r/title-42-THE-PUBLIC-HEALTH-AND-WELFARE wiki — defined terms
The statute’s own glossary: every term Title 42 defines, in section order.
“claim” applies in that section
The term “claim” means an application for payments for items and services under a Federal health care program (as defined in section 1320a–7b(f) of this title ).;
“Department” applies in that section
The term “Department” means the Department of Health and Human Services.;
“item or service” applies in that section
The term “item or service” includes (A) any particular item, device, medical supply, or service claimed to have been provided to a patient and listed in an itemized claim for payment, and (B) in the case of a claim based on costs, any entry in the cost report, books of account or other documents supporting such claim.;
“material” applies in that section
The term “material” means having a natural tendency to influence, or be capable of influencing, the payment or receipt of money or property.;
“obligation” applies in that section
the term “obligation” means an established duty, whether or not fixed, arising from an express or implied contractual, grantor-grantee, or licensor-licensee relationship, for a fee-based or similar relationship, from statute or regulation, or from the retention of any overpayment.
“other agreement” applies in that section
The term “other agreement” includes a cooperative agreement, scholarship, fellowship, loan, subsidy, payment for a specified use, donation agreement, award, or subaward (regardless of whether one or more of the persons entering into the agreement is a contractor or subcontractor).;
“program beneficiary” applies in that section
The term “program beneficiary” means, in the case of a grant, contract, or other agreement designed to accomplish the objective of awarding or otherwise furnishing benefits or assistance to individuals and for which the Secretary provides funding, an individual who applies for, or who receives, such benefits or assistance from such grant, contract, or other agreement. Such term does not include, with respect to such grant, contract, or other agreement, an officer, employee, or agent of a person or entity that receives such grant or that enters into such contract or other agreement.;
“recipient” applies in that section
The term “recipient” includes a subrecipient or subcontractor.;
“remuneration” applies in that section
The term “remuneration” includes the waiver of coinsurance and deductible amounts (or any part thereof), and transfers of items or services for free or for other than fair market value. The term “remuneration” does not include— (A) the waiver of coinsurance and deductible amounts by a person, if— (i) the waiver is not offered as part of any advertisement or solicitation; (ii) the person does not routinely waive coinsurance or deductible amounts; and (iii) the person— (I) waives the coinsurance and deductible amounts after determining in good faith that the individual is in financial need; or (II) fails to collect coinsurance or deductible amounts after making reasonable collection efforts; …
“should know” applies in that section
The term “should know” means that a person, with respect to information— (A) acts in deliberate ignorance of the truth or falsity of the information; or (B) acts in reckless disregard of the truth or falsity of the information, and no proof of specific intent to defraud is required. (j) Subpoenas (1) The provisions of subsections (d) and (e) of section 405 of this title shall apply with respect to this section to the same extent as they are applicable with respect to subchapter II.
“specified claim” applies in that section
the term “specified claim” means any application, request, or demand under a grant, contract, or other agreement for money or property, whether or not the United States or a specified State agency has title to the money or property, that is not a claim (as defined in subsection (i)(2)) and that— (1) is presented or caused to be presented to an officer, employee, or agent of the Department or agency thereof, or of any specified State agency; or (2) is made to a contractor, grantee, or any other recipient if the money or property is to be spent or used on the Department’s behalf or to advance a Department program or interest, and if the Department— (A) provides or has provided any portion of …
“specified State agency” applies in that section
The term “specified State agency” means an agency of a State government established or designated to administer or supervise the administration of a grant, contract, or other agreement funded in whole or in part by the Secretary. (r) Definition of “specified claim” For purposes of this section,
“State agency” applies in that section
The term “State agency” means the agency established or designated to administer or supervise the administration of the State plan under subchapter XIX of this chapter or designated to administer the State’s program under subchapter V or division A 12 of subchapter XX of this chapter.;
“Federal health care program” applies in that section
the term “Federal health care program” means— (1) any plan or program that provides health benefits, whether directly, through insurance, or otherwise, which is funded directly, in whole or in part, by the United States Government (other than the health insurance program under chapter 89 of title 5); or (2) any State health care program, as defined in section 1320a–7(h) of this title .
“health plan” applies in that section
the term “health plan” means a plan or program that provides health benefits, whether directly, through insurance, or otherwise, and includes— (1) a policy of health insurance; (2) a contract of a service benefit organization; and (3) a membership agreement with a health maintenance organization or other prepaid health plan.
“trusted third party” applies in that section
the term “trusted third party” means an entity that— (i) demonstrates the capability to carry out the duties of the partnership described in subparagraph (C); (ii) complies with such conflict of interest standards determined appropriate by the Secretary; and (iii) meets such other requirements as the Secretary may prescribe.
“final adverse action” applies in that section
The term “final adverse action” includes: (i) Civil judgments against a health care provider, supplier, or practitioner in Federal or State court related to the delivery of a health care item or service. (ii) Federal or State criminal convictions related to the delivery of a health care item or service.
“Government agency” applies in that section
The term “Government agency” shall include: (A) The Department of Justice. (B) The Department of Health and Human Services. (C) Any other Federal agency that either administers or provides payment for the delivery of health care services, including, but not limited to the Department of Defense and the Department of Veterans Affairs. (D) Federal agencies responsible for the licensing and certification of health care providers and licensed health care practitioners. (4) Health plan
“health plan” applies in that section
The term “health plan” has the meaning given such term by section 1320a–7c(c) of this title . (5) Determination of conviction For purposes of paragraph (1), the existence of a conviction shall be determined under paragraphs (1) through (4) of section 1320a–7(i) of this title .
