Below are current national coverage determination updates. Click the "view details" button to read more about the determination and what has changed.
|Posted||Coverage Determination||Clinical Trial|
|7/29/2015||Final Scope of Benefit NCD: Speech Generating Devices||No||View Details|
|7/9/2015||Decision Memo for Screening for Cervical Cancer with Human Papillomavirus (HPV) Testing (CAG-00442N)||No||View Details|
|4/13/2015||Screening for the Human Immunodeficiency Virus (HIV) Infection|
Expansion of existing coverage of original NCD effective in 2013.
|2/5/2015||Final Decision Memo on Screening for Lung Cancer with Low Dose Computed Tomography||No||View Details|
|1/13/2015||Final Decision Memorandum: Microvolt T-wave Alternans||No||View Details|
Please use this link to see the updates published January 2016.
For clinical trials covered under the Clinical Trials National Coverage Determination 310.1 (NCD) (NCD manual, Pub. 100-03, Part 4, section 310), original Medicare covers the routine costs of qualifying clinical trials for all Medicare enrollees, including those enrolled in Senior Health Plan, as well as reasonable and necessary items and services used to diagnose and treat complications arising from participating in qualifying clinical trials. All other original Medicare rules apply.
You may refer to Medicare's Clinical Trial Policy at: http://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=1&ncdver=2&bc=BAABAAAAAAAA for more information on the definition of routine costs and the clinical trial Medicare qualification process. Medicare's Clinical Trial Policy does not withdraw Medicare coverage for items and services that may be covered according to Local Coverage Determinations (LCDs) or the regulations on category B investigational device exemptions (IDE) found in 42 CFR 405, Subpart B, 411.15, and 411.406.
Senior Health Plan will pay the enrollee the difference between original Medicare cost-sharing incurred for qualified clinical trial items and services and Senior Health Plan's in-network cost-sharing for the same category of items and services. This cost-sharing reduction requirement applies to all qualifying clinical trials as defined in the NCD manual, Pub. 100-03, Part 4, section310.1. Senior Health Plan may not choose the clinical trial or clinical trial items and services to which this policy applies. Senior Health Plan owes the difference even if the enrollee has not yet paid the clinical trial provider. Additionally, the enrollee's in-network cost-sharing portion also must be included in the plan's out-of-pocket maximum calculation.
To be eligible for reimbursement, an enrollee (or providers acting on the enrollee's behalf) must notify Senior Health Plan that he or she has received a qualified clinical trial service and provide documentation of the cost-sharing incurred, such as a provider bill. Senior Health Plan is also permitted to seek the enrollee's original Medicare cost-sharing information directly from clinical trial providers.
Senior Health Plan enrollees are free to participate in any qualifying clinical trial that is open to beneficiaries in original Medicare. If Senior Health Plan decides to conduct its own clinical trial, Senior Health Plan will explain the benefits of participating in its clinical trial; however, Senior Health Plan may not require prior authorization for participation in a Medicare-qualified clinical trial not sponsored by Senior Health Plan, nor may it create impediments to an enrollee's participation in a non-plan-sponsored clinical trial, even if Senior Health Plan believes it is sponsoring a clinical trial of a similar nature. Examples of impediments to an enrollee's participation include, but are not limited to, requiring enrollees to pay the original Medicare cost-sharing amount for routine care services before being compensated by Senior Health Plan for the difference or unduly delaying any required cost-sharing refund. Enrollees retain the right to choose the clinical trial(s) in which they wish to participate. However, Senior Health Plan may request, but not require, enrollees to notify the plan in advance when they choose to participate in Medicare-qualified clinical trials.