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Medicare and Medicaid programs; requirements for physician incentive plans in prepaid health care organizations--HCFA. Final rule correction; notice of changes in compliance dates, with comment period.

In the March 27, 1996, issue of the Federal Register, we published, at 61 FR 13430, a final rule with comment period that implements requirements in sections 4204(a) and 4731 of the Omnibus Budget Reconciliation Act of 1990 that concern physician incentive plans. In the preamble of that rule, we set forth dates by which prepaid health plans had to comply with certain of the rule's provisions. This document clarifies and changes some of those deadlines, and provides an opportunity for public comments on them. It does not otherwise change the requirements set forth in the rule. In addition this document corrects the March 27 rule's inadvertent reversal of the nomenclature change made by a previous final rule.

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

Solicitation of comments on the OIG/HCFA Special Advisory Bulletin on the patient anti-dumping statute--OIG and HCFA. Notice of proposed special advisory bulletin.

This Federal Register notice seeks the input and comments of interested parties on a Special Advisory Bulletin being developed by the OIG and HCFA designed to address requirements of the patient anti-dumping statute and the obligations of hospitals to screen all patients seeking emergency services and provide stabilizing medical treatment to enrollees of managed care plans if their condition warrants it. In developing this proposed issuance and soliciting public comment, it is our goal to provide clear and meaningful advice with regard to the application of the anti-dumping provisions, and ensure greater public awareness of the hospitals' obligations in providing emergency medical services to those individuals insured by managed care plans.

Awareness↗

Health Care Financing Administration: Medicare Program; collection of unpaid Medicare premiums. Final rule with comment period.

This regulation specifies (1) the conditions under with HCFA will cease collection action on unpaid hospital insurance and supplementary medical insurance premiums; and (2) when collection action will be renewed. We are also clarifying the provision that specifies the sources from which we recover unpaid premiums. Under the regulations we will stop collection efforts when: 1 An individual, who is no longer entitled to a civil service annuity or to benefits under Title II or Title XVIII (Medicare) of the Social Security Act or the Railroad Retirement Act, is unable to make payment: 2. An individual's estate is unable to make payment; or 3. The cost of the collection activity is likely to exceed the amount to be recovered. (If an individual against whom collection activity has ceased later becomes entitled to benefits, HCFA will renew collection activity.) Ceasing collection activity in these cases will enable us to reduce the costs of billing and records maintenance. We are issuing these regulations as a final rule because they are technical regulations that authorize an internal operating procedure to clear our records. The regulations will not adversely affect any person or organization. Accordingly, we find good cause to waive the notice of proposed rulemaking. However, we are providing a comment period and will make any further revisions we find necessary based on comments we receive.

Medicare↗

Medicaid program; plans of correction for intermediate care facilities for the mentally retarded--Health Care Financing Administration. Final rule with comment period.

This regulation amends 42 CFR 442.115 to authorize a State survey agency, in specified circumstances to certify an intermediate care facility for the mentally retarded for participation in the Medicaid program when the facility has not met the July 18, 1980 compliance deadline provided in 42 CFR 442.115(a). The regulation would permit plans to correct certain deficiencies by July 18, 1982 based on the length of time needed to complete the plan. It would also allow extensions beyond either the 1980 or 1982 deadline where, under limited circumstances a delay has been caused by litigation. We are publishing this regulation as a final rule because of the need to protect facilities from disruption of Federal funding where the criteria for an extension of the deadline are satisfied, including the assurance that the health and safety of the residents will not be jeopardized by the granting of an extension. However, we are providing a comment period and will make any further revisions we find necessary based upon comments we receive.

Certification↗

Medicare program; payment for physician services furnished in hospitals, skilled nursing facilities, and comprehensive outpatient rehabilitation facilities--Health Care Financing Administration. Final rule with comment period.

