42 C.F.R. Subpart D—Cost Control and Quality Improvement Requirements
Title 42 - Public Health
This subpart sets forth the requirements relating to the following: (a) Drug utilization management programs, quality assurance measures and systems, and medication therapy management programs (MTMP) for Part D sponsors. (b) Consumer satisfaction surveys of Part D plans. (c) Electronic prescription drug programs for prescribers, dispensers, and Part D sponsors. (d) Quality improvement organization (QIO) activities. (e) Compliance deemed on the basis of accreditation. (f) Accreditation organizations. (g) Procedures for the approval of accreditation organizations as a basis for deeming compliance. [70 FR 4525, Jan. 28, 2005, as amended at 70 FR 67593, Nov. 7, 2005] (a) General rule. Each Part D sponsor must have established, for covered Part D drugs furnished through a Part D plan, a drug utilization management program, quality assurance measures and systems, and an MTMP as described in paragraphs (b), (c), and (d) of this section. (b) Drug utilization management. A Part D sponsor must have established a reasonable and appropriate drug utilization management program that— (1) Includes incentives to reduce costs when medically appropriate; (2) Maintains policies and systems to assist in preventing over-utilization and under-utilization of prescribed medications; and (3) Provides CMS with information concerning the procedures and performance of its drug utilization management program, according to guidelines specified by CMS. (c) Quality assurance. A Part D sponsor must have established quality assurance measures and systems to reduce medication errors and adverse drug interactions and improve medication use that include all of the following— (1) Representation that network providers are required to comply with minimum standards for pharmacy practice as established by the States. (2) Concurrent drug utilization review systems, policies, and procedures designed to ensure that a review of the prescribed drug therapy is performed before each prescription is dispensed to an enrollee in a sponsor's Part D plan, typically at the point-of-sale or point of distribution. The review must include, but not be limited to, (i) Screening for potential drug therapy problems due to therapeutic duplication. (ii) Age/gender-related contraindications. (iii) Over-utilization and under-utilization. (iv) Drug-drug interactions. (v) Incorrect drug dosage or duration of drug therapy. (vi) Drug-allergy contraindications. (vii) Clinical abuse/misuse. (3) Retrospective drug utilization review systems, policies, and procedures designed to ensure ongoing periodic examination of claims data and other records, through computerized drug claims processing and information retrieval systems, in order to identify patterns of inappropriate or medically unnecessary care among enrollees in a sponsor's Part D plan, or associated with specific drugs or groups of drugs. (4) Internal medication error identification and reduction systems. (5) Provision of information to CMS regarding its quality assurance measures and systems, according to guidelines specified by CMS. (d) Medication therapy management program (MTMP)—(1) General rule. A Part D sponsor must have established a MTMP that— (i) Is designed to ensure that covered Part D drugs prescribed to targeted beneficiaries described in paragraph (d)(2) of this section are appropriately used to optimize therapeutic outcomes through improved medication use; (ii) Is designed to reduce the risk of adverse events, including adverse drug interactions, for targeted beneficiaries described in paragraph (d)(2) of this section; (iii) May be furnished by a pharmacist or other qualified provider; and (iv) May distinguish between services in ambulatory and institutional settings. (2) Targeted beneficiaries. Targeted beneficiaries for the MTMP described in paragraph (d)(1) of this section are enrollees in the sponsor's Part D plan who— (i) Have multiple chronic diseases; (ii) Are taking multiple Part D drugs; and (iii) Are likely to incur annual costs for covered Part D drugs that exceed a predetermined level as specified by the Secretary. (3) Use of experts. The MTMP must be developed in cooperation with licensed and practicing pharmacists and physicians. (4) Coordination with care management plans. The MTMP must be coordinated with any care management plan established for a targeted individual under a chronic care improvement program (CCIP) under section 1807 of the Act. A Part D sponsor must provide drug claims data to CCIPs for those beneficiaries that are enrolled in CCIPs in a manner specified by CMS. (5) Considerations in pharmacy fees. An applicant to become a Part D sponsor must— (i) Describe