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Approved CFR sections in title 42, title 45, and title 20 (note: sections in title 45 are preceded by ''45 CFR,'' and sections OMB control Nos. in title 20 are preceded by ''20 CFR'')
0938–0897 ............. 412.22, 412.533.
[FR Doc. 03–24069 Filed 9–25–03; 8:45 am] service of the U.S. Government Printing Historically, we have based our BILLING CODE 4120–03–P Office. The Web site address is: http:// coverage determinations on descriptive www.access.gpo.gov/nara/index.html. information, and scientific and clinical evidence. Under the revised BIPA I. Background DEPARTMENT OF HEALTH AND coverage process, we will continue to HUMAN SERVICES In the April 27, 1999 Federal Register use descriptive information, and (64 FR 22619), we published a notice scientific and clinical evidence as a Centers for Medicare & Medicaid that announced changes to our internal basis for our coverage determinations. Services procedures for developing a national coverage determination (NCD) and II. Purpose of This Notice [CMS–3062–N] making the NCD process more open and This notice outlines the process we RIN 0938–AK61 understandable to the public. As we will use to make an NCD under the strive for continuous improvement of Medicare program. It sets forth the steps Medicare Program; Revised Process our processes, and in recognition of the we are taking to make the NCD process for Making Medicare National changes that section 522 of the more efficient, while maintaining as Coverage Determinations Medicare, Medicaid, and SCHIP open and transparent a process as AGENCY: Centers for Medicare & Benefits Improvement and Protection appropriate. It describes the following: Medicaid Services (CMS), HHS. Act of 2000 (BIPA) requires, we are • A tracking system that provides ACTION: Notice. revising our process for developing an public notice of our acceptance of a NCD in order to make the process more complete, formal request and SUMMARY: This notice revises the efficient and ensure that we have access subsequent actions in a web-based process we will use to make a national to all relevant information to make fully format. coverage determination for a specific informed decisions. (BIPA, Pub. L. 106– • The process we will institute to item or service under sections 1812, 554, was enacted on December 21, afford notice and opportunity to 1832, 1861, 1862, 1869, and 1871 of the 2000.) The processes described in this comment before implementation of an Social Security Act, as revised by notice apply to both scope of benefit NCD. sections of the Medicare, Medicaid, and and section 1862(a)(1) determinations as • Information that does and does not SCHIP Benefits Improvement and defined in the Social Security Act (the constitute a complete, formal request. Protection Act of 2000. This notice Act). This notice replaces the April 27, • The process for asking us to further clarifies our decision-making 1999 notice and will be effective on reconsider an existing NCD based on process and increases the opportunities October 27, 2003. Improvements new information, including new for public participation. include the following: medical or scientific evidence. • Updating and organizing the • The basis and purpose of a decision EFFECTIVE DATE: This notice is effective reconsideration process into one memorandum and where it can be on October 27, 2003. section, and distinguishing it from an accessed on our Web site. FOR FURTHER INFORMATION CONTACT: initial request to make an NCD. • The revisions made to the NCD Vadim Lubarsky, (410) 786–0840. process under BIPA, including a • Defining, streamlining, and SUPPLEMENTARY INFORMATION: organizing the contact/inquiry response to public comments, and how Availability of Copies and Electronic information into one section. these revisions affect the current NCD Access Copies: To order hard copies of • Revising, formalizing, and updating process and any subsequent challenges the Federal Register containing this the elements that constitute a complete, to an NCD. document, send your request to: New formal request to reflect best practices. In addition, we will continue to Orders, Superintendent of Documents, • Adding a section on information pursue an ongoing effort to work with PO Box 371954, Pittsburgh, PA 15250– that does not constitute a complete, various sectors of the scientific and 7954. Specify the date of the issue formal request. medical community to develop and requested and enclose a check or money • Updating and clarifying the publish on the CMS Web site order payable to Superintendent of conditions for acceptance of a complete, documents that describe our approach Documents, or enclose your Visa or formal request. when analyzing scientific and clinical Master Card number and expiration • Making it clear that all evidence evidence to develop an NCD. Interested date. Credit card orders can also be currently available must be adequate for parties will be able to offer comments. placed by calling the order desk at (202) us to conclude that the item or service Accordingly, these documents will 512–1800, or by faxing to (202) 512– is reasonable and necessary. make our coverage process more open 2250. The cost for each copy is $9. As • Establishing two main tracks for the and offer the public a better an alternative, you can view and initial NCD request. One track is a understanding into our NCD process. photocopy the Federal Register highly time-structured track only In our April 1999 notice, we document at most libraries designated available to aggrieved parties (section announced that we anticipated as Federal Depository Libraries and at IV.E track #2), as defined in section 522 publishing a final coverage criteria rule many other public and academic of BIPA. The other track is open to that would be followed by sector- libraries throughout the country that anyone, including aggrieved parties, specific guidance documents (64 FR receive the Federal Register. beneficiaries, and manufacturers, and 22620). Since then, we published a This Federal Register document is offers a more collaborative and less notice of intent to engage in rulemaking also available from the Federal Register time-stringent process (section IV.E for coverage criteria (May 16, 2000, 65 online database through GPO Access, a track #1). FR 31124) and had a subsequent town
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hall meeting. Given that there are categories are defined more broadly could not be reviewed by administrative substantial competing interests about than others. Specific health care law judges (ALJs). Effective October 1, the coverage criteria, we believe it best services must fit into one of these 2001, BIPA expanded the definition of not to pursue rulemaking. In the benefit categories, and not be otherwise NCDs, and provides that all NCDs shall meantime, as we have done in the past excluded, to be eligible for coverage not be reviewed by ALJs under section 35 years, we would continue to need to under the Medicare program. 1869(f)(1) of the Act. make coverage decisions and interpret The Act does not contain a It is important to distinguish between what is ''reasonable and necessary.'' We comprehensive list of specific items or a decision memorandum and an NCD. believe that in the interest of expediting services eligible for Medicare coverage. The decision memorandum is the public NCDs and making the process as Rather, it lists categories of items and document that lays out and describes predictable as possible that, in the services, and vests in the Secretary the the analytic framework for our decision interim, nonbinding sector-specific authority to make determinations about on a topic under NCD review. Its guidance documents would be helpful. which specific items and services purpose is to inform the reader of the Sector-specific guidance documents within these categories can be covered decision, the reasons for the decision refer to how our expectations and under the Medicare program. That is, and process followed, and provide a evaluation of evidence may differ in the Act allows Medicare to cover summary of the evidence considered. some respects depending on the nature medical devices, surgical procedures, The decision memorandum alerts the of the topic under review. Evidence can and diagnostic services, but generally public of our intent to implement the vary greatly, for example, between a does not identify specific covered or decision at some point in the future. diagnostic and an item of DME or excluded items or services. The NCD itself follows the decision between a near-term fatal condition and Medicare payment is contingent upon memorandum, sometimes by a number a life-long chronic condition. a determination that a service meets a of months. It is the formal instruction to Thus, we are notifying the public that benefit category, is not specifically our claims processing contractors we may choose to publish sector- excluded from coverage, and the item or regarding how to process claims (when specific guidance documents even in service is ''reasonable and necessary.'' to pay, when not to pay, pay only when the absence of a final rule. We will Section 1862(a)(1)(A) of the Act states certain clinical conditions are met). consider doing so as the need arises. that, subject to certain limited Those instructions have a specific This is also notice that we currently do exceptions, no payment may be made effective date dictating when claims will not plan to develop a proposed rule for any expenses incurred for items or be processed according to the new based on the May 2000 Notice of Intent. services that are not ''reasonable and criteria. Section 522(b) of BIPA amends necessary'' for the diagnosis and Generally, once we receive a complete section 1862(a) of the Act to require the treatment of illness or injury or to formal request, it takes 90 days to Secretary ''to make available to the improve the functioning of a malformed develop a decision memorandum. As public the data (other than proprietary body member. For over 30 years, we noted above, the decision memorandum data) considered in making the have exercised these authorities to make is not the NCD, but rather is one step determination.'' In a notice of proposed a coverage determination regarding towards making an NCD for an item or rulemaking published on August 22, whether a specific item or service meets service. After the decision 2002 (67 FR 54534), we described the one of the broadly defined benefit memorandum is prepared, we must process for handling proprietary categories and can be covered under the prepare the actual NCD. The NCD may information related to NCDs. After Medicare program. be issued as a manual instruction or As revised by section 522 of BIPA, an other document such as a program considering public comments, we will NCD is now defined to be a memorandum, ruling, or Federal establish and announce a policy that determination by the Secretary with Register notice. The NCD may be addresses that issue and defines respect to whether or not a particular accompanied by additional information ''proprietary'' data in the final rule. item or service is covered nationally for our contractors that is necessary to III. Medicare Coverage—General under title XVIII of the Act, but does not ensure that Medicare claims will be Principles include a determination about which properly processed when the NCD is code, if any, is assigned to a particular effective. As noted above, except in very A. Statutory Authority item or service covered under title limited circumstances, preparing the Administration of the Medicare XVIII, or a determination with respect to NCD will occur after this 90-day review program is governed by title XVIII of the the amount of payment for a particular process. Act. Under the Medicare program, the covered item or service. We expect to make any payment scope of benefits available to eligible In general, an NCD is a national changes or other systems changes beneficiaries is prescribed by law and policy statement granting, limiting, or dictated by the NCD instructions divided into several main parts. Part A excluding Medicare coverage for a effective within 180 calendar days of the is the hospital insurance program, and specific medical item or service. Often, first day of the next full calendar quarter Part B is the voluntary supplementary an NCD is written in terms of a that follows the date we issue the medical insurance program. particular patient population that may decision memorandum. Thus, the The scope of benefits under Part A receive (or not receive) Medicare decision memorandum and payment and Part B is defined in the Act. See reimbursement for a particular item or change can take up to 270 days from the sections 1812 (scope of Part A), 1832 service. An NCD is binding on all date a formal request for an NCD is (scope of Part B); and 1861(s) (definition Medicare carriers, fiscal intermediaries accepted for review by CMS. The date of medical and other health services). (FIs), quality improvement when a Medicare beneficiary may obtain Part C, known as the Medicare+Choice organizations (QIOs), health the item or service and receive Medicare program, includes at a minimum, all of maintenance organizations (HMOs), payment for that item or service under the items and services (other than competitive medical plans (CMPs), and an NCD that expands coverage will not hospice care) available under Part A and health care prepayment plans (HCPPs). be known until the NCD is completed Part B to individuals residing in the area Before October 1, 2001, NCDs made and has been assigned an effective date. served by the plan. Some benefit under section 1862(a)(1) of the Act The NCD will be implemented by all of
