Cancer Interim Final Rule

February 14, 2014

I would like to announce the publication of an Interim Final Rule (IFR) which amends the List of WTC-Related Health Conditions (List) found in the WTC Health Program regulations, and results in four specific cancers becoming eligible for coverage as WTC-related health conditions.

First, the table of medical codes (ICD codes) (Table 1) has been removed from the regulation to avoid confusion about which cancers are covered by the WTC Health Program. Second, the definition of childhood cancer has been revised to clarify that a childhood cancer is any cancer diagnosed in a person less than 20 years of age.

The most important change revises the definition of “rare cancers.” Based on a review of the leading authorities on rare cancer, “rare cancers” are now defined as any cancer that has an incidence rate of less than 15 cases per 100,000 persons per year. In addition, the notice announces that the Administrator now regards brain and pancreatic cancers as eligible for consideration as “rare cancers.” As a result of the revised definition of “rare cancers” and the Administrator’s policy decision, four specific cancers are now eligible for coverage as WTC-related health conditions. The four specific cancers are malignant neoplasms of the brain, cervix uteri (invasive cervical cancer), pancreas, and testis. No type of cancer currently covered by the WTC Health Program is removed by the Interim Final Rule published today.

The IFR is effective February 18, 2014. It is available for public review and comment for 60 days until April 21, 2014. If you wish to read the IFR, please visit: https://federalregister.gov/a/2014-03370 . The new regulatory text will be found at the end of the document. Please follow the instructions in the draft to submit your comments.

If you are a current member of the WTC Health Program, you should contact your current Clinical Center of Excellence (CCE) or the Nationwide Provider Network (NPN) to determine if your cancer may be certified as a WTC-related health condition. If you do not know which CCE you attend, please contact the WTC Health Program call center at 1-888-982-4748.

If you are not currently enrolled in the WTC Health Program and believe you may be eligible for the Program, please visit our website for information about the application process, www.cdc.gov/wtc. You can also contact the WTC Health Program call center at 1-888-982-4748 for information on how to apply.

FAQs

• What is the February 18, 2014 cancer amendment rule?
  The WTC Health Program published an interim final rule (IFR) on February 18, 2014, entitled "World Trade Center Health Program; Amendments to List of WTC-Related Health Conditions; Cancer; Revision." The purpose of the IFR is to amend WTC Health Program regulations found in 42 C.F.R. § 88.1 to correct problems found by the Administrator. An IFR is similar to a final rule, but public comments are accepted after the rule is effective.
• How soon are the February 18, 2014 cancer amendments effective?
  The interim final rule, entitled "World Trade Center Health Program; Amendments to List of WTC-Related Health Conditions; Cancer; Revision" (RIN 0920-AA50); went into effect February 18, 2014. This means members could begin to be certified, or approved, for treatment starting February 18, 2014.
• Why was the February 18, 2014 cancer amendments rule published?
  The original rule text created an administrative burden for the Program, did not reflect the intended definition of "rare cancers," and created confusion for members and stakeholders. The WTC Health Program was not aware of these issues until after the 2012 cancer rule was implemented.
  
