for Patients and Medicare Improvements for Patients and

Providers Act of 2008 (Section 1834 of theProviders Act of 2008 (Section 1834 of theProviders Act of 2008 (Section 1834 of the Providers Act of 2008 (Section 1834 of the Social Security Act, (e) (2) (A) Factors for Social Security Act, (e) (2) (A) Factors for Designation of Accreditation Organizations)Designation of Accreditation Organizations) signed into law in July 2008 Requires practice accreditation for the

“advanced imaging” modalities which includesadvanced imaging modalities which includes CT, MR, and Nuclear Medicine.

Does not include x-ray, fluoroscopy, sonography, or anything in radiation oncologyor anything in radiation oncology.

MIPPA [2]MIPPA [2][ ][ ] MIPPA facts:MIPPA facts: Only addressed the big ticket imaging itemsy g g g They only impact 17% of Medicare diagnostic

imaging expenditures Only accredits the facility not the personnel Only accredits the facility, not the personnel

performing the imaging The accrediting body can place requirements on

th t f i i i t b t ththe operators of imaging equipment but these requirements can be very minimal such as completing a manufactures operators coursep g p

Requires Centers for Medicare and Medicaid Services (CMS) to recognize accrediting bodies

Accrediting Bodies Recognized By Accrediting Bodies Recognized By CMS U d MIPPACMS U d MIPPACMS Under MIPPACMS Under MIPPA

American College of RadiologyAmerican College of Radiology IntersocietalIntersocietal Accreditation Commission Accreditation Commission

on Accreditationon Accreditation The Joint CommissionThe Joint Commission The Problem/ConcernThe Problem/Concern All have different requirements for personnel,

AAPM i d i di ti ithAAPM is on record indicating concern with not requiring board certification for medical physicists

A i M di l I tA i M di l I tAmerican Medical Isotopes American Medical Isotopes Production Act of 2010 Production Act of 2010

American Medical Isotopes American Medical Isotopes P d i A f 2010P d i A f 2010Production Act of 2010 Production Act of 2010

•Rep. Edward Markey, [MA-7]•Passed House•Pending in the SenatePending in the Senate

To promote the production ofTo promote the production of molybdenum-99 in the United States for medical isotope production, and to condition and p ,phase out the export of highly enriched uraniumfor the production of medical isotopes.

Increased regulation likely:Increased regulation likely:Increased regulation likely:Increased regulation likely:

Learning from errors:Learning from errors:Learning from errors:Learning from errors:

Most areMost are processprocessMost are Most are process process failuresfailures resulting resulting from inadequate from inadequate SOPs, staffing, SOPs, staffing, resources:resources:

AdvocacyAdvocacy

How to get involved.How to get involved.gg

GrassrootsGrassrootsGrassroots Grassroots Grassroots advocacy means Grassroots advocacy means promotingpromoting

the profession’sthe profession’s interestsinterests and issues byand issues bythe profession’s the profession’s interestsinterests and issues by and issues by communicating with elected officialscommunicating with elected officials or or regulatorsregulators in an effective and efficientin an effective and efficientregulatorsregulators in an effective and efficient in an effective and efficient manner.manner.

Grassroots involvement rarely takes up Grassroots involvement rarely takes up y py pmuch of your time yet a few moments much of your time yet a few moments spent could have a huge impact.spent could have a huge impact.

If you have a phone or if you’ve ever sent If you have a phone or if you’ve ever sent an email, you can be an active part of the an email, you can be an active part of the process.process.

When You’re at HomeWhen You’re at HomeWhen You re at HomeWhen You re at Home

Become active in state and local Become active in state and local affiliate societies.affiliate societies.

Vote in state and local elections.Vote in state and local elections. Keep up to date on state and local Keep up to date on state and local

d t liti l t d id t liti l t d inews and current political trends in news and current political trends in your community.your community.

Serve as a resource for your stateServe as a resource for your state Serve as a resource for your state Serve as a resource for your state and local lawmakers on health care and local lawmakers on health care issuesissuesissues.issues.

When You’re Not on the HillWhen You’re Not on the HillWhen You re Not on the HillWhen You re Not on the Hill

Some of the most effective Some of the most effective lobbyists never step foot in the lobbyists never step foot in the Capitol.Capitol. Volunteer for campaigns. Make yourself a resource Make yourself a resource. Be a “polite pest.” Show and tell.S o a d te Don’t be a “one issue advocate.”

Up On The HillUp On The HillUp On The HillUp On The Hill

Now that I’m here, how do I make Now that I’m here, how do I make them listen?them listen?t e stet e ste Understand your issue – the pros and

the cons. Play the numbers game. Make it personal.

M k “Th A k ” Make “The Ask.” FOLLOW UP! Be honest gracious and courteous Be honest, gracious and courteous.

