A. Allogeneic transplantation. Consider under a disability until at least 12 months from the date of transplantation. Thereafter, evaluate any residual impairment(s) under the criteria for the affected body system.

OR

B. Autologous transplantation. Consider under a disability until at least 12 months from the date of the first treatment under the treatment plan that includes transplantation. Thereafter, evaluate any residual impairment(s) under the criteria for the affected body system.

Allogeneic transplantation – uses bone marrow stem cells or peripheral blood stem cells from someone else.

Autologous transplantation – uses the patient’s own bone marrow stem cells or peripheral blood stems cells.

“Bone marrow transplantation” refers to stem cells derived from bone marrow.

“Stem cell transplantation” refers to stem cells derived from peripheral blood.

Stem cells from bone marrow or peripheral blood are immature precursors of blood cells; and when they mature, form white blood cells (fight infection), red blood cells (carry oxygen), and platelets (help blood clot).

One reason bone marrow (stem cell) transplantation and (peripheral blood) stem cell transplantation are used in cancer treatment is to make it possible for patients to get very high doses of chemotherapy and/or radiation. This high-dose therapy is a form of very intense cancer treatment above and beyond “standard” therapy.

Chemotherapy and radiation mostly affect cells that divide rapidly, and cancer cells are the main target because they divide more rapidly than most healthy cells.

However, because normal bone marrow cells also divide rapidly, high-dose chemotherapy and/or radiation can damage or destroy the patient’s own bone marrow. Without healthy bone marrow, the patient can no longer make white blood cells to fight infection, red blood cells to carry oxygen, and platelets to help blood clot.

Both bone marrow transplantation and (peripheral blood) stem cell transplantation place stem cells into the blood after the patient has received high-dose chemotherapy and/or radiation. These new transplanted stem cells travel to the bone marrow to restore the bone marrow’s ability to produce new mature blood cells the patient needs to survive.

SSA instructs that in planning autologous (using own stem cells) bone marrow or stem cell transplantation to support high-dose chemotherapy; it is general practice to treat the individual with one or two cycles of “standard” chemotherapy to check for tumor responsiveness.

A cancer that is totally unresponsive to “standard” chemotherapy is unlikely to successfully respond to autologous bone marrow or stem cell transplantation.

If the therapy plan consists of several cycles of “standard” chemotherapy to be followed by bone marrow or stem cell transplantation, the date of “first treatment” is the date of the first “standard” chemotherapy.

If no “standard” chemotherapy is planned prior to bone marrow or stem cell transplantation, the date of “first treatment” is the date of the transplant.

In my opinion, this approach by SSA regarding the onset of “standard” chemotherapy to set the date of “first treatment” as onset for this listing is fraught with ambiguity and complexity. One could argue for an onset based purely on the point at which the severity of the impairment prevented work, not just when the “standard” therapy began. Though establishing an onset prior to transplantation would probably entail invoking a "less than sedentary RFC" or some other form of medical-vocational allowance.

The listing used to evaluate bone marrow or stem cell transplant depends on the specific malignancy. The criteria in listings 13.05C, 13.06A, 13.06B1, 13.06B2a, 13.07B, 113.05C, 113.06A, 113.06B1, or 113.06B2a do not specify the type of transplant. Only listing 13.28 distinguishes between autologous and allogeneic transplants. SSA evaluates any other malignant neoplastic disease treated with bone marrow or stem cell transplantation under listing 13.28, regardless of whether there is another listing that addresses that impairment.

Bone marrow or stem cell transplantation for aplastic anemia is evaluated under listing 7.17.

Bone marrow or stem cell transplantation for severe auto-immune disorders would be considered as a possible equals under listing 13.28.

Regardless, an individual who has received an autologous bone marrow or stem cell transplant for a malignant neoplastic disease has an impairment that meets a listing.

If the impairment is evaluated under listing 13.28 B, the individual is considered disabled until at least 12 months from the date of the “first treatment” under the treatment plan that involves an autologous transplant.

If the impairment is evaluated under another listing for bone marrow or stem cell transplantation, the individual is disabled until at least 12 months from the date of the transplant.

SSA further instructs that a listing for bone marrow or stem cell transplantation can not be met or medically equaled until the claimant has undergone the transplant. Therefore, if a transplant can not be done because there is no match, or because of funding issues, the listings for bone marrow or stem cell transplantation should not be used to evaluate the claim.

Umbilical cord blood contains large numbers of stem cells; therefore, umbilical cord blood transplants are considered stem cell transplants.

Except for a solitary squamous cell carcinoma found in the neck, any other metastatic carcinoma or sarcoma found in the body; and the primary site of origin of that tumor is unknown after a thorough metastatic work up, will meet this listing.

