Oplinc

staying informed and involved

In the last three years we have experienced profound changes in cancer service delivery, coding, billing, reimbursement and regulations. The pace and complexity of these changes along with the knowledge that further changes are certain can lead to the perception that we have no voice in the future of cancer care in our communities.

This is not the case. We have many opportunities to become actively involved in this process. Advocacy is defined as “active support.” To be an effective advocate for our patients and our practices we need to be educated on the issues affecting cancer care delivery and we need to actively participate in the process of determining how cancer care will be delivered and reimbursed in our communities. This special edition is a resource guide for staying informed and involved.

Staying Informed and Involved

The Centers for Medicare and Medicaid Services

Freedom of Information Act
Through the Freedom of Information Act  (FOIA) you can request and receive most records in the custody of CMS. The FOIA only applies to documents and the FOIA does not require an agency to compile data into a document.

The FOIA, enacted in 1966, can be found in Title 5 of the United States Code, section 552. The act provides access upon request to any non-privileged Federal agency record. Records that are specifically exempt from FOIA release are:

  1. Classified national defense and foreign relations information
  2. Internal agency personnel rules and practices
  3. Material prohibited from disclosure by another law
  4. Trade secrets and other confidential business information
  5. Certain inter-agency or intra-agency communications
  6. Personnel, medical, and other files involving personal privacy
  7. Certain records compiled for law enforcement purposes
  8. Matters relating to the supervision of financial institutions
  9. Geological information on oil wells

The CMS Web site and your Medicare Carrier’s Web site contain detailed instructions on the FOIA and how to request information under the act. Physicians most commonly request Medicare Part B charge and reimbursement information. 

A practical example of a recent request under the FOIA to a Medicare Carrier:

A written request to a Medicare carrier under the FOIA described the USPDI listed unlabeled use of a particular drug, and cited the reference to the Medicare Carrier Manual section 2049.4C giving Medicare carriers the authority to extend coverage to unlabeled uses in specified compendia.

The requestor asked the carrier whether the newly listed unlabeled use would be included in an update as a covered diagnosis by the carrier. The requestor also asked for the effective date of coverage and recommended coding and billing guidelines.

Approximately 6 weeks later the Freedom of Information Coordinator for the Medicare carrier responded in writing with the affirmation of coverage for the unlabeled use of the drug and the primary and secondary diagnoses necessary for proper claim submission.

The written confirmation of coverage and the primary and secondary diagnoses necessary for proper coding and billing received from the carrier on their letterhead provides support for the practice should there be an improper denial.

Comment on Proposed Regulations
The Centers for Medicare and Medicaid Services (CMS) maintains a Web page, e-Rulemaking listing regulations with open comment periods. From this page click on the link, Submit electronic comments on CMS regulations with an open comment period. You will be directed to a page that lists dockets that are currently open for comment, the title of the docket, the published date and the date the comment period ends.

To view the document and comment electronically, click on Go in the column titled Submit Comment. At this point you must enter your postal code (zip code), country and choose the appropriate category from the drop down list, enter your name and that of your organization (optional) and hit enter.

Read Electronic Comments on CMS Regulations sent in by other interested parties to gather information on the point of view of others in the oncology community.

At Regulations.gov search for all CMS documents open for comment by clicking on Documents Open for Comment and choosing the Centers for Medicare and Medicaid Services in the drop-down menu. The Docket ID, Document ID, Document Title and the PDF and HTML version of the proposed rule open for comment will be displayed. Comments on the proposed rule may be submitted directly from this page.

CMS publishes proposed rules and regulations in the Federal Register, the daily newspaper of the Federal government. The Federal Register is published Monday-Friday by the National Archives and Records Administration (NARA). All information in the Federal Register is public information and may be reproduced without restriction.

Stay informed on the publication of these proposed regulations by signing up to receive the daily Federal Register Table of Contents on the Federal Register Main Page. The daily table of contents will be received by email. Scroll down the list to Centers for Medicare and Medicaid to see the daily list of notices and meetings pertaining to CMS.

National Coverage Determinations
A National Coverage Determination (NCD) is a determination of coverage by CMS. The Medicare Modernization Act of 2003 (MMA) mandated changes to the NCD process with the goal of making the NCD process more transparent.

