The Rule outlines what bone marrow transplant procedures an insurer or health maintenance organization (HMO) must cover.

 

AGENCY FOR HEALTH CARE ADMINISTRATION
Cost Management and Control

RULE NO.:RULE TITLE:
59B-12.001Bone Marrow Transplantation
PURPOSE AND EFFECT: The Rule outlines what bone marrow transplant procedures an insurer or health maintenance organization (HMO) must cover.
SUMMARY: Per Section 627.4236, F.S., “The advisory panel shall conduct, at least biennially, a review of scientific evidence to ensure that its recommendations are based on current research findings and that insurance policies offer coverage for the latest medically acceptable bone marrow transplant procedures.” The advisory panel convened in late 2010 to update the Rule to meet current standards of care. The panel included a consumer representative and representatives from insurers.
SUMMARY OF STATEMENT OF ESTIMATED REGULATORY COSTS AND LEGISLATIVE RATIFICATION:
The Agency has determined that this will not have an adverse impact on small business or likely increase directly or indirectly regulatory costs in excess of $200,000 in the aggregate within one year after the implementation of the rule. A SERC has been prepared by the agency.
The Agency has determined that the proposed rule is not expected to require legislative ratification based on the statement of estimated regulatory costs or if no SERC is required, the information expressly relied upon and described herein:
Any person who wishes to provide information regarding a statement of estimated regulatory costs, or provide a proposal for a lower cost regulatory alternative must do so in writing within 21 days of this notice.
RULEMAKING AUTHORITY: 627.4236 FS.
LAW IMPLEMENTED: 627.4236 FS.
IF REQUESTED WITHIN 21 DAYS OF THE DATE OF THIS NOTICE, A HEARING WILL BE SCHEDULED AND ANNOUNCED IN THE FAR.
THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: Karin Jacobson, Bureau of Managed Health Care, [phone]

THE FULL TEXT OF THE PROPOSED RULE IS:

59B-12.001 Bone Marrow Transplantation.

Bone marrow transplant refers collectively to hematopoietic stem cell transplantation using stem cells that are collected from peripheral blood and cord blood as well as bone marrow following a conditioning regimen. As used in this rule, the term “appropriate oncological specialty” means that where a particular kind of tumor or disease is usually treated by a subspecialty group within the general discipline of oncology, those who practice within that subspecialty have had specific input into the decision making process.

(1) Upon the recommendation of the Bone Marrow Transplant Panel, each of the following procedures meets a minimum level of evidence based on high quality systematic reviews of case-control or cohort studies, high quality case-control or cohort studies with a very low risk of confounding, bias, or chance, and a high probability that the relationship is causal, and is considered accepted within the appropriate oncological specialty and not experimental for the purposes of Section 627.4236, F.S. Bone marrow transplant refers collectively to hematopoietic stem cell transplantation using stem cells that are collected from peripheral blood and cord blood as well as bone marrow. As used in this rule, the term “appropriate oncological specialty” means that where a particular kind of tumor or disease is usually treated by a subspecialty group within the general discipline of oncology, those who practice within that subspecialty have had specific input into the decision making process:

(a)  Autologous bone marrow transplant for acute myelogenous leukemia (stem cells collected in remission);

(b)  Allogeneic bone marrow transplant for acute myelogenous leukemia and myeloid sarcoma;

(c) Autologous bone marrow transplant for acute lymphoblastic leukemia (stem cells collected in remission);

(c)(d) Allogeneic bone marrow transplant for acute lymphoblastic leukemia;

(d)(e) Allogeneic bone marrow transplant for chronic myelogenous leukemia;

(e)(f) Autologous bone marrow transplant for Hodgkin’s disease lymphoma;

(f) Allogeneic bone marrow transplant for Hodgkin lymphoma relapsed after autologous transplant but not progressing on salvage chemotherapy;

(g) Autologous bone marrow transplant for nNon-Hodgkin’s lymphoma;

(h) Allogeneic bone marrow transplant for nNon-Hodgkin’s lymphoma;

(i) Autologous bone marrow transplant for Ewing’s sarcoma, chemotherapy sensitive after first relapse;

(j) Autologous bone marrow transplant for nNeuroblastoma;

(k) Autologous bone marrow transplant for germ cell tumor, after failure of first therapy but not progressing on salvage therapy;

(l) Autologous bone marrow transplant for multiple myeloma (including double bone marrow transplant) and primary amyloidosis;

(m) Allogeneic bone marrow transplant for myelodysplastic syndrome;

(n) Autologous bone marrow transplant for primitive neuroectodermal tumor (PNET), (including medulloblastoma and pinealoblastoma), chemotherapy sensitive after first relapse;

(o) Autologous bone marrow for medulloblastoma and other PNET tumors, metastatic, at diagnosis;

(p) Allogeneic bone marrow transplant for chronic lymphocytic lymphoblastic leukemia;

(q) Allogeneic bone marrow transplant for severe or very severe aplastic anemia from HLA compatible siblings for patients below 40 years of age, and any type of bone marrow transplant for severe aplastic anemia unresponsive to immunosuppression.

