(Medicare National Coverage Determinations Manual)

Surgical and other invasive procedures are defined as operative procedures in which skin or mucous membranes and connective tissue are incised or an instrument is introduced through a natural body orifice.  Invasive procedures include a range of procedures from minimally invasive dermatological procedures (biopsy, excision, and deep cryotherapy for malignant lesions) to extensive multi-organ transplantation.  They include all procedures described by the codes in the surgery section of the Current Procedural Terminology (CPT) and other invasive procedures such as percutaneous transluminal angioplasty and cardiac catheterization.  They include minimally invasive procedures involving biopsies or placement of probes or catheters requiring the entry into a body cavity through a needle or trocar.  They do not include use of instruments such as otoscopes for examinations or very minor procedures such as drawing blood.  D. Other  2 http://www.qualityforum.org/pdf/reports/sre.pdf    N/A  (NCD last reviewed January 2009.)  140.8  Surgical or Other Invasive Procedure Performed on the Wrong Patient (Effective January 15, 2009)  (Rev. 102; Issued: 07-02- 09; Effective Date:  01 -15-09; Implementation Date:  JULY 6, 2009 FOR B MACS AND CARRIERS OCTOBER 5, 2009, FOR A MACS, FIs, AND FISS)   A. General   In 2002, the National Quality Forum (NQF) published Serious Reportable Events in Healthcare: A Consensus Report3, which listed 27 adverse events that were serious, largely preventable and of concern to both the public and health care providers.  These events and subsequent revisions to the list became known as never events.  This concept and need for the proposed reporting led to NQFs Consensus Standards Maintenance Committee on Serious Reportable Events, which maintains and updates the list which currently contains 28 items.  Among surgical events on the list is Surgical procedure performed on the wrong patient.  Similar to any other patient population, Medicare beneficiaries experience serious injury and/or death if wrong surgeries are performed and may require additional healthcare in order to correct adverse outcomes resulting from such errors.  B. Nationally Covered Indications  N/A  C. Nationally Non- covered Indications   The CMS does not cover a particular surgical or other invasive procedure to treat a particular medical condition when a practitioner erroneously performs a procedure that was intended for a different patient on a Medicare beneficiary who does not need that procedure because it is not a reasonable and necessary treatment for the Medicare beneficiarys particular medical condition.   A surgical or other invasive procedure is considered to have been performed on the wrong patient if that procedure is not consistent with the correctly documented informed consent for that patient.  Surgical and other invasive procedures are defined as operative procedures in which skin or mucous membranes and connective tissue are incised or an instrument is introduced through a natural body orifice.  Invasive procedures include a range of procedures from minimally invasive dermatological procedures (biopsy, excision, and deep cryotherapy for malignant lesions) to extensive multi-organ transplantation.  They include all procedures described by the codes in the surgery section of the Current Procedural Terminology (CPT) and other invasive procedures such as percutaneous transluminal angioplasty and cardiac catheterization.  They include minimally invasive procedures involving biopsies or placement of probes or catheters requiring the entry into a body cavity through a needle or trocar.  They do not include use of instruments such as otoscopes for examinations or very minor procedures such as drawing blood.  D. Other  N/A  (NCD last reviewed January 2009.)  140.9 - Gender Reassignment Surgery for Gender Dysphoria   3 http://www.qualityforum.org/pdf/reports/sre.pdf   (Rev.  194, Issued: 03- 03-17, Effective: 08 -30-16, Implementation; 04- 04-17)  A. General   Gender reassignment surgery is a general term to describe a surgery or surgeries that affirm a persons gender identity.   B. Nationally Covered Indications   N/A  C. Nationally Non -Covered Indications   N/A  D. Other  The Centers for Medicare & Medicaid Coverage (CMS) conducted a National Coverage Analysis that focused on the topic of gender reassignment surgery.  Effective August 30, 2016, after examining the medical evidence, CMS determined that no national coverage determination (NCD) is appropriate at this time for gender reassignment surgery for Medicare beneficiaries with gender dysphoria.  In the absence of an NCD, coverage determinations for gender reassignment surgery, under section 1862(a)(1)(A) of the Social Security Act (the Act) and any other relevant statutory requirements, will continue to be made by the local Medicare Administrative Contractors (MACs) on a case- by-case basis.    (This policy last reviewed August 2016.)   150 - Musculoskeletal System  (Rev. 1, 10- 03-03)  150.1 - Manipulation  (Rev. 1, 10- 03-03) CIM 35 -2  A.  Manipulation of the Rib Cage   Manual manipulation of the rib cage contributes to the treatment of respiratory conditions such as bronchitis, emphysema, and asthma as part of a regimen that includes other elements of therapy, and is covered only under such circumstances.  B.  Manipulation of the Head   Manipulation of the occipitocervical  or temporomandibular regions of the head when indicated for conditions affecting those portions of the head and neck is a covered service.   150.2 - Osteogenic Stimulator (Various Effective Dates Below)  (Rev. 41, Issued: 06- 24-05, Effective: 04- 27-05, Implementation: 08- 01-05) CIM -35-48  Electrical Osteogenic Stimulators   A. General   Electrical stimulation to augment bone repair can be attained either invasively or non- invasively.  Invasive devices provide electrical stimulation directly at the fracture site either through percutaneously placed cathodes or by implantation of a coiled cathode wire into the fracture site.  The power pack for the latter device is implanted into soft tissue near the fracture site and subcutaneously connected to the cathode, creating a self -contained system with no external components.  The power supply for the former device is externally placed and the leads connected to the inserted cathodes.  