in its application how it takes into account the resources used and time required to implement the MTMP it chooses to adopt in establishing fees for pharmacists or others providing MTMP services for covered Part D drugs under a Part D plan. (ii) Disclose to CMS upon request the amount of the management and dispensing fees and the portion paid for MTMP services to pharmacists and others upon request. Reports of these amounts are protected under the provisions of section 1927(b)(3)(D) of the Act. (6) MTMP reporting. A Part D sponsor must provide CMS with information regarding the procedures and performance of its MTMP, according to guidelines specified by CMS. (e) Exception for private fee-for-service MA plans offering qualified prescription drug coverage. In the case of an MA plan described in §422.4(a)(3) of this chapter providing qualified prescription drug coverage, the requirements under paragraphs (b) and (d) of this section do not apply. CMS conducts consumer satisfaction surveys of Part D plan enrollees similar to the surveys it conducts of MA enrollees under §422.152 (b) of this chapter. (a) Definitions. For purposes of this section, the following definitions apply: Dispenser means a person or other legal entity licensed, registered, or otherwise permitted by the jurisdiction in which the person practices or the entity is located to provide drug products for human use by prescription in the course of professional practice. Electronic media has the same meaning given this term in 45 CFR 160.103. E-prescribing means the transmission using electronic media, of prescription or prescription-related information between a prescriber, dispenser, pharmacy benefit manager, or health plan, either directly or through an intermediary, including an e-prescribing network. E-prescribing includes, but is not limited to, two-way transmissions between the point of care and the dispenser. Electronic prescription drug program means a program that provides for e-prescribing for covered Part D drugs prescribed for Part D eligible individuals. Prescriber means a physician, dentist, or other person licensed, registered, or otherwise permitted by the U.S. or the jurisdiction in which he or she practices, to issue prescriptions for drugs for human use. Prescription-related information means information regarding eligibility for drug benefits, medication history, or related health or drug information for Part D eligible individuals. (b) [Reserved] (c) Requirement. Part D sponsors must support and comply with electronic prescription standards relating to covered Part D drugs for Part D enrollees developed by CMS once final standards are effective. (d) Promotion of electronic prescribing by MA-PD plans. An MA organization offering an MA-PD plan may provide for a separate or differential payment to a participating physician that prescribes covered Part D drugs in accordance with electronic prescription standards, including initial standards and final standards established by CMS once final standards are effective. Any payments must be in compliance with applicable Federal and State laws related to fraud and abuse, including the physician self-referral prohibition (section 1877 of the Act) and the Federal anti kickback statute (section 1128B(b) of the Act). [70 FR 4525, Jan. 28, 2005, as amended at 70 FR 67593, Nov. 7, 2005] (a) General rules. (1) Part D sponsors must establish and maintain an electronic prescription drug program that complies with the applicable standards in paragraph (b) of this section when transmitting, directly or through an intermediary, prescriptions and prescription-related information using electronic media for covered Part D drugs for Part D eligible individuals. (2) Except as provided in paragraph (a)(3) of this section, prescribers and dispensers that transmit, directly or through an intermediary, prescriptions and prescription-related information using electronic media must comply with the applicable standards in paragraph (b) of this section when e-prescribing for covered Part D drugs for Part D eligible individuals. (3) Exemptions. (i) Entities transmitting prescriptions or prescription-related information by means of computer-generated facsimile are exempt from the requirement to use the NCPDP SCRIPT Standard adopted by this section in transmitting such prescriptions or prescription-related information. (ii) Entities may use either HL7 messages or the NCPDP SCRIPT Standard to transmit prescriptions or prescription-related information internally when the sender and the recipient are part of the same legal entity. If an entity sends prescriptions outside the entity (for example, from an HMO to a non-HMO pharmacy), it must use the adopted NCPDP SCRIPT Standard or other applicable