“licensed health care practitioner” applies in that section
The terms “licensed health care practitioner”, “licensed practitioner”, and “practitioner” mean, with respect to a State, an individual who is licensed or otherwise authorized by the State to provide health care services (or any individual who, without authority holds himself or herself out to be so licensed or authorized). (3) Government agency
“licensed practitioner” applies in that section
The terms “licensed health care practitioner”, “licensed practitioner”, and “practitioner” mean, with respect to a State, an individual who is licensed or otherwise authorized by the State to provide health care services (or any individual who, without authority holds himself or herself out to be so licensed or authorized). (3) Government agency
“practitioner” applies in that section
The terms “licensed health care practitioner”, “licensed practitioner”, and “practitioner” mean, with respect to a State, an individual who is licensed or otherwise authorized by the State to provide health care services (or any individual who, without authority holds himself or herself out to be so licensed or authorized). (3) Government agency
“applicable group purchasing organization” applies in that section
The term “applicable group purchasing organization” means a group purchasing organization (as defined by the Secretary) that purchases, arranges for, or negotiates the purchase of a covered drug, device, biological, or medical supply which is operating in the United States, or in a territory, possession, or commonwealth of the United States. (2) Applicable manufacturer
“applicable manufacturer” applies in that section
The term “applicable manufacturer” means a manufacturer of a covered drug, device, biological, or medical supply which is operating in the United States, or in a territory, possession, or commonwealth of the United States. (3) Clinical investigation
“clinical investigation” applies in that section
The term “clinical investigation” means any experiment involving 1 or more human subjects, or materials derived from human subjects, in which a drug or device is administered, dispensed, or used. (4) Covered device
“covered device” applies in that section
The term “covered device” means any device for which payment is available under subchapter XVIII or a State plan under subchapter XIX or XXI (or a waiver of such a plan). (5) Covered drug, device, biological, or medical supply
“covered drug, device, biological, or medical supply” applies in that section
The term “covered drug, device, biological, or medical supply” means any drug, biological product, device, or medical supply for which payment is available under subchapter XVIII or a State plan under subchapter XIX or XXI (or a waiver of such a plan). (6) Covered recipient (A) In general Except as provided in subparagraph (B),
“covered recipient” applies in that section
the term “covered recipient” means the following: (i) A physician. (ii) A teaching hospital. (iii) A physician assistant, nurse practitioner, or clinical nurse specialist (as such terms are defined in section 1395x(aa)(5) of this title ). (iv) A certified registered nurse anesthetist (as defined in section 1395x(bb)(2) of this title ). (v) A certified nurse-midwife (as defined in section 1395x(gg)(2) of this title ).
“employee” applies in that section
The term “employee” has the meaning given such term in section 1395nn(h)(2) of this title . (8) Knowingly
“knowingly” applies in that section
The term “knowingly” has the meaning given such term in section 3729(b) of title 31 . (9) Manufacturer of a covered drug, device, biological, or medical supply
“manufacturer of a covered drug, device, biological, or medical supply” applies in that section
The term “manufacturer of a covered drug, device, biological, or medical supply” means any entity which is engaged in the production, preparation, propagation, compounding, or conversion of a covered drug, device, biological, or medical supply (or any entity under common ownership with such entity which provides assistance or support to such entity with respect to the production, preparation, propagation, compounding, conversion, marketing, promotion, sale, or distribution of a covered drug, device, biological, or medical supply). (10) Payment or other transfer of value (A) In general
“payment or other transfer of value” applies in that section
The term “payment or other transfer of value” means a transfer of anything of value. Such term does not include a transfer of anything of value that is made indirectly to a covered recipient through a third party in connection with an activity or service in the case where the applicable manufacturer is unaware of the identity of the covered recipient.
“physician” applies in that section
The term “physician” has the meaning given that term in section 1395x(r) of this title .
“applicable drug” applies in that section
The term “applicable drug” means a drug— (A) which is subject to subsection (b) of such section 353 of title 21 ; and (B) for which payment is available under subchapter XVIII or a State plan under subchapter XIX or XXI (or a waiver of such a plan). (2) Authorized distributor of record
“authorized distributor of record” applies in that section
The term “authorized distributor of record” has the meaning given that term in subsection (e)(3)(A) of such section. (3) Manufacturer
“manufacturer” applies in that section
The term “manufacturer” has the meaning given that term for purposes of subsection (d) of such section.
“compliance and ethics program” applies in that section
the term “compliance and ethics program” means, with respect to a facility, a program of the operating organization that— (A) has been reasonably designed, implemented, and enforced so that it generally will be effective in preventing and detecting criminal, civil, and administrative violations under this chapter and in promoting quality of care; and (B) includes at least the required components specified in paragraph (4).
“facility” applies in that section
the term “facility” means— (1) a skilled nursing facility (as defined in section 1395i–3(a) of this title ); or (2) a nursing facility (as defined in section 1396r(a) of this title ). (b) Effective compliance and ethics programs (1) Requirement On or after the date that is 36 months after March 23, 2010 , a facility shall, with respect to the entity that operates the facility (in this subparagraph 1 referred to as the “operating organization” or “organization”), have in operation a compliance and ethics program that is effective in preventing and detecting criminal, civil, and administrative violations under this chapter and in promoting quality of care consistent with regulations developed …
“applicable individual” applies in that section
the term “applicable individual” means an individual— (A) entitled to, or enrolled for, benefits under part A of subchapter XVIII or enrolled under part B of such subchapter; (B) eligible for medical assistance under a State plan under subchapter XIX or under a waiver of such plan; or (C) eligible for child health assistance under a child health plan under subchapter XXI.
“knowing” applies in that section
The terms “knowing” and “knowingly” have the meaning given those terms in section 3729(b) of title 31 . (B) Overpayment
“knowingly” applies in that section
The terms “knowing” and “knowingly” have the meaning given those terms in section 3729(b) of title 31 . (B) Overpayment
“overpayment” applies in that section
The term “overpayment” means any funds that a person receives or retains under subchapter XVIII or XIX to which the person, after applicable reconciliation, is not entitled under such subchapter. (C) Person (i) In general
“person” applies in that section
The term “person” means a provider of services, supplier, medicaid managed care organization (as defined in section 1396b(m)(1)(A) of this title ), Medicare Advantage organization (as defined in section 1395w–28(a)(1) of this title ), or PDP sponsor (as defined in section 1395w–151(a)(13) of this title ). (ii) Exclusion Such term does not include a beneficiary.
