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Medicare program; improvement to the Medicare+Choice appeal and grievance procedures. Final rule with comment period.

This final rule with comment period responds to comments on the January 24, 2001, proposed rule regarding improvements to the Medicare+Choice (M+C) appeal and grievance procedures. It establishes new notice and appeal procedures for enrollees when an M+C organization decides to terminate coverage of provider services. The January 24, 2001 proposed rule was published as a required element of an agreement entered into between the parties in Grijalva v. Shalala, civ. 93-711 (U.S.D.C. Az.), to settle a class action lawsuit. This rule also specifies a Medicare-participating hospital's responsibility for issuing discharge or termination notices under both the original Medicare and M+C programs, amends the Medicare provider agreement regulations with regard to beneficiary notification requirements, and amends M+C enrollee grievance procedures.

Humans↗

Medicaid program; time limitation on price recalculations and recordkeeping requirements under the drug rebate program. Final rule with comment period.

On September 19, 1995, we published a proposed rule in the Federal Register that introduced requirements for States and manufacturers pertaining to the Medicaid drug rebate program. We received several comments from States and manufacturers regarding recordkeeping requirements and drug price recalculations. This final rule with comment period finalizes separately, in an accelerated timeframe, two specific provisions of the September 1995 proposed rule. It establishes new recordkeeping requirements for drug manufacturers under the Medicaid drug rebate program. It also sets forth a 3-year time limitation during which manufacturers must report changes to average manufacturer price and best price for purposes of reporting data to us. In addition, it announces the pressing need for codification of fundamental recordkeeping requirements. Furthermore, it announces our intention to continue to work on finalizing the complete drug rebate regulation for the Medicaid drug rebate program.

Drug Costs↗

Medicare program, changes to the hospital outpatient prospective payment system and calendar year 2004 payment rates. Final rule with comment period.

This final rule with comment period revises the Medicare hospital outpatient prospective payment system to implement applicable statutory requirements and changes arising from our continuing experience with this system. In addition, it describes changes to the amounts and factors used to determine the payment rates for Medicare hospital outpatient services paid under the prospective payment system. These changes are applicable to services furnished on or after January 1, 2004. Finally, this rule responds to public comments received on the August 12, 2003 proposed rule for revisions to the hospital outpatient prospective payment system and payment rates (68 FR 47966).

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

Medicare program; expedited determination procedures for provider service terminations. Final rule with comment period.

This final rule with comment period responds to comments on one discrete aspect of the proposed rule published in the Federal Register on November 15, 2002. The portion of that proposed rule addressed here involves the expedited determination and reconsideration procedures available to beneficiaries when a provider informs them of a decision that Medicare coverage of their provider services is about to end.

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

Medicare and Medicaid programs; fire safety requirements for certain health care facilities; amendment. Interim final rule with comment period.

This interim final rule with comment period adopts the substance of the April 15, 2004 temporary interim amendment (TIA) 00-1 (101), Alcohol Based Hand Rub Solutions, an amendment to the 2000 edition of the Life Safety Code, published by the National Fire Protection Association (NFPA). This amendment will allow certain health care facilities to place alcohol-based hand rub dispensers in egress corridors under specified conditions. This interim final rule with comment period also requires that nursing facilities install smoke detectors in resident rooms and public areas if they do not have a sprinkler system installed throughout the facility or a hard-wired smoke detection system in those areas.

Alcohols↗

Medicare program; update of ambulatory surgical center list of covered procedures. Interim final rule with comment period.

This interim final rule with comment period revises the list of procedures that are covered when furnished in an ambulatory surgery center (ASC) in accordance with section 1833(i)(1) of the Social Security Act. We published our proposed deletions and additions in the Federal Register on November 26, 2004. In this interim final rule, we respond to public comments and make final additions to and deletions from the current list of Medicare approved ambulatory surgical center (ASC) procedures.

Ambulatory Surgical Procedures↗

Medicare program; electronic submission of cost reports: revision to effective date of cost reporting period. Interim final rule with comment period.

This interim final rule with comment period revises the existing effective date by which all organ procurement organizations (OPOs), rural health clinics (RHCs), Federally qualified health centers (FQHCs), and community mental health centers (CMHCs) are required to submit their Medicare cost reports in a standardized electronic format from cost reporting periods ending on or after December 31, 2004 to cost reporting periods ending on or after March 31, 2005. This interim final rule with comment does not affect the current cost reporting requirement for hospices and end-stage renal disease (ESRD) facilities. Hospices and ESRD facilities are required to continue to submit cost reports under the Medicare regulations in a standardized electronic format for cost reporting periods ending on or after December 31, 2004.

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

Case comment: Moore v. Regents of the University of California.

