On May 23, 2019, the Centers for Medicare & Medicaid Services (CMS) published a final rule (CMS-4180-F) which adopted new processing timeframe requirements for preservice organization determinations and plan reconsiderations related to Part B drug requests, effective January 1, 2020. Additionally, CMS incorporated the shorter processing timeframes for Part B drug requests into the contract deadlines that apply to Part C Independent Review Entity (IRE) reconsiderations under § 422.592(b). These Part B drug request timeframe changes in CMS-4180-F were intended to address the most frail population with clinical circumstances that require a shortened processing timeframe to ensure enrollees maintain access to all medically necessary Part B covered drugs. In previous CMS Program Audits, BluePeak has seen CMS show a particular interest interested in Part B drug processing. For example, BluePeak has seen CMS target audit samples pertaining to Part B drugs to ensure accuracy and timeliness of processing.
Summary of the Part B Drug Timeframes in CMS-4180-F:
Effective January 1, 2020, this rule modified Part C processing timeframes for organization determinations and reconsiderations involving Part B drugs. These changes apply to only preservice organization determinations and reconsiderations and do not apply to post-service determinations or reconsiderations.
- Requests and corresponding notifications for Part B drugs, including Part B drugs subject to step therapy, must be processed under the same timeframes as used in the Part D drug program. This includes timeframes for standard organization determinations (72 hours), expedited organization determinations (24 hours), standard reconsiderations (7 days), and expedited reconsiderations (72 hours) related to coverage of Part B drugs.
- In all circumstances for requests for a Part B drug, the MA organization must notify the enrollee, and the physician, or other prescriber involved, of its decision as expeditiously as the enrollee’s health condition requires but no later than the timeframes set forth above.
- Extensions of the processing timeframes for Part B drug requests are not permitted.
- Effective January 1, 2021 (when the integrated D-SNP rules set forth in CMS-4185-F are effective): Requires certain D-SNPs with aligned enrollment with Medicaid managed care plans to use the same Part B drug organization determination and reconsiderations timeframes set forth in this rule.
CMS Enforcement:
CMS has indicated to BluePeak that they are not planning on testing the new timeliness standards of Part B drug organization determinations and reconsiderations in its 2020 Program Audits (if 2020 Program Audits resume). Although CMS is not going to separate Part B drugs in timeliness tests in 2020 CMS Program Audits, it is still important that the plan is compliant with the new CMS guidance and is processing organization determinations and reconsiderations Part B drugs within the new, shorter timeframes.
While CMS is not assessing the timeliness of Part B drug organization determinations and reconsiderations, this is an area of CMS interest and plans should expect Part B drug requests and reconsiderations to be targeted for sampling in the clinical decision making review in audits starting in 2021. Beginning in 2021, CMS Program Audit timeliness will evaluate Table 1 and Table 2 at the universe level for both standard and expedited pre-service organization determination and reconsideration requests for Part B drugs to determine whether the plan provided notification of the determination within the required, more stringent Part B processing timeframe requirements. On June 4, 2020, CMS issued the latest draft of the proposed 2021 audit protocols with a 30-day comment period. In this latest draft, CMS proposes to incorporate the Part B drug data request for pre-service organization determination and reconsideration requests into the OD and RECON record layouts (Universe Table 1: Standard and Expedited Pre-service Organization Determinations (OD) Record Layout) and Universe Table 2: Standard and Expedited Pre-service Reconsiderations (RECON) Record Layout), in lieu of implementing a separate record layout just for Part B Pre-Service Organization Determinations and Reconsiderations.
Plans will need to determine whether to include the Part B drug requests in the respective ODAG table based on the way in which the request was processed. Additionally, CMS clarified: “While untimely decisions are considered adverse decisions, sponsoring organizations are not required to auto-forward untimely Part B drug organization determinations to the IRE.” It will be critical to a plan’s audit success to establish new processes for creation of the modified universes and ensure that internal processes are established within the plan’s operational departments to closely monitor Part B drug processing.
Operational Area Impacts to consider:
The stringent Part B drug processing time periods will create a paradigm shift in the level of scrutiny needed by plans when it comes to processing management and monitoring.
