evekhm/cms_iom_500 huggingface dataset:
Proposed LCD - Facet Joint Interventions for Pain Management (DL35936)
Use of Moderate or Deep Sedation, General Anesthesia, and Monitored Anesthesia Care (MAC) is not considered medically reasonable and necessary during facetprocedures of IA, MBB, and facet cyst aspiration/rupture.The use of Moderate Anesthesia for RFA will be considered in individual cases with documentation of medical necessity such as a longstanding well-documented history of inability to cooperate, medical conditions that would prohibit performance of the procedure, or inability to remain motionless. Patient anxiety or preference alone is not sufficient justification. Routine use of Moderate Sedation or Monitored Anesthesia Care (MAC) or use of General Anesthesia or Deep Sedation for RFA is not considered reasonable and necessary.1It is not expected that patients will routinely present with pain in both cervical/thoracic and lumbar spinal regions. Therefore, facet joint interventions (both diagnostic and therapeutic) are limited to one spinal region per session.It is not routinely necessary for multiple blocks (e.g., epidural injections, sympathetic blocks, trigger point injections, etc.) to be provided to a patient on the same day as facet joint procedures. Multiple blocks on the same day could lead to improper or lack of diagnosis. If performed, the medical necessity of each injection (at the same or a different level[s]) must be clearly documented in the medical record. For example, the performance of both paravertebral facet joint procedures(s) and a transforaminal epidural injection (TFESI) at the same or close spinal level at the same encounter would not be expected unless a synovial cyst is compressing the nerve root. In this situation, TFESI may provide relief for the radicular pain, while the facet cyst rupture allows nerve root decompression. Frequent reporting of multiple blocks on the same day may trigger a focused medical review.Facet joint intraarticular injections and medial branch blocks may involve the use of anesthetic, corticosteroids, anti-inflammatories and/or contrast agents, and does not include injections of biologicals or other substances not FDA designated for this use.
Proposed LCD - Facet Joint Interventions for Pain Management (DL35936)
One to two levels, either unilateral or bilateral, are allowed per session per spine region. Three or four-level procedures are not medically necessary and therefore are non-covered. A session is a time period, which includes all procedures (i.e., medial branch block (MBB), intraarticular injections (IA), facet cyst ruptures, and RFA ablations that are performed during the same day.If there is an extended time, two years or more, since the last RFA or there is a question as to the source of the recurrent pain then diagnostic procedures must be repeated.Therapeutic intraarticular facet injections are not covered unless there is justification in the medical documentation on why RFA cannot be performed. Facet joint procedures in patients for the indication of generalized pain conditions (such as fibromyalgia) or chronic centralized pain syndromes are considered not reasonable and necessary. Individual consideration may be considered under unique circumstances and with sufficient documentation of medical necessity on appeal.In patients with implanted electrical devices, providers must follow manufacturer instructions and extra planning as indicated to ensure safety of procedure.
Proposed LCD - Facet Joint Interventions for Pain Management (DL35936)
The following are considered not reasonable and necessary and therefore will be denied:Intraarticular and extraarticular facet joint prolotherapyNon-thermal modalities for facet joint denervation including chemical, low-grade thermal energy (less than 80 degrees Celsius), laser neurolysis, and cryoablation.Intra-facet implantsFacet joint procedure performed after anterior lumbar interbody fusion or ALIF.Definitive clinical and/or imaging findings pointing to a specific diagnosis other than facet joint syndromeDiagnostic injections or MMB at the same level as the previously successful RFA procedureNote: The scales used for measurement of pain and/or disability must be documented in the medical record. Acceptable scales include but are not limited to: verbal rating scales, Numerical Rating Scale (NRS) and Visual Analog Scale (VAS) for pain assessment, and Pain Disability Assessment Scale (PDAS), Oswestry Disability Index (ODI), Oswestry Low Back Pain Disability Questionnaire (OSW), Quebec Back Pain Disability Scale (QUE), Roland Morris Pain Scale, Back Pain Functional Scale (BPFS), and the PROMIS profile domains to assess function.Notice:Services performed for any given diagnosis must meet all the indications and limitations stated in this policy, the general requirements for medical necessity as stated in CMS payment policy manuals, all existing CMS national coverage determinations, and all Medicare payment rules.Provider Qualifications:Medicare Program Integrity Manual states services will be considered medically reasonable and necessary only if performed by appropriately trained providers.
