Department of Health and Human Services February 4, 2005 – Federal Register Recent Federal Regulation Documents

Currently, application scores for New Access Point (NAP) applications under the President's Health Centers Initiative (Program) cluster at the high end of the scoring range, providing little distinction among applicants. Since the intent of the Program is to provide grants to the neediest communities, HRSA is considering placing more emphasis on assessing the need for comprehensive primary and preventive health care services in the service area or for the population for which the applicant is seeking support, by revising the Need for Assistance Criteria and changing the relative weights of the review criteria used in evaluating such applications. This notice offers public and private nonprofit entities an opportunity to comment on the proposed changes in the Need for Assistance Criteria (NFA), and on the degree to which need should be weighted relative to other criteria used in evaluating future applications. In order to solicit comments from the public on these proposed changes, HRSA is delaying the due date (May 23, 2005) for the second round of fiscal year (FY) 2005 New Access Point applications. Authorizing Legislation: Section 330(e)(1)(A) of the Public Health Service Act, as amended, authorizes support for the operation of public and nonprofit private health centers that provide health services to medically underserved populations. Reference: For the current Need for Assistance (NFA) criteria and other application review criteria, including weights used most recently, see Program Information Notice (PIN) 2005-01, titled ARequirements of Fiscal Year 2005 Funding Opportunity for Health Center New Access Point Grant Applications,'' are available on HRSA's Bureau of Primary Health Care (BPHC) Web site at https://bphc.hrsa.gov/ pinspals/pins.htm. That PIN detailed the eligibility requirements, review criteria, and awarding factors for applicants seeking support for the operation of New Access Points in FY 2005. Background: The goal of the President's Health Centers Initiative, which began in FY 2002, is to increase access to comprehensive primary and preventive health care services to 1,200 of the Nation's neediest communities through new and/or significantly expanded health center access points over five years. These health center access points are to provide comprehensive primary and preventive health care services in areas of high need that will improve the health status of the medically underserved populations to be served and decrease health disparities. Services at these new access points may be targeted toward an entire community or service area or toward a specific population group in the service area that has been identified as having unique and significant barriers to affordable and accessible health care services. While it is extremely important that NAP grant awards be made to entities that will successfully implement a viable and compliant program for the delivery of comprehensive primary health services to the populations or communities they propose to serve, HRSA also needs to assure that all applicants seeking support for a NAP applicant can demonstrate the need for such services in the community (area or population group) to be served and be evaluated on that need. Under the current guidance, NFA criteria are used to quantify barriers to access and identify health disparities. The NFA process also establishes a threshold which applicants must meet in order for their applications to be reviewed by the Objective Review Committee (ORC). Description of Current NFA process. The current NFA process (as described in Form 9-Part A of PIN 2005-01) involves two major groups of indicators. First, from eight (8) ``Barriers and Access to Care'' measures, the applicant must select five (5). These measures are: Shortage of primary care physicians, as measured by whether the target service area has been designated as a geographic or population group Health Professions Shortage Area (HPSA); Percent of the population with incomes below 200% of the Federal poverty level; Life expectancy of target population (in years); percentage of target population uninsured; unemployment rate of target population; average travel time or distance to nearest source of primary care for target population; percentage of target population age 5 or older who speak a language other than English at home; and length of waiting time for public housing and Section 8 certificates for target population. For the first of these measures, the applicant receives 14 points if HPSA-designated and zero otherwise; for each of the other measures, the NFA criteria define a 6-level scale from 0 to 14 points. The applicant provides data for its service area or target population for each of the 5 measures selected, and identifies the source of data used. Given 5 indicators and a maximum of 14 points for each, there are a possible 70 points for the ``Barriers and Access to Care'' indicators. Second, from 28 ``Health Disparity Factors'', the applicant selects 10 and provides data on each for its service areas or target populations. For each factor selected, the applicant can receive 3 points if the value for the target population exceeds the benchmark used. The applicant defines the benchmark, and gives a source for that benchmark as well as a source for the target population data provided. The guidance lists 27 specific factors, plus an ``other'' category allowing the applicant to select one additional locally-relevant factor not anticipated by the guidance. This approach produces a possible 30 points for the ``Health Disparities Factors'' section; combined with the possible 70 for ``Barriers and Access to Care'' section, allowing a possible 100 total points are possible. In current guidance, the threshold for having the application reviewed has been set at an NFA score of 70 out of the possible 100 total points.

In accordance with section 10(a) of the Federal Advisory Committee Act, this notice announces a meeting of the Practicing Physicians Advisory Council (the Council). The Council will be meeting to discuss certain proposed changes in regulations and carrier manual instructions related to physicians' services, as identified by the Secretary of the Department of Health and Human Services (the Secretary). This meeting is open to the public.

This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 404.7(a)(1)(i), that the National Institutes of Health (NIH), Department of Health and Human Services, is contemplating the grant of a an exclusive license to practice the invention embodied in: (1) U.S. Patent No. 4,968,690, issued Nov. 6, 1990, entitled ``3- DEAZANEPLANOCIN A AND METHOD OF PREPARATION'' (E-493-1985/0-US-02) (Inventors: Victor E. Marquez, John S. Driscoll, Mu-III Lim, Christopher K Tseng, Alberto Haces and Robert Glazer) (NCI), a continuation of prior application 867,583, filed May 27, 1986, now abandoned. (2) U.S. Patent No. 4,975,434, issued Dec. 4, 1990, entitled ``ANTIVIRAL AND ANTICANCER CYCLOPENTENYL CYTOSINE'' (E-493-1985/1-US- 01) (Inventors: Victor E. Marquez, John S. Driscoll, Mu-III Lim, Christopher K Tseng, Alberto Haces and Robert Glazer) (NCI), a continuation of prior application 867,583, filed May 27, 1986, now abandoned to GRX Pharmaceuticals (hereafter GRX), having a place of business in Marlboro, New Jersey. The patent rights in these inventions have been assigned to the United States of America.

This notice, in accordance with Section 1153(i) of the Social Security Act, gives at least 6-months' advance notice of the expiration dates of contracts with out-of-State Utilization and Quality Control Peer Review Organizations. It also specifies the period of time in which in-State organizations may submit a statement of interest so that they may be eligible to compete for these contracts.

This proposed rule would set forth the requirements that heart, heart-lung, intestine, kidney, lung, and pancreas transplant centers must meet to participate as Medicare-approved transplant centers. These proposed revised requirements focus on an organ transplant center's ability to perform successful transplants and deliver quality patient care as evidenced by good outcomes and sound policies and procedures. We are proposing that approval, as determined by a center's compliance with the proposed data submission, outcome, and process requirements would be granted for 3 years. Every 3 years, approvals would be renewed for transplant centers that continue to meet these requirements. We are proposing these revised requirements to ensure that transplant centers continually provide high-quality transplantation services in a safe and efficient manner.

This proposed rule would revise the requirements that end stage renal disease (ESRD) dialysis facilities must meet to be certified under the Medicare program. The revised requirements focus on the patient and the results of the care provided to the patient, establish performance expectations for facilities, encourage patients to participate in their care plan and treatment, eliminate many procedural requirements from the current conditions for coverage, and preserve strong process measures when necessary to promote patient well being and continuous quality improvement. These changes are necessary to reflect the advances in dialysis technology and standard care practices since the requirements were last revised in their entirety in 1976.