MedWorm.com provides a medical RSS filtering service. Over 6000 RSS medical sources are combined and output via different filters. This feed contains the latest items from the 'Fed Regist' source. Wed, 08 Feb 2012 07:07:08 +0100 http://www.medworm.com/index.php?rid=5603863&cid=s_27980_4_f&fid=27980&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D22242232%26dopt%3DAbstract Authors: Abstract The Administration for Children and Families (ACF) is issuing this interim final rule to implement statutory provisions related to the Tribal title IV-E program. Effective October 1, 2009, section 479B(b) of the Social Security Act (the Act) authorizes direct Federal funding of Indian Tribes, Tribal organizations, and Tribal consortia that choose to operate a foster care, adoption assistance and, at Tribal option, a kinship guardianship assistance program under title IV-E of the Act. The Fostering Connections to Success and Increasing Adoptions Act of 2008 requires that ACF issue interim final regulations which address procedures to ensure that a transfer of responsibility for the placement and care of a child under a State title IV-E plan to a Tribal title IV-E... Fed Regist journals http://www.medworm.com/rss/comments.php?id=5603863 Fri, 06 Jan 2012 05:00:00 +0100 5603863 http://www.medworm.com/index.php?rid=5603864&cid=s_27980_4_f&fid=27980&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D22242229%26dopt%3DAbstract Authors: Abstract The Food and Drug Administration (FDA) is revising the labeling requirements for blood and blood components intended for use in transfusion or for further manufacture by combining, simplifying, and updating specific regulations applicable to labeling and circulars of information. These requirements will facilitate the use of a labeling system using machine-readable information that would be acceptable as a replacement for the ``ABC Codabar'' system for the labeling of blood and blood components. FDA is taking this action as a part of its efforts to comprehensively review and, as necessary, revise its regulations, policies, guidances, and procedures related to the regulation of blood and blood components. This final rule is intended to help ensure the continued s... Fed Regist journals http://www.medworm.com/rss/comments.php?id=5603864 Tue, 03 Jan 2012 05:00:00 +0100 5603864 http://www.medworm.com/index.php?rid=5603865&cid=s_27980_4_f&fid=27980&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D22242228%26dopt%3DAbstract Authors: Abstract The Food and Drug Administration (FDA) is amending the regulation classifying ovarian adnexal mass assessment score test systems to restrict these devices so that a prescribed warning statement that addresses a risk identified in the special controls guidance document must be in a black box and must appear in all labeling, advertising, and promotional material. The black box warning mitigates the risk to health associated with off-label use as a screening test, stand-alone diagnostic test, or as a test to determine whether or not to proceed with surgery. PMID: 22242228 [PubMed - in process] (Source: Fed Regist) Fed Regist journals http://www.medworm.com/rss/comments.php?id=5603865 Fri, 30 Dec 2011 05:00:00 +0100 5603865 http://www.medworm.com/index.php?rid=5603866&cid=s_27980_4_f&fid=27980&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D22242227%26dopt%3DAbstract Authors: Abstract The Department of Veterans Affairs (VA) is issuing this interim final rule to amend its adjudication regulation regarding compensation for disabilities suffered by veterans who served in the Southwest Asia Theater of Operations during the Persian Gulf War. This amendment is necessary to extend the period during which disabilities associated with undiagnosed illnesses and medically unexplained chronic multi-symptom illnesses must become manifest in order for a veteran to be eligible for compensation. PMID: 22242227 [PubMed - in process] (Source: Fed Regist) Fed Regist journals http://www.medworm.com/rss/comments.php?id=5603866 Thu, 29 Dec 2011 05:00:00 +0100 5603866 http://www.medworm.com/index.php?rid=5603868&cid=s_27980_4_f&fid=27980&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D22238834%26dopt%3DAbstract Authors: Abstract The Department is publishing this final rule to implement section 703 of the National Defense Authorization Act for Fiscal Year 2010 (NDAA for FY10). Specifically, that legislation amends the transitional health care dental benefits for Reserve Component members on active duty for more than 30 days in support of a contingency operation. The legislation entitles these Reserve Component members to dental care in the same manner as a member of the uniformed services on active duty for more than 30 days, thus providing care to the Reserve member in both military dental treatment facilities and authorized private sector dental care. This final rule does not eliminate any medical or dental care that is currently covered as transitional health care for the member. ... Fed Regist journals http://www.medworm.com/rss/comments.php?id=5603868 Wed, 28 Dec 2011 05:00:00 +0100 5603868 http://www.medworm.com/index.php?rid=5603867&cid=s_27980_4_f&fid=27980&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D22238835%26dopt%3DAbstract Authors: Abstract The Department of Defense is publishing this final rule to implement section 711 of the National Defense Authorization Act (NDAA) for Fiscal Year 2009 (FY 2009), Public Law 110-417. Section 711 eliminates copayments for authorized preventive services for TRICARE Standard beneficiaries other than Medicare-eligible beneficiaries. This rule also realigns the covered preventive services listed in the Exclusions section of the regulation to the Special Benefits section in the regulation. PMID: 22238835 [PubMed - in process] (Source: Fed Regist) Fed Regist journals http://www.medworm.com/rss/comments.php?id=5603867 Wed, 28 Dec 2011 05:00:00 +0100 5603867 http://www.medworm.com/index.php?rid=5603869&cid=s_27980_4_f&fid=27980&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D22238833%26dopt%3DAbstract Authors: Abstract This rule is submitted as an interim final rule (IFR) in order to meet the Congressional requirement set forth in the National Defense Authorization Act (NDAA) for Fiscal Year (FY) 2011, Section 724, which required the Department of Defense to prescribe regulations by June 20, 2011, to establish the criteria, as had previously been studied in accordance with Section 717 of the NDAA 2008, that would allow licensed or certified mental health counselors to be able to independently provide care to TRICARE beneficiaries and receive payment for those services. Under current TRICARE requirements, mental health counselors (MHCs) are authorized to practice only with physician referral and supervision. This interim final rule establishes a transition period to phase out t... Fed Regist journals http://www.medworm.com/rss/comments.php?id=5603869 Tue, 27 Dec 2011 05:00:00 +0100 5603869 http://www.medworm.com/index.php?rid=5603870&cid=s_27980_4_f&fid=27980&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D22238832%26dopt%3DAbstract Authors: Abstract We are revising our rules of conduct and standards of responsibility for representatives. These revisions further clarify our expectations regarding representatives' obligations to competently represent their clients and constitute official notice concerning our requirements and procedures. We are also updating other rules about the representation of parties. These changes are necessary because our current regulations are insufficient to address some representative conduct that is inappropriate, but has technically fallen outside the scope of our regulations. These changes will allow us to better protect the integrity of our administrative process, ensure that claimants receive competent and effective representation, and further clarify representatives' responsi... Fed Regist journals http://www.medworm.com/rss/comments.php?id=5603870 Fri, 23 Dec 2011 05:00:00 +0100 5603870 http://www.medworm.com/index.php?rid=5603871&cid=s_27980_4_f&fid=27980&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D22238831%26dopt%3DAbstract Authors: Abstract This document amends the Department of Veterans Affairs (VA) medical regulations concerning emergency hospital care and medical services provided to eligible veterans at non-VA facilities. The amendments are required by section 402 of the Veterans' Mental Health and Other Care Improvements Act of 2008. Among other things, the amendments authorize VA to pay for emergency treatment provided to a veteran at a non-VA facility up to the time the veteran can be safely transferred to a VA or other Federal facility and such facility is capable of accepting the transfer, or until such transfer was actually accepted, so long as the non-VA facility made and documented reasonable attempts to transfer the veteran to a VA or other Federal facility. PMID: 22238831 [PubMed ... Fed Regist journals http://www.medworm.com/rss/comments.php?id=5603871 Wed, 21 Dec 2011 05:00:00 +0100 5603871 http://www.medworm.com/index.php?rid=5550722&cid=s_27980_4_f&fid=27980&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D22180935%26dopt%3DAbstract Authors: Abstract The Department of Veterans Affairs (VA) is amending its regulation concerning the medical benefits package offered to veterans enrolled in the VA health care system. This rulemaking updates the regulation to conform to amendments made by the enactment of the Caregivers and Veteran Omnibus Health Services Act of 2010, which authorized VA to provide certain health care services to a newborn child of a woman veteran who is receiving maternity care furnished by VA. Health services for newborn care will be authorized for no more than seven days after the birth of the child if the veteran delivered the child in a VA facility or in another facility pursuant to a VA contract for maternity services. PMID: 22180935 [PubMed - indexed for MEDLINE] (Source: Fed Regist) Fed Regist journals http://www.medworm.com/rss/comments.php?id=5550722 Mon, 19 Dec 2011 05:00:00 +0100 5550722 http://www.medworm.com/index.php?rid=5550723&cid=s_27980_4_f&fid=27980&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D22175093%26dopt%3DAbstract Authors: Abstract With the issuance of this final rule, the Administrator of the Drug Enforcement Administration (DEA) places the substance ezogabine, including its salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible, into Schedule V of the Controlled Substances Act (CSA). This action is pursuant to the CSA which requires that such actions be made on the record after opportunity for a hearing through formal rulemaking. PMID: 22175093 [PubMed - indexed for MEDLINE] (Source: Fed Regist) Fed Regist journals http://www.medworm.com/rss/comments.php?id=5550723 Thu, 15 Dec 2011 05:00:00 +0100 5550723 http://www.medworm.com/index.php?rid=5514518&cid=s_27980_4_f&fid=27980&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D22165169%26dopt%3DAbstract Authors: Abstract This final rule implements Section 10332 of the Affordable Care Act regarding the release and use of standardized extracts of Medicare claims data for qualified entities to measure the performance of providers of services (referred to as providers) and suppliers. This rule explains how entities can become qualified by CMS to receive standardized extracts of claims data under Medicare Parts A, B, and D for the purpose of evaluation of the performance of providers and suppliers. This rule also lays out the criteria qualified entities must follow to protect the privacy of Medicare beneficiaries. PMID: 22165169 [PubMed - in process] (Source: Fed Regist) Fed Regist journals http://www.medworm.com/rss/comments.php?id=5514518 Wed, 07 Dec 2011 05:00:00 +0100 5514518 http://www.medworm.com/index.php?rid=5514517&cid=s_27980_4_f&fid=27980&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D22165170%26dopt%3DAbstract Authors: Abstract This final rule with comment period revises the regulations implementing medical loss ratio (MLR) requirements for health insurance issuers under the Public Health Service Act in order to address the treatment of "mini-med" and expatriate policies under these regulations for years after 2011; modify the way the regulations treat ICD-10 conversion costs; change the rules on deducting community benefit expenditures; and revise the rules governing the distribution of rebates by issuers in group markets. PMID: 22165170 [PubMed - in process] (Source: Fed Regist) Fed Regist journals http://www.medworm.com/rss/comments.php?id=5514517 Wed, 07 Dec 2011 05:00:00 +0100 5514517 http://www.medworm.com/index.php?rid=5514516&cid=s_27980_4_f&fid=27980&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D22165171%26dopt%3DAbstract Authors: Abstract This interim final rule with comment period revises the regulations implementing medical loss ratio (MLR) requirements for health insurance issuers under the Public Health Service Act in order to establish rules governing the distribution of rebates by issuers in group markets for non-Federal governmental plans. PMID: 22165171 [PubMed - in process] (Source: Fed Regist) Fed Regist journals http://www.medworm.com/rss/comments.php?id=5514516 Wed, 07 Dec 2011 05:00:00 +0100 5514516 http://www.medworm.com/index.php?rid=5514519&cid=s_27980_4_f&fid=27980&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D22145191%26dopt%3DAbstract Authors: Abstract The Department of Veterans Affairs (VA) is issuing this interim final rule that amends the regulations governing the Servicemembers' Group Life Insurance Traumatic Injury Protection (TSGLI) program by adding certain genitourinary (GU) system losses to the TSGLI Schedule of Losses and defining terms relevant to these new losses. This amendment is necessary to make qualifying GU losses a basis for paying GU-injured Servicemembers TSGLI benefits. The intended effect is to expand the list of losses for which TSGLI payments can be made. PMID: 22145191 [PubMed - in process] (Source: Fed Regist) Fed Regist journals http://www.medworm.com/rss/comments.php?id=5514519 Fri, 02 Dec 2011 05:00:00 +0100 5514519 http://www.medworm.com/index.php?rid=5514520&cid=s_27980_4_f&fid=27980&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D22145189%26dopt%3DAbstract Authors: Abstract In October 2008, the President signed the Methamphetamine Production Prevention Act of 2008 (MPPA), which clarifies the information entry and signature requirements for electronic logbook systems permitted for the retail sale of scheduled listed chemical products. On March 23, 2010, DEA published a Notice of Proposed Rulemaking to implement the provisions of the MPPA and make its regulations consistent with the new requirements. This action finalizes without change the Notice of Proposed Rulemaking published on March 23, 2010. The Final Rule will make it easier for regulated sellers to maintain electronic logbooks by allowing greater flexibility as to how information may be captured. PMID: 22145189 [PubMed - in process] (Source: Fed Regist) Fed Regist journals http://www.medworm.com/rss/comments.php?id=5514520 Thu, 01 Dec 2011 05:00:00 +0100 5514520 http://www.medworm.com/index.php?rid=5514521&cid=s_27980_4_f&fid=27980&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D22145188%26dopt%3DAbstract Authors: Abstract This final rule with comment period revises the Medicare hospital outpatient prospective payment system (OPPS) for CY 2012 to implement applicable statutory requirements and changes arising from our continuing experience with this system. In this final rule with comment period, we describe the changes to the amounts and factors used to determine the payment rates for Medicare hospital outpatient services paid under the OPPS. In addition, this final rule with comment period updates the revised Medicare ambulatory surgical center (ASC) payment system to implement applicable statutory requirements and changes arising from our continuing experience with this system. In this final rule with comment period, we set forth the relative payment weights and payment amounts... Fed Regist journals http://www.medworm.com/rss/comments.php?id=5514521 Wed, 30 Nov 2011 05:00:00 +0100 5514521 http://www.medworm.com/index.php?rid=5514522&cid=s_27980_4_f&fid=27980&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D22145186%26dopt%3DAbstract Authors: Abstract This final rule with comment period addresses changes to the physician fee schedule and other Medicare Part B payment policies to ensure that our payment systems are updated to reflect changes in medical practice and the relative value of services. It also addresses, implements or discusses certain statutory provisions including provisions of the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act of 2010 (collectively known as the Affordable Care Act) and the Medicare Improvements for Patients and Providers Act (MIPPA) of 2008. In addition, this final rule with comment period discusses payments for Part B drugs; Clinical Laboratory Fee Schedule: Signature on Requisition; Physician Quality Reporting System; ... Fed Regist journals http://www.medworm.com/rss/comments.php?id=5514522 Mon, 28 Nov 2011 05:00:00 +0100 5514522 