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Week Ending June 17, 2005
HR 1812 Act to authorize a demonstration grant program
to provide patient navigator services to reduce barriers and improve health care
outcomes, and for other purposes.
BRIEF
Similar to a bill passed last year but not signed into law, HR 1812 would provide grants to initiate and maintain programs called Patient Navigator services. A Patient Navigator would be a person who is trained and knowledgeable about directing the ill to early diagnosis and proper treatment, find health insurance and when appropriate participate in clinical trials for new treatments.
Patients challenged by cancer an other chronic diseases would be likely candidates for the service.
The grants would originate with the Department of Health and Human Services and would be given to eligible recipients. Eligible recipients are described as including “a public or nonprofit private health center, a community health center, a health facility operated by or pursuant to a contract with the Indian Health Service, a hospital, a cancer center, a rural health clinic, an academic health center, or a nonprofit entity that enters into a partnership or coordinates referrals with such health care facilities to provide patient navigator services.”
The grants would be spent to “recruit, assign, train, and employ patient navigators who have a direct knowledge of the communities they serve.” The Secretary of HHS would define what training is required.
Sponsor: Representative Robert Menendez (D-NJ-13th)
Vote: passé House by voice vote (June 14, 2005)
Cost to the taxpayers: Up to $25 million through 2010.
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MORE INFORMATION
BACKGROUND AND NEED FOR THE LEGISLATION
Improving health care outcomes for all Americans requires substantial improvement in health disparity populations, populations--not defined solely by race and ethnicity--that have a significant disparity in the overall rate of disease incidence, prevalence, morbidity, mortality, or survival rates as compared to the health status of the general population. Patient navigator programs provide outreach to communities to seek preventative care and coordinate health care services for individuals who are at risk for or who have a chronic disease. For example, the Ralph Lauren Center for Cancer Care and Prevention, a partnership between Memorial Sloan-Kettering and North General Hospital in Harlem, New York, operates a patient navigator program to help patients and family members deal with the complexities of the health care system. By coordinating health care services through a patient navigator, the patient navigator programs strive to shorten the period of time when a patient is screened for cancer or other chronic disease and further diagnosis and treatment, if needed.
Section 1. Short title
Section one provides the short title of the bill, the `Patient Navigator Outreach and Chronic Disease Prevention Act of 2005.'
Section 2. Patient navigator grants
Section 2 authorizes the Secretary of the Department of Health and Human Services, acting through the Administrator of the Health Resources and Services Administration (HRSA), to make grants to eligible entities for the development and operation of demonstration programs to provide patient navigator services to improve health care outcomes.
Eligible entities include a public or nonprofit private health center, a community health center, a health facility operated by or pursuant to a contract with the Indian Health Service, a hospital, a cancer center, a rural health clinic, an academic health center, or a nonprofit entity that enters into a partnership or coordinates referrals with such health care facilities to provide patient navigator services. With respect to a nonprofit entity, the Committee does not intend the term `coordinates referrals with' to imply that a nonprofit entity must jointly file a grant application with a health care facility. Instead, the Committee fully expects the Administrator of HRSA to evaluate nonprofit entity applications by the strength of the nonprofit entity's ability to provide all of the requirements of patient navigator services, including referrals to specific facilities, as well as the ability of the nonprofit organization to conduct outreach activities for prevention services and treatment programs.
The Committee recognizes the challenges of some communities in overcoming significant barriers to high quality health care services, including geographic isolation, cultural and linguistic barriers, limited transportation services, lack of health insurance and information about health options, and socioeconomic status. Therefore, section 2 requires the Administrator of HRSA to give preference to grant applicants who target populations in greatest need and utilize patient navigators to help overcome these and other barriers in order to reduce health care disparities and improve health care outcomes.
Eligible entities shall use the grant to recruit, assign, train, and employ patient navigators who have a direct knowledge of the communities they serve. The term `patient navigator' is defined to mean an individual who has completed a training program approved by the Secretary to perform the duties outlined in the legislation. It is the Committee's intent that the Secretary develop specific requirements related to the patient navigator training programs to ensure the quality of services provided to patients by patient navigators. Such requirements may include minimum qualification requirements, such as education requirements, prior work experience, appropriate background checks, specified levels of expertise in health care of the community, and oversight or supervision requirements by licensed professionals. The Committee recognizes that there will be grant applicants with varying levels of experience in patient navigation. Some may have existing trained patient navigators who want to expand their services; others may have no trained navigators, but are well positioned to begin providing patient navigator services with appropriate training. An allowable use of part of the funds under this grant would be to provide navigator training, a plan for which should be included in the grant application.
Patient navigators must coordinate health care services and provider referrals, facilitate the involvement of community organizations to provide assistance to patients, facilitate enrollment in clinical trials, anticipate barriers within the health care system and help ensure prompt diagnostic care and treatment, coordinate with appropriate health insurance ombudsman programs, and conduct ongoing outreach to health disparity populations and other individuals to seek preventative care.