adopted standards. Any pharmacy within an entity must be able to receive electronic prescription transmittals for Medicare beneficiaries from outside the entity using the adopted NCPDP SCRIPT Standard. This exemption does not supersede any HIPAA requirement that may require the use of a HIPAA transaction standard within an organization. (iii) Entities transmitting prescriptions or prescription-related information where the prescriber is required by law to issue a prescription for a patient to a non-prescribing provider (such as a nursing facility) that in turn forwards the prescription to a dispenser are exempt from the requirement to use the NCPDP SCRIPT Standard adopted by this section in transmitting such prescriptions or prescription-related information. (4) In accordance with section 1860D–4(e)(5) of the Act, the standards under this paragraph (b) of this section supersede any State law or regulation that— (i) Is contrary to the standards or restricts the ability to carry out Part D of Title XVIII of the Act; and (ii) Pertains to the electronic transmission of medication history and of information on eligibility, benefits, and prescriptions with respect to covered Part D drugs under Part D of Title XVIII of the Act. (b) Standards. (1) Prescription. The National Council for Prescription Drug Programs SCRIPT Standard, Implementation Guide, Version 5, Release 0, May 12, 2004, or Prescriber/Pharmacist Interface SCRIPT Standard, Implementation Guide, Version 8, Release 1, October 2005, to provide for the communication of a prescription or prescription-related information between prescribers and dispensers, for the following: (i) Get message transaction. (ii) Status response transaction. (iii) Error response transaction. (iv) New prescription transaction. (v) Prescription change request transaction. (vi) Prescription change response transaction. (vii) Refill prescription request transaction. (viii) Refill prescription response transaction. (ix) Verification transaction. (x) Password change transaction. (xi) Cancel prescription request transaction. (xii) Cancel prescription response transaction. (2) Eligibility. (i) The Accredited Standards Committee X12N 270/271-Health Care Eligibility Benefit Inquiry and Response, Version 4010, May 2000, Washington Publishing Company, 004010X092 and Addenda to Health Care Eligibility Benefit Inquiry and Response, Version 4010, A1, October 2002, Washington Publishing Company, 004010X092A1, for transmitting eligibility inquiries and responses between prescribers and Part D sponsors. (ii) The National Council for Prescription Drug Programs Telecommunication Standard Specification, Version 5, Release 1 (Version 5.1), September 1999, and equivalent NCPDP Batch Standard Batch Implementation Guide, Version 1, Release 1 (Version 1.1), January 2000 supporting Telecommunications Standard Implementation Guide, Version 5, Release 1 (Version 5.1), September 1999, for the NCPDP Data Record in the Detail Data Record, for transmitting eligibility inquiries and responses between dispensers and Part D sponsors. (c) Incorporation by reference. The Director of the Federal Register approves, in accordance with 5 U.S.C. 552(a) and 1 CFR part 51, the incorporation by reference of the National Council for Prescription Drug Programs SCRIPT Standard, Implementation Guide, Version 5, Release 0, May 12, 2004, excluding the Prescription Fill Status Notification Transaction (and its three business cases; Prescription Fill Status Notification Transaction—Filled, Prescription Fill Status Notification Transaction—Not Filled, and Prescription Fill Status Notification Transaction—Partial Fill), Prescriber/Pharmacist Interface SCRIPT Standard, Implementation Guide, Version 8, Release 1, October 2005, excluding the Prescription Fill Status Notification Transaction (and its three business cases; Prescription Fill Status Notification Transaction—Filled, Prescription Fill Status Notification Transaction—Not Filled, and Prescription Fill Status Notification Transaction—Partial Fill); the Accredited Standards Committee X12N 270/271—Health Care Eligibility Benefit Inquiry and Response, Version 4010, May 2000, 004010X092 and Addenda to Health Care Eligibility Benefit Inquiry and Response, Version 4010, October 2002, Washington Publishing Company, 004010X092A1, and the National Council for Prescription Drug Programs Telecommunication Standard Specification, Version 5, Release 1 (Version 5.1), September 1999, and equivalent NCPDP Batch Standard Batch Implementation Guide, Version 1, Release 1 (Version 1.1), January 2000 supporting Telecommunications Standard Implementation Guide, Version 5, Release 1 (Version 5.1), September 1999, for the NCPDP Data Record in the Detail Data Record. You may