November 14, 2002.
BEFORE THE UNITED STATES DEPARTMENT OF HEALTH AND HUMAN SERVICES
CENTERS FOR MEDICARE AND MEDICAID SERVICES
INFORMATION QUALITY REQUEST FOR CORRECTION OF CERTAIN
SafeBlood® Technologies, Inc. ("SafeBlood®"), brings this information quality request for correction (hereinafter, the "Complaint") pursuant to the Federal Data Health Quality Act (the "Act") and the guidelines promulgated pursuant thereto, and states the following in support thereof:
- This Complaint requesting correction of information is proper under the Act, and the Office of Management and Budget ("OMB") Guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility, and Integrity of Information Disseminated by Federal Agencies (hereinafter, the "OMB Guidelines"), and the Department of Health and Human Services ("HHS") and the Centers for Medicare and Medicaid Services ("CMS") Guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility, and Integrity of Information Disseminated to the Public1 (the OMB Guidelines, the HHS Guidelines, and the CMS Guidelines will collectively hereinafter be referred to as the "Guidelines"). The Act and the Guidelines create a mechanism for affected persons to seek correction of information which is not in compliance with the quality requirements of the Act and the Guidelines. See OMB Guidelines, 67 Fed. Reg. 8452, 8458 (Feb. 22, 2002); HHS Guidelines, at E; CMS Guidelines, at VI. This Complaint is proper because SafeBlood® is an affected person and because certain information disseminated by HHS and CMS does not comply with the quality requirements of the Act and the Guidelines.
- SafeBlood®, an Arkansas corporation, is a company headquartered in Little Rock, Arkansas. SafeBlood® developed and supports a therapeutic medical procedure and related Standard Operating Procedures ("SOPs"), processes and protocols known as Autologous Platelet GraftingTM and Autologous Tissue GraftingTM2, designed for use in acute interoperative incisions and procedures and for treating chronic wounds. Numerous adjunct or ancillary medical procedures that are currently and normally reimbursable under CMS national coverage issues or policy may be indicated and medically supported in the overall procedure. See Overview Comments on Local Medical Review Policy: Draft (hereinafter, "Overview Comments"), Tab 9 (containing a letter from Phil Zarlengo).3 SafeBlood® provides education, training, supplies, services and FDA-cleared equipment to providers participating in private medical insurance programs and the Medicare Program. These providers, which include facilities, physicians and wound care technicians, in turn, perform Autologous Tissue GraftingTM and ancillary procedures on individuals who evidence a medical necessity in the treatment of chronic wounds. A portion of these individuals are beneficiaries of the Medicare Program.
- The Medicare Program is administered by CMS and HHS. See HHS Guidelines, at D., 4., a., v.; CMS Guidelines, at 1. In administering the Medicare Program, HHS and CMS disseminate certain information, including, but not limited to, programmatic, administrative and regulatory information and authoritative and interpretive health, medical and human services information, aimed at consumers and health and human services professionals. See HHS Guidelines, at D., 4., b., xv-xvi; CMS Guidelines, at 111, B.
- In order to assist CMS and HHS in administering the Medicare Program, HHS and CMS are authorized to engage public or private organizations to act as fiscal intermediaries. See 42 U.S.C. § 1395(h) (Law Co-op. 2002). HHS and CMS have chosen Arkansas Blue Cross and Blue Shield (hereinafter, the "Arkansas Fiscal Intermediary") to act as the fiscal intermediary in Arkansas, New Mexico, Louisiana, Missouri, and Oklahoma.
- Fiscal intermediaries are authorized to carry out various functions on behalf of CMS and HHS, including, but not limited to, the development of local medical review policies ("LMRPs"). See Medicare Program Integrity Manual, at Chap. 13, § 1.3. The purpose of a LMRP is to specify or clarify, without contradicting any statute, ruling, regulation and national coverage, payment, and coding policy, the clinical circumstances under which a service is covered at a local level by Medicare and is correctly coded. See id. LMRPs are an administrative and educational tool used to assist providers in submitting direct claims for payment. See id. CMS has issued extensive instructions to its fiscal intermediaries regarding the development of LMRPs, covering when a LMRP should be issued, its content, its format, and its development process. See id.
