, State Attorney General, or other appropriate State official certifying that the applicant organization has a nonprofit status and that none of its net earnings accrue to any private shareholder or individuals. (d) A certified copy of the organization's certificate of incorporation or similar document if it clearly establishes the nonprofit status of the organization. (e) Any of the above proof for a State or national parent

(a) The regulations in this part apply to research traineeships awarded by the Director, NIH, each director of a national research institute of NIH, the Director of the National Library of Medicine, and the Director of the National Center for Complementary and Alternative Medicine, or their designees, pursuant to sections 402(b)(13), 405(b)(1)(C), 413(b)(3), 472, and 485(D)(a) of the Act, respectively. (b) The regulations of this part

(d) Require institutions to develop and implement policies and procedures for— (1) Reporting and responding to allegations of research misconduct covered by this part; (2) Providing HHS with the assurances necessary to permit the institutions to participate in PHS supported research. (e) Protect the health and safety of the public, promote the integrity of PHS supported

proceedings under §93.403. (2) Under §93.517(g), HHS administrative hearings must be open to the public. (b) Except as may otherwise be prescribed by applicable law, confidentiality must be maintained for any records or evidence from which

Before revising or amending the regulations in this subpart, the Secretary shall take the following actions: (a) Consult with Indian Tribes and national and regional Indian organizations to the extent practicable about the need for revision or amendment and consider their views in preparing the proposed revision or amendment. (b) Present the proposed revision or amendment to the Committees on Interior

check through the Criminal Justice Information Services Division of the Federal Bureau of Investigation (FBI), under procedures approved by the FBI, and inquiries to State and Tribal law enforcement agencies for the previous five years of residence listed on the individual's application; and (c) A determination as to whether the individual has been found guilty of or entered a plea of nolo contendere or guilty to any felonious offense or any of two or more

Except as provided in §137.261 for immediate reassumption, prior to a reassumption becoming effective, the Secretary must: (a) Notify the Self-Governance Tribe in writing by certified mail of the details of findings required under §137.256

§401.126), or any other provision of law. (b) Misappropriation, alteration, or destruction of records. No person may remove any record made available to him for inspection or copying under this part, from the place where it is made available. In addition, no person may steal, alter, mutilate, obliterate, or destroy in whole or

methods, constitute prima facie evidence of the number and amount of claims or requests for payment subject to sanction under §402.1. (c) Burden of proof. Once CMS or OIG has made a prima facie case, the burden is on the respondent to produce evidence reasonably calculated to rebut the findings of the statistical sampling study. CMS or

(a) For purposes of certification requests submitted under §403.232(b) and subsequent review as specified in §403.239(a), statement of actuarial opinion means a signed declaration in which a qualified actuary states that the

(a) For any device that meets the requirements of the exception at §411.15(o) of this chapter, the following procedures apply: (1) The FDA notifies CMS, when it notifies the sponsor, that the device is categorized by FDA as Category B (Nonexperimental/investigational). (2) CMS uses the categorization

(a) Subparts B through F of this part pertain to the Federal qualification of HMOs under title XIII of the Public Health Service (PHS) Act. (b) Subparts G through R of this part set forth the rules for Medicare contracts with, and payment to, HMOs and competitive medical plans (CMPs) under section 1876 of the Act and 8 U.S.C. 1611.

(a) A hearing officer may not conduct a hearing in a case in which he or she is prejudiced or partial to any party or has any interest in the matter pending for decision. (b) A party to the hearing who objects to the designated hearing officer must notify that officer in writing at the earliest opportunity. (c) The hearing officer must consider the objections, and may, at his or her discretion, either

Non-claims costs means those expenses for administrative services that are not— (1) Incurred claims (as provided in §422.2420(b)(2) through (4)); (2) Expenditures on quality improving activities (as provided in

(a) A hearing officer may not conduct a hearing in a case in which he or she is prejudiced or partial to any party or has any interest in the matter pending for decision. (b) A party to the hearing who objects to the designated hearing officer must notify that officer in writing at the earliest opportunity. (c) The hearing officer must consider the objections, and may, at his or her discretion, either

ALJ stands for Administrative Law Judge. Departmental Appeals Board or Board means a Board established in the Office of the Secretary to provide impartial review of disputed decisions made by the operating components of the Department. Part D sponsor has the meaning given the term in 423.4.