“system of records” applies in that section
the term “system of records” has the meaning given such term in section 552a(a)(5) of title 5 . (2) Access to claims and payment databases For purposes of conducting law enforcement and oversight activities and to the extent consistent with applicable information, privacy, security, and disclosure laws, including the regulations promulgated under the Health Insurance Portability and Accountability Act of 1996 and section 552a of title 5 , and subject to any information systems security requirements under such laws or otherwise required by the Secretary, the Inspector General of the Department of Health and Human Services and the Attorney General shall have access to claims and payment data …
“conviction for a relevant crime” applies in that section
The term “conviction for a relevant crime” means any Federal or State criminal conviction for— (i) any offense described in section 1128(a) of the Social Security Act ( 42 U.S.C. 1320a–7 [(a)]); or (ii) such other types of offenses as a participating State may specify for purposes of conducting the program in such State. (B) Disqualifying information
“direct patient access employee” applies in that section
The term “direct patient access employee” means any individual who has access to a patient or resident of a long-term care facility or provider through employment or through a contract with such facility or provider and has duties that involve (or may involve) one-on-one contact with a patient or resident of the facility or provider, as determined by the State for purposes of the nationwide program. Such term does not include a volunteer unless the volunteer has duties that are equivalent to the duties of a direct patient access employee and those duties involve (or may involve) one-on-one contact with a patient or resident of the long-term care facility or provider.
“disqualifying information” applies in that section
The term “disqualifying information” means a conviction for a relevant crime or a finding of patient or resident abuse. (C) Finding of patient or resident abuse
“finding of patient or resident abuse” applies in that section
The term “finding of patient or resident abuse” means any substantiated finding by a State agency under section 1819(g)(1)(C) or 1919(g)(1)(C) of the Social Security Act ( 42 U.S.C. 1395i–3(g)(1)(C) , 1396r(g)(1)(C)) or a Federal agency that a direct patient access employee has committed— (i) an act of patient or resident abuse or neglect or a misappropriation of patient or resident property; or (ii) such other types of acts as a participating State may specify for purposes of conducting the program in such State. (D) Direct patient access employee
“long-term care facility or provider” applies in that section
The term “long-term care facility or provider” means the following facilities or providers which receive payment for services under title XVIII or XIX of the Social Security Act [ 42 U.S.C. 1395 et seq., 1396 et seq.]: (i) A skilled nursing facility (as defined in section 1819(a) of the Social Security Act ( 42 U.S.C. 1395i–3(a) )). (ii) A nursing facility (as defined in section 1919(a) of such Act ( 42 U.S.C. 1396r(a) )). (iii) A home health agency. (iv) A provider of hospice care (as defined in section 1861(dd)(1) of such Act ( 42 U.S.C. 1395x(dd)(1) )). (v) A long-term care hospital (as described in section 1886(d)(1)(B)(iv) of such Act ( 42 U.S.C. 1395ww(d)(1)(B)(iv) )).
“CHIP” applies in that section
The term “CHIP” means the Children’s Health Insurance Program established under title XXI of the Social Security Act ( 42 U.S.C. 1397aa et seq.). (3) Medicaid
“commonwealth and territories” applies in that section
The term “commonwealth and territories” includes the Commonwealth of Puerto Rico, the Virgin Islands, Guam, American Samoa, the Commonwealth of the Northern Mariana Islands, and any other territory or possession of the United States in which the Medicare fee-for-service program, Medicaid, or CHIP operates. (2) CHIP
“Medicaid” applies in that section
The term “Medicaid” means the program to provide grants to States for medical assistance programs established under title XIX of the Social Security Act ( 42 U.S.C. 1396 et seq.). (4) Medicare beneficiary
“Medicare beneficiary” applies in that section
The term “Medicare beneficiary” means an individual enrolled in the Medicare fee-for-service program. (5) Medicare fee-for-service program
“Medicare fee-for-service program” applies in that section
The term “Medicare fee-for-service program” means the original medicare fee-for-service program under parts A and B of title XVIII of the Social Security Act ( 42 U.S.C. 1395 [c] et seq.[; 1395j et seq.]). (6) Medicare provider
“Medicare provider” applies in that section
The term “Medicare provider” means a provider of services (as defined in subsection (u) of section 1861 of the Social Security Act ( 42 U.S.C. 1395x )) and a supplier (as defined in subsection (d) of such section). (7) Secretary
“Secretary” applies in that section
The term “Secretary” means the Secretary of Health and Human Services, acting through the Administrator of the Centers for Medicare & Medicaid Services. (8) State
“State” applies in that section
The term “State” means each of the 50 States and the District of Columbia.
“covered algorithm” applies in that section
the term “covered algorithm”— (1) means a predictive modeling or other analytics technology, as used for purposes of section 1320a–7m(a) of this title to identify and prevent waste, fraud, and abuse with respect to the Medicare program under subchapter XVIII, the Medicaid program under subchapter XIX, and the Children’s Health Insurance Program under subchapter XXI; and (2) includes the mathematical expressions utilized in the application of such technology and the means by which such technology is developed.
“benefits under subchapter VIII or XVI” applies in that section
the term “benefits under subchapter VIII or XVI” includes State supplementary payments made by the Commissioner pursuant to an agreement under section 1010a or 1382e(a) of this title or section 212(b) of Public Law 93–66 , as the case may be. (f) Consultations The Commissioner of Social Security shall consult with the Inspector General of the Social Security Administration regarding initiating actions under this section.
“threats of force” applies in that section
the term “threats of force” means threats of harm to the officer or employee of the United States or to a contractor of the Social Security Administration, or to a member of the family of such an officer or employee or contractor.
