the United States Senate

“ DIRECT PATIENT ACCESS EMPLOYEE- 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. ”

“ APPLICABLE MANUFACTURER- 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. ”

“ IN GENERAL- The term `long-term care' means supportive and health services specified by the Secretary for individuals who need assistance because the individuals have a loss of capacity for self-care due to illness, disability, or vulnerability. ”

“ TAKING INTO ACCOUNT POTENTIAL DIFFERENCES- Research shall be designed, as appropriate, to take into account the potential for differences in the effectiveness of health care treatments, services, and items as used with various subpopulations, such as racial and ethnic minorities, women, age, and groups of individuals with different comorbidities, genetic and molecular sub-types, or quality of life preferences and include members of such subpopulations as subjects in the research as feasible and appropriate. ”

“ Effective Compliance and Ethics Programs- (1) REQUIREMENT- On or after the date that is 36 months after the date of the enactment of this section, a facility shall, with respect to the entity that operates the facility (in this subparagraph 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 Act and in promoting quality of care consistent with regulations developed under paragraph (2) . ”

“ GRANT- The term `grant' includes a contract, cooperative agreement, or other mechanism for providing financial assistance. (11) GUARDIANSHIP- The term `guardianship' means-- (A) the process by which a State court determines that an adult individual lacks capacity to make decisions about self-care or property, and appoints another individual or entity known as a guardian, as a conservator, or by a similar term, as a surrogate decisionmaker ”

“ The Patient-Centered Outcomes Research Institute established under section 1181 (b) (1) shall not develop or employ a dollars-per-quality adjusted life year (or similar measure that discounts the value of a life because of an individual's disability) as a threshold to establish what type of health care is cost effective or recommended. The Secretary shall not utilize such an adjusted life year (or such a similar measure) as a threshold to determine coverage, reimbursement, or incentive programs under title XVIII.'. ”

“ ELIGIBLE ENTITY- The term `eligible entity' means a State or local government agency, Indian tribe or tribal organization, or any other public or private entity that is engaged in and has expertise in issues relating to elder justice or in a field necessary to promote elder justice efforts. ”

“ DESIGN OF REGULATIONS- Such regulations with respect to specific elements or formality of a program shall, in the case of an organization that operates 5 or more facilities, vary with the size of the organization, such that larger organizations should have a more formal program and include established written policies defining the standards and procedures to be followed by its employees. Such requirements may specifically apply to the corporate level management of multi unit nursing home chains. ”

“ CLINICAL INVESTIGATION- 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- The term `covered device' means any device for which payment is available under title XVIII or a State plan under title XIX or XXI (or a waiver of such a plan) . ”

“ CONFLICT OF INTEREST- The term `conflict of interest' means an association, including a financial or personal association, that have the potential to bias or have the appearance of biasing an individual's decisions in matters related to the Institute or the conduct of activities under this section. ”

“ Not less frequently than every 5 years, the dissemination and training activities and data networks established under section 937 of the Public Health Service Act, including the methods and products used to disseminate research, the types of training conducted and supported, and the types and functions of the data networks established, in order to determine whether the activities and data are produced in a manner consistent with the requirements under such section. ”

“ WAIVER FOR CERTAIN MEDICAID PROVIDERS- The Secretary may, on a case-by-case basis, exempt a provider of medical or other items or services or supplier from the imposition of an application fee under this subparagraph if the Secretary determines that the imposition of the application fee would result in a hardship. The Secretary may waive the application fee under this subparagraph for providers enrolled in a State Medicaid program for whom the State demonstrates that imposition of the fee would impede beneficiary access to care. ”

“ The hospital (or any owner or investor in the hospital) does not directly or indirectly guarantee a loan, make a payment toward a loan, or otherwise subsidize a loan, for any individual physician owner or investor or group of physician owners or investors that is related to acquiring any ownership or investment interest in the hospital. (v) Ownership or investment returns are distributed to each owner or investor in the hospital in an amount that is directly proportional to the ownership or investment interest of such owner or investor in the hospital. ”