Proposed LCD - Facet Joint Interventions for Pain Management (DL35936)
Patient safety and quality of care mandate that healthcare professionals who perform facet injections/procedures are appropriately trained and/or credentialed by a formal residency/fellowship program and/or are certified by either an accredited and nationally recognized organization or by a post-graduate training course accredited by an established national accrediting body or accredited professional training program. If the practitioner works in a hospital facility at any time and/or is credentialed by a hospital for any procedure, the practitioner must be credentialed to perform the same procedure in the outpatient setting. At a minimum, training must cover and develop an understanding of anatomy and drug pharmacodynamics and kinetics as well as proficiency in diagnosis and management of disease, the technical performance of the procedure, and utilization of the required associated imaging modalities.In addition to the above requirements, non-physician providers, such as certified nurse anesthetist, with certain exceptions, may certify, order and establish the plan of care as authorized by State law. (See Sections 1861[s][2] and 1862[a][14] of Title XVIII of the Social Security Act; 42 CFR, Sections 410.74, 410.75, 410.76 and 419.22; 58 FR 18543, April 7, 2000.) Each practitioner must provide only those services within the scope of practice for each state.DefinitionsAcute pain-The temporal definition of pain persisting for up to 4 weeks after the onset of the pain.Axial-Relating to or situated in the central part of the body, in the head and trunk as distinguished from the limbs, e.g., axial skeleton.Biopsychosocial model-interdisciplinary model that looks at the interconnection between biology, pathology and socioenvironmental factors.Central neuropathic pain Pain, which is causally related to a lesion or disease of the central somatosensory nerves.
Proposed LCD - Facet Joint Interventions for Pain Management (DL35936)
Central neuropathic pain Pain, which is causally related to a lesion or disease of the central somatosensory nerves.Centralized Pain A neurological chronic pain syndrome of the central nervous system (brain, brainstem, and spinal cord) which commonly presents with widespread generalized allodynia which is causally related to the increased responsiveness of nociceptive nerves in the central nervous system to the normal threshold or subthreshold simulation from the afferent nerves. The condition has also been called central sensitization, central amplification, and central pain syndrome. Fibromyalgia is considered one of the most common centralized pain syndromes.Cervical facet pain Pain located in the cervical spine, which may be characterized by chronic headaches, restricted motion, and axial neck pain, which may radiate sub-occipitally to the shoulders or mid-back.Chronic pain- The temporal definition of pain persisting for greater than or equal to 12 weeks after the onset of the pain.Dual diagnostic blocks- The diagnostic technique of injecting the same spinal nerve on two separate occasions to be used as an efficacy comparison to increase diagnostic accuracy.Epidural steroid injection-The administration via injection of steroid medicine into the potential epidural space in the spinal column to deliver steroids to the spinal nerves.Facet Joint Intraarticular Injections, DiagnosticThe placement of local anesthetic and possibly a corticosteroid into the facet joint to diagnose facet joint pain.Facet Joint Intraarticular Injections, Therapeutic The placement of local anesthetic and possibly a corticosteroid into the facet joint to produce the beneficial effect of pain reduction.Facet joint- A diarthrodial joint in the spinal column (also called the zygapophysial joint or z-joint), producing the articulation of the posterior elements of one vertebra with its neighboring vertebra. They are bilateral superior and inferior articular surfaces at each spinal level. The terminology or nomenclature of the facet joint is classified by the specific vertebrae level that forms it (e.g., C4-5 or L2-3). There are two (2) facet joints, right and left, at each spinal level.