“long-term therapeutic family treatment center” applies in that section
the term “long-term therapeutic family treatment center” means a State licensed or certified program that enables parents and their children to live together in a safe environment for a period of not less than 6 months and provides, on-site or by referral, substance abuse treatment services, children’s early intervention services, family counseling, legal services, medical care, mental health services, nursery and preschool, parenting skills training, pediatric care, prenatal care, sexual abuse therapy, relapse prevention, transportation, and job or vocational training or classes leading to a secondary school diploma or a certificate of general equivalence.
“youth” applies in that section
the term “youth” means, with respect to a State, an individual who has attained age 12 but has not attained the age at which an individual is no longer considered to be a child under the State plans under parts B and E of subchapter IV, and;
“authorized person” applies in that section
The term “authorized person” means— (A) any agency of a State (or of a political subdivision of a State) which has duties or authority under State law relating to the public health or otherwise has the duty or authority under State law to regulate blood donations, and (B) any entity engaged in the acceptance of blood donations which is licensed or registered by the Food and Drug Administration in connection with the acceptance of such blood donations, and which, in accordance with such regulations as may be prescribed by the Commissioner of Social Security, provides for— (i) the confidentiality of any address information received pursuant to this section and related blood donor records, …
“related blood donor record” applies in that section
The term “related blood donor record” means any record, list, or compilation which indicates, directly or indirectly, the identity of any individual with respect to whom a request for address information has been made pursuant to this section. (3) State
“State” applies in that section
The term “State” includes the District of Columbia, the Commonwealth of Puerto Rico, the Virgin Islands, Guam, the Commonwealth of the Northern Marianas, and the Trust Territory of the Pacific Islands.
“eligible individual” applies in that section
the term “eligible individual” means an individual— (A) who has a social security account number, (B) who has attained age 25 or over, and (C) (i) who has wages or net earnings from self-employment, or (ii) with respect to whom the Commissioner has information that the pattern of wages or self-employment income indicate a likelihood of noncovered employment. (b) Notice to eligible individuals The Commissioner shall, to the maximum extent practicable, take such steps as are necessary to assure that eligible individuals are informed of the availability of the statement described in subsection (a).
“Medicare Savings Program” applies in that section
the term “Medicare Savings Program” means the program of medical assistance for payment of the cost of medicare cost-sharing under the Medicaid program pursuant to sections 1396a(a)(10)(E) and 1396u–3 of this title.
“Federal fund” applies in that section
the term “Federal fund” means— (1) the Federal Old-Age and Survivors Insurance Trust Fund; (2) the Federal Disability Insurance Trust Fund; (3) the Federal Hospital Insurance Trust Fund; and (4) the Federal Supplementary Medical Insurance Trust Fund.
“public debt obligation” applies in that section
the term “public debt obligation” means any obligation subject to the public debt limit established under section 3101 of title 31 . (c) “Federal fund” defined For purposes of this section,
“Commissioner” applies in that section
The term “Commissioner” means the Commissioner of Social Security. (2) Disabled beneficiary
“disabled beneficiary” applies in that section
The term “disabled beneficiary” means a title II disability beneficiary or a title XVI disability beneficiary. (3) Title II disability beneficiary
“outcome payment period” applies in that section
The term “outcome payment period” means, in connection with any individual who had assigned a ticket to work and self-sufficiency to an employment network under the Program, a period— (i) beginning with the first month, ending after the date on which such ticket was assigned to the employment network, for which benefits (described in paragraphs (3) and (4) of subsection (k)) are not payable to such individual by reason of engagement in substantial gainful activity or by reason of earnings from work activity; and (ii) ending with the 60th month (consecutive or otherwise), ending after such date, for which such benefits are not payable to such individual by reason of engagement in substantial …
“payment calculation base” applies in that section
The term “payment calculation base” means, for any calendar year— (i) in connection with a title II disability beneficiary, the average disability insurance benefit payable under section 423 of this title for all beneficiaries for months during the preceding calendar year; and (ii) in connection with a title XVI disability beneficiary (who is not concurrently a title II disability beneficiary), the average payment of supplemental security income benefits based on disability payable under subchapter XVI (excluding State supplementation) for months during the preceding calendar year to all beneficiaries who have attained 18 years of age but have not attained 65 years of age.
“supplemental security income benefit under subchapter XVI” applies in that section
The term “supplemental security income benefit under subchapter XVI” means a cash benefit under section 1382 or 1382h(a) of this title, and does not include a State supplementary payment, administered federally or otherwise. (l) Regulations Not later than 1 year after December 17, 1999 , the Commissioner shall prescribe such regulations as are necessary to carry out the provisions of this section.
“title II disability beneficiary” applies in that section
The term “title II disability beneficiary” means an individual entitled to disability insurance benefits under section 423 of this title or to monthly insurance benefits under section 402 of this title based on such individual’s disability (as defined in section 423(d) of this title ). An individual is a title II disability beneficiary for each month for which such individual is entitled to such benefits. (4) Title XVI disability beneficiary
“title XVI disability beneficiary” applies in that section
The term “title XVI disability beneficiary” means an individual eligible for supplemental security income benefits under subchapter XVI on the basis of blindness (within the meaning of section 1382c(a)(2) of this title ) or disability (within the meaning of section 1382c(a)(3) of this title ). An individual is a title XVI disability beneficiary for each month for which such individual is eligible for such benefits. (5) Supplemental security income benefit
“Commissioner” applies in that section
The term “Commissioner” means the Commissioner of Social Security. (2) Disabled beneficiary
“disabled beneficiary” applies in that section
The term “disabled beneficiary” means an individual— (A) who is a disabled beneficiary as defined in section 1320b–19(k)(2) of this title ; (B) who is receiving a cash payment described in section 1382e(a) of this title or a supplementary payment described in section 212(a)(3) of Public Law 93–66 (without regard to whether such payment is paid by the Commissioner pursuant to an agreement under section 1382e(a) of this title or under section 212(b) of Public Law 93–66 ); (C) who, pursuant to section 1382h(b) of this title , is considered to be receiving benefits under subchapter XVI of this chapter; or (D) who is entitled to benefits under part A of subchapter XVIII of this chapter by reason …
“Commissioner” applies in that section
The term “Commissioner” means the Commissioner of Social Security. (2) Disabled beneficiary
“disabled beneficiary” applies in that section
The term “disabled beneficiary” means an individual— (A) who is a disabled beneficiary as defined in section 1320b–19(k)(2) of this title ; (B) who is receiving a cash payment described in section 1382e(a) of this title or a supplementary payment described in section 212(a)(3) of Public Law 93–66 (without regard to whether such payment is paid by the Commissioner pursuant to an agreement under section 1382e(a) of this title or under section 212(b) of Public Law 93–66 ); (C) who, pursuant to section 1382h(b) of this title , is considered to be receiving benefits under subchapter XVI of this chapter; or (D) who is entitled to benefits under part A of subchapter XVIII of this chapter by reason …
“protection and advocacy system” applies in that section
The term “protection and advocacy system” means a protection and advocacy system established pursuant to part C of title I of the Developmental Disabilities Assistance and Bill of Rights Act ( 42 U.S.C. 6041 et seq.). 1 (h) Authorization of appropriations There are authorized to be appropriated to carry out this section $7,000,000 for each of the fiscal years 2000 through 2011.
