The Centers for Medicare & Medicaid Services (CMS) published its final combined Parts C and D grievances and appeals guidance, along with related Frequently Asked Questions (FAQs), on February 22, 2019. As promised, CMS did not make many significant changes from its draft guidance. Additionally, CMS indicated it does not expect to audit any changes or updates from the previous guidance until January 2020.
Reminders and changes from the draft guidance are reiterated below.
Model Notices: CMS revised several of its model notices to reflect changes in guidance. These may be found on CMS’ Parts C and D Appeals & Grievances websites.
Jane Scott, our Senior Vice President of Population Health & Clinical commented on the following regarding the role of the Plan Medical Director:
Role of the Plan Medical Director: As per CMS-issued FAQ fact sheet, the question was asked: Can the role of the medical director be delegated? The answer was NO; “an MA organization or Part D sponsor must employ a medical director who is responsible for ensuring the clinical accuracy of all organization or coverage determinations and reconsiderations or redeterminations involving medical necessity.”
42 CFR 422.562(a)(4) also goes on to state, “The medical director must be a physician with a current and unrestricted license to practice medicine in a State, Territory, Commonwealth of the United States (that is, Puerto Rico), or the District of Columbia.”
42 CFR 422.562(a)(5) states the same for Part D sponsors. This clarification may pose more questions from many plans as outsourcing utilization management (UM) and prior authorization (PA) are common activities. CMS does not clarify what “ensuring the accuracy” means or exactly how that is effectuated within the fact sheet, thus plans must look to the new guidance to find the answer:
Section 10. 4.2 “CMS expects plans to have processes in place for elevating issues of clinical concern to the medical director; however, it is not expected that a plan’s medical director will review every medical necessity decision and CMS considers he or she to be fulfilling their responsibility through the plan’s established process for when a medical director must be involved.
The medical director has overall responsibility for the plan’s clinical decision-making, and as such, is expected to be involved in various aspects of related plan policies and operations which may include: medical and utilization review, benefits and claims management, formulary administration, processing coverage decisions in accordance with adjudication timeframes and notice requirements, provider/prescriber outreach, staff training, and oversight of delegated entities.”
This may require some plans to reassess the policies which govern the role of the medical directors and to elevate the involvement of the medical directors in day-to-day review/pharmacy operations as well as delegation oversight. Oftentimes, plans have an “oversight unit” that manages delegates and looks at data via reports as stated within the contracts but does not involve true medical director oversight frequent enough. This clearly spells out CMS expectations for medical directors and what plans must do to evidence their involvement. A similar question was posed for Part D redeterminations in the FAQ fact sheet. The question was asked of CMS if a pharmacist can review Part D redeterminations, even if it resulted in an approval; CMS again stated no, it must be done, even when favorable, by a physician with the expertise in the field of medicine appropriate for the services at issue.
GHG suggests plans review their own internal and outsourced processes to ensure compliance with these answered questions.
Julie Billman, our Senior Vice President of Operations discusses the following regarding verbal notifications:
Good Faith Effort to Provide Verbal Notification: CMS expanded the Part D good faith effort of notification to the Part C service and benefits. This means if the plan has the enrollee’s phone number and makes attempts to reach the member, if they are unable to reach the enrollee, it counts as a good faith effort to provide verbal notice and satisfies the verbal notice requirements. This includes instances such as when:
• The number is incorrect
• The number is out of service
• Or no person or voicemail answers the phone call
Plans must document the good faith effort and include it in the case file. Written notice must be sent to the enrollee within the applicable time frame. In these instances, the plan is not at fault for the inability to reach the member. If the plan makes a successful verbal notice, the subsequent written notification is still required and must be sent within three calendar days of the verbal notice.
Plan Communication to an Enrollee: CMS reminds plans they must provide written communication and notices described in its guidance in alternate formats and languages consistent with Section 1557 of the Affordable Care Act and Section 504 of the Rehabilitation Act of 1973. Enrollees requesting an alternate format should have the same level of access to information as an individual not requesting information in an accessible format. Delays in providing materials in alternate formats can impact time frames enrollees may have to take certain actions.
