Friday, July 19, 2019

CPT modifier 78 and 79 - Usage Guidelines


Modifier 79 Unrelated Procedure or Service by the Same Physician During the Postoperative Period:


Modifier 78 Unplanned Return to the Operating/Procedure Room by the Same Physician or Other Qualified Health Care Professional Following Initial Procedure for a Related Procedure During the Postoperative Period Anesthesia, CCI Editing, Global Days, Multiple Procedure Reduction, Rebundling

The physician may need to indicate that the performance of a procedure or service during the postoperative period was unrelated to the original procedure. This circumstance may be reported by using the modifier 79. (For repeat procedures on the same day, see modifier 76).



POST-OPERATIVE PERIOD BILLING GUIDELINES

Unrelated Procedure or Service or E/M Service by the Same Physician During a Post-operative Period

Two CPT modifiers are used to simplify billing for visits and other procedures that are furnished during the post-operative period of a surgical procedure, but not included in the payment for surgical procedure. These modifiers are:

• Modifier “-79” (Unrelated procedure or service by the same physician during a post-operative period).

The physician may need to indicate that a procedure or service furnished during a post-operative period was unrelated to the original procedure. A new post-operative period begins when the unrelated procedure is billed.



Return to the OR for a Related Procedure during the Post-Operative Period

When treatment for complications requires a return trip to the operating room, physicians bill the CPT code that describes the procedure(s) performed during the return trip. If no such code exists, the physician should use the unspecified procedure code in the correct series, which is, 47999 or 64999. The procedure code for the original surgery is not used except when the identical procedure is repeated.

In addition to the CPT code, physicians report modifier “-78” (Unplanned return to the operating or procedure room by the same physician following initial procedure for a related procedure during the post-operative period).  The physician may also need to indicate that another procedure was performed during the post-operative period  of the initial procedure. When this subsequent procedure is related to the first procedure, and requires the use of the operating room, this circumstance may be reported by adding the modifier “-78” to the related procedure.

NOTE: The CPT definition for modifier “-78” does not limit its use to treatment for complications.

Modifier 78 may not be used with place of service 11 (office). Modifier 78 requires a return to the operating room or procedure room (e.g. Cath Lab, Interventional Radiology Procedure Room, Endoscopy Room).

Unrelated Procedures or Visits during the Postoperative Period


Modifier 79 reports an unrelated procedure by the same physician during a postoperative period. The physician may need to indicate that the performance of a procedure or service during a postoperative period was unrelated to the original procedure.

When the next surgical procedure is billed a new postoperative period begins.


Reimbursement Guidelines


Modifiers 58, 78, and 79 are not valid to use with or attach to evaluation and management (E/M) procedure codes. Modifiers 58, 78, and 79 are considered valid for procedures with a Global Days indicator setting of 010 or 090. Modifiers 58, 78, and 79 are not considered valid for procedures with a Global Days indicator setting of 000, XXX, or ZZZ.

Modifiers 58, 78, and 79 are mutually exclusive to one another; only one of these modifiers may apply to a service or procedure performed within a postoperative global period. Services may not be “unrelated” to the procedure code creating the postoperative global period and also “related” to another procedure code performed by the same physician during that same original surgical session.

Example usage

A septoplasty (30520, 90-day global) and a functional endoscopic sinus surgery (FESS, 0-day or 10-day global) are performed during the same surgical session. An endoscopic sinus debridement (31237, S2342) is performed in the office 14 days later. Because the debridement is related to the FESS, then it is also related to the septoplasty, and the 90-day global period applies to the post-operative sinus debridement.

Multiple Procedures During the Same Surgical Session Modifiers 78 and 79 should not be used to distinguish multiple procedure codes performed during the same operative session. The postoperative period does not begin until the surgical session ends. This is not a valid use of modifier 78 or 79, and represents a billing error.

During the initial surgery performed by this provider, a variety of procedures are performed on multiple skin lesions in multiple locations during the same surgical session. Neither modifier 78 nor modifier 79 should be attached to the procedure codes for the second and third lesions treated. Treatment of a second, separate lesion is correctly identified with the Distinct Procedural Service modifier (-59).

Wednesday, March 13, 2019

CPT Q2043 - Cellular Immunotherapy for Prostate Cancer

Code Description HCPCS
Q2043 Sipuleucel-T, minimum of 50 million autologous CD54+ cells activated with PAP-GMCSF, including leukapheresis and all other preparatory procedures, per infusion (Provenge®)





 Cellular Immunotherapy for Prostate Cancer


Introduction

Immunotherapy is a way to fight disease, even cancer, by using a person’s own immune system. Dendritic cells are part of the immune system. They help the immune system spot cancer cells. When the dendritic cells find and start to break down cancer cells, other immune cells are activated to also attack the cancer cells. In some cases of advanced prostate cancer, a vaccine can be made using a person’s own immune cells. Certain immune cells are removed, treated in a lab to create dendritic cells, and then given back to the person. This very specialized vaccine then helps the body fight prostate cancer. This policy describes when this type of immunotherapy may be approved for prostate cancer.

Note:  The Introduction section is for your general knowledge and is not to be taken as policy coverage criteria. The rest of the policy uses specific words and concepts familiar to medical professionals. It is intended for providers. A provider can be a person, such as a doctor, nurse, psychologist, or dentist. A provider also can be a place where medical care is given, like a hospital, clinic, or lab. This policy informs them about when a service may be covered.


Therapy Medical Necessity

Sipuleucel-T therapy Sipuleucel-T therapy may be considered medically necessary in the treatment of asymptomatic or minimally symptomatic, androgen-independent (castration-resistant) metastatic prostate cancer. 

Note: Provenge® is the brand or trade name for sipuleucel-T.