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our contractors on the effective date. for use by consumers, generally we will time-structured. The other track is open Additional details concerning this not accept a request for a device or to anyone, including aggrieved parties, process, as well as certain limited pharmaceutical that has not been other beneficiaries, and manufacturers, exceptions, are described later in this approved or cleared for marketing by and offers a more collaborative and less notice. the FDA for at least one indication; one time-stringent process. The NCD exception is Category B IDE devices. An development process under BIPA- B. Medicare Contractors and Coverage IDE Category B device is a non- legislated time frames will only be Policies experimental/investigational device for initiated when we receive a complete, We contract with private insurance which the incremental risk is the formal request from an aggrieved party. companies, referred to as carriers and primary risk in question (that is, FIs, to process Medicare claims; that is, underlying questions of safety and A. Informal Contacts and Inquiries claims-payment contractors. Local QIOs effectiveness of that device type have The public frequently raises general are also involved in the claims been resolved), or it is known that the questions about the coverage of items adjudication process. We refer to all of device type can be safe and effective and services to us by telephone, the these entities as ''Medicare contractors.'' because, for example, other postal mail system, electronic means, or Medicare contractors review and manufacturers have obtained FDA in person. These questions may include, adjudicate claims to ensure that approval or clearance for that device but are not limited to, asking us to Medicare payments are made only for type. explain the current coverage of a those items or services covered under Both CMS and the FDA review particular item or service, or requesting Medicare Part A or Part B. In the scientific evidence, and may review the assistance with, or advice about, a absence of a specific NCD, coverage same evidence, to make purchasing and possible submission of a formal request determinations are made locally by the regulatory decisions, respectively. for an NCD. We consider all of these Medicare contractors within the However, CMS and its contractors make contacts to be informal. Although boundaries established by the law. coverage determinations and the FDA informal contacts are not confidential, Sometimes these determinations are conducts premarket review of products we will not announce the substance of made on a claim-by-claim basis. under different statutory standards and these contacts on our Web site. Medicare contractors will also publish different delegated authority (67 FR If the requestor asks for specific local coverage determinations (LCDs) 66755, November 1, 2002). Whereas the information about how to request an that will provide guidance to the public FDA must determine that a product is NCD, we will advise them on and medical community within a safe and effective as a condition of implications of such a request and specified geographic area. An LCD is approval, CMS must determine that the explain what is required for us to accept defined in section 522 of BIPA as a product is reasonable and necessary as a submission as a complete, formal determination made by an FI or a carrier a condition of coverage under section request. We will offer suggestions to the under Medicare Part A or Part B, as 1862(a)(1)(A) of the Act. CMS adopts requestor to clarify the amount and kind applicable, for whether or not a FDA determinations of safety and of information necessary for us to particular item or service is covered on effectiveness, and CMS evaluates evaluate whether an item or service is an intermediary-wide or carrier-wide whether or not the product is reasonable ''reasonable and necessary'' under the basis under those parts, in accordance and necessary for the Medicare Act, and in limited instances, we may with section 1862(a)(1)(A) of the Act. population. Although an FDA-regulated offer to assist the requestor in meeting An LCD may not conflict with an NCD, product must receive FDA approval or these requirements. but the LCD may supplement an NCD. clearance (unless exempt from the FDA premarket review process) for at least B. What Constitutes a Complete, Formal C. Procedural one indication to be eligible for Initial Request for a National Coverage We continue to expect that all Medicare coverage, except for Category Determination or Formal Request for evidence currently available must be B devices under an IDE clinical trial (see Reconsideration adequate for us to conclude that the 60 FR 48417, September 19, 1995), FDA We consider a request to be a item or service is reasonable and approval/clearance alone does not complete, formal request, only if all of necessary. In the absence of adequate generally entitle that device to coverage. the following conditions are met: evidence, we may conclude that the • The formal request letter must be in item or service is not reasonable and IV. CMS's Process for Making National writing. necessary. Coverage Determinations • The formal request letter and There are several ways an individual supporting documentation must be D. Differences Between Food and Drug or entity can contact us about NCDs. submitted electronically (unless there is Administration (FDA) and CMS Review One approach involves informal good cause for only a hardcopy Parties interested in the coverage of a contacts, discussed in section IV.A of submission). drug or device (other than a Category B this notice. The other approach involves • The requestor must identify the investigational device exemption (IDE) ''formal requests.'' request as a ''formal request for an device, which is addressed through a If we have not issued an NCD for a NCD'' or a ''formal request for separate process as described in 42 CFR particular item or service, an external reconsideration'' and identify the NCD 405.201 through 405.215) may contact requestor may use one of two formal development track chosen (described in us with an inquiry on Medicare tracks to submit a request to make an detail in section IV.E of this notice). coverage while the particular drug or initial NCD. One track, established by • The requestor must state the benefit device is proceeding through the Food section 522 of BIPA, is available only to category or categories of the Medicare and Drug Administration (FDA) aggrieved parties, as defined by statute program to which the requestor believes premarket review process. We are to be ''individuals entitled to benefits the item or service applies. Examples of willing to meet and discuss issues under Part A, or enrolled under Part B, benefit categories may include durable within this context. Because the FDA is or both, who are in need of the items or medical equipment, physician services, charged with regulating whether devices services that are the subject of the inpatient hospital services, and or pharmaceuticals are safe and effective coverage determination'' and is highly diagnostic tests. The requestor may
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recommend one or more benefit population. using the equipment for which the categories for the item or service and ++In the case of an aggrieved party, request is made. must submit supporting documentation how that party is ''in need'' of the • Information provided is not justifying the recommendation. We item or service. supported by scientific or clinically must have all information, both from the —A description of any clinical trials or relevant data. requestor and internally, to make a studies currently underway that • Information provided is not benefit category determination, before might be relevant to a decision relevant to the item or service for which the request can be considered complete. regarding coverage of the item or the request is made. If an item or service can fit into more service. than one benefit category, we have the —Information involving the use of a • Request does not clearly identify discretion to assign it to the most drug or device subject to FDA the statutorily defined benefit category appropriate benefit category. regulation as well as the status of to which the requestor believes the item • The requestor must submit current FDA regulatory review of or service applies and does not contain adequate supporting documentation the drug or device involved. An enough information for us to make a along with the formal letter, including FDA regulated article would benefit category determination. the following: include the labeling submitted to • Request is considered an informal —A full and complete description of the the FDA or approved by the FDA contact described in section IV.A. item or service in question. for that article, together with an D. Acceptance of a Complete, Formal —A specific, detailed description of the indication of whether the article for National Coverage Determination or proposed use of the item or service, which a review is being requested Reconsideration Request including the target Medicare is covered under the labeled population and the medical indication(s). (We recognize that the In the rare event that we have a large condition(s) for which it can be labeling on FDA-approved products volume of NCD requests to review at used. sometimes changes. For purposes of once, we retain the flexibility to —A compilation of the supporting our review, we are interested in the prioritize these requests based on the medical and scientific information labeled indications at the time a magnitude of the impact on the currently available that measures requestor submits a formal request. Medicare program and beneficiaries. the medical benefits of the item or If, during our review, the labeled This flexibility will enable us to ensure service. This may include portions indication or status of a pending that we can pay priority attention to of primary study data that have FDA approval or clearance changes, those requests that have potential for been separately submitted to the we expect the requestor to notify significant impact on our beneficiaries— FDA as part of its submission us.) a life-saving cancer treatment, a —In the case of items that are eligible breakthrough in cardiac pacing, etc. In package and are deemed most for a 510(k) clearance by the FDA, order to do so, we may have to relevant for our review. identification of the predicate temporarily suspend or diminish our —If the requestor has submitted an device to which the item is claimed review of other issues that, while application to the FDA for market to be substantially equivalent. important, do not have the same approval of the product for which coverage is sought, then a copy of C. When a National Coverage profound potential. We expect to use the ''integrated summary of safety Determination Request or any such authority infrequently. data'' and ''integrated summary of Reconsideration Request Is Not For these cases, two lists, an accepted effectiveness data,'' or the Considered Complete and Formal list and lower priority list (based on combined ''summary of safety and impact) will be maintained and When a requestor submits a request effectiveness data,'' portions of the available on our Web site; the lower for an NCD or reconsideration, we will FDA application should be priority list will be processed based on review the materials to determine if it included in the request for an NCD. the order of acceptance as resources meets the definition of a complete, These documents will ensure that become available. Requestors can use formal request as defined in section IV.B our review is comprehensive. this public priority list to verify whether of this notice. If the request lacks —An explanation of the design, the request has been accepted, the status adequate supporting documentation to purpose, and method of using the of the request, and where the requestor enable us to conduct our review, we item or equipment, including is in the order of priorities. will notify the requestor and explain our whether the item or equipment is rationale. If we accept the request, we Upon acceptance of a request, we will for use by health care practitioners will notify the requestor of the notify the requestor and post a tracking or patients. acceptance. We will also post our sheet announcing our review of this —A statement from the requestor (in acceptance on our Web site under our issue on the list of pending coverage cases in which there is an aggrieved list of pending coverage issues. issues on the coverage Web site. Posting party, the statement must be from As we previously stated, we will not of the tracking sheets permits interested that party) containing the following: consider a request to be a complete, individuals to participate and monitor ++An explanation of the relevance of formal request if any of the following the progress of the NCD process. This is the evidence selected. occur: a key element in making our NCD ++Rationale for how the evidence • Request is not in writing. process more efficient, open, and selected demonstrates the medical • Request is not accompanied by accessible to the public. Once a formal benefits for the target Medicare sufficient, supporting documentation. request is posted, there will be an population. • Information provided does not opportunity for public participation and ++Information that examines the address relevance, usefulness, or the submission of additional evidence. (If magnitude of the medical benefit. medical benefits of the item or service after accepting the request, we decide ++Reasoning for how coverage of the to the Medicare population. that the request does not fall under a item or service will help improve • Information does not fully explain benefit category, we will issue a the medical benefit to the target the design, purpose, and method of noncoverage NCD.)
