The Importance of

Advocacy to the Nuclear

Medicine Professional

Lynne Roy

Director, Imaging

Cedars Sinai Medical Center

PSWTC Spring Meeting, April 2016.

Objectives

To understand the current environment

that effect the nuclear medicine

profession

To learn about the Health Policy and

Regulatory Affairs Committee

To understand the importance of

involvement in advocacy

Discussion Topics

Education, Credentialing, Scope of

Practice and Actual Practice of NMTs

Reimbursement Pressures

Radiopharmaceutical Pressures

Radiopharmaceutical Availability

To learn about the SNMMI’s Health Policy

and Regulatory Affairs Department

Understand that you can make a difference

So, You want to Be a Nuclear

Medicine Technologist

NMT Scope of Practice

Patients: care, contact, and monitoring

Radiopharmaceuticals: procurement, preparation, QC,

dispensing, dose calibration, administration, and

disposing

Adjunctive Pharmaceuticals: oral, iv, contrast

administration

Procedures: scanners, laboratory equipment, computers

Under Direction of an Authorized User

includes but is not limited to:

Educational Requirements for CNMTs

Certificate

High School graduate

College graduate

Assorted degrees (BS, BA)

Other related certificates (RT,RN)

Associate Degree

SNMMI: Baccalaureate Degree 2015

Educational/Program Certification

JRCNMT

• Establishes Essential Curriculum

• Added CT in 2010

• Considering MR

• Surveys and accredits programs

Has not mandated BS program as the minimum

With added essentials many AA programs take 4

years to complete full time

Nuclear Medicine Technologist

Certification

NMTCB Certifies Entry Level NMTS Offers advanced Cardiac, CT, and PET certifications

OJT recognized until 2016: Now accredited Program

ARRT certifies entry level NMTs Allows CNMTs to sit for ARRT (CT) and ARRT (MR)

Graduate of accredited program

Minimum AA

State Licensing BoardsNuclear Medicine (35 States)

Arizona Arkansas California

Colorado Connecticut Delaware

Florida Georgia Hawaii

Illinois Indiana Iowa

Kansas Kentucky Louisiana

Maine Maryland Massachusetts

Mississippi New Jersey New Mexico

New York North Dakota Ohio

Oregon Pennsylvania Rhode Island

South Carolina Texas Utah

Vermont Virginia Washington

West Virginia Wyoming

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Nuclear Medicine Technologists

Multiple educational pathways

Multiple Standards

Multiple State/National licensure (if any)

Multiple Professional Associations

U.S. Department of Labor: Trade or “paraprofessional”

◦ “You have muddied the waters”

◦ Multiple educational pathways

Multiple standards

State/National Licensure not required

Erosion of NMT Scope of

Practice

Scope of Practice in Reality Patients: Monitoring? Care?

◦ RN

Radiopharmaceuticals: Preparation? Dispensing?

◦ Direct challenges by regulators

◦ Indirect due to fiscal realities of USP 797

Adjunctive Meds: ??? administer

◦ RN

◦ Hospitals Rules and Regulations

Procedures: More and more fusion equipment

◦ States licensing laws or lack there-of

Continuous Decrease in Reimbursement

Medical Imaging Target

for Decreased Reimbursement

• Prior authorization

• Appropriateness criteria

• Increased denials

Contiguous body parts

Accreditation of non-hospital

outpatient labs

Reduction in physician

reimbursement

Increase in equipment

utilization %

Continuous APC repackaging

Elimination of CPT codes

(bundled into “parent”)

Private Insurance CMS

Preparation of Radiopharmaceuticals

Disparate Radiopharmaceutical

Regulations

USP 797

FDA

NRC

State Radiologic Departments

State’s Boards of Pharmacy

CMS

TJC

USP 797

Standards for all aspects of sterile

compounding Preparation of CSPs (compounded sterile products)

Personnel Requirements

Environmental and Room Requirements

Documentation

SOPs

FDA: Drug Quality and Security Act

Prepare drugs from FDA approved ingredients, according to package

insert or compendial methods

Pursuant to a physicians order or prescription for an individually

identified patient

Do not distribute an inordinate amount of drug across state lines.

