Medicare Coverage of Clotting Factor Presented by Ellen Riker March 10, 2015

Topics for Discussion National Coverage and Payment Policy for Clotting Factor under Medicare Part B Medicare Administrative Contractors (MACs) Novitas’ Local Coverage Decision on Hemophilia Products How should HTCs respond? What can the Hemophilia Alliance and NHF do? Questions and Discussion www.hemoalliance.org

Medicare Part B Coverage of Clotting Factor Two ways Medicare provides coverage for clotting factor for hemophilia patients: Clotting factor for patients that can not self-administer is provided “incident to” a physician service where the provider administers and bills for the clotting factor. Self-administered clotting factors for patients that are “competent to use such factors to control bleeding without medical supervision.” Part B existed before Part D – for patients that can not self-administer their drugs. Drugs were covered as part of a service. The self-admin language was added later as more patients were eligible for Medicare through SSDI. Allowed coverage for those who can self-administer. www.hemoalliance.org

Medicare Payment Policy Medicare reimburses clotting factor based on Average Sales Price (ASP) + 6%. Medicare also pays a furnishing fee, which is equal to $0.197/unit. Medicare pays separately (outside the bundled payment rate) for clotting factor on a per unit basis for inpatients at acute, rehabilitation, and long-term care hospitals. www.hemoalliance.org

Medicare National Coverage Policy Based on the Medicare law when medically necessary Implementing regulations published annually Physician fee schedule Inpatient prospective payment system Outpatient prospective payment system National Coverage Determinations - NCDs

Medicare Administrative Contractors (MACs) MACs process all claims for services provided to Medicare beneficiaries in the states in their jurisdictions There are 12 Medicare Part A/B MACs and 4 Durable Medical Equipment (DME) MACs MACs can determine the clinical circumstances under which services are covered by Medicare within their jurisdiction through Local Coverage Determinations (LCDs).

Medicare Administrative Contractors (MACs) MACs develop new or revised LCDs for the following reasons: When the MAC identifies an item or service that should not be covered under certain circumstances When a widespread problem is identified that may pose a significant risk to Medicare trust funds To ensure beneficiary access to care To develop uniform LCDs across multiple states When the MAC anticipates frequent denials of a service

Novitas Hemophilia Products LCD Novitas is a Medicare Administrative Contractor (MAC) for two jurisdictions: Jurisdiction JH – AR, CO, NM, OK, TX, LA, MS Jurisdiction JL - PA, DC, MD, DE, NJ, and parts of Northern VA Draft LCD on Hemophilia Factor Products released 9/18/2014; open for comment through 11/6/2014. On 2/20/2014 posted final LCD to take effect 4/9/2015 www.hemoalliance.org

Novitas Hemophilia Products LCD Specifies clotting factor coverage for patients with a diagnosis of: Factor VIII deficiency/Hemophilia A Factor IX deficiency/Hemophilia B von Willebrand Disease Acquired Hemophilia Factor 13 deficiency Factor VII deficiency NOT included www.hemoalliance.org

Novitas Hemophilia Products LCD Self-administration coverage criteria: Clotting factor is used to control bleeds associated with hemophilia Patient is competent to self-administer without medical supervision Amount of clotting factor covered will be based on historical utilization pattern/profile developed by carrier. Changes may require adjustments to profile. Treating source expected to have such information www.hemoalliance.org

Novitas Hemophilia Product LCD Utilization Guidelines Novitas recognizes that “unanticipated occurrences involving extraordinary events such as accidents or hospitalizations” may change the patient’s utilization profile. Novitas expects that the provider will include the rationale for any changes in the patient’s medical record.

Novitas Hemophilia Product LCD For patients new to Medicare Contractor include in documentation: A profile of patient’s use and prescription for supplies submitted with first claim or if beneficiary has not previously enrolled with contractor. Document any wastage – amount and reason for the wastage. www.hemoalliance.org

Novitas Hemophilia Products LCD Anti-inhibitor Products Coverage Anti-inhibitor Coagulation Complex (AICC) – listed as Feiba, VH Immuno, Autoplex or hemophilia clotting factor for patients with hemophilia A or B and inhibitor antibodies to factor VIII. NovoSeven – for patients with hem A or B or acquired hemophilia. “Novitas notes this product would not be appropriate to be used in a self-administration situation and the supervision should be ‘direct’ as in an ‘incident to’ situation.” www.hemoalliance.org

How Should HTCs Respond? Identify all your Medicare patients. Determine their historical utilization profile (look at past year’s claims). Determine whether changes to the profile are anticipated this year – update medical record. Identify patients that can self-administer their factor and those who have family members or assistance in the home to help them self-administer. Identify patients that need assistance with administration and how the service is being provided. www.hemoalliance.org

How Should HTCs Respond? For patients that need to go to a physician’s office or hospital for administration of clotting factor – See if the patient can come to the HTC for infusions and the HTC can bill for the infusion service and factor. If patients must go to another provider (hospital or physician office) the other provider must bill for the infusion and for the clotting factor for Medicare coverage. Come up with a plan for each patient that can not self-administer.

HTCs in Novitas’ Jurisdictions Proactively reach out to the Medical Director at Novitas to tell them how you plan on responding to the new policy. Send them the utilization profiles for your patients Share with them your plans for patients that can not self administer. Discuss how to handle emergency situations for your patients. Identify patients on NovoSeven to see if an allowance can be made for patients that self-administer

What the Hemophilia Alliance and NHF are doing? NHF and chapters submitted comments on the draft policy. NHF alerted CMS nationally that we have concerns with the Novitas policy and have been denied a meeting with the Medical Director of Novitas. Hemophilia Alliance is educating members about the policy on webinars and at its upcoming meeting and will join with NHF in advocacy efforts. www.hemoalliance.org

Questions? www.hemoalliance.org