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E. Review of a Complete, Formal request that the Secretary issue a considered during the initial review, Request for a National Coverage national coverage or noncoverage that is, results from new clinical trials, Determination determination with respect to a new scientific or medical publications, Development of a complete, formal particular type or class of items or or studies supporting the request. services, if the Secretary had not • Arguments that our conclusion request for an NCD can be initiated in previously made a coverage or materially misinterpreted the existing one of three ways: noncoverage determination. Thus, this evidence at the time the NCD was made. Track #1: Request for New National • If the request is for reconsideration Coverage Determinations Initiated by track can be invoked only for an initial request if we have not issued a coverage of the benefit category determination, Any Party, Including Beneficiaries, the requestor must recommend a benefit Manufacturers, Providers, or Suppliers. or noncoverage NCD. As noted in section E, track 1, category and, in support of the A request to make an NCD can be recommendation, submit either (1) new generally we expect to make a payment received from an individual or entity information that was not considered change effective within 180 calendar who identifies an item or service as a during the initial benefit category days of the first day of the next full potential benefit (or to prevent potential determination, or (2) arguments that our calendar quarter that follows the date harm) to the Medicare population; this determination decision materially we issue a decision memorandum. This requestor can be either an aggrieved misinterpreted the applicable statutory time is necessary to identify and make party as defined by section 522 of BIPA, any necessary coding, payment, and provisions, the applicable regulatory or a nonaggrieved party. This may systems changes. However, if an provisions, or the existing evidence at include a manufacturer, provider, aggrieved party initiates a request under the time the benefit category supplier, or party who requests our track 2, we expect to issue a decision determination was made. consideration of a particular issue for an memorandum and an NCD (that is, the We will not accept a request for NCD. All requests must meet the manual instruction or other appropriate reconsideration that is not submitted in requirements in this notice. An initial document) to our contractors by no later writing, identified as ''A Formal Request request can only be made if we have not than the end of the 90-day period, in for Reconsideration,'' and accompanied previously issued an NCD for a accordance with the statutory by the required, additional, supporting particular item or service. timeframe. The NCD will include the information as described more fully in If an individual or other entity effective date of the policy. In cases sections IV.B and IV.C. Upon receipt of initiates a request, we expect to where we are not able to complete our the additional information as outlined generally issue a decision memorandum review within this 90-day timeframe, above, we will consider this a formal within a 90-day period. More complex the law requires that we issue a notice request for an NCD reconsideration and issues, or issues that require referral to that includes an identification of the initiate the reconsideration process. We the Medicare Coverage Advisory remaining steps in the review process generally expect to complete the Committee or for a Technology and a deadline by which we will reconsideration process and issue a Assessment, would generally take complete that review. decision memorandum within 90 longer than 90 days. Generally, we A decision memorandum will include calendar days. Our current NCD will expect to make a payment change a clear statement of the basis for the remain in effect during the effective within 180 calendar days of the determination including our responses reconsideration process until we issue a next full calendar quarter that follows to comments we receive from the revised NCD, if applicable. the date we issue the decision public. The actual effective date of the A reconsideration of an NCD must be memorandum. NCDs will depend on whether we must distinguished from a challenge to an Though the 90-day clock in this make changes to our claims processing existing NCD. Under section 522 of option is not as strict as the process systems to allow Medicare payment; BIPA and section 1869(f)(1) of the Act, used only for aggrieved parties, this this step is not included in the 90-day aggrieved parties may elect to challenge track offers a more collaborative process clock. However, whether systems an existing NCD. On August 22, 2002, than track two. The opportunities for changes are needed and how long they we published a proposed rule (67 FR greater collaboration will flow from the may take to implement will be reflected 54534) that addresses procedures for the more flexible approach to the 90-day in the effective date contained in the Departmental Appeals Board (Board) clock. Requestors and other interested NCD. review process under section 522 of parties will be able to provide Track #3: Internally Generated BIPA. additional information, clarify issues, Request. A request for review of new clinical and engage in dialogue as questions We may generate a request to make an and scientific evidence that was arise. The ability to follow this path is NCD in the interest of the general health published or available only after the necessarily constrained when we are and safety of Medicare beneficiaries. date the initial NCD was issued may be under a strict, narrowly-framed 90-day Generally, this process is similar to the submitted as a request for response timeline. externally generated request process. reconsideration. The reconsideration of Track #2: Request by an Aggrieved an existing NCD is part of our coverage Party for New National Coverage F. NCD Reconsideration Process determination process so that our Determinations Where There Were No When an NCD currently exists, any medical and scientific experts have an National Coverage or Noncoverage individual or entity may request that we opportunity to examine this new Determinations. reconsider any provision of that NCD by evidence. Thus, a reconsideration of an Aggrieved parties are defined in filing an acceptable request for an NCD NCD is separate and distinct from an section 1869(f)(5) of the Act as reconsideration. We will consider a initial NCD request and separate from ''individuals entitled to benefits under request to revise an existing NCD at any the Board review process under section Part A, or enrolled under Part B, or both, time, but only if the requestor presents 522 of BIPA. who are in need of the items or services documentation that meets either of the As noted above, because that are the subject of the coverage following criteria: reconsiderations are outside of the strict determination.'' Section 1869(f)(4) of the • Additional material medical and/or BIPA timeline, they offer several Act permits these individuals to make a scientific information that was not alternative opportunities for individuals
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and entities that may make the process memorandum and before implementing coverage determination on our Web site. more advantageous: the NCD for the particular item or The decision memorandum is not • The reconsideration process does service. binding on our contractors, and no not involve a formal adjudicatory We will use the remainder of the 90 change in existing policy is effective hearing. day timeframe to research and evaluate until we publish the revised NCD in the • The process may be more the NCD request. This process entails, relevant coverage manual or other collaborative with the original clinical but is not limited to, the following issuance with a specific effective date. reviewers at CMS, with greater activities: Generally, by the end of the 270-day opportunity for clarification and • Review pertinent data and scientific period following formal acceptance of dialogue. literature a requestor submits. an NCD or reconsideration request, we • Research relevant sources of will make effective the payment changes G. Improvements in the National Coverage Determination Process evidence in addition to evidence a for an NCD on that request. requestor submits. These may include, We will create and maintain a Our 90-day clock for considering or but are not limited to, other peer- complete and adequate record of all reconsidering coverage requests will reviewed medical, technical, and NCDs that are developed. The record begin once we have accepted the scientific literature, recommendations of will provide an explanation of our complete, formal request. Acceptance of expert panels, unpublished data used to rationale for an NCD and include the a complete formal request begins a secure FDA approval, and clinical evidence we considered. This record series of internal timeframes over the experience. will form the basis for any subsequent course of 90 days. • Formulate inclusion and exclusion requests for reconsideration of the NCD, We will post the acceptance of a parameters for literature searches. and will also serve as the formal record complete, formal request on our Web • Develop analytic questions needed of review for any subsequent challenges site. This initiates a 30-day comment for subsequent policy formulation. to the NCD under section 1869(f)(1) of (public input) period, during which • Determine whether the issue the Act. Information contained in the submission of evidence or other warrants further review either by the record will conform to the proprietary comments relevant to the request will be MCAC or through a health technology data policy in the 522 BIPA final rule. accepted in accordance with section assessment (HTA) from an agency such 522(b) of BIPA. During this time, the as the Agency for Healthcare Research H. Health Technology Assessments public, including the requestor of the and Quality (AHRQ). (HTAs) NCD or reconsideration, may submit • Evaluate all pertinent evidence. During our review of an NCD request, comments and additional information or In general, by the end of the 90-day we may require an HTA to complete our evidence of studies regarding the NCD period following formal acceptance of review. Generally, an HTA provides an issue under review. We will provide a an NCD or reconsideration request, we independent analysis of all scientific response to these comments in our will issue a decision memorandum on and clinical evidence available on a decision memoranda. that request. We will