http://www.medworm.com/index.php?rid=5514523&cid=s_27980_4_f&fid=27980&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D22141187%26dopt%3DAbstract Authors: Abstract Under the authority granted to the National Coordinator for Health Information Technology by section 3001(c)(5) of the Public Health Service Act (PHSA) as added by the Health Information Technology for Economic and Clinical Health (HITECH) Act, this final rule establishes a process for addressing instances where the ONC-Approved Accreditor (ONC-AA) engages in improper conduct or does not perform its responsibilities under the permanent certification program. This rule also addresses the status of ONC-Authorized Certification Bodies (ONC-ACBs) in instances where there may be a change in the accreditation organization serving as the ONC-AA and clarifies the responsibilities of the new ONC-AA. PMID: 22141187 [PubMed - in process] (Source: Fed Regist) Fed Regist journals http://www.medworm.com/rss/comments.php?id=5514523 Fri, 25 Nov 2011 05:00:00 +0100 5514523 http://www.medworm.com/index.php?rid=5514524&cid=s_27980_4_f&fid=27980&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D22103021%26dopt%3DAbstract Authors: Abstract This document affirms as final, without changes, a provision included in a final rule with request for comments that amended the Department of Veterans Affairs (VA) regulations concerning community residential care facilities, contract facilities for certain outpatient and residential services, and State home facilities. That provision established a five-year period within which all covered buildings with nursing home facilities existing as of June 25, 2001, must conform to the automatic sprinkler requirement of the 2009 edition of the National Fire Protection Association (NFPA) 101. This rule helps ensure the safety of veterans in the affected facilities. PMID: 22103021 [PubMed - indexed for MEDLINE] (Source: Fed Regist) Fed Regist journals http://www.medworm.com/rss/comments.php?id=5514524 Wed, 16 Nov 2011 05:00:00 +0100 5514524 http://www.medworm.com/index.php?rid=5514525&cid=s_27980_4_f&fid=27980&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D22103020%26dopt%3DAbstract Authors: Abstract This final rule updates and makes certain revisions to the End-Stage Renal Disease (ESRD) prospective payment system (PPS) for calendar year (CY) 2012. We are also finalizing the interim final rule with comment period published on April 6, 2011, regarding the transition budget-neutrality adjustment under the ESRD PPS,. This final rule also sets forth requirements for the ESRD quality incentive program (QIP) for payment years (PYs) 2013 and 2014. In addition, this final rule revises the ambulance fee schedule regulations to conform to statutory changes. This final rule also revises the definition of durable medical equipment (DME) by adding a 3-year minimum lifetime requirement (MLR) that must be met by an item or device in order to be considered durable for the ... Fed Regist journals http://www.medworm.com/rss/comments.php?id=5514525 Thu, 10 Nov 2011 05:00:00 +0100 5514525 http://www.medworm.com/index.php?rid=5422755&cid=s_27980_4_f&fid=27980&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D22059280%26dopt%3DAbstract Authors: Abstract This final rule sets forth updates to the home health prospective payment system (HH PPS) rates, including: the national standardized 60-day episode rates; the national per-visit rates; and the low utilization payment amount (LUPA) under the Medicare PPS for home health agencies effective January 1, 2012. This rule applies a 1.4 percent update factor to the episode rates, which reflects a 1 percent reduction applied to the 2.4 percent market basket update factor, as mandated by the Affordable Care Act. This rule also updates the wage index used under the HH PPS, and further reduces home health payments to account for continued nominal growth in case-mix which is unrelated to changes in patient health status. This rule removes two hypertension codes from the HH P... Fed Regist journals http://www.medworm.com/rss/comments.php?id=5422755 Fri, 04 Nov 2011 04:00:00 +0100 5422755 http://www.medworm.com/index.php?rid=5381737&cid=s_27980_4_f&fid=27980&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D22046632%26dopt%3DAbstract Authors: Abstract This interim final rule with comment period establishes waivers of the application of the Physician Self-Referral Law, the Federal anti-kickback statute, and certain civil monetary penalties (CMP) law provisions to specified arrangements involving accountable care organizations (ACOs) under section 1899 of the Social Security Act (the Act) (the Shared Savings Program), including ACOs participating in the Advance Payment Initiative. Section 1899(f) of the Act, as added by the Affordable Care Act, authorizes the Secretary to waive certain fraud and abuse laws as necessary to carry out the provisions of section 1899 of the Act. PMID: 22046632 [PubMed - in process] (Source: Fed Regist) Fed Regist journals http://www.medworm.com/rss/comments.php?id=5381737 Wed, 02 Nov 2011 04:00:00 +0100 5381737 http://www.medworm.com/index.php?rid=5381736&cid=s_27980_4_f&fid=27980&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D22046633%26dopt%3DAbstract Authors: Abstract This final rule implements section 3022 of the Affordable Care Act which contains provisions relating to Medicare payments to providers of services and suppliers participating in Accountable Care Organizations (ACOs) under the Medicare Shared Savings Program. Under these provisions, providers of services and suppliers can continue to receive traditional Medicare fee-for-service (FFS) payments under Parts A and B, and be eligible for additional payments if they meet specified quality and savings requirements. PMID: 22046633 [PubMed - in process] (Source: Fed Regist) Fed Regist journals http://www.medworm.com/rss/comments.php?id=5381736 Wed, 02 Nov 2011 04:00:00 +0100 5381736 http://www.medworm.com/index.php?rid=5381738&cid=s_27980_4_f&fid=27980&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D22022736%26dopt%3DAbstract Authors: Abstract This final rule revises the ambulatory surgical centers (ASCs) conditions for coverage (CfC) to allow patient rights information to be provided to the patient, the patient's representative, or the patient's surrogate prior to the start of the surgical procedure. In addition, we made minor changes to the CfC for patient rights requirements, as specified in the proposed rule. This final rule reflects the Centers for Medicare and Medicaid Services' (CMS') commitment to the general principles of the President's Executive Order 13563 released January 18, 2011, entitled "Improving Regulation and Regulatory Review.'' PMID: 22022736 [PubMed - in process] (Source: Fed Regist) Fed Regist journals http://www.medworm.com/rss/comments.php?id=5381738 Mon, 24 Oct 2011 04:00:00 +0100 5381738 http://www.medworm.com/index.php?rid=5346061&cid=s_27980_4_f&fid=27980&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D22016902%26dopt%3DAbstract Authors: Abstract We are revising the procedures for how claimants who receive fully favorable revised determinations based on prehearing case reviews or fully favorable attorney advisor decisions may seek further review. We are also revising our procedure to provide that we will notify claimants who receive partially favorable determinations based on prehearing case reviews that an administrative law judge (ALJ) will still hold a hearing unless all parties to the hearing tell us in writing that we should dismiss the hearing request. These changes will simplify our administrative review process and free up scarce administrative resources that we can better use to reduce the hearings-level case backlog. PMID: 22016902 [PubMed - in process] (Source: Fed Regist) Fed Regist journals http://www.medworm.com/rss/comments.php?id=5346061 Fri, 21 Oct 2011 04:00:00 +0100 5346061 http://www.medworm.com/index.php?rid=5346060&cid=s_27980_4_f&fid=27980&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D22016903%26dopt%3DAbstract Schedules of controlled substances: temporary placement of three synthetic cathinones in Schedule I. Final Order. Fed Regist. 2011 Oct 21;76(204):65371-5 Authors: Abstract The Administrator of the Drug Enforcement Administration (DEA) is issuing this final order to temporarily schedule three synthetic cathinones under the Controlled Substances Act (CSA) pursuant to the temporary scheduling provisions of 21 U.S.C. 811(h). The substances are 4-methyl-N-methylcathinone (mephedrone), 3,4-methylenedioxy-N-methylcathinone (methylone), and 3,4-methylenedioxypyrovalerone (MDPV). This action is based on a finding by the Administrator that the placement of these synthetic cathinones and their salts, isomers, and salts of isomers into Schedule I of the CSA is necessary to avoid an i... Fed Regist journals http://www.medworm.com/rss/comments.php?id=5346060 Fri, 21 Oct 2011 04:00:00 +0100 5346060 http://www.medworm.com/index.php?rid=5346062&cid=s_27980_4_f&fid=27980&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D22013621%26dopt%3DAbstract Authors: Abstract This document amends the Department of Veterans Affairs (VA) regulation pertaining to the applicability of certain VA regulations that restrict the disclosure of certain medical information to the Department of Defense (DoD). This interim final rule removes a restriction that is not required by the applicable statute, 38 U.S.C. 7332(e), and is inconsistent with the intent and purpose of that statute. PMID: 22013621 [PubMed - in process] (Source: Fed Regist) Fed Regist journals http://www.medworm.com/rss/comments.php?id=5346062 Thu, 20 Oct 2011 04:00:00 +0100 5346062 http://www.medworm.com/index.php?rid=5282002&cid=s_27980_4_f&fid=27980&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D21961195%26dopt%3DAbstract Authors: Abstract The Secretary issues final regulations governing the Early Intervention Program for Infants and Toddlers with Disabilities. These regulations are needed to reflect changes made to the Individuals with Disabilities Education Act, as amended by the Individuals with Disabilities Education Improvement Act of 2004 (Act or IDEA). PMID: 21961195 [PubMed - in process] (Source: Fed Regist) Fed Regist journals http://www.medworm.com/rss/comments.php?id=5282002 Wed, 28 Sep 2011 04:00:00 +0100 5282002 http://www.medworm.com/index.php?rid=5262171&cid=s_27980_4_f&fid=27980&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D21938885%26dopt%3DAbstract Authors: Abstract This final rule executes the expansion of section 1078a of title 10, United States Code (U.S.C). With the recent expansions of Military Health System (MHS) coverage, particularly with the Reserve Component (RC) members, some MHS beneficiaries would not be eligible to purchase Continued Health Care Benefit Program (CHCBP) coverage under certain circumstances that terminate their MHS coverage. This provision allows the Secretary to establish CHCBP eligibility for any category of MHS beneficiaries who otherwise would lose MHS coverage with no continued care eligibility. Although the proposed rule listed each authorized category of MHS beneficiary eligible to receive care, on further examination this format for the rule appeared cumbersome and perhaps confusing. Thu... Fed Regist journals http://www.medworm.com/rss/comments.php?id=5262171 Fri, 16 Sep 2011 04:00:00 +0100 5262171 http://www.medworm.com/index.php?rid=5262170&cid=s_27980_4_f&fid=27980&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D21938886%26dopt%3DAbstract Authors: Abstract The Department of Defense is publishing this final rule to allow coverage for otherwise covered services and supplies required in the treatment of complications (unfortunate sequelae) resulting from a noncovered incident of treatment provided in a Military Treatment Facility (MTF), when the initial noncovered service has been authorized by the MTF Commander and the MTF is unable to provide the necessary treatment of the complications. This final rule is necessary to protect TRICARE beneficiaries from incurring financial hardships due to the current regulatory restrictions that prohibit TRICARE coverage of treatment of the complications resulting from noncovered procedures, even when those procedures were conducted in a Department of Defense facility. PMID: 2... Fed Regist journals http://www.medworm.com/rss/comments.php?id=5262170 Fri, 16 Sep 2011 04:00:00 +0100 5262170 http://www.medworm.com/index.php?rid=5262169&cid=s_27980_4_f&fid=27980&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D21938887%26dopt%3DAbstract Authors: Abstract The Department is publishing this final rule to implement the National Defense Authorization Act for Fiscal Year 2010 (NDAA for FY10), as amended by the National Defense Authorization Act for Fiscal Year 2011 (NDAA for FY11). Specifically, that legislation expands the survivor eligibility under the TRICARE Dental Program (TDP). The 2011 amendment to the legislation entitles the surviving spouse and child(ren) continuation of eligibility for the TDP regardless of whether they were previously enrolled in the TDP. Prior enrollment in the TDP had been a requirement of the 2010 legislation for both the spouse and children. The period of continued eligibility for a spouse will be 3 years beginning on the date of the member's death. The legislation entitles a child to ... Fed Regist journals http://www.medworm.com/rss/comments.php?id=5262169 Fri, 16 Sep 2011 04:00:00 +0100 5262169 http://www.medworm.com/index.php?rid=5262168&cid=s_27980_4_f&fid=27980&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D21938888%26dopt%3DAbstract Authors: Abstract This final rule implements section 6411 of the Patient Protection and Affordable Care Act (the Affordable Care Act), and provides guidance to States related to Federal/State funding of State start-up, operation and maintenance costs of Medicaid Recovery Audit Contractors (Medicaid RACs) and the payment methodology for State payments to Medicaid RACs. This rule also directs States to assure that adequate appeal processes are in place for providers to dispute adverse determinations made by Medicaid RACs. Lastly, the rule directs States to coordinate with other contractors and entities auditing Medicaid providers and with State and Federal law enforcement agencies. PMID: 21938888 [PubMed - in process] (Source: Fed Regist) Fed Regist journals http://www.medworm.com/rss/comments.php?id=5262168 Fri, 16 Sep 2011 04:00:00 +0100 5262168 http://www.medworm.com/index.php?rid=5262172&cid=s_27980_4_f&fid=27980&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D21938883%26dopt%3DAbstract Authors: Abstract We are revising our rules to require that claimant representatives use our electronic services as they become available on matters for which the representatives request direct fee payment. In the future, we will publish a notice in the Federal Register when we require representatives who request direct fee payment on a matter to use our available electronic services. We are also adding the requirement to use our available electronic services on matters for which the representative requests direct fee payment as an affirmative duty in our representative conduct rules. These revisions reflect the increased use of technology in representatives' business practices. We expect that the use of electronic services will improve our efficiency by allowing us to manage our... Fed Regist journals http://www.medworm.com/rss/comments.php?id=5262172 Mon, 12 Sep 2011 04:00:00 +0100 5262172 http://www.medworm.com/index.php?rid=5219486&cid=s_27980_4_f&fid=27980&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D21905332%26dopt%3DAbstract Authors: Abstract The Department of Veterans Affairs (VA) amends its regulations concerning per diem payments to States to permit continuation of such payments in some situations for veterans who have been evacuated from a State home as a result of an emergency. Per diem is the daily rate paid by VA to a State for providing a specified level of care to eligible veterans in a facility that is officially recognized and certified by VA. This final rule authorizes VA to continue to pay per diem when veterans for whom VA is paying per diem are evacuated as a result of an emergency from a State home to a facility that is not recognized by VA as a State home. The rule requires, in order for per diem payments to continue while the veteran is relocated due to an emergency, that an appropr... Fed Regist journals http://www.medworm.com/rss/comments.php?id=5219486 Thu, 08 Sep 2011 04:00:00 +0100 5219486 http://www.medworm.com/index.php?rid=5219488&cid=s_27980_4_f&fid=27980&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D21894661%26dopt%3DAbstract Authors: Abstract This final rule modifies the electronic prescribing (eRx) quality measure used for certain reporting periods in calendar year (CY) 2011; provides additional significant hardship exemption categories for eligible professionals and group practices to request an exemption during 2011 for the 2012 eRx payment adjustment due to a significant hardship; and extends the deadline for submitting requests for consideration for the two significant hardship exemption categories for the 2012 eRx payment adjustment that were finalized in the CY 2011 Medicare Physician