Proposed LCD - Facet Joint Interventions for Pain Management (DL35936)
Facet injection-(also called facet block)- A general term used to describe the injection of local anesthetic and possibly a corticosteroid in the facet joint capsule or along the medial branch nerves supplying the facet joints.Facet Joint Denervation or Radiofrequency Ablation (RFA)-A general term used to describe the minimally invasive procedure that uses thermal energy generated by the radiofrequency current to deprive the facet joint of its nerve supply. The procedure is also known as a Medial Branch Radiofrequency Neurotomy (Ablation) because it is used to thermally remove the medial branch nerve by using electrical current to create thermal energy to coagulate the adjacent tissues around the targeted medial branch nerve.Facet joint syndrome-A set of concurrent signs or symptoms to describe facet joint pain as the pain generator. The typical clinical signs or symptoms of a facet syndrome may include local paraspinal tenderness; pain that is brought about or increased on hyperextension, rotation, and lateral bending; low back stiffness; absence of neurologic deficit; absence of root tension signs (non- radiating below the knee, absence of paresthesia). Cervical facet pain is often characterized by chronic headaches, restricted motion, and axial neck pain, which may radiate sub- occipitally to the shoulders or mid-back.Facet Level-Refers to the zygapophyseal joint or the two medial branch (MB) nerves that innervate that zygapophyseal joint. Each level has a pair of facet joints: one on the right side and one of the left side of the spine.Intra-articular injection (IA)- The injection of local anesthetic and possibly a corticosteroid into the facet joint capsule.Medial Branch- The dorsal ramus is the dorsal branch of a spinal nerve that forms from the dorsal root of the nerve after it emerges from the spinal cord.Medial Branch Block (MBB) The placement of local anesthetic and possibly a corticosteroid near the medial branch nerve which supplies the sensory innervation to a specific facet jointNeuropathic pain the pain which is caused by a lesion or disease of the somatosensory nerves.
Proposed LCD - Facet Joint Interventions for Pain Management (DL35936)
Neuropathic pain the pain which is caused by a lesion or disease of the somatosensory nerves.Neurogenic claudication-intermittent leg pain from impingement of the nerves emanating from the spinal cord (also called pseuduoclaudication)New Onset of Spinal Pain- The new onset of the spinal pain must be materially and significantly different in location, type, duration and character from the previously treated spine pain.Non-invasive conservative management- The use of nonsteroidal anti-inflammatory drugs (NSAIDs), acetaminophen, physical therapy, acupuncture (applies to only chronic low back pain), or spinal manipulation. This management should include the application a biopsychosocial treatment techniques.Non-Radicular Back Pain-The radiating non-neuropathic pain which is not causally related to a spinal nerve root irritation and does not produce reproducible neuropathic symptoms in an objective dermatomal pattern.Peripheral neuropathic pain Pain, which is causally related to a lesion or disease of the peripheral somatosensory nerves.Radicular Back Pain- The radiating neuropathic pain causally related to the spinal nerve root irritation which extends into the distal distribution, typically the lower extremity, producing neuropathic pain in a dermatomal patternRadiculopathy- Radiating neuropathic pain causally related to the spinal nerve root irritation, which extends distally producing neuropathic pain in a dermatomal pattern.Region-The segments of the back involved will be define in this policy as two regions:
Proposed LCD - Facet Joint Interventions for Pain Management (DL35936)
Cervical/Thoracic region= C1-C7/T1-T12Lumbar/Sacral region= L1-L5/S1-S5Session- A time period, which includes all procedures (i.e., medial branch blocks (MBB), intraarticular injections (IA), facet cyst ruptures, and RFA ablations) performed during one day.Subacute Pain-The temporal definition of pain occurring during the 4-12-week time period.Transforaminal epidural steroid injection (TFESI)-An epidural injection performed via a paramedian approach to enter the epidural space by placing the needle in the posterior-superior quadrant of the intervertebral foramen (neuroforamen) to inject near the dorsal root ganglion and exiting spinal nerve root (previously known as a selective nerve root block).Zygapophysial joint or z-joint- see Facet joint
Proposed LCD - Facet Joint Interventions for Pain Management (DL35936)
History/Background and/or General InformationThe spine is the most common source of chronic pain. Chronic axial spinal pain is one of the major causes of disability and accounts for a substantial US health burden. Chronic spine pain poses a peculiar diagnostic and therapeutic challenge due to multiple pain sources, overlapping clinical features, and nonspecific radiological findings.The facet joints can cause axial spinal pain and referred pain in the extremities. The pathology of the pain source is due to facet joints being richly innervated by the nerve fibers from the medial branch of the dorsal ramus of spinal nerves. Each facet has a dual nerve supply. One exception is at the C2C3 zygapophysial joint, which has a singular nerve supply from the third occipital nerve (the superficial medial branch of C3 dorsal ramus)1.Facet joint interventions may be used in pain management for chronic cervical/thoracic and back pain arising from the paravertebral facet joints. The facet block procedure is an injection of a local anesthetic, with or without a steroid medication, either into the facet joint (intra-articular) or outside the joint space around the nerve supply to the joint (the medial branch nerve) known as medial branch block (MBB). Imaging guidance (fluoroscopy or CT per code descriptor) is used to assure accurate placement of the needle for the injection. Paravertebral facet joint denervation is a therapeutic intervention used to provide both long-term pain relief and reduce the likelihood of recurrence of chronic cervical/thoracic or back pain confirmed as originating in the facet joints medial branch nerve1.
