Medicare and Medicaid programs, freedom of information (FOI) guidelines--HCFA. Notice

In accordance with the settlement agreement reached in the case of Home Health Line v. HCFA, District Court of District of Columbia, Civil Action (D.D.C., C.A.) No. 90-1006 LFO, HCFA is publishing in the Federal Register a notice describing and clarifying HCFA's guidelines concerning expedited processing of Freedom of Information (FOI) requests.     

New vaccine information materials for hepatitis B, Haemophilus influenzae type b (Hib), and varicella (chickenpox) vaccines, and revised vaccine information materials for measles, mumps, rubella (MMR) vaccines. Centers for Disease Control and Prevention (CDC), Department of Health and Human Services. Notice

Under the National Childhood Vaccine Injury Act (42 U.S.C. 300aa-26), the CDC must develop vaccine information materials that all health care providers, whether public or private, are required to distribute to patients/parents prior to administration of each dose of specific vaccines. On September 3, 1998, CDC published a notice in the Federal Register (63 FR 47026) seeking public comment on proposed vaccine information materials for the newly covered vaccines hepatitis B, Haemophilus influenzae type b, and varicella vaccines, and also seeking comment on proposed revised vaccine information materials for measles, mumps, rubella (MMR) vaccines. The 60 day comment period ended on November 2, 1998. Following review of the comments submitted and consultation as required under the law, CDC has finalized these vaccine information materials. The final materials are contained in this notice.     

Proposed vaccine information materials for hepatitis B, Haemophilus influenzae type b (Hib), Varicella (chickenpox), and measles, mumps, rubella (MMR) vaccines--CDC. Notice with comment period

Under the National Childhood Vaccine Injury Act (42 U.S.C. section 300aa-26), CDC must develop vaccine information materials that health care providers are required to give to patients/parents prior to administration of specific vaccines. CDC seeks written comment on proposed new vaccine information materials for hepatitis B, Haemophilus influenzae type b, and Varicella vaccines, and revised vaccine information materials for measles, mumps, rubella (MMR) vaccines.     

Interim polio vaccine information materials. Centers for Disease Control and Prevention (CDC), Department of Health and Human Services. Notice

The Centers for Disease Control and Prevention has modified its recommendation for use of the two polio vaccines to discourage use of oral poliovirus vaccine (OPV) for the first two doses administered, except in limited circumstances. This revised recommendation necessitates a revision of the vaccine information statement entitled, "Polio Vaccines: What You Need to Know" (dated February 6, 1997), which was developed by the CDC as required by the National Childhood Vaccine Injury Act of 1986 (NCVIA). To ensure that up-to-date information is available regarding this revised recommendation, CDC is distributing the following interim polio vaccine information statement for use pending completion of the formal revision process mandated by the NCVIA.     

Revised precautionary measures to reduce the possible transmission of Creutzfeldt-Jakob disease (CJD) by blood and blood products; guidance document; availability--FDA. Notice

The Food and Drug Administration (FDA) is announcing the availability of a guidance document entitled "Revised Precautionary Measures to Reduce the Possible Transmission of Creutzfeldt-Jakob Disease (CJD) by Blood and Blood Products," dated December 11, 1996. The guidance document is intended to provide recommendations to the blood industry and may include information useful to other interested persons.     

Changes to Medicare Secondary Payer (MSP) provisions--HCFA. Notice

This notice describes how subsections 6202(b), (c), and (e) of the Omnibus Budget Reconciliation Act of 1989 (Pub. L. 101-239) affect the Medicare Program These subsections: Create uniform rules for computing Medicare secondary payments for all MSP situations; Exempt from the MSP provisions services performed for a religious order by members of the order who take a vow of poverty; Prohibit group health plans (GHPs) from "taking into account" that an individual is entitled to Medicare when Medicare is the secondary payer; Prohibit GHPs from differentiating, in the services they provide, between individuals with end-stage renal disease (ESRD) and other individuals covered by the plan; Require that GHPs of employers of 20 or more employees provide the same benefits under the same conditions to employees age 65 or older and employees' spouses age 65 or older as they provide to employees and spouses under age 65; Impose a 25 percent excise tax on contributions that employers and employee organizations make to nonconforming GHPs, i.e., plans that do not comply with the MSP provisions; Extend to all MSP situations the Federal Government's right to take legal action to collect double damages if a primary plan fails to comply with the Medicare secondary payment requirements of the law; Make the provisions for special enrollment periods for the disabled parallel to those in effect for the working aged. The statutory changes made by subsections 6202(b), (c), and (e) can be put into effect without first issuing regulations because it is clear on the face of the statute what the Congress intended.(ABSTRACT TRUNCATED AT 250 WORDS)     