Preparation of a FDA approved radiopharmaceutical pursuant to a

physicians order for an individual patient according to package insert

– is not considered compounding according to the law

Regulated by state boards of pharmacy

States, CMS, TJC

Licensing Requirements

Supervision Requirements

General

Direct

Personal

2004 TJC: Radiopharmaceuticals are drugs and as such,

come under direction of pharmacy

Pharmacy Directors and State BOD lack understanding of

unique issues

Aging Reactors, Homeland

Security and Acts of God

Is there really a 99m-TC Shortage

• Reactors end of life (20 years going on 50)

• Chalk River (NRU) Canada closing Oct 2016

• Highly Enriched Uranium (95%) *

• WMD

• Non-proliferation treaties

• Low Enriched Uranium (20%) **

• More radioactive waste

• Climate Change• Storms, volcanoes, and other disruptions to the fragile supply change

The Future of Moly Production

• Conversion of existing HEU reactors to LEU

• More reactors coming online using only LEU

• Alternative methods of nHEU-based Mo-99 production are in development by various entities• Production of Mo-99 (100Mo(y,n)99Mo) in accelerators, but material produced is

Low Specific Activity

• Neutron activation using Mo-98 (98Mo(n,y)99Mo) in reactors, but material produced is Low Specific Activity. (NorthStar)• Need a different generator due to LSA

• Producing using MURR

• Accelerator Driven fission process using LEU solution (Shine)• Can use current generator due to fissioned Mo-99 (HSA)

• Other recent (spring 2015) entrants• National Security Technologies/Global Medical Isotope Systems

• Coqui Pharma building a production facility in Florida

• * Fissioned U-235 Mo-99 is desirable due to HSA of Moly-99.

Radiation Awareness

Use of ionizing radiation has increased 72% in the last 30

years (CT and NM)

Publicity

FDA and CMS

Requires reporting of doses (CT, NM, fluoro)

SNMMII HPRA Department:

Watching Your Back

Health Policy and

Regulatory Affairs (HPRA)

Collaborates with regulators, policymakers, and medical stakeholders to ensure nuclear medicine continues to be a valued part of the medical imaging community.

Due to the complexities of the field, policymakers and regulators are not aware of what the profession entails. We use advocacy to educate these decision makers so that they can make decisions beneficial to the nuclear medicine community and patient care.

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Government Affairs

Radiation Dose

Assessment Response

Medical Internal

Radiation Dose

Committee on

Radiopharmaceuticals

Joint Compounding

Task ForceAdvocacy

Coding &

Reimbursement

Coalition for PET

Drugs

FDA Task Force

Health Policy and Regulatory

Affairs - SNMMI Org Chart

Government Relations

Committee

Member/Board oversight of HPRA

Coordinates with other professional societies (ASRT, ARRT, ACR, etc).

Works with Coding and reimbursement to address policy needs with CMS legislation

Monitors and responds to issues at NRC, DOE, FDA and other federal agencies

Collaborates with Radiopharmaceutical Committee: Compounding, Isotope Production, Domestic Supply of M0-99.

Works with Advocacy on Grass Roots Issues

Coding and Reimbursement Committee

• Monitor, analyze, influence and disseminate information about

coding and reimbursement policies (e.g., CPT, ICD-9 and ICD-10,

HCPCS codes and APC)

• Provide coding and reimbursement education through the Coding

Corner

• Participate in the Practice Expense Committee of the AMA RUC and

the process to obtain appropriate codes, procedure descriptions and

reimbursement

• Work with stakeholders to obtain appropriate reimbursement for all

nuclear medicine resources, including radiopharmaceuticals in all

settings

• Work with CMS, Congress, local carriers and other medical societies

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Capitol Hill Day - May 2, 2016

SNMMI Delegation and Patient Advocates: Lobby Congress to urge CMS to adopt SNMMI’s alternative APC packaging which would ensure appropriate reimbursement for tracers/drugs and procedures

2015 Hill Day Participants

SNMMI’s APC Letter to

CMS

Committee on

Radiopharmaceuticals Liaise with Congress and government agencies to ensure a stable supply of isotopes

after 2016 deadline

Example: Mo-99 Availability

Congress – Implementation of American Medical Isotopes Production Act (AMIPA) 2011: To ensure a stable supply of Mo-99 before end of this year

U.S. Department of Energy - HEU phase-out

White House Working Group (OSTP, NNSA, FDA, CMS, NRC)

National Academy of Sciences presentations

OSTP - U.S. Office of Science and Technology Policy (part of the White House)

NNSA - U.S. National Nuclear Security Administration (part of the Department of

Energy)

CMS - Centers of Medicare and Medicaid Services (part of the Department of

Health and Human Services)

NRC - U.S. Nuclear Regulatory Commission

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FDA Task Force

Liaise with Congress and government agencies for faster approvals of new tracers/products

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– C-11 Choline - prostate

– R-82 Cardiogen - mpi

– Neuraceq (florbetaben) –Alzheimer’s

– Amyvid (florbetapir) –Alzheimer’s

– Vizamyl - (flutemetamol) -Alzheimer’s

– F-18 Sodium fluoride - bone

– N-13 Ammonia - mpi

– FDG – bone & glioblastoma

Drugs with NDAs filed:– Ga-68 DOTATATE

(neuroendocrine tumor imaging)

– F-18 DOPA (Parkinson’s)

– F-18 fluciclovine (prostate cancer)