Therapy Investigational


Sipuleucel-T therapy Sipuleucel-T therapy is considered investigational in all other situations, including but not limited to: * Treatment of hormone-responsive prostate cancer * Treatment of moderate to severe symptomatic metastatic



Documentation Requirements

prostate cancer * Treatment of visceral (liver, lung, or brain) metastases


The patient’s medical records submitted for review for all conditions should document that medical necessity criteria are met. The record should include clinical documentation of all of the following: * Patient has metastatic prostate cancer that is castrate-resistant (does not respond to hormone
treatment) * Patient is asymptomatic or minimally symptomatic * Patient has no liver, lung, or brain metastases




Evidence Review 

Description


Sipuleucel-T (Provenge) is a class of therapeutic agent used to treat symptomatic castrationresistant, metastatic prostate cancer. The agent comprises specially treated dendritic cells obtained from the patient through leukapheresis. The cells are then exposed in vitro to proteins that contain prostate antigens and immunologic-stimulating factors and reinfused into the patient. The proposed mechanism of action is that treatment stimulates the patient’s own immune system to resist cancer spread.



Background

Prostate Cancer

Prostate cancer is the second leading cause of cancer-related deaths among American men, with an estimated incidence of 164,690 cases and an estimated number of 29,430 deaths in 2018.

In most cases, prostate cancer is diagnosed at a localized stage and is treated with prostatectomy or radiotherapy. However, some patients are diagnosed with metastatic disease or recurrent disease after treatment of localized disease.



Treatment

Androgen ablation is the standard treatment for metastatic or recurrent disease. Most patients who survive long enough eventually develop androgen-independent (castration-resistant) prostate cancer. At this stage of metastatic disease, docetaxel, a chemotherapeutic agent, has demonstrated a survival benefit of 1.9 to 2.4 months in randomized clinical trials.

Chemotherapy with docetaxel causes adverse effects in large proportions of patients, including alopecia, fatigue, neutropenia, neuropathy, and other symptoms. Trials evaluating docetaxel included both asymptomatic and symptomatic patients, and results have suggested a survival benefit for both groups. Because of the burden of treatment and its adverse effects, most patients therefore defer docetaxel treatment until cancer recurrence is symptomatic.

Cancer immunotherapy has been investigated as a treatment that could be instituted at the point of detection of androgen-independent metastatic disease before significant symptomatic manifestations have occurred. The quantity of cancer cells in the patient during this time is thought to be relatively low, and it is thought that an effective immune response to the cancer during this interval could effectively delay or prevent progression. Such a delay could allow a course of effective chemotherapy, such as docetaxel, to be deferred or delayed until necessary, thus providing an overall survival benefit.



Summary of Evidence

For individuals who have asymptomatic or minimally symptomatic metastatic castrationresistant prostate cancer who receive sipuleucel-T (Provenge), the evidence includes 3 randomized controlled trials (RCTs) and a systematic review of these RCTs. Relevant outcomes are overall survival, disease-specific survival, change in disease status, and treatment-related morbidity. The 2 earlier RCTs of sipuleucel-T were not specifically designed to demonstrate a difference in overall mortality but did show a survival difference. The third RCT, which was designed to demonstrate a mortality difference, showed a similar improvement in overall survival. All 3 studies were consistent in demonstrating that sipuleucel-T does not delay time to measureable progression of disease. A meta-analysis of the 3 RCTs found significantly improved overall survival, but not time to progression, with sipuleucel-T compared with placebo. Serious adverse events did not increase in the sipuleucel-T group. However, the available data suggested, but did not confirm, an increase in stroke risk; this risk is being evaluated in a postmarketing study. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome.

For individuals who have nonmetastatic androgen-dependent prostate cancer who receive sipuleucel-T (Provenge), the evidence includes an RCT. Relevant outcomes are overall survival, disease-specific survival, change in disease status, and treatment-related morbidity. The RCT did not find a statistically significant difference between sipuleucel-T and a control in time to biochemical failure. The RCT was not designed to evaluate the impact of sipuleucel-T on mortality. The evidence is insufficient to determine the effects of the technology on health outcomes.



Medicare National Coverage

The Centers for Medicare & Medicaid Services released a national coverage determination in 2011 approving sipuleucel-T for treatment of asymptomatic or minimally symptomatic castrateresistant prostate cancer.



Coverage for off-label indications was left to the discretion of local Medicare administrative contractors.

Regulatory Status
In  2010, the U.S. Food and Drug Administration approved Provenge® (sipuleucel-T; Dendreon Corp., now Sanpower) under a Biologics Licensing Application for “the treatment of asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer.”

Approval was contingent on the manufacturer conducting a postmarketing study, based on a registry design, to assess the risk of cerebrovascular events in 1500 men with prostate cancer who receive sipuleucel-T.

Wednesday, February 13, 2019

CPT 20999, 38206, 38241 - Mesenchymal stem cells


Code Description CPT

20999 Unlisted procedure, musculoskeletal system, general

38206 Blood-derived hematopoietic progenitor cell harvesting for transplantation, per collection; autologous

38241 Hematopoietic progenitor cell (HPC); autologous transplantation





Orthopedic Applications of Stem Cell Therapy (Including Allografts and Bone Substitutes Used with Autologous Bone Marrow)


Mesenchymal stem cells are adult stem cells which are usually found in the bone marrow. These stem cells can generate other types of cells that are part of the body’s musculoskeletal system, such as bone, cartilage, and muscle. Stem cells are being studied as a way to treat orthopedic problems like damaged bone, ligaments, tendons, and the discs between the bones of the spine. Using stem cells to treat orthopedic problems is unproven. Studies have not yet shown the best ways to gather and deliver these cells. Studies also have not yet shown that using stem cells for orthopedic conditions leads to better health results compared to usual treatments.

Note:   The Introduction section is for your general knowledge and is not to be taken as policy coverage criteria. The rest of the policy uses specific words and concepts familiar to medical professionals. It is intended for providers. A provider can be a person, such as a doctor, nurse, psychologist, or dentist. A provider also can be a place where medical care is given, like a hospital, clinic, or lab. This policy informs them about when a service may be covered. 


Policy Coverage Criteria 

Note: This policy does not address unprocessed allograft bone.  Service Investigational

Mesenchymal stem cell therapy
Allograft bone products containing viable stem cells
Allograft or synthetic bone graft substitutes

Coding 

Mesenchymal stem cell therapy is considered investigational for all orthopedic applications, including use in repair or regeneration of musculoskeletal tissue.

Allograft bone products containing viable stem cells, including but not limited to demineralized bone matrix (DBM) with stem cells, are considered investigational for all orthopedic applications.

Allograft or synthetic bone graft substitutes that must be combined with autologous blood or bone marrow are considered investigational for all orthopedic applications.



Benefit Application

The Regenexx® procedure is currently performed at select centers in the United States. Therefore, requests for it may be made for an out-of-network facility.



Evidence Review 

Description

Mesenchymal stem cells (MSCs) have the capability to differentiate into a variety of tissue types, including various musculoskeletal tissues. Potential uses of MSCs for orthopedic applications include treatment of damaged bone, cartilage, ligaments, tendons and intervertebral discs.

Background  Mesenchymal Stem Cells 

MSCs are multipotent cells (also called stromal multipotent cells) that can differentiate into various tissues including organs, trabecular bone, tendon, articular cartilage, ligaments, muscle, and fat. MSCs are associated with the blood vessels within bone marrow, synovium, fat, and muscle, where they can be mobilized for endogenous repair as occurs with healing of bone fractures. Tissues such as muscle, cartilage, tendon, ligaments, and vertebral discs show limited capacity for endogenous repair because of the limited presence of the triad of tissue functional components: vasculature, nerves, and lymphatics. Orthobiologics is a term introduced to describe interventions using cells and biomaterials to support healing and repair. Cell therapy is the application of MSCs directly to a musculoskeletal site. Tissue engineering techniques use MSCs and/or bioactive molecules such as growth factors and scaffold combinations to improve the efficiency of repair or regeneration of damaged musculoskeletal tissues.

Bone-marrow aspirate is considered to be the most accessible source and, thus, the most common place to isolate MSCs for treatment of musculoskeletal disease. However, harvesting MSCs from bone marrow requires an additional procedure that may result in donor-site morbidity. In addition, the number of MSCs in bone marrow is low, and the number and differentiation capacity of bone marrow*derived MSCs decreases with age, limiting their efficiency when isolated from older patients. 


In vivo, the fate of stem cells is regulated by signals in the local 3-dimensional microenvironment from the extracellular matrix and neighboring cells. It is believed that the success of tissue engineering with MSCs will also require an appropriate 3-dimensional scaffold or matrix, culture conditions for tissue-specific induction, and implantation techniques that provide appropriate biomechanical forces and mechanical stimulation. The ability to induce cell division and differentiation without adverse effects, such as the formation of neoplasms, remains a significant concern. Given that each tissue type requires different culture conditions, induction factors (signaling proteins, cytokines, growth factors), and implantation techniques, each preparation must be individually examined. 

Summary of Evidence

For individuals who have cartilage defects, meniscal defects, joint fusion procedures, or osteonecrosis who receive stem cell therapy, the evidence includes small randomized controlled trials and nonrandomized comparative trials. Relevant outcomes are symptoms, morbid events, functional outcomes, quality of life, and treatment-related morbidity. Use of mesenchymal stem cells (MSCs) for orthopedic conditions is an active area of research. Despite continued research into the methods of harvesting and delivering treatment, there are uncertainties regarding the optimal source of cells and the delivery method. Studies have included MSCs from bone marrow, adipose tissue, peripheral blood, and synovial tissue. The largest body of evidence is on use of autologous MSCs, either concentrated or expanded in culture, for cartilage repair. This evidence includes small randomized and nonrandomized comparative trials with insufficient data to evaluate health outcomes. In addition, expanded MSCs for orthopedic applications are not U.S. Food and Drug Administration (FDA)*approved (concentrated autologous MSCs do not require FDA approval). Overall, there is a lack of evidence that clinical outcomes are improved. The evidence is insufficient to determine the effects of the technology on health outcomes.

Ongoing and Unpublished Clinical Trials

Some currently unpublished trials that might influence this review are listed in Table 1. Many are observational studies with commercially available products (eg, Cartistem, AlloStem, Trinity Evolution, Osteocel Plus).



Practice Guidelines and Position Statements

American Association of Orthopaedic Surgeons


The 2013 and 2014 American Association of Orthopaedic Surgeons’ guidelines on treatment of glenohumeral joint osteoarthritis have indicated:

* Treatment using allograft, autograft, biologic, and interpositional grafts in patients with glenohumeral joint osteoarthritis is inconclusive
, and that

* Treatment using growth factor injections and/or platelet rich plasma for patients with symptomatic osteoarthritis of the knee is inconclusive.

Sunday, January 13, 2019

cpt 38230, 38232, 38240- 38241, S2140, S2142, S2150 - Chronic Myeloid Leukemia

Code Description CPT

38230 Bone marrow harvesting for transplantation; allogeneic

38232 Bone marrow harvesting for transplantation; autologous

38240 Hematopoietic progenitor cell (HPC); allogeneic transplantation per donor

38241 Hematopoietic progenitor cell (HPC); autologous transplantation

38242 Allogeneic lymphocyte infusions

HCPCS

S2140 Cord blood harvesting for transplantation, allogeneic

S2142 Cord blood derived stem cell transplantation, allogeneic

S2150 Bone marrow or blood-derived stem cells (peripheral or umbilical), allogeneic or autologous, harvesting, transplantation and related complications; including: pheresis and cell preparation/storage; marrow ablative therapy; drugs, supplies, hospitalization with outpatient follow-up; medical/surgical, diagnostic, emergency, and rehabilitative service; and the number of days of pre- and post-transplant care in the global definition


Hematopoietic Cell Transplantation for Chronic Myeloid Leukemia


Introduction

Chronic myeloid leukemia (CML) is a type of cancer that starts in certain blood-forming cells within the bone marrow. These blood-forming calls are called “hematopoietic” cells.  When a person has CML, they make too many white blood cells. Different types of treatment have been used against CML, including chemotherapy and other medications. Another common type of treatment is a hematopoietic cell transplant. In a hematopoietic cell transplant, hematopoietic cells are taken from a donor’s bone marrow and are given to the person with CML, just like in a transfusion. It is hoped that these new cells will then settle into the bone marrow and start producing normal blood cells, and the person will no longer have CML.