- On or about July 17, 2002, the Arkansas Fiscal Intermediary released for public comment a draft of an LMRP entitled "Chronic Wound Care - DRAFT" (the "Wound LMRP Draft"). The Wound LMRP Drab may be located at www.arkmedicare.cowlproviderlmedpol\drafts\ac02025.asp. It may also be found in the Overview Comments at Tab 13.
- The Wound LMRP Draft will effectively exclude Autologous Tissue GraftingTM, related or similarly situated autologous procedures, and related, adjunct, ancillary precursory or succeeding medically indicated and necessary procedures currently covered and reimbursable under national coverage policy when not associated with Autologous Tissue GraftingTM, from coverage under Medicare. The Wound LMRP Draft provides that "[p]latelet derived formula containing growth factors intended to treat non-healing wounds (e.g. Procuran) [sic]" and "[o]ther systems of treatment that are based on the principle of using a platelet derived formula to enhance or augment healing" are not covered by Medicare due to "a lack of sufficient published data to determine the[ir] safety and efficacy" as determined in Coverage Issue Manual 45-26. See Overview Comments, Tab 13, at p. 3. It further provides that "systems such as the Autologous Wound Care process that is known by various names such as AuToloGel [TM], is not covered. Various companies have marketed this process under different names. The processconsists of removing approximately one unit of blood from the patient by a venipuncture. The whole blood is then processed whereby theplatelets are separated. The remainder of the blood is returned to the patient. The segment of blood withdrawn is then mixed with Fibin [sic], Vitamin C, Calcium and other biological products. The material is then applied to a wound bed and dressing is applied. See `Coding Guidelines' for instructions." See id. Additionally, the Wound LMRP Draft states: "The Autologous Wound Care process is to be billed with the 977994 code. Activities that have been known to be associated with this process will be denied [i.e., 36426 (venipuncture, cutdown), P9019 (platelet concentrate), 36430 (transfusion, blood or blood components), 15000 (surgical preparation or creation of recipient site by excision of open wounds, burn eschar, or scar), 15350 (application of allograft, skin) 20926 (tissue graft [other])." See id at p. 8.
- In its Wound LMRP Draft, the Arkansas Fiscal Intermediary attempts to exclude coverage of Autologous Tissue GraftingTM and other related or ancillary medical procedures that are nationally covered and reimbursable from Medicare coverage. Hence, the Wound LMRP Draft will adversely impact the quality of chronic wound care available to Medicare beneficiaries located within the jurisdiction of the Arkansas Fiscal Intermediary and will harm SafeBlood® and providers if it is used to exclude reimbursable coverage of Autologous Tissue GraftingTM and other related, medically indicated, necessary and nationally covered procedures from Medicare coverage.
- The OMB and HHS Guidelines define "information" as "any communication or representation of knowledge such as facts or data, in any medium or form, including textual, numerical, graphic, cartographic, narrative or audiovisual forms." See OMB Guidelines, 67 Fed. Reg. 8452, 8460 (Feb. 22, 2002); HHS Guidelines, at D., 2., e. Because the Wound LMRP Draft constitutes a communication or representation of knowledge, it falls within such definition of information.
- The OMB and HHS Guidelines only apply to information that a federal agency disseminates. The OMB and HHS Guidelines define "dissemination" as either "agency initiated or sponsored distribution of information to the public." See OMB Guidelines, 67 Fed. Reg. at8460; IIIIS Guidelines, at D., 2., h. Information is not disseminated when the distribution is limited to government employees or agency contractors; when it is for intra- or inter-agency use, and when information is distributed in response to Freedom of Information Act ("FOIA") requests. See id. Since CMS has given fiscal intermediaries the authority to issue LMRPs, since CMS has distributed instructions directing the issuance of such policies, and since the Wound LMRP Draft constitutes information as defined in the Act and Guidelines, CMS has either initiated or sponsored the LMRP. Because of this; because the LMRP's distribution is not limited to government employees or agency contractors, but is published via public print and electronic media and distributed to the public for use by the public, including Medicare beneficiaries, suppliers and providers; because the LMRP is not merely for intra- or inter-agency use; and because the LMRP is not a distribution of information in response to a FOIA request; the Wound LMRP Draft falls within the Act's and Guidelines' definition of "dissemination."