Under the revised listings, SSA evaluates tumors based on histology. For example, there is no histology for a “primary abdominal neoplasm.” Tumors that have spread to the abdomen should be evaluated under the site of origin, if known. If the primary site is unknown, SSA will use this listing to evaluate this or any similar impairment.

Metastases to regional lymph nodes (or beyond) – will be described in the pathology report (microscopic exam of tissue) or in medical imaging studies, such as MRI or CT scan.

“Metastatic disease” is disease that has spread through the blood or lymphatic system.

May be local, regional, or distant metastases.

Progressive – malignancy becomes more extensive after completion of initial chemotherapy.

OR

Recurrent – recurrence of the tumor in any part of the body after completion of initial chemotherapy.

A. Progressive or recurrent despite initial hormonal intervention.

“Hormonal intervention” for prostate cancer is any medical treatment that lowers androgen (male hormone) levels. If carcinoma of the prostate tumor progresses or recurs despite initial hormonal intervention, the prognosis is poor.

Carcinoma of the prostate that progresses or recurs despite chemotherapy or radiation given as the initial treatment my still respond to hormonal therapy. Therefore, failure of prostate cancer to respond to chemotherapy or radiation does not have the same significance as failure to respond to hormonal therapy and cannot be used to equal 13.24 A.

The intent of this listing is that the cancer must be resistant to hormonal therapy before it can be considered of listing-level severity. This is why the listing uses the wording “despite initial hormonal intervention,” rather than “following initial hormonal intervention.”

Often, hormonal therapy for prostate cancer is given on an ongoing basis for an indefinite period. The listing is met when the disease progresses or recurs while on initial hormonal therapy. To meet this listing, the person must be receiving hormonal treatment. Or the listing would be met if the tumor continues to progress if the initial hormonal therapy was stopped and restarted for some reason.

Progression of prostate carcinoma should be decided based on the evaluation of all appropriate signs and symptoms. SSA opines that serial PSA (prostate-specific antigen) levels can help assess disease activity, but cannot be used to document progression without additional corroborating evidence, such as radiologic studies or findings on physical examinations. While a rise in serial PSA level reflects does reflect ongoing disease activity, be sure the medical evidence corroborates progression or recurrence. If this issue is not clear, contact the treating source for clarification.

OR

B. With visceral metastases.

“Visceral metastases” is metastases to non-bone structures, such as the liver or lung.

“Metastatic disease” is disease that has spread through the blood or lymphatic system. For prostate cancer, extension to the intestines or rectum is usually through direct extension; and, if so, SSA opines this does not necessarily represent metastatic disease. Though I think this opinion is wrong, and it could easily be argued that direct extension of prostate cancer to structures, such as the intestines, represents “visceral metastases.”

A. Uterus (corpus), as described in 1, 2, or 3:

Corpus – body of the uterus.

1. Invading adjoining organs.

Spread to the pelvic wall equals 13.23 A.1.

OR

2. With metastases to or beyond the regional lymph nodes.

Metastases to regional lymph nodes (or beyond) – will be described in the pathology report (microscopic exam of tissue) or in medical imaging studies, such as MRI or CT scan.

OR

3. Persistent or recurrent following initial antineoplastic therapy.

Persistent – failure to achieve complete remission after completion of initial antineoplastic therapy.

OR

Recurrent – recurrence of the tumor in any part of the body after completion of initial antineoplastic therapy.

OR

B. Uterine cervix, as described in 1 or 2:

Cervix – mouth of the uterus

1. Extending to the pelvic wall, lower portion of the vagina, or adjacent or distant organs.

Will be described in the physical exam, operative report, pathology report (microscopic exam of tissue), or in medical imaging, such as MRI or CT scan.

OR

2. Persistent or recurrent following initial antineoplastic therapy.

Persistent – failure to achieve complete remission after completion of initial antineoplastic therapy.

OR

Recurrent – recurrence of the tumor in any part of the body after completion of initial antineoplastic therapy.

OR

C. Vulva, as described in 1, 2, or 3:

1. Invading adjoining organs.

Spread to the pelvic wall equals 13.23 C.1.

OR

2. With metastases to or beyond the regional lymph nodes.

Metastases to regional lymph nodes (or beyond) – will be described in the pathology report (microscopic exam of tissue) or in medical imaging studies, such as MRI or CT scan.

OR

3. Persistent or recurrent following initial antineoplastic therapy.

Persistent – failure to achieve complete remission after completion of initial antineoplastic therapy.

OR

Recurrent – recurrence of the tumor in any part of the body after completion of initial antineoplastic therapy.