R l t PR l t PRegulatory ProcessRegulatory Process

Regulatory InteractionsRegulatory InteractionsRegulatory InteractionsRegulatory Interactions Key AgenciesKey Agencies Nuclear Regulatory Commission (NRC) Nuclear Regulatory Commission (NRC) Food and Drug Administration (FDA)

Center for Radiological Devices and Health Center for DrugsCenter 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 Homeland Security (DHS) Department of Transportation (DOT)

The Nuclear Regulatory Commission The Nuclear Regulatory Commission (NRC)(NRC)(NRC)(NRC)

Created by the Energy Reorganization Act of 1974, Created by the Energy Reorganization Act of 1974, recent amendment Energy Policy Act of 2005recent amendment Energy Policy Act of 2005

Exercises authority through licensing regulationsExercises authority through licensing regulations Exercises authority through licensing, regulations, Exercises authority through licensing, regulations, and enforcementand enforcement

Scope of authority includes commercial nuclear Scope of authority includes commercial nuclear l di l d i d i d i ll di l d i d i d i l

p yp ypower plants; medical, academic, and industrial use; power plants; medical, academic, and industrial use; transport, storage, and disposal of radioactive transport, storage, and disposal of radioactive materialmaterial

May relinquish authority over radioactive materials May relinquish authority over radioactive materials to Agreement statesto Agreement states

NRC CommissionersNRC CommissionersNRC CommissionersNRC Commissioners

Chairman Gregory Chairman Gregory JazckoJazckog yg y Sworn In: 1/21/05Term

Ends: 6/30/13

Kristine L. Kristine L. SvinickiSvinicki Sworn In: 3/28/08Term

Ends: 6/30/12

George ApostolakisGeorge Apostolakis George ApostolakisGeorge Apostolakis Sworn In: 4/23/10Term

Ends: 6/30/14

NRC Commissioners ContinuedNRC Commissioners ContinuedNRC Commissioners ContinuedNRC Commissioners Continued

William MagwoodWilliam Magwoodgg Sworn In: 4/01/10 Term

Ends: 6/30/15

William C. OstendorffWilliam C. Ostendorff Sworn In: 4/01/10 Term

Ends: 6/30/11

NRC Web AddressesNRC Web Addresses NRC Medical Uses Toolkit:NRC Medical Uses Toolkit:

http://www.nrc.gov/materials/miau/med-use-toolkit.html

NRC Part 35 Regulation:NRC Part 35 Regulation: http://www.nrc.gov/reading-rm/doc-collections/cfr/part035/

NUREG 1556, Volume 9, Revision 1;NUREG 1556, Volume 9, Revision 1; http://www.nrc.gov/reading-rm/doc-

collections/nuregs/staff/sr1556/v9/#abstract

Specialty Board(s) Certification Recognized by NRC Specialty Board(s) Certification Recognized by NRC Under 10 CFR Part 35Under 10 CFR Part 35 http://www nrc gov/materials/miau/miau reg initiatives/spec board http://www.nrc.gov/materials/miau/miau-reg-initiatives/spec-board-

cert.html

Purpose of the ACMUIPurpose of the ACMUIpp AdvisesAdvises NRC on policy and technical issues NRC on policy and technical issues

that arise in the regulation of that arise in the regulation of the medical the medical uses uses f di ti t i l i di i d thf di ti t i l i di i d th

ggof radioactive material in diagnosis and therapy. of radioactive material in diagnosis and therapy.

EvaluatesEvaluates certain noncertain non--routine uses of routine uses of di i i ldi i i l idid h i lh i lradioactive material; radioactive material; provides provides technical technical

assistance in licensing, inspection, and assistance in licensing, inspection, and enforcement cases; and enforcement cases; and brings brings key issues to key issues to the attention of the Commission for appropriatethe attention of the Commission for appropriatethe attention of the Commission for appropriate the attention of the Commission for appropriate actionaction..

Membership includes health care professionalsMembership includes health care professionals Membership includes health care professionals Membership includes health care professionals from various disciplines who comment on from various disciplines who comment on changes to NRC regulations and guidance.changes to NRC regulations and guidance.

CRCPDCRCPDCRCPDCRCPD Mission is to “promote consistency” in addressing Mission is to “promote consistency” in addressing

and resolving radiation protection issues. Began and resolving radiation protection issues. Began g p gg p gwith the agreement state initiatives in 1959.with the agreement state initiatives in 1959.

19681968 CRCPD established as a nonprofit nonCRCPD established as a nonprofit non 1968 1968 -- CRCPD established as a nonprofit, nonCRCPD established as a nonprofit, non--governmental organizations dedicated to radiation governmental organizations dedicated to radiation protection. Established a forum for states to discuss protection. Established a forum for states to discuss

d t lk b t t t i iti ti d t hd t lk b t t t i iti ti d t hand talk about state initiatives and to share and talk about state initiatives and to share resources.resources.

