LCD ID Number: L35111 Status: A-Approved
LCD Title: Hemophilia Factor Products
Geographic Jurisdiction: New Mexico Other Jurisdictions
Original Determination Effective Date:
Original Determination Ending Date:
Revision Effective Date:
Revision End Date:
CMS National Coverage Policy:
This LCD supplements but does not replace, modify or supersede existing Medicare applicable National Coverage Determination(s) or payment policy rules and regulations for blood-clotting factors for hemophilia. 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 blood-clotting factors for hemophilia 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 IOM Publication 100-02, Medicare Benefit Policy Manual
- Chapter 6, Section 30 Drugs and Biologicals
- Chapter 15, Section 50.5.5 Hemophilia Clotting Factors
- CMS IOM Publication 100-03, Medicare National Coverage Determinations (NCD) Manual
- Chapter 1, Part 2, Section 110.3 Anti-Inhibitor Coagulant Complex (AICC)
- CMS IOM Publication 100-04, Medicare Claims Processing Manual
- Chapter 3, Section 20.7.3 Payment for Blood Clotting Factor Administered to Hemophilia Inpatients
- Chapter 17, Section 80.4 Billing for Hemophilia Clotting Factors, Section 80.4.1 Clotting Factor Furnishing Fee
- CMS IOM Publication 100-08, Medicare Program Integrity Manual
- Chapter 13, Section 13.5.4 Reasonable and Necessary Provision in an LCD
Change Request References:
- Transmittal 2332. Change Request (CR) 7553, October 28, 2011.
Social Security Act (Title XVIII) Standard References:
- Title XVIII of the Social Security Act (the Act), Section 1862(a)(1)(A) - This section allows coverage and payment of those services that are considered to be medically reasonable and necessary.
- Title XVIII of the Social Security Act, Section 1862 (a)(7). This section excludes routine physical examinations.
Payment for Blood Clotting Factor Administered to Hemophilia Inpatients, 20.7.3 - Section 6011 of Public Law (PL) 101-239 amended Section 1886(a)(4) of the Act to provide that Prospective Payment System (PPS) hospitals receive an additional payment for the costs of administering blood-clotting factor to Medicare hemophiliacs who are hospital inpatients. Section 6011(b) of PL 101.239 specified that the payment be based on a predetermined price per unit of clotting factor multiplied by the number of units provided. This add-on payment originally was effective for blood-clotting factors furnished on or after June 19, 1990, and before December 19,1991. Section 13505 of PL 103-66 amended Section 6011(d) of PL 101-239 to extend the period covered by the add-on payment for blood-clotting factors administered to Medicare inpatients with hemophilia through September 30,1994. Section 4452 of PL 105-33 amended Section 6011(d) of PL 101-239 to reinstate the add-on payment for the costs of administering blood-clotting factor to Medicare beneficiaries who have hemophilia and who are hospital inpatients for discharges occurring on or after October 1,1998.
Federal Register References:
42 CFR 410.10(q) - Hemophilia clotting factors (the limitation contained in 42 CFR 410.10(q) states that this applies to hemophilia patients competent to use these factors without supervision).
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