“employed” applies in that section
The term “employed” means— (I) earning at least the applicable minimum wage requirement under section 206 of title 29 and working at least 40 hours per month; or (II) being engaged in a work effort that meets substantial and reasonable threshold criteria for hours of work, wages, or other measures, as defined and approved by the Secretary. (ii) Personal assistance services
“personal assistance services” applies in that section
The term “personal assistance services” means a range of services, provided by 1 or more persons, designed to assist an individual with a disability to perform daily activities on and off the job that the individual would typically perform if the individual did not have a disability. Such services shall be designed to increase the individual’s control in life and ability to perform everyday activities on or off the job.
“State” applies in that section
the term “State” means each of the 50 States, the District of Columbia, Puerto Rico, Guam, the United States Virgin Islands, American Samoa, and the Commonwealth of the Northern Mariana Islands. (b) Grants for infrastructure and outreach (1) In general Out of the funds appropriated under subsection (e), the Secretary shall award grants to States to— (A) support the establishment, implementation, and operation of the State infrastructures described in subsection (a); and (B) conduct outreach campaigns regarding the existence of such infrastructures.
“covered individual” applies in that section
the term “covered individual” means each individual who is an owner, operator, employee, manager, agent, or contractor of a long-term care facility that is the subject of a determination described in paragraph (1). (b) Reporting requirements (1) In general Each covered individual shall report to the Secretary and 1 or more law enforcement entities for the political subdivision in which the facility is located any reasonable suspicion of a crime (as defined by the law of the applicable political subdivision) against any individual who is a resident of, or is receiving care from, the facility.
“elder justice” applies in that section
the terms “elder justice”, “long-term care facility”, and “law enforcement” have the meanings given those terms in section 1397j of this title .
“law enforcement” applies in that section
the terms “elder justice”, “long-term care facility”, and “law enforcement” have the meanings given those terms in section 1397j of this title .
“long-term care facility” applies in that section
the terms “elder justice”, “long-term care facility”, and “law enforcement” have the meanings given those terms in section 1397j of this title .
“underserved population” applies in that section
the term “underserved population” means the population of an area designated by the Secretary as an area with a shortage of elder justice programs or a population group designated by the Secretary as having a shortage of such programs. Such areas or groups designated by the Secretary may include— (i) areas or groups that are geographically isolated (such as isolated in a rural area); (ii) racial and ethnic minority populations; and (iii) populations underserved because of special needs (such as language barriers, disabilities, alien status, or age).
“eligible health care provider” applies in that section
The term “eligible health care provider” means— (A) a provider of services (as defined in section 1395x(u) of this title ) or a supplier (as defined in section 1395x(d) of this title ) that— (i) is enrolled in the Medicare program under subchapter XVIII under section 1395cc(j) of this title (including temporarily enrolled during the emergency period described in section 1320b–5(g)(1)(B) of this title for such period); (ii) provides diagnoses, testing, or care for individuals with possible or actual cases of COVID–19; and (iii) is a rural provider or supplier; or (B) a provider or supplier that— (i) is enrolled with a State Medicaid plan under subchapter XIX (or a waiver of such plan) in …
“health care related expenses attributable to COVID–19” applies in that section
The term “health care related expenses attributable to COVID–19” means health care related expenses to prevent, prepare for, and respond to COVID–19, including the building or construction of a temporary structure, the leasing of a property, the purchase of medical supplies and equipment, including personal protective equipment and testing supplies, providing for increased workforce and training (including maintaining staff, obtaining additional staff, or both), the operation of an emergency operation center, retrofitting a facility, providing for surge capacity, and other expenses determined appropriate by the Secretary. (3) Lost revenue attributable to COVID–19
“lost revenue attributable to COVID–19” applies in that section
The term “lost revenue attributable to COVID–19” has the meaning given that term in the Frequently Asked Questions guidance released by the Department of Health and Human Services in June 2020, including the difference between such provider’s budgeted and actual revenue if such budget had been established and approved prior to March 27, 2020 . (4) Payment
“payment” applies in that section
The term “payment” includes, as determined appropriate by the Secretary, a pre-payment, a prospective payment, a retrospective payment, or a payment through a grant or other mechanism. (5) Rural provider or supplier
“rural provider or supplier” applies in that section
The term “rural provider or supplier” means— (A) a— (i) provider or supplier located in a rural area (as defined in section 1395ww(d)(2)(D) of this title ); or (ii) provider treated as located in a rural area pursuant to section 1395ww(d)(8)(E) of this title ; (B) a provider or supplier located in any other area that serves rural patients (as defined by the Secretary), which may include, but is not required to include, a metropolitan statistical area with a population of less than 500,000 (determined based on the most recently available data); (C) a rural health clinic (as defined in section 1395x(aa)(2) of this title ); (D) a provider or supplier that furnishes home health, hospice, or …
“health care provider” applies in that section
The term “health care provider” means any entity that furnishes health care items or services, and includes a hospital or other provider of services, a physician or other health care practitioner or professional, a health care facility, or a supplier of health care items or services.