outline, in a particular health care technology. We There may be times, such as a public decision memorandum, one of the may request an HTA when there is health emergency, when there is good following three actions: conflicting or complex medical and cause for developing an NCD more (1) Our intention to issue an NCD, scientific literature available, or when rapidly, and we may need to reduce the with or without limitations. we believe an independent analysis of time period for public comment. For (2) Our intention to issue a national all relevant literature will assist us in instance, in the case of a national noncoverage determination. determining whether an item or service disaster, it may be necessary to quickly (3) A determination that an NCD or a is reasonable and necessary. We may modify an NCD to facilitate access to noncoverage determination is not also request an HTA in preparation for covered services in a particular service appropriate at the present time. an upcoming MCAC meeting. area. In these emergency situations, we We will provide notice if we We will obtain services from the may expedite the development of an determine that additional time will be Agency for Healthcare Research and NCD and reduce the notice and necessary to complete an NCD review. Quality, or a third party with the comment period, during which We will identify the remaining steps in requisite experience in HTA and evidence can be submitted. For the review process and the deadline by evidence-based medicine to ensure the instance, following the flooding in which we will complete the review and technical competence and fairness of Texas in the summer of 2001, we issued take an action described in (1), (2), or (3) the HTA. an NCD shortly after a request was made above. This option may include such If we receive a formal request for in order to permit payments for actions as referring the request to the coverage on an item or service for which transplant recipients. MCAC or to a third party for an HTA as an HTA is already underway, we will After the close of the 30-day comment described in section IV.H of this notice. inform the subsequent requestor of the (public input) period, we will only A decision memorandum is not an status of the pending HTA, as well as an accept additional information or NCD, but rather a statement announcing estimated time for completion. Any evidence from the public if we request our intent to issue policy. The decision request for an HTA will be reflected on information or during subsequent memorandum details the analysis of the our Web site tracking sheet, followed by Medicare Coverage Advisory Committee scientific and clinical literature, and either the executive summary or the full (MCAC) proceedings, if applicable. We provides the rationale for the coverage and complete HTA. must strictly enforce the 30-day determination. The decision comment (public input) period, in memorandum will include the rationale I. Medicare Coverage Advisory which evidence can be submitted, to we used in reaching our determination. Committee (MCAC) ensure that we make timely decisions. If we make a coverage determination to On December 14, 1998, we published We will consider and incorporate the modify an existing NCD that results in a notice in the Federal Register (63 FR relevant public input, and any a reduction of coverage, in whole or in 68780) announcing establishment of the subsequent information received during part, we will also publish a notice in the MCAC, and requesting nominations for MCAC meetings, in the decision Federal Register and announce our membership. The MCAC has met
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periodically since September 1999, to public comment. We ask that all NCD is binding on all Medicare discuss coverage issues, make requests for presentation and contractors; that is, carriers, FIs, QIOs, judgments about the adequacy and consideration of evidence to the MCAC, HMOs, CMPs, and HCPPs. NCDs that conclusions of existing scientific submit a request to us in writing at least expand coverage are binding on evidence, make recommendations to us 20 days before the meeting. The MCAC Medicare+Choice plans. We will also about whether particular items or considers all available evidence, publish a reference to each national services can be considered ''reasonable presentations, and comments. The coverage decision in the Federal and necessary'' under title XVIII of the MCAC makes recommendations to us. Register as part of our quarterly listing Act, and to advise the Secretary on Those recommendations are advisory. of program issuances. matters relating to the interpretation, We expect the MCAC to make application, or implementation of recommendations as expeditiously as K. Essential Differences in This Notice section 1862(a)(1) of the Act. The MCAC possible. We will provide an estimate of In summary, this notice distinguishes operates under a 2-year charter. The when we believe we will receive the between the two tracks available for an MCAC charter is available on our Web MCAC recommendation. Once the external party to request a new NCD site. MCAC makes a formal recommendation, when no NCD currently exists. For an The primary role of the MCAC is to we will post it on our Web site. initial request, the highly time- provide independent, expert advice and Generally, within 60 calendar days of structured track is only available to assistance to us in making sound receiving the formal MCAC aggrieved parties, as defined in section coverage decisions based upon the recommendation, we will issue a 522 of BIPA. The other track is open to reasoned application of scientific decision memorandum. In the decision anyone, including aggrieved parties, evidence. Voting members must possess memorandum, we will explain the beneficiaries, and manufacturers, and the scientific and technical competence MCAC recommendation, and how it was offers a more collaborative and less commensurate with this purpose. In considered in our final determination. time-stringent process. We also explain addition, a consumer and industry the steps that anyone can take to request J. Implementation of National Coverage representative serve as nonvoting a reconsideration of an existing NCD. Determinations members on each panel. To ensure their full participation, nonvoting members The general 90-day clock for NCD and L. How To Access CMS's Home Page have access to all information and data reconsideration requests described for Our home page can be accessed by (other than information exempt from individuals who are not aggrieved entering ''http://www.cms.hhs.gov.'' To disclosure relating to trade secrets or parties or aggrieved parties who elect access information about our coverage where the disclosure would present a the collaborative approach includes process, select ''Development of conflict of interest) made available to time for the analysis, processing, and Coverage Policies'' and then ''Medicare voting members. The MCAC meetings development of a decision Coverage Process,'' or http:// are open to the public, and time is memorandum. Upon making a decision, www.cms.hhs.gov/coverage. allotted for public comment on the numerous internal, related steps remain particular coverage issue under before a payment change can take place. V. Collection of Information consideration. We must determine which codes the Requirements In general, we may refer a coverage providers, suppliers, and Medicare Under the Paperwork Reduction Act issue to the MCAC if it meets any of the contractors will use for submission and (PRA) of 1995, we are required to following conditions: payment of claims consistent with the provide 60 days notice in the Federal • It is the subject of significant decision and issue corresponding Register and solicit public comment scientific or medical controversy; that instructions. We must also determine before a collection of information is, there is a major split in opinion the appropriate Medicare payment level. requirement is submitted to the Office of among researchers and clinicians As previously mentioned, coding and Management and Budget (OMB) for regarding the medical benefits of the payment decisions are not included review and approval. In order to fairly item or service, the appropriateness of within the definition of an NCD for evaluate whether an information staff or setting, or some other significant purposes of a Board review. Finally, collection should be approved by OMB, controversy that would affect whether NCDs often require us to develop and section 3506(c)(2)(A) of PRA requires the item or service is ''reasonable and issue claims processing instructions to that we solicit comment on the necessary'' under the Act. our systems maintainers and Medicare following issues: • It is the subject of controversy contractors to ensure accurate payment. • Need for the information collection among the general public. Medicare contractors generally and its usefulness in carrying out the • It has the potential to have a major implement systems changes at the start proper functions of our agency. impact on a target population of the of a calendar quarter, and instructions • Accuracy of our estimate of the Medicare program. are required well in advance of the information collection burden. If we refer a coverage issue to the beginning of each quarter in order to • Quality, utility, and clarity of the MCAC, we will schedule a public install and test the systems changes. information to be collected. meeting to discuss the coverage issue The NCD (issued as a program • Recommendations to minimize the under consideration. All MCAC memorandum, manual instruction, information collection burden on the meetings are subject to the requirements Federal Register notice, or CMS ruling) affected public, including automated of the Federal Advisory Committee Act. will include the effective date when our collection techniques. We will publish a notice in the Federal Medicare contractors will implement However, the collection requirements Register generally 30 days before any change in payment that may result referenced in section IV.B ''What holding an MCAC meeting. We will from the NCD. Generally, we expect to Constitutes a Complete, Formal Initial announce in our notice the draft agenda, make a payment change effective within Request for a National Coverage time, and place of the meeting so that 180 calendar days of the first day of the Determination or Formal Request for all interested persons will have ample next full calendar quarter that follows Reconsideration'' of this notice, are notification. During the course of each the date we issue the decision currently approved under OMB meeting, there will be time allotted for memorandum. As stated previously, an approval number 0938–0776.