Section 2 includes a rule of construction to clarify that the bill does not authorize funding for the delivery of health care services other than the patient navigator duties outlined in the legislation. It is the Committee's view that this provision would prohibit use of demonstration program funds by a patient navigator to provide direct health care or treatment to a patient, even if the patient navigator is a licensed medical provider.
The Committee fully expects that patient navigators will assist uninsured individuals with enrolling in appropriate health coverage programs, including private insurance, publicly funded programs like
Medicaid, as well as health care savings accounts. Section 2 further clarifies that grant recipients cannot accept any referral fee, kickback, or other item of value in return for referring an individual to a particular health care provider, nor may the grant recipient will use any of the funds provided under this program to pay any fees or costs resulting from any litigation, arbitration, mediation, or other proceeding to resolve a legal dispute.
Maintaining confidentiality of patient medical information is a concern, given that patient navigators will likely receive sensitive health information during the performance of their activities. It is the Committee's view that most, if not all eligible entities would be covered health care providers under, and thus subject to, the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule. Beside health care providers, other nonprofit entities are also eligible entities under this program, but only if they enter into a `partnership or coordinates referrals' with one of these health care providers. It is the Committee's view that these nonprofit entities would be considered to be `business associates' of the covered entities under HIPAA and thus also subject to the requirements of HIPAA.
To the extent the patient navigator services are provided through an eligible entity that is a covered entity for HIPAA purposes, the patient navigator is likely to be a workforce member of the covered entity or of a business associate of a covered entity. Thus, the Committee expects the majority, if not all patient navigators will need to abide by the Privacy Rule in using or disclosing protected health information about the patients to whom they provide services. The Privacy Rule allows protected health information to be used and disclosed by a covered entity for the core functions of treatment, payment, and health care operations, and that do not need patient authorization of these uses or disclosures. In reviewing the types of functions that a patient navigator is likely to perform and that the purposes for these services is to facilitate the patient's access to quality care, it appears that most of the services would fit within one or more of the HIPAA core functions.
The Secretary, acting through the Administrator of HRSA, must coordinate and ensure the participation of the Indian Health Service, the National Cancer Institute, the Office of Rural Health Policy, and other such office and agencies deemed appropriate by the Secretary, regarding the design and evaluation of the demonstration program. The Committee strongly encourages the Administrator of HRSA to also coordinate with the Office of Minority Health and Health Disparities at HRSA and Bureau of Primary Health Care at HRSA, as well as other similar offices throughout the Department of Health and Human Services. To facilitate the operation of the program, the Committee has assigned primary responsibility to the Administrator of HRSA. However, the Committee recognizes the distinct role of each of these offices and agencies within the Department of Health and Human Services, and therefore requires close coordination to maximize the impact of the patient navigator demonstration program.
Section 2 also requires the Secretary to ensure coordination of the demonstration program with existing authorized programs in order to facilitate access to high-quality health care services (e.g., the Community Access Program administered by HRSA and the breast and cervical cancer screening programs administered by the Centers for Disease Control and Prevention.) Additionally, if grant recipients are already receiving federal funds for activities similar to those described under this program, at the time of the grant application, the applicant may not receive a grant under this section unless the entity can demonstrate that amounts received under this grant will be utilized to provide new services, or to serve new classes of individuals who would not otherwise be served. By including this provision, the Committee wants to ensure that the patient navigator grants provided for under this section provide added value or new community services without duplicating programs or efforts that would qualify for funding under current law.
An eligible entity may receive a grant for a period of not more than three years. The Secretary may, based on extenuating circumstances, approve an extension of the grant period for up to one year. The demonstration program expires on September 30, 2010.
Eligible entities must establish baseline measures and benchmarks to evaluate program outcomes. The Secretary may require grant recipients to submit interim reports on grant program outcomes. The Secretary may provide Congress with interim reports on the progress of the demonstration program. The Secretary is required to conduct an evaluation of the results of the program no later than six months after the completion of the demonstration grant program. To effectively measure program outcomes, the Committee recommends that the Secretary collect and include the following data in the final report to Congress: the patient's insurance status, income, education level, gender, age, race and ethnicity, the number of patients navigated, demographic coverage area, screening location and date, type and stage of diagnosis, point at which the navigator was brought into the process, type of navigator (lay or professional), barriers the patient encountered and how they were resolved, compliance rate for appointments and follow-up exams, number of patients referred (e.g., to treatment, pharmaceutical assistance programs, ombudsman programs/other health insurance programs, community organizations) and follow-up outcomes (e.g., number of uninsured who get health coverage, etc.), time interval between diagnosis or referral and resolution date, and the final outcome or result. For applicants who are providing training for patient navigators, the report should also include the plan for such training and the outcomes.
Finally, section 2 authorizes to be appropriated $2 million in fiscal year 2006, $5 million in fiscal year 2007, $8 million in fiscal year 2008, $6.5 million in fiscal year 2009, and $3.5 million in fiscal year 2010 to carry out the patient navigator demonstration program. Amounts appropriated will be available through the end of fiscal year 2010.
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No reproduction or distribution without written permission from TheWeekInCongress.com.