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Grants to states for operation of qualified high risk pools. Final rule with comment period.

This final rule with comment period implements a provision of the Trade Assistance Reform Act of 2002 by providing $40 million in Federal fiscal year 2003 and $40 million in Federal fiscal year 2004 to States that have incurred losses in connection with the operation of qualified high risk pools that meet certain criteria. This grant program implements section 2745 of the Public Health Service Act, as added by the Trade Adjustment Assistance Reform Act of 2002.

Financing, Government↗

Medicare program; third party liability insurance regulations. Final rule with comment period.

This final rule with comment period removes Sec. 411.54(c)(2) and a portion of Sec. 489.20(g) from our regulations. These regulations were held by a court to be inconsistent with the Medicare Secondary Payer provisions that are found in section 1862(b)(2)(a) of the Social Security Act. Specifically, the court held that Sec. 411.54(c)(2) and a portion of Sec. 489.20(g) are unenforceable to the extent that these regulations require providers and suppliers to only bill Medicare and prohibits them from billing a liability insurer or asserting or maintaining a lien against a beneficiary's liability insurance settlement during the "promptly" period.

Cost Sharing↗

Eosinophilic gastroenteritis: report of two cases and comment on the literature.

Two cases of eosinophilic gastroenteritis (EGE) are reported. One recovered spontaneously, the other relapsed after bowel resection. Comments outline the immunological processes. They relate EGE to the hypereosinophilic syndrome (HES) and other collagenous diseases. Bowel resection is discouraged in favor of more conservative treatment.

Adult↗

[Investigation, treatment and monitoring of late-onset hypogonadism in males: the official guidelines of the International Society for the Study of the Study of the Aging Male (ISSAM) with comments].

There is increasing interest in the subject of hormone changes in the aging male, which is likely to become particularly important with the expected growth in the population of men over 50. The main concerns at present are androgen decline in the aging male (ADAM), or partial androgen deficiency of the aging male (PADAM), commonly known as the andropause. Although there have been advances in our knowledge of androgen deficiency in the aging male, it is still incomplete, sometimes confusing, and some aspects of androgen replacement therapy remain controversial. The International Society for the Study of the Aging Male (ISSAM) therefore felt it was a good time to review the current situation by publishing a series of practical and official guidelines concerning the diagnosis, treatment and monitoring of late-onset hypogonadism in males. The aim of this study is to present the French translation of these recent international guidelines, and to comment on them.

Aging↗

Medicare program; hospital outpatient prospective payment system; payment reform for calendar year 2004. Interim final rule with comment period.

This interim final rule with comment period implements provisions of the Medicare Prescription Drug, Improvement, and Modernization Act (DIMA) of 2003 that affect the Medicare outpatient prospective payment system (OPPS) that become effective January 1, 2004. Sections 303 and 621 of the DIMA include provisions that alter the methods for drug payment in hospital outpatient departments, some of which become effective January 1, 2004. These provisions affect the methodology for paying for pass-through and non-pass-through drugs under the OPPS. Further, the new law includes a requirement that all brachytherapy sources be paid separately. Section 411 of the DIMA reinstates the hold-harmless protection for small rural hospitals with fewer than 100 beds and extends that protection to sole community hospitals in rural areas.

Economics, Hospital↗

Medicare program; manufacturer submission of manufacturer's average sales price (ASP) data for Medicare Part B drugs and biologicals. Interim final rule with comment period.

This interim final rule with comment period will implement the provisions of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) related to the calculation and submission of manufacturer's average sales price (ASP) data on certain Medicare Part B drugs and biologicals to CMS by manufacturers.

Drug Costs↗

[Comment on main species of herba epimedii].