Medtronic, Inc.; premarket approval of the Interstim Sacral Nerve Stimulation (SNS) System--FDA. Notice

The Food and Drug Administration (FDA) is announcing its approval of the application by Medtronic, Inc., Minneapolis, MN, for premarket approval, under the Federal Food, Drug, and Cosmetic Act (the act), of the Interstim Sacral Nerve Stimulation (SNS) System. After reviewing the recommendation of the Gastroenterology and Urology Devices Panel, FDA's Center for Devices and Radiological Health (CDRH) notified the applicant, by letter of September 29, 1997, of the approval of the application.     

Order for transitional class III devices; submission of safety and effectiveness information under section 520(1)(5)(A) of the Federal Food, Drug, and Cosmetic Act--FDA. Notice

The Food and Drug Administration (FDA) is issuing an order requiring manufacturers of transitional class III devices to submit to FDA a summary of, and a citation to, any information known or otherwise available to the manufacturers respecting the devices, including adverse safety or effectiveness information which has not been submitted under section 519 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360i). This is the first step in the process of determining the appropriate classification of transitional devices under the Safe Medical Devices Act of 1990.     

Solicitation of information and recommendations for developing OIG compliance program guidance for certain Medicare+Choice organizations--OIG, HHS. Notice

This Federal Register notice seeks the input and recommendations of interested parties into the OIG's development of a compliance program guidance for Medicare+Choice organizations that offer coordinated care plans (M+CO/CCPs). The OIG has previously developed compliance program guidances for hospitals, clinical laboratories and home health agencies in order to provide clear and meaningful guidance to those segments of the health care industry. In an effort to provide similar guidance to certain M+C organizations, we are soliciting comments, recommendations and other suggestions from concerned parties and organizations on how best to develop compliance program guidance and reduce fraud and abuse within M+CO/CCPs.     

Privacy Act of 1974; computer matching program--HCFA. Notice of a matching program--HCFA's Health Insurance (HI) Master Record and information from four Railroad Retirement Board (RRB) systems of records

The Department of Health and Human Services is providing public notice that the RRB agrees to disclose information concerning Medicare eligible railroad retirees to HCFA. The matching report set forth below is in compliance with the Computer Matching and Privacy Protection Act of 1988 (Pub. L. No. 100-503).     

Public Health Service--Information regarding requirements for health maintenance organizations. Notice, information regarding requirements for qualified health maintenance organizations

This notice contains information relating to the requirements for federally qualified health maintenance organizations (HMOs) as set out in Title XIII of the Public Health Service Act (the Act), as amended, and its implementing regulations at 42 CFR Part 110. This information, which includes a number of interpretive rulings, is being published in response to significant questions that have been raised regarding those requirements.     

Availability of funds for Community Health Centers (CHCs)--Health Resources and Services Administration. Notice

Under the present Continuing Resolution, Pub. L. 97-377, providing funding for the Department of Health and Human Services, approximately $14 million are available for funding new CHCs and expanding existing CHCs. This notice contains information of interest to prospective applicants for such funding.     

Notice of specific list for categorization of laboratory test systems, assays, and examinations by complexity--CDC. Notice with comment period

Regulations codified at 42 CFR 493.17, implementing the Clinical Laboratory Improvement Amendments of 1988 (CLIA), Public Law 100-578, require that the Secretary provide for the categorization of specific laboratory test systems, assays, and examinations by level of complexity. The criteria for such categorizations also are set forth in those regulations. This Notice announces the addition of approximately 1,300 test systems, assays, and examinations that have been categorized and notified between June 7, 1996 and December 31, 1996. These categorizations were effective on the issue date of the notification letter sent to the manufacturer and are subject to the 30 day comment period for this Notice.     

Civilian Health and Medical Program of the Uniformed Services (CHAMPUS)--DoD. Notice of revised rates

This notice provides the updated adjusted standardized amounts, DRG relative weights, outlier thresholds, and beneficiary cost-share per diem rates to be used for FY 1993 under the CHAMPUS DRG-based payment system. It also describes the non-regulatory changes made to the CHAMPUS DRG-based payment system in order to conform to changes made to the Medicare Prospective Payment System (PPS).