The Centers for Medicare & Medicaid Services (CMS) is considering changes to the Medicare coverage policy for ventricular assist devices (VAD) as destination therapy in end-stage heart failure patients.

In a proposed decision memo dated Aug. 19, CMS proposes removing the requirement that patients must have a body size greater than 1.5 m² and raising the peak oxygen-consumption threshold from 12 mL/kg/min to 14 mL/kg/min.

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The Centers for Medicare & Medicaid Services (CMS) has merged the magnetic resonance angiography (MRA) national coverage determination (NCD) into the magnetic resonance imaging (MRI) NCD. The effect of this change maintains existing national coverage for both MRI and MRA, and eliminates the non-coverage language for MRA. Effective for claims with service dates on or after June 3, Medicare contractors now have the discretion to cover or not cover all indications of MRA that are not specifically nationally covered or non-covered.

MRA is a non-invasive diagnostic test that is an application of MRI. By analyzing the amount of energy released from tissues exposed to a strong magnetic field, MRA provides images of normal and diseased blood vessels, as well as visualization and quantification of blood flow through these vessels.

Currently covered indications include using MRA for specific conditions to evaluate flow in internal carotid vessels of the head and neck, peripheral arteries of lower extremities, abdomen and pelvis, and the chest.

See CMS Transmittal 123 for claims processing instructions in Pub. 100-03, NCD Manual, section 220.2, for the MRA (and MRI) coverage policy, and Pub. 100-04, Claims Processing Manual, chapter 13, section 40.1.

Source: CMS Transmittal 1998, Change Request (CR) 7040, issued July 9.

Effective for dates on or after May 25, claims submitted for a collagen meniscus implant procedure will be denied by Medicare. The Centers for Medicare & Medicaid Services (CMS) completed a National Coverage Determination (NCD) for collagen meniscus implants in May, rendering the procedure non-covered for Medicare beneficiaries.

Effective with the July 2010 updates of the Medicare Physician Fee Schedule Database (MPFSDB) and the Integrated Outpatient Code Editor (I/OCE), new HCPCS Level II code G0428 Collagen or other tissue engineered meniscus knee implant procedure for filling meniscal defects (e.g., collagen scaffold, Menaflex) should be used to report non-covered collagen meniscus implant claims with service dates on and after May 25.

As is custom, notifying the Medicare patient of his or her responsibility to pay for this non-covered service and asking the patient to sign an Advanced Beneficiary Notice (ABN) would be appropriate.

NOTE:  This NCD does not include cadaver meniscus transplants, for which you would report CPT® code 29868 Arthroscopy, knee, surgical; meniscal transplantation (includes arthrotomy for meniscal insertion), medial or lateral.

Source: CMS Transmittal 1977, CR 6903, issued May 28.

The Centers for Medicare & Medicaid Services (CMS) recently informed Medicare payers in Change Request (CR 6964) of changes that will be included in the July 2010 release of Medicare’s edit module for clinical diagnostic laboratory National Coverage Determinations (NCDs).

The following changes affect physicians, providers and suppliers submitting claims to Medicare for clinical diagnostic laboratory services:

• ICD-9-CM codes V17.4 Family history of other cardiovascular diseases and V18.1 Family history of other endocrine and metabolic diseases have been deleted from the list of non-covered ICD-9-CM codes for all 23 NCDs; and
• ICD-9-CM codes V17.41 Family history of sudden cardiac death (SCD), V17.49 Family history of other cardiovascular diseases, V18.11 Family history of multiple endocrine neoplasia [MEN] syndrome, and V18.19 Family history of other endocrine and metabolic diseases have been added to the list of non-covered ICD-9-CM codes for all 23 NCDs.

These changes to the laboratory edit module are effective for service dates on or after July 1.

Provider education article MLN Matters MM6964 is also available on the CMS website.

The Centers for Medicare & Medicaid Services (CMS) recently revised National Coverage Determination (NCD) 220.6 – Positron Emission Tomography (NaF-18) to Identify Bone Metastasis of Cancer.

Effective Feb. 26, CMS will cover NaF-18 positron emission tomography (PET) imaging when the Medicare beneficiary’s treating physician determines that it is needed to inform the initial antitumor treatment strategy or to guide subsequent antitumor treatment strategy after the completion of initial treatment, and when the beneficiary is enrolled in, and the NaF-18 PET provider is participating in, a clinical study.