When the hematopoietic cells are harvested from another person, it is called an allogeneic transplant. When the cells come from the patient himself, it is called an autologous cell transplant. This policy discusses when an allogeneic hematopoietic cell transplant would be medically necessary to treat CML.


Policy Coverage Criteria 

Transplant Medical Necessity

Allogeneic hematopoietic cell transplantation (HCT)


Allogeneic hematopoietic cell transplantation (HCT) using a myeloablative conditioning regimen may be considered medically necessary as a treatment of chronic myeloid leukemia.  Allogeneic hematopoietic cell transplantation using a reducedintensity conditioning regimen may be considered medically necessary as a treatment of chronic myeloid leukemia in patients who meet clinical criteria for an allogeneic HCT but who are not considered candidates for a myeloablative conditioning allogeneic HCT.


Transplant Investigational

Autologous HCT Autologous HCT is investigational as a treatment of chronic myeloid leukemia.



Additional Information

* Some patients for whom a conventional myeloablative allotransplant could be curative may be considered candidates for reduced-intensity conditioning allogeneic hematopoietic stem-cell transplantation (HCT). These include those patients whose age (typically >60 years) or comorbidities (eg, liver or kidney dysfunction, generalized debilitation, prior intensive chemotherapy, low Karnofsky Performance Status) preclude use of a standard myeloablative conditioning regimen.

* For patients who qualify for a myeloablative allogeneic HCT on the basis of clinical status, either a myeloablative or reduced-intensity conditioning regimen may be considered medically necessary.






Related Information 

Benefit Application


The following considerations may supersede this policy: * State mandates requiring coverage for autologous bone marrow transplantation offered as  part of clinical trials of autologous bone marrow transplantation approved by the National Institutes of Health (NIH).
* Some plans may participate in voluntary programs offering coverage for patients participating in NIH-approved clinical trials of cancer chemotherapies, including autologous bone marrow transplantation.



* Some contracts or certificates of coverage may include specific conditions in which autologous bone marrow transplantation would be considered eligible for coverage.


Evidence Review 

Description

Chronic myeloid leukemia (CML) is a hematopoietic stem cell disorder that is characterized by the presence of a chromosomal abnormality called the Philadelphia chromosome, which results from reciprocal translocation between the long arms of chromosomes 9 and 22. CML most often presents in a chronic phase from which it progresses to an accelerated and then a blast phase. Allogeneic hematopoietic cell transplantation (allo-HCT) is a treatment option for CML.

Background  Chronic Myeloid Leukemia

CML is a hematopoietic stem-cell disorder that is characterized by the presence of a chromosomal abnormality called the Philadelphia chromosome, which results from reciprocal translocation between the long arms of chromosomes 9 and 22. This cytogenetic change results in constitutive activation of BCR-ABL, a tyrosine kinase (TK) that stimulates unregulated cell proliferation, inhibition of apoptosis, genetic instability, and perturbation of the interactions between CML cells and the bone marrow stroma only in malignant cells. CML accounts for about 15% of newly diagnosed cases of leukemia in adults and occurs in about 1 to 2 cases per 100,000 adults.

The natural history of the disease consists of an initial (indolent) chronic phase, lasting a median of 3 years, which typically transforms into an accelerated phase, followed by a "blast crisis," which is usually the terminal event. Most patients present in chronic phase, often with nonspecific symptoms that are secondary to anemia and splenomegaly. CML is diagnosed based on the presence of the Philadelphia chromosome abnormality by routine cytogenetics, or by detection of abnormal BCR-ABL products by fluorescence in situ hybridization or molecular studies, in the setting of persistent unexplained leukocytosis. Conventional-dose chemotherapy regimens used for chronic-phase disease can induce multiple remissions and delay the onset of  blast crisis to a median of 4 to 6 years. However, successive remissions are usually shorter and more difficult to achieve than their predecessors.

Treatment

Historically, the only curative therapy for CML in blast phase has been allogeneic hematopoietic cell transplantation (allo-HCT), which was used more widely earlier in the disease process given the lack of other curative therapies for chronic phase CML as well as improved efficacy when used prior to blast phase. Prior to the current TKI (tyrosine kinase inhibitor) drug era therapies for chronic phase CML were limited to nonspecific agents including busulfan, hydroxyurea, and interferon-a.

Imatinib mesylate (Gleevec®), a selective inhibitor of the abnormal BCR-ABL TK protein, for example, among the initial treatments of choice for newly diagnosed CML. Imatinib and other TKIs can be highly effective in suppressing CML in most patients, and some patients can achieve complete molecular remissions unmaintained after several years of therapy.  The overall survival (OS) of patients who present in chronic phase is greater than 95% at 2 years and 80% to 90% at 5 years.

For CML, 2 other tyrosine kinase inhibitors (TKIs; dasatinib, nilotinib) have received marketing approval from the U.S. Food and Drug Administration (FDA) as front-line therapies or following failure or patient intolerance of imatinib. Recently two additional TKIs (bosutinib, ponatinib) have been approved for use in patients resistant or intolerant to prior therapy.

For patients who progress on imatinib, the therapeutic options include increasing the imatinib dose, changing to another TKI, or allo-HCT. Detection of BCR-ABL variants may be important in determining an alternative TKI; the presence of T315I mutation is associated with resistance to all TKIs except ponitinib and may indicate the need for allo-HCT or an experimental therapy. TKIs have been associated with long-term remissions; if progression occurs after exhausting TKI therapy, allo-HCT is generally indicated and offers the potential for cure.

Hematopoietic Cell Transplant

Hematopoietic cell transplantation (HCT) is a procedure in which hematopoietic stem cells are infused to restore bone marrow function in cancer patients who receive bone-marrow-toxic doses of drugs with or without whole body radiotherapy. Hematopoietic stem cells may be obtained from the transplant recipient (autologous HCT) or from a donor (allogeneic HCT). They  can be harvested from bone marrow, peripheral blood, or umbilical cord blood shortly after delivery of neonates. Although cord blood is an allogeneic source, the stem cells in it are antigenically “naive” and thus are associated with a lower incidence of rejection or graft-versushost disease (GVHD). Cord blood is discussed in greater detail in another policy. (See Related Policies.)

Immunologic compatibility between infused hematopoietic stem cells and the recipient is not an issue in autologous HCT. However, immunologic compatibility between donor and patient is a critical factor for achieving a good outcome of allogeneic HCT. Compatibility is established by typing of human leukocyte antigens (HLAs) using cellular, serologic, or molecular techniques. HLA refers to the tissue type expressed at the HLA A, B, and DR loci on each arm of chromosome 6. Depending on the disease being treated, an acceptable donor will match the patient at all or most of the HLA loci (with the exception of umbilical cord blood).
 
Conditioning for HCT


The conventional (“classical”) practice of allogeneic HCT involves administration of cytotoxic agents (eg, cyclophosphamide, busulfan) with or without total body irradiation at doses sufficient to destroy endogenous hematopoietic capability in the recipient. The beneficial treatment effect in this procedure is due to a combination of initial eradication of malignant cells and subsequent graft-versus-malignancy (GVM) effect that develops after engraftment of allogeneic stem cells within the patient’s bone marrow space. While the slower GVM effect is considered to be the potentially curative component, it may be overwhelmed by extant disease without the use of pretransplant conditioning. However, intense conditioning regimens are limited to patients who are sufficiently fit medically to tolerate substantial adverse effects that include pre-engraftment opportunistic infections secondary to loss of endogenous bone marrow function and organ damage and failure caused by the cytotoxic drugs. Furthermore, in any allogeneic HCT, immune suppressant drugs are required to minimize graft rejection and GVHD, which also increases susceptibility of the patient to opportunistic infections. The immune reactivity between donor T cells and malignant cells that is responsible for the GVM effect also leads to acute and chronic GVHD. 

The success of autologous HCT is predicated on the ability of cytotoxic chemotherapy with or without radiation to eradicate cancerous cells from the blood and bone marrow. This permits subsequent engraftment and repopulation of bone marrow space with presumably normal hematopoietic stem cells obtained from the patient before undergoing bone marrow ablation. As a consequence, autologous HCT is typically performed as consolidation therapy when the patient’s disease is in complete remission. Patients who undergo autologous HCT are

susceptible to chemotherapy-related toxicities and opportunistic infections before engraftment, but not GVHD.

RIC (Reduced Intensity Conditioning) for Allogeneic HCT

RIC refers to the pretransplant use of lower doses or less intense regimens of cytotoxic drugs or radiation than are used in conventional full-dose myeloablative conditioning treatments. The goal of RIC is to reduce disease burden but also to minimize as much as possible associated treatment-related morbidity and nonrelapse mortality (NRM) in the period during which the beneficial GVM effect of allogeneic transplantation develops. Although the definition of RIC remains arbitrary, with numerous versions employed, all seek to balance the competing effects of NRM and relapse due to residual disease. RIC regimens can be viewed as a continuum in effects, from nearly totally myeloablative, to minimally myeloablative with lymphoablation, with intensity tailored to specific diseases and patient condition. Patients who undergo RIC with allogeneic HCT initially demonstrate donor cell engraftment and bone marrow mixed chimerism. Most will subsequently convert to full-donor chimerism, which may be supplemented with donor lymphocyte infusions to eradicate residual malignant cells. For the purposes of this Policy, the term “reduced-intensity conditioning” will refer to all conditioning regimens intended to be nonmyeloablative, as opposed to fully myeloablative (conventional) regimens.

For CML, RIC regimens were initially used to extend the use of allogeneic HCT to the estimated 70% of CML patients who were ineligible for myeloablative conditioning regimens because of advanced age or comorbidities. The use of RIC and allogeneic HCT is of particular interest for treatment of CML given the relatively pronounced susceptibility of this malignancy to the graft versus leukemia (GVL) effect of allogeneic hematopoietic progenitor cells following their engraftment in the host.


Friday, December 14, 2018

CPT 0017u, 0037u, 81445, 81450, 81455

Coding Code Description CPT

0017U Oncology (hematolymphoid neoplasia), JAK2 mutation, DNA, PCR amplification of  exons 12 - 14 and sequence analysis, blood or bone marrow, report of  JAK2 mutation not detected or detected

0037U Targeted genomic sequence analysis, solid organ neoplasm, DNA analysis of 324  genes, interrogation for sequence variants, gene copy number  amplifications, gene  rearrangements, microsatellite instability and tumor mutational burden

81445 Targeted genomic sequence analysis panel, solid organ  neoplasm, DNA analysis, and  RNA analysis when performed, 5 - 50 genes (eg, ALK, BRAF, CDKN2A, EGFR, ERBB2, KIT,  KRAS, NRAS, MET, PDGFRA, PDGFRB, PGR, PIK3CA, PTEN, RET), interrogation for  sequence variants and copy number variants or rearrangements, if performed

81450 Targeted genomic sequence analysis panel, hematolymphoid neoplasm or disorder,  DNA analysis, and RNA analysis when performed, 5 - 50 genes (eg, BRAF, CEBPA,  DNMT3A, EZH2, FLT3, IDH1, IDH2, JAK2, KRAS, KIT, MLL, NRAS, NPM1, NOTCH1),  interrogation  for sequence variants, and copy number variants or rearrangements, or isoform expression or mRNA expression levels, if performed

81455 Targeted genomic sequence analysis panel, solid organ or hematolymphoid neoplasm,  DNA analysis, and RNA analysis when performed, 51 or greater genes (eg, ALK, BRAF, CDKN2A, CEBPA, DNMT3A, EGFR, ERBB2, EZH2, FLT3, IDH1, IDH2, JAK2, KIT, KRAS, MLL, NPM1, NRAS, MET, NOTCH1, PDGFRA, PDGFRB, PGR, PIK3CA, PTEN, RET), interrogation for sequence variants and copy number variants or rearrangements, if performed



Introduction

Medical studies have shown that doing  specific genetic tests on  certain  tumors  is useful  in  choosing which treatment to use .  These genetic tests look  for the presence or absence of known  genetic changes.  The results can be used to match a person to  the  therapy that will be most  helpful .  There are other types of genetic tests that look at a very large number of genes.  These tests  are known as expanded molecular panels. They can  test hundreds of genes. The difficulty with expanded molecular panels is that most of the genetic markers tested haven’t been shown to affect either cancer growth or cancer therapies. Because more study is needed,  expanded  molecular panels  are considered  investigational.