Outreach for Additional Information to Support Coverage Decisions: If additional information is needed to make a coverage or appeal decision, a minimum of one attempt must be made. Plans may, but are not required, to adopt best practices (e.g., multiple attempts, multiple methods, involving plan physicians) for outreach in order to increase the likelihood of obtaining necessary information. CMS dictates the time frames for outreach in specified situations only. “This is quite a different expectation from the Health Plan Management System (HPMS) memo on “Guidance on Outreach for Information to Support Coverage Decisions” issued February 2017, which this guidance supersedes,” explained Caron Wingerchuk, our Senior Director of Pharmacy.
Procedure for Handling Withdrawn Grievances CMS clarified an enrollee may submit a verbal or written request to withdraw a grievance any time before the decision is mailed by the plan. The plan should, but is not required to, send a written confirmation of that withdrawal to the enrollee within 3 calendar days of receipt of the withdrawal request. Quality of care grievances are still required to be investigated, even if the enrollee requests to withdraw the grievance.
Part D At-Risk Determinations This section is added to support the implementation of the Comprehensive Addiction and Recovery Act (CARA). An at-risk determination is a decision made under a plan sponsor’s drug management program that involves: identification of an at-risk enrollee, issuance of a limitation on access to coverage of frequently abused drugs, such as a prescriber and/or pharmacy lock-in, and information sharing for Part D plan enrollments. If an enrollee disagrees with an at-risk determination, they have a right to request a redetermination, and plans would be expected to follow requirements as they pertain to the redetermination process. Per CMS’ Program Audit FAQs and its 2019 Program Audit memo, CMS clarified that beneficiary at-risk determinations are not defined as coverage determinations for 2019, and, therefore, at-risk determination data will not be collected via the coverage determination audit universe record layouts. However, if a beneficiary appeals the at-risk determination, the appeal is a redetermination and should be included in the applicable redetermination universes.
Tiering Exceptions Plans must establish and maintain reasonable and comprehensive procedures to allow enrollees to receive non-preferred drugs in a higher tier at a lower tier applicable to alternative drugs in the lower tier. Specifically, the following limitations may be applied by the plan:
• Brand drugs are eligible for tiering exceptions to the lowest applicable cost sharing associated with brand alternatives.
• Biological products are eligible for tiering exceptions to the lowest applicable cost sharing associated with biological alternatives.
• Non-preferred generic drugs are eligible for tiering exceptions to the lowest applicable cost sharing associated with alternatives that are either brand or generic drugs.
Plans do not have to offer tiering exceptions for brand name drugs or biological products at the cost-sharing level of alternative drugs where the alternatives include only generic or authorized generic drugs.
Adjudication Time Frame for Coverage Determinations Involving an Exception: CMS recommends tolling for an exception request should not exceed 14 calendar days when awaiting a supporting statement for exception requests, provided the plan sponsor has contacted the enrollee and/or physician or other prescriber and clearly identified the information needed to process the request.
Part D Payment Time Frame Plans must authorize payment for the benefit within 14 calendar days from the date it receives the redetermination request and make payment no later than 30 days after the request is received. The 14-day time frame now applies to both initial and redetermination payment requests.
Part C Notification Requirements Medicare Advantage plans are not required to notify beneficiaries upon forwarding cases to the Part C Independent Review entity (IRE).
Forwarding Untimely Cases to the IRE for a Fully Favorable Decision When a Part C or Part D plan makes a fully favorable determination on a Level 1 appeal less than 24 hours after the end of the adjudication time frame, the plan should effectuate and notify the enrollee of the favorable appeal decision in lieu of forwarding the appeal to the IRE.
When reviewing the new guidance and pondering operational changes, consider any potential Star Ratings impact and a universal approach to business process improvements and member experience.
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