Fee Schedule final rule with comment period. PMID: 21894661 [PubMed - in process] (Source: Fed Regist) Fed Regist journals http://www.medworm.com/rss/comments.php?id=5219488 Tue, 06 Sep 2011 04:00:00 +0100 5219488 http://www.medworm.com/index.php?rid=5219487&cid=s_27980_4_f&fid=27980&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D21894663%26dopt%3DAbstract Authors: Abstract This final rule amends a May 23, 2011, final rule entitled "Rate Increase Disclosure and Review". The final rule provided that, for purposes of rate review only, definitions of "individual market" and "small group market" under State rate filing laws would govern even if those definitions departed from the definitions that otherwise apply under title XXVII of the Public Health Service Act (PHS Act). The preamble to the final rule requested comments on whether this policy should apply in cases in which State rate filing law definitions of "individual market" and "small group market" exclude association insurance policies that would be included in these definitions for other purposes under the PHS Act. In response to comments, this final rule amends the definition... Fed Regist journals http://www.medworm.com/rss/comments.php?id=5219487 Tue, 06 Sep 2011 04:00:00 +0100 5219487 http://www.medworm.com/index.php?rid=5219489&cid=s_27980_4_f&fid=27980&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D21894660%26dopt%3DAbstract Authors: Abstract This final rule finalizes revisions to the regulations governing the Medicare Advantage (MA) program (Part C), prescription drug benefit program (Part D) and section 1876 cost plans including conforming changes to the MA regulations to implement statutory requirements regarding special needs plans (SNPs), private fee-for-service plans (PFFS), regional preferred provider organizations (RPPO) plans, and Medicare medical savings accounts (MSA) plans, cost-sharing for dual-eligible enrollees in the MA program and prescription drug pricing, coverage, and payment processes in the Part D program, and requirements governing the marketing of Part C and Part D plans. PMID: 21894660 [PubMed - in process] (Source: Fed Regist) Fed Regist journals http://www.medworm.com/rss/comments.php?id=5219489 Thu, 01 Sep 2011 04:00:00 +0100 5219489 http://www.medworm.com/index.php?rid=5219490&cid=s_27980_4_f&fid=27980&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D21894659%26dopt%3DAbstract Authors: Abstract This final rule implements changes to the regulations on the Responsibility of Applicants for Promoting Objectivity in Research for which Public Health Service Funding is Sought and Responsible Prospective Contractors. Since the promulgation of the regulations in 1995, biomedical and behavioral research and the resulting interactions among government, research Institutions, and the private sector have become increasingly complex. This complexity, as well as a need to strengthen accountability, led to changes that expand and add transparency to Investigators' disclosure of Significant Financial Interests (SFIs), enhance regulatory compliance and effective institutional oversight and management of Investigators' financial conflicts of interests, as well as increas... Fed Regist journals http://www.medworm.com/rss/comments.php?id=5219490 Thu, 25 Aug 2011 04:00:00 +0100 5219490 http://www.medworm.com/index.php?rid=5219492&cid=s_27980_4_f&fid=27980&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D21894657%26dopt%3DAbstract Authors: Abstract This final rule establishes regulations for contracting with community-based treatment facilities in the Health Care for Homeless Veterans (HCHV) program of the Department of Veterans Affairs (VA). The HCHV program assists certain homeless veterans in obtaining treatment from non-VA community-based providers. The final rule formalizes VA's policies and procedures in connection with this program and clarifies that veterans with substance use disorders may qualify for the program. PMID: 21894657 [PubMed - in process] (Source: Fed Regist) Fed Regist journals http://www.medworm.com/rss/comments.php?id=5219492 Tue, 23 Aug 2011 04:00:00 +0100 5219492 http://www.medworm.com/index.php?rid=5219491&cid=s_27980_4_f&fid=27980&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D21894658%26dopt%3DAbstract Authors: Abstract The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled "E2F Development Safety Update Report." The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance describes the format, content, and timing of a development safety update report (DSUR) for an investigational drug. The DSUR will serve as a common standard for periodic reporting on drugs under development (including marketed drugs that are under further study) among the ICH regions. The DSUR can be submitted in the United States in place of an annual report for an investigational new drug application (IND). The harmonized DSUR is intended to p... Fed Regist journals http://www.medworm.com/rss/comments.php?id=5219491 Tue, 23 Aug 2011 04:00:00 +0100 5219491 http://www.medworm.com/index.php?rid=5219494&cid=s_27980_4_f&fid=27980&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D21894653%26dopt%3DAbstract Authors: Abstract This final rule amends Department of Veterans Affairs (VA) medical regulations to incorporate statutory amendments. Certain statutes authorizing VA health care benefits were amended by the Caregivers and Veterans Omnibus Health Services Act of 2010. The statutory amendments affect enrollment in certain health care priority categories and exempt catastrophically disabled veterans from copayment requirements. PMID: 21894653 [PubMed - in process] (Source: Fed Regist) Fed Regist journals http://www.medworm.com/rss/comments.php?id=5219494 Mon, 22 Aug 2011 04:00:00 +0100 5219494 http://www.medworm.com/index.php?rid=5219493&cid=s_27980_4_f&fid=27980&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D21894654%26dopt%3DAbstract Authors: Abstract This document amends Department of Veterans Affairs (VA) regulations concerning the payment of per diem to a State for providing nursing home care to eligible veterans. The amendments remove a restriction on VA's payment of per diem, which required all non-veteran residents of a State home to be spouses of veterans, or parents of veterans all of whose children died while serving in the Armed Forces of the United States. Under this final rule, non-veteran residents of the State home must be spouses of veterans, or parents of veterans any of whose children died while serving in the Armed Forces. PMID: 21894654 [PubMed - in process] (Source: Fed Regist) Fed Regist journals http://www.medworm.com/rss/comments.php?id=5219493 Mon, 22 Aug 2011 04:00:00 +0100 5219493 http://www.medworm.com/index.php?rid=5219495&cid=s_27980_4_f&fid=27980&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D21894651%26dopt%3DAbstract Authors: Abstract The Food and Drug Administration (FDA) is classifying the eyelid thermal pulsation system into class II (special controls). The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. PMID: 21894651 [PubMed - in process] (Source: Fed Regist) Fed Regist journals http://www.medworm.com/rss/comments.php?id=5219495 Fri, 19 Aug 2011 04:00:00 +0100 5219495 http://www.medworm.com/index.php?rid=5219496&cid=s_27980_4_f&fid=27980&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D21894648%26dopt%3DAbstract Authors: Abstract We are revising the Medicare hospital inpatient prospective payment systems (IPPS) for operating and capital-related costs of acute care hospitals to implement changes arising from our continuing experience with these systems and to implement certain statutory provisions contained in the Patient Protection and Affordable Care Act and the Health Care and Education Reconciliation Act of 2010 (collectively known as the Affordable Care Act) and other legislation. We also are setting forth the update to the rate-of-increase limits for certain hospitals excluded from the IPPS that are paid on a reasonable cost basis subject to these limits. We are updating the payment policy and the annual payment rates for the Medicare prospective payment system (PPS) for inpatient h... Fed Regist journals http://www.medworm.com/rss/comments.php?id=5219496 Thu, 18 Aug 2011 04:00:00 +0100 5219496 http://www.medworm.com/index.php?rid=5141873&cid=s_27980_4_f&fid=27980&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D21845785%26dopt%3DAbstract Authors: Abstract The Food and Drug Administration (FDA) is issuing a final rule to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for the following three class III preamendments devices: Ventricular bypass (assist) device; pacemaker repair or replacement material; and female condom. The Agency has summarized its findings regarding the degree of risk of illness or injury designed to be eliminated or reduced by requiring the devices to meet the statute's approval requirements and the benefits to the public from the use of the devices. This action implements certain statutory requirements. PMID: 21845785 [PubMed - indexed for MEDLINE] (Source: Fed Regist) Fed Regist journals http://www.medworm.com/rss/comments.php?id=5141873 Mon, 15 Aug 2011 23:00:00 +0100 5141873 http://www.medworm.com/index.php?rid=5141874&cid=s_27980_4_f&fid=27980&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D21834216%26dopt%3DAbstract Authors: Abstract The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ``E16 Biomarkers Related to Drug or Biotechnology Product Development: Context, Structure, and Format of Qualification Submissions.'' The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance describes recommendations regarding the context, structure, and format of qualification submissions for clinical and nonclinical genomic biomarkers related to development of drug or biotechnology products, including translational medicine approaches, pharmacokinetics, pharmacodynamics, and efficacy and safety aspects. The guidance is intended to create ... Fed Regist journals http://www.medworm.com/rss/comments.php?id=5141874 Wed, 10 Aug 2011 23:00:00 +0100 5141874 http://www.medworm.com/index.php?rid=5141875&cid=s_27980_4_f&fid=27980&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D21826824%26dopt%3DAbstract Authors: Abstract The Food and Drug Administration (FDA) is amending the special controls for the herpes simplex virus (HSV) serological assay device type, which is classified as class II (special controls). These device types are devices that consist of antigens and antisera used in various serological tests to identify antibodies to herpes simplex virus in serum, and the devices that consist of herpes simplex virus antisera conjugated with a fluorescent dye (immunofluorescent assays) used to identify herpes simplex virus directly from clinical specimens or tissue culture isolates derived from clinical specimens. PMID: 21826824 [PubMed - indexed for MEDLINE] (Source: Fed Regist) Fed Regist journals http://www.medworm.com/rss/comments.php?id=5141875 Mon, 08 Aug 2011 23:00:00 +0100 5141875 http://www.medworm.com/index.php?rid=5141876&cid=s_27980_4_f&fid=27980&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D21823267%26dopt%3DAbstract Authors: Abstract This final rule updates the payment rates used under the prospective payment system for skilled nursing facilities (SNFs) for fiscal year 2012. In addition, it recalibrates the case-mix indexes so that they more accurately reflect parity in expenditures between RUG-IV and the previous case-mix classification system. It also includes a discussion of a Non-Therapy Ancillary component currently under development within CMS. In addition, this final rule discusses the impact of certain provisions of the Affordable Care Act, and reduces the SNF market basket percentage by the multi-factor productivity adjustment. This rule also implements certain changes relating to the payment of group therapy services and implements new resident assessment policies. Finally, this ru... Fed Regist journals http://www.medworm.com/rss/comments.php?id=5141876 Sun, 07 Aug 2011 23:00:00 +0100 5141876 http://www.medworm.com/index.php?rid=5141877&cid=s_27980_4_f&fid=27980&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D21818878%26dopt%3DAbstract Authors: Abstract This final rule will implement section 3004 of the Affordable Care Act, which establishes a new quality reporting program that provides for a 2 percent reduction in the annual increase factor beginning in 2014 for failure to report quality data to the Secretary of Health and Human Services. This final rule will also update the prospective payment rates for inpatient rehabilitation facilities (IRFs) for Federal fiscal year (FY) 2012 (for discharges occurring on or after October 1, 2011 and on or before September 30, 2012) as required under section 1886(j)(3)(C) of the Social Security Act (the Act). Section 1886(j)(5) of the Act requires the Secretary to publish in the Federal Register on or before the August 1 that precedes the start of each FY the classification... Fed Regist journals http://www.medworm.com/rss/comments.php?id=5141877 Thu, 04 Aug 2011 23:00:00 +0100 5141877 http://www.medworm.com/index.php?rid=5105700&cid=s_27980_4_f&fid=27980&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D21815310%26dopt%3DAbstract Authors: This final rule will set forth the hospice wage index for fiscal year (FY) 2012 and continue the phase-out of the wage index budget neutrality adjustment factor (BNAF), with an additional 15 percent BNAF reduction, for a total BNAF reduction in FY 2012 of 40 percent. The BNAF phase-out will continue with successive 15 percent reductions from FY 2013 through FY 2016. This final rule will change the hospice aggregate cap calculation methodology. This final rule will also revise the hospice requirement for a face-to-face encounter for recertification of a patient's terminal illness. Finally, this final rule will begin implementation of a hospice quality reporting program. PMID: 21815310 [PubMed - in process] (Source: Fed Regist) Fed Regist journals http://www.medworm.com/rss/comments.php?id=5105700 Wed, 03 Aug 2011 23:00:00 +0100 5105700 http://www.medworm.com/index.php?rid=5105701&cid=s_27980_4_f&fid=27980&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D21812152%26dopt%3DAbstract Authors: , , This document contains amendments to the interim final regulations implementing the rules for group health plans and health insurance coverage in the group and individual markets under provisions of the Patient Protection and Affordable Care Act regarding preventive health services. PMID: 21812152 [PubMed - in process] (Source: Fed Regist) Fed Regist journals http://www.medworm.com/rss/comments.php?id=5105701 Tue, 02 Aug 2011 23:00:00 +0100 5105701 http://www.medworm.com/index.php?rid=5105702&cid=s_27980_4_f&fid=27980&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D21800457%26dopt%3DAbstract Authors: The Food and Drug Administration (FDA) is announcing the re-establishment of the Medical Imaging Drugs Advisory Committee in FDA's Center for Drug Evaluation and Research. This rule amends the current language for the Medical Imaging Drugs Advisory Committee in the Agency's list of standing advisory committees in FDA's regulations. PMID: 21800457 [PubMed - in process] (Source: Fed Regist) Fed Regist journals http://www.medworm.com/rss/comments.php?id=5105702 Thu, 28 Jul 2011 23:00:00 +0100 5105702 http://www.medworm.com/index.php?rid=5105704&cid=s_27980_4_f&fid=27980&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D21796845%26dopt%3DAbstract Authors: The Food and Drug Administration (FDA) is amending the final monograph (FM) for over-the-counter (OTC) bronchodilator drug products to add additional warnings (e.g., an ``Asthma alert'') and to revise the indications, warnings, and directions in the labeling of products containing the ingredients ephedrine, ephedrine hydrochloride, ephedrine sulfate, epinephrine, epinephrine bitartrate, racephedrine hydrochloride, and racepinephrine hydrochloride. FDA is issuing this final rule after considering data and information submitted in response to the Agency's proposed labeling revisions for these products. This final rule is part of FDA's ongoing review of OTC drug products. PMID: 21796845 [PubMed - in process] (Source: Fed Regist) Fed Regist journals http://www.medworm.com/rss/comments.php?id=5105704 Mon, 25 Jul 2011 23:00:00 +0100 5105704 http://www.medworm.com/index.php?rid=5105703&cid=s_27980_4_f&fid=27980&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D21796846%26dopt%3DAbstract Authors: The Food and Drug Administration (FDA) is classifying the repetitive transcranial magnetic stimulation (rTMS) system into class II (special controls). The Agency is classifying this device type into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of these devices. PMID: 21796846 [PubMed - in process] (Source: Fed Regist) Fed Regist journals http://www.medworm.com/rss/comments.php?id=5105703 Mon, 25 Jul 2011 23:00:00 +0100 5105703 http://www.medworm.com/index.php?rid=5105705&cid=s_27980_4_f&fid=27980&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D21780327%26dopt%3DAbstract Authors: The Food and Drug Administration (FDA) is classifying the electrocardiograph electrode, intended to acquire and transmit the electrical