“social security programs” applies in that section
The term “social security programs” means the program providing for monthly insurance benefits under subchapter II, and the program providing for monthly supplemental security income benefits to individuals under subchapter XVI (including State supplementary payments made by the Commissioner pursuant to an agreement under section 1382e(a) of this title or section 212(b) of Public Law 93–66 ).
“satisfactory immigration status” applies in that section
the term “satisfactory immigration status” means an immigration status which does not make the individual ineligible for benefits under the applicable program. (2) If such an individual is not a citizen or national of the United States, there must be presented either— (A) alien registration documentation or other proof of immigration registration from the Immigration and Naturalization Service that contains the individual’s alien admission number or alien file number (or numbers if the individual has more than one number), or (B) such other documents as the State determines constitutes reasonable evidence indicating a satisfactory immigration status.
“agreement” applies in that section
the term “agreement” means an agreement described in section 273(b)(3)(A) of this title ;
“designated organ procurement agency” applies in that section
the term “designated organ procurement agency” means, with respect to a hospital or critical access hospital, the organ procurement agency designated pursuant to subsection (b) for the service area in which such hospital is located; and;
“organ” applies in that section
the term “organ” means a human kidney, liver, heart, lung, pancreas, and any other human organ or tissue specified by the Secretary for purposes of this subsection. (b) (1) The Secretary shall provide that payment may be made under subchapter XVIII or XIX with respect to organ procurement costs attributable to payments made to an organ procurement agency only if the agency— (A) (i) is a qualified organ procurement organization (as described in section 273(b) of this title ) that is operating under a grant made under section 273(a) of this title , or (ii) has been certified or recertified by the Secretary within the previous 2 years (4 years if the Secretary determines appropriate for an …
“core set” applies in that section
the term “core set” means a group of valid, reliable, and evidence-based quality measures that, taken together— (A) provide information regarding the quality of health coverage and health care for children; (B) address the needs of children throughout the developmental age span; and (C) allow purchasers, families, and health care providers to understand the quality of care in relation to the preventive needs of children, treatments aimed at managing and resolving acute conditions, and diagnostic and treatment services whose purpose is to correct or ameliorate physical, mental, or developmental conditions that could, if untreated or poorly treated, become chronic.
“Federally-qualified health center” applies in that section
The term “Federally-qualified health center” has the meaning given that term in section 1396d( l )(2)(B) of this title. (B) Indian tribe
“Indian tribe” applies in that section
The term “Indian tribe” has the meaning given that term in section 1603 of title 25 . (C) Self-assessment
“ongoing support” applies in that section
The term “ongoing support” means— (i) to provide any target individual with information, feedback, health coaching, and recommendations regarding— (I) the results of a self-assessment given to the individual; (II) behavior modification based on the self-assessment; and (III) any need for clinical preventive and screening services or treatment including medical nutrition therapy; (ii) to provide any target individual with referrals to community resources and programs available to assist the target individual in reducing health risks; and (iii) to provide the information described in clause (i) to a health care provider, if designated by the target individual to receive such information.
“pediatric quality measure” applies in that section
the term “pediatric quality measure” means a measurement of clinical care that is capable of being examined through the collection and analysis of relevant information, that is developed in order to assess 1 or more aspects of pediatric health care quality in various institutional and ambulatory health care settings, including the structure of the clinical care system, the process of care, the outcome of care, or patient experiences in care. (7) Construction Nothing in this section shall be construed as supporting the restriction of coverage, under subchapter XIX or XXI or otherwise, to only those services that are evidence-based.
“self-assessment” applies in that section
The term “self-assessment” means a form that— (i) includes questions regarding— (I) behavioral risk factors; (II) needed preventive and screening services; and (III) target individuals’ preferences for receiving follow-up information; (ii) is assessed using such computer generated assessment programs; and (iii) allows for the provision of such ongoing support to the individual as the Secretary determines appropriate. (D) Ongoing support
“quality improvement organization” applies in that section
The term “quality improvement organization” means an entity which— (1) is able, as determined by the Secretary, to perform its functions under this part in a manner consistent with the efficient and effective administration of this part and subchapter XVIII; (2) has at least one individual who is a representative of health care providers on its governing body; and (3) has at least one individual who is a representative of consumers on its governing body.
“organization with a contract with the Secretary under this part” applies in that section
the term “organization with a contract with the Secretary under this part” includes an entity with a contract with the Secretary under section 1320c–3(a)(4)(C) 1 of this title.
“code set” applies throughout its part
The term “code set” means any set of codes used for encoding data elements, such as tables of terms, medical concepts, medical diagnostic codes, or medical procedure codes. (2) Health care clearinghouse
“health care clearinghouse” applies throughout its part
The term “health care clearinghouse” means a public or private entity that processes or facilitates the processing of nonstandard data elements of health information into standard data elements. (3) Health care provider
“health care provider” applies throughout its part
The term “health care provider” includes a provider of services (as defined in section 1395x(u) of this title ), a provider of medical or other health services (as defined in section 1395x(s) of this title ), and any other person furnishing health care services or supplies. (4) Health information
“health information” applies throughout its part
The term “health information” means any information, whether oral or recorded in any form or medium, that— (A) is created or received by a health care provider, health plan, public health authority, employer, life insurer, school or university, or health care clearinghouse; and (B) relates to the past, present, or future physical or mental health or condition of an individual, the provision of health care to an individual, or the past, present, or future payment for the provision of health care to an individual. (5) Health plan
“health plan” applies throughout its part
The term “health plan” means an individual or group plan that provides, or pays the cost of, medical care (as such term is defined in section 300gg–91 of this title ). Such term includes the following, and any combination thereof: (A) A group health plan (as defined in section 300gg–91(a) of this title ), but only if the plan— (i) has 50 or more participants (as defined in section 1002(7) of title 29 ); or (ii) is administered by an entity other than the employer who established and maintains the plan. (B) A health insurance issuer (as defined in section 300gg–91(b) of this title ). (C) A health maintenance organization (as defined in section 300gg–91(b) of this title ).