Claims should contain ALL of the following information:

• PI Initial Treatment Strategy or PS Subsequent Treatment Strategy modifier
• PET or PET/CT CPT® code (78608, 78811-78816)
• ICD-9-CM cancer diagnosis code
• HCPCS Level II A9580 Sodium fluoride F-18, diagnostic, per study dose, up to 30 millicuries
• Q0 modifier Investigational clinical service provided in a clinical research study that is in an approved clinical research study.

Institutional claims should continue to report ICD-9 diagnosis code V70.7 Examination of participant in clinical trial and condition code 30.

Note that, although this coverage decision is effective Feb. 26, it will not be fully implemented until a clinical study is ready to enroll providers and patients. Check the CMS coverage webpage for updates.

Read MLN Matters® No. MM6861, issued March 26, for complete details.

The Centers for Medicare & Medicaid Services (CMS) has rendered outpatient intravenous insulin therapy (OIVIT) nationally non-covered by Medicare, effective Dec. 23, 2009.

CMS says it will create a new HCPCS Level II code for use of this non-covered service that will be effective Dec. 23, 2009 and implemented with the April 2010 Integrated Outpatient Code Editor (IOCE) and Medicare Physician Fee Schedule Database (MPFSDB).

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August of last year, the Centers for Medicare & Medicaid Services (CMS) rendered a final National Coverage Determination (NCD) for warfarin responsiveness via pharmacogenomic testing. The news was not good. In short, CMS said there was insufficient evidence to support such testing improves health outcomes. The agency also said, however, that there was evidence to support pharmacogenomic testing for warfarin responsiveness under coverage with evidence development (CED). Medicare participating practitioners can, in fact, claim reimbursement for such services—providing they play by the rules.

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The Centers for Medicare & Medicaid Services (CMS) is now encouraging physicians to provide annual voluntary human immunodeficiency virus (HIV) screening to at-risk individuals—including pregnant women—covered under Medicare Part A and Part B. Read more »

The Centers for Medicare & Medicaid Services (CMS) has made a few important changes to the National Coverage Determination (NCD) edit software for clinical diagnostic laboratory services worth noting. In particular, a change to the effective date of coverage for three NCD ICD-9-CM diagnosis code lists will allow clinics to recoup any lost payments due to erroneous denials.

The effective date for three NCDs was “inadvertently” changed from Oct. 1, 2007 to July 1, 2009 with the July 1 quarterly release. The January 2010 quarterly release of the edit module for clinical diagnostic laboratory services corrects this mistake.

The affected ICD-9 code lists are those in the following NCDs:

• Prothrombin Time (PT) (190.17)
• Serum Iron Studies (190.18)
• Gamma Glutamyl Transferase (190.32)

The effective date for the ICD-9 codes listed in these NCDs will be revised from July 1, 2009 to Oct. 1, 2007, effective Jan. 1, 2010.

The January 2010 quarterly update also relocates ICD-9 codes 453-50 – 453.52 from the Serum Iron Studies NCD to the Gamma Glutamyl Transferase NCD, effective Jan. 1, 2010.

Medicare instructs contractors in Transmittal 1847, issued Nov. 6, not to search their files to retroactively pay claims but to adjust claims brought to their attention. A provider education article is available on the CMS Web site, and includes a list of affected ICD-9 codes.

The Centers for Medicare & Medicaid Services (CMS) has initiated a national coverage analysis (NCA) for the use of allogeneic hematopoietic stem cell transplantation (HSCT) for Medicare patients with myelodysplastic syndrome (MDS).

MDS refers to a heterogeneous group of acquired bone marrow disorders characterized by dysplastic growth of hematopoietic progenitors and a hypercellular bone marrow with peripheral cytopenia. Medicare patients age 65 and older represent 80 percent of the total population receiving an MDS diagnosis. One potential therapy for MDS is allogeneic HSCT.

This analysis is in response to an NCA request letter industry stakeholders composed and sent to CMS.

Currently, allogeneic HSCT for MDS is neither a covered or non-covered indication under the national coverage determination (NCD) for Stem Cell Transplantation (110.8.1). As it is not in either of these two categories, it may be covered at local contractor discretion. National Government Services (NGS), jurisdiction 13 Part A/Part B Medicare Administrative Contractor (A/B MAC), recently developed a local coverage determination (LCD) for stem cell transplantation that includes MDS and myelofibrosis with myeloid metaplasia.

CMS is seeking public comment on this topic and says it is particularly interested in any additional recent clinical studies and other scientific information related to the outcomes of this treatment. “If the evidence is determined to be inadequate for coverage, we are especially interested in what types of studies are needed,” CMS states in the tracking sheet.

Public comment may be submitted until Dec. 10. The proposed decision memo is due out May 10, 2010 and the NCA is expected to be completed by Aug. 8, 2010.