- The Act and Guidelines require that agencies implement methods and procedures to maximize the quality of information. "Quality" is defined as including utility, objectivity and integrity. See OMB Guidelines, 67 Fed. Reg. at 8459; HHS Guidelines, at D., 2., a. Objectivity ensures accurate, reliable and unbiased information, See OMB Guidelines, 67 Fed. Reg. at 8459-60; HHS Guidelines, at D., 2., c.; CMS Guidelines, at II. and V. Furthermore, the Guidelines require that the quality of information be integral to every step of the development of information, including the creation, collection, maintenance and dissemination. See id. Objectivity is achieved by using reliable data sources and sound analytical techniques, and carefully reviewing information products prepared by qualified people using proven methods. See HHS Guidelines, at D., 4., d.; CMS Guidelines, at V.
- The sources of the information and basis for the Wound LMRP Draft, as stated therein, are (i) Trailblazer LMRP for Chronic Wound Care (hereinafter, "Trailblazer LMRP"), (ii) CCI-Correct Coding Initiative, (iii) Program Memorandum AB-01-68 of May 1, 2001, and (iv) Coverage and Issue Manual 45-26 Platelet Derived Wound Healing Formula (hereinafter, "CIM 45-26").
- None of the sources of information and basis for the Wound LMRP Draft address Autologous Tissue GraftingTM or similarly situated autologous platelet gel procedures.
- The Correct Coding Initiative and the Program Memorandum AB-01-68 of May 1, 2001 sources address coding in general and the coding that is applied to outpatient rehabilitation therapy, respectively.
- The Trailblazer LMRP for Chronic Wound Care provides the circumstances in which Medicare covers synthetic graft skin procedures. It neither addresses Autologous Tissue GraftingTM as supported by SafeBlood® or similarly situated autologous platelet gel procedures supported by others, nor does it imply that Autologous Tissue GraftingTM or similarly situated autologous platelet gel procedures are not covered by the Medicare Program. Rather, the Trailblazer LMRP states "synthetic graftskin and other adjunctive services to chronic wound care such as skin autographs, allografts, or xenografts ... are covered on a medically reasonable and necessary basis." See Trailblazer LMRP, available at www.trailblazerhealth.comllmrp.asp, at p. 3.
- CIM 45-26 also does not address Autologous Platelet GraftingTM or Autologous Tissue GraftingTM, as supported by SafeBlood® or as performed by providers trained and supported by SafeBlood®.5 It specifically and expressly addresses ProcurenTM, a product containing extracted and derived growth factors intended to treat non-healing wounds. See Overview Comments, Tab 10 (containing a copy of CIM 45-26). CIM 45-26 specifically addressed ProcurenTM because ProcurenTM, its surrounding treatment regimens, and a handful of available papers in 1992 and 1993 provided the basis for the determination made in CIM 45-26. See id. Autologous Tissue GraftingTM and other similar platelet gel procedures did not provide that basis, and are not addressed in CIM 45-26. The autologous wound care SOPs encompassing Autologous Tissue GraftingTM supported by SafeBlood® and performed by trained and licensed providers is remarkably different from platelet derived healing formulas, such as ProcurenTM for the reasons hereinafter stated and for the reasons found in the Overview Comments, attached hereto.