These rules revise the regulations that govern Medicare coverage and reimbursement for services of physicians who practice in providers such as hospitals, skilled nursing facilities (SNFs), and comprehensive outpatient rehabilitation facilities (CORFs). The regulations incorporate our decisions on the proposed rules published October 1, 1982 (47 FR 43578), based on public comments and our analysis of those comments and the issues they raised. The regulations set forth basic criteria for distinguishing physician services reimbursable on a reasonable charge basis from physician services reimbursable only on a reasonable cost basis, establish how the amounts reimbursed will be determined on both charge and cost bases, set limits on the amounts reimbursable on a reasonable cost basis to providers for physician services, and establish more specific criteria for determining the basis and amount of payment for the services of anesthesiologists, radiologists, and pathologists.

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

Medicare and Medicaid; requirements for long term care facilities--HCFA. Final rule with comment period.

These final regulations with comment period revise and consolidate the requirements that facilities furnishing long term care are required to meet to participate in both the Medicare and Medicaid programs. They contain revisions to our proposal of October 16, 1987 (52 FR 38582) based on comments submitted by the public. Long term care facilities include both skilled nursing facilities (SNFs) and intermediate care facilities (ICFs) and, as of October 1, 1990, nursing facilities (NF) created by the Omnibus Budget Reconciliation Act of 1987 (OBRA '87). Under these regulations, one set of requirements replaces the existing separate ones for SNFs participating in the Medicare program, and for SNFs and ICFs participating in the Medicare program. (After October 1, 1990, SNFs, and ICFs participating in the Medicaid program will be known as nursing facilities (NFs).) Although some essential distinctions imposed by the statute remain, these new requirements reflect common needs in SNFs and ICFs. These regulations do not apply to ICFs for the mentally retarded or persons with related conditions.

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

Health Care Financing Administration--Medicaid program; payments for long-term care facility services. Final rule with request for additional comments.

This final rule amends the regulation limiting Medicaid payments for long-term care facility services. Under the current regulations, Medicaid payments for skilled nursing facility (SNF) and intermediate care facility (ICF) services are subject to cost limits published under 42 CFR 405.460. On August 31, 1979, we published a schedule of limits on adjusted SNF inpatient routine service costs (44 FR 51542). Those limits apply to Medicare and Medicaid payments made under State plans that do not use the same payment method as Medicare. We are amending the current regulations to remove the requirement that Medicaid payments for SNF and ICF services be subject to the cost limits published under 405.460. We also are requesting additional comments on whether Medicaid payments for SNF and ICF services should be subject to those limits, to limits developed on a State-byState basis, or to limits derived by some other method. After we have analyzed the comments we receive, we will publish a notice that sets forth our position on this issue.

Insurance, Health↗

Conditions for the use of methadone; intent to propose revisions to regulations and request for comments.

The Food and Drug Administration (FDA) and the National Institute on Drug Abuse (NIDA) are requesting comments on: (1) Whether to make the methadone regulations concerning narcotic addiction more flexible to accommodate more readily changes in medical practice while at the same time providing quality care and protecting against illicit diversion; and (2) whether to revise or eliminate the recordkeeping, reporting, and other requirements that may be unnecessary and/or overly burdensome as a result of changes in the state-of-the-art. The agencies will use information received in comments to determine appropriate changes to the methadone regulations. This action is the result of a retrospective review of the methadone regulations as required by law and by directive of the Office of Management and Budget.

Drug and Narcotic Control↗

Establishment registration and listing for manufacturers of human cellular and tissue-based products--FDA. Proposed rule; reopening of comment period.

The Food and Drug Administration (FDA) is reopening the comment period for the proposed rule concerning establishment registration and listing for manufacturers of human cellular and tissue-based products that was published in the Federal Register of May 14, 1998 (63 FR 26744). FDA is taking this action in response to a request for an extension and to allow interested parties additional time for review and to submit comments.

Cell Transplantation↗

Medicare program; limited additional opportunity to request certain hospital wage data revisions for FY 1999--HCFA. Final rule with comment period.

