March Regulatory Updates

Review of Statistical Sampling Methods: Pursuant to the regular updates to the Office of Inspector General Work Plan, the Centers for Medicare & Medicaid Services (CMS) is assessing statistical sampling methods used within the Medicare fee-for-service administrative appeal process.  Specifically, CMS is reviewing if the Medicare Administrative Contractors and Qualified Independent Contractors are reviewing statistical estimates in an “appropriate and consistent manner”.  The outcome of this review may be significant for many healthcare organizations that have received demands based on extrapolation.

Cardiac Device Coverage: CMS updated the 13 year old coverage determination for implantable cardiac devices in an effort to allow for easier patient access and reduce regulatory burden on providers. Key aspects of the updated coverage determination include:

  • Elimination of wait periods for device implantation: Patients with an existing implantable cardiac device who suffer a heart attack or undergo a coronary revascularization procedure can obtain a replacement device without waiting the prior 40 days from heart attack or 90 days from bypass or angioplasty.
  • Removal of registry tracking requirement
  • Requires “shared decision-making”: Objective is to spur conversation between the provider and patient addressing more than risks and benefits of the procedure so the patient can make an informed decision.

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