title: Value-based interventional pain management: a review of medicare national and local coverage determination policies.
abstract: 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.
authors.affiliation: Pain Management Center of Paducah, Paducah, KY 42003, USA. drlm@thepainmd.com
authors.forename: Laxmaiah
authors.initials: L
authors.lastname: Manchikanti
authors.forename: Frank J E
authors.initials: FJ
authors.lastname: Falco
authors.forename: Ramsin M
authors.initials: RM
authors.lastname: Benyamin
authors.forename: Standiford
authors.initials: S
authors.lastname: Helm
authors.forename: Vijay
authors.initials: V
authors.lastname: Singh
authors.forename: Joshua A
authors.initials: JA
authors.lastname: Hirsch
mesh_terms: D014487:Centers for Medicare and Medicaid Services, U.S.; D019317:Evidence-Based Medicine; D006291:Health Policy; D006801:Humans; D019458:Insurance Coverage / Q000706:statistics & numerical data*; D059408:Pain Management; D012189:Retrospective Studies; D014481:United States