This final rule with comment period provides hospitals with a limited additional opportunity to request certain revisions to their wage data used to calculate the FY 1999 hospital wage index. In addition, it explains the criteria that must be met to request a revision, the types of revisions that will be considered, the procedures for requesting a revision, the implementation of wage index revisions, and other related issues. Requests for wage data revisions must be received by the date and time specified in the "DATES" section of this preamble. We will implement revisions to the hospital wage index in accordance with this final rule with comment period on a prospective basis only.

Abstracting and Indexing↗

Medicare program; revisions to payment policies under the physician fee schedule for calendar year 2000. Health Care Financing Administration (HCFA), HHS. Final rule with comment period.

This final rule makes several changes affecting Medicare Part B payment. The changes include: implementation of resource-based malpractice insurance relative value units (RVUs); refinement of resource-based practice expense RVUs; payment for physician pathology and independent laboratory services; discontinuous anesthesia time; diagnostic tests; prostate screening; use of CPT modifier -25; qualifications for nurse practitioners; an increase in the work RVUs for pediatric services; adjustments to the practice expense RVUs for physician interpretation of Pap smears; and revisions to the work RVUs for new and revised CPT codes for calendar year 1999 and a number of other changes relating to coding and payment. Furthermore, we are finalizing the 1999 interim physician work RVUs and are issuing interim RVUs for new and revised codes for 2000. This final rule solicits public comments on the second 5-year refinement of work RVUs for services furnished beginning January 1, 2002 and requests public comments on potentially misvalued work RVUs for all services in the CY 2000 physician fee schedule. This final rule also conforms the regulations to existing law and policy regarding: removal of the x-ray as a prerequisite for chiropractic manipulation; the exclusion of payment for assisted suicide; and optometrist services. This final rule also announces the calendar year 2000 Medicare physician fee schedule conversion factor under the Medicare Supplementary Insurance (Part B) program as required by section 1848(d) of the Social Security Act. The 2000 Medicare physician fee schedule conversion factor is $36.6137.

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

Human drugs and biologics; determination that informed consent is NOT feasible or is contrary to the best interests of recipients; revocation of 1990 interim final rule; establishment of new interim final rule. Food and Drug Administration, HHS. Interim final rule; opportunity for public comment.

The Food and Drug Administration (FDA) is revoking its 1990 interim final regulations that permitted the Commissioner of Food and Drugs (the Commissioner) to determine that obtaining informed consent from military personnel for the use of an investigational drug or biologic is not feasible in certain situations related to military combat. FDA also is issuing a new interim final rule addressing waiver of informed consent in military operations. FDA is taking these actions based on its analysis and consideration of all relevant facts, including its evaluation of the Department of Defense's (DOD) experience during the Persian Gulf War, its evaluation of the comments received by the agency in response to the agency's July 31, 1997, request for comments on whether the agency should revise or revoke the interim regulations, and the enactment of the Strom Thurmond National Defense Authorization Act for Fiscal Year 1999 (the Defense Authorization Act). Under the Defense Authorization Act, the President is authorized to waive the Federal Food, Drug, and Cosmetic Act's (the act) informed consent requirements in military operations if the President finds that obtaining consent is infeasible or contrary to the best interests of recipients and on an additional ground that obtaining consent is contrary to national security interests. In light of the enactment of the Defense Authorization Act, with an immediate effective date, and because the President could be called upon to make a waiver determination for military personnel engaged in a specific military operation at any time, the agency believes that it is critical to have in place adequate criteria and standards for the President to apply in making an informed consent waiver determination. Therefore, FDA is issuing a new interim final regulation with an immediate effective date to establish criteria and standards for the President to apply in making a determination that informed consent is not feasible or is contrary to the best interests of the individual recipients.