Note: The Introduction section is for your general knowledge and is not to be  taken as policy coverage criteria. The  rest of the policy uses specific words and concepts familiar to medical professionals. It is intended for  providers. A provider can be a person, such as a doctor, nurse, psychologist, or dentist. A provider also can be a place where medical care is given, like a hospital, clinic, or lab.This policy informs them about when a service may be covered.


Genetic Counseling

Genetic counseling is primarily aimed at patients who are at risk for inherited disorders, and  experts recommend formal genetic counseling in most cases when genetic testing for an  inherited condition is considered. The interpretation of the results of genetic tests and the understanding of risk factors can be very difficult and complex. Therefore, genetic counseling will assist individuals in understanding the possible benefits and harms of genetic testing,  including the possible impact of the information on the individual’s family. Genetic counseling may alter the utilization of genetic testing substantially and may reduce inappropriate testing. Genetic counseling should be performed by an individual with experience and expertise in genetic medicine and genetic testing methods.

Description

There is interest in treating cancers by targeting biologic pathways  that are influenced by specific genetic markers. Genetic panel testing offers the potential to evaluate a large number of  genetic markers at a single time to identify treatments that target specific pathways.  Some individual markers have established benefit in certain types of cancers; they are not addressed in this medical policy. Rather,  this review focuses  on “expanded” panels, which are defined as panels that test a wide variety of genetic markers in cancers without regard for whether specific  targeted treatment has demonstrated benefit. This approach may result in a treatment different than that usually selected for a patient based on the type of cancer and stage.

Background


Traditional Therapeutic Approaches to Cancer Tumor location, grade, stage, and the patient’s underly ing physical condition have traditionally  been used in clinical oncology to determine the therapeutic approach to a specific cancer, which could include surgical resection, ionizing radiation, systemic chemotherapy, or combinations thereof. Currently, some 100 different types of tumors are broadly categorized according to the tissue, organ, or body compartment in which  they arise. Most treatment approaches in clinical care were developed and evaluated in studies that recruited subjects and categorized results based on this traditional classification scheme.

This traditional approach to cancer treatment does not reflect the wide diversity of cancer at the
molecular level. While treatment by organ type, stage, and grade may demonstrate statistically significant therapeutic efficacy overall, only a subgroup of patients may actually derive clinically significant benefit. It is unusual for a cancer treatment to be effective for all patients treated in a traditional clinical trial. Spear et al analyzed the efficacy of major drugs used to treat several important diseases.They reported heterogeneity of therapeutic responses, noting a low of 25%  for cancer chemotherapeutics , with response  rates for most drugs falling in the range of 50% to 75%. The low rate for  cancer treatments is indicative of the need for better identification of  characteristics associated with treatment response and better targeting of treatment in order to have higher rates of therapeutic responses.

 Targeted Cancer Therapy

Much of the variability in clinical response may result from genetic variations. Within each broad  type of cancer, there may be a large amount of variability in the genetic underpinnings of the cancer. Targeted cancer treatment refers to the identification of genetic abnormalities present in
the cancer of a particular patient, and the use of drugs that target the specific genetic abnormality.  The use of genetic markers allows cancers  to be further classified by “pathways” defined at the molecular level. An expanding number  of genetic markers have been identified.  Dienstmann et al (2013) categorized these  markers into 3 classes : 2 ( 1)  genetic  markers that have  a direct impact on care for the specific cancer of interest,  (2) genetic  markers that may be biologically important but are not currently actionable, and (3) genetic markers of unknown importance.

A small number of individual genetic markers fall into the first category (ie, have established utility for a particular cancer type). The utility of these markers has been demonstrated by randomized controlled trials that select patients with the marker and report significant improvements in outcomes with targeted therapy compared with standard therapy. This medical policy does not apply to the individual markers that have demonstrated efficacy. According to  recent National Comprehensive Cancer Network guidelines,the following markers have demonstrated utility for predicting treatment response to targeted therapies for the specific cancers listed:

* Breast cancer
o HER2 (ERBB2
* Colon cancer
oRAS variants(KRAS, NRAS)
oBRAF c1799T>A
*Non-small-cell lung cancer (NSCLC)
oEGFR
oALK/ROS1
oKRAS
oRET
oMET
*Metastatic melanoma
oBRAF v600
oC-KIT
*Ovarian cancer
oBRCA (germline)
*Chronic myeloid leukemia
oBRC-ABL
*Gastrointestinal stromal tumors
oC-KIT
Testing for these individual variants with established utility is not  addressed in this medical  policy.In some cases, limited panels may be offered that are specific to 1 type of cancer (eg, a panel of several markers for NSCLC). This policy is also not intended to address the use of these cancer
-specific panels that include a few variants. Rather, the intent is to address expanded panels that test for many potential variants that do not have established efficacy for the specific cancer in question.

When advanced cancers are tested with expanded  molecular panels, most patients are found to  have at least 1 potentially pathogenic  variant. The number of  variants varies widely by types of cancers, different variants included in testing, and different testing methods among the available studies. In a 2015 study, 439 patients with diverse cancers were tested with a 236 - gene panel.A  total of 1,813 molecular alterations were identified, and almost all patients (420/439 [96%]) had at least 1 molecular alteration. The median number of alterations per patient was 3, and 85% of patients (372/439) had 2 or more alterations. The most common alterations were in the genes TP53 (44%), KRAS (16%), and PIK3CA (12%).

Some evidence is available on the generalizability of targeted treatment based on a specific  variant among cancers that originate from different organs. 2,3,7 There are several examples of variant-directed treatment that was effective in 1 type of cancer but ineffective in another. For example, targeted therapy for epidermal growth factor receptor (EGFR) variants has been successful in NSCLC but not in trials of other cancer types. Treatment with tyrosine kinase inhibitors based on variant testing has been effective for renal cell carcinoma, but has not demonstrated effectiveness for other cancer types tested.  “Basket” studies, in which tumors of  various histologic types that share a common genetic variant are treated with a targeted agent, also have been performed. One such study was published in 2015 by Hyman etal.