Is the only association that addresses all radiation Is the only association that addresses all radiation protection issues. Responsible for developing protection issues. Responsible for developing suggested state regulations.suggested state regulations.suggested state regulations.suggested state regulations.

How Regulations Are IntroducedHow Regulations Are IntroducedHow Regulations Are IntroducedHow Regulations Are Introduced

Agency initiatedAgency initiated Advanced Notice of Proposed Rulemaking

P d R l Proposed Rule Final Rule

Petition for RulemakingPetition for Rulemaking Petition for RulemakingPetition for Rulemaking Initiated by member of public Must include all elements of rulemaking

k l t th i iti t d bpackage equal to those initiated by an agency

Developing RegulationsDeveloping RegulationsDeveloping RegulationsDeveloping Regulations

Rule Language

Implementation and Interpretation

R t USAR t USARecent USA Recent USA Today ArticleToday Article

March 17, 2010.

NRC’s Patient Release RuleNRC’s Patient Release RuleNRC s Patient Release RuleNRC s Patient Release Rule

Questions 10 CFR Questions 10 CFR §§ 35.7535.75 In 2005 Peter Crane filed a Petition for In 2005 Peter Crane filed a Petition for

Rulemaking questioning the regulationRulemaking questioning the regulation Most in the medical community Most in the medical community

requested NRC deny the Petitionrequested NRC deny the Petition NRC denied the Petition but this did not NRC denied the Petition but this did not

end Mr. Cane’s concerns end Mr. Cane’s concerns

Rep. MarkeyRep. Markey –– Patient ReleasePatient ReleaseRep. Markey Rep. Markey Patient ReleasePatient Release

State regulationsState regulationsState regulationsState regulations

Professional Licensure or registry.Professional Licensure or registry.

More states are implementing strongMore states are implementing strong More states are implementing strong More states are implementing strong definitions of a QMP, with Board definitions of a QMP, with Board certification the only pathway. certification the only pathway. y p yy p y

CRCPD SSRs incorporate QMP definitionCRCPD SSRs incorporate QMP definition

Licensure & the AAPM/ACMPLicensure & the AAPM/ACMPLicensure & the AAPM/ACMPLicensure & the AAPM/ACMP

Joint subcommittee formed to promoteJoint subcommittee formed to promoteJoint subcommittee formed to promote Joint subcommittee formed to promote minimum practice standards through minimum practice standards through licensure or registration regulations.licensure or registration regulations.

The AAPM Board has approved significant The AAPM Board has approved significant funding to support this effort (new stafffunding to support this effort (new stafffunding to support this effort (new staff funding to support this effort (new staff member, IT support, lobbying).member, IT support, lobbying).

State regulationsState regulationsState regulationsState regulations

LicensureLicensureLicensureLicensure

NY, FL, TX, HI.NY, FL, TX, HI.

NY law:NY law: NY law:NY law:

NY LicensureNY LicensureNY LicensureNY Licensure

1818--month phasemonth phase--in period, then Board in period, then Board certification required.certification required.

RegistrationRegistrationRegistrationRegistration

20 states, with more drafting new regs.20 states, with more drafting new regs.

Many follow ACMP/AAPM QMP definition.Many follow ACMP/AAPM QMP definition.yy

Wide variation in professional standards Wide variation in professional standards and enforcementand enforcementand enforcement and enforcement

MA RegistryMA Registry

CT: Proposed RegistryCT: Proposed Registry

Accreditation: State lawsAccreditation: State laws

Accreditation Accreditation -- Private insurers: Private insurers: BCBS MABCBS MABCBS MABCBS MA

The ABR through MOC:The ABR through MOC:The ABR, through MOC:The ABR, through MOC:

TGTG--127 is working with the ABR to 127 is working with the ABR to ggimplement a peer reviewimplement a peer review--based system to based system to satisfy the PQI requirement.satisfy the PQI requirement.

Task Group 11 Task Group 11 –– standards for solo standards for solo practice physicists inpractice physicists in RadOncRadOncpractice physicists in practice physicists in RadOncRadOnc

In 2003, In 2003, d dd drecommended recommended

peer review, peer review, practice practice ppaccreditation, accreditation, and standardized and standardized proceduresproceduresprocedures.procedures.

Task Group 103 Task Group 103 –– peer reviewpeer reviewpp pp

In 2005, In 2005, d dd drecommended a recommended a

specific process specific process for peer review, for peer review, ppprovided tools provided tools for reviewers to for reviewers to ensure efficientensure efficientensure efficient ensure efficient use of time & use of time & consistent consistent

iireviews.reviews.

