National Coverage Determination

Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer’s Disease

The Centers for Medicare & Medicaid Services (CMS) covers Food and Drug Administration (FDA) approved monoclonal antibodies directed against amyloid for the treatment of Alzheimer’s disease (AD) when furnished in accordance with Section B (Coverage Criteria) under coverage with evidence development (CED) for patients who have:

• A clinical diagnosis of mild cognitive impairment (MCI) due to AD or mild AD dementia, both with confirmed presence of amyloid beta pathology consistent with AD.

For detailed coverage requirements, you may view the full text of the NCD at https://www.cms.gov/medicare-coverage-database/view/ncacal-decision-memo.aspx?proposed=N&ncaid=305.

Screening for Lung Cancer with Low Dose Computed Tomography (LDCT)

The Centers for Medicare & Medicaid Services (CMS) reconsidered the national coverage determination established at section 210.14 of the Medicare National Coverage Determinations manual and has determined that the evidence is sufficient to expand the eligibility criteria for Medicare beneficiaries receiving low dose computed tomography (LDCT) when the following beneficiary eligibility criteria are met:

• Age 50 – 77 years;
• Asymptomatic (no signs or symptoms of lung cancer);
• Tobacco smoking history of at least 20 pack-years (one pack-year = smoking one pack per day for one year; 1 pack = 20 cigarettes);
• Current smoker or one who has quit smoking within the last 15 years; and
• Receive an order for lung cancer screening with LDCT.

For detailed coverage requirements, you may view the full text of the NCD at https://www.cms.gov/medicare-coverage-database/view/ncacal-decision-memo.aspx?proposed=N&ncaid=304.

Next Generation Sequencing (NGS)

Effective March 16, 2018, the Centers for Medicare & Medicaid Services (CMS) cover diagnostic laboratory tests using Next Generation Sequencing (NGS) when performed in a Clinical Laboratory Improvement Amendments-certified (CLIA-certified) laboratory, when ordered by a treating doctor, and when specific requirements are met.

CMS will cover such testing under the Medicare program for beneficiaries with recurrent, relapsed, refractory, or metastatic cancer, or advanced stages III or IV cancer if the beneficiary has either not been previously tested using the same NGS test for the same primary diagnosis of cancer, or for repeat testing using the same NGS test only when a new primary cancer diagnosis is made by the treating doctor, and the beneficiary decided to seek further cancer treatment (e.g., therapeutic chemotherapy).

For detailed coverage requirements, you may view the full text of the NCD at cms.gov/mcd/search.asp

Implantable Cardiac Defibrillators (ICDs)

Effective for claims with dates of service on or after February 15, 2018, CMS advised that coverage of Implantable Cardiac Defibrillators (ICDs) is no longer contingent upon participation in a trial/study/registry. Specific clinical criteria do need to be met for coverage.

You may view the full text of the NCD at cms.gov/mcd/search.asp.

On May 25, 2017, the Centers for Medicare and Medicaid Services (CMS) issued an NCD to cover supervised exercise therapy (SET) for beneficiaries with intermittent claudication (IC) for the treatment of symptomatic peripheral artery disease (PAD). Implementation Date: 07/02/2018

SET involves the use of intermittent walking exercise, which alternates periods of walking to moderate-to-maximum claudication, with rest. SET has been recommended as the initial treatment for patients suffering from IC, the most common symptom experienced by people with PAD. The SET program must consist of sessions lasting 30-60 minutes comprising a therapeutic exercise-training program for PAD in patients with claudication; be conducted in a hospital outpatient setting or a doctor’s office; be delivered by qualified auxiliary personnel necessary to ensure benefits exceed harms, and who are trained in exercise therapy for PAD; and be under the direct supervision of a doctor, physician assistant, or nurse practitioner/clinical nurse specialist who must be trained in both basic and advanced life support techniques.

For detailed coverage requirements, you may view the full text of the NCD at cms.gov/mcd/search.asp.

Medicare Advantage plans shall cover screening for HIV when ordered by the beneficiary's doctor or a practitioner within the context of a health care setting and performed by an eligible Medicare provider or supplier for these services, for beneficiaries who meet certain conditions.

A list of conditions and the complete NCD announcement can be found at cms.gov.

February 5, 2015

Medicare covers lung cancer screening counseling and shared decision making, and for appropriate beneficiaries, annual screening for lung cancer with low dose computed tomography (LDCT), as an additional preventive service benefit under the Medicare program if eligibility criteria is met.

June 2, 2014

Hepatitis C is an infectious disease caused by the hepatitis C virus (HCV) that affects the liver. HCV is spread by blood-to-blood contact. A newly-infected individual goes through an acute phase where there may or may not be symptoms of infection such as abdominal pain, fatigue, or nausea. A few individuals are able to clear the virus after an acute infection but most will go on to develop chronic HCV infection. The most serious risks from chronic HCV infection are cirrhosis, liver failure, and liver cancer. Currently, Medicare doesn't cover HCV screening but will cover testing for individuals with blood work showing elevated liver enzymes or prior to a liver transplant. The new NCD expands coverage for HCV screening in individuals considered by their primary care provider as "high risk." High risk individuals include persons with a current or past history of illicit injection drug use and persons who have a history of receiving a blood transfusion prior to 1992. Illicit drug users are covered for repeat screening annually if they continue to use. A single screening test is covered for adults who don't meet the high risk criteria but who were born between 1945 and 1965.