OR

D. Fallopian tubes, as described in 1 or 2:

1. Extending to the serosa or beyond.

Serosa – membrane that lines the organs.

Will be described in the operative report or pathology report (microscopic exam of tissue). Entails extension through the fallopian tube wall to its lining or beyond.

OR

2. Persistent or recurrent following initial antineoplastic therapy.

Persistent – failure to achieve complete remission after completion of initial antineoplastic therapy.

OR

Recurrent – recurrence of the tumor in any part of the body after completion of initial antineoplastic therapy.

OR

E. Ovaries, as described in 1 or 2:

1. All tumors except germ-cell tumors, with at least one of the following:

a. Tumor extension beyond the pelvis; for example, tumor implants on peritoneal, omental, or bowel surfaces.

Peritoneum - membrane that lines the walls of the abdominal cavity

Omentum - folds of the peritoneum that connect the stomach with other abdominal organs 

Will be described in the operative report, pathology report (microscopic exam of tissue), or in medical imaging, such as MRI or CT scan.

OR

b. Metastases to or beyond the regional lymph nodes.

Metastases to regional lymph nodes (or beyond) – will be described in the pathology report (microscopic exam of tissue) or in medical imaging studies, such as MRI or CT scan.

OR

c. Ruptured ovarian capsule, tumor on the serosal surface of the ovary, ascites with malignant cells, or positive peritoneal washings.

Serosa - membrane that lines the organs.

Ascites - fluid in the abdominal cavity.

Peritoneal washings - the intraabdominal cavity is bathed with fluid during the surgical procedure; the fluid is suctioned and sent for examination by a pathologist. If tumor cells are present, the washing is considered "positive."

These findings will be described best in the operative report or pathology report (microscopic exam of tissue).

OR

d. Recurrent following initial antineoplastic therapy.

Recurrent – recurrence of the tumor in any part of the body after completion of initial antineoplastic therapy.

OR

2. Germ-cell tumors--progressive or recurrent following initial antineoplastic therapy.

Germ-cell tumors form in the reproductive cells (egg) of the ovary. Usually occurs in teenage girls and young women. These include dysgerminoma, yolk sac tumors, embryonal carcinoma, immature teratoma, choriocarcinoma, polyembryomas, and mixed germ cell tumors.

In adults, the most majority of germ cell tumors are benign, such as the benign cystic teratoma.

Progressive – malignancy becomes more extensive after completion of initial antineoplastic therapy.

OR

Recurrent – recurrence of the tumor in any part of the body after completion of initial antineoplastic therapy.

A. With infiltration beyond the bladder wall.

The pathology report (microscopic exam of tissue) or medical imaging, such as MRI or CT scan will show this.

OR

B. Recurrent after total cystectomy.

Tumor recurs after surgical removal of the entire bladder.

OR

C. Inoperable or unresectable.

Inoperable - surgery is of no therapeutic value or cannot be performed due to risk to the patient.

OR

Unresectable - operation was performed but all of the tumor could not be removed.

OR

D. With metastases to or beyond the regional lymph nodes.

Metastases to regional lymph nodes (or beyond) – will be described in the pathology report (microscopic exam of tissue) or in medical imaging studies, such as MRI or CT scan.

A. Inoperable, unresectable, or recurrent.

Inoperable - surgery is of no therapeutic value or cannot be performed due to risk to the patient.

OR

Unresectable - operation was performed but all of the tumor could not be removed.

OR

Recurrent – recurrence of the tumor in any part of the body after completion of initial antineoplastic therapy.

OR

B. With metastases to or beyond the regional lymph nodes.

Similar to stomach (gastric) cancer, requiring metastases to regional lymph nodes (or beyond) – will be described in the pathology report (microscopic exam of tissue) or in medical imaging studies, such as MRI or CT scan.

A. Carcinoma (except islet cell carcinoma).

OR

B. Islet cell carcinoma that is inoperable or unresectable and physiologically active.

Islet (pronounced eye-let) cell carcinoma is rare and may either be functional (physiologically active) or non-functional.

Functional (physiologically active) islet cell tumors produce different clinical manifestations depending on the type of hormone it produces in excess.

If it is unclear whether the tumor is physiologically active, contact the treating source.

Keep in mind that to meet Listing 13.20 B, the islet cell tumor must be physiologically active and either inoperable (surgery is of no therapeutic value or cannot be performed due to risk to the patient) or unresectable (operation was performed but all of the tumor could not be removed).

As stated in 13.00C, SSA applies the criteria in a specific listing to a malignancy originating from that site. Listing 13.19 should be used to evaluate primary tumors of the liver, and not tumors that metastasize to the liver.