42 CFR 423.566 - Coverage determinations.

Status message

There is 1 rule appearing in the Federal Register for 42 CFR 423. View below or at eCFR (GPOAccess)
§ 423.566 Coverage determinations.
(a) Responsibilities of the Part D plan sponsor. Each Part D plan sponsor must have a procedure for making timely coverage determinations in accordance with the requirements of this subpart regarding the prescription drug benefits an enrollee is entitled to receive under the plan, including basic prescription drug coverage as specified in § 423.100 and supplemental benefits as specified in § 423.104(f)(1)(ii), and the amount, including cost sharing, if any, that the enrollee is required to pay for a drug. The Part D plan sponsor must have a standard procedure for making determinations, in accordance with § 423.568, and an expedited procedure for situations in which applying the standard procedure may seriously jeopardize the enrollee's life, health, or ability to regain maximum function, in accordance with § 423.570.
(b) Actions that are coverage determinations. The following actions by a Part D plan sponsor are coverage determinations:
(1) A decision not to provide or pay for a Part D drug (including a decision not to pay because the drug is not on the plan's formulary, because the drug is determined not to be medically necessary, because the drug is furnished by an out-of-network pharmacy, or because the Part D plan sponsor determines that the drug is otherwise excludable under section 1862(a) of the Act if applied to Medicare Part D) that the enrollee believes may be covered by the plan;
(2) Failure to provide a coverage determination in a timely manner, when a delay would adversely affect the health of the enrollee;
(3) A decision concerning an exceptions request under § 423.578(a);
(4) A decision concerning an exceptions request under § 423.578(b); or
(5) A decision on the amount of cost sharing for a drug.
(c) Who can request a coverage determination. Individuals who can request a standard or expedited coverage determination are—
(1) The enrollee;
(2) The enrollee's appointed representative, on behalf of the enrollee; or
(3) The prescribing physician or other prescriber, on behalf of the enrollee.
(d) Who must review coverage determinations. If the Part D plan sponsor expects to issue a partially or fully adverse medical necessity (or any substantively equivalent term used to describe the concept of medical necessity) decision based on the initial review of the request, the coverage determination must be reviewed by a physician or other appropriate health care professional with sufficient medical and other expertise, including knowledge of Medicare coverage criteria, before the Part D plan sponsor issues the coverage determination decision. The physician or other health care professional must have a current and unrestricted license to practice within the scope of his or her profession in a State, Territory, Commonwealth of the United States (that is, Puerto Rico), or the District of Columbia.
[70 FR 4525, Jan. 28, 2005, as amended at 74 FR 1546, Jan. 12, 2009; 76 FR 21576, Apr. 15, 2011]

Title 42 published on 2013-10-01

The following are only the Rules published in the Federal Register after the published date of Title 42.

For a complete list of all Rules, Proposed Rules, and Notices view the Rulemaking tab.

  • 2013-12-10; vol. 78 # 237 - Tuesday, December 10, 2013
    1. 78 FR 74730 - Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule, Clinical Laboratory Fee Schedule & Other Revisions to Part B for CY 2014
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Centers for Medicare & Medicaid Services
      Final rule with comment period.
      Effective date: The provisions of this final rule with comment period are effective on January 1, 2014, except for the amendments to §§ 405.350, 405.355, 405.405.2413, 405.2415, 405.2452, 410.19, 410.26, 410.37, 410.71, 410.74, 410.75, 410.76, 410.77, and 414.511, which are effective January 27, 2014, and the amendments to §§ 405.201, § 405.203, § 405.205, § 405.207, § 405.209, § 405.211, § 405.212, § 405.213, § 411.15, and 423.160, which are effective on January 1, 2015. The incorporation by reference of certain publications listed in the rule is approved by the Director of the Federal Register as of January 1, 2014. Applicability dates: Additionally, the policies specified in under the following preamble sections are applicable January 27, 2014: • Physician Compare Web site (section III.G.); • Physician Self-Referral Prohibition: Annual Update to the List of CPT/HCPCS Codes. (section III.N.) Comment date: To be assured consideration, comments must be received at one of the addresses provided below, no later than 5 p.m. on January 27, 2014. (See the SUPLEMENTARY INFORMATION section of this final rule with comment period for a list of the provisions open for comment.)
      42 CFR Parts 405, 410, 411, 414, 423, and 425

Title 42 published on 2013-10-01

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 42 CFR 423 after this date.

  • 2014-01-10; vol. 79 # 7 - Friday, January 10, 2014
    1. 79 FR 1918 - Medicare Program; Contract Year 2015 Policy and Technical Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Programs
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Centers for Medicare & Medicaid Services
      Proposed rule.
      To be assured consideration, comments must be received at one of the addresses provided below, no later than 5 p.m. on March 7, 2014.
      42 CFR Parts 409, 417, 422, 423, and 424