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National Coverage Determinations

National Coverage Determinations

(Updated March 2016)
NCDs are coverage updates made by CMS through an evidence-based process, with opportunities for public participation. These updates typically occur outside the regularly scheduled Annual Election Period, which begins each year in October. CDPHP Medicare Choices notifies members about all NCDs that affect our plan benefits, including via this website.

If you have any questions about your CDPHP Medicare Choices coverage, please contact Member Services at the number on your ID card. 

CMS HAS MADE THE FOLLOWING BENEFIT CHANGES FOR ALL MEDICARE PLANS:

Percutaneous Left Atrial Appendage Closure
Effective:
February 8, 2016

Description: CMS posted a final decision memo for percutaneous left atrial appendage closure (LAAC). CMS will provide national coverage for percutaneous LAAC under Medicare’s Coverage with Evidence Development (CED) program. A national non-coverage determination will remain for percutaneous LAAC outside of a clinical trial.

Medicare’s CED program allows for coverage of items or services that are reasonable and necessary for research to support evidence development for technologies likely to show benefit for the Medicare population. The coverage decision memo allows for coverage of percutaneous LAAC for patients with non-valvular atrial fibrillation when all of the specified conditions for coverage are met. Patients must be enrolled in a CMS-approved prospective national registry, and the implanted device must be FDA approved for patients with non-valvular atrial fibrillation.

The Watchman LAAC device is the only device that is FDA approved for LAAC closure in patients with non-valvular atrial fibrillation. The FDA-approved indication is to reduce the risk of thromboembolism from the left atrial appendage in patients with non-valvular atrial fibrillation who:

  • Are at increased risk for stroke and systemic embolism and are recommended for anticoagulation therapy
  • Are deemed by their physicians to be suitable for warfarin
  • Have an appropriate rationale to seek a non-pharmacologic alternative to warfarin, taking into account the safety and effectiveness of the device compared to warfarin

The CMS decision memo notes that devices other than the FDA-approved Watchman that are either not FDA approved or are used off-label for LAAC (Lariat) do not have adequate data to demonstrate a health benefit and could have the potential for harm. All approved registries will be posted on the CED website

Visit the CMS website for more details.

Stem Cell Transplantation (Multiple Myeloma, Myelofibrosis, and Sickle Cell Disease)
Effective: January 27, 2016
Description: CMS posted a final decision that modifies the NCD for allogenic hematopoietic stem cell transplantation to include coverage for treatment of multiple myeloma, myelofibrosis, and sickle cell disease. This came from a request for reconsideration and expansion of the prior NCD, which allowed for coverage of stem cell transplantation only for treatment of leukemia, aplastic anemia, severe combined immunodeficiency disease, myelodystplastic syndromes, and Wiskott-Aldrich syndrome. Coverage will be available for patients who meet coverage criteria and are participating in an approved prospective clinical study.

Visit the CMS website to learn more.

HIV Screening
Effective: April 13, 2015
Description:
In keeping with the recommendations of the United States Preventive Services Task Force (USPSTF), Medicare now covers one-time HIV infection screening for all individuals between the ages of 15 and 65 years, regardless of perceived risk. Such screening is already covered annually for Medicare beneficiaries in that age group who are at increased risk for HIV, and up to three times per pregnancy.

Low-Dose CT Screening for Lung Cancer
Effective: February 5, 2015
Description: Medicare now covers preventive lung cancer screening with low-dose computed tomography (LDCT) once per year for beneficiaries age 55 to 77 who meet the following criteria:

  • Do not currently display lung cancer symptoms;
  • Are current smokers or have quit smoking within the previous 15 years;
  • Have a tobacco smoking history of at least 30 “pack years” (an average of one pack a day for 30 years); and
  • Have a written order from a physician or other qualified practitioner documenting that the member meets the above criteria, has been counseled on the importance of tobacco abstinence, and is willing to go ahead with treatment for lung cancer, if found.

Coverage includes a visit for counseling and shared decision-making on the benefits and risks of lung cancer screening.

Visit the CMS website to learn more.


Cologuard™
Effective: October 9, 2014
Description: Cologuard™, a stool DNA screening for colorectal cancer, will be covered every three years for Medicare beneficiaries meeting the following criteria:

  • Age 50 to 85 years
  • Showing no signs or symptoms of colorectal disease (including but not limited to lower gastrointestinal pain, blood in stool, positive guaiac fecal occult blood test or fecal immunochemical test)
  • At average risk of developing colorectal cancer (no personal history of colorectal cancer or inflammatory bowel disease and no family history of colorectal cancers).