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VI. Regulatory Impact Statement have a consequential effect on the gene therapies, and human cellular and We have examined the impacts of this governments mentioned or on the tissue-based products). notice as required by Executive Order private sector. Date and Time: The workshop will be 12866 (September 1993, Regulatory Executive Order 13132 establishes held on October 23, 2003, from 8:30 Planning and Review) and the certain requirements that an agency a.m. to 5 p.m., and on October 24, 2003, Regulatory Flexibility Act (RFA) must meet when it promulgates a from 8:30 a.m. to 5 p.m. (September 19, 1980 Pub. L. 96–354). proposed rule (and subsequent final Location: The workshop will be held Executive Order 12866 directs agencies rule) that imposes substantial direct at the Hyatt Regency Bethesda, One to assess all costs and benefits of requirement costs on State, local, or Bethesda Metro Center, Bethesda, MD. available regulatory alternatives and, if tribal governments, preempts State law, Contact Person: Gloria Blankenship, regulation is necessary, to select or otherwise has Federalism CBER (HFM–49), Food and Drug regulatory approaches that maximize implications. We have determined that Administration, 1401 Rockville Pike, net benefits (including potential this notice does not significantly affect Rockville, MD 20852, 301–827–2000, economic, environmental, public health the rights, roles, and responsibilities of FAX 301–827–3079, e-mail: and safety effects, distributive impacts, State, local, or tribal governments. firstname.lastname@example.com. and equity). A regulatory impact In accordance with the provisions of Registration: Mail, e-mail, or fax your analysis (RIA) must be prepared for Executive Order 12866, this notice was registration information (including major rules with economically reviewed by the Office of Management name, professional degree, title, e-mail significant effects ($100 million or more and Budget. address, firm name, address, telephone, annually). Since this notice revises the Authority: Sections 1862, 1869(f), and and fax number) to Gloria Blankenship, process we will use to make an NCD for 1871 of the Social Security Act (42 U.S.C. (see Contact Person) by October 10, a specific item or service and has no 1395y, 1395ff(b)(3), and 1395hh). 2003. There is no registration fee for the economic impact on the Medicare (Catalog of Federal Domestic Assistance public workshop. Because seating is program, we have determined this is not Program No. 93.773, Medicare-Hospital limited, we recommend early a major notice. Insurance; and Program No. 93774, Medicare- registration. There will be no onsite The RFA requires agencies to analyze Supplementary Medical Insurance Program). registration. options for regulatory relief of small If you need special accommodations businesses. For purposes of the RFA, Dated: September 15, 2003. due to a disability, please contact Gloria small entities include small businesses, Thomas A. Scully, Blankenship (see Contact Person) at nonprofit organizations, and Administrator, Centers for Medicare & least 7 days in advance. government agencies. Most hospitals Medicaid Services. and most other providers and suppliers Dated: September 15, 2003. SUPPLEMENTARY INFORMATION: The are small entities, either by nonprofit Tommy G. Thompson, purpose of this public workshop is to status or by having revenues of $5 to provide a forum for sharing information Secretary. $25 million or less annually. We have and strategies to assist in the efficient [FR Doc. 03–24361 Filed 9–25–03; 8:45 am] determined that this notice will not and successful development of products BILLING CODE 4120–01–P have a significant economic impact on regulated by CBER and used for counter a substantial number of small entities. terrorism efforts. CBER is interested in We believe that few small entities will promoting a discussion of issues related DEPARTMENT OF HEALTH AND submit requests. We estimate that to the development of counter terrorism HUMAN SERVICES approximately five beneficiaries or products, including manufacturing and small entities may submit a request in Food and Drug Administration clinical issues, and other relevant a year. issues. The workshop is intended to In addition, section 1102(b) of the Act Counter Terrorism Products Regulated help sponsors address commonly asked requires us to prepare a regulatory by the Center for Biologics Evaluation questions and avoid common impact analysis if a rule may have a and Research: Effective Strategies to misunderstandings and to provide significant impact on the operations of Assist in Product Development; Public practical information on successful a substantial number of small rural Workshop product development strategies. hospitals. This analysis must conform to FDA invites participants to submit the provisions of section 604 of the AGENCY: Food and Drug Administration, issues for discussion prior to the RFA. For purposes of section 1102(b) of HHS. workshop. There will be an opportunity the Act, we define a small rural hospital ACTION: Notice of public workshop. to raise additional questions and issues as a hospital that is located outside of for discussion at the meeting. Mail or a Metropolitan Statistical Area and has The Food and Drug Administration fax your issues and questions to Gloria fewer than 100 beds. We have (FDA) is announcing a public workshop Blankenship (see Contact Person) by determined that this notice will not entitled ''Counter Terrorism Products October 10, 2003. have a significant impact on the Regulated by the Center for Biologics FDA will post on CBER's Web site operations of a substantial number of Evaluation and Research: Effective (http://www.fda.gov/cber/) the agenda small rural hospitals. Strategies to Assist in Product for this meeting, when finalized. Section 202 of the Unfunded Development.'' The purpose of the Transcripts: Please note that Mandates Reform Act of 1995 also public workshop is to provide a forum transcripts of the meeting will not be requires that agencies assess anticipated for discussing strategies to assist in the prepared. costs and benefits before issuing any effective development of products rule that may result in expenditure in regulated by the Center for Biologics Dated: September 17, 2003. any 1 year by State, local, or tribal Evaluation and Research (CBER) that Jeffrey Shuren, governments, in the aggregate, or by the may be used in counter terrorism efforts Assistant Commissioner for Policy. private sector, of $110 million. We have (e.g., vaccines, blood and blood [FR Doc. 03–24303 Filed 9–25–03; 8:45 am] determined that this notice will not products including immunoglobulins, BILLING CODE 4160–01–S
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Minnesota: A Bite of History of the Green Bean Casserole…a Classic!
Green bean casserole may be a staple, made uniquely to each family and on many Thanksgiving plates, but you'll mostly find it in the middle of the country.
Midwesterners consider the canned cream of mushroom soup, fried onions, and green bean dish to be an important part of the November/December holiday's. Canned cream of mushroom soup, green beans, and crunchy onions: a classic!
Here, a historical article about the recipe and one creator:
Inventor of the green bean casserole, a Thanksgiving favorite, has died at 92.
eat / drink
St. Paul's Newest Cocktail Bar Focuses on Women-Run Distilleries
Just down the street from the Fitzgerald Theater and in the shadow of the State Capitol, the Celeste St. Paul Parlour Bar officially opened its doors on November 1. Nestled on the first floor of the boutique Celeste St. Paul Hotel, the bespoke cocktail program places...
11 Icons of Twin Cities Dining – Minneapolis/St. Paul MN
Murray's Steakhouse Visit Website It's no coincidence that the best eateries that stand the test of time are family owned. No one cares for the customer like those who have been raised in the hot kitchens and helping stock these perfectly worn bars. Murray's treats...

subset: commoncrawl


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Studio 101 Salon & Spa Gift Cards
A perfect gift for that special someone
Introducing Danica Gineman LMT to our team!!
Danica is a Licensed Massage Therapist specializing in all massage services.
Thru the month of December Danica is offering $20 off the purchase of any Gift Card purchase.
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Purchase a $100 Gift Card for only $80 ~ good towards any salon service or Aveda product.
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Search for dissertations about: "Marianne Hedlund"
Found 1 swedish dissertation containing the words Marianne Hedlund.
1. Shaping Justice: Defining the disability benefit category in Swedish social policyUniversity dissertation from Department of Sociology, Lund University
Abstract : This thesis is about what qualifies to be characterised as disability in Swedish social security legislation and which principles are used to decide who is entitled to social security benefit as disabled. The thesis brings into focus which definitions of needs and criteria that are found 'worthy' and acceptable to include in a disability category in Swedish social policy. READ MORE
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"Everybody counts. Everybody matters." That's more than my campaign slogan; it's a promise to count everyone because being counted, being recognized, indicates our regard for the dignity inherent in each individual. President TrumpDonald John TrumpStates slashed 4,400 environmental agency jobs in past decade: study Biden hammers Trump over video of world leaders mocking him Iran building hidden arsenal of short-range ballistic missiles in Iraq: report MORE's plan to to add a question about citizenship on the 2020 census is a rejection of the commitment we should have to each individual person.
Counting everyone is a central pillar of our democracy, and it's dictated by the Fourteenth Amendment to the Constitution, which states that the census must count "the whole number of persons in each state." It is a guarantee that no matter who you are or where you live, you count just as much as your neighbor.
Make no mistake: The addition of a citizenship question in the Census is intended to intimidate our immigrant friends and neighbors from participating, which will lead to an inaccurate count. That's why six former U.S. Census Bureau directors, who served under both Democratic and Republican administrations, wrote a letter to the Trump administration expressing their serious concern over the change.
Census officials have already discovered in their pretesting interviews that immigrants expressed fears about the census, saying "[t]he possibility that the Census could give my information to internal security and immigration could come and arrest me for not having documents terrifies me." Given the anti-immigrant messages and policies coming out of the Trump White House and the increase in White Nationalist activity around the country, it is no surprise that our undocumented and minority neighbors would fear answering this citizenship question.
The consequences of an undercount in the next census will have a serious negative impact on every individual, citizen or not, in our country. Without an accurate count of everyone in this country, we cannot ensure the government fairly distributes funding to schools, or adequately funds plans for natural disasters or the outbreak of epidemics. Cities across the country will not be able to fund fire and police departments to ensure our homes and communities are safe. It would become close to impossible to enforce civil rights protections for fair housing or equal employment.