Proposed LCD - Facet Joint Interventions for Pain Management (DL35936)
There are various methods that may be used in performing facet joint denervation. Percutaneous radiofrequency ablation (RFA) is a minimally invasive procedure done with imaging guidance (fluoroscopy or CT per code descriptor) and involves using energy in the radiofrequency range to cause necrosis of specific nerves (medial branches of the dorsal rami), preventing the neural transmission of pain. Conventional radiofrequency ablation (non- pulsed or continuous) applies thermal energy of typically 80 to 85 degrees Celsius. The terms radiofrequency ablation (RFA) and radiofrequency neurotomy are used interchangeably. Both terms refer to a procedure that destroys the functionality of the nerve using radiofrequency energy. Non-thermal methods of denervation include chemical (chemodenervation), low-grade thermal energy (less than 80 degrees Celsius), pulsed RFA, laser neurolysis, and cryoablation1.Throughout this document, societal recommendations with the grading of evidence are referenced. There are multiple systems to grade or rank the quality of medical evidence and develop evidence-based recommendations. Not all grading systems are equivalent, so while there are typically similarities in the grades or recommendations from various grading systems, they must be considered independent of the other. The references in this document refer to the following grading systems.
Proposed LCD - Facet Joint Interventions for Pain Management (DL35936)
GRADE Guidelines used in some systematic reviews, the basis for NASS recommendations aligns with GRADE.A Modified approach to the grading of evidence2and development of interventional pain management specific instrument3used in ASIPP Guidelines and some systematic reviews.US Preventive Services Task Force grading of evidence guidelines used by 2020 Consensus Guidelines by Cohen et al4.Levels of Evidence for Primary Research Question and Grades of Recommendation for Summaries or Review of Studies adopted by North American Spine Society (NASS)5.A Multi-MAC Subject Matter Expert (SME) Panel on Facet Joint and Medial Nerve Branch Procedures meeting on was held on 5/28/2020.General InformationAssociated InformationPlease refer to the Local Coverage Article: Billing and Coding: Facet Joint Interventions for Pain Management (A57826) for documentation requirements that apply to the reasonable and necessary provisions outlined in this LCD.Sources of InformationN/ABibliography
Proposed LCD - Drugs and Biologicals, Coverage of, for Label and Off-Label Uses (DL33394)
CMS National Coverage PolicyLanguage quoted from Centers for Medicare and Medicaid Services (CMS), National Coverage Determinations (NCDs) and coverage provisions in interpretive manuals is italicized throughout the policy. NCDs and coverage provisions in interpretive manuals are not subject to the LCD Review Process (42 CFR 405.860[b] and 42 CFR 426 [Subpart D]). In addition, an administrative law judge may not review an NCD. See Section 1869(f)(1)(A)(i) of the Social Security Act.Unless otherwise specified,italicizedtext represents quotation from one or more of the following CMS sources:Title XVIII of the Social Security Act (SSA):Section 1862(a)(1)(A) excludes expenses incurred for items or services which are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.Section 1833(e) prohibits Medicare payment for any claim which lacks the necessary information to process the claim.CMS PublicationsCMS Publication Pub 100-02,Medicare Benefit Policy Manual,Chapter 15:50 - Drugs and Biologicals50.4.5 - Off-Label Use of Drugs and Biologicals in an Anti-Cancer Chemotherapeutic RegimenCMS Publication 100-04,Medicare Claims Processing Manual,Chapter 17:10 - Payment Rules for Drugs and BiologicalsCoverage Indications, Limitations, and/or Medical NecessityAbstract:
Proposed LCD - Drugs and Biologicals, Coverage of, for Label and Off-Label Uses (DL33394)