- Identification of these requests: It is important that pre-service operational areas have adequate controls in place to be able to quickly identify requests pertaining to Part B drugs. Plans should implement clear and concise receipt procedures, coverage guidelines, training and monitoring to ensure the staff is able to identify and process pre-service Part B drug organization determinations and reconsideration requests within the new required timeframes.
- Timely Processing of these requests: Due to the more stringent processing timelines, it is more important than ever for plans to have a robust and timely service request management and tracking/monitoring process to ensure all pre-service Part B drug organization determinations and reconsiderations are processed timely. Plans will need to develop and maintain adequate reporting for receipt, decision and notice for requests, with the capability of effective tracking when cases require manual review. Below are some pointers that plans can take into consideration.
- Put in place policies and procedures to adequately manage the process and outline all necessary requirements for clinical review, outreach and notification.
- Develop daily timeliness reports to assist in effective management of all organization determination requests, breaking out pre-service Part B standard and expedited organization determinations and reconsiderations from Part C standard and expedited organization determinations and reconsiderations.
- Monitor volume of Part B pre-service requests received, review the open cases against the decision timeframe and in particular, review all Part B drug pre-service organization determination denials.
- Plans should consider having a distinct queue for working Part B pre-service drug and reconsideration requests to ensure these are worked immediately upon receipt. For example, cases that require outreach must be prioritized with outbound calls/faxes to ensure timeliness is met, allowing the provider enough time to submit documentation before a final decision must be made for the pre-service organization determination or reconsideration. Per CMS, if upon receipt of a coverage request a plan does not have enough information to make a coverage decision it must make reasonable and diligent efforts to obtain the necessary information. A minimum of one attempt to obtain additional information is sufficient but it is a best practice for plans to make additional attempts.
- Oversight and Management of Delegates: In order to be compliant with Parts C & D Enrollee Grievances, Organization/Coverage Determinations, and Appeals Guidance: Section 10.4.3, plans need to implement an effective delegation and oversight process to ensure all First-Tier, Downstream, and related Entities (FDRs) are compliant with the CMS processing timeframes. It is critical that Plans ensure all utilization management and appeals delegates are aware of this change and have compliant processes built to address the stringent turn around times for processing Part B drug requests and reconsiderations. Plans should have monitoring reports at the member level provided by the delegate that separate pre-service Part B standard and expedited organization determinations and reconsiderations from Part C standard and expedited organizations and reconsiderations in order to best monitor this change. When CMS assessed timeliness in 2021, a delegate that is not processing these requests in a timely fashion will have a negative effect on Plan timeliness results.
- CMS Program Audit Risk – Record Layout: Plans will need to ensure that their systems are able to capture and populate all required information as outlined in the CMS Parts C & D Enrollee Grievances, Organization/Coverage Determinations, and Appeals Guidance (ODAG) Audit Protocol for 2021. BluePeak frequently sees that plans are not yet able to prepare and submit compliant ODAG universes with the required Part B drug information, when applicable. This is an area of opportunity and important that plans must consider going forward to mitigate the risk of an Invalid Data Submission (IDS) condition for the plan if either they or their delegate are not able to populate the universes in a compliant manner.
Guidance applicable to Part B change in processing time periods:
| Date Published | Guidance | Title |
| May 23, 2019 | CMS-4180-F | Final Rule – Modernizing Part D and Medicare Advantage To Lower Drug Prices and Reduce Out-of-Pocket Expenses |
| December 19, 2019 | HPMS Memo to MMPs | Applicability of New Part B Drug Appeal Timeline Rules to Medicare-Medicaid Plans (MMPs) |
| December 30, 2019 | HPMS Memo to MAOs, PDPs, Cost Plans, MMPs and PACE organizations | Updates to Parts C & D Enrollee Grievances, Organization/Coverage Determinations, and Appeals Guidance |
| June 4, 2020 | HPMS Email | Proposed Collection for New Medicare Part C and Part D Program Audit and Industry-Wide Part C Timeliness Monitoring Project (TMP) Protocols – 30-Day Comment Period |