  This rulemaking is necessary to amend the original list of certain types of cancer included on the List of WTC-Related Health Conditions in 42 C.F.R. §88.1. To correct the problems with the original text, the Administrator published the IFR to remove the complex table of medical codes (replacing it with a narrative list of covered cancers), and correct the definitions of "rare cancers" and "childhood cancers." In addition to those amendments, the Administrator has also reversed a prior policy decision that excluded cancers of the brain and pancreas from Program coverage. Those two cancers can now be considered rare cancers, along with invasive cervical cancer and testicular cancer.
• What does the February 18, 2014 cancer amendments rule do for coverage of cancers in the WTC Health Program?
  As a result of revising the definition of rare cancer and the Administrator's policy change, four specific cancers are now eligible for coverage as WTC-related health conditions within the category rare cancer: malignant neoplasms of the brain, cervix uteri (invasive cervical cancer), pancreas, and testis. No type of cancer currently covered by the WTC Health Program is removed by the IFR.
• Which cancers are considered rare by the WTC Health Program?
  Pursuant to the amended regulatory text, "rare cancers" are now defined as any cancer that has an incidence rate of less than 15 cases per 100,000 persons per year (based on 2005–2009 average annual data age-adjusted to the 2000 U.S. population). This is a category under which a member of the WTC Health Program can be certified, or approved, for treatment for a condition. If a person is diagnosed with a cancer that is not specifically included on the List of WTC-Related Health Conditions found in the WTC Health Program regulations, but which meets the definition of rare cancer, then the member can be certified for treatment.
• Is there a list of rare cancers?
  No. Rare cancer is a category, not a list of certain types of cancer. Rare cancer is defined as any type of cancer which occurs at a rate less than 15 cases per 100,000 people per year (called the "incidence rate"). Every cancer submitted for certification is reviewed by the WTC Health Program to assess if that cancer meets the definition of a rare cancer.
  
  As of, March 27, 2014, the WTC Health Program certified the following health conditions as rare cancers:
  • Adrenal
  • Central Nervous System
  • Gallbladder/Biliary Tract
  • Gastrointestinal Stromal
  • Male Breast
  • Neuroendocrine
  • Penis
  • Small Intestine
  • Testis
  • Thymus

  This list only includes rare cancers certified as of the date listed and is not a comprehensive list of all of the types of cancers that are considered rare. You should discuss whether a specific type of cancer meets the rare cancer criteria with your WTC Health Program physician at your Clinical Center of Excellence or Nationwide Provider Network.

• Are malignant neoplasms of the brain, cervix uteri (invasive cervical cancer), pancreas, and testis specifically named on the List of WTC-Related Health Conditions (List)?
  No. These four cancers are considered covered under the rare cancer category, along with any other cancer that has an incidence rate of less than 15 cases per 100,000 persons per year (based on 2005–2009 average annual data age-adjusted to the 2000 U.S. population).
• Are there other types of cervical cancers besides cervix uteri (invasive cervical cancer) and are those not covered?
  Invasive cervical cancer is a special type of cervical cancer and is the only type of cervical cancer covered by the WTC Health Program. The other type is called non-invasive cervical cancer, which does not meet the WTC Health Program's definition of a rare cancer.
• Does the WTC Health Program offer screening for the four new cancers that are now considered rare under the new definition?
  The WTC Health Program follows the recommendations of the U.S. Preventive Services Task Force (USPSTF) for establishing cancer screening benefits. For cervical cancer, USPSTF recommends that females age 21–65 receive one Pap test every 3 years; females age 30–65, are recommended to receive one HPV screening every 5 years. The USPSTF does not recommend screening for cancer of the brain, pancreas, or testis. The WTC Health Program and the Clinical Centers of Excellence and the Nationwide Provider Network are preparing now to add screening for cervical cancer to its services and we expect that service to be available soon.
• What should you do if you are a current member and you believe you have a rare cancer?
  If you are a current member of the WTC Health Program you should contact your Clinical Center of Excellence (CCE) or Nationwide Provider Network (NPN) to determine if your cancer may be certified as a WTC-related health condition. If you do not know which CCE you attend, please contact the WTC Health Program call center at 1-888-982-4748. If you are not a member and believe you may be eligible you can obtain a copy of the application at www.cdc.gov/wtc or by calling 1-888-982-4748.
• How do you provide comments on the February 18, 2014 cancer amendments rule?
  Comments on the interim final rule (IFR), entitled "World Trade Center Health Program; Amendments to the List of WTC-Related Health Conditions; Cancer; Revision" (RIN 0920-AA50), will be accepted until April 21, 2014. You can find the IFR at https://federalregister.gov/a/2014-03370 . Please follow the instructions in the draft to submit comments.