And, of course, the integrity of the census is necessary to make sure that people living in any state have an accurate and fair number of U.S. representatives who can advocate on their behalf in the halls of Congress. For example, an inaccurate census could cost California roughly $20 billion over ten years and up to two congressional seats.
An accurate census count helps ensure that everyone's roads will be paved, schools will be repaired; it puts us on a path for everyone to have access to housing, jobs and the dreams America promises. By adding this citizenship question, the Trump White House has chosen to prioritize xenophobia over our American values of freedom and justice. They have chosen to erode the legitimacy and proper functioning of our democracy in order to continue stoking a politics of fear and division.
I hope you will join me in demanding that the Trump White House revoke their decision. Until they do, I will continue to fight in Congress alongside my colleagues, like Rep. Carolyn MaloneyCarolyn Bosher MaloneyTwo budget staffers resigned after voicing concerns about halted Ukraine aid, official says On The Money: Dems say Ukraine aid documents from OMB show 'pattern of abuse' | Blue states file appeal over GOP tax law deduction cap | Dems sue Barr, Ross over census documents House Democrats release final transcripts from impeachment depositions MORE (D-N.Y.), to revoke this question through legislation. I also applaud attorneys general from across the nation who are fighting this unconstitutional decision in court.
Americans of all stripes and backgrounds who believe in fairness must join together and oppose this decision. The future of our democracy depends on it.
Ellison represents Minnesota's 5th District.


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While you can always DIY family portraits with your point and shoot camera and a tripod and timer for no cost at all, it will likely not look so great, considering you are not a professional photographer, aren't using a great camera and don't know how to set up the shoot for optimal lighting and composition. Your camera will be limited in its size and quality abilities.
If you have followed our tips from the start you will of discussed any group shots with the couple before the wedding. A good idea is to get these into a list on paper. Having a print out means you can have one copy and the person you have tasked with rounding people up can have a copy. This way you can simply tick them off as you make your way through the list.
Examine a photographer's online presence. As with anybody advertising themselves on the internet you will need to think carefully and critically about how they present themselves. Try to find reviews of the people you are interested in by searching for their names. You should be cautious with reviews and be prepared to make up your own mind, but the more information you have the better.
"I recently did a photo shoot with James and he was great! I contacted him 4 days before I needed to have the photos done and he was responsive within 15 minutes. He is really flexible with times and locations. We went to a few cool locations downtown that I would have never thought of. Very nice young man who knows what he is doing. I would do another photo shoot in the future!"
K-Rae Images is a luxury MATERNITY, BIRTH, and NEWBORN portrait business located in Frisco, TX. Clients are provided with heirloom quality art designed to last for generations. Parents are treated wonderfully from the initial consultation to the final Reveal, with a closet of maternity gowns to select from as well as newborn props that are sure to create stunning images. Documenting Birth Stories is another way Kristin (photographer) captures the raw and fleeting moments of a new baby's arrival. Parents can relax knowing that Kristin will take care of their entire portrait experience. K-Rae Images has received the prestigious "Best of Frisco Portrait Studio Award" for 3 consecutive years, and is a Premium Member of INP (International Association of Newborn Photographers) and Best Newborn Photographers. Set up your complimentary Portrait Design Consultation today, and come see why clients continue to choose K-Rae Images for all their portrait needs!
35. Newborn Photography Ideas At Home in the Nursery – Taking a newborn's pictures in the nursery is such a great idea! Not only do you capture the sweetness of a newborn, but also the personality of the the family in their environment! The new addition will love to see these photos years from now. When you have your photos all complete, make sure you display one. This is one of our favorite newborn displays.
With Jessica Cook as your newborn photographer, you'll get stunning photographs of your growing family. The studio offers digital images with all of our packages. So, you will receive your edited digital files with a print release. They also offer printing services from a professional lab. So, you can get professional prints, albums, canvases and custom woodblocks to feature around your home at an affordable price.
despite my wanting it to be, my baby bump never got very big. this photo above was taken only a few weeks before delivering our daughter and everyone always said, "there is no way you are having a baby in a couple weeks!" smaller bumps can be harder to photograph sometimes, but laying down is a great way to show that belly off. plus, laying down just feels plain good when you are in your third trimester. am i right?
Oh wow!!! Thank you! Thank you! Thank you! I've been looking for information like this for a while and here it is, in a 5 part series. I've been asked to take maternity and newborn pictures of my nephew that will be born in about 1 1/2 month…so excited…except I was a bit nervous as I had never done a newborn photoshoot before. Again thank you so much for the information…will be of great use. Great job!
5. Consider some technical details. There are photos I took 5 years ago that I thought were amazing at the time and now realize they were out of focus, or my editing made the people look purple, or the highlights were blown out. If you (like a normal person) haven't spent a lot of time poring over tons of professional photos with a discerning eye, you may not really know what to look for. Maybe some of these finer technical points wouldn't bother you, or maybe the photographer you can afford isn't quite as technically proficient as the photographer who charges $500 more. That's okay, these are just a few things to consider. First let's talk about focus. Often, the best way to tell if a photo is properly focused is to look at the eyes. In the two photos below, you can see a lot more detail in her eyes on the left than on the right. I missed the focus on the second image, so that one was not given to my clients.
Tipping a photographer for family portraits is not standard etiquette. A great way to recognize a family photographer who goes above and beyond is to write them a glowing review. You probably found your photographer by reading online reviews, so paying it forward by letting everyone know how much you appreciate their work is a great gift. Write your review after they have delivered the final edited photos on time and you've confirmed that you're happy with the terrific portraits they took.
Quality should be the primary driving factor because no matter how great the deal, you barely have time to do it once, let alone time (or money) to do it over. So what do we mean when we say "quality?" While "style" may influence the overall appearance and presentation of the final gallery, a level of technical expertise should be demonstrated by the photographer. Images should be properly exposed. The highlights and shadows of the images should not be void of any color, to bright or too dark, saturation should not be so intense that that colors will be comprised when they are printed. Subjects should be in focus and images should never be be pixelated or posterized when printed. Composition should be intentional and the photographer should be able to capture subjects with flattering light and angles. Images shouldn't be "saved" by Photoshop actions and should look as good printed at 24×30 as they do online. Typically being able to CONSISTENTLY perform to a level of quality requires significant experience rather than just a hobbyist who can pull out 5-10 great shots out of 100 snapped. One of the best ways a photographer can demonstrate quality and experience is to have a portfolio and a broad representation of full client galleries to show.
Last tip is to no take yourself so seriously. Create a few really whacky shots at the end of the session (or even in the middle if the energy seems to be fading). Tell them to do a group squish and really get them to squish. Often they will start laughing and as they pull apart you grab the shot. Do a pile on down in the grass. Ask them to jump in the air or make goofy faces (you make one too). It breaks the tension and lightens up the mood.
Lifestyle newborn sessions – Are a bit more casual approach to newborn photography. There may be some posing but the intention is to capture more natural images of the baby and their home. These sessions can be done up to 6 weeks old and usually last 1-2 hours max. My favorite thing about lifestyle newborn photography is capturing the wonder and amazement between the family members. Newborns are incredible but so is the love in the air. Memories of this time-frame often become fuzzy for new parents and that is precisely why I feel these types of shoots are so important.
3. Pay attention to where your light is coming from. If you're using the same setup you used to take photos of the baby alone, your subjects should already be positioned correctly in relation to your light source (large window). They should be facing either the right or left edge of the window (which is where you'll be standing). Light coming at a 45 degree angle casts nice, soft shadows that define both baby and Mom's features, while also providing nice catchlights (bright spots) in their eyes.
This is great news for you photographers who want to try out different types of photography, or make a little money from your photography. Newborn baby pics are also an amazing addition to your online photography portfolio; a great newborn photoshoot can really show off your skill and range as a shooter (to say nothing of your subject wrangling skills!).
"AMAZING! Stop looking and just book with him. Garrett is very professional and genuinely cares about his clients. He has amazing prices and really is willing to work with you. I was hesitant about hiring a professional photographer but I am so glad I did because the photos look amazing. If I ever need a photographer I will definitely be hiring him again."
Danielle and Tony are the husband and wife team of professional photographers behind Mon Petit Chou Photography. Based in Toronto, we specialize in maternity, newborn, baby, family and lifestyle photography. Our style is natural and relaxed, and we strive to create a custom experience for each family that we work with. Learn more about us or get in touch.
You've probably seen a wide variety of newborn baby poses, from a sweet swaddle to a baby in a basket or hanging in a sling from a branch. Lots of the poses you may have seen might take half an hour just to set up, and some actually require having an assistant hold the baby in position and then editing out the assistant's hands in post processing. Some people love these more creative poses; some people hate them. Personally I think some (when well done) are kind of cool, but I really prefer more natural poses that don't look contrived. Since my goal here is to help you take better photos of your own newborn at home, I'm going to share three simple, go-to poses that you'll be able to use without extra equipment (or even extra help).
8) Market, market, market. The key to success in a photography business is marketing. You can't take and get paid for photos if no one hires you. Along with business cards, brochures and a website, use your personal and professional networks to spread the word about your business. Attend trade shows and events geared toward your market. For example, if you want to do wedding photography, attend wedding shows. If you want to take pet portraits, attend dog shows.