signal at the body surface to a processor that produces an electrocardiogram (ECG) or vectorcardiogram, into class II (special controls). FDA is also exempting this device from the premarket notification requirement. PMID: 21780327 [PubMed - indexed for MEDLINE] (Source: Fed Regist) Fed Regist journals http://www.medworm.com/rss/comments.php?id=5105705 Wed, 20 Jul 2011 23:00:00 +0100 5105705 http://www.medworm.com/index.php?rid=5058685&cid=s_27980_4_f&fid=27980&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D21774154%26dopt%3DAbstract Authors: The Food and Drug Administration (FDA) is classifying the focused ultrasound stimulator system for aesthetic use into class II (special controls). The special control(s) that will apply to the device is the guidance document entitled "Class II Special Controls Guidance Document: Focused Ultrasound Stimulator System for Aesthetic Use." The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. PMID: 21774154 [PubMed - in process] (Source: Fed Regist) Fed Regist journals http://www.medworm.com/rss/comments.php?id=5058685 Tue, 19 Jul 2011 23:00:00 +0100 5058685 http://www.medworm.com/index.php?rid=5058687&cid=s_27980_4_f&fid=27980&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D21770076%26dopt%3DAbstract Authors: We are revising our regulations to reflect our use of electronic case processing at the initial and reconsideration levels of our administrative review process. Our prior rule required adjudicators at these levels to complete a Form SSA-538, Childhood Disability Evaluation Form, in all cases of children alleging disability or continuing disability under title XVI of the Social Security Act (Act). However, we developed and now use a Web-based tool that assists our adjudicators in making disability determinations in several States, and we plan to expand its use to other States. We are revising our regulation to reflect the new tool. We are not changing the requirement that State agency medical and psychological consultants must affirm the accuracy and completeness of their fin... Fed Regist journals http://www.medworm.com/rss/comments.php?id=5058687 Thu, 14 Jul 2011 23:00:00 +0100 5058687 http://www.medworm.com/index.php?rid=5058686&cid=s_27980_4_f&fid=27980&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D21770077%26dopt%3DAbstract Authors: The Department of Veterans Affairs (VA) adopts as a final rule the proposal to amend its adjudication regulations regarding presumptive service connection for medically unexplained chronic multisymptom illnesses associated with service in the Southwest Asia theater of operations for which there is no record during service. This amendment implements a decision by the Secretary that there is a positive association between service in Southwest Asia during certain periods and the subsequent development of functional gastrointestinal disorders (FGIDs) and clarifies that FGIDs fall within the scope of the existing presumptions of service connection for medically unexplained chronic multisymptom illnesses. PMID: 21770077 [PubMed - in process] (Source: Fed Regist) Fed Regist journals http://www.medworm.com/rss/comments.php?id=5058686 Thu, 14 Jul 2011 23:00:00 +0100 5058686 http://www.medworm.com/index.php?rid=5058688&cid=s_27980_4_f&fid=27980&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D21770075%26dopt%3DAbstract Authors: This final rule allows a TRICARE retail network pharmacy to be an authorized provider for the administration of TRICARE-covered vaccines in the retail pharmacy setting. The value of vaccines lies in the prevention of disease and reduced healthcare costs in the long term. When vaccines are made more readily accessible, a broader section of the population will receive them. PMID: 21770075 [PubMed - in process] (Source: Fed Regist) Fed Regist journals http://www.medworm.com/rss/comments.php?id=5058688 Tue, 12 Jul 2011 23:00:00 +0100 5058688 http://www.medworm.com/index.php?rid=5058689&cid=s_27980_4_f&fid=27980&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D21739765%26dopt%3DAbstract Authors: Section 1104 of the Administrative Simplification provisions of the Patient Protection and Affordable Care Act (hereafter referred to as the Affordable Care Act) establishes new requirements for administrative transactions that will improve the utility of the existing HIPAA transactions and reduce administrative costs. Specifically, in section 1104(b)(2) of the Affordable Care Act, Congress required the adoption of operating rules for the health care industry and directed the Secretary of Health and Human Services to "adopt a single set of operating rules for each transaction * * * with the goal of creating as much uniformity in the implementation of the electronic standards as possible." This interim final rule with comment period adopts operating rules for two Health Insur... Fed Regist journals http://www.medworm.com/rss/comments.php?id=5058689 Thu, 07 Jul 2011 23:00:00 +0100 5058689 http://www.medworm.com/index.php?rid=5058691&cid=s_27980_4_f&fid=27980&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D21735763%26dopt%3DAbstract Authors: The Food and Drug Administration (FDA) is issuing this final rule to establish procedures for requesting an exemption from the substantial equivalence requirements of the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act). The final rule describes the process and statutory criteria for requesting an exemption and explains how FDA reviews requests for exemptions. This regulation satisfies the requirement in the Tobacco Control Act that FDA issue regulations implementing the exemption provision. PMID: 21735763 [PubMed - indexed for MEDLINE] (Source: Fed Regist) Fed Regist journals http://www.medworm.com/rss/comments.php?id=5058691 Mon, 04 Jul 2011 23:00:00 +0100 5058691 http://www.medworm.com/index.php?rid=5058692&cid=s_27980_4_f&fid=27980&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D21721318%26dopt%3DAbstract Authors: This final rule incorporates into the regulations governing the Programs authorized under the Richard B. Russell National School Lunch Act (NSLA) and the Child Nutrition Act of 1966 (CNA) two nondiscretionary provisions of the Healthy, Hunger-Free Kids Act of 2010 (HHFK Act). The HHFK Act requires State and local cooperation in Department of Agriculture studies and evaluations related to Programs authorized under the NSLA and the CNA. The HHFK Act also amends the NSLA to stipulate that Federal funds must not be subject to State budget restrictions or limitations, including hiring freezes, work furloughs, and travel restrictions. This final rule amends regulations for the National School Lunch Program; the Special Milk Program for Children; the School Breakfast Program; the S... Fed Regist journals http://www.medworm.com/rss/comments.php?id=5058692 Tue, 28 Jun 2011 23:00:00 +0100 5058692 http://www.medworm.com/index.php?rid=5058690&cid=s_27980_4_f&fid=27980&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D21736160%26dopt%3DAbstract Authors: The Food and Drug Administration (FDA) is issuing a final regulation to confirm, with one change, the interim final rule (IFR) entitled "Medical Devices; Exception From General Requirements for Informed Consent." This final rule confirms the IFR's establishment of a new exception from the general requirements for informed consent to permit the use of investigational in vitro diagnostic devices to identify chemical, biological, radiological, or nuclear agents without informed consent in certain circumstances. FDA has created this exception to help ensure that individuals who may have been exposed to a chemical, biological, radiological, or nuclear agent are able to benefit from the timely use of the most appropriate diagnostic devices, including those that are investigational... Fed Regist journals http://www.medworm.com/rss/comments.php?id=5058690 Thu, 23 Jun 2011 23:00:00 +0100 5058690 http://www.medworm.com/index.php?rid=5011309&cid=s_27980_4_f&fid=27980&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D21736161%26dopt%3DAbstract Authors: This document amends the regulations of the Department of Veterans Affairs (VA) concerning the reimbursement of medical care and services delivered to veterans for nonservice-connected conditions. This rule applies in situations where third-party payers are required to reimburse VA for costs related to care provided by VA to a veteran covered under the third-party payer's plan. This final rule adds a new section barring offsets by third-party payers and requires that third-party payers submit a request for a refund for claims when there is an alleged overpayment. PMID: 21736161 [PubMed - in process] (Source: Fed Regist) Fed Regist journals http://www.medworm.com/rss/comments.php?id=5011309 Thu, 23 Jun 2011 23:00:00 +0100 5011309 http://www.medworm.com/index.php?rid=5011288&cid=s_27980_4_f&fid=27980&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D21736162%26dopt%3DAbstract Authors: , , This document contains amendments to interim final regulations implementing the requirements regarding internal claims and appeals and external review processes for group health plans and health insurance coverage in the group and individual markets under provisions of the Affordable Care Act. These rules are intended to respond to feedback from a wide range of stakeholders on the interim final regulations and to assist plans and issuers in coming into full compliance with the law through an orderly and expeditious implementation process. PMID: 21736162 [PubMed - in process] (Source: Fed Regist) Fed Regist journals http://www.medworm.com/rss/comments.php?id=5011288 Thu, 23 Jun 2011 23:00:00 +0100 5011288 http://www.medworm.com/index.php?rid=4962984&cid=s_27980_4_f&fid=27980&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D21696014%26dopt%3DAbstract Authors: On September 13, 2010, the Secretary of Health and Human Services (the Secretary) published in the Federal Register a Notice of Proposed Rulemaking (NPRM) proposing changes to the regulations governing the National Vaccine Injury Compensation Program (VICP). Specifically, the Secretary proposed revisions to the Vaccine Injury Table (Table) to create distinct listings for hepatitis A, trivalent influenza, meningococcal, and human papillomavirus vaccines. The Secretary is now making this amendment to the Table by final rule; it is technical in nature. The four categories of vaccines described in this final rule are already covered vaccines under the VICP (starting in 2004) and are currently listed in a placeholder category (box XIII) in the Table. This final rule will list the... Fed Regist journals http://www.medworm.com/rss/comments.php?id=4962984 Tue, 21 Jun 2011 23:00:00 +0100 4962984 http://www.medworm.com/index.php?rid=4962983&cid=s_27980_4_f&fid=27980&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D21696017%26dopt%3DAbstract Authors: The Food and Drug Administration (FDA) is amending its regulations to add a new requirement for the display of health warnings on cigarette packages and in cigarette advertisements. This rule implements a provision of the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) that requires FDA to issue regulations requiring color graphics, depicting the negative health consequences of smoking, to accompany the nine new textual warning statements required under the Tobacco Control Act. The Tobacco Control Act amends the Federal Cigarette Labeling and Advertising Act (FCLAA) to require each cigarette package and advertisement to bear one of nine new textual warning statements. This final rule specifies the color graphic images that must accompany each of the n... Fed Regist journals http://www.medworm.com/rss/comments.php?id=4962983 Tue, 21 Jun 2011 23:00:00 +0100 4962983 http://www.medworm.com/index.php?rid=4962985&cid=s_27980_4_f&fid=27980&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D21682059%26dopt%3DAbstract Authors: The Food and Drug Administration (FDA) is issuing this document to address labeling and effectiveness testing for certain over-the counter (OTC) sunscreen products containing specified active ingredients and marketed without approved applications. This document addresses labeling and effectiveness testing issues raised by the nearly 2,900 submissions that we received in response to the sunscreen proposed rule of August 27, 2007 (2007 proposed rule). The document also identifies specific claims that render a product that is subject to this rule misbranded or would not be allowed on any OTC sunscreen product marketed without an approved application. The document does not address issues related to sunscreen active ingredients or certain other issues regarding the GRASE determin... Fed Regist journals http://www.medworm.com/rss/comments.php?id=4962985 Thu, 16 Jun 2011 23:00:00 +0100 4962985 http://www.medworm.com/index.php?rid=4962986&cid=s_27980_4_f&fid=27980&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D21675382%26dopt%3DAbstract Authors: The Food and Drug Administration (FDA) is classifying the wireless air-conduction hearing aid into class II (special controls). The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. PMID: 21675382 [PubMed - indexed for MEDLINE] (Source: Fed Regist) Fed Regist journals http://www.medworm.com/rss/comments.php?id=4962986 Tue, 14 Jun 2011 23:00:00 +0100 4962986 http://www.medworm.com/index.php?rid=4919978&cid=s_27980_4_f&fid=27980&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D21644388%26dopt%3DAbstract Authors: This final rule will implement section 2702 of the Patient Protection and Affordable Care Act which directs the Secretary of Health and Human Services to issue Medicaid regulations effective as of July 1, 2011 prohibiting Federal payments to States under section 1903 of the Social Security Act for any amounts expended for providing medical assistance for health care-acquired conditions specified in the regulation. It will also authorize States to identify other provider-preventable conditions for which Medicaid payment will be prohibited. PMID: 21644388 [PubMed - indexed for MEDLINE] (Source: Fed Regist) Fed Regist journals http://www.medworm.com/rss/comments.php?id=4919978 Sun, 05 Jun 2011 23:00:00 +0100 4919978 http://www.medworm.com/index.php?rid=4870359&cid=s_27980_4_f&fid=27980&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D21604603%26dopt%3DAbstract Authors: This final rule with comment period implements requirements for health insurance issuers regarding disclosure and review of unreasonable premium increases under section 2794 of the Public Health Service Act. The final rule establishes a rate review program to ensure that all rate increases that meet or exceed a specified threshold are reviewed by a State or CMS to determine whether they are unreasonable and that certain rate information be made public. PMID: 21604603 [PubMed - in process] (Source: Fed Regist) Fed Regist journals http://www.medworm.com/rss/comments.php?id=4870359 Sun, 22 May 2011 23:00:00 +0100 4870359 http://www.medworm.com/index.php?rid=4815500&cid=s_27980_4_f&fid=27980&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D21548399%26dopt%3DAbstract Authors: This final rule updates the prospective payment rates for Medicare inpatient hospital services provided by inpatient psychiatric facilities (IPFs) for discharges occurring during the rate year (RY) beginning July 1, 2011 through September 30, 2012. The final rule also changes the IPF prospective payment system (PPS) payment rate update period to a RY that coincides with a fiscal year (FY). In addition, the rule implements policy changes affecting the IPF PPS teaching adjustment. It also rebases and revises the Rehabilitation, Psychiatric, and Long-Term Care (RPL) market basket, and makes some clarifications and corrections to terminology and regulations text. PMID: 21548399 [PubMed - in process] (Source: Fed Regist) Fed Regist journals http://www.medworm.com/rss/comments.php?id=4815500 Thu, 05 May 2011 23:00:00 +0100 4815500 http://www.medworm.com/index.php?rid=4815499&cid=s_27980_4_f&fid=27980&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D21548401%26dopt%3DAbstract Authors: This final rule implements a Hospital Inpatient Value-Based Purchasing program (Hospital VBP program or the program) under section 1886(o) of the Social Security Act (the Act), under which value-based incentive payments will be made in a fiscal year to hospitals that meet performance standards with respect to a performance period for the fiscal year involved. The program will apply to payments for discharges occurring on or after October 1, 2012, in accordance with section 1886(o) (as added by section 3001(a) of the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act of 2010 (collectively known as the Affordable Care Act)). Scoring in the Hospital VBP program will be based on whether a hospital meets or exceeds the perfo... Fed Regist journals http://www.medworm.com/rss/comments.php?id=4815499 Thu, 05 May 2011 23:00:00 +0100 4815499 http://www.medworm.com/index.php?rid=4815502&cid=s_27980_4_f&fid=27980&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D21545046%26dopt%3DAbstract Authors: This final rule will revise the conditions of participation (CoPs) for both hospitals and critical access hospitals (CAHs). The final rule will