In this study, 122 patients with BRAF V600 variants in nonmelanoma cancers were treated with vemurafenib.The authors reported that there appeared to be antitumor activity for some but not all cancers, with the most promising results seen for NSCLC, Erdheim-Chester disease, and Langerhans cell histiocytosis.


Summary of Evidence

For individuals who have cancers that have not responded to standard therapy and whose tumors were tested with an expanded cancer molecular panel, the evidence includes a randomized controlled trial, nonrandomized trials, and numerous case series. Relevant outcomes are overall survival, disease-specific survival, test accuracy and validity, and other test performance measures. The analytic validity of these panels is likely to be high when next-generation sequencing is used. The clinical validity of the individual variants for particular types of cancer is not easily obtained from the available published literature. The large number of variants and many different types of cancer preclude determination of clinical validity for the panels as a whole. Some evidence has reported that many of the identified variants are false positives (ie, not biologically active), after filtering by comparison with matched normal tissue and cancer variant databases. To demonstrate clinical utility, direct evidence from interventional trials, ideally randomized controlled trials, are needed that compare the strategy of targeted treatment based on panel results with standard care. The first such published randomized controlled trial (the SHIVA trial)reported that there was no difference in progression-free survival when panels were used in this way. Some nonrandomized comparative studies, comparing matched treatment with nonmatched treatment, have reported that outcomes are superior for patients receiving matched treatment. However, these studies are inadequate to determine treatment efficacy ,because the populations with matched and unmatched cancers may differ on several important clinical and prognostic variables. Also , there is potential for harm if ineffective therapy is given based on test results, because there may be adverse effects of therapy in absence of a benefit. The evidence is insufficient to determine the effects of the technology on health outcomes.

Tuesday, November 13, 2018

CPT 43284, 438285 - sphincter augmentation device - GERD


Coding Code Description CPT

43284 Laparoscopy, surgical, esophageal sphincter augmentation procedure, placement of  sphincter  augmentation device (ie,magnetic band), including cruroplasty when performed

43285 Removal of esophageal sphincter augmentation device

GERD

gastroesophageal reflux disease  — is a  long - term medical condition. It’s a digestive  problem that affects the ring of muscles between the esophagus (the tube that carries swallowed food to the stomach) and the stomach. When food is swallowed, the muscles at the end of the esophagus open so food can pass into the stomach. The muscles then close to prevent acid from backing up into the esophagus. In GERD, however, the ring of muscles is too weak. GERD is usually treated with changes to lifestyle and diet. A number of other treatments have been studied.

One technique calls for placing a ring of magnetic beads around the base of the esophagus, just above the stomach. The ring opens to allow swallowed food into the stomach and then immediately tightens . This technique is investigational (unproven). More and longer studies are needed to find out how well such devices work.

Note:
The Introduction section is for your general knowledge and is not to be taken as policy coverage criteria. The  rest of the policy uses specific words and concepts familiar to medical professionals. It is intended for providers. A provider can be a person, such as a doctor, nurse, psychologist, or dentist. A provider also can be a place where medical care is given, like a hospital, clinic, or lab. This policy  informs them about  when a  service may be covered.


Description


A laparoscopically implanted ring composed of interlinked titanium beads with magnetic cores has been developed for the treatment of gastroesophageal reflux disease (GERD). The device is placed around the esophagus at the level of the gastroesophageal junction and is being evaluated in patients who have GERD symptoms, despite maximal medical therapy.

Background

Gastroesophageal Reflux Disease


Gastroesophageal reflux disease (GERD) is defined as reflux of stomach acid into the esophagus that causes symptoms and/or mucosal injury.  GERD is a common medical disorder, with  estimates of 10% to 20% prevalence in developed countries. The severity of GERD varies widely.  Many patients have mild, intermittent symptoms that do not require treatment or only require occasional use of acid blocker medications. Other patients have chronic, severe GERD that can  lead to complications such as Barrett esophagus and esophageal cancer.

Treatment

For patients with severe disease, chronic treatment with acid blockers is one option. For some  patients, medications are not adequate to control symptoms; other patients prefer to avoid the use of indefinite, possibly lifelong medications. Surgical treatments are available for these  patients, primarily a Nissen fundoplication performed either laparoscopically or by open surgery.  A number of less invasive procedures are also being evaluated as an intermediate option between medical therapy and surgery

The LINX Reflux Management System is composed of a small flexible band of 10 to 18 interlinked titanium beads with magnetic cores. Using standard  laparoscopic techniques,the band is placed around the esophagus at the level of the gastroesophageal junction. The magnetic attraction between the beads is intended to augment the lower esophageal sphincter to prevent gastric reflux into the esophagus, without compressing the esophageal wall. It is proposed that swallowing food or liquids creates sufficient pressure to overcome the magnetic bond between the beads, allowing the beads to separate and temporarily increase the size of the ring. The target population is patients who have GERD symptoms despite maximum medical therapy (eg,proton pump inhibitors) but who
do not want to risk having the adverse effects of a surgical procedure like Nissen fundoplication. Adverse events of the LINX Reflux Management System may include dysphagia or odynophagia. The device can be removed by a laparoscopic procedure if severe adverse events occur or if magnetic resonance imaging is needed for another condition.

Summary of Evidence
For individuals who have GERD who receive MSA, the evidence includes prospective and retrospective observational comparative studies, 2 single -arm inter ventional trials, and a number of single-arm observational studies.Relevant outcomes are symptoms, change in disease status,  medication use, and treatment -related morbidity. In the 2 single - arm, uncontrolled  manufacturer - sponsored studies  submitted to the U.S. Food and Drug Administration for device   approval,  subjects showed improvements in GERD-HRQL scores and reduced proton pump inhibitor use. Similarly, observational comparative studies, most often comparing MSA with laparoscopic Nissen fundoplication, generally have shown that GERD-HRQL scores do not differ significantly between fundoplication and MSA, and patients can reduce proton pump inhibitor use after MSA. However, the comparative studies are retrospective and nonrandomized, may be affected by  selection bias, and the subjective outcome measures used in these studies (eg, the  GERD - HRQL scores) may be biased. A randomized trial is in progress ( NCT02505945); it will compare treatment with the MSA and treatment with double-dose proton pump inhibitors. Randomized comparisons of MSA with laparoscopic Nissen fundoplication are also needed to evaluate the relative risk-benefit of these 2 procedures. The evidence is insufficient to determine the effects of the technology on health outcomes.