TG 103 recommendationsTG 103 recommendations

Regular review by an outside QMPRegular review by an outside QMP

Review includes onReview includes on--site visit and written site visit and written reportreport

Major components:Major components: Independent output verification Independent output verification Chart audit using a template QA/QC program and documentation (standard

procedures for calibrations dose calcs)procedures for calibrations, dose calcs) Is physics coverage sufficient for services

provided? Continued professional development & new

technologies

TG 103 documentsTG 103 documents

Path forward?Path forward?

Minimum standards for practicing clinical Minimum standards for practicing clinical medical physics will likely have the force ofmedical physics will likely have the force ofmedical physics will likely have the force of medical physics will likely have the force of regulation in most states within a decade.regulation in most states within a decade.

Major components:Major components: Major components:Major components: Minimum education & training requirements Board certification Board certification Peer review at regular intervals Continuing professional development (MOC)

Error prevention programs will gain more Error prevention programs will gain more prominence.prominence.

How do we respond?How do we respond? If If wewe ((AAPM/ACMP) AAPM/ACMP) do not define our do not define our

profession, others will do it for us.profession, others will do it for us.

Current efforts:Current efforts: Licensure / registration with strong template Licensure / registration with strong template ASTRO/ACR/IAC/TJC – strong accreditation Develop Minimum Practice Standards Develop Minimum Practice Standards Work with CRCPD (SSRs) & FDA (devices) Congress: Congress:

CARE bill for Training & Education standards Tie Medicare funding to accreditation

Part 37Part 37 Intent to move orders into regulationIntent to move orders into regulation

Proposed rule to be issued midProposed rule to be issued mid June 2010June 2010 Proposed rule to be issued midProposed rule to be issued mid--June 2010June 2010

120120--day Comment Periodday Comment Period

Need input from members currently under Need input from members currently under orders orders –– HDR and Gamma Knife licensesHDR and Gamma Knife licenses

Review against current order Review against current order

Table 1 – Radionuclides of Concern1. The aggregate activity of multiple,

Radionuclide Cat 2 (TBq) 1 Cat 2 (Ci) 2Am 241 0 6 16

gg g y p ,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 Am-241 0.6 16

Am -241/BE 0.6 16Cf-252 0.2 5.4Co-60 0.3 8.1C 244 0 5 14

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

Cm-244 0.5 14Cs-137 1 27Gd-153 10 270Ir-192 0.8 22P 238 0 6 16

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 Pu-238 0.6 16Pu-239/BE 0.6 16Pm-147 400 11,000Ra-226 0.4 11

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 h i f di lid A(i ) Se-75 2 54

Sr-90 (Y-90) 10 270Tm-170 200 5,400Yb-169 3 81

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 source activity for Combinations of radioactive materials listed above3

See footnote 4[( gg g y

radionuclide A) ÷ (quantity of concern for radionuclide A)] + [(aggregated source

activity for radionuclide B) ÷ (quantity of concern for radionuclide B)] + etc..... ≥1.

Good Practice? Or how to get to know your Good Practice? Or how to get to know your local FBI or Homeland Security Agent!!!!!local FBI or Homeland Security Agent!!!!!

We have a CsWe have a Cs--137 brachytherapy sealed137 brachytherapy sealedWe have a CsWe have a Cs 137 brachytherapy sealed 137 brachytherapy sealed source '3M' type sources that we no source '3M' type sources that we no longer use and would like to find a new longer use and would like to find a new h f thh f th Th 22 iTh 22 ihome for them.home for them. There are 22 sources in There are 22 sources in the current inventory ranging in activity the current inventory ranging in activity from 9.1 to 33.7 mgfrom 9.1 to 33.7 mg--RaRa--eq. There is a eq. There is a storage safe, 'Lstorage safe, 'L--Block', wheeled transport Block', wheeled transport pig and sturdy wheeled steel work table in pig and sturdy wheeled steel work table in the package.the package.the package.the package.If you are interested please contact me at . If you are interested please contact me at . . . . !!!!!. . . !!!!!

*From the medical physics list serve *From the medical physics list serve –– 9/13/079/13/07

Good Practice? Or how to get to know your Good Practice? Or how to get to know your l l FBI H l d S it A t!!!!!l l FBI H l d S it A t!!!!!local FBI or Homeland Security Agent!!!!!local FBI or Homeland Security Agent!!!!! We have Cesium 137 for LDR We have Cesium 137 for LDR

Brachytherapy procedures that we Brachytherapy procedures that we no longer do. If anyone is no longer do. If anyone is interested in the Cesium pleaseinterested in the Cesium pleaseinterested in the Cesium please interested in the Cesium please respond to this post. respond to this post. If you are interested please contact If you are interested please contact y py p

me at . . . . !!!!!me at . . . . !!!!!*From the medical physics list serve *From the medical physics list serve ––9/25/079/25/07

Questions????????Questions????????

external factors impacting the pti fmdilphipractice of ... · external factors impacting the pti...

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