inspect copies of these materials at the headquarters of the Centers for Medicare & Medicaid Services (CMS), 7500 Security Boulevard, Baltimore, Maryland 21244, Monday through Friday from 8:30 a.m. to 4 p.m. or at the National Archives and Records Administration (NARA). For information on the availability of this material at CMS, call 410–786–0273. For information on the availability of this material at NARA, call 202–741–6030, or go to http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.php. You may obtain a copy of the National Council for Prescription Drug Programs SCRIPT Standard, Version 5, Release 0, May 12, 2004 or the Prescriber/Pharmacist Interface SCRIPT Standard, Implementation Guide, Version 8, Release 1, October 2005, from the National Council for Prescription Drug Programs, Incorporated, 9240 E. Raintree Drive, Scottsdale, AZ 85260–7518; Telephone (480) 477–1000; and fax (480) 767–1042 or http://www.ncpdp.org. You may obtain a copy of the Accredited Standards Committee X12N 270/271—Health Care Eligibility Benefit Inquiry and Response, Version 4010, May 2000, Washington Publishing Company, 004010X092 and Addenda to Health Care Eligibility Benefit Inquiry and Response, Version 4010, 004010X092A1, October 2002, from the Washington Publishing Company,301 West North Bend Way, Suite 107, P.O. Box 15388, North Bend, WA 98045; Telephone (425) 831–4999; and fax (425) 831–3233 or http://www.wpc-edi.com/. You may obtain a copy of the National Council for Prescription Drug Programs Telecommunication Standard Guide, Version 5, Release 1 (Version 5.1), September 1999, and equivalent NCPDP Batch Standard Batch Implementation Guide, Version 1, Release 1 (Version 1.1), January 2000 supporting Telecommunications Standard Implementation Guide, Version 5, Release 1 (Version 5.1), September 1999, for the NCPDP Data Record in the Detail Data Record, from the National Council for Prescription Drug Programs, Incorporated, 9240 E. Raintree Drive, Scottsdale, AZ 85260–7518; Telephone (480) 477–1000; and FAX (480) 767–1042 or http://www.ncpdp.org. Authority: Section 1860D–4(e) of the Social Security Act (42 U.S.C. 1395w–104(e)) [70 FR 67593, Nov. 7, 2005, as amended at 71 FR 36023, June 23, 2006] (a) General rule. Quality improvement organizations (QIOs) are required to offer providers, practitioners, and Part D sponsors quality improvement assistance pertaining to health care services, including those related to prescription drug therapy, in accordance with contracts established with the Secretary. (b) Collection of information. Information collected, acquired, or generated by a QIO in the performance of its responsibilities under this section is subject to the confidentiality provisions of part 480 of this chapter. Part D sponsors are required to provide specified information to CMS for distribution to the QIOs as well as directly to QIOs. (c) Applicability of QIO confidentiality provisions. The provisions of part 480 of this chapter apply to Part D sponsors in the same manner as such provisions apply to institutions under part 480 of this chapter. (a) General rule. A Part D sponsor is deemed to meet all of the requirements of any of the areas described in paragraph (b) of this section if— (1) The Part D sponsor is fully accredited (and periodically reaccredited) for the standards related to the applicable area under paragraph (b) of this section by a private, national accreditation organization approved by CMS; and (2) The accreditation organization uses the standards approved by CMS for the purposes of assessing the Part D sponsor's compliance with Medicare requirements. (b) Deemable requirements. The requirements relating to the following areas are deemable: (1) Access to covered drugs, as provided under §423.120 and §423.124. (2) Drug utilization management programs, quality assurance measures and systems, and MTMPs as provided under §423.153. (3) Privacy, confidentiality, and accuracy of enrollee records, as provided under §423.136. (4) A program to protect against fraud, waste and abuse, as described in §423.504(b)(4)(vi)(H). (c) Effective date of deemed status. The date the Part D sponsor is deemed to meet the applicable requirements is the later of the following: (1) The date the accreditation organization is approved by CMS. (2) The date the Part D sponsor is accredited by the accreditation organization. (d) Obligations of deemed Part D sponsors. A Part D sponsor deemed to meet Medicare requirements must— (1) Submit to surveys by CMS to validate its accreditation organization's accreditation process; and (2) Authorize its accreditation organization to release to CMS a copy of its most recent accreditation survey, together with any survey-related information that CMS may require (including corrective action plans and summaries of unmet CMS requirements). (e) Removal of deemed status. CMS removes part or all of a Part D sponsor's deemed status for any of the following reasons— (1) CMS determines, on the basis of its own investigation, that the Part D sponsor does not meet the Medicare requirements for which deemed status was granted. (2) CMS withdraws its approval of the accreditation organization that accredited the Part D sponsor. (3) The Part D sponsor fails to meet the requirements of paragraph (d) of this section. (f) Enforcement authority. CMS retains the authority to initiate enforcement action against any Part D sponsor that it determines, on the basis of its own survey or the results of an accreditation survey, no longer meets the Medicare requirements for which deemed status was granted. (a) Conditions for approval. CMS may approve an accreditation organization for a given standard under this part if the organization meets the following conditions: (1) In accrediting Part D sponsors and Part D plans, it applies and enforces standards that are at least as stringent as Medicare requirements for the standard or standards in question. (2) It complies with the application and reapplication procedures set forth in §423.171. (3) It ensures that— (i) Any individual associated with it, who is also associated with an entity it accredits, does not influence the accreditation decision concerning that entity; (ii) The majority of the membership of its governing body is not comprised of managed care organizations, Part D sponsors or their representatives; and (iii) Its governing body has a broad and balanced representation of interests and acts without bias. (b) Notice and comment—(1) Proposed notice. CMS publishes a notice in the (i) Announces CMS's receipt of the accreditation organization's application for approval; (ii) Describes the criteria CMS uses in evaluating the application; and (iii) Provides at least a 30-day comment period. (2) Final notice. (i) After reviewing public comments, CMS publishes a final notice in the (ii) If CMS grants the request, the final notice specifies the effective date and the term of the approval that may not exceed 6 years. (c) Ongoing responsibilities of an approved accreditation organization. An accreditation organization approved by CMS must undertake the following activities on an ongoing basis: (1) Provide to CMS in written form and on a monthly basis all of the following: (i) Copies of all accreditation surveys, together with any survey-related information that CMS may require including corrective action plans and summaries of unmet CMS requirements). (ii) Notice of all accreditation decisions. (iii) Notice of all complaints related to deemed Part D sponsors. (iv) Information about any Part D sponsor against which the accrediting organization has taken remedial or adverse action, including revocation, withdrawal, or revision of the Part D sponsor's accreditation. (The accreditation organization must provide this information within 30 days of taking the remedial or adverse action.) (v) Notice of any proposed changes in its accreditation standards or requirements or survey process. If the organization implements the changes before or without CMS approval, CMS may withdraw its approval of the accreditation organization. (2) Within 30 days of a change in CMS requirements, submit the following to CMS— (i) An acknowledgment of CMS's notification of the change. (ii) A revised crosswalk reflecting the new requirements. (iii) An explanation of how the accreditation organization plans to alter its standards to conform to CMS's new requirements, within the timeframes specified in the notification of change it receives from CMS. (3) Permit its surveyors to serve as witnesses if CMS takes an adverse action based on accreditation findings. (4) Within 3 days of identifying, in an accredited Part D sponsor, a deficiency that as determined by the accrediting organization poses immediate jeopardy to the plan's enrollees or to the general public, give CMS written notice of the deficiency. (5) Within 10 days of CMS's notice of withdrawal of approval, give written notice of the withdrawal to all accredited Part D sponsors. (6) On an annual basis, provide summary data specified by CMS that relate to the past year's accreditation activities and trends. (d) Continuing Federal oversight of approved accreditation organizations. Specific criteria and procedures for continuing oversight and for withdrawing approval of an accreditation organization include the following: (1) Equivalency review. CMS compares the accreditation organization's standards and its application and enforcement of those standards to the comparable CMS requirements and processes