An NCD is binding to all Medicare contractors, Medicare Advantage Plans, quality improvement organizations and Administrative Law Judges.

Comment on Proposed Coverage Issue
The Medicare Coverage Database page on the CMS Web site lists open and closed National Coverage Analyses (NCA). Click on the subject of interest to read about the issue, track the actions taken, comment on open items and view public comments received.

Comment on Proposed RegulationsAnother opportunity to comment occurs when a Proposed Decision Memo (PDM) is issued. There is a 30 day public comment period on PDMs. This comment period may be used to offer informed opinions, provide additional information and insights on the issue and to request clarification of posted information.

In formulating your comments on specific issues it may be helpful to read the comments that have been submitted by other providers, professional organizations such as the American Society of Clinical Oncology (ASCO), the Association of Community Cancer Centers (ACCC) as well as those submitted by other interested industry members.

Any party may request an NCD. According to CMS, a complete formal initial request for an NCD or formal request for reconsideration must include the following:

  • Be in writing
  • The formal request letter and supporting documentation must be submitted electronically (unless there is good cause for only a hardcopy submission)
  • The requestor must identify the request as a ‘‘formal request for an NCD’’ or a ‘‘formal request for reconsideration’’ and identify the NCD development track chosen
  • The requestor must state the benefit category or categories of the Medicare program to which the requestor believes the item or service applies
  • Must include adequate supporting documentation along with the formal request letter

If you are not familiar with the NCD process, CMS encourages that you contact them informally prior to formally requesting an NCD. CMS can be contacted by email at cms_caginquiries@cms.hhs.gov.

Local Coverage Determinations
A Local Coverage Determination as established by section 522 of the Benefits Improvement and Protection Act (BIPA) is a coverage decision made by a Medicare contractor concerning what items and services are reasonable and necessary. According to CMS an LCD may not conflict with an NCD but may supplement it.

The process under which LCDs are developed is defined in the Medicare Program Integrity Manual (PIM), chapter 13.

Contractors are required to develop LCDs for the following situations:

  • When they have identified a service that is never covered under certain circumstances and wish to establish automated review in the absence of an NCD or coverage provision in an interpretive manual that supports automated review.
  • To implement new Least Costly Alternative (LCA) determinations. “Least Costly Alternative” is a national policy provision that shall be applied by contractors when determining payment for all durable medical equipment (DME). Contractors have the discretion to apply this principle to payment for non-DME services as well.

Contractors may develop LCDs for other reasons, including these situations:

  • A validated widespread problem demonstrates a significant risk to the Medicare trust funds;
  • An LCD is needed to assure beneficiary access to care;
  • A contractor has assumed the LCD development workload of another contractor and is undertaking an initiative to create uniform LCDs across its multiple jurisdictions; or is a multi-state contractor undertaking an initiative to create uniform LCDs across its jurisdiction; or
  • Frequent denials are issued (following routine or complex review) or frequent denials are anticipated.

Medicare Part B contractors develop LCDs through the Contractor Advisory Committee (CAC) process described in this newsletter. However, under the following situations LCDs may be revised without requiring a comment and notice period:

  • Liberalizing an existing LCD, e.g., adding covered indications and diagnoses to the LCD
  • Annual ICD-9-CM and HCPCS updates
  • Clarification or correction of an existing LCD
  • Coding updates that do not restrict coverage
  • Incorporating national coverage provision changes

Final LCDs may be considered for revision when new evidence is presented to the carrier by an interested party. A reconsideration request that would conflict with a NCD will not be reviewed.

To submit a request for a LCD reconsideration, review the instructions on your Medicare carriers Web site.

Open Door Forums
CMS hosts Open Door Forums to allow for a live dialogue between CMS and the provider community on current program issues. These forums are held by conference call and are open to the public. Anyone can attend and participate in these forums.

The forums are commonly attended by Carrier Medical Directors (CMDs), CMS personnel, providers, office administrators, billing managers, industry representatives and others interested in the particular forums topic. Audio files of Special Open Door Forums may also be available on the Open Door Forums Web page.