Medicare pays the beneficiary for the following services, if covered, in the specified circumstances: (a) Emergency inpatient and outpatient services furnished by a nonparticipating U.S. hospital that has not elected to claim payment in accordance with subpart G of this part. (b) Certain medical and other health services covered under Medicare Part B and furnished by a nonparticipating U.S. hospital

. (2) If CMS requests additional information, the 90-day period for CMS action on the plan or plan amendment begins on the day it receives that information. (b) Notice of final determination. (1) The Regional Administrator or the Administrator notifies the Medicaid agency of the approval of a State plan or plan amendment. (2

reports of findings to CMS in accordance with paragraphs (b)(1) and (2) of this section. (1) For all active and negative cases reviewed, the State must submit a detailed case-level report in a format provided by CMS. (2) All case-level findings will be due by August 1 following the end of the MEQC review period. [82 FR 31183, July 5, 2017]

(c) For any beneficiary whose SSN was established as part of the case record without evidence required under the SSA regulations as to age, citizenship, alien status, or true identity, the agency must obtain verification of these factors in accordance with §435.910. [44 FR 17937, Mar. 23, 1979, as amended at 51 FR 7211, Feb

(a) The plan must specify the amount, duration, and scope of each service that it provides for— (1) The categorically needy; and (2) Each covered group of medically needy. (b) Each service must be sufficient in amount, duration, and scope to reasonably achieve its purpose. (c) The Medicaid agency may not arbitrarily deny or reduce the

must permit participants, or their representatives, as applicable, using the cash option to choose to use the financial management entity for some or all of the functions described in §441.484(c). (d) States must make available a financial management entity to a participant, or the participant's representative, if applicable, who has demonstrated, after additional

The UR plan must provide that— (a) When a beneficiary is admitted to the ICF under admission review requirements of this subpart, the group performing UR assigns a specified date by which the need for his continued stay will be reviewed; (b) The group performing UR bases its assignment of the initial continued stay review date on the methods and criteria required to be described under

(a) Except as provided in paragraph (b) of this section— (1) [Reserved] (2) No member of a team that reviews care in an ICF may have a financial interest in or be employed by any ICF. (b) A member of a team that reviews care in an IMD or an institution for Individuals with Intellectual Disabilities or persons with related conditions—

(a) Disclosure to conduct review. The QIO must disclose or arrange for disclosure of information to individuals and institutions within the QIO review system as necessary to fulfill their particular duties and functions under Title XI Part B of the Act. (b) Disclosure to consultants and subcontractors. The QIO must disclose to consultants or subcontractors

authorities. (b) In making their determinations, however, the State mental health and intellectual disability authorities must not use criteria relating to the need for NF care or specialized services that are inconsistent with this regulation and any supplementary criteria adopted by the State Medicaid agency under its approved State plan. (c) To the maximum extent practicable, in order to avoid duplicative testing and effort, the PASARR

(a) Each State must provide a system for: (1) A resident of a SNF or a NF to appeal a notice from the SNF or NF of intent to discharge or transfer the resident; and (2) An individual who has been adversely affected by any PASARR determination made by the State in the context of either a preadmission screening or an annual resident review under subpart C of part 483 to appeal that determination.

(a) Clinical staff trained in the use of emergency safety interventions must be physically present, continually assessing and monitoring the physical and psychological well-being of the resident and the safe use of restraint throughout the duration of the emergency safety intervention. (b) If the emergency safety situation continues beyond the time limit of the order for the use of restraint, a registered nurse or other licensed staff

(a) For each SNF and NF, the State survey agency must conduct standard surveys that include all of the following: (1) A case-mix stratified sample of residents; (2) A survey of the quality of care furnished, as measured by indicators of medical, nursing, and rehabilitative care, dietary and nutrition services, activities and social participation, and sanitation, infection control, and the physical

with the requirements of this subpart; or (iv) Use Federal standards, protocols, and the forms, methods and procedures specified by CMS in manual instructions; or (2) Fails to identify an immediate jeopardy situation. (b) Inadequate survey performance does not— (1) Relieve a SNF or NF of its obligation to meet all requirements for program participation; or