lunes, 1 de febrero de 2016

Improving Antibiotic Prescribing for Uncomplicated Acute Respiratory Tract Infections - Research Review - Final | AHRQ Effective Health Care Program

Improving Antibiotic Prescribing for Uncomplicated Acute Respiratory Tract Infections - Research Review - Final | AHRQ Effective Health Care Program

AHRQ--Agency for Healthcare Research and Quality: Advancing Excellence in Health Care



Research Review - Final – Jan. 27, 2016

Improving Antibiotic Prescribing for Uncomplicated Acute Respiratory Tract Infections

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CMS NEWS: New Proposal to Give Providers and Employers Access to Information to Drive Quality and Patient Care Improvement

Centers for Medicare & Medicaid Services

CMS NEWS


FOR IMMEDIATE RELEASE
January 29, 2016

Contact: CMS Media Relations
(202) 690-6145 | CMS Media Inquiries

New Proposal to Give Providers and Employers Access to Information to Drive Quality and Patient Care Improvement
MACRA provides expanded opportunity for the use of Medicare and private sector claims data to drive higher quality, lower cost care
The Centers for Medicare & Medicaid Services (CMS) today proposed rules that will expand access to analyses and data that will help providers, employers, and others make more informed decisions about care delivery. The new rules, as required by the Medicare Access and CHIP Reauthorization Act (MACRA), will allow organizations approved as qualified entities to confidentially share or sell analyses of Medicare and private sector claims data to providers, employers, and other groups who can use the data to support improved care. In addition, qualified entities will be allowed to provide or sell claims data to providers. The rule also includes strict privacy and security requirements for all entities receiving Medicare analyses or data, as well as new annual reporting requirements.

This initiative is part of a broader effort by the Obama Administration to create a health care system that delivers better care, spends dollars more wisely, and results in healthier people.
“Increasing access to analyses and data that include Medicare data will make it easier for stakeholders throughout the healthcare system to make smarter and more informed healthcare decisions,” said CMS Acting Administrator Andy Slavitt.

The qualified entity program was authorized by Section 10332 of the Affordable Care Act and allows organizations that meet certain qualifications to access to patient-protected Medicare data to produce public reports. Qualified entities must combine the Medicare data with other claims data (e.g., private payer data) to produce quality reports that are representative of how providers and suppliers are performing across multiple payers, for example Medicare, Medicaid, or various commercial payers. Currently, 13 organizations have applied and received approval to be a qualified entity.  Of these organizations, two have completed public reporting while the other 11 are preparing for public reporting.

Today’s rules seek to enhance the current qualified entity program to allow innovative use of Medicare data for non-public uses while ensuring the privacy and security of beneficiary information. Comments are welcome on this set of proposed rules.  You can submit your comments until March 29, 2016 here: http://www.regulations.gov




The proposed rule is on display at the Office of the Federal Register at: https://s3.amazonaws.com/public-inspection.federalregister.gov/2016-01790.pdf  and on 02/02/2016 and available online athttp://federalregister.gov/a/2016-01790
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Get CMS news at cms.gov/newsroom, sign up for CMS news via email and follow CMS on Twitter@CMSgov
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MercatorNet: Canadian euthanasia raises weighty conscience issues for doctors