when— (i) CMS imposes new requirements or changes its survey process; (ii) An accreditation organization proposes to adopt new standards or changes in its survey process; or (iii) The term of an accreditation organization's approval expires. (2) Validation review. CMS or its agent may conduct a survey of an accredited organization, examine the results of the accreditation organization's own survey, or attend the accreditation organization's survey to validate the organization's accreditation process. At the conclusion of the review, CMS identifies any accreditation programs for which validation survey results indicate— (i) A 20 percent rate of disparity between certification by the accreditation organization and certification by CMS or its agent on standards that do not constitute immediate jeopardy to patient health and safety if unmet; (ii) Any disparity between certification by the accreditation organization and certification by CMS or its agent on standards that constitute immediate jeopardy to patient health and safety if unmet; or (iii) That, regardless of the rate of disparity, there are widespread or systematic problems in an organization's accreditation process that accreditation no longer provides assurance that the Medicare requirements are met or exceeded. (3) Onsite observation. CMS may conduct an onsite inspection of the accreditation organization's operations and offices to verify the organization's representations and assess the organization's compliance with its own policies and procedures. The onsite inspection may include, but is not limited to the following: (i) Reviewing documents. (ii) Auditing meetings concerning the accreditation process. (iii) Evaluating survey results or the accreditation status decision-making process. (iv) Interviewing the organization's staff. (4) Notice of intent to withdraw approval. If an equivalency review, validation review, onsite observation, or CMS's daily experience with the accreditation organization suggests that the accreditation organization is not meeting the requirements of this subpart, CMS gives the organization written notice of its intent to withdraw approval. (5) Withdrawal of approval. CMS may withdraw its approval of an accreditation organization at any time if CMS determines that— (i) Deeming, based on accreditation, no longer guarantees that the Part D sponsor meets the requirements for offering qualified prescription drug coverage, and failure to meet those requirements may jeopardize the health or safety of Medicare enrollees and constitute a significant hazard to the public health; or (ii) The accreditation organization has failed to meet its obligations under this section or under §423.165 or §423.171. (6) Reconsideration of withdrawal of approval. An accreditation organization dissatisfied with a determination to withdraw CMS approval may request a reconsideration of that determination in accordance with subpart D of part 488 of this chapter. (a) Required information and materials. A private, national accreditation organization applying for approval must furnish to CMS all of the following information and materials (when reapplying for approval, the organization need furnish only the particular information and materials requested by CMS): (1) The types of Part D plans and sponsors that it reviews as part of its accreditation process. (2) A detailed comparison of the organization's accreditation requirements and standards with the Medicare requirements (for example, a crosswalk). (3) Detailed information about the organization's survey process, including the following: (i) Frequency of surveys and whether surveys are announced or unannounced. (ii) Copies of survey forms, and guidelines and instructions to surveyors. (iii) Descriptions of— (A) The survey review process and the accreditation status decision making process; (B) The procedures used to notify accredited Part D sponsors of deficiencies and to monitor the correction of those deficiencies; and (C) The procedures used to enforce compliance with accreditation requirements. (4) Detailed information about the individuals who perform surveys for the accreditation organization, including the— (i) Size and composition of accreditation survey teams for each type of plan reviewed as part of the accreditation process; (ii) Education and experience requirements surveyors must meet; (iii) Content and frequency of the in-service training provided to survey personnel; (iv) Evaluation systems used to monitor the performance of individual surveyors and survey teams; and (v) Organization's policies and practice for the participation, in surveys or in the accreditation decision process by an individual who is professionally or financially affiliated with the entity