“individually identifiable health information” applies throughout its part
The term “individually identifiable health information” means any information, including demographic information collected from an individual, that— (A) is created or received by a health care provider, health plan, employer, or health care clearinghouse; and (B) relates to the past, present, or future physical or mental health or condition of an individual, the provision of health care to an individual, or the past, present, or future payment for the provision of health care to an individual, and— (i) identifies the individual; or (ii) with respect to which there is a reasonable basis to believe that the information can be used to identify the individual.
“operating rules” applies throughout its part
The term “operating rules” means the necessary business rules and guidelines for the electronic exchange of information that are not defined by a standard or its implementation specifications as adopted for purposes of this part.
“standard setting organization” applies throughout its part
The term “standard setting organization” means a standard setting organization accredited by the American National Standards Institute, including the National Council for Prescription Drug Programs, that develops standards for information transactions, data elements, or any other standard that is necessary to, or will facilitate, the implementation of this part. (9) Operating rules
“family member” applies in that section
The terms “genetic information”, “genetic test”, and “family member” have the meanings given such terms in section 300gg–91 of this title , as amended by the Genetic Information Nondiscrimination Act of 2007. 1 (2) Group health plan; health insurance coverage; medicare supplemental policy
“genetic information” applies in that section
The terms “genetic information”, “genetic test”, and “family member” have the meanings given such terms in section 300gg–91 of this title , as amended by the Genetic Information Nondiscrimination Act of 2007. 1 (2) Group health plan; health insurance coverage; medicare supplemental policy
“genetic test” applies in that section
The terms “genetic information”, “genetic test”, and “family member” have the meanings given such terms in section 300gg–91 of this title , as amended by the Genetic Information Nondiscrimination Act of 2007. 1 (2) Group health plan; health insurance coverage; medicare supplemental policy
“group health plan” applies in that section
The terms “group health plan” and “health insurance coverage” have the meanings given such terms under section 300gg–91 of this title , and
“health insurance coverage” applies in that section
The terms “group health plan” and “health insurance coverage” have the meanings given such terms under section 300gg–91 of this title , and
“HIPAA privacy regulation” applies in that section
The term “HIPAA privacy regulation” means the regulations promulgated by the Secretary under this part and section 264 of the Health Insurance Portability and Accountability Act of 1996 ( 42 U.S.C. 1320d–2 note). (4) Underwriting purposes
“medicare supplemental policy” applies in that section
the term “medicare supplemental policy” has the meaning given such term in section 1395ss(g) of this title . (3) HIPAA privacy regulation
“underwriting purposes” applies in that section
The term “underwriting purposes” means, with respect to a group health plan, health insurance coverage, or a medicare supplemental policy— (A) rules for, or determination of, eligibility (including enrollment and continued eligibility) for, or determination of, benefits under the plan, coverage, or policy; (B) the computation of premium or contribution amounts under the plan, coverage, or policy; (C) the application of any pre-existing condition exclusion under the plan, coverage, or policy; and (D) other activities related to the creation, renewal, or replacement of a contract of health insurance or health benefits.
“Board” applies in that section
The term “Board” means the Board of Governors established under subsection (f). (2) Comparative clinical effectiveness research; research (A) In general
“comparative clinical effectiveness research” applies in that section
The terms “comparative clinical effectiveness research” and “research” mean research evaluating and comparing health outcomes and the clinical effectiveness, risks, and benefits of 2 or more medical treatments, services, and items described in subparagraph (B).
“conflict of interest” applies in that section
The term “conflict of interest” means an association, including a financial or personal association, that have 1 the potential to bias or have 1 the appearance of biasing an individual’s decisions in matters related to the Institute or the conduct of activities under this section. (4) Real conflict of interest
“real conflict of interest” applies in that section
The term “real conflict of interest” means any instance where a member of the Board, the methodology committee established under subsection (d)(6), or an advisory panel appointed under subsection (d)(4), or a close relative of such member, has received or could receive either of the following: (A) A direct financial benefit of any amount deriving from the result or findings of a study conducted under this section. (B) A financial benefit from individuals or companies that own or manufacture medical treatments, services, or items to be studied under this section that in the aggregate exceeds $10,000 per year.
“research” applies in that section
The terms “comparative clinical effectiveness research” and “research” mean research evaluating and comparing health outcomes and the clinical effectiveness, risks, and benefits of 2 or more medical treatments, services, and items described in subparagraph (B).
“research findings” applies in that section
the term “research findings” means the results of a study or assessment. (9) Adoption Subject to subsection (h)(1), the Institute shall adopt the national priorities identified under paragraph (1)(A), the research project agenda established under paragraph (1)(B), the methodological standards developed and updated by the methodology committee under paragraph (6)(C)(i), and any peer-review process provided under paragraph (7) by majority vote.
“information exchange” applies in that section
The term “information exchange” means the automated comparison of a system of records maintained by the Commissioner of Social Security with records maintained by a payroll data provider.