- ProcurenTM was an autologous, cellular free, pure platelet derivative primarily containing extracted platelet releasate known as alpha granule material. See Overview Comments, Tab 1 and 6 (containing key points regarding ProcurenTM and Autologous Tissue Grafting TM and containing letters and various other documents comparing ProcurenTM and AuTOGeI TM and Autologous Tissue GraftingTM). After an assessment of the patient was made and viral testing was performed, approximately 160 ml. of the patient's whole blood was drawn at a wound care facility, then packaged and shipped cold to the state-localized processing facility distant from the patient in time and geography. See id. Upon arrival, and following then-current good manufacturing protocol, the whole blood samples were separated by refrigerated centrifugation into platelet rich plasma and packed red blood cells. The platelet rich plasma was collected and transferred to 50 ml. centrifugation tubes and centrifuged to concentrate the platelet rich plasma. See id. The resultant concentrated platelet button was re-suspended in a small aliquot of modified HEPES buffer. This buffered, re-suspended platelet button, was then activated with Thrombin to release the platelet's alpha granule content. See id. After platelet activation/growth factor release, the buffered, activated platelet button material was then recentrifuged to remove the platelet membranes and all cellular ghosts resulting in a non-cellular containing, (i.e. cellular free) alpha granule concentrated platelet releasate. See id, This material was further processed by a I to a 100 times dilution of the releasate in modified, proprietary HEPES buffer, creating an approximate volume of 1,000 ml. This, the "platelet derived wound healing formula" product, known as ProcurenTM, was then measured and placed into approximately 90 tubes which were 10 ml. single use vials, frozen and stored. The ProcurenTM tubes were then shipped frozen back to the wound care center for an initial application to the wound and then distributed, as a medical product or commodity, to the patient for their subsequent personal application. ProcurenTM did not contain any platelets, or any other cellular, or tissue/blood components. See id.
- AuToGelTM is an autologous, whole blood derivative containing plasma and other concentrated cellular and tissue structures, including whole platelets. It is a process that is initiated by obtaining approximately 50 ml. of autologous platelet concentrate by platelet pheresis in a closed system from the patient, or by an alternative process where the platelets are separated from the whole blood while being centrifuged in individual tubes or containers. See id. This material has been aliquoted to 10 ml. syringes and Thrombin, Vitamin C, and possibly other proprietary agents are added to activate the material that is then applied to a previously prepared wound. The activated material forms a coagulum containing plasma proteins, cellular and tissue components, and activated whole platelets. See id.
- Autologous Tissue GraftingTM is an autologous, viable, cellular blood derivative of the "Buffy Coat" containing whole platelets, white cells, red blood cells and stem cells, as well as fibrin and other plasma proteins. See id.; see also Overview Comments, Tab 7 (containing Pathology and Flow Cytometry reports). The process is initiated by harvesting 60400 ml. of whole blood from the patient and processing in a Class II, FDA-cleared sequestration machine at the patient's side. See Overview Comments, Tab 6. The entire sequestered "Buffy Coat" component is then combined with Thrombin and/or other proprietary activators to create an extracellular matrix or scaffolding. This structural matrix consists of, among other components, Fibrin, Fibronectin, Leucocytes, red blood cells, platelet membranes, and stem cells. See id. The resulting structural Autologous Tissue coagulum Graft prosthesis is immediately placed into the physician prepared wound bed as an integral tissue graft structure, filling the volume of the wound and assisting in the wound sealing and closure process. In addition to being a delivery vehicle for the intracellular proteins, this concentrated, fibrin reinforced, tissue/cellular structure provides support for new cells to "build on" as they are generated and for recruitment of cells from surrounding the wound. See id.