May 30, 2014

The Department of Health and Human Services Departmental Appeals Board – Appellate Division, issued a ruling (the "HHS Decision") on May 30, 2014 holding that the existing NCD that prohibited transsexual surgery dating from 1981 is "no longer a valid basis for denying claims for Medicare coverage of transsexual surgery, and local coverage determinations (LCDs) used to adjudicate such claims may not rely on the provisions of the NCD." (NCD 140.3, Transsexual Surgery; Docket No. A-13-87, Decision No. 2576, May 30, 2014). Since the NCD is no longer valid, effective May 30, 2014, its provisions are no longer a valid basis for denying claims for Medicare coverage of transsexual surgery, and local coverage determinations (LCDs) used to adjudicate such claims may not rely on the provisions of NCD 140.3. The decision does not bar CMS or its contractors from denying individual claims for payment for transsexual surgery for other reasons permitted by law. Nor does the decision address treatments for transsexualism other than transsexual surgery. According to the HHS Decision, "transsexual surgery," also known as "sex reassignment surgery" or "intersex surgery," is the culmination of a series of procedures designed to change the anatomy of transsexuals to conform to their gender identity. The HHS Decision notes that transsexuals are persons with an overwhelming desire to change anatomic sex because of their fixed conviction that they are members of the opposite sex.

April 3, 2013

Age-related macular degeneration is a condition, usually associated with advancing age, that results in a deterioration of eyesight, although it rarely results in total blindness. One form of this condition, known as wet macular degeneration, is due to an abnormal growth of blood vessels in the part of the eye that accounts for the majority of our visual acuity, i.e., sharpness of our vision. There are grades of severity of the abnormal growth of these blood vessels. Wet macular degeneration is typically treated by injecting a drug into the bloodstream, followed by shining a laser at the part of the eye that is degenerating. This treatment destroys the abnormal blood vessels and prevents the ongoing deterioration of vision.

Until now, the laser treatment was covered for only the most severe grade of blood vessel growth. The new NCD expands coverage to the less severe grades as well. This is the major change in the new NCD. In addition, the old NCD required that the initial diagnosis and monthly follow-ups after treatments be conducted using a test called fluorescein angiography, which involves injecting a dye into the bloodstream that fluoresces and taking pictures of the back of the eye using a special camera. The new NCD allows for the use of a different test to follow the results of treatment. This test is known as optical coherence tomography. It essentially uses a sophisticated microscope to look at the back of the eye and does not require any injections into the bloodstream.

March 8, 2013

This revised NCD indicates that Medicare will cover the use of special proteins that are extracted from a patient's own blood to promote healing in three types of wounds: (1) Non-healing wounds in patients with diabetes, (2) Non-healing wounds in patients with disease of the veins in the legs, (3) Non-healing wounds caused by pressure from lying in one position for too long. Coverage is only provided when the treatments with these special proteins for the above indications are given as part of a clinical research study to determine whether the proteins in fact do promote healing of these wounds.

June 27, 2012

Medicare contractors may cover a weight-reduction surgical procedure called Laparoscopic Sleeve Gastrostomy (LSG). This will be in addition to the coverage for Bariatric Surgery for the treatment of morbid obesity, as defined by Medicare.

June 21, 2012

Medicare covers liver transplantation for patients with certain malignancies in carefully selected cases.

June 8, 2012

Medicare will only allow coverage of Transcutaneous Electrical Nerve Stimulators (TENS) for Chronic Low Back Pain (CLBP) under certain conditions.

May 1, 2012

Medicare covers Transcatheter Aortic Valve Replacement (TAVR - a new technology for use in treating certain patients with aortic stenosis) under certain conditions.

April 30, 2012

CMS covers extracorporeal photopheresis for the treatment of bronchiolitis obliterans syndrome (BOS) following lung allograft transplantation if it is a part of a clinical research study.

November 29, 2011

Medicare covers certain screenings and counseling for obesity.

November 8, 2011

Medicare covers intensive behavioral therapy for cardiovascular disease (CVD).

November 8, 2011

Medicare covers screening for Sexually Transmitted Infections (STI) and high intensity behavioral counseling to prevent STI.

October 14, 2011

Medicare covers certain screenings for depression in adults.

October 14, 2011

Medicare covers certain screenings and behavioral counseling interventions in primary care to reduce alcohol misuse.

July 7, 2011

Medicare covers Magnetic Resonance Imaging (MRI) with FDA-Approved implanted permanent pacemaker.

June 30, 2011

Medicare covers autologous cellular immunotherapy treatment with sipuleuce-T PROVENGE®.