implement a new credentialing and privileging process for physicians and practitioners providing telemedicine services. Currently, a hospital or CAH receiving telemedicine services must go through a burdensome credentialing and privileging process for each physician and practitioner who will be providing telemedicine services to its patients. This final rule will remove this undue hardship and financial burden. PMID: 21545046 [PubMed - in process] (Source: Fed Regist) Fed Regist journals http://www.medworm.com/rss/comments.php?id=4815502 Wed, 04 May 2011 23:00:00 +0100 4815502 http://www.medworm.com/index.php?rid=4815501&cid=s_27980_4_f&fid=27980&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D21545047%26dopt%3DAbstract Authors: This document promulgates Department of Veterans Affairs (VA) interim final regulations concerning a new caregiver benefits program provided by VA. This rule implements title I of the Caregivers and Veterans Omnibus Health Services Act of 2010, which was signed into law on May 5, 2010. The purpose of the new caregiver benefits program is to provide certain medical, travel, training, and financial benefits to caregivers of certain veterans and servicemembers who were seriously injured in the line of duty on or after September 11, 2001. PMID: 21545047 [PubMed - in process] (Source: Fed Regist) Fed Regist journals http://www.medworm.com/rss/comments.php?id=4815501 Wed, 04 May 2011 23:00:00 +0100 4815501 http://www.medworm.com/index.php?rid=4815503&cid=s_27980_4_f&fid=27980&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D21542396%26dopt%3DAbstract Authors: We are eliminating the Decision Review Board (DRB) portions of part 405 of our rules, which we currently use as the final step in our administrative review process for adjudicating initial disability claims in our Boston region. As of the effective date of this regulation, we will replace the DRB step with review by the Appeals Council. The Appeals Council will follow most of the rules in parts 404 and 416 that we use in the rest of the country to adjudicate disability claims at the Appeals Council level, with some differences needed to accommodate the rules that govern administrative law judge (ALJ) hearings in the Boston region. We will also authorize attorney advisors in the Boston region to conduct certain prehearing proceedings and make fully favorable decisions as they... Fed Regist journals http://www.medworm.com/rss/comments.php?id=4815503 Mon, 02 May 2011 23:00:00 +0100 4815503 http://www.medworm.com/index.php?rid=4815504&cid=s_27980_4_f&fid=27980&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D21528617%26dopt%3DAbstract Authors: This interim final rule implements Section 702 of the Ike Skelton National Defense Authorization Act for Fiscal Year 2011 (NDAA for FY11). It establishes the TRICARE Young Adult (TYA) program to provide an extended medical coverage opportunity to most unmarried children under the age of 26 of uniformed services sponsors. The TRICARE Young Adult program is a premium-based program. PMID: 21528617 [PubMed - in process] (Source: Fed Regist) Fed Regist journals http://www.medworm.com/rss/comments.php?id=4815504 Tue, 26 Apr 2011 23:00:00 +0100 4815504 http://www.medworm.com/index.php?rid=4815505&cid=s_27980_4_f&fid=27980&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D21516875%26dopt%3DAbstract Authors: The Food and Drug Administration (FDA) is reclassifying the topical oxygen chamber for extremities (TOCE) from class III to class II. This device is intended to surround a patient's limb and apply humidified oxygen topically at a pressure slightly greater than atmospheric pressure to aid healing of chronic skin ulcers, such as bedsores. This reclassification is on the Secretary of Health and Human Services's own initiative based on new information. This action is being taken under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) as amended by the Medical Device Amendments of 1976 (the 1976 Amendments), the Safe Medical Devices Act of 1990 (the SMDA), and the Food and Drug Administration Modernization Act of 1997 (FDAMA). Elsewhere in this issue of the Federal Regi... Fed Regist journals http://www.medworm.com/rss/comments.php?id=4815505 Sun, 24 Apr 2011 23:00:00 +0100 4815505 http://www.medworm.com/index.php?rid=4815507&cid=s_27980_4_f&fid=27980&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D21513174%26dopt%3DAbstract Authors: This final rule will revise Medicaid regulations for Mechanized Claims Processing and Information Retrieval Systems. We are also modifying our regulations so that the enhanced Federal financial participation (FFP) is available for design, development and installation or enhancement of eligibility determination systems until December 31, 2015. This final rule also imposes certain defined standards and conditions in terms of timeliness, accuracy, efficiency, and integrity for mechanized claims processing and information retrieval systems in order to receive enhanced FFP. PMID: 21513174 [PubMed - indexed for MEDLINE] (Source: Fed Regist) Fed Regist journals http://www.medworm.com/rss/comments.php?id=4815507 Mon, 18 Apr 2011 23:00:00 +0100 4815507 http://www.medworm.com/index.php?rid=4815508&cid=s_27980_4_f&fid=27980&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D21513173%26dopt%3DAbstract Authors: The Food and Drug Administration (FDA) is classifying the hemorrhoid prevention pressure wedge into class II (special controls). The special controls will apply to the device in order to provide a reasonable assurance of safety and effectiveness of the device. A hemorrhoid prevention pressure wedge provides support to the perianal region during the labor and delivery process. PMID: 21513173 [PubMed - indexed for MEDLINE] (Source: Fed Regist) Fed Regist journals http://www.medworm.com/rss/comments.php?id=4815508 Thu, 14 Apr 2011 23:00:00 +0100 4815508 http://www.medworm.com/index.php?rid=4815506&cid=s_27980_4_f&fid=27980&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D21513175%26dopt%3DAbstract Authors: This final rule makes revisions to the Medicare Advantage (MA) program (Part C) and Prescription Drug Benefit Program (Part D) to implement provisions specified in the Patient Protection and Affordable Care Act and the Health Care and Education Reconciliation Act of 2010 (collectively referred to as the Affordable Care Act) (ACA) and make other changes to the regulations based on our experience in the administration of the Part C and Part D programs. These latter revisions clarify various program participation requirements; make changes to strengthen beneficiary protections; strengthen our ability to identify strong applicants for Part C and Part D program participation and remove consistently poor performers; and make other clarifications and technical changes. PMID: 21... Fed Regist journals http://www.medworm.com/rss/comments.php?id=4815506 Thu, 14 Apr 2011 23:00:00 +0100 4815506 http://www.medworm.com/index.php?rid=4815509&cid=s_27980_4_f&fid=27980&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D21491809%26dopt%3DAbstract Authors: The Food and Drug Administration (FDA) is classifying the low level laser system for aesthetic use into class II (special controls). The special control(s) that will apply to the device is entitled ``Class II Special Controls Guidance Document: Low Level Laser System for Aesthetic Use.'' The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document that will serve as the special control for this device type. PMID: 21491809 [PubMed - indexed for MEDLINE] (Source: Fed Regist) Fed Regist journals http://www.medworm.com/rss/comments.php?id=4815509 Wed, 13 Apr 2011 23:00:00 +0100 4815509 http://www.medworm.com/index.php?rid=4815511&cid=s_27980_4_f&fid=27980&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D21491807%26dopt%3DAbstract Authors: The Food and Drug Administration (FDA) is amending the biologics regulations to permit the Director of the Center for Biologics Evaluation and Research (CBER) or the Director of the Center for Drug Evaluation and Research (CDER), as appropriate, to approve exceptions or alternatives to the regulation for constituent materials. A request for an exception or alternative will be considered for approval when the data submitted in support of such a request establish the safety, purity, and potency of the biological product for the conditions of use, including indication and patient population, for which the applicant is seeking approval. FDA is taking this action due to advances in developing and manufacturing safe, pure, and potent biological products licensed under the Public H... Fed Regist journals http://www.medworm.com/rss/comments.php?id=4815511 Tue, 12 Apr 2011 23:00:00 +0100 4815511 http://www.medworm.com/index.php?rid=4815510&cid=s_27980_4_f&fid=27980&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D21491808%26dopt%3DAbstract Authors: On October 12, 2010, the President signed the Combat Methamphetamine Enhancement Act of 2010 (MEA). It establishes new requirements for mail-order distributors of scheduled listed chemical products. Mail-order distributors must now self-certify to DEA in order to sell scheduled listed chemical products at retail. Sales at retail are those sales intended for personal use; mail-order distributors that sell scheduled listed chemical products not intended for personal use, e.g., sale to a university, are not affected by the new law. This self-certification must include a statement that the mail-order distributor understands each of the requirements that apply under part 1314 and agrees to comply with these requirements. Additionally, mail-order distributors are now required to t... Fed Regist journals http://www.medworm.com/rss/comments.php?id=4815510 Tue, 12 Apr 2011 23:00:00 +0100 4815510 http://www.medworm.com/index.php?rid=4815512&cid=s_27980_4_f&fid=27980&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D21491806%26dopt%3DAbstract Authors: We are revising the criteria in the Listing of Impairments (the listings) that we use to evaluate claims under titles II and XVI of the Social Security Act (Act) involving endocrine disorders in adults and children. The revisions reflect our adjudicative experience, advances in medical knowledge, information from medical experts, and comments we received from the public in response to an advance notice of proposed rulemaking (ANPRM), a notice of proposed rulemaking (NPRM), and at an outreach policy conference. PMID: 21491806 [PubMed - indexed for MEDLINE] (Source: Fed Regist) Fed Regist journals http://www.medworm.com/rss/comments.php?id=4815512 Thu, 07 Apr 2011 23:00:00 +0100 4815512 http://www.medworm.com/index.php?rid=4815513&cid=s_27980_4_f&fid=27980&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D21491804%26dopt%3DAbstract Authors: This interim final rule with comment will revise the end-stage renal disease (ESRD) transition budget-neutrality adjustment finalized in the CY 2011 ESRD Prospective Payment System (PPS) final rule for renal dialysis services provided on April 1, 2011 through December 31, 2011. We are revising the transition budget-neutrality adjustment to reflect the actual election decision to receive payment under the ESRD PPS for renal dialysis services furnished on or after January 1, 2011 made by ESRD facilities, rather than projected elections using the same methodology as described in the ESRD PPS proposed and final rules. This results in a zero percent adjustment for renal dialysis services furnished April 1, 2011 through December 31, 2011. PMID: 21491804 [PubMed - indexed for M... Fed Regist journals http://www.medworm.com/rss/comments.php?id=4815513 Tue, 05 Apr 2011 23:00:00 +0100 4815513 http://www.medworm.com/index.php?rid=4654977&cid=s_27980_4_f&fid=27980&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D21434456%26dopt%3DAbstract Authors: The Food and Drug Administration (FDA) is classifying the ovarian adnexal mass assessment score test system into class II (special controls). The special control that will apply to these devices is the guidance document entitled “Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Ovarian Adnexal Mass Assessment Score Test System.” The Agency is classifying these devices into class II (special controls) because special controls, in addition to general controls, will provide a reasonable assurance of safety and effectiveness of these devices and there is sufficient information to establish special controls. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document that will serve as the special... Fed Regist journals http://www.medworm.com/rss/comments.php?id=4654977 Wed, 23 Mar 2011 00:00:00 +0100 4654977 http://www.medworm.com/index.php?rid=4654978&cid=s_27980_4_f&fid=27980&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D21434455%26dopt%3DAbstract Authors: This final rule will revise and expand current Medicare and Medicaid regulations regarding the imposition and collection of civil money penalties by CMS when nursing homes are not in compliance with Federal participation requirements in accordance with section 6111 of the Affordable Care Act of 2010. PMID: 21434455 [PubMed - in process] (Source: Fed Regist) Fed Regist journals http://www.medworm.com/rss/comments.php?id=4654978 Fri, 18 Mar 2011 00:00:00 +0100 4654978 http://www.medworm.com/index.php?rid=4592918&cid=s_27980_4_f&fid=27980&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D21351680%26dopt%3DAbstract Authors: The Department of Health and Human Services issues this final rule which provides that enforcement of the federal statutory health care provider conscience protections will be handled by the Department's Office for Civil Rights, in conjunction with the Department's funding components. This Final Rule rescinds, in part, and revises, the December 19, 2008 Final Rule entitled "Ensuring That Department of Health and Human Services Funds Do Not Support Coercive or Discriminatory Policies or Practices in Violation of Federal Law" (the "2008 Final Rule"). Neither the 2008 final rule, nor this final rule, alters the statutory protections for individuals and health care entities under the federal health care provider conscience protection statutes, including the Church Amendments, Se... Fed Regist journals http://www.medworm.com/rss/comments.php?id=4592918 Wed, 23 Feb 2011 00:00:00 +0100 4592918 http://www.medworm.com/index.php?rid=4592919&cid=s_27980_4_f&fid=27980&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D21351679%26dopt%3DAbstract Authors: This document affirms as final an interim final rule that froze until January 1, 2012, the copayment required for certain medications. Under those amendments, the copayment amount for veterans in the Department of Veterans Affairs (VA) health care system, enrollment priority categories 2 through 6, will remain at $8 and the copayment amount for veterans in enrollment priority categories 7 and 8 will remain at $9. The maximum annual copayment amount will also not increase. On January 1, 2012, the copayment amounts will increase based on the prescription drug component of the Medical Consumer Price Index (CPI-P). When the copayment increases, the maximum annual copayment amount automatically increases in turn. PMID: 21351679 [PubMed - in process] (Source: Fed Regist) Fed Regist journals http://www.medworm.com/rss/comments.php?id=4592919 Tue, 22 Feb 2011 00:00:00 +0100 4592919 http://www.medworm.com/index.php?rid=4592920&cid=s_27980_4_f&fid=27980&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D21351678%26dopt%3DAbstract Authors: This final rule describes the implementation of funding provisions under Title XXI of the Social Security Act (the Act), for the Children's Health Insurance Program (CHIP), as amended by the Children's Health Insurance Program Reauthorization Act of 2009 (CHIPRA), by the Medicare, Medicaid, and SCHIP Extension Act of 2007 (MMSEA), by other related CHIP legislation, and most recently by the Patient Protection and Affordable Care Act of 2010 (the Affordable Care Act). Specifically, this final rule addresses methodologies and procedures for determining States' fiscal years 2009 through 2015 allotments and payments in accordance with sections 2104 and 2105 of the Act, as amended by CHIPRA and the Affordable Care Act. PMID: 21351678 [PubMed - in process] (Source: Fed Regist) Fed Regist journals http://www.medworm.com/rss/comments.php?id=4592920 Thu, 17 Feb 2011 00:00:00 +0100 4592920 http://www.medworm.com/index.php?rid=4592921&cid=s_27980_4_f&fid=27980&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D21351676%26dopt%3DAbstract Authors: The Food and Drug Administration (FDA), on its own initiative, is issuing a final rule to reclassify Medical Device Data Systems (MDDSs) from class III (premarket approval) into class I (general controls). MDDS devices are intended to transfer, store, convert from one format to another according to preset specifications, or display medical device data. MDDSs perform all intended functions without controlling or altering the function or parameters of any connected medical devices. An MDDS is not intended to be used in connection with active patient monitoring. FDA is exempting MDDSs from the premarket notification requirements. PMID: 21351676 [PubMed - in process] (Source: Fed Regist) Fed Regist journals