Visit www.cms.gov for more information.

Transcatheter Mitral Valve Repair
Effective: August 7, 2014
Description: CMS released a determination on transcatheter mitral valve repair (TMVR). CMS will cover TMVR for the treatment of significant symptomatic mitral regurgitation if performed by an interventional cardiologist and/or a cardiothoracic surgeon, using a device specifically approved by the Food and Drug Administration (FDA) for TMVR, and the beneficiary is enrolled in a prospective, national, audited registry. The MitraClip Mitral Valve Repair System (Abbott Vascular Inc.) is currently the only eligible device.

Visit the CMS website to learn more.

Screening for Hepatitis C Virus
Effective:
June 2, 2014
Description: CMS has concluded that screening for Hepatitis C Virus (HCV), consistent with the grade B recommendations by the U.S. Preventive Services Task Force (USPSTF), is reasonable and necessary for the prevention or early detection of an illness or disability. CDPHP already covers this testing when ordered by the member’s primary care practitioner and performed by an eligible Medicare provider, and the following apply:

  • The adult patient is at high risk for Hepatitis C Virus infection, meaning a history of illicit injection drug use and/or received a blood transfusion prior to 1992. Repeat screening is covered annually for high-risk individuals with continued illicit injection drug use subsequent to a prior negative screening test.
  • A single screening test is covered for those born from 1945 through 1965, regardless of whether they meet the high-risk criteria.

Visit the CMS website to learn more.

Intensive Cardiac Rehabilitation
Effective: May 6, 2014
Description: The Centers for Medicare & Medicaid Services (CMS) has determined that the evidence is sufficient to expand the intensive cardiac rehabilitation (ICR) benefit to include the Benson-Henry Institute Cardiac Wellness Program. Previously, only the Pritikin Program and the Ornish Program met the requirements for ICR. This did not require a change to current CDPHP policy.

Visit the CMS website for more details.

Cardiac Rehabilitation
Effective:
February 18, 2014
Description: CMS has expanded coverage for cardiac rehabilitation services to beneficiaries with stable, chronic heart failure. “Chronic heart failure” is considered present in patients with left ventricular ejection fraction of 35 percent or less and New York Heart Association (NYHA) class II to IV symptoms, despite being on optimal heart failure therapy for at least six weeks. To be considered “stable,” the patient must not have not had a major cardiovascular hospitalization or procedure within the previous six weeks nor reasonably be expected to undergo a major cardiovascular hospitalization or procedure within the next six months.

Visit the CMS website to learn more.

Percutaneous Image-Guided Lumbar Decompression for Lumbar Spinal Stenosis (LSS)
Effective:
January 9, 2014
Description: CMS has determined that this procedure is not reasonable and necessary but may be covered by Medicare only when provided for beneficiaries with LSS who are enrolled in an approved clinical trial. This determination will not result in any changes to current CDPHP policy.

Visit the CMS website for more details. 

Ventricular Assist Devices
Effective: October 30, 2013
Description: CMS has modified its policies regarding use of a ventricular assist device (VAD) as a bridge to transplant (BTT) and for destination therapy (DT).

  • With regard to BTT, a VAD can be covered if the patient is actively on the heart transplant waitlist maintained by the Organ Procurement and Transplantation Network. A requirement stating that a “Medicare-approved heart transplant center should make every reasonable effort to transplant patients on such devices as soon as medically reasonable” was removed.
  • For DT, patient selection criteria have not changed, but the policy clarifies that the identification of patients who are not candidates for heart transplantation is based on information available at the time of VAD implant.
  • CMS also concluded that facilities currently credentialed by the Joint Commission for placement of VADs as DT may continue as Medicare-approved facilities until October 30, 2014. At the conclusion of this transition period, these facilities must be in compliance with criteria as determined by a credentialing organization approved by CMS.

PET Scans for Neurodegenerative Disease
Effective: September 27, 2013
Description: CMS has determined that there is not enough evidence to warrant the use of positron emission tomography (PET) amyloid-beta (Aβ) imaging for Medicare beneficiaries with dementia or neurodegenerative disease, and therefore will not cover PET Aβ imaging for this indication.

