Response to Comments Document - 60-day

60-Day Comment Period: Response to Comments

Part D Coordination of Benefits Data

(CMS-10171, OMB 0938-0978)

Out-of-Scope Comments: We received comments on upper payment limits set by prescription drug affordability boards and other pricing and reimbursement programs and their impact on AIDS drug assistance programs (ADAPs). These comments are outside the scope of coordination of benefits (COB) and will not be addressed.

Comment: We received comments on a variety of issues related to COB processes and suggestions for improvement:

• Manufacturer patient assistance programs (PAPs) are not required to report assistance they are providing to Medicare beneficiaries to CMS, resulting in paper mailings and faxes sent to Part D sponsors and manual processing by Part D sponsors.

• There are issues with the data being reported to CME by some Responsible Reporting Entities (RREs). Non-group health plan (NGHP) insurers are not consistently reporting OHI under Section 111. NGHP OHI records being sent to Part D sponsors by CMS contain missing/invalid data and are unusable for coordination of benefits activities. “Termination Date” on NGHP OHI records is not consistent with the definition of the field as described in the MAPD Plan Communication User Guide. RREs are incorrectly reporting coverage to CMS (e.g., reporting terminated coverage as active or reporting secondary coverage as primary).

• CMS internal systems are out-of-sync resulting in OHI discrepancies and Part D sponsors are unable to submit corrections via Electronic Correspondence Referral System (ECRS).

• Not all supplemental payers are reporting OHI to CMS leaving Part D sponsors with incomplete information.

• NGHP insurers continue to send paper mailings to Part D sponsors subsequent to the PAID Act, which results in a labor-intensive, manual process to determine if the Part D plan paid for prescription drugs that should have been covered by the NGHP. CMS should enhance data collection from NGHPs and add additional data to COB-OHI files to facilitate recoveries between Part D plans and NGHPs.

• Chapter 14 of the Prescription Drug Benefit Manual, the chapter for COB, is out-of-date and requires revision.

• CMS should ensure COB systems provide accurate True Out-of-Pocket TrOOP tracking to prevent errors and delay of high-cost medications for chronic diseases.

• CMS should leverage the Part D transaction facilitator (PDTF) to improve coordination of benefits and prescription drug access for underserved and rural populations.

Response: We thank commenters for their input, however these comments do not directly relate to the burden estimates in this information collection. We may take these comments into consideration for future guidance or improvements in internal data systems. Issues related to Section 111 mandatory reporting of other health insurance coverage and the PAID Act are outside the scope of this information collection.

Comment: Commenters suggested improvements to the annual COB notification process. One commenter suggested that the annual COB notification letter should be sent and managed by the Benefits Coordination and Recovery Center (BCRC), not Part D sponsors. Another commenter requested that Part D sponsors be permitted to exclude state pharmaceutical assistance programs (SPAPs) and ADAPs from the notification letter because the Part D sponsor does not have permission to update those records in ECRS.

Response: While guidance specific to the annual COB notification letter is outside the scope of this information collection, we realized that the information collection did not adequately capture the burden associated with annual COB notification letter mailings and the Part D sponsors’ responsibility for entering OHI updates via ECRS. Related to this is the fact that beneficiaries must respond to the COB notification letter if any updates to their OHI are required. Although this is not a new requirement, we have updated the information collection accordingly to reflect the burden associated with these longstanding requirements. We may consider recommendations regarding which types of OHI records must be included in the annual COB notification letter for future guidance.