http://www.medworm.com/rss/comments.php?id=4592921 Tue, 15 Feb 2011 00:00:00 +0100 4592921 http://www.medworm.com/index.php?rid=4592922&cid=s_27980_4_f&fid=27980&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D21348347%26dopt%3DAbstract Authors: This final rule adds a definition of Bariatric Surgery, amends the definition of Morbid Obesity, and revises the language relating to the treatment of morbid obesity to allow benefit consideration for newer bariatric surgical procedures that are considered appropriate medical care. The final rule removes language that specifically limits the types of surgical procedures to treat co-morbid conditions associated with morbid obesity and retains the TRICARE Program exclusion of non-surgical interventions related to morbid obesity, obesity and/or weight reduction. This final rule is necessary to allow coverage for other surgical procedures that reduce or resolve co-morbid conditions associated with morbid obesity and the use of the Body Mass Index (BMI), which is the more accurat... Fed Regist journals http://www.medworm.com/rss/comments.php?id=4592922 Mon, 14 Feb 2011 00:00:00 +0100 4592922 http://www.medworm.com/index.php?rid=4592916&cid=s_27980_4_f&fid=27980&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D21351682%26dopt%3DAbstract Authors: This document amends Department of Veterans Affairs (VA) regulations to reflect changes made by section 504 of the Caregivers and Veterans Omnibus Health Services Act of 2010. Section 504 authorizes a VA practitioner, when the practitioner deems it necessary to ensure an informed medical decision, to share certain, otherwise protected medical information with the representative of a patient who lacks decision-making capacity. This rulemaking amends VA regulations consistent with this new authority. PMID: 21351682 [PubMed - in process] (Source: Fed Regist) Fed Regist journals http://www.medworm.com/rss/comments.php?id=4592916 Tue, 08 Feb 2011 00:00:00 +0100 4592916 http://www.medworm.com/index.php?rid=4592917&cid=s_27980_4_f&fid=27980&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D21351681%26dopt%3DAbstract Authors: The Food and Drug Administration (FDA) is classifying the contact cooling system for aesthetic use into class II (special controls). The special control that will apply to the device is the guidance document entitled "Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Contact Cooling System for Aesthetic Use." The Agency is classifying the device into class II (special controls) in order to provide reasonable assurance of safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document that will serve as the special control for this device type. PMID: 21351681 [PubMed - in process] (Source: Fed Regist) Fed Regist journals http://www.medworm.com/rss/comments.php?id=4592917 Mon, 07 Feb 2011 00:00:00 +0100 4592917 http://www.medworm.com/index.php?rid=4479092&cid=s_27980_4_f&fid=27980&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D21287774%26dopt%3DAbstract Authors: This final rule with comment period will implement provisions of the ACA that establish: Procedures under which screening is conducted for providers of medical or other services and suppliers in the Medicare program, providers in the Medicaid program, and providers in the Children's Health Insurance Program (CHIP); an application fee imposed on institutional providers and suppliers; temporary moratoria that may be imposed if necessary to prevent or combat fraud, waste, and abuse under the Medicare and Medicaid programs, and CHIP; guidance for States regarding termination of providers from Medicaid and CHIP if terminated by Medicare or another Medicaid State plan or CHIP; guidance regarding the termination of providers and suppliers from Medicare if terminated by a Medicaid S... Fed Regist journals http://www.medworm.com/rss/comments.php?id=4479092 Wed, 02 Feb 2011 00:00:00 +0100 4479092 http://www.medworm.com/index.php?rid=4479093&cid=s_27980_4_f&fid=27980&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D21275190%26dopt%3DAbstract Authors: This document adopts as a final rule the Department of Veterans Affairs' (VA) proposal to amend VA adjudication, medical, and vocational rehabilitation and employment regulations to incorporate relevant provisions of the Veterans Benefits Act of 2003. Specifically, this document amends VA regulations regarding herbicide exposure of certain veterans who served in or near the Korean demilitarized zone and regulations regarding spina bifida in their children. It also amends VA's medical regulations by correcting the Health Administration Center's hand-delivery address. PMID: 21275190 [PubMed - indexed for MEDLINE] (Source: Fed Regist) Fed Regist journals http://www.medworm.com/rss/comments.php?id=4479093 Tue, 25 Jan 2011 00:00:00 +0100 4479093 http://www.medworm.com/index.php?rid=4414286&cid=s_27980_4_f&fid=27980&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D21261129%26dopt%3DAbstract Authors: This final rule adds coverage of National Cancer Institute (NCI) sponsored Phase I studies for certain beneficiaries. The NCI sponsored clinical treatment trials are conducted in a series of steps called phases. Phase I trials are the first studies conducted in people. They evaluate how a new drug should be given (by mouth, injected into the blood, or injected into the muscle), how often, and what dose is safe. PMID: 21261129 [PubMed - in process] (Source: Fed Regist) Fed Regist journals http://www.medworm.com/rss/comments.php?id=4414286 Thu, 13 Jan 2011 00:00:00 +0100 4414286 http://www.medworm.com/index.php?rid=4414300&cid=s_27980_4_f&fid=27980&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D21261128%26dopt%3DAbstract Authors: This final rule establishes a permanent certification program for the purpose of certifying health information technology (HIT). This final rule is issued pursuant to the authority granted to the National Coordinator for Health Information Technology (the National Coordinator) by section 3001(c)(5) of the Public Health Service Act (PHSA), as added by the Health Information Technology for Economic and Clinical Health (HITECH) Act. The permanent certification program will eventually replace the temporary certification program that was previously established by a final rule. The National Coordinator will use the permanent certification program to authorize organizations to certify electronic health record (EHR) technology, such as Complete EHRs and/or EHR Modules. The permanent... Fed Regist journals http://www.medworm.com/rss/comments.php?id=4414300 Fri, 07 Jan 2011 00:00:00 +0100 4414300 http://www.medworm.com/index.php?rid=4479094&cid=s_27980_4_f&fid=27980&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D21261127%26dopt%3DAbstract Authors: This final rule will implement a quality incentive program (QIP) for Medicare outpatient end-stage renal disease (ESRD) dialysis providers and facilities with payment consequences beginning January 1, 2012, in accordance with section 1881(h) of the Act (added on July 15, 2008 by section 153(c) of the Medicare Improvements for Patients and Providers Act (MIPPA)). Under the ESRD QIP, ESRD payments made to dialysis providers and facilities under section 1881(b)(14) of the Social Security Act will be reduced by up to two percent if the providers/facilities fail to meet or exceed a total performance score with respect to performance standards established with respect to certain specified measures. PMID: 21261127 [PubMed - indexed for MEDLINE] (Source: Fed Regist) Fed Regist journals http://www.medworm.com/rss/comments.php?id=4479094 Wed, 05 Jan 2011 00:00:00 +0100 4479094 http://www.medworm.com/index.php?rid=4479095&cid=s_27980_4_f&fid=27980&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D21261126%26dopt%3DAbstract Authors: The Food and Drug Administration (FDA) is amending the current informed consent regulations to require that informed consent documents and processes for applicable drug (including biological products) and device clinical trials include a specific statement that clinical trial information will be entered into a databank. The databank referred to in this final rule is the clinical trial registry databank maintained by the National Institutes of Health/National Library of Medicine (NIH/NLM) which was created by statute. The submission of clinical trial information to this data bank also is required by statute. This amendment to the informed consent regulations is required by the Food and Drug Administration Amendments Act of 2007 (FDAAA) and is designed to promote transparency ... Fed Regist journals http://www.medworm.com/rss/comments.php?id=4479095 Tue, 04 Jan 2011 00:00:00 +0100 4479095 http://www.medworm.com/index.php?rid=4479096&cid=s_27980_4_f&fid=27980&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D21261125%26dopt%3DAbstract Authors: We are revising our regulations to incorporate changes to the Medicare prescription drug coverage low-income subsidy (Extra Help) program made by the Affordable Care Act which was enacted on March 23, 2010. Under our interpretation of section 3304 of the Affordable Care Act and this interim final rule, if the death of a beneficiary's spouse would decrease or eliminate the subsidy provided by the Extra Help program, we will, based on a determination, or redetermination, extend the effective period of eligibility for the most recent determination or redetermination until 1 year after the month following the month we are notified of the death of the spouse. These regulatory changes will allow us to implement this provision of the Affordable Care Act when it goes into effect on ... Fed Regist journals http://www.medworm.com/rss/comments.php?id=4479096 Wed, 29 Dec 2010 00:00:00 +0100 4479096 http://www.medworm.com/index.php?rid=4281597&cid=s_27980_4_f&fid=27980&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D21171485%26dopt%3DAbstract Authors: With the issuance of this final rule, the Deputy Administrator of the Drug Enforcement Administration (DEA) places the substance 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT), including its salts, isomers and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible, into schedule I of the Controlled Substances Act (CSA). This action by the DEA Deputy Administrator is based on a scheduling recommendation from the Assistant Secretary for Health of the Department of Health and Human Services (DHHS) and a DEA review indicating that 5-MeO-DMT meets the criteria for placement in schedule I of the CSA. This final rule will impose the criminal sanctions and regulatory controls of schedule I substances under the CSA on the manufacture, distribut... Fed Regist journals http://www.medworm.com/rss/comments.php?id=4281597 Mon, 20 Dec 2010 00:00:00 +0100 4281597 http://www.medworm.com/index.php?rid=4281598&cid=s_27980_4_f&fid=27980&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D21166263%26dopt%3DAbstract Authors: This document affirms as final, with changes, a proposed rule that updates the Department of Veterans Affairs (VA) medical regulations concerning the payment methodology used to calculate VA payments for inpatient and outpatient health care professional services and other medical services associated with non-VA outpatient care. The rule has been designed to ensure that it will not have adverse effects on access to care. PMID: 21166263 [PubMed - in process] (Source: Fed Regist) Fed Regist journals http://www.medworm.com/rss/comments.php?id=4281598 Fri, 17 Dec 2010 00:00:00 +0100 4281598 http://www.medworm.com/index.php?rid=4281599&cid=s_27980_4_f&fid=27980&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D21140595%26dopt%3DAbstract Authors: We are modifying our regulations to establish a 12-month time limit for the withdrawal of old-age benefits applications, allow one withdrawal per lifetime, and limit the voluntary suspension of benefits for purposes of receiving delayed retirement credits to months for which you have not received a payment. We are making these changes to revise current policies that have the potential for misuse. PMID: 21140595 [PubMed - in process] (Source: Fed Regist) Fed Regist journals http://www.medworm.com/rss/comments.php?id=4281599 Wed, 08 Dec 2010 00:00:00 +0100 4281599 http://www.medworm.com/index.php?rid=4253401&cid=s_27980_4_f&fid=27980&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D21137594%26dopt%3DAbstract Authors: We are adding a new subpart to our regulations, which contains the rules we will apply to determine the income-related monthly adjustment amount for Medicare prescription drug coverage premiums. This new subpart implements changes made to the Social Security Act (Act) by the Affordable Care Act. These rules parallel the rules in subpart B of this part, which describes the rules we apply when we determine the income-related monthly adjustment amount for certain Medicare Part B (medical insurance) beneficiaries. These rules describe the new subpart; what information we will use to determine whether you will pay an income-related monthly adjustment amount and the amount of the adjustment when applicable; when we will consider a major life-changing event that results in a signif... Fed Regist journals http://www.medworm.com/rss/comments.php?id=4253401 Tue, 07 Dec 2010 00:00:00 +0100 4253401 http://www.medworm.com/index.php?rid=4253403&cid=s_27980_4_f&fid=27980&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D21128372%26dopt%3DAbstract Authors: The U.S. Office of Personnel Management is issuing final regulations on the use of sick leave and advanced sick leave for serious communicable diseases, including pandemic influenza when appropriate. We are also permitting employees to substitute up to 26 weeks of accrued or accumulated sick leave for unpaid Family and Medical Leave Act (FMLA) leave to care for a seriously injured or ill covered servicemember, as authorized under the National Defense Authorization Act for Fiscal Year 2008, including up to 30 days of advanced sick leave for this purpose. Finally, we are reorganizing the existing sick leave regulations to enhance reader understanding and administration of the program. PMID: 21128372 [PubMed - in process] (Source: Fed Regist) Fed Regist journals http://www.medworm.com/rss/comments.php?id=4253403 Fri, 03 Dec 2010 00:00:00 +0100 4253403 http://www.medworm.com/index.php?rid=4253407&cid=s_27980_4_f&fid=27980&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D21121184%26dopt%3DAbstract Authors: This document contains the interim final regulation implementing medical loss ratio (MLR) requirements for health insurance issuers under the Public Health Service Act, as added by the Patient Protection and Affordable Care Act (Affordable Care Act). PMID: 21121184 [PubMed - in process] (Source: Fed Regist) Fed Regist journals http://www.medworm.com/rss/comments.php?id=4253407 Wed, 01 Dec 2010 00:00:00 +0100 4253407 http://www.medworm.com/index.php?rid=4253416&cid=s_27980_4_f&fid=27980&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D21121182%26dopt%3DAbstract Authors: The Food and Drug Administration (FDA) is amending certain of its general regulations to include tobacco products, where appropriate, in light of FDA's authority to regulate these products under the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act). With these amendments, tobacco products will be subject to the same general requirements that apply to other FDA-regulated products. Elsewhere in this issue of the Federal Register, we are publishing a companion proposed rule under FDA's usual procedures for notice and comment to provide a procedural framework to finalize the rule in the event we receive significant adverse comment and withdraw this direct final rule. PMID: 21121182 [PubMed - in process] (Source: Fed Regist) Fed Regist journals http://www.medworm.com/rss/comments.php?id=4253416 Tue, 30 Nov 2010 00:00:00 +0100 4253416 http://www.medworm.com/index.php?rid=4253410&cid=s_27980_4_f&fid=27980&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D21121183%26dopt%3DAbstract Authors: This final rule amends Medicaid regulations to conform with the decision by the United States District Court for the District of Columbia on May 23, 2008 in Alameda County Medical Center, et al. v. Michael O. Leavitt, Secretary, U.S. Department of Health and Human Services, et al., 559 F. Supp. 2d (2008) that vacated a final rule with comment period published in the Federal Register in May 29, 2007. This regulatory action takes ministerial steps to remove the vacated provisions from the Code of Federal Regulations and reinstate the prior regulatory language impacted by the May 29, 2007 final rule with comment period. PMID: 21121183 [PubMed - in process] (Source: Fed Regist) Fed Regist journals http://www.medworm.com/rss/comments.php?id=4253410 Tue, 30 Nov 2010 00:00:00 +0100 4253410 http://www.medworm.com/index.php?rid=4253417&cid=s_27980_4_f&fid=27980&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D21121181%26dopt%3DAbstract Authors: This final rule with comment period addresses changes to the physician fee schedule and other Medicare Part B payment policies to ensure that our payment systems are updated to reflect changes in medical practice and the relative value of services. It finalizes the calendar year (CY) 