Forum participants have an opportunity to learn from the discussion and to comment or ask questions related to the forum topic. For example, on January 24, 2006 CMS hosted a two-hour Open Door Forum on Medicare Part B and Part D coverage and payment. During this call participants had an opportunity to ask questions and request clarifications regarding the program.

To be notified of upcoming forums by email register for the CMS Mailing Lists  by choosing areas of interest. Once registered, you will be notified by email of upcoming forums.

Physicians Regulatory Issues Team
The Physicians Regulatory Issues Team (PRIT) was created by CMS in 1998 in an effort to simplify Medicare requirements or eliminate unnecessary regulations and to improve the responsiveness of the agency to providers. Physicians can contact the PRIT directly to report problems they are encountering or to ask the PRIT to clarify an issue.

The PRIT is composed of CMS subject matter experts. Dr. William Rogers leads the team of CMS leadership staff, regional office staff, physicians and technical experts that make up the PRIT.

Providers can view past and Active PRIT Issues and track their status by clicking on the issue on the PRIT Web page. An example of an issue that the PRIT addressed is the clarification of language in CMS Transmittal 788 regarding consultations. The following is from the PRIT Web page:

Issue Name
Written consultation orders
Issue
Do consultants need to verify that a written order is on the chart for the consultation they are performing?
Status
See below
Date Issue Created
03/30/2006

Status: In December of 2005 Transmittal 788 seemed to impose the additional requirement that the consulting physician verify that a written request for a consultation has been made in the patient chart before billing for the consultation. The MGMA has asked that this requirement be reconsidered. The PRIT is discussing the issue with appropriate staff.

April 12:  Medicare does not expect the consulting physician to verify that the requesting physician has documented the consultation request in his/her patient’s medical record.

PRIT Contact Information:
PRIT can be contacted by email or by phone 24 hours a day, 7 days a week.

Contractor Advisory Committee
The Contractor Advisory Committee (CAC) includes physicians from various specialties including oncology and hematology, a beneficiary representative and representatives of other medical organizations. The CAC assist the Medicare contractors in developing Local Coverage Determinations (LCDs), and facilitate the dissemination of information and the discussion of policies between physicians and Medicare.

In the Medicare Program Integrity Manual (MPIM) Chapter 13 – Local Coverage Determinations CMS dictates that Medicare Carriers and Intermediaries present draft LCDs for public comment prior to presenting the draft policy to the Contractor Advisory Committee (CAC).

Comments on draft policies can be submitted in writing, by email, through teleconference or in person at Open Meetings. Open Meetings are held prior to each CAC meeting allowing interested parties to present relevant information and comments regarding the draft LCD.

Parties interested in making a presentation at one of these open meetings must register with their Medicare Carrier/Intermediary. Information on registering to present at an Open Meeting is available on the Medicare Contractor’s Web site.

Draft LCDs requiring a comment period are open for comment for a minimum of 45 calendar days. After the comment period ends, a Final LCD is developed, and there is another 45 calendar day comment period on the Final LCD. All draft LCDs, the start and stop date of the comment period as well as information on how to comment on the policy must be posted on the contractor’s Web site.  

The American Society of Clinical Oncology (ASCO) maintains a list of hematology and oncology CAC members, State Hematology/Oncology Societies, Medicare Contractors, Medicare Carrier Medical Directors, and their contact information on their Web site.

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Cancer Professional Advocacy Organizations

Oncology advocacy organizations and their stated Mission Statements:

The Association of Community Cancer Centers (ACCC) www.accc-cancer.org
The Association of Community Cancer Centers (ACCC) is the leading national multidisciplinary organization that defines quality care for patients with cancer and influences change to continually improve cancer care. The Association focuses on enhancing, promoting and protecting the entire continuum of quality cancer care for our patients and our communities.

The American Society of Clinical Oncology (ASCO) www.asco.org
As a nonprofit organization, ASCO is dedicated to achieving its charitable mission outlined by the organization’s founders in 1964. ASCO strongly supports all types of cancer research, but in particular, patient-oriented clinical research. ASCO is committed to:

  • IMPROVING cancer care and prevention;
  • ADVANCING the education of physicians and other professionals in the care of patients with cancer and supporting research and the development of clinical cancer researchers;
  • FOSTERING communication among cancer-related medical subspecialties and the exchange of a wide range of ideas related to cancer, including its biology, prevention, diagnosis, staging, treatment, and psychosocial impact;
  • ADVOCATING public policy that ensures patient access to high-quality cancer care and that supports increased clinical cancer research; and
  • ASSISTING oncologists in addressing the challenges of the modern-day practice of oncology.