Drugs, Investigational↗

State child health; revisions to the regulations implementing the State Children's Health Insurance Program. Interim final rule with comment period; revisions, delay of effective date, and technical amendments to final rule.

Title XXI authorizes the State Children's Health Insurance Program (SCHIP) to assist State efforts to initiate and expand the provision of child health assistance to uninsured, low-income children. On January 11, 2001 we published a final rule in the Federal Register to implement SCHIP that has not gone into effect. This interim final rule further delays the effective date, revises certain provisions and solicits public comment, and makes technical corrections and clarifications to the January 2001 final rule based on further review of the comments received and applicable law. Only the provisions set forth in this document have changed. All other provisions set forth in the January 2001 final rule will be implemented without change.

Child↗

Disaster unemployment assistance program. Interim final rule; request for comments.

The Employment and Training Administration (ETA) of the Department of Labor (Department) is issuing this interim final rule, effective upon publication, to clarify eligibility for disaster unemployment assistance (DUA) in the wake of the major disasters declared as a result of the terrorist attacks of September 11, 2001. To provide an opportunity for public participation in this emergency rulemaking, this interim final rule includes a post-publication comment period. The Department will publish a final rule after taking into account any comments that are received.

Disasters↗

Registration and reregistration application fees. Final rule; remanded for further notice and comment.

On October 6, 1992, Congress passed the Departments of Commerce, Justice, and State, the Judiciary, and Related Agencies Appropriations Act of 1993, Pub. L. No. 102-395, 106 Stat. 1828 (1992) (codified at 21 U.S.C. 886a) (Act). In section 886a(3) of this Act, Congress directed that "fees charged by the DEA under its Diversion Control Program (DCP) shall be set at a level that ensures the recovery of the full costs of operating the various aspects of the (diversion control) program." On December 18, 1992, DEA published its proposal to adjust the existing registration fee schedule. 57 FR 60,148. After notice and comment, DEA published a Final Rule on March 22, 1993, setting the new registration fees. 58 FR 15,272. Following publication of the final rule, a complaint was filed by the American Medical Association (AMA) and others in the United States District Court for the District of Columbia. On July 5, 1994, the district court issued its final order granting the government's motion for summary judgment, and thus disposed of all claims with respect to all parties. American Medical Association v. Reno, 857 F. Supp. 80 (D.D.C. 1994). The AMA appealed. On June 27, 1995, the United States Court of Appeals for the District of Columbia Circuit issued its decision holding that DEA's rulemaking was inadequate and that the rule must be remanded, without being vacated, to the DEA for further proceedings in which DEA provides both an opportunity for meaningful notice and comment on, and an explanation of, the components of the diversion control program. 57 F.3d 1129 (D.C. Cir. 1995) On August 29, 1995, the United States Court of Appeals for the District of Columbia Circuit remanded this action to the district court with instructions. On November 22, 1995, the District Court remanded the matter to DEA for proceedings consistent with the opinion of the United States Court of Appeals for the District of Columbia Circuit. This document responds to that requirement and provides a description of the components of the fee-funded diversion control program.

Drug and Narcotic Control↗

Medicare program; revisions to payment policies under the physician fee schedule for calendar year 2003 and inclusion of registered nurses in the personnel provision of the critical access hospital emergency services requirement for frontier areas and remote locations. Final rule with comment period.