- ProcurenTM and similarly situated products can not be accurately compared to Autologous Tissue GraftingTM. In Autologous Tissue GraftingTM, the concentrated, freshly sequestered, viable, living tissue and cellular elements needed for wound repair are being placed, as a stage in a medical procedure, directly into the clean, receptive and immediately physicianprepared wound bed. See generally Overview Comments, Tab 6 (containing letters and other documents attempting to compare ProcurenTM with Autologous Tissue GraftingTM). This procedure and resultant living tissue graft differs mechanically, physiologically, and histologically from the platelet derived wound healing formula(s) evidenced by ProcurenTM or products such as RegranexTM. See id. (describing further the differences between ProcurenTM and Autologous Tissue GraftingTM and other similarly situated procedures). The platelet derived wound healing formula applies nothing more than repackaged, extracted, diluted and sometimes synthesized growth factors in a thin layer carried via a dressing, to a wound bed, which may not have been properly prepared. The viable cellular elements in Autologous Tissue GraftingTM, including fibrinogenlfibrin, fibronectin, leucocytes, and stem cells, can affect wound healing in the absence of platelets or platelet-derived wound healing factors. Each of the cellular elements imparts its own unique effect on wound repair and works in harmony with the other cellular elements to heal the wound. See id.; see also Overview Comments, Tab 6. Likewise, the fact that the Autologous Tissue GraftingTM procedure contains platelets, or that at some point the graft or wound will evidence the presence of growth factors, should not preclude it, or related and nationally covered and reimbursable adjunct medical procedures, from being a covered procedure(s) under Medicare. See Overview Comments, Tabs 9 and 11. In fact, recent LMRP policies confirm the efficacy and medical necessity of skin substitutes and grafts that contain, stimulate, attract and promote the same components evidenced in Autologous Tissue GraftingTM. See Overview Comments, Tab 15 (containing a LMRP from Blue Cross and Blue Shield of Tennessee entitled Human Skin Equivalent, dated Sept. 29, 2002).
Therefore, the naturally designed and occurring cellular tissue elements concentrated in the Autologous Tissue GraftingTM procedure work in concert with one another, balancing the sealant and closure process with a more physiological and biological complete and compatible process than any synthetic graft material.
- Because the sources for the Wound LMRP Draft only address ProcurenTM and similarly related "derived" formulas, product(s) and/or formula(s) vastly different from AuToGeITM or Autologous Tissue GraftingTM, because none of the sources relied on by the Arkansas Fiscal Intermediary in its Wound LMRP Draft specifically address AuToGeITM or Autologous Tissue GraftingTM, and because the Arkansas Fiscal Intermediary's Wound LMRP Draft does not rely on quality information which accurately and reliably addresses AuToGeITM Autologous Tissue GraftingTM, or ancillary or adjunct nationally covered medical procedures, the Wound LMRP Draft does not comply with the quality and objectivity requirements in the Act and Guidelines.
- Additionally, in attempting to promulgate the Wound LMRP Draft, the Arkansas Fiscal Intermediary Advisory Committee, consisting of the Arkansas Consortium, reviewed and accepted the Wound LMRP Draft in August 2002. See Overview Comments, Tab 14 (containing the final, but not yet in effect, form of the Arkansas Fiscal Intermediary's LMRP entitled "Chronic Wound Care"). This review and acceptance by the Advisory Committee occurred prior to the end of the public comment period. By reviewing and accepting the Wound LMRP Draft prior to the end of the public comment period, the Arkansas Fiscal Intermediary deprived itself of relevant, accurate, reliable, objective and quality information which was submitted in the form of comments to the Wound LMRP Draft and which disputes the accuracy and objectivity of the Wound LMRP Draft. See id.
- The Wound LMRP Draft is based on information that lacks quality and objectivity, two cornerstones of the Act and Guidelines. Rather than basing the Wound LMRP Draft on studies and material that specifically address Autologous Tissue GraftingTM and other similarly situated autologous procedures, the Wound LMRP Draft is based on information concerning formulas and products vastly different from Autologous Tissue GraftingTM and other similarly situated autologous procedures.