The increasing use of human tissues in medical research has spawned a host of ethical and legal debates. Legal analysis in this area has almost exclusively focused on the question of property rights in both the tissues used in research and in the resulting products. One illustrative case is Moore v. Regents of the University of California, in which a patient sued his doctor for conversion of his spleen which had been removed for therapeutic purposes. The doctor later used the spleen to develop a patented and profitable cell-line. This Comment examines and rejects the property law approach to this issue. Instead, this Comment proposes two legislative changes which would 1) eliminate any trade in human tissues and 2) require doctors to inform their patients of any research interest in proposed medical procedures. These proposals resolve the problem presented in Moore, and avoid the misleading, and inevitably unanswerable, question of property rights.

Humans↗

Medicare program; identification of backward compatible version of adopted standard for e-prescribing and the Medicare prescription drug program (version 8.1). Interim final rule with comment period.

This interim final rule with comment period identifies the Prescriber/Pharmacist Interface SCRIPT Standard, Implementation Guide, Version 8.1 (hereafter referred to as "Version 8.1 of the National Council for Prescription Drug Programs (NCPDP) SCRIPT Standard") as a backward compatible update of the adopted Version 5.0. This interim final rule with comment period also permits the voluntary use of Version 8.1 of the NCPDP SCRIPT Standard for conducting certain e-prescribing transactions for the electronic prescription drug program under Title I of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA).

Humans↗

Medicare program; rural health clinics: amendments to participation requirements and payment provisions; and establishment of a quality assessment and performance improvement program; suspension of effectiveness. Interim final rule with comment period; partial suspension of effectiveness.

This interim final rule with comment period revises the rural health clinic (RHC) regulations to revert to those provisions set forth in regulations before publication of the December 24, 2003 RHC final rule. That final rule implemented certain provisions of the Balanced Budget Act (BBA) of 1997 to establish a process and criteria for disqualifying from the RHC program clinics that no longer meet basic location requirements (rural and medically underserved), and to require RHCs to establish quality assessment and performance improvement programs. That rule also prohibited "commingling" (the use of the space, professional staff, equipment, and other resources) of an RHC with another entity. [In addition, it addressed comments on the February 28, 2000 proposed rule. Since the publication of the RHC final rule exceeded the 3-year timeline for finalizing proposed rules set by the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, we are suspending the effectiveness of the current provisions by removing the RHC provisions set forth in the December 2003 final rule and reverting to those RHC provisions previously in effect.] We intend to reissue new proposed and final RHC rules to reinstate the current provisions. However, these revisions do not impact the effectiveness of the self-implementing provisions of the BBA or any provisions we had previously implemented or enforced through program memoranda.

Ambulatory Care Facilities↗

Medicare program; revisions to payment policies, five-year review of work relative value units, changes to the practice expense methodology under the physician fee schedule, and other changes to payment under part B; revisions to the payment policies of ambulance services under the fee schedule for ambulance services; and ambulance inflation factor update for CY 2007. Final rule with comment period.

This final rule with comment period addresses certain provisions of the Deficit Reduction Act of 2005, as well as making other changes to Medicare Part B payment policy. These changes are intended to ensure that our payment systems are updated to reflect changes in medical practice and the relative value of services. This final rule with comment period also discusses geographic practice cost indices (GPCI) changes; requests for additions to the list of telehealth services; payment for covered outpatient drugs and biologicals; payment for renal dialysis services; policies related to private contracts and opt-out; policies related to bone mass measurement (BMM) services, independent diagnostic testing facilities (IDTFs), the physician self-referral prohibition; laboratory billing for the technical component (TC) of physician pathology services; the clinical laboratory fee schedule; certification of advanced practice nurses; health information technology, the health care information transparency initiative; updates the list of certain services subject to the physician self-referral prohibitions, finalizes ASP reporting requirements, and codifies Medicare's longstanding policy that payment of bad debts associated with services paid under a fee schedule/charge-based system are not allowable. We are also finalizing the calendar year (CY) 2006 interim RVUs and are issuing interim RVUs for new and revised procedure codes for CY 2007. In addition, this rule includes revisions to payment policies under the fee schedule for ambulance services and the ambulance inflation factor update for CY 2007. As required by the statute, we are announcing that the physician fee schedule update for CY 2007 is -5.0 percent, the initial estimate for the sustainable growth rate for CY 2007 is 2.0 percent and the CF for CY 2007 is $35.9848.

Fee Schedules↗

Comment on Kartell v. Blue Shield of Massachusetts, Inc.: an antitrust analysis of Blue Shield's reimbursement schemes.

