423.562—General provisions.
(a) Responsibilities of the Part D plan sponsor.
A Part D plan sponsor must meet all of the following requirements.
(i)
A grievance procedure as described in § 423.564 for addressing issues that do not involve coverage determinations;
(ii)
A procedure for making timely coverage determinations, including determinations on requests for exceptions to a tiered cost-sharing structure or to a formulary; and
(iii)
Appeal procedures that meet the requirements of this subpart for issues that involve coverage determinations.
(ii)
Complaint process available to the enrollee under the QIO process as set forth under section 1154(a)(14) of the Act.
(3)
A Part D plan sponsor must arrange with its network pharmacies to post or distribute notices instructing enrollees to contact their plans to obtain a coverage determination or request an exception if they disagree with the information provided by the pharmacist.
(4)
In accordance with subpart K of this part, if the Part D plan sponsor delegates any of its responsibilities under this subpart to another entity or individual through which the Part D plan sponsor provides covered benefits, the Part D plan sponsor is ultimately responsible for ensuring that the entity or individual satisfies the relevant requirements of this subpart.
(b) Rights of enrollees.
In accordance with the provisions of this subpart, enrollees have all of the following rights under Part D plans:
(1)
The right to have grievances between the enrollee and the Part D plan sponsor heard and resolved by the plan sponsor, as described in § 423.564.
(2)
The right to a timely coverage determination by the Part D plan sponsor, as specified in § 423.566 and § 423.568, including the right to request from the Part D plan sponsor an exception to its tiered cost-sharing structure or formulary, as specified in § 423.578.
(3)
The right to request from the Part D plan sponsor an expedited coverage determination, as specified in § 423.570.
(i)
The right to a redetermination of the adverse coverage determination by the Part D plan sponsor, as specified in § 423.580.
(iii)
If, as a result of a redetermination, a Part D plan sponsor affirms, in whole or in part, its adverse coverage determination, the right to a reconsideration or expedited reconsideration by an independent review entity (IRE) contracted by CMS, as specified in § 423.600.
(iv)
If the IRE affirms the plan's adverse coverage determination, in whole or in part, the right to an ALJ hearing if the amount in controversy meets the requirements in § 423.1970.
(v)
If the ALJ affirms the IRE's adverse coverage determination, in whole or in part, the right to request MAC review of the ALJ hearing decision, as specified in § 423.1974.
(vi)
If the MAC affirms the ALJ's adverse coverage determination, in whole or in part, the right to judicial review of the hearing decision if the amount in controversy meets the requirements in § 423.1976.
(c) When other regulations apply.
Unless this subpart provides otherwise, the regulations in part 422, subpart M of this chapter (concerning the administrative review and hearing processes under titles II and XVIII, and representation of parties under title XVIII of the Act) and any interpretive rules or CMS rulings issued under these regulations, apply under this subpart to the extent they are appropriate.
(d) Relation to ERISA Requirements.
Consistent with section 1860D-22(b) of the Act, provisions of this subpart may, to the extent applicable under the regulations adopted by the Secretary of Labor, apply to claims for benefits under group health plans subject to the Employee Retirement Income Security Act.
[70 FR 4525, Jan. 28, 2005, as amended at 74 FR 65363, Dec. 9, 2009]