being surveyed. (5) A description of the organization's data management and analysis system for its surveys and accreditation decisions, including the kinds of reports, tables, and other displays generated by that system. (6) A description of the organization's procedures for responding to and investigating complaints against accredited organizations, including policies and procedures regarding coordination of these activities with appropriate licensing bodies and ombudsmen programs. (7) A description of the organization's policies and procedures for the withholding or removal of accreditation for failure to meet the accreditation organization's standards or requirements, and other actions the organization takes in response to noncompliance with its standards and requirements. (8) A description of all types (for example, full or partial) and categories (for example, provisional, conditional, or temporary) of accreditation offered by the organization, the duration of each type and category of accreditation, and a statement identifying the types and categories that serve as a basis for accreditation if CMS approves the accreditation organization. (9) A list of all currently accredited Part D sponsors and MA organizations and the type, category, and expiration date of the accreditation held by each of them. (10) A list of all full and partial accreditation surveys scheduled to be performed by the accreditation organization as requested by CMS. (11) The name and address of each person with an ownership or control interest in the accreditation organization. (b) Required supporting documentation. A private, national accreditation organization applying or reapplying for approval also must submit the following supporting documentation— (1) A written presentation that demonstrates its ability to furnish CMS with electronic data in CMS compatible format. (2) A resource analysis that demonstrates that it's staffing, funding, and other resources are adequate to perform the required surveys and related activities. (3) A statement acknowledging that, as a condition for approval, it agrees to comply with the ongoing responsibility requirements of §423.168(c). (c) Additional information. If CMS determines that it needs additional information for a determination to grant or deny the accreditation organization's request for approval, it notifies the organization and allows time for the organization to provide the additional information. (d) Onsite visit. CMS may visit the accreditation organization's offices to verify representations made by the organization in its application, including, but not limited to, review of documents and interviews with the organization's staff. (e) Notice of determination. CMS gives the accreditation organization, within 210 days of receipt of its completed application, a formal notice that— (1) States whether the request for approval is granted or denied; (2) Gives the rationale for any denial; and (3) Describes the reconsideration and reapplication procedures. (f) Withdrawal. An accreditation organization may withdraw its application for approval at any time before it receives the formal notice specified in paragraph (e) of this section. (g) Reconsideration of adverse determination. An accreditation organization that has received a notice of denial of its request for approval may request a reconsideration in accordance with subpart D of part 488 of this chapter. (h) Request for approval following denial. (1) Except as provided in paragraph (h)(2) of this section, an accreditation organization that has received notice of denial of its request for approval may submit a new request if it— (i) Has revised its accreditation program to correct the deficiencies on which the denial was based. (ii) Can demonstrate that the Part D sponsors that it has accredited meet or exceed applicable Medicare requirements; and (iii) Resubmits the application in its entirety. (2) An accreditation organization that has requested reconsideration of CMS' denial of its request for approval may not submit a new request until the reconsideration is administratively final.
Title 42: Public Health
PART 423—VOLUNTARY MEDICARE PRESCRIPTION DRUG BENEFIT
Subpart D—Cost Control and Quality Improvement Requirements
§ 423.150 Scope.
§ 423.153 Drug utilization management, quality assurance, and medication therapy management programs (MTMPs).
§ 423.156 Consumer satisfaction surveys.
§ 423.159 Electronic prescription drug program.
§ 423.160 Standards for electronic prescribing.
§ 423.162 Quality improvement organization activities.
§ 423.165 Compliance deemed on the basis of accreditation.
§ 423.168 Accreditation organizations.
§ 423.171 Procedures for approval of accreditation as a basis for deeming compliance.