Intern with a professional photographer. If you are an amateur photographer or you're just starting out, you should intern or apprentice with a professional photographer to get a sense for how a photography business should be run. It's likely that you won't agree with the way your mentor does everything in her business, but it will give you a good idea of the "big picture" of running a photography business.
Trust your photographer to direct you in posing so you can look your best. What makes maternity photos different from other portraits is that the images focus on you, your personality, feelings and the bond you have with your much-awaited baby. Many maternity poses such as hands on the belly and eyes looking down express emotions and connection to your belly. Other maternity poses empathize the beautiful curves of your body.
I know many portrait & wedding photographers love to shoot wide open at f/1.2 & f/1.4. However, with newborn photography, many of the baby poses can have extreme angles and you often will have better luck with your depth of field and sharpness by shooting around f/2 & f/2.2. Remember, it will be rare that the baby's eyes are on the same plane of focus all the time and by closing down my aperture a bit from wide open I get that little bit extra of depth of field that is often needed.
Yahay! What an exciting time – you're engaged and apart from planning your wedding celebration, we're guessing that you're on the lookout for ways in which to celebrate your engagement! Planning an engagement party may be the first step, and if it is, then be sure to check out this 5-step Planning Your Engagement Party {Wedding Planning Series} guide! Next, we suggest that you have a little fun with an e-shoot inspired by your personalities and by this collection of handpicked Engagement Photo Poses and Ideas! GO ahead and dig in!
Apply lotion one hour before the photo shoot. Moisturizing your skin just before a photo shoot can create a glare when the flash goes off. Be sure to apply moisturizer If you are going to have a close-up photograph of your bare baby bump, be sure to apply lotion early in the day or one hour before the photo shoot at the latest.[7] This will give the lotion enough time to properly sink into your skin.
Amy McDaniel is a child, newborn and maternity photographer. She is the owner of Dewdrops Photography and her work is based in Alabama, United States. Amy McDaniel loves children and this is why she is interested in photographing them. She focuses in her photographs on fun, simplicity, capturing a moment in time and recording those true expressions which make the photos look stunning even with those babies who are not easy to be photographed. 4 Dave Engledow – United States
Spring is the perfect time to take your photo idea outdoors. Choose from beautiful pastel colors are more prominent in the springtime, along with white and blue hues. Other trendy springtime outfit ideas include floral patterns, which can be incorporated throughout accessories or clothing items. Dresses and skirts are also popular for spring family photos. These springtime trends paired with simple basics will give your family photos a polished and fresh look.
Deciding what to wear in family photos can be just as challenging as finding the perfect photographer. These are photos you are going to hang on your walls and cherish for years to come. It can seem overwhelming when considering what to wear but it doesn't need to be. Use these tips to help you pick out the perfect wardrobe for you and your family.Even before little ones are born, parents begin searching for the perfect photographer to capture the moments that will last a lifetime. The glow of motherhood in maternity portraits. The beautiful delivery details in birth photography. Photography plays such an important role in parenthood, we know those decisions aren't made lightly. To help answer one of the biggest questions we often receive "Where Can I Find a Photographer?", we created this guide.
Inspiration is everywhere – probably even in the form of Pinterest emails from your client. It is a great idea to have some poses in mind before you arrive at the session. However, like letting the love story of a wedding day unfold organically, I believe the best images are unplanned and inspired by the uniqueness of each baby. Whether it is cute dimples, big beautiful eyes, full lips, or a great head of hair, try to highlight the beauty of the baby.
The best photographs are often the ones where everyone is engaged or interacting with each other. Understand that not every picture needs to have everyone looking at the camera and smiling at the same time. If you are engaged as a family and loving on each other, your eyes will be on your family members and your smile with be natural. These are the photographs that you will cherish most because they depict your family connection and your love.
Before joining the team at A Practical Wedding, Maddie was a sought after wedding photographer and an entertainment industry dropout with stints at the Academy Award-winning independent film house Focus Features, The Montel Williams Show, and Rosie O'Donnell's documentary production company. She's been with the APW team going on eight years, and now spends a significant amount of time thinking about internet trends and the future of feminist television. A Maine native, she lives on a pony farm in the Bay Area with her husband and their toddler.
Happy family. With male and female childrenHappy family. Happy young family spending time together outside in green natureHappy family outdoors. Happy family is standing near their modern house, smiling and looking at cameraFamily health care and insurance concept. Top viewFamily time father and son watch the sunset. Family time father and son watch and praise the sunsetHappy family: mother father and child daughter on sunset. Happy family: mother father and child daughter on nature on sunsetPaper chain family protected in cupped hands. Cutout paper chain family with the protection of cupped hands, concept for security and careFamily with children blow soap bubbles. NatureHappy black family standing outside their house, dad holding the keyHappy family travel by car in the mountains. Happy family travel by car. People having fun in the mountains. Father, mother and child on summer vacationHappy family having fun on summer vacation. Happy family on the beach. People having fun on summer vacation. Father, mother and child against blue sea and skyFamily Relaxing In Garden With Pet DogHappy family father and children reading a book in tent at hom. Happy family father and children reading a book with a flashlight in a tent at homeFamily of noble deer in a snowy winter forest. Christmas fantasy image in blue and white color. Snowing. Underwater photo. Happy family snorkelling in tropical sea. Happy family - father, mother, child in snorkeling mask dive underwater with tropical fishes in coralBig family have a dinner with fresh cooked meal on open garden t. ErraceNewborn Baby and Family Concept, Parents Holding New Born Child. Newborn Baby and Family Concept, Parents Couple Holding New Born Child in Hands, Mother FatherHappy family. Young father playing silly with his daughter lifting her upClinking glasses of wine. Cheers after speech. Party at cafe or restaurant. Family celebration or anniversary. Portrait happy attractive young family posing embracing. Portrait of multi-ethnic attractive mother father adorable little preschool daughter sitting togetherFamily on a camping trip walking near a lake, back viewHappy Couple Dreaming Of Their New Home Or Furnishing On Blue Background. Family With Sketch Drawing Of Their Future Flat Interior. Back view Of Happy CoupleFamily. Lying on green grass. Children having fun outdoors in spring park. Retro toned imageFamily Carrying Boxes Into New Home On Moving DayFamily outdoors. Family of three generations outdoors, smilingBusy Family Home With Mother Working As Father Prepares MealPortrait of Happy Family Piled Up In Park. SmilingHappy black family standing outside their houseMulti generation black family, parents piggybacking kidsFamily in a hike. Family with two kids have hiking through the mountainsFamily preparing for Easter. Mother and child painting eggs. Happy family preparing for EasterTime with family is always on the first place. We making fun . Rear viewMedical or travel insurance. Man covers the family with his hands from his father, mother, son and daughter. Fallow deer family - doe and fawn babies. Fallow deer family - doe mothers and fawn babiesFamily New Home Moving Day House Concept. Happy family playing into new home. Father, mother and child having fun together. Moving house day and real estatePortrait Of Multi-Generation Chinese Family. Relaxing In Park TogetherHispanic Family Viewing Potential New HomePortrait of happy multi generation family sitting on sofa in living room. At homeBaby Newborn Feet Mother Hands. New Born Kid Foot, Family Love. Baby Newborn Feet in Mother Hands. New Born Kid Foot, Family Love ConceptMother and kids, family coloring Easter eggs. Mother and kids with pet rabbit color Easter eggs. Mom, little girl and boy with bunny ears dying and painting forLaughing family spend time having fun at new home. Multi-ethnic family spend time together sitting on couch in living room have fun play with little preschoolSmiling multi-generation family using mobile phone in living room. At homeHappy family mother and child girl paints eggs for Easter. At homeFamily lying on grass. Outdoors in spring parkTime for family always exists. Young parents playing with daughters at homeHappy loving family. Mother and her daughters children girls playing and huggingFamily New Home Moving Day House Concept. Happy family playing into new home. Father, mother and child having fun together. Moving house day and real estateConcept housing young family. Mother father and child in new h. Concept housing a young family. Mother father and child in new house with a roof at empty brickMulti Generation Family Giving Children Piggybacks OutdoorsFamily in iceland. Back view of family, father and son, enjoying beautiful view at iceberg lagoon in jokulsarlon national park in iceland, copy space on rightHappy family shopping. A happy family is shopping together in a mallPretty yong family in bed. Parents kissing their baby, top viewEnjoy family. Family enjoy playing singing togetherHappy family: mother, father, children son and daughter on sunset. Happy family: mother, father, children son and daughter on nature on sunsetHappy family mother and daughter read a book in evening. Happy family mother and daughter read a book in the evening at homeHappy family mother and baby son on autumn walk. Happy family mother and baby son playing and laughing on autumn walkMother and child daughter practicing yoga together at home. Sport and family concept. Mother and child daughter practicing yoga together in living room at homeYoung woman having fun with kids doing yoga. Family sport concep. T. Close upEvening family reading. father reads children . book before going to bed . Evening family reading. father reads children a book before going to bedAmerican soldier with family outdoors. Military service. American soldier with happy family outdoors. Military serviceHappy African-American family of four on beach. Happy African-American family with two children on beachFamily reading bedtime. Mom and child reading book with a flashlight under blanket. Family reading bedtime. Mom and child daughter reading a book with aFamily on Easter. Happy holiday! Mother and her daughter with painting eggs. Family preparing for Easter. Cute little child girl is wearing bunny earsHappy family father, mother and child daughter launch a kite on. Nature at sunsetHappy family father and daughter reading book in bed. Happy family father and child daughter reading book in bedLarge Family by Tree. A large family with two parents and eight children, some biological and some adopted, multi racial children by a cool treeFamily moving into their new home. Young happy family moving into their new homeFamily with red umbrella. Happy funny family with red umbrella under the autumn shower. Girl and her mother are enjoying rainfall. Kid and mom are playing on theExcited Family At New Home Sweet HomeMerry Christmas! happy family mother father and child with magic. Gift near treeHappy family mother and children on autumn walk. In parkFamily. Mother and daughter. Together. Family, mother and daughter on the river bank. The girl bends over and says something to her daughter. Girls in whiteHappy family. Young mother and father with baby boy, leafy green trees in backgroundKangaroo family on the beach. A family of kangaroos enjoying a beach sunset on the Australian coast, hopping in unison on the wet sand that shows theirFather`s day. Happy family daughter hugging dad and laughs. On holidayFamily walking through poppy field. Holding handsFamily reading bedtime. Pretty young mother reading a book to her daughter. Happy time at homeHappy family on a camping trip relaxing by their tentChristmas magic gift box and a happy family mother and baby. Christmas magic gift box and a women happy family mother and Child babyHappy family in kitchen. mother and children preparing dough, ba. Happy family in the kitchen. mother and children preparing the dough, bake cookies
Tipping a photographer for family portraits is not standard etiquette. A great way to recognize a family photographer who goes above and beyond is to write them a glowing review. You probably found your photographer by reading online reviews, so paying it forward by letting everyone know how much you appreciate their work is a great gift. Write your review after they have delivered the final edited photos on time and you've confirmed that you're happy with the terrific portraits they took.