Practice Guidelines and Position Statements

Society of American Gastrointestinal and Endoscopic Surgeons In 2013, the Society of American Gastrointestinal and Endoscopic Surgeons  published guidelines

on the safety and effectiveness of the LINX Reflux Management System.The Society indicated that safety analyses of the LINX system suggested the procedure is associated with few serious adverse events and no reported mortality, and that currently available data demonstrated a reasonable assurance as to the efficacy of the system. The guidelines concluded that direct comparative studies between the LINX procedure and Nissen fundoplication would be needed.

But based on the available evidence, the LINX device should be an option available to patients and providers for the management of medically refractory gastroesophageal reflux disease.

Monday, April 24, 2017

Anesthesia CPT code that require authorization


Anesthesiologists are NOT required to request prior authorization. The surgeon must obtain prior authorization when required for procedures identified in the Medical and Surgical Procedure Code List included with the Utah Medicaid
Provider Manual for Physician Services.

The anesthesiologist is required to enter the prior authorization number obtained by the surgeon for the CPT code when billing an ASA code related to a CPT procedure for a hysterectomy, sterilization or abortion. The ASA procedure codes listed below are associated with surgical codes that may require prior authorization by Medicaid.

If federal requirements for obtaining prior authorization for a hysterectomy, sterilization or abortion are not met,Medicaid cannot reimburse either the physician or the anesthesiologist. Exceptions (to the requirement that the surgeon obtain Prior Authorization before the procedure is performed) can
be considered ONLY under one of the following circumstances:

1. The procedure was performed in a life-threatening or justifiable emergency situation.
2. Medicaid is responsible for the delay in prior authorization.
3. The patient is retroactively eligible for Medicaid.

Retroactive authorization for services related to these exceptions may be granted "after-the-fact" with appropriate documentation and review. If approved, the associated ASA code may also be reimbursed.

For additional information about the prior authorization process, refer to the Utah Medicaid Provider Manual, SECTION I, or contact Medicaid Information.

ASA Codes Associated with CPT Codes That May Require Prior Authorization

00402 Anesthesia for reconstructive breast procedures (reduction, augmentation, muscle flaps)

00580 Anesthesia for heart transplant or heart-lung transplant

00796 Liver transplant (recipient)

00840 Anesthesia for intraperitoneal procedures in lower abdomen (hysterectomy and sterilization)

00846 Anesthesia for radical hysterectomy

00848 Anesthesia for pelvic exenteration

00855 Anesthesia for cesarean hysterectomy

00922 Anesthesia for seminal vesicles

00926 Male, external genitalia; radical orchiectomy, inguinal

00928 Anesthesia for inguinal orchiectomy

00932 Anesthesia for complete amputation of penis

00934 Anesthesia for radical amputation of penis with bilateral inguinal lymphadenectomy

00936 Anesthesia for radical amputation of penis with bilateral inguinal and iliac lymphadenectomy

00940 Anesthesia for abortion procedures

00944 Anesthesia for vaginal hysterectomy

00952 Anesthesia for hysteroscopy

Concurrent Medically Directed Anesthesia Procedures

Concurrent Medically Directed Procedures

Concurrency is defined with regard to the maximum number of procedures that the physician is medically directing within the context of a single procedure and whether the other procedures overlap each other. Concurrency is not dependent on each of the cases involving a Medicare patient. For example, if an anesthesiologist directs three concurrent procedures, two of which involve non-Medicare patients and one Medicare patient, this represents three (3) concurrent cases.

The following example illustrates this concept and guides physicians in determining how many procedures are directed:
Procedures A through E are medically directed procedures involving CRNAs. The starting and ending times for each procedure represent the periods during which anesthesia times are counted.

Procedure A begins at 8:00AM and ends at 8:20AM
Procedure B begins at 8:10AM and ends at 8:45AM
Procedure C begins at 8:30AM and ends at 9:15AM
Procedure D begins at 9:00AM and ends at 12:00 noon
Procedure E begins at 9:10AM and ends at 9:55AM

Procedure     Number of Concurrent Medically Directed Procedures     Base Unit Reduction Percentage

A                           2                                                                                              10%
B                           2                                                                                              10%
C                           3                                                                                              25%
D                           3                                                                                              25%
E                           3                                                                                               25%

A physician who is concurrently directing the administration of anesthesia to not more than four (4) surgical patients cannot ordinarily be involved in rendering additional services to other patients. However, addressing an emergency of short duration in the immediate area,administering an epidural or caudal anesthetic to ease labor pain, or periodic, rather than continuous monitoring of an obstetrical patient, does not substantially diminish the scope of control exercised by the physician in directing the administration of anesthesia to the surgical patients.

It does not constitute a separate service for the purpose of determining whether the medical direction criteria are met. Further, while directing concurrent anesthesia procedures, a physician may receive patients entering the operating suite for the next surgery, check or discharge patients in the recovery room, or handle scheduling matters without affecting fee schedule payment.

However, if the physician leaves the immediate area of the operating suite for other than short durations or devotes extensive time to an emergency case or is otherwise not available to respond to the immediate needs of the surgical patients, the physician’s services to the surgical patients are supervisory in nature. No fee schedule payment is made.

The examples listed above are not intended to be an exclusive list of allowed situations. It is expected that the medically-directing anesthesiologist is aware of the nature and type of services he or she is medically directing, and is personally responsible for determining whether his supervisory capacity would be diminished if he or she became involved in the performance of a procedure. It is the responsibility of this medically-directing anesthesiologist to provide services consistent with these regulations.

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