OBJECTIVE: To comment on main resource species of Herba Epimedii. METHOD: Taxonomy, resource investigation and quality evaluation of flavonoid contents were made. RESULT: 7 species of Herba Epimedii having broad distribution were summarized. According the area of their distribution, they were named Epimedium sagittatum, E. brevicornu, E. acuminatum, E. koreanum, E. pubescens, E. leptorrhizum and E. wushanense. Each distribution in detail and icariin and likewise compounds contents of these 7 species were provided. Other 8 Epimedium species much used were proposed. Medicinal characters 15 species were provided in this paper. CONCLUSION: On the basis of distribution character, resource quantity and growing with other species mingled, it is suggested that 4 main production or purchasing districts in China be divided. The most important district is northeastern district, where only E. koreanum grows there, with the best guality. Northwestern and northern district is the second one, where E. brevicornu, mainly grows with much stable guality. Then it is eastern and southern district, where E. sagittatum grows with the largest quantity but unstable quality. Southwestern district is the last one, mingle species complex and identification important. In Sichuan province, E. acuminatum and E. pubescens are main species, with other 12 species growing there. In Guizhou province, E. acuminatum, E. leptorrhizum and E. wushanense are main species, other 7 species growing there and E. leptorrhizum with poor quality. It is suggested that E. acuminatum be recorded in Chinese Pharmacopoeia.

China↗

Aplatophis zorro, a new species of eastern Pacific snake-eel, with comments on New World ophichthid distributions (Anguilliformes: Ophichthidae).

Aplatophis zorro n. sp., the first known eastern Pacific species of this New World genus, is described from a shallow water trawl-caught specimen from the Golfo de San Miguel, Pacific Panama. It is similar to its only known congener, A. chauliodus from the tropical western Atlantic, but differs in its vertebral number, dentition, coloration, and other characters. Comments concerning the distribution of New World ophichthids are provided.

Animals↗

[New artificial blood: sensation without any sensation (comments to the article in the journal New Scientist of 13 March, 2004)].

In the article of Sylvia P. Westphal "New artificial blood shows promise" the sensational, at first sight, contention is adduced that numerous researchers engaged in the development of artificial blood substituents have many years followed the false pathway and did not understand the mechanisms of action of gas-transporting blood substituents, and now this understanding is available. In the paper being commented, the author gives three criteria that gas-transporting blood substituents must meet. The statement that the developers of gas-transporting blood substituents were unaware of these criteria is, in our opinion, questionable. We have known and have taken them into account development of the Russian gas-transporting blood substituent perftoran.

Blood Substitutes↗

Medicare program; revisions to payment policies under the physician fee schedule for calendar year 2005. Final rule with comment period.

This final rule refines the resource-based practice expense relative value units (RVUs) and makes other changes to Medicare Part B payment policy. These policy changes concern: supplemental survey data for practice expense; updated geographic practice cost indices for physician work and practice expense; updated malpractice RVUs; revised requirements for supervision of therapy assistants; revised payment rules for low osmolar contrast media; changes to payment policies for physicians and practitioners managing dialysis patients; clarification of care plan oversight requirements; revised requirements for supervision of diagnostic psychological testing services; clarifications to the policies affecting therapy services; revised requirements for assignment of Medicare claims; addition to the list of telehealth services; and, several coding issues. We are making these changes to ensure that our payment systems are updated to reflect changes in medical practice and the relative value of services. This final rule also addresses the following provisions of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (Pub. L. 108-17) (MMA): coverage of an initial preventive physical examination; coverage of cardiovascular (CV) screening blood tests; coverage of diabetes screening tests; incentive payment improvements for physicians in shortage areas; payment for covered outpatient drugs and biologicals; payment for renal dialysis services; coverage of routine costs associated with certain clinical trials of category A devices as defined by the Food and Drug Administration; hospice consultation service; indexing the Part B deductible to inflation; extension of coverage of intravenous immune globulin (IVIG) for the treatment in the home of primary immune deficiency diseases; revisions to reassignment provisions; and, payment for diagnostic mammograms, physicians' services associated with drug administration services and coverage of religious nonmedical health care institution items and services to the beneficiary's home. In addition, this rule updates the codes subject to the physician self-referral prohibition, discusses payment for set-up of portable x-ray equipment, discusses the third five-year refinement of work RVUs, and solicits comments on potentially misvalued work RVUs. We are also finalizing the calendar year (CY) 2004 interim RVUs and are issuing interim RVUs for new and revised procedure codes for CY 2005. As required by the statute, we are announcing that the physician fee schedule update for CY 2005 is 1.5 percent, the initial estimate for the sustainable growth rate for CY 2005 is 4.3, and the conversion factor for CY 2005 is $37.8975.