If the couple has requested family photos let them know how it is going to go. For example, say you will photograph the Brides family first. You will then ask the grooms family to join so you can photograph both families together. Finally, you will ask the Brides family to leave so you can capture the Grooms family. If everyone knows what is going on it makes the whole process a lot less stressful for you and the guests.
Thaddeus Harden Photography is a photography studio based in Southlake, Texas, serving Dallas, Arlington, Irving, Fort Worth, Colleyville, Bedford, Grapevine, Flower Mound Denton, Frisco, Garland, Plano, Carrolton, and Southlake. They have served renowned clients in the City of New York for more than 28 years. Now, Thaddeus Harden brings their talent to Texas as a newborn, maternity, and family photographer. Thaddeus Harden Photography conducts portrait photography services.
Whether you are all playing outside in the falling leaves, posing by the cozy fireplace or walking along the beach, you are the ones who will make the photo unique. We know that it sometimes takes the inspiration from others to get your creative juices flowing, so we have put together a list of 80 photo family photo ideas. Sort through the filters to find the best fit for your family. Don't forget to share your photos with friends and family—easily order prints from your desk or mobile phone. And for additional inspiration check out this article: family photo wall ideas.


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From Syed Mohsin NaqviCNN
ISLAMABAD, Pakistan (CNN) -- Pakistani authorities arrested two senior officials from Afghanistan's deposed Taliban regime Saturday, including one who may know the whereabouts of elusive Taliban leader Mullah Mohammed Omar, Pakistani intelligence sources said.
The two men were found in western Pakistan near the Afghan border, the intelligence sources said.
One was identified as Maulvi Abdul Mannan, governor of Badghais province under the Taliban. He was close to Omar, whom the United States has been seeking since it toppled the regime three months after the al Qaeda terrorist network carried out the attacks of September 11, 2001.
Coalition intelligence sources have said there are persistent reports that Omar is in western Afghanistan, particularly in the Kandahar region, once a stronghold of the Taliban.
While in power, Omar refused to be photographed or filmed, and was known to remain close to Kandahar. (Profile: Mullah Mohammed Omar)
Pakistan, which the United States considers an ally in the effort to crack down on terrorist groups, has carried out numerous raids and arrested various Taliban figures.
The Pakistani intelligence sources said they hope to gain more information about Omar's whereabouts from Mannan.
Also, Najeeb Ullaha, a Taliban military commander, was arrested Saturday, the intelligence sources said.
Separately, Pakistani Information Minster Sheikh Rashid said a DNA analysis determined that a leading al Qaeda figure, Abdur Rehman Khadar, was killed in a raid by the Pakistani army in October.
Eight al Qaeda members were killed in that raid, in a tribal area northwest of Pakistan, the information ministry said. The names of the others were not released.


text: Since 1997.FREE downtown event! The event will take place at Flatiron Park at 100 N. Apache Trail. There will be lots of activities throughout the evening for the whole family! Activities include: Santa, vendor booths, arts and crafts, games, music, 30 feet of snow, inflatables, food, tree lighting at the Focal point and will conclude with the annual light parade. Most of the youth activities will be free but there will be vendors and food options. The snow area is broken up into two age groups, one for the littles and one for older kids. We expect line wait times to be anywhere from 20- 40 minutes, depending on the number of attendees. We recommend wearing gloves and hats-it is real snow. Join the Mayor at the focal point to help light up the town! The tree lighting will begin around 6:30pm. Then join us for the light parade. The light parade starts at 7pm. It begins at Phelps/Main Street heads west to Thunderbird, turns and comes back to Phelps Road. Expect road closures will be from Idaho to Ironwood from about 5pm to 10pm or until roads are clear and can safely be open. Enjoy an Apache Junction Main Street tradition - the Annual Holiday Light Parade will take place on Apache Trail between Phelps and Thunderbird. Parade begins at 7:00pm. Parking at the event. There will be parking in the dirt lots east of the Park, please don't park in areas designated for business. We recommend not using North Apache Trail for a pass through, as this area will be slowed and will have pedestrian traffic. You will not be able to exit to Main street from North Apache Trail after 5pm.


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Welcome to the Kalamazoo Bee Club
Our annual bee school is February 15, and registration is now open. There's even an early-bee special, so save some money–and perhaps even take care of a few Christmas gifts–by signing up now.
Our keynote speaker is the amazing, super-knowledgeable and super-engaging Dr. James Tew. We also have two queen rearing experts, a comb honey presenter, lots of bee-ginners sessions, LOTS of vendors from whom you can purchase bees, supplies and equipment. More details in the months ahead, but while we do a school every year, 2020's annual bee school with Dr. James Tew is one you don't want to miss.
A big thank you to the following organizations, businesses, and individuals for their generous financial support of 2019's Kalamazoo Bee School:


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"Everything about our stay was great. The size of our room, the king size beds very comfortable...the breakfast was delicious and the dinging area was ... " More
In Petaluma
Within 2 miles (3 km) of this Petaluma motel, you'll find Petaluma Arts Center and Phoenix Theater. University of Northern California and Petaluma Historical Museum are also within 2 miles (3 km).
Free perks
A restaurant and an outdoor pool are featured at this motel. Traveling on business? Take advantage of the business center and free WiFi in public areas. Guests will appreciate freebies like continental breakfast and free self parking.
Free WiFi, refrigerators
Featuring conveniences like refrigerators and microwaves, the 73 guestrooms also offer free WiFi and TVs with cable channels. Other amenities include coffee/tea makers, free long-distance calls, and free local calls.
There's a restaurant on site. Free breakfast is available. WiFi is free in public spaces. A business center and a meeting room are available. The business-friendly Best Western Petaluma Inn also features an outdoor pool, complimentary newspapers in the lobby, and laundry facilities. Self parking is free. This Petaluma motel is smoke free.
Available in all rooms: Free WiFi
Available in some public areas: Free WiFi
Free self parking
Best Western Petaluma Inn offers 73 air-conditioned accommodations with coffee/tea makers and hair dryers. Premium cable television is provided. Guests can make use of the in-room refrigerators and microwaves. Guests can surf the web using the complimentary wireless Internet access. Business-friendly amenities include desks; local and long-distance calls are complimentary (restrictions may apply). Additionally, rooms include irons/ironing boards and complimentary toiletries. Housekeeping is provided daily.
Guests are served free continental breakfast.
Gourmet Garden - This buffet restaurant specializes in Chinese cuisine and serves lunch and dinner.
Recreational amenities at the motel include an outdoor pool.
If you have requests for specific accessibility needs, please note them in the special requests field on the booking page after selecting your room.
Extra-person charges may apply and vary depending on property policy.
Government-issued photo identification and a credit card, debit card, or cash deposit are required at check-in for incidental charges.
Special requests are subject to availability upon check-in and may incur additional charges. Special requests cannot be guaranteed.
Charges for extra guests may apply and vary according to property policy.
A cash deposit, credit card, or debit card for incidental charges and government-issued photo identification are required upon check-in.
Special requests are subject to availability at the time of check-in. Special requests can't be guaranteed and may incur additional charges.
The fees and deposits listed below will be charged at the time of service, check-in, or check-out.
This may not be a comprehensive list. Fees and deposits are subject to change and might not include tax.


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Instrument Verkauf
Großbritannien (UK)
Veröffentlicht am: 02 Dec 2019
Andreas Zeller Stentor Cello, Made in Romania
Preis: £350
3/4 size Stentor cello in excellent condition, with well set-up strings. Including bow and soft, light case.
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