Oncology Nursing Society
The mission of the Oncology Nursing Society is to promote excellence in oncology nursing and quality cancer care.

ADVOCACY
We, as an organization and as individuals, advocate on behalf of people with cancer to ensure their quality of life and their access to exemplary care throughout the continuum of life. We advocate on behalf of the nursing profession and the oncology specialty to ensure respect and recognition, access to education, safe working environments, and fair reimbursement. We also serve as advocates for public policy, particularly in matters of health.

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ABOUT THE EDITOR
Risë Marie Cleland is the founder and President of Oplinc, a national organization of oncology professionals. Through Oplinc Ms. Cleland publishes the weekly Oplinc Fax Tracts focusing on the timely dissemination of information pertaining to billing, reimbursement and practice management in the oncology office and Oplinc’s Best Practices Review, which provides a more in-depth look at the issues and challenges facing oncology practices. Ms. Cleland also works as a consultant and advisor for physician practices, pharmaceutical companies and distributors.

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CONTACT US
Risë Marie Cleland
Rise@Oplinc.com

Oplinc
300 West 8th Street, Unit 419
Vancouver, WA 98660-3440
580.695.0632 phone
360-993-5065 fax
www.Oplinc.com

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UPCOMING ISSUE
Comments and suggestions for future issues are welcome, please forward correspondence to Risë Marie Cleland by email at: Rise@Oplinc.com

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NEWSLETTER ARCHIVES

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IMPORTANT NOTICE
Please note that this newsletter is presented for informational purposes only. It is not intended to provide coding, billing or legal advice. Regulations and policies concerning Medicare reimbursement are a rapidly changing area of the law. While we have made every effort to be current as of the issue date, the information may not be as current or comprehensive when you review it. Please consult with your legal counsel for any specific reimbursement information. For Medicare regulations visit: www.cms.hhs.gov.

 

State Societies

State Societies
In response to the MMA and the complex and challenging changes in oncology reimbursement most states now have active oncology societies. In some areas state societies are joining forces to form regional societies that will reflect the future Medicare Administrator Contractor (MAC) regions.

State societies are particularly powerful voices for the oncology community. Many of these societies have developed strong cooperative partnerships with their Medicare Carrier Medical Director (CMD) and insurance companies.  

These societies provide many services to their members including:

  • Educational meetings
  • Networking opportunities
  • Billing and reimbursement seminars, resources and tools
  • Advocacy efforts for patients
  • Advocacy for state oncology/hematology practices on issues such as:
    • Medical policies
    • Government legislation
    • State-level issues

State societies provide a vehicle for grassroots efforts on issues benefiting patients and providers. Become an engaged and active member in your state oncology/hematology society.

State Medical Societies
State medical societies provide advocacy for all state providers and patients. These associations generally focus on issues that affect providers of all specialties such as Medicare Physician Fee Schedule reimbursement, prompt pay initiatives, “hassle-factor” claims assistance, and Medicaid reimbursement.

These societies provide members with resources and tools including practice forms, form letters for correspondence with payers, publications dealing with practice management and reimbursement, and state legislative contacts.

Additionally, most state medical associations have lobbying and legal staff. In the state of Washington, the state medical association, Washington State Medical Association (WSMA) has been assisting the Washington State Medical Oncology Society (WSMOS) in their efforts to repeal the 1.5% Business and Occupation tax that oncologists pay on their drug receipts.