In Kartell v. Blue Shield of Massachusetts, Inc., the First Circuit held that Blue Shield's reimbursement practice known as the "ban on balance billing" did not constitute an unlawful restraint of trade in violation of the antitrust laws. Underlying the First Circuit's decision was deference to what it viewed as efforts by Blue Shield and by the Commonwealth to promote cost containment. This Comment argues that, to the contrary, under an appropriate analysis of antitrust law, the practices employed by Blue Shield did constitute unreasonable restraints of trade on the physicians' service industry in Massachusetts, given Blue Shield's market dominance in the Commonwealth. The Comment also argues that such inhibition of the competitive functioning of this industry is unwise, and that costs should instead be contained by effectuating the antitrust laws and encouraging the development of competitive forces within this industry.

Blue Cross Blue Shield Insurance Plans↗

The value of microscopic features in the examination of human head hairs: analysis of comments contained in questionnaire returns.

Comments received in response to a questionnaire seeking opinion about hair examination have been considered. The questionnaire was in two parts: the first was concerned with the description of microscopic features and the second with the use of numerical features and data sheets in hair examinations. The same format is used to present a synopsis of the many individual comments and suggestions contained in questionnaire returns. It is argued that a hair examination form can contribute to more effective hair examinations although not replacing direct side-by-side comparisons. A hair examination form is presented with recommendations for its use.

Forensic Medicine↗

[Good practices of publication of clinical cases of pharmacovigilance: comments, Groupe de Travail sur les Bonnes Pratiques de Publication de Cliniques en Pharmacovigilance: commentary].

This paper introduces some comments on the complete text of Good Pharmacovigilance Publishing Practices, which forms appendix number 2 of the Good Pharmacovigilance Practices now published by the French Drug Agency, as was Good Clinical Practices. Each good practice is printed in italic and presented in a frame; the following comments are designed to facilitate its application. The technical terms that are used in this text are presented according to the glossary in Good Pharmacovigilance Practices.

Adverse Drug Reaction Reporting Systems↗

Antiscientific attitudes within psychotherapy: concluding comments.

In all of the articles of this special section (Beutler & Harwood, Erwin, Jopling, and Spence), the authors express their commitment to a conventional view of truth and objectivity, a view which serves as a precondition for their commitment to a true science of psychotherapy. In my concluding comments, I first describe the particular focus of each author's concerns about current standards of truth and objectivity in the field. I then anticipate the ways in which their arguments might be challenged by those who now challenge the possibility of truth and objectivity (in any conventional sense) within psychotherapy, or, more broadly, within the human sciences, or, more radically, within the physical sciences.

Attitude↗

Maintaining psychology's scientific and professional credibility and ethical responsibility to self-regulate: a comment on "validations" of mental health assessment instruments.

Recent growth of "managed" mental health care in the United States has spawned huge demand for products that draw on one of psychology's most well developed subdisciplines, tests and measurement. The commercial potential of mental health assessment instruments intended for widespread use, to meet what Kraus, Seligman, and Jordan (this volume) describe as "an industry-wide surge in outcome evaluations in naturalistic ... settings," necessarily raises conflict of interest dilemmas for those who develop and market them. The American Psychological Association has devoted intensive effort to the preceding issue as it pertains to other aspects of the science and practice of clinical psychology. Comparable attention has not been focused recently on the development and marketing of assessment instruments. This Comment highlights the issue and suggests types of self-regulatory actions that might be taken, e.g., requiring and publishing full disclosure statements of authors' relationships to companies that market instruments like the Treatment Outcome Package in psychometric articles in which they are evaluated.

Conflict of Interest↗

Orthographic analogies and phonological priming: a comment on Bowey, Vaughan, and Hansen (1998)

J. A. Bowey, L. Vaughan, and J. Hansen (1998, Journal of Experimental Child Psychology, 68, 108-133) carried out two experiments on 6- and 7-year-old children's use of orthographic analogies in word reading. They reported that, following apparently stringent controls for phonological priming effects, beginning analogies (beak-bean) were more frequent in this age group than rime (beak-peak) analogies. From this, they concluded that beginning readers do not reliably use orthographic rimes in reading, even in the clue word task (p. 129). However, the clue word task was not used in this study. This comment highlights two problems with Bowey et al.'s paper. The first is a theoretical one, and the second is methodological. Firstly, Bowey et al. base their investigation on a misunderstanding of U. Goswami and P. E. Bryant's (1990, Phonological skills and learning to read, Hillsdale, NJ: Erlbaum) claims about the role of rhyme and analogy in beginning reading. Secondly, methodological weaknesses, in particular unintended intralist priming effects, seriously limit the conclusions that can be drawn from Bowey et al.'s booklet analogy task.

Association↗