Coverage Indications, Limitations, and/or Medical NecessityAbstract:An off-label/unlabeled use of a drug is defined as a use for a non-FDA approved indication, that is, one that is not listed on the drug's official label/prescribing information. An indication is defined as a diagnosis, illness, injury, syndrome, condition, or other clinical parameter for which a drug may be given. Off-label use is further defined as giving the drug in a way that deviates significantly from the labeled prescribing information for a particular indication. This includes but is not necessarily limited to, dosage, route of administration, duration and frequency of administration, and population to whom the drug would be administered. Drugs used for indications other than those in the approved labeling may be covered under Medicare if it is determined that the use is medically accepted, taking into consideration the major drug compendia, authoritative medical literatures and/or accepted standards of medical practice. Determinations as to whether medication is reasonable and necessary for an individual patient are made on appeal on the same basis as all other such determinations (i.e., with support from the peer-reviewed literature, with the advice of medical consultants, with reference to accepted standards of medical practice, and in consideration of the medical circumstance of the individual case).In the case of drugs used in an anti-cancer chemotherapeutic regimen, off-label uses are covered for a medically accepted indication as defined in theMedicare Benefit Policy Manual(CMS publication 100-2, Chapter 15, Section 50.4.5).In order to meet the requirement that the use of the drug is reasonable and necessary for the treatment of disease, the drugs must be safe and effective. Drugs approved for marketing by the Food and Drug Administration (FDA) are considered safe and effective when used for indications specified on the labeling. Therefore, Medicare pays for the use of a FDA-approved drug, if:It was injected on or after the date of the FDA's approval;It is reasonable and necessary for the individual patient; andAll other applicable coverage requirements are met.Indications:A medically accepted indication, which is covered by National Government Services is one of the following:
Proposed LCD - Drugs and Biologicals, Coverage of, for Label and Off-Label Uses (DL33394)
Indications:A medically accepted indication, which is covered by National Government Services is one of the following:An FDA approved, labeled indication or a use supported in the American Hospital Formulary Service Drug Information (AHFS-DI), NCCN Drugs and Biologics Compendium, Truven Health Analytics Micromedex DrugDex, Elsevier/Gold Standard Clinical Pharmacology and Wolters Kluwer Lexi-Drugs as the acceptable compendia based on CMS' Change Request 6191 (Compendia as Authoritative Sources for Use in the Determination of a "Medically Accepted Indication" of Drugs and Biologicals Used Off-Label in an Anti-Cancer Chemotherapeutic Regimen); orArticles or Local Coverage Determinations (LCDs) published by National Government Services.The compendia listed above will be accepted at the following levels;American Hospital Formulary Service-Drug Information (AHFS-DI)  indication is supportiveNCCN Drugs and Biologics Compendium - indication is a Category 1 or 2AMicromedex DrugDex  indication is Class I, Class IIa, or Class IIb orClinical Pharmacology  indication is supportiveLexi-Drugs - indication is rated as Evidence Level AWhen new off-label uses for drugs are published in the above compendia at the accepted level of recommendation, the effective date for National Government Services coverage of those off-label uses is the date of publication of our revised coverage article, not the date of inclusion in the compendia.In an effort to limit the number of LCD's or articles related to off label indications for drug use, National Government Services will publish articles relating to drugs approved for off-label use for which there is a need for education or concern about utilization. These articles will include drugs with links to their FDA approved and compendiaapproved usesas listed in the American Hospital Formulary Services (AHFS), Elsevier/Gold Standard Clinical Pharmacology, NCCN Drugs and Biologics Compendium, Truven Health Analytics Micromedex DrugDex compendium and/or Wolters Kluwer Lexi-Drugs. Only off-label uses requested by providers according to the following criteria will be considered for inclusion.