State Societies

Alabama
Alabama Society of Clinical Oncology

Medical Association of the State of Alabama

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Alaska
Society of Administrators in Medical Oncology-Northwest

Alaska State Medical Association

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Arizona
The Arizona Clinical Oncology Society

Arizona Medical Association

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Arkansas
Arkansas Clinical Oncology Association

Arkansas Medical Society

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California
Association of Northern California Oncologists

Medical Oncology Association of Southern California

California Medical Association

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Colorado
Rocky Mountain Oncology Society

Colorado Medical Society

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Connecticut
Connecticut Oncology Association

Oncology Network of Connecticut, LLC

Connecticut State Medical Society

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Delaware
Delaware Society of Clinical Oncology

Medical Society of Delaware

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District of Columbia
Maryland/DC Society of Clinical Oncology

Medical Society of the District of Columbia

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Florida
Florida Society of Clinical Oncology

Oncology Managers of Florida

Florida Medical Association

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Georgia
Georgia Society of Clinical Oncology

Medical Association of Georgia

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Hawaii
Hawaii Society of Clinical Oncology

Hawaii Medical Association

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Idaho
Idaho Society of Clinical Oncology

Society of Administrators in Medical Oncology-Northwest

Idaho Medical Association

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Illinois
Illinois Medical Oncology Society

Illinois State Medical Society

Chicago Medical Society

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Indiana
Indiana Medical Oncology Society

Indiana State Medical Association

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Iowa
Iowa Oncology Society

Iowa Medical Society

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Kansas
Kansas Society of Clinical Oncology

Kansas Medical Society

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Kentucky
Kentucky Association of Medical Oncologists

Kentucky Medical Association

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Louisiana
Louisiana Oncology Society

Louisiana State Medical Society

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Maine
Northern New England Clinical Oncology Society

Maine Medical Association

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Maryland
Maryland/DC Society of Clinical Oncology

Maryland State Medical Society

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Massachusetts
Massachusetts Society of Clinical Oncologists

Massachusetts Medical Society

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Michigan
Michigan Society of Hematology & Oncology

Michigan State Medical Society

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Minnesota
Minnesota Society of Clinical Oncology

Minnesota Medical Association

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Mississippi
Mississippi Society of Oncology

Mississippi State Medical Association

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Missouri
Missouri Cancer Coalition

Missouri State Medical Association

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Montana
Montana Society of Clinical Oncology

Society of Administrators in Medical Oncology-Northwest

Montana Medical Association

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Nebraska
Nebraska Oncology Society

Nebraska Medical Association

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Nevada
Nevada Oncology Society

Nevada State Medical Association

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New Hampshire
Northern New England Clinical Oncology Society

New Hampshire Medical Society

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New Jersey
Medical Oncology Society of New Jersey

Medical Society of New Jersey

New Jersey Society of Oncology Managers

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New Mexico
New Mexico Society of Clinical Oncology

New Mexico Medical Society

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New York
New York State Society of Medical Oncologists & Hematologists

New York Association of Oncology & Hematology Practice Administrators

Medical Society of the State of NY

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North Carolina
North Carolina Oncology Association

North Carolina Medical Society

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North Dakota
Dakota Oncology Society

North Dakota Medical Association

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Ohio
Ohio/West Virginia Hematology Oncology Society

Ohio State Medical Association

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Oklahoma
Oklahoma Society of Clinical Oncology

Oklahoma State Medical Association

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Oregon
Oregon Society of Medical Oncology

Oregon Medical Association

Society of Administrators in Medical Oncology-Northwest

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Pennsylvania
Pennsylvania Oncology Hematology

Pennsylvania Oncology Hematology Managersí Society

Pennsylvania Medical Society

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Rhode Island
Society of Rhode Island Clinical Oncologists

Rhode Island Medical Society

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South Carolina
South Carolina Oncology Society

South Carolina Medical Association

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South Dakota
Dakota Oncology Society

South Dakota State Medical Association

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Tennessee
Tennessee Oncology Practice Society

Tennessee Medical Association

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Texas
Texas Society of Medical Oncology

Texas Medical Association

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Utah
Society of Utah Medical Oncologists

Utah Medical Association

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Vermont
Northern New England Clinical Oncology Society

Vermont Medical Society

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Virginia
Virginia Association of Hematology & Oncology

Virginia Association of Hematology Oncology Managers

Medical Society of Virginia

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Washington
Washington State Medical Oncology Society

Society of Administrators in Medical Oncology-Northwest

Washington State Medical Association

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West Virginia
Ohio/West Virginia Hematology Oncology Society

West Virginia State Medical Association

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Wisconsin
Wisconsin Association of Medical Oncologists

Wisconsin Medical Society

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Wyoming
Wyoming State Medical Society

 


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