Radiation Dose Assessment Response

Committee

Collaborate with regulatory agencies to ensure nuclear

medicine industry is a leader in radiation safety issues

Example: NRC

Patient release after treatment with I-131: NRC staff gaining

input from SNMMI on I-131 treatment procedures and best

practices on releasing I-131 patients

Part 35 Rule: Medical Use of Byproduct Material – Medical

event definitions, training and experience, and clarifying

amendments

Part 20 Rule: Standards for Protection Against Radiation

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Joint Compounding Task Force

Monitor and comment on federal and state compounding legislation in coordination with the Committee on Radiopharmaceuticals

Develop SNMMI official statements in relation to compounding policies for approval by the SNMMI Board of Directors

Create educational programs for compounding professionals who prepare radiopharmaceuticals (both for immediate use and bulk batch preparations)

Develop a white paper describing that properly trained and credentialed nuclear medicine technologists are compounding professionals

SNMMITS Advocacy Committee

Scope of Practice Committee

Aligns SNMMITS

documents to the CNMT

SOP

Aligns other professional

societies’ documents to

the CNMT SOP

Updates current SOP to

include changes: PET, CT.. MRI is coming

Lobbies agencies to allow

SOP

Technologist Advocacy

Group

State focused

Monitor state activities land policy changes impacting CNMTs

Updates members regarding changes to state regulations

Responds to CNMT inquiries

SOP Must be Able to Be Defended

Taught

Scope of Practice Successes

Meetings, Letters, and a Well

Defended SOP Consensus Statement for PET/CT

All major professional societies RTs and CNMTs can with specified training

TJC: removed requirement for DIRECT supervision of radiopharmaceutical preparation

CMS: removed DIRECT supervision from CoP

Radiation Control Officers via CRCPD:◦ Part Z: Defined necessary training/certification for diagnostic CT scans

◦ Anyone, explicitly CNMTs with a CT certification

TJC: Any one who performs CT must be certified in CT by ARRT or NMTCB Implicit recognition that CNMTs can perform CT scans

SOP and Practice

Guidelines

http://www.snmmi.org/ClinicalPractice/

content.aspx?ItemNumber=4417

Technologist Advocacy Group

What is a TAG and What Do They Do?

Dedicated members in each state who are involved

at the local level. Identify changes in state laws/regulations concerning the

practice of nuclear medicine

Address any concerns or questions submitted by

SNMMI-TS members from their state

Keep aware of all other news or policy changes that

might affect SNMMI’s technologists

Six vacancies (Colorado, D.C., Florida, Minnesota, New

Hampshire, West Virginia)

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TAGs Need to Know

Modalities that are licensed in State

State requirements regarding a state licensing exam in

addition to or in lieu of certification

The licensing term in State (2 years, 5 years, etc.)

CNMT certifications that are recognized in state (NMTCB,

ARRT)

The State’s Continuing Education requirement?

The name of the head of the Radiation Control Program

The name of the state’s Conference of Radiation

Control Program Directors (CRCPD) and contact

information?

Names of the Assembly Speaker and Head of the State

Senate

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Watching Your Back By Monitoring

State Legislation New Jersey did not allow CNMTs to operate ANY CT portion of

hybrid equipment TAG: CNMTs can now operate hybrid equipment for attenuation and

anatomical localization.

California did not allow CNMTs to perform diagnostic CT scans on hybrid equipment TAG: CNMTs with CT certification are now allowed to fully operate the CT

portion of a hybrid system including performance of diagnostic CTs.

Arizona did not allow CNMTs to perform diagnostic CT scan on hybrid equipment TAG: CNMTs with CT certification are now allowed to perform CT scans on

hybrid and stand-alone CT scanners.

Mississippi regulation was about to severely limit a CNMTs SOP TAG: Stopped bill in Senate, reversed unfavorable language and added CT

and adjunctive administration to existing SOP

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PSWTC TAG Contact or Ask a Question

Contact information for other TAGs can be found

at: www.snmmi.org/TAGmembers

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Arizona NevadaJeanne Dial, Med,CNMT,RSO Frank Talbot, MBA, CNMT, PET,

ARRT (N) (R) Tahoe Forest Hospital District

Gateway Community College Nuc Med/PET

602-286-8512 530-582-3434

dial@gatewaycc.edu FTalbot@tdhd.com

California

Lynne Roy, MBA, CNMT, FSNMMITS

Cedars Sinai Medical Center

Department of Imaging

310-423-4203

Roy@cshs.org

How TAGs Remain “In The Know”

They Sign up for SCOUTFree service (search engine) that provides information

about regulations and legislation introduced or pending

Washington, DC and State Capitols

Sends custom alerts on designated terms appearing in: Congressional Bills

State Bills

Federal Regulations

Congressional Hearings

https://scout.sunlightfoundation.com

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Scout45

Visit the Scout website and find the search box

Click on advanced and enter your search term

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Summary

Advocacy controls our destiny

Advocacy needs your help and support to have your back

Advocacy is everything