Centers for Medicare and Medicaid Services, U.S.↗

[The effectiveness of health promotion in France: comments from a round table of French experts].

In order to comment on the situation in France, a panel of six experts originating from the academic, the governmental and the service providing worlds responded to two questions, in a format that left room for significant interaction with the participants. The first question was: According to your own experience, please identify one health promotion or health education initiative that you consider effective. The second: If there was one priority to address in relation to the issue of health promotion effectiveness in France, what would that be? This paper summarises the key elements of the experts' answers to each question.

France↗

Medicare program: changes to the Medicare claims appeal procedures. Interim final rule with comment period.

Medicare beneficiaries and, under certain circumstances, providers and suppliers of health care services, can appeal adverse determinations regarding claims for benefits under Medicare Part A and Part B under sections 1869 and 1879 of the Social Security Act (the Act). Section 521 of the Medicare, Medicaid, and SCHIP Benefits Act of 2000 (BIPA) amended section 1869 of the Act to provide for significant changes to the Medicare claims appeal procedures. This interim final rule responds to comments on the November 15, 2002 proposed rule regarding changes to these appeal procedures, establishes the implementing regulations, and explains how the new procedures will be implemented. It also sets forth provisions that are needed to implement the new statutory requirements enacted in Title IX of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA).

Child↗

Civilian Health and Medical Program of the Uniformed Services (CHAMPUS); TRICARE Reserve Select for certain members of the selected reserve; Transitional Assistance Management Program; early eligibility for TRICARE for certain reserve component members. Interim final rule with comment period.

This interim final rule establishes requirements and procedures for implementation of TRICARE Reserve Select. It also revises requirements and procedures for the Transitional Assistance Management Program. In addition, it establishes requirements and procedures for implementation of the earlier TRICARE eligibility for certain reserve component members. The rule is being published as an interim final rule with comment period in order to comply with statutory effective dates.

Eligibility Determination↗

Proposed amendments to medical marijuana regulations released for comment.

On 23 October 2004, Health Canada released proposed amendments to the Marihuana Medical Access Regulations (MMAR) for public comment. The amendments are intended to respond to consumer concerns about the onerous bureaucratic requirements for obtaining legal permission to possess and cultivate marijuana for medical purposes, and to address the need for a safe, reliable, legal source of medical marijuana. Under the proposed amendments, police forces throughout Canada will be able to access limited information about people authorized to possess marijuana, people licensed to produce marijuana, and legal grow operations.

Canada↗

Correlation and causation: a comment.

Some purely methodological comments are made on the pitfalls and difficulties in making causal inferences from observational data, including in studies of disparity in medicine. The ideas of spurious correlation and measurement error are discussed with an eye towards their impact upon inferences about causality, and cautions are offered about over-reliance upon testing hypotheses.

Bias↗

Human cells, tissues, and cellular and tissue-based products; donor screening and testing, and related labeling. Interim final rule; opportunity for public comment.

The Food and Drug Administration (FDA) is issuing an interim final rule to amend certain regulations regarding the screening and testing of donors of human cells, tissues, and cellular and tissue-based products (HCT/Ps), and related labeling. FDA is taking this action in response to comments from affected interested persons regarding the impracticability of complying with certain regulations as they affect particular HCT/Ps.

Biological Products↗

Medicare program; competitive acquisition of outpatient drugs and biologicals under Part B. Interim final rule with comment period.

This interim final rule with comment period implements provisions of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 that require the implementation of a competitive acquisition program for certain Medicare Part B drugs not paid on a cost or prospective payment system basis. Beginning January 1, 2006, physicians will generally be given a choice between obtaining these drugs from vendors selected through a competitive bidding process or directly purchasing these drugs and being paid under the average sales price system.

Biological Products↗