However, CMS does note that there is sufficient evidence to suggest that PET Aβ imaging could be used to exclude Alzheimer's disease (AD) in narrowly defined and clinically difficult differential diagnoses, such as AD versus frontotemporal dementia. CMS agrees to cover one PET Aβ scan for members with cognitive impairment possibly caused by AD if they are enrolled in an approved clinical study designed to determine whether PET Aβ imaging can lead to improved health outcomes for such patients.

Visit the CMS website for more details.

Bariatric Surgery Facility Certification
Effective: September 25, 2013
Description: CMS has determined that the evidence is sufficient to conclude that continuing the requirement for certification of bariatric surgery facilities would not improve health outcomes for Medicare beneficiaries. Therefore, CMS has decided to remove this certification requirement.

Since February 21, 2006, these procedures were covered only when performed at facilities certified by: (1) the American College of Surgeons as a Level 1 Bariatric Surgery Center or (2) the American Society for Bariatric Surgery as a Bariatric Surgery Center of Excellence.

Visit the CMS website for more details.

Implanted Permanent Cardiac Pacemakers
Effective: August 13, 2013
Description:
CMS has determined that the evidence is sufficient to conclude that implanted permanent cardiac pacemakers, single chamber or dual chamber, are reasonable and necessary for the treatment of non-reversible symptomatic bradycardia due to sinus node dysfunction and second and/or third degree atrioventricular block. Symptoms of bradycardia are symptoms that can be directly attributable to a heart rate less than 60 beats per minute (for example: syncope, seizures, congestive heart failure, dizziness, or confusion).

The following indications are covered for implanted permanent single chamber or dual chamber cardiac pacemakers:

  • Documented non-reversible symptomatic bradycardia due to sinus node dysfunction.
  • Documented non-reversible symptomatic bradycardia due to second degree and/or third degree atrioventricular block.

This determination will not result in any changes to current CDPHP policy.

Visit the CMS website for more details.

Aprepitant for Chemotherapy Induced Emesis
Effective: June 28, 2013
Description:
CDPHP will update how we administer benefits for Emend (aprepitant). The memo expands coverage for Emend to include the use of the three drug regimen of oral aprepitant (Emend), and oral 5 HT₃ antagonist and oral dexamethasone when the beneficiary is receiving moderately emetogenic chemotherapy immediately before and within 48 hours after the administration of the anticancer treatment. This all oral regimen is covered when it is administered in that time frame with any of the following chemotherapeutic agents, administered either singularly or in combination:

  • alemtuzumab*
  • azacitidine*
  • bendamustine*
  • carboplatin*
  • carmustine
  • cisplatin
  • clofarabine*
  • cyclophosphamide
  • cytarabine*
  • dacarbazine
  • daunorubicin*
  • doxorubicin
  • epirubicin
  • idarubicin*
  • ifosfamide*
  •  irinotecan*
  • lomustine
  • mechlorethamine
  • oxaliplatin *
  • streptozocin 

*new to list

This expands the list of anticancer chemotherapy agents considered as highly emetogenic or moderately emetogenic.

Visit the CMS website for more details.

FDG-PET for Solid Tumors
Effective: June 11, 2013
Description:
The Centers for Medicare & Medicaid Services (CMS) will now pay for up to three scans using 18F-fluorodeoxyglucose-enhanced positron emission tomography (FDG-PET) technology when the scans are used to plan cancer treatments, including prostate cancer. Previously, FDG-PET scans were covered only when provided in certain clinical studies.

Visit the CMS website for more details.

Ocular Photodynamic Therapy (OPT) With Verteporfin
Effective: April 3, 2013
Description:
The Centers for Medicare & Medicaid Services (CMS) has expanded coverage of ocular photodynamic therapy (OPT) with verteporfin for “wet” age-related macular edema (AMD).  Previously, fluorescein angiography (FA) testing was required for coverage of follow-up treatments.  They have revised the requirements for testing to permit either optical coherence tomography (OCT) or FA to assess treatment response.  All other coverage criteria continue to apply.

Visit the CMS website for more details.

Oncologic Uses of Radiopharmaceuticals
Effective: March 7, 2013
Description:
CDPHP has been granted jurisdiction by CMS regarding coverage for radiopharmaceuticals used for positron emission tomography (PET) oncologic imaging. CDPHP currently provides reimbursement for radiopharmaceuticals only when the code is defined as therapeutic. Except in limited situations, reimbursement is not provided for radiopharmaceuticals defined as diagnostic. CMS may make future national coverage decisions on the use of any radiopharmaceuticals, which would supersede this determination.