- Autologous Tissue GraftingTM and other similarly situated autologous procedures are supported by objective and quality information. See generally Overview Comments. In addition to being supported by quality information, Autologous Tissue GraftingTM and similar processes and protocols are easy to use, have evidenced the healing of chronic wounds more quickly compared to other procedures,6 have evidenced greater utility and broader applicability than HBO, ApligraftTM, RegranexTM or other reimbursed synthetic skin substitutes or protocols, and are more cost-effective than HBO, ApligrafrM, RegranexTM or other reimbursed synthetic skin substitutes. See id. No clinically adverse side effects have been reported with the proper use of Autologous Tissue GraftingTM. Numerous patients have been healed after using Autologous Tissue GraftingTM after years of receiving conservative and advanced wound care therapies. See Overview Comments, Tabs 2-5 and CD. It is inappropriate and unfair to the beneficiaries, who have and could benefit from the simple, effective and cost-efficient Autologous Tissue GraftingTM, that such procedure, similarly situated procedures, and the ancillary or adjunct medically indicated, necessary and nationally covered procedures, be excluded from Medicare coverage based on information lacking quality and objectivity.
- For the reasons contained herein, SafeBlood® prays for the following relief:
- That CMS act expeditiously, as the final form of the Arkansas Fiscal Intermediary's LMRP entitled "Chronic Wound Care" is to become effective December 15, 2002;
- That the Wound LMRP Draft be rescinded;
- That the patients and providers that have been denied coverage by the Arkansas Fiscal Intermediary to-date based on erroneous, inaccurate and unreliable information be paid for the physician determined and coded, medically necessary and indicated procedures that are ancillary or adjunct to Autologous Tissue GraftingTM and similarly situated autologous procedures;
- That CMS correct the flawed objectivity and quality of the Wound LMRP Draft by distinguishing Autologous Tissue GraftingTM and similarly situated autologous procedures from platelet-derived wound healing formula (e.g. ProcurenTM) and by permitting proper coding and payment for Autologous Tissue GraftingTM and similarly situated autologous procedures; and e. That the Wound LMRP Draft result in payment for Autologous Tissue GraftingTM, similarly situated autologous procedures, and the ancillary or adjunct procedures, where such procedures are medically necessary and indicated, as determined and coded by a physician, and in accordance with the reimbursement coverage amounts commensurate with the normally reimbursed rates for the same nationally covered, coded and payable procedures.
SAFEBLOOD® TECHNOLOGIES, INC.
Debby Thetford Nye, Ark.Bar No 80107
Bryan Gray Looney
MITCHELL, WILLIAMS, SELIG,
GATES & WOODYARD, P.L.L.C.
5414 Pinnacle Point Drive, Suite 500
Rogers, Arkansas 72758
(479) 273-9561 - Office
(479) 273-0527 - Fax
ATTORNEYS FOR COMPLAINANT
1Part I of the Guidelines for Ensuring the Quality, Objectivity, Utility and Integrity of Information Disseminated to the Public will hereinafter be referred to as the "HHS Guidelines." Part II, Paragraph E of this document will hereinafter be referred to as the "CMS Guidelines."
2The Autologous Tissue GraftingTM name evolved as a trademark name as pathology and flow Cytometry reports substantiated a variety of tissue and cellular components in Autologous Platelet GraftingTM, to include plasma, white cells, platelets, red cells and stem cells.
3The Overview Comments are attached to this Complaint as "Attachment One."
4The Wound LMRP Draft uses the incorrect code for the Autologous Wound Care process. This incorrect code was corrected in the final, but not yet effective, LMRP to 17999. See Overview Corninents, Tab 14, Part A, p 7, #No. 12, and Part B, p 8, #No. 12.
5As a matter of fact, an administrative law judge has ruled that ProcurenTM and an autologous procedure similar to Autologus Platelet Grafting and Autologous Tissue Grafting, AuToGelTM, are different and that CIM 45-26 does not preclude payment for the AuToGelTMprocedure. See Overview Comments, Tab 12.
6See Overview Comments, Tabs 2-5; see also the compact disc, enclosed with this Complaint, dated November 2002 (containing news clips and outcome summary sheets discussing Autologous Tissue GraftingTM) (hereinafter, "CD")
Last Revised: August, 2004