“payroll data provider” applies in that section
The term “payroll data provider” means payroll providers, wage verification companies, and other commercial or non-commercial entities that collect and maintain data regarding employment and wages, without regard to whether the entity provides such data for a fee or without cost. (2) Information exchange
“initial price applicability year” applies throughout its part
The term “initial price applicability year” means a year (beginning with 2026). (2) Price applicability period
“manufacturer” applies throughout its part
The term “manufacturer” has the meaning given that term in section 1395w–3a(c)(6)(A) of this title . (2) Maximum fair price eligible individual
“maximum fair price” applies throughout its part
The term “maximum fair price” means, with respect to a year during a price applicability period and with respect to a selected drug (as defined in section 1320f–1(c) of this title ) with respect to such period, the price negotiated pursuant to section 1320f–3 of this title , and updated pursuant to section 1320f–4(b) of this title , as applicable, for such drug and year. (4) Reference product
“maximum fair price eligible individual” applies throughout its part
The term “maximum fair price eligible individual” means, with respect to a selected drug— (A) in the case such drug is dispensed to the individual at a pharmacy, by a mail order service, or by another dispenser, an individual who is enrolled in a prescription drug plan under part D of subchapter XVIII or an MA–PD plan under part C of such subchapter if coverage is provided under such plan for such selected drug; and (B) in the case such drug is furnished or administered to the individual by a hospital, physician, or other provider of services or supplier, an individual who is enrolled under part B of subchapter XVIII, including an individual who is enrolled in an MA plan under part C of …
“negotiation period” applies throughout its part
The term “negotiation period” means, with respect to an initial price applicability year with respect to a selected drug, the period— (A) beginning on the sooner of— (i) the date on which the manufacturer of the drug and the Secretary enter into an agreement under section 1320f–2 of this title with respect to such drug; or (ii) February 28 following the selected drug publication date with respect to such selected drug; and (B) ending on November 1 of the year that begins 2 years prior to the initial price applicability year. (c) Other definitions For purposes of this part: (1) Manufacturer
“price applicability period” applies throughout its part
The term “price applicability period” means, with respect to a qualifying single source drug, the period beginning with the first initial price applicability year with respect to which such drug is a selected drug and ending with the last year during which the drug is a selected drug. (3) Selected drug publication date
“reference product” applies throughout its part
The term “reference product” has the meaning given such term in section 262(i) of this title . (5) Total expenditures
“selected drug publication date” applies throughout its part
The term “selected drug publication date” means, with respect to each initial price applicability year, February 1 of the year that begins 2 years prior to such year. (4) Negotiation period
“total expenditures” applies throughout its part
The term “total expenditures” includes, in the case of expenditures with respect to part D of subchapter XVIII, the total gross covered prescription drug costs (as defined in section 1395w–115(b)(3) of this title ). The term “total expenditures” excludes, in the case of expenditures with respect to part B of such subchapter, expenditures for a drug or biological product that are bundled or packaged into the payment for another service. (6) Unit
“unit” applies throughout its part
The term “unit” means, with respect to a drug or biological product, the lowest identifiable amount (such as a capsule or tablet, milligram of molecules, or grams) of the drug or biological product that is dispensed or furnished. (d) Timing for initial price applicability year 2026 Notwithstanding the provisions of this part, in the case of initial price applicability year 2026, the following rules shall apply for purposes of implementing the program: (1) Subsection (b)(3) shall be applied by substituting “ September 1, 2023 ” for “, with respect to each initial price applicability year, February 1 of the year that begins 2 years prior to such year”.
“authorized generic drug” applies in that section
the term “authorized generic drug” means— (i) in the case of a drug, an authorized generic drug (as such term is defined in section 355(t)(3) of title 21 ); and (ii) in the case of a biological product, a product that— (I) has been licensed under section 262(a) of this title ; 1 and (II) is marketed, sold, or distributed directly or indirectly to retail class of trade under a different labeling, packaging (other than repackaging as the reference product in blister packs, unit doses, or similar packaging for use in institutions), product code, labeler code, trade name, or trade mark than the reference product.
“biosimilar biological product” applies in that section
the term “biosimilar biological product” has the meaning given such term in section 1395w–3a(c)(6) of this title .
“negotiation-eligible drug” applies throughout its part
the term “negotiation-eligible drug” means, with respect to the selected drug publication date with respect to an initial price applicability year, a qualifying single source drug, as defined in subsection (e), that is described in either of the following subparagraphs (or, with respect to the initial price applicability year 2026 or 2027, that is described in subparagraph (A)): (A) Part D high spend drugs The qualifying single source drug is, determined in accordance with subsection (e)(2), among the 50 qualifying single source drugs with the highest total expenditures under part D of subchapter XVIII, as determined by the Secretary in accordance with paragraph (3), during the most recent …
“partnership” applies throughout its part
the term “partnership” means a syndicate, group, pool, joint venture, or other organization through or by means of which any business, financial operation, or venture is carried on by the manufacturer of the biological product and the manufacturer of the biosimilar biological product.
“qualifying single source drug” applies throughout its part
the term “qualifying single source drug” means, with respect to an initial price applicability year, subject to paragraphs (2) and (3), a covered part D drug (as defined in section 1395w–102(e) of this title ) that is described in any of the following or a drug or biological product for which payment may be made under part B of subchapter XVIII that is described in any of the following: (A) Drug products A drug— (i) that is approved under section 355(c) of title 21 and is marketed pursuant to such approval; (ii) for which, as of the selected drug publication date with respect to such initial price applicability year, at least 7 years will have elapsed since the date of such approval; and …
“average non-Federal average manufacturer price” applies throughout its part
the term “average non-Federal average manufacturer price” means the average of the non-Federal average manufacturer price (as defined in section 8126(h)(5) of title 38 ) for the 4 calendar quarters of the year involved.
“extended-monopoly drug” applies throughout its part
the term “extended-monopoly drug” means, with respect to an initial price applicability year, a selected drug for which at least 12 years, but fewer than 16 years, have elapsed since the date of approval of such drug under section 355(c) of title 21 or since the date of licensure of such drug under section 262(a) of this title , as applicable. (B) Exclusions The term “extended-monopoly drug” shall not include any of the following: (i) A vaccine that is licensed under section 262 of this title and marketed pursuant to such section.
“long-monopoly drug” applies throughout its part
the term “long-monopoly drug” means, with respect to an initial price applicability year, a selected drug for which at least 16 years have elapsed since the date of approval of such drug under section 355(c) of title 21 or since the date of licensure of such drug under section 262(a) of this title , as applicable. (B) Exclusion The term “long-monopoly drug” shall not include a vaccine that is licensed under section 262 of this title and marketed pursuant to such section. (6) Average non-Federal average manufacturer price In this part,