Visit the CMS website for more details.

Autologous Platelet-Rich Plasma
Effective: August 2, 2012
Description: Autologous platelet-rich plasma (PRP) can be covered for patients who have chronic non-healing diabetic, pressure, and/or venous wounds and are enrolled in a clinical research study that addresses specified questions using validated and reliable methods of evaluation. Clinical study applications for coverage pursuant to this National Coverage Determination (NCD) must be received by August 2, 2014.

Visit the CMS website for more details.

Adult Liver Transplant – Additional Malignancies Now Covered
Effective: June 21, 2012
Description: The Centers for Medicare & Medicaid Services (CMS) has issued a final decision memo stating that health plans may now consider liver transplant coverage for the following malignancies: (1) extrahepatic unresectable cholangiocarcinoma (CCA); (2) liver metastases due to a neuroendocrine tumor (NET); and (3) hemangioendothelioma (HAE).

Visit the CMS website for more details.

Extracorporeal Photopheresis
Effective:
April 30, 2012
Description: Extracorporeal photopheresis (EP) can be covered when administered as part of a sanctioned clinical research study involving Medicare members who have undergone a lung allograft and subsequently developed progressive bronchiolitis obliterans syndrome refractory to immunosuppressive drug treatment.

Visit the CMS website for more information. 

Transcatheter Aortic Valve Replacement
Effective:
May 1, 2012
Description: Transcatheter Aortic Valve Replacement (TAVR) using the Edwards Sapien® heart valve replacement system can be covered for Medicare members suffering from aortic stenosis. Previously, surgical repair of aortic stenosis was covered only when performed via open heart surgery. 

Certain provider, facility, and data collection criteria must be met as a condition of coverage:

  • The procedure must use a device approved by the FDA.
  • Two cardiac surgeons must have reviewed the patient's suitability for surgery.
  • The patient must be under the care of a multidisciplinary heart team, and the facility must have the appropriate infrastructure to perform transcatheter aortic valve implantation (TAVI).
  • Interventional cardiologists and cardiac surgeons must jointly participate in the intraoperative technical aspects of the procedure.
  •  The hospital in which it is performed must participate in a prospective, national, audited registry that follows the patient for at least one year but tracks outcomes for five years.

More information can be found on the CMS website.

Transcutaneous Electrical Nerve Stimulation (TENS)
Effective:
June 8, 2012
Description: Although CMS has determined that transcutaneous electrical nerve stimulation (TENS) will be covered only for those Medicare patients who are enrolled in a prospective clinical study with a randomized controlled design, CDPHP will continue to cover TENS units for all lines of business, subject to criteria and coverage guidelines, and has removed the prior authorization requirement.   

Visit the CMS website for more information.

Bariatric Surgical Procedures
Effective:
June 27, 2012
Description: Stand-alone laparoscopic sleeve gastrectomy can be covered for the treatment of co-morbid conditions related to obesity for Medicare beneficiaries. This approach is in addition to the following procedures already approved by CMS: open and laparoscopic Roux-en-Y gastric bypass (RYGBP), laparoscopic adjustable gastric banding (LAGB); and open and laparoscopic biliopancreatic diversion with duodenal switch (BPD/DS).  For each of these procedures, the following conditions must be satisfied:

  • The beneficiary has a body-mass index (BMI) ≥ 35 kg/m2
  • The beneficiary has at least one co-morbidity related to obesity
  • The beneficiary has been previously unsuccessful with medical treatment for obesity

More information can be found by logging in to cdphp.com and clicking the My Resources tab or on the CMS website.

Intensive behavioral counseling for obesity
Effective: November 29, 2011
Description: Intensive behavioral (medical nutrition) therapy for obesity (BMI of 30 kg/m2 or higher) when provided by a qualified primary care physician, or other primary car practictioner, in a primary case setting as follow:

  • One face-to-face visit every week for the first month;
  • One face-to-face visit every other week for months two through six;
  • One face-to-face visit every month for months seven through twelve, if the enrollee has achieved a minimum 3 kg reduction in weight during the first six months of intensive therapy.

CDPHP is an HMO with a Medicare contract. Enrollment in CDPHP Medicare Choices depends on contract renewal.

Y0019_17_1486 Approved Last Updated 05/01/2017

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