This final rule with comment period refines the resource-based practice expense relative value units (RVUs) and makes other changes to Medicare Part B payment policy. In addition, as required by statute, we are announcing the physician fee schedule update for CY 2003. The update to the physician fee schedule occurs as a result of a calculation methodology specified by law. That law required the Department to set annual updates based in part on estimates of several factors. Although subsequent after-the-fact data indicate that actual increases were different to some degree from earlier estimates, the law does not permit those estimates to be revised. A subsequent law required estimates to be revised for FY 2000 and beyond. Although we have exhaustively examined opportunities for a different interpretation of law that would allow us to correct the flaw in the formula administratively, current law does not permit such an interpretation. Accordingly, without Congressional action to address the current legal framework, the Department is compelled to announce herein a physician fee schedule update for CY 2003 of -4.4 percent. Because the Department would adopt a change in the formula that determines the physician update if the law permitted it, we have examined how proper adjustments to past data could result in a positive update. The Department believes that revisions of estimates used to establish the sustainable growth rates (SGR) for fiscal years (FY) 1998 and 1999 and Medicare volume performance standards (MVPS) for 1990-1996 would, under present calculations, result in a positive update. The Department intends to work closely with Congress to develop legislation that could permit a positive update, and hopes that such legislation can be passed before the negative update takes effect. Because the Department wishes to change the update promptly in the event that Congress provides the Department legal authority to do so, we are requesting comments regarding how physician fee schedule rates could and should be recalculated prospectively in the event that Congress provides the Department with legal authority to revise estimates used to establish the sustainable growth rates (SGR) and for 1998 and 1999 and the NVPS for 1990-1996. The other policy changes concern: the pricing of the technical component for positron emission tomography (PET) scans, Medicare qualifications for clinical nurse specialists, a process to add or delete services to the definition of telehealth, the definition for ZZZ global periods, global period for surface radiation, and an endoscopic base for urology codes. In addition, this rule updates the codes subject to physician self-referral prohibitions. We are expanding the definition of a screening fecal-occult blood test and are modifying our regulations to expand coverage for additional colorectal cancer screening tests through our national coverage determination process. We also make revisions to the sustainable growth rate, the anesthesia conversion factor, and the work values for some gastroenterologic services. 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 clarifies the enrollment of physical and occupational therapists as therapists in private practice and clarifies the policy regarding services and supplies incident to a physician's professional services. In addition, this final rule discusses physical and occupational therapy payment caps and makes technical changes to the definition of outpatient rehabilitation services. In addition, we are finalizing the calendar year (CY) 2002 interim RVUs and are issuing interim RVUs for new and revised procedure codes for calendar year (CY) 2003. As required by the statute, we are announcing that the physician fee schedule update for CY 2003 is -4.4 percent, the initial estimate of the sustainable growth rate for CY 2003 is 7.6 percent, and the conversion factor for CY 2003 is $34.5920. This final rule will also allow registered nurses (RNs) to provide emergency care in certain critical access hospitals (CAHs) in frontier areas (an area with fewer than six residents per square mile) or remote locations (locations designated in a State's rural health plan that we have approved.) This policy applies if the State, following consultation with the State Boards of Medicine and Nursing, and in accordance with State law, requests that RNs be included, along with a doctor of medicine or osteopathy, a physician's assistant, or a nurse practitioner with training or experience in emergency care, as personnel authorized to provide emergency services in CAHs in frontier areas or remote locations.

Critical Care↗

Medicare program; update of ambulatory surgical center list of covered procedures effective July 1, 2003. Final rule with comment period.

This final rule with comment period will make additions to and deletions from the current list of Medicare approved ambulatory surgical center (ASCs) procedures. In addition, it responds to comments received on the June 12, 1998 proposed rule (63 FR 32290) that addressed proposed additions to and deletions from the list of ASC covered procedures. This rule also implements requirements of section 1833(i)(1) and (2) of the Social Security Act.

Ambulatory Care↗

Management of prenatal care information: integration of the problem list and clinical comments.

To improve the functionality of our MAternal Record System (MARS), we reviewed the clinical problems entered into the MARS database from approximately 2800 patient records and interviewed representative clinicians about their use of the Clinical Comments and Problem List sections of MARS. Problems were assigned a unique term that corrected for spelling, spacing, synonyms, and abbreviation variations. Analysis of these terms suggested design changes that would increase the number of unique entries into the Problem List, including (1) modifications in the automated problem entry functions within MARS and (2) integration of the Problem List and Clinical Comments sections.

Attitude of Health Personnel↗