2010 interim relative value units (RVUs) and issues interim RVUs for new and revised procedure codes for CY 2011. It also addresses, implements, or discusses certain provisions of both the Affordable Care Act (ACA) and the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA). In addition, this final rule with comment period discusses payments under the Ambulance Fee Schedule (AFS), the Ambulatory Surgical Center (ASC) payment system, and the Clinical Laboratory Fee Schedule (CLFS... Fed Regist journals http://www.medworm.com/rss/comments.php?id=4253417 Mon, 29 Nov 2010 00:00:00 +0100 4253417 http://www.medworm.com/index.php?rid=4253418&cid=s_27980_4_f&fid=27980&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D21121180%26dopt%3DAbstract Authors: The final rule with comment period in this document revises the Medicare hospital outpatient prospective payment system (OPPS) to implement applicable statutory requirements and changes arising from our continuing experience with this system and to implement certain provisions of the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act of 2010 (Affordable Care Act). In this final rule with comment period, we describe the 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, 2011. In addition, this final rule with comment period updates the revised M... Fed Regist journals http://www.medworm.com/rss/comments.php?id=4253418 Wed, 24 Nov 2010 00:00:00 +0100 4253418 http://www.medworm.com/index.php?rid=4203380&cid=s_27980_4_f&fid=27980&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D21090147%26dopt%3DAbstract Authors: This final rule will revise the Medicare conditions of participation for hospitals and critical access hospitals (CAHs) to provide visitation rights to Medicare and Medicaid patients. Specifically, Medicare- and Medicaid-participating hospitals and CAHs will be required to have written policies and procedures regarding the visitation rights of patients, including those setting forth any clinically necessary or reasonable restriction or limitation that the hospital or CAH may need to place on such rights as well as the reasons for the clinical restriction or limitation. PMID: 21090147 [PubMed - in process] (Source: Fed Regist) Fed Regist journals http://www.medworm.com/rss/comments.php?id=4203380 Fri, 19 Nov 2010 00:00:00 +0100 4203380 http://www.medworm.com/index.php?rid=4203383&cid=s_27980_4_f&fid=27980&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D21090144%26dopt%3DAbstract Authors: The Food and Drug Administration (FDA) is classifying the non-powered suction apparatus device intended for negative pressure wound therapy (NPWT) into class II (special controls). The special control that will apply to the device is the guidance document entitled "Class II Special Controls Guidance Document: Non-Powered Suction Apparatus Device Intended for Negative Pressure Wound Therapy." The agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA is publishing a notice of availability for the guidance document entitled "Class II Special Controls Guidance Document: Non-Powered Suction Apparatus Device Intended for Negative Pr... Fed Regist journals http://www.medworm.com/rss/comments.php?id=4203383 Wed, 17 Nov 2010 00:00:00 +0100 4203383 http://www.medworm.com/index.php?rid=4203382&cid=s_27980_4_f&fid=27980&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D21090145%26dopt%3DAbstract Authors: , , This document contains an amendment to interim final regulations implementing the rules for group health plans and health insurance coverage in the group and individual markets under provisions of the Patient Protection and Affordable Care Act regarding status as a grandfathered health plan; the amendment permits certain changes in policies, certificates, or contracts of insurance without loss of grandfathered status. PMID: 21090145 [PubMed - in process] (Source: Fed Regist) Fed Regist journals http://www.medworm.com/rss/comments.php?id=4203382 Wed, 17 Nov 2010 00:00:00 +0100 4203382 http://www.medworm.com/index.php?rid=4203381&cid=s_27980_4_f&fid=27980&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D21090146%26dopt%3DAbstract Authors: This final rule sets forth an update to the Home Health Prospective Payment System (HH PPS) rates, including: the national standardized 60-day episode rates, the national per-visit rates, the nonroutine medical supply (NRS) conversion factors, and the low utilization payment amount (LUPA) add-on payment amounts, under the Medicare prospective payment system for HHAs effective January 1, 2011. This rule also updates the wage index used under the HH PPS and, in accordance with the Patient Protection and Affordable Care Act of 2010 (Affordable Care Act), updates the HH PPS outlier policy. In addition, this rule revises the home health agency (HHA) capitalization requirements. This rule further adds clarifying language to the "skilled services" section. The rule finalizes a 3.79... Fed Regist journals http://www.medworm.com/rss/comments.php?id=4203381 Wed, 17 Nov 2010 00:00:00 +0100 4203381 http://www.medworm.com/index.php?rid=4203384&cid=s_27980_4_f&fid=27980&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D21090143%26dopt%3DAbstract Authors: This final rule amends the Department of Veterans Affairs (VA) regulation that authorizes appropriate action when a patient engages in disruptive behavior at a VA medical facility. This amendment updates VA's current regulation to reflect modern medical care and ethical practices. The final rule authorizes VA to modify the time, place, and/or manner in which VA provides treatment to a patient, in order to ensure the safety of others at VA medical facilities, and to prevent any interference with the provision of medical care. PMID: 21090143 [PubMed - in process] (Source: Fed Regist) Fed Regist journals http://www.medworm.com/rss/comments.php?id=4203384 Tue, 16 Nov 2010 00:00:00 +0100 4203384 http://www.medworm.com/index.php?rid=4203385&cid=s_27980_4_f&fid=27980&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D21090142%26dopt%3DAbstract Authors: This final rule withdraws two provisions from the "Medicaid Program; Prescription Drugs'' final rule (referred to hereafter as "AMP final rule") published in the July 17, 2007 Federal Register. The provisions we are withdrawing are as follows: The determination of average manufacturer price, and the Federal upper limits for multiple source drugs. We are also withdrawing the definition of "multiple source drug" as it was revised in the ``Medicaid Program; Multiple Source Drug Definition'' final rule published in the October 7, 2008 Federal Register. PMID: 21090142 [PubMed - in process] (Source: Fed Regist) Fed Regist journals http://www.medworm.com/rss/comments.php?id=4203385 Mon, 15 Nov 2010 00:00:00 +0100 4203385 http://www.medworm.com/index.php?rid=4170180&cid=s_27980_4_f&fid=27980&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D21066902%26dopt%3DAbstract Authors: The Food and Drug Administration (FDA) is classifying the tissue adhesive with adjunct wound closure device intended for topical approximation into class II (special controls). The special control that will apply to the device is the guidance document entitled ``Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Tissue Adhesive With Adjunct Wound Closure Device Intended for the Topical Approximation of Skin.'' The agency is classifying the device into class II (special controls) in order to provide reasonable assurance of safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document that will serve as the special control for this device type. PMID: 21066902... Fed Regist journals http://www.medworm.com/rss/comments.php?id=4170180 Wed, 10 Nov 2010 00:00:00 +0100 4170180 http://www.medworm.com/index.php?rid=4170181&cid=s_27980_4_f&fid=27980&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D21053532%26dopt%3DAbstract Authors: The Food and Drug Administration (FDA) is announcing the reclassification of the full-field digital mammography (FFDM) system from class III (premarket approval) to class II (special controls). The device type is intended to produce planar digital x-ray images of the entire breast; this generic type of device may include digital mammography acquisition software, full-field digital image receptor, acquisition workstation, automatic exposure control, image processing and reconstruction programs, patient and equipment supports, component parts, and accessories. The special control that will apply to the device is the guidance document entitled "Class II Special Controls Guidance Document: Full-Field Digital Mammography System." FDA is reclassifying the device into class II (spe... Fed Regist journals http://www.medworm.com/rss/comments.php?id=4170181 Fri, 05 Nov 2010 00:00:00 +0100 4170181 http://www.medworm.com/index.php?rid=4140143&cid=s_27980_4_f&fid=27980&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D21033184%26dopt%3DAbstract Authors: The Advance Planning Document (APD) process governs the procedure by which States obtain approval for Federal financial participation in the cost of acquiring automated data processing equipment and services. This final rule reduces the submission requirements for lower-risk information technology (IT) projects and procurements and increases oversight over higher-risk IT projects and procurements by making technical changes, conforming changes and substantive revisions in the documentation required to be submitted by States, counties, and territories for approval of their Information Technology plans and acquisition documents. PMID: 21033184 [PubMed - in process] (Source: Fed Regist) Fed Regist journals http://www.medworm.com/rss/comments.php?id=4140143 Thu, 28 Oct 2010 00:00:00 +0100 4140143 http://www.medworm.com/index.php?rid=4090597&cid=s_27980_4_f&fid=27980&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D20960975%26dopt%3DAbstract Authors: Section 703 of the National Defense Authorization Act for Fiscal Year 2008 (NDAA-08) states with respect to any prescription filled on or after the date of enactment, the TRICARE Retail Pharmacy Program shall be treated as an element of the DoD for purposes of procurement of drugs by Federal agencies under section 8126 of title 38, United States Code (U.S.C.), to the extent necessary to ensure pharmaceuticals paid for by the DoD that are provided by network retail pharmacies under the program to eligible covered beneficiaries are subject to the pricing standards in such section 8126. DoD issued a final rule on March 17, 2009, implementing the law. On November 30, 2009, the U.S. District Court for the District of Columbia remanded the final rule to DoD (without vacating the r... Fed Regist journals http://www.medworm.com/rss/comments.php?id=4090597 Thu, 14 Oct 2010 23:00:00 +0100 4090597 http://www.medworm.com/index.php?rid=4090596&cid=s_27980_4_f&fid=27980&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D20960976%26dopt%3DAbstract Authors: The Public Readiness and Emergency Preparedness Act (PREP Act) authorizes the Secretary of Health and Human Services (the Secretary) to establish the Countermeasures Injury Compensation Program (CICP or Program). The Department of Health and Human Services (HHS) is issuing this interim final rule with request for comments in order to establish administrative policies, procedures, and requirements for the CICP. This Program is designed to provide benefits to certain persons who sustain serious physical injuries or death as a direct result of administration or use of covered countermeasures identified by the Secretary in declarations issued under the PREP Act. In addition, the Secretary may provide death benefits to certain survivors of individuals who died as the direct resul... Fed Regist journals http://www.medworm.com/rss/comments.php?id=4090596 Thu, 14 Oct 2010 23:00:00 +0100 4090596 http://www.medworm.com/index.php?rid=4078346&cid=s_27980_4_f&fid=27980&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D20941886%26dopt%3DAbstract Authors: We are revising our rules on a temporary basis to permit State agency disability examiners to make fully favorable determinations in certain claims for disability benefits under titles II and XVI of the Social Security Act (Act) without the approval of a State agency medical or psychological consultant. These changes apply only to claims we consider under our rules for quick disability determinations (QDD) or under our compassionate allowance initiative. PMID: 20941886 [PubMed - in process] (Source: Fed Regist) Fed Regist journals http://www.medworm.com/rss/comments.php?id=4078346 Tue, 12 Oct 2010 23:00:00 +0100 4078346 http://www.medworm.com/index.php?rid=4078345&cid=s_27980_4_f&fid=27980&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D20941887%26dopt%3DAbstract Authors: This document announces maintenance changes to some of the Health Insurance Portability and Accountability Act of 1996 standards made by the Designated Standard Maintenance Organizations. The maintenance changes are non-substantive changes to correct minor errors, such as typographical errors, or to provide clarifications of the standards adopted in our regulations entitled "Health Insurance Reform; Modifications to the Health Insurance Portability and Accountability Act (HIPAA) Electronic Transaction Standards," published in the Federal Register on January 16, 2009. This document also instructs interested persons on how to obtain the corrections. PMID: 20941887 [PubMed - in process] (Source: Fed Regist) Fed Regist journals http://www.medworm.com/rss/comments.php?id=4078345 Tue, 12 Oct 2010 23:00:00 +0100 4078345 http://www.medworm.com/index.php?rid=4078344&cid=s_27980_4_f&fid=27980&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D20941888%26dopt%3DAbstract Authors: The Department of Health and Human Services (HHS) is issuing this interim final rule with a request for comment to remove the implementation specifications related to public health surveillance. PMID: 20941888 [PubMed - in process] (Source: Fed Regist) Fed Regist journals http://www.medworm.com/rss/comments.php?id=4078344 Tue, 12 Oct 2010 23:00:00 +0100 4078344 http://www.medworm.com/index.php?rid=4066043&cid=s_27980_4_f&fid=27980&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D20931727%26dopt%3DAbstract Authors: This document amends the medical regulations of the Department of Veterans Affairs (VA) concerning ``reasonable charges'' for medical care or services provided or furnished by VA to a veteran for a nonservice-connected disability. More specifically, VA amends the regulations regarding charges billed for prescription drugs not administered during treatment by changing the billing formula to reflect VA's actual drug costs for each drug rather than using a national average drug cost for all prescriptions dispensed. The revised formula for calculating reasonable charges for prescription drug costs will also continue to include an average administrative cost for each prescription. The purpose is to provide VA with a more accurate billing methodology for prescription drugs. PM... Fed Regist journals http://www.medworm.com/rss/comments.php?id=4066043 Tue, 05 Oct 2010 23:00:00 +0100 4066043 http://www.medworm.com/index.php?rid=4027556&cid=s_27980_4_f&fid=27980&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D20879180%26dopt%3DAbstract Authors: The Food and Drug Administration (FDA) is amending its regulations governing safety reporting requirements for human drug and biological products subject to an investigational new drug application (IND). The final rule codifies the agency's expectations for timely review, evaluation, and submission of relevant and useful safety information and implements internationally harmonized definitions and reporting standards. The revisions will improve the utility of IND safety reports, reduce the number of reports that do not contribute in a meaningful way to the developing safety profile of the drug, expedite FDA's review of critical safety information, better protect human subjects enrolled in clinical trials, subject bioavailability and bioequivalence studies to safety reporting ... Fed Regist journals http://www.medworm.com/rss/comments.php?id=4027556 Tue, 28 Sep 2010 23:00:00 +0100 4027556 http://www.medworm.com/index.php?rid=3958093&cid=s_27980_4_f&fid=27980&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D20824947%26dopt%3DAbstract Authors: The Food and Drug Administration (FDA) is reclassifying the device type, standard percutaneous transluminal coronary angioplasty (PTCA) catheters, from class III (premarket approval) into class II (special controls). Cutting/scoring PTCA catheters remain in class III and continue to require premarket approval applications (PMAs). FDA is reclassifying these devices in accordance with the Federal Food, Drug, and Cosmetic Act (the act). Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document entitled ``Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters'' that will serve as the special control for the reclassified device typ... Fed Regist journals http://www.medworm.com/rss/comments.php?id=3958093 Tue, 07 Sep 2010 23:00:00 +0100 3958093 http://www.medworm.com/index.php?rid=3958094&cid=s_27980_4_f&fid=27980&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D20812423%26dopt%3DAbstract Discussion Group (PDG). The guidance conveys recognition of the three pharmacopoeial methods by the three ICH regulatory regions and provides specific information regarding the recognition. The guidance is intended to recognize the interchangeability between the local regional pharmacopoeias, thus avoiding redundant testing in favor of a common testing strategy in each regulatory region. This guidance is in the form of an annex to the core guidance on the Q4B process entitled "Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions" (the core ICH Q4B guidance). PMID: 20812423 [PubMed - in process] (Source: Fed Regist) Fed Regist journals http://www.medworm.com/rss/comments.php?id=3958094 Wed, 01 Sep 2010 23:00:00 +0100 3958094 http://www.medworm.com/index.php?rid=3958096&cid=s_27980_4_f&fid=27980&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D20806490%26dopt%3DAbstract Authors: This document makes technical amendments to the Department of Veterans Affairs (VA) regulation concerning enrollment and disenrollment from the VA medical care system. It removes the "automatic enrollment" provision relevant to a 1998 trial enrollment program that has been discontinued. It also amends the regulation to reflect current VA practice and to update the address for documents mailed to the VA Health Eligibility Center. Finally, it provides an internet address for accessing VA Form 10-10EZ online. PMID: 20806490 [PubMed - in process] (Source: Fed Regist) Fed Regist journals http://www.medworm.com/rss/comments.php?id=3958096 Thu, 26 Aug 2010 23:00:00 +0100 3958096 http://www.medworm.com/index.php?rid=3958095&cid=s_27980_4_f&fid=27980&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D20806491%26dopt%3DAbstract Authors: This final rule will clarify, expand, and add to the existing enrollment requirements that Durable Medical Equipment and Prosthetics, Orthotics, and Supplies (DMEPOS) suppliers must meet to establish and maintain billing privileges in the Medicare program. PMID: 20806491 [PubMed - in process] (Source: Fed Regist) Fed Regist journals http://www.medworm.com/rss/comments.php?id=3958095 Thu, 26 Aug 2010 23:00:00 +0100 3958095 http://www.medworm.com/index.php?rid=3902518&cid=s_27980_4_f&fid=27980&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D20718124%26dopt%3DAbstract Authors: The Department of Defense is publishing this final rule to provide TRICARE approval for authorizing certified physician assistants and certified nurse practitioners (non-physicians) to engage in referrals of beneficiaries to the Military Health System for physical therapy, occupational therapy, and speech therapy. Upon implementation of this provision, certified physician assistants, or certified nurse practitioners will be allowed to issue referrals to patients for physical therapy, occupational therapy, and speech therapy without having the patient see a physician. This rule will align TRICARE with Medicare's allowance of "non-physician providers" to provide, certify, or supervise therapy services. PMID: 20718124 [PubMed - in process] (Source: Fed Regist) Fed Regist journals http://www.medworm.com/rss/comments.php?id=3902518 Tue, 17 Aug 2010 23:00:00 +0100 3902518 http://www.medworm.com/index.php?rid=3902517&cid=s_27980_4_f&fid=27980&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D20718125%26dopt%3DAbstract Authors: The Department of Defense is publishing this final rule to implement section 4 of the Hubbard Actand section 734 of the Duncan Hunter National Defense Authorization Act for Fiscal Year 2009. These Acts provide two new categories of beneficiaries for the Transitional Assistance Management Program (TAMP). Specifically, a member who receives a sole survivorship discharge and a member who is separated from Active Duty who agrees to become a member of the Selected Reserve of the Ready Reserve of a reserve component are eligible for TAMP. PMID: 20718125 [PubMed - in process] (Source: Fed Regist) Fed Regist journals http://www.medworm.com/rss/comments.php?id=3902517 Tue, 17 Aug 2010 23:00:00 +0100 3902517 http://www.medworm.com/index.php?rid=3902516&cid=s_27980_4_f&fid=27980&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D20718126%26dopt%3DAbstract Authors: TRICARE has recognized the unique circumstances existing in Alaska which make the provision of medical care to TRICARE beneficiaries through the TRICARE program operated in the other 49 states unrealistic. Recognizing these unique conditions and circumstances, the Department of Defense has conducted a demonstration project in the state of Alaska since implementation of the TRICARE program under which certain exceptions have been made for administration of the program in Alaska. This rule incorporates the waiver of the requirement for financial underwriting by a TRICARE contractor as a permanent change to the administration of the TRICARE program in Alaska. This rule proposes no change to the TRICARE benefit or to those who are eligible for it. However, the rule does eliminat... Fed Regist journals http://www.medworm.com/rss/comments.php?id=3902516 Tue, 17 Aug 2010 23:00:00 +0100 3902516 http://www.medworm.com/index.php?rid=3902519&cid=s_27980_4_f&fid=27980&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D20712087%26dopt%3DAbstract Authors: : We are revising the Medicare hospital inpatient prospective payment systems (IPPS) for operating and capital-related costs of acute care hospitals to implement changes arising from our continuing experience with these systems and to implement certain provisions of the Affordable Care Act and other legislation. In addition, we describe the changes to the amounts and factors used to determine the rates for Medicare acute care hospital inpatient services for operating costs and capital-related costs. We also are setting forth the update to the rate-of-increase limits for certain hospitals excluded from the IPPS that are paid on a reasonable cost basis subject to these limits. We are updating the payment policy and the annual payment rates for the Medicare prospective payment ... Fed Regist journals http://www.medworm.com/rss/comments.php?id=3902519 Sun, 15 Aug 2010 23:00:00 +0100 3902519 http://www.medworm.com/index.php?rid=3902520&cid=s_27980_4_f&fid=27980&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D20712086%26dopt%3DAbstract Authors: This final rule implements a case-mix adjusted bundled prospective payment system (PPS) for Medicare outpatient end-stage renal disease (ESRD) dialysis facilities beginning January 1, 2011 (ESRD PPS), in compliance with the statutory requirement of the Medicare Improvements for Patients and Providers Act (MIPPA), enacted July 15, 2008. This ESRD PPS also replaces the current basic case-mix adjusted composite payment system and the methodologies for the reimbursement of separately billable outpatient ESRD services. PMID: 20712086 [PubMed - in process] (Source: Fed Regist) Fed Regist journals http://www.medworm.com/rss/comments.php?id=3902520 Wed, 11 Aug 2010 23:00:00 +0100 3902520 http://www.medworm.com/index.php?rid=3902521&cid=s_27980_4_f&fid=27980&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D20712085%26dopt%3DAbstract Authors: This final rule implements provisions from the Children's Health Insurance Program Reauthorization Act of 2009 (CHIPRA) (Pub. L. 111-3) with regard to the Medicaid Eligibility Quality Control (MEQC) and Payment Error Rate Measurement (PERM) programs. This final rule also codifies several procedural aspects of the process for estimating improper payments in Medicaid and the Children's Health Insurance Program (CHIP). PMID: 20712085 [PubMed - in process] (Source: Fed Regist) Fed Regist journals http://www.medworm.com/rss/comments.php?id=3902521 Tue, 10 Aug 2010 23:00:00 +0100 3902521 http://www.medworm.com/index.php?rid=3855801&cid=s_27980_4_f&fid=27980&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D20695127%26dopt%3DAbstract Authors: The Department of Defense is publishing this final rule to implement the requirements enacted by Congress in Section 732 of the Duncan Hunter National Defense Authorization Act for Fiscal Year 2009 which changes the limit of the Government's share of providing certain benefits under the Extended Care Health Option (ECHO) from $2,500 per month to $36,000 per year, and for other non-legislated changes to the ECHO. PMID: 20695127 [PubMed - in process] (Source: Fed Regist) Fed Regist journals http://www.medworm.com/rss/comments.php?id=3855801 Sun, 08 Aug 2010 23:00:00 +0100 3855801 http://www.medworm.com/index.php?rid=3855800&cid=s_27980_4_f&fid=27980&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D20695128%26dopt%3DAbstract Authors: This final rule eliminates the 1 year lock out for non-Active Duty members who disenroll from TRICARE Prime before their annual enrollment renewal date. PMID: 20695128 [PubMed - in process] (Source: Fed Regist) Fed Regist journals http://www.medworm.com/rss/comments.php?id=3855800 Sun, 08 Aug 2010 23:00:00 +0100 3855800 http://www.medworm.com/index.php?rid=3855805&cid=s_27980_4_f&fid=27980&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D20690232%26dopt%3DAbstract Authors: This interim final rule establishes requirements and procedures for implementation of TRICARE Retired Reserve. This interim final rule addresses provisions of the National Defense Authorization Act for Fiscal Year 2010 (NDAA-10). The purpose of this interim final rule is to establish the TRICARE Retired Reserve program that implements section 705 of the NDAA-10. Section 705 allows members of the Retired Reserve who are qualified for non-regular retirement, but are not yet 60 years of age, to qualify to purchase medical coverage equivalent to the TRICARE Standard (and Extra) benefit unless that member is either enrolled in, or is eligible to enroll in, a health benefit plan under Chapter 89 of Title 5, United States Code, as well as certain survivors. The amount of the premiu... Fed Regist journals http://www.medworm.com/rss/comments.php?id=3855805 Thu, 05 Aug 2010 23:00:00 +0100 3855805 http://www.medworm.com/index.php?rid=3855804&cid=s_27980_4_f&fid=27980&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D20690233%26dopt%3DAbstract Authors: This final rule revises the definition of rare diseases to adopt the definition of a rare disease as promulgated by the National Institutes of Health, Office of Rare Diseases. The rule modification will result in the definition used by the TRICARE program for a rare disease to be consistent with the definition used by the National Institutes of Health and the Food and Drug Administration. TRICARE has generally been applying the broader National Institutes of Health and Food and Drug Administration definitions when making coverage decisions for treatments; therefore, there will be no practical changes for beneficiaries. PMID: 20690233 [PubMed - in process] (Source: Fed Regist) Fed Regist journals http://www.medworm.com/rss/comments.php?id=3855804 Thu, 05 Aug 2010 23:00:00 +0100 3855804 http://www.medworm.com/index.php?rid=3855803&cid=s_27980_4_f&fid=27980&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D20690236%26dopt%3DAbstract Authors: The Department is publishing this final rule to implement section 703 of the National Defense Authorization Act (NDAA) for Fiscal Year 2007 (FY07), Public Law 109-364. Specifically, that legislation authorizes breast cancer screening and cervical cancer screening for female beneficiaries of the Military Health System, instead of constraining such testing to mammograms and Papanicolaou smears. The rule allows coverage for "breast cancer screening" and "cervical cancer screening" for female beneficiaries of the Military Health System, instead of constraining such testing to mammograms and Papanicolaou tests. This rule ensures new breast and cervical cancer screening procedures can be added to the TRICARE benefit as such procedures are proven to be a safe, effective, and nation... Fed Regist journals http://www.medworm.com/rss/comments.php?id=3855803 Thu, 05 Aug 2010 23:00:00 +0100 3855803 http://www.medworm.com/index.php?rid=3855802&cid=s_27980_4_f&fid=27980&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D20695037%26dopt%3DAbstract Authors: The Department of Defense is publishing this final rule to clarify TRICARE coverage for diabetic education. This rule introduces new definitions and addresses revisions or omissions in policy or procedure inadvertently missed in previous regulatory changes pertaining to diabetic education. PMID: 20695037 [PubMed - in process] (Source: Fed Regist) Fed Regist journals http://www.medworm.com/rss/comments.php?id=3855802 Thu, 05 Aug 2010 23:00:00 +0100 3855802 http://www.medworm.com/index.php?rid=3827382&cid=s_27980_4_f&fid=27980&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D20677417%26dopt%3DAbstract Authors: Section 1101 of Title I of the Patient Protection and Affordable Care Act of 2010 (Affordable Care Act) requires that the Secretary establish, either directly or through contracts with States or nonprofit private entities, a temporary high risk health insurance pool program to provide affordable health insurance coverage to uninsured individuals with pre-existing conditions. This program will continue until January 1, 2014, when Exchanges established under sections 1311 and 1321 of the Affordable Care Act will be available for individuals to obtain health insurance coverage. This interim final rule implements requirements in section 1101 of the Affordable Care Act. Key issues addressed in this interim final rule include administration of the program, eligibility and enrollme... Fed Regist journals http://www.medworm.com/rss/comments.php?id=3827382 Thu, 29 Jul 2010 23:00:00 +0100 3827382 http://www.medworm.com/index.php?rid=3827384&cid=s_27980_4_f&fid=27980&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D20677415%26dopt%3DAbstract Authors: This final rule implements the provisions of the American Recovery and Reinvestment Act of 2009 (ARRA) (Pub. L. 111-5) that provide incentive payments to eligible professionals (EPs), eligible hospitals and critical access hospitals (CAHs) participating in Medicare and Medicaid programs that adopt and successfully demonstrate meaningful use of certified electronic health record (EHR) technology. This final rule specifies--the initial criteria EPs, eligible hospitals, and CAHs must meet in order to qualify for an incentive payment; calculation of the incentive payment amounts; payment adjustments under Medicare for covered professional services and inpatient hospital services provided by EPs, eligible hospitals and CAHs failing to demonstrate meaningful use of certified EHR t... Fed Regist journals http://www.medworm.com/rss/comments.php?id=3827384 Tue, 27 Jul 2010 23:00:00 +0100 3827384 http://www.medworm.com/index.php?rid=3827383&cid=s_27980_4_f&fid=27980&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D20677416%26dopt%3DAbstract Authors: The Department of Health and Human Services (HHS) is issuing this final rule to complete the adoption of an initial set of standards, implementation specifications, and certification criteria, and to more closely align such standards, implementation specifications, and certification criteria with final meaningful use Stage 1 objectives and measures. Adopted certification criteria establish the required capabilities and specify the related standards and implementation specifications that certified electronic health record (EHR) technology will need to include to, at a minimum, support the achievement of meaningful use Stage 1 by eligible professionals, eligible hospitals, and/or critical access hospitals (hereafter, references to "eligible hospitals" in this final rule shall ... Fed Regist journals http://www.medworm.com/rss/comments.php?id=3827383 Tue, 27 Jul 2010 23:00:00 +0100 3827383 http://www.medworm.com/index.php?rid=3795674&cid=s_27980_4_f&fid=27980&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D20653112%26dopt%3DAbstract Authors: , , This document contains interim final regulations implementing the requirements regarding internal claims and appeals and external review processes for group health plans and health insurance coverage in the group and individual markets under the Patient Protection and Affordable Care Act. The regulations will generally affect health insurance issuers; group health plans; and participants, beneficiaries, and enrollees in health insurance coverage and in group health plans. The regulations provide plans and issuers with guidance necessary to comply with the law. PMID: 20653112 [PubMed - in process] (Source: Fed Regist) Fed Regist journals http://www.medworm.com/rss/comments.php?id=3795674 Thu, 22 Jul 2010 23:00:00 +0100 3795674 http://www.medworm.com/index.php?rid=3786475&cid=s_27980_4_f&fid=27980&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D20648725%26dopt%3DAbstract Authors: , , This document contains interim final regulations implementing the rules for group health plans and health insurance coverage in the group and individual markets under provisions of the Patient Protection and Affordable Care Act regarding preventive health services. PMID: 20648725 [PubMed - in process] (Source: Fed Regist) Fed Regist journals http://www.medworm.com/rss/comments.php?id=3786475 Sun, 18 Jul 2010 23:00:00 +0100 3786475