MercatorNet: Canadian euthanasia raises weighty conscience issues for doctors





Canadian euthanasia raises weighty conscience issues for doctors

Complicity in evil is a legitimate concern.
Sean Murphy | Feb 1 2016




After last year’s decision by the Supreme Court of Canada, Canadian legislators are attempting to draft laws to exempt physicians from prosecution if they provide euthanasia or assisted suicide according to guidelines set by the Court.
No matter what one thinks about the acceptability of these options, Canadian lawmakers must ensure that health care workers who object to providing or participating in homicide and suicide for reasons of conscience or religion are not compelled to do so, or punished or disadvantaged for refusal.
The Provincial-Territorial Expert Advisory Group on Physician Assisted Dying made 43 recommendations concerning the implementation of the Supreme Court of Canada ruling in Carter v. Canada (Attorney General). The following are of particular concern:
  • that objecting facilities should be forced to arrange for homicide or assisted suicide elsewhere by initiating patient/resident transfers;
  • that objecting physicians or health care workers should be forced to actively enable homicide or suicide by
  • providing referrals, or
  • arranging direct transfers, or
  • enlisting or arranging the enlistment of patients in a euthanasia/assisted suicide delivery system analogous to an organ transplant system.
These recommendations are inconsistent with genuine accommodation of freedom of conscience and religion, in as much as many conscientious objectors reasonably consider them to involve unacceptable complicity in homicide and suicide. The reasonableness of their position can be verified by considering it within the context of law and public policy.
With respect to the legal context, but for the Carter decision, physicians who acted in accordance with any of these recommendations would be exposed to criminal prosecution as a party to the offence of first degree murder or assisted suicide, or conspiracy to commit first degree murder or assisted suicide. In addition, they would be civilly liable for damages arising from the homicides or suicides to which they were parties.
Complicity is a legitimate concern
The public policy context is provided by the case of Maher Arar. In 2002, Arar, a Canadian citizen, was detained in New York, interrogated and "rendered" to Syria by US authorities. In Syria he was imprisoned for almost a year, "interrogated, tortured and held in degrading and inhumane conditions." A subsequent "comprehensive and thorough" investigation "did not turn up any evidence that he had committed any criminal offence" and disclosed "no evidence" that he was a threat to Canadian security." A commission of inquiry was appointed to investigate "the actions of Canadian officials" in the case.
What concerned the Canadian public and the government was whether or not Canada was complicit in the torture of Maher Arar. That concern surfaces repeatedly in the report of the commission of inquiry: in briefing notes to the Commissioner of the Royal Canadian Mounted Police RCMP), in the testimony of the Canadian Ambassador to Syria, in references to the possibility of RCMP complicity in his deportation, about the perception of complicity if CSIS agents met Mr Arar in Syria, in the suggestion that evidence of complicity could show "a pattern of misconduct," and in the conclusions and recommendations of the report itself.
The issue of complicity arose again in 2007 when a report in Toronto's Globe and Mail alleged that prisoners taken in Afghanistan by Canadian troops and turned over to Afghan authorities were being mistreated and tortured. "Canada is hardly in a position to claim it did not know what was going on," said the Globe. "At best, it tried not to know; at worst, it knew and said nothing."
On this view, one can be complicit in wrongdoing not only by acting, but by failing to act, and even by silence.
We can be morally responsible for others’ acts
The Arar Inquiry and the concerns raised by the Globe and Mail story about Afghan detainees make sense only on the premise that one can be morally responsible for acts actually committed by another person: precisely the position taken by physicians who would refuse to comply with demands that they help find a colleague who will kill patients or help a patients kill themselves.
The Carter decision changed the law on murder and assisted suicide by making exemptions in defined circumstances, but it did not change the reasoning that underpins the law on parties to offences - the same reasoning that triggered the commission of inquiry investigating the treatment of Maher Arar, the same reasoning that sparked the Globe and Mail editorial about the treatment of Afghan detainees, and the same reasoning used by physicians and health care providers who would refuse to facilitate euthanasia or assisted suicide by referral.
The reasoning that underpins the law on parties to criminal offences and public policy on complicity in torture cannot be dismissed as ethically or legally irrelevant to the exercise and protection of fundamental freedoms of conscience and religion.
A reprehensible attack
The position of the Provincial-Territorial Expert Advisory Group and some influential or powerful individuals or groups is that a learned or privileged class, a profession or state institutions can legitimately compel people to be parties to homicide or suicide - and punish them if they refuse.
Nothing of the kind is stated or implied in Carter. This is not a reasonable limitation of fundamental freedoms, but a reprehensible attack on them and a serious violation of human dignity.
From an ethical perspective, it is incoherent, because it posits the existence of a moral or ethical duty to do what one believes to be wrong.
From a legal and civil liberties perspective, it is profoundly dangerous. If the state can demand that citizens must be parties to killing other people, and threaten to punish them or discriminate against them if they refuse, what can it not demand? Yet the Group appears to experience resistance to coerced participation in homicide and suicide as a "uniquely Canadian" mountain to be climbed.
Other countries have demonstrated that it is possible to provide euthanasia and physician assisted suicide without suppressing fundamental freedoms. None of them require "effective referral," physician-initiated "direct transfer" or otherwise conscript objecting physicians into euthanasia/assisted suicide service. It appears that they recognize