In cases where treatment for any of the above conditions includes a clinical trial that conforms to subsection (5), routine care costs associated with the bone marrow transplant will be covered.

(2) Each of the following procedures is considered accepted within the appropriate oncological specialty and not experimental for the purposes of Section 627.4236, F.S., provided that the bone marrow transplantation procedure is performed in the context of a well-designed and conducted Phase II or Phase III clinical treatment trial as described in subsection (5)(3).

(a) Autologous bone marrow transplant for chronic myelogenous leukemia;

(a)(b) Autologous bone marrow transplant for chronic lymphocytic lymphoblastic leukemia;

(b)(c) Autologous bone marrow transplant for plasma cell dyscrasias other than multiple myeloma (e.g., Waldenstrom’s);

(c)(d) Allogeneic bone marrow transplant for multiple myeloma and other plasma cell dyscrasias (e.g., Waldenstrom’s, amyloid);

(d)(e) Autologous bone marrow transplant for breast carcinoma;

(e)(f) Autologous bone marrow transplant for Ewing’s sarcoma, localized, greater than eight cm or metastatic at presentation;

(f)(g) Autologous bone marrow transplant for soft tissue sarcoma, pediatric, after failure of first therapy;

(g)(h) Autologous bone marrow transplant for Wilms’ tumor, at relapse;

(h)(i) Autologous bone marrow transplant for germ cell tumor, high risk, at diagnosis;

(i)(j) Allogeneic bone marrow transplant for renal cell carcinoma;

(j)(k) Multiple autologous bone marrow transplants for pediatric solid tumors;

(k)(l) Allogeneic bone marrow transplant for Hodgkin’s disease lymphoma;

(l)(m) Autologous bone marrow transplant for metastatic malignant melanoma.;

(m) Allogeneic bone marrow transplant for sickle cell anemia, thalassemia, and other severe red cell disorders.

(3) The following rare diseases, where there are no existing clinical trials available, are covered for bone marrow transplant at the Blood and Marrow Transplant Clinical Trials Network (BMT CTN) core or non-core facilities when deemed medically necessary:

(a)     Myelofibrosis;

(b)     Chronic myelomonocytic leukemia (CMML);

(c)     Paroxysmal nocturnal hemoglobinuria (PNH);

(d)     POEMS syndrome.

(4) Any bone marrow transplant performed outside of a clinical trial will be covered when all of the following criteria are met:

(a)     The plan of care follows a clinical trial protocol that meets the requirements of subsection (5);

(b)     Patient cannot be enrolled in the proposed clinical trial;

(c)     Bone marrow transplant treatment is medically necessary;

(d)     Patient is an appropriate candidate for bone marrow transplant;

(e)     Treatment center is part of the BMT CTN as a core or non-core center.

(5)(3) A well-designed and conducted clinical treatment trial is one which includes an IRB-approved written protocol. At a minimum, such protocol shall have specific criteria for evaluating the effect of treatment with defined endpoints that are precise, meaningful, and reliable and which allow valid conclusions to be drawn about therapeutic efficacy and safety. Protocols should include an adequate statistical section describing the method of randomization and stratification, if any, expected outcome parameters relating to response rates, time to progression, survival times and other relevant information. Such clinical treatment trials shall be consistent with protocols reviewed and approved by the National Cancer Institute for scientific merit.

(6)(4) It should be noted that there are other non-malignant (not oncological) diseases that are genetic disorders, or that result in bone marrow failure or lead to immunodeficiency syndromes for which bone marrow transplantation may be appropriate. While these non-malignant diseases are not described in the preceding lists, there are generally accepted and appropriate indications for bone marrow transplantation in these cases. In addition, there are malignant diseases that are uncommon in their occurrence that also are not detailed in the above lists for which the appropriateness of bone marrow transplantation may be determined on a case by case basis.

Rulemaking Specific Authority 627.4236 FS. Law Implemented 627.4236 FS. History–New 11-9-95, Formerly 10D-127.001, Amended 9-26-00, 8-10-05,_________.

 

NAME OF PERSON ORIGINATING PROPOSED RULE: Karin Jacobson, Medical Health Care Program Analyst, Agency for Health Care Administration
NAME OF AGENCY HEAD WHO APPROVED THE PROPOSED RULE: Elizabeth Dudek, Secretary, Agency for Health Care Administration
DATE PROPOSED RULE APPROVED BY AGENCY HEAD: January 29, 2013