This LCD supplements but does not replace, modify, or supersede existing Medicare applicable National Coverage Determinations (NCDs) or payment policy rules and regulations for transurethral waterjet ablation of the prostate. Federal statute and subsequent Medicare regulations regarding provision and payment for medical services are lengthy. They are not repeated in this LCD. Neither Medicare payment policy rules nor this LCD replace, modify, or supersede applicable state statutes regarding medical practice or other health practice professions acts, definitions and/or scopes of practice. All providers who report services for Medicare payment must fully understand and follow all existing laws, regulations and rules for Medicare payment for transurethral waterjet ablation of the prostate and must properly submit only valid claims for them. Please review and understand them and apply the medical necessity provisions in the policy within the context of the manual rules. Relevant CMS manual instructions and policies may be found in the following Internet-Only Manuals (IOMs) published on the CMS Web site:
CMS Internet-Only Manual, Pub. 100-02, Medicare Benefit Policy Manual, Chapter 14, §10 Coverage of Medical Devices
CMS Internet-Only Manual, Pub. 100-04, Medicare Claims Processing Manual, Chapter 23, §30 Services paid under the Medicare Physician’s Fee Schedule
CMS Internet-Only Manual, Pub. 100-08, Medicare Program Integrity Manual, Chapter 13, §13.5.4 Reasonable and Necessary Provision in an LCD
Title XVIII of the Social Security Act, §1862(a)(1)(A) allows coverage and payment for only those services that are considered to be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.
21 CFR §876.4350 Fluid jet system for prostate tissue removal
42 CFR §410.32 Diagnostic x-ray tests, diagnostic laboratory tests, and other diagnostic tests: Conditions
42 CFR §410.33 Independent diagnostic testing facility
42 CFR §414.510 Laboratory date of service for clinical laboratory and pathology specimens
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