With the non- invasive device, opposing pads, wired to an external power supply, are placed over the cast.  An electromagnetic  field is created between the pads at the fracture site.   B. Nationally Covered Indications   1. Noninvasive Stimulator   The noninvasive stimulator device is covered only for the following indications:    Nonunion of long bone fractures;    Failed fusion, where a minimum of 9 months has elapsed since the last surgery;    Congenital pseudarthroses;    Effective July 1, 1996, as an adjunct to spinal fusion surgery for patients at high risk of pseudarthrosis due to previously failed spinal fusion at the same site or for those undergoing multiple level fusion.  A multiple level fusion involves 3 or more ve rtebrae (e.g., L3- L5, L4 -S1, etc).    Effective September 15, 1980, nonunion of long bone fractures is considered to exist only after 6 or more months have elapsed without healing of the fracture.    Effective April 1, 2000, nonunion of long bone fractures is considered to exist only when serial radiographs have confirmed that fracture healing has ceased for 3 or more months prior to starting treatment with the electrical osteogenic stimulator.  Serial radiographs must include a minimum of 2 sets of radiographs, each including multiple views of the fracture site, separated by a minimum of 90 days.  2. Invasive (Implantable) Stimulator   The invasive stimulator device is covered only for the following indications:    Nonunion of long bone fractures;    Effective July 1, 1996, as an adjunct to spinal fusion surgery for patients at high risk of pseudarthrosis due to previously failed spinal fusion at the same site or for those undergoing multiple level fusion.  A multiple level fusion involves 3 or more vertebrae (e.g., L3- L5, L4 -S1, etc).    Effective September 15, 1980, nonunion of long bone fractures is considered to exist only after 6 or more months have elapsed without healing of the fracture.    Effective April 1, 2000, nonunion of long bone fractures is considered to exist only when serial radiographs have confirmed that fracture healing has ceased for 3 or more months prior to starting treatment with the electrical osteogenic stimulator.  Serial radiographs must include a minimum of 2 sets of radiographs, each including multiple views of the fracture site, separated by a minimum of 90 days.  Ultrasonic Osteogenic Stimulators   A. General   An ultrasonic osteogenic stimulator is a noninvasive device that emits low intensity, pulsed ultrasound.  The device is applied to the surface of the skin at the fracture site and ultrasound waves are emitted via a conductive coupling gel to stimulate fracture healing.  The ultrasonic osteogenic stimulators are not be used concurrently with other non- invasive osteogenic devices.   B. Nationally Covered Indications  Effective January 1, 2001, ultrasonic osteogenic stimulators are covered as medically reasonable and necessary for the treatment of nonunion fractures. In demonstrating non-union fractures, CMS expects:   A minimum of 2 sets of radiographs, obtained prior to starting treatment with the osteogenic stimulator, separated by a minimum of 90 days.  Each radiograph set must include multiple views of the fracture site accompanied with a written interpretation by a physician stating that there has been no clinically significant evidence of fracture healing between the 2 sets of radiographs; and,   Indications that the patient failed at least one surgical intervention for the treatment of the fracture.    Effective April 27, 2005, upon reconsideration of ultrasound stimulation for nonunion fracture healing, CMS determines that the evidence is adequate to conclude that noninvasive ultrasound stimulation for the treatment of nonunion bone fractures prior to surgical intervention is reasonable and necessary.  In demonstrating non-union fractures, CMS expects:   A minimum of 2 sets of radiographs, obtained prior to starting treatment with the osteogenic stimulator, separated by a minimum of 90 days.  Each radiograph set must include multiple views of the fracture site accompanied with a written interpretation by a  physician stating that there has been no clinically significant evidence of fracture healing between the 2 sets of radiographs.  C. Nationally Non-Covered Indications  Nonunion fractures of the skull, vertebrae and those that are tumor -related are excluded from coverage.   Ultrasonic osteogenic stimulators may not be used concurrently with other non-invasive osteogenic devices.   Ultrasonic osteogenic stimulators for fresh fractures and delayed unions remains non- covered.   (This NCD last reviewed June 2005.)  150.3 - Bone (Mineral) Density Studies (Effective January 1, 2007)  (Rev. 69, Issued: 05-11- 07, Effective: 01 -01-07, Implementation: 07-02-07)  Conditions for coverage of bone mass measurements are now contained in chapter 15, section 80.5 of Pub. 100-02, Medicare Benefit Policy Manual.  Claims processing instructions can be found in chapter 13, section 140 of Pub. 100- 04, Medicare Claims Processi ng Manual.  150.5 - Diathermy Treatment  (Rev. 173, Issued: 09-04- 14, Effective: Upon Implementation: of ICD -10, Implementation: Upon Implementation of ICD -10)  High energy pulsed wave diathermy machines have been found to produce some degree of therapeutic benefit for essentially the same conditions and to the same extent as standard diathermy.  Accordingly, where the A/B MACs medical staff has determined that the pulsed wave diathermy apparatus used is one which is considered therapeutically effective, the treatments are considered a covered service, but only for those conditions for which standard diathermy is medically indicated and only when rendered by a physician or incident to a physicians professional services.  Cross -reference: 240.3.  (This NCD last reviewed June 2006.)  150.6 - Vitamin B12 Injections to Strengthen Tendons, Ligaments, etc., of the Foot  (Rev. 1, 10-03-03) CIM 45 -4  Not Covered  Vitamin B12 injections to strengthen tendons, ligaments, etc., of the foot are not covered under Medicare because (1) there is no evidence that vitamin B12 injections are effective for the purpose of strengthening weakened tendons and ligaments, and (2) this is nonsurgical treatment under the subluxation exclusion.  Accordingly, vitamin B12 injections are not considered reasonable and necessary within the meaning of 1862(a)(1) of the Act.   Cross reference: