Medicare and Medicaid programs; revaluation of assets--HCFA. Final rule

This final rule revises the Medicare and Medicaid regulations that are affected by section 2314 of the Deficit Reduction Act of 1984 and sections 9110 and 9509 of the Consolidation Omnibus Budget Reconciliation Act of 1985. Those provisions amended sections 1861(v)(1) and 1902(a)(13) of the Social Security Act. This rule describes new limitations on the valuation of assets acquired as the result of changes in ownership occurring on or after July 18, 1984. These changes affect hospitals and skilled nursing facilities under the Medicare program and hospitals, nursing facilities, and intermediate care facilities for the mentally retarded under the Medicaid program.     

TRICARE; certain survivors of deceased active duty members; and adoption intermediaries. Final rule

This rule confirms as final a January 2007 interim final rule which implements two provisions of the National Defense Authorization Act for Fiscal Year 2006 (NDAA FY06). First, Section 715 of the NDAA FY06 extends the time frame certain dependents of active duty service members (ADSM) who die while on active duty for more than 30 days shall receive TRICARE medical benefits at active duty dependent payment rates. Second, Section 592 of the NDAA FY06 modifies the requirement for those intermediaries who provide adoption placements. Additionally, this final rule makes an administrative clarification to the following two eligibility provisions: those placed in the legal custody of a member or former member; and those placed in the home of a member or former member in anticipation of adoption. This clarification makes a distinction between the two groups and specifies that for placement into legal custody by court order, the court order must be for a period of 12 consecutive months.     

Medicare program; provisions of the Balanced Budget Refinement Act of 1999; hospital inpatient payments and rates and costs of graduate medical education. Health Care Financing Administration (HCFA), HHS. Interim final rule with comment period

This interim final rule with comment period implements, or conforms the regulations to, certain statutory provisions relating to Medicare payments to hospitals for inpatient services that are contained in the Medicare, Medicaid, and State Children's Health Insurance Program Balanced Budget Refinement Act of 1999 (Public Law 106-113). These provisions relate to reclassification of hospitals from urban to rural status, reclassification of certain hospitals for purposes of payment during Federal fiscal year 2000, critical access hospitals, payments to hospitals excluded from the hospital inpatient prospective payment system, and payments for indirect and direct graduate medical education costs. Many of the provisions of Public Law 106-113 modify changes to the Social Security Act made by the Balanced Budget Act of 1997 (P.L. 105-33). These provisions are already in effect in accordance with Public Law 106-113.     

Medicare, Medicaid, and Children's Health Insurance Programs; additional screening requirements, application fees, temporary enrollment moratoria, payment suspensions and compliance plans for providers and suppliers. Final rule with comment period

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 State agency; and requirements for suspension of payments pending credible allegations of fraud in the Medicare and Medicaid programs. This final rule with comment period also discusses our earlier solicitation of comments regarding provisions of the ACA that require providers of medical or other items or services or suppliers within a particular industry sector or category to establish compliance programs. We have identified specific provisions surrounding our implementation of fingerprinting for certain providers and suppliers for which we may make changes if warranted by the public comments received. We expect to publish our response to those comments, including any possible changes to the rule made as a result of them, as soon as possible following the end of the comment period. Furthermore, we clarify that we are finalizing the adoption of fingerprinting pursuant to the terms and conditions set forth herein.     

Medicaid program; deduction of incurred medical expenses (spenddown)--HCFA. Final rule with comment period

This final rule with comment period permits States flexibility to revise the process by which incurred medical expenses are considered to reduce an individual's or family's income to become Medicaid eligible. This process is commonly referred to as "spenddown." Only States which cover the medically needy, and States which use more restrictive criteria to determine eligibility of the aged, blind, and disabled, than the criteria used to determine eligibility for Supplemental Security Income (SSI) benefits (section 1902(f) States) have a spenddown. These revisions permit States to: Consider as incurred medical expenses projected institutional expenses at the Medicaid reimbursement rate, and deduct those projected expenses from income in determining eligibility; combine the retroactive and prospective medically needy budget periods; either include or exclude medical expenses incurred earlier than the third month before the month of application (States must, however, deduct current payments on old bills not previously deducted in any budget period); and deduct incurred medical expenses from income in the order in which the services were provided, in the order each bill is submitted to the agency, by type of service. All States with medically needy programs using the criteria of the SS program may implement any of the provisions. States using more restrict criteria than the SSI program under section 1902(f) of the Social Security Act may implement all of these provisions except for the option to exclude medical expenses incurred earlier than the third month before the month of application.     

Medicaid program; limitations on provider-related donations and health care-related taxes; limitations on payments to disproportionate share hospitals--HCFA. Interim final rule with comment period

This interim final rule establishes in Medicaid regulations limitations on Federal financial participation (FFP) in State medical assistance expenditures when States receive funds from provider-related donations and revenues generated by certain health care-related taxes. The rule also adds provisions that establish limits on the aggregate amount of payments a State may make to disproportionate share hospitals for which FFP is available. This interim final rule implements provisions of the Medicaid Voluntary Contribution and Provider Specific Tax Amendments of 1991.     

Policy on 180-day marketing exclusivity for drugs marketed under abbreviated new drug applications; clarification--FDA. Clarification

The Center for Drug Evaluation and Research (CDER) of the Food and Drug Administration (FDA) is publishing this document to clarify the status of its practices governing 180 days of marketing exclusivity for generic drugs and the approval of abbreviated new drug applications (ANDA's) subject to patent litigation. This document is being published due to recent court decisions interpreting provisions of the Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) (the 1984 amendments).     

Natural rubber-containing medical devices; user labelling--FDA. Final rule; interpretation

The Food and Drug Administration (FDA) is providing notice that it does not intend to apply to combination products currently regulated under human drug or biologic labeling provisions its September 30, 1997, final rule requiring certain labeling statements for all medical devices that contain or have packaging that contains natural rubber that contacts humans. FDA is taking this action, in part, in response to a citizen petition and other communications from industry that the agency has received since the publication of the final rule. FDA intends to initiate a proceeding to propose natural rubber labeling requirements for drugs and biologics, including combination products that are currently regulated under drug and biologic labeling provisions. Such a proceeding may include a combination of rulemaking and guidance and will offer opportunity for public comment.     

TRICARE; certain survivors of deceased active duty members; and adoption intermediaries. Interim final rule

This interim final rule implements two provisions of the National Defense Authorization Act for Fiscal Year 2006 (NDAA FY06), Public Law 109-163. First, Section 715 of the NDAA FY06 extends the time frame certain dependents of Active Duty Service Members (ADSM) who die while on active duty for more than 30 days shall receive TRICARE medical benefits at active duty dependent payment rates. Second, Section 592 of the NDAA FY06 modifies the requirement for those intermediaries who provide adoption placements. Additionally, this interim final rule makes an administrative clarification to the following two eligibility provisions: those placed in the legal custody of a member or former member; and those placed in the home of a member or former member in anticipation of adoption. This clarification makes a distinction between the two groups and specifies that for placement into legal custody by court order, the court order must be for a period of 12 consecutive months. Public comments are invited and will be considered for possible revisions to the final rule.     

Medicaid program; limitations on provider-related donations and health care-related taxes; limitations on payments to disproportionate share hospitals--HCFA. Final rule

This final rule clarifies HCFA's policies concerning provider related donations and health care related taxes. In addition, this final rule revises regulations with regard to disproportionate share hospital spending limitations. This final rule amends an interim final rule that was published in the Federal Register on November 24, 1992. The interim final rule established in Medicaid regulations limitations on Federal financial participation (FFP) in State medical assistance expenditures when States receive funds from provider-related donations and revenues generated by certain health care-related taxes. The interim final rule also added provisions that establish limits on the aggregate amount of payments a State may make to disproportionate share hospitals for which FFP is available. The provisions of the interim final rule were required by the Medicaid Voluntary Contribution and Provider Specific Tax Amendments of 1991.     

Medical devices; procedures for premarket notification, premarket approval, classification, performance standards establishment, banning devices, and availability of regulatory hearings--FDA. Final rule

The Food and Drug Administration (FDA) is amending the medical device regulations governing procedures for premarket notification, premarket approval, classification, performance standards development, banning devices, and availability of regulatory hearings to conform these procedures to applicable provisions of the Safe Medical Devices Act of 1990 (the SMDA). Its publication promotes clarity and certainty to regulated industry and thus fosters economic growth by correcting the provisions in FDA's existing regulations to conform them to the now-governing statutory provisions.     

Medicare program; clarifying policies related to the responsibilities of Medicare-participating hospitals in treating individuals with emergency medical conditions. Final rule

This final rule clarifies policies relating to the responsibilities of Medicare-participating hospitals in treating individuals with emergency medical conditions who present to a hospital under the provisions of the Emergency Medical Treatment and Labor Act (EMTALA). The final rule responds to public comments received on a May 9, 2002 proposed rule (67 FR 31404) that both reiterated the agency's interpretations under EMTALA and proposed clarifying changes relating to the implementation of the EMTALA provisions. These reiterations and clarifying changes related to, among other areas, seeking prior authorization from insurers for services, emergency patients presenting at off-campus outpatient clinics that do not routinely provide emergency services, the applicability of the EMTALA provisions to hospital inpatients and outpatients, the circumstances under which physicians must serve on hospital medical staff "on-call" lists, and the responsibilities of hospital-owned ambulances. These reiterations and clarifying changes are needed to ensure uniform and consistent application of policy and to avoid any misunderstanding of EMTALA requirements by individuals, physicians, or hospital employees.     

医疗损害责任的规制逻辑与适用路径——以《民法典》与“医事法”的协调为视角

为推进对《民法典》的规范阐释,促使其与医事法的衔接、互补,应对"医疗损害责任"的规制逻辑与适用路径进行明晰。"医疗损害责任"整体延续了《侵权责任法》的概念体系和框架结构,在说明义务、责任主体以及责任构成等方面加以创新。其作为《民法典》的具体规范,对总则编之规定予以遵从,是侵权责任编一般规定的特别法;其作为医事法的基本范畴,处于上位效力层级之中,与其他规范条文形成条件关系和并列关系。鉴于此,应遵循"从民法典到医事法"的适用路径,藉由内外在规范的自足与互助,明确规范条文之间的内在关联,实现规范概念的阐明和规范内涵的拓补,以推动《民法典》相关规则的贯彻实施,促进我国医事法学的蓬勃发展。     

Medicare program; Medicare secondary payer for individuals entitled to Medicare and also covered under group health plans--HCFA. Final rule with comment period

These regulations establish limits on Medicare payment for services furnished to individuals who are entitled to Medicare on the basis of disability and who are covered under large group health plans (LGHPs) by virtue of their own or a family member's current employment status with an employer; and prohibit LGHPs from taking into account that those individuals are entitled to Medicare on the basis of disability. They also implement certain other provisions of section 1862(b) of the Social Security Act, as amended by the Omnibus Budget Reconciliation Acts of 1986, 1989, 1990, and 1993 and the Social Security Act Amendments of 1994. Those amendments affect the Medicare secondary payer rules for individuals who are entitled to Medicare on the basis of age or who are eligible or entitled on the basis of end stage renal disease and who are also covered under group health plans (GHPs). The provisions that apply to all three groups include-- The rules under which HCFA determines that a GHP or LGHP is not in conformance with the requirements and prohibitions of the statute; The appeals procedures respecting GHPs and LGHPs that HCFA finds to be nonconforming. The referral of nonconforming plans to the Internal Revenue Service; and The rules for recovery of conditional or mistaken Medicare payments made by HCFA. The intent of the MSP provisions is to ensure that Medicare does not pay primary benefits for services for which a GHP or LGHP is the proper primary payer and that beneficiaries covered under these plans are not disadvantaged vis-a-vis other individuals who are covered under the plan but are not entitled to Medicare.     

Medicare program; waiver of recovery of overpayments--HCFA. Final rule

This final rule duplicates in HCFA's regulations the content of two sections of the Social Security Administration's regulations concerning waiver of recovery of overpayments. In the past, regulations in 20 CFR part 404 were applicable to both the Federal Old-Age, Survivors and Disability Insurance program (OASDI), which provides monthly Social Security checks directly to beneficiaries or their representatives, and the Medicare program. Since the Social Security Administration (SSA) is now independent of HHS, and SSA is restructuring its regulations to apply only to the OASDI program, we are establishing the content of these sections in 42 CFR part 405 to preserve provisions that are applicable to the Medicare program.     

Medical devices; reports of corrections and removals; lift of stay of effective date--FDA. Final rule; lift of stay of effective date

The Food and Drug Administration (FDA) is lifting a stay of the effective date of certain provisions in a final rule on establishing procedures for submission of reports of corrections and removals of medical devices. The Office of Management and Budget (OMB) has approved the collection of information requirements contained in the final rule.     

Basic concepts and issues: a primer on distribution and sales representative agreements in the medical device and durable medical equipment industries

Counsel for a manufacturer of medical devices or durable medical equipment must have working knowledge of various legal disciplines to draft contracts with intermediaries (sales representatives and distributors) for the marketing and sale of the manufacturer's products. If the manufacturer wishes to sell its products abroad, counsel must become familiar with the laws and business practices of the target country, and methods of gaining access to the foreign market. This Article gives readers an overview of the applicable legal principles, under U.S. and foreign laws, in the areas of agency, contracts, healthcare regulation, consumer protection, intellectual property protection, and dealer protection. To aid counsel in drafting intermediary agreements, specific contractual terms and issues are explored in depth, including: appointment clauses, performance provisions, provisions concerning pricing and payment, protective clauses (shielding the manufacturer from liability), term and termination provisions, independent contractor clauses, export control clauses, recordkeeping and audit provisions, choice of law clauses, and dispute resolution clauses.