Major policies, regulations, and practice patterns related to interventional pain management are
dependent on Medicare policies which include national coverage policies – national coverage
determinations (NCDs), and local coverage policies – local coverage determinations (LCDs).
The NCDs are Medicare coverage policies issued by the Centers for Medicare and Medicaid
Services (CMS). The process used by the CMS in deciding what is and what is not medically
necessary is lengthy, involving a review of evidence-based literature on the subject, expert
opinion, and public comments. In contrast, LCDs are rules and Medicare coverage that are
issued by regional contractors and fiscal intermediaries when an NCD has not addressed the
policy at issue. The evidence utilized in preparing LCDs includes the highest level of evidence
which is based on published authoritative evidence derived from definitive randomized clinical
trials or other definitive studies, and general acceptance by the medical community (standard
of practice), as supported by sound medical evidence.
In addition, the intervention must be safe and effective and appropriate including duration and
frequency that is considered appropriate for the item or service in terms of whether it is furnished
in accordance with accepted standards of medical practice for the diagnosis or treatment of
the patient’s condition or to improve the function. In addition, the safe and effective provision
includes that service must be furnished in a setting appropriate to the patient’s medical needs
and condition, ordered and furnished by qualified personnel, the service must meet, but does
not exceed, the patient’s medical need, and be at least as beneficial as an existing and available
medically appropriate alternative. The LCDs are prepared with literature review, state medical
societies, and carrier advisory committees (CACs) of which interventional pain management is
a member. The LCDs may be appealed by beneficiaries.
The NCDs are prepared by the CMS following a request for a national coverage decision after
an appropriate national coverage request along with a draft decision memorandum, and public
comments. After the request, the staff review, external technology assessment, Medicare
Evidence Development and Coverage Advisory Committee (MedCAC) assessment, public
comments, a draft decision memorandum may be posted which will be followed by a final
decision and implementation instructions. This decision may be appealed to the department
appeals board, but may be difficult to reverse.
This manuscript describes NCDs and LCDs and the process of development, their development,
issues related to the development, and finally their relation to interventional pain management.
Key words: Interventional pain management, interventional techniques, national coverage
determinations (NCDs), local coverage determinations (LCDs), contractor medical director
(CMD), Centers for Medicare and Medicaid Services (CMS), Department of Health and Human
Services (HHS), guidelines, evidence-based medicine, evidence development with coverage
Society of Vascular and Interventional Neurology Standards and Parameters for Guideline Development and Publication