“ Procedure- The provisions of section 1128A (other than subsections (a) and (b) and the second sentence of subsection (f) ) shall apply to a civil money penalty or exclusion under this section in the same manner as such provisions apply to a penalty or proceeding under section 1128A (a) . (f) Definitions- In this section, the terms `elder justice', `long-term care facility', and `law enforcement' have the meanings given those terms in section 2011.'. ”

“ INCLUSION OF SKILLED NURSING FACILITY- The term `nursing facility' includes a skilled nursing facility (as defined in section 1819 (a) ) . (18) SELF-NEGLECT- The term `self-neglect' means an adult's inability, due to physical or mental impairment or diminished capacity, to perform essential self-care tasks including-- (A) obtaining essential food, clothing, shelter, and medical care; (B) obtaining goods and services necessary to maintain physical health, mental health, or general safety; or (C) managing one's own financial affairs. ”

“ DEVELOPMENT OF FORENSIC EXPERTISE- An eligible entity that receives a grant under this section shall use funds made available through the grant to develop forensic expertise regarding elder abuse, neglect, and exploitation in order to provide medical and forensic evaluation, therapeutic intervention, victim support and advocacy, case review, and case tracking. ”

“ DEVELOPMENT BY THE SECRETARY- The Secretary shall develop a standardized complaint form for use by a resident (or a person acting on the resident's behalf) in filing a complaint with a State survey and certification agency and a State long-term care ombudsman program with respect to a facility. (2) COMPLAINT FORMS AND RESOLUTION PROCESSES- (A) COMPLAINT FORMS- The State must make the standardized complaint form developed under paragraph (1) available upon request to-- (i) a resident of a facility; and (ii) any person acting on the resident's behalf. ”

“ AVAILABILITY OF FEES- Fees collected pursuant to section 1128E (d) (2) of the Social Security Act prior to the effective date specified in paragraph (6) for the disclosure of information in the Healthcare Integrity and Protection Data Bank shall be available to the Secretary, without fiscal year limitation, for payment of costs related to the transition process described in paragraph (1) . Any such fees remaining after the transition period is complete shall be available to the Secretary, without fiscal year limitation, for payment of the costs of operating the National Practitioner Data Bank. ”

“ DEFINITIONS- In this paragraph: (i) IN GENERAL- The term `applicable provider of services or supplier' means a provider of services or supplier that has the same taxpayer identification number assigned under section 6109 of the Internal Revenue Code of 1986 as is assigned to the obligated provider of services or supplier under such section, regardless of whether the applicable provider of services or supplier is assigned a different billing number or national provider identification number under the program under this title than is assigned to the obligated provider of services or supplier. ”

“ DIRECT CARE- The term `direct care' means care by an employee or contractor who provides assistance or long-term care services to a recipient. (5) ELDER- The term `elder' means an individual age 60 or older. (6) ELDER JUSTICE- The term `elder justice' means-- (A) from a societal perspective, efforts to-- (i) prevent, detect, treat, intervene in, and prosecute elder abuse, neglect, and exploitation; and (ii) protect elders with diminished capacity while maximizing their autonomy ”

“ IN GENERAL- Subject to subparagraph (B) , the term `final adverse action' includes-- (i) civil judgments against a health care provider, supplier, or practitioner in State court related to the delivery of a health care item or service; (ii) State criminal convictions related to the delivery of a health care item or service; (iii) exclusion from participation in State health care programs (as defined in section 1128 (h) ) ; (iv) any licensing or certification action described in subsection (a) (1) (A) taken against a supplier by a State licensing or certification agency ”

“ DEFINITION OF RESEARCH FINDINGS- In this paragraph, 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. ”

“ USE OF FUNDS- A grant awarded under subparagraph (A) shall be used for the purpose of designing and implementing complaint investigations systems that-- (i) promptly prioritize complaints in order to ensure a rapid response to the most serious and urgent complaints; (ii) respond to complaints with optimum effectiveness and timeliness; and (iii) optimize the collaboration between local authorities, consumers, and providers, including-- (I) such State agency; (II) the State Long-Term Care Ombudsman; (III) local law enforcement agencies; (IV) advocacy and consumer organizations ”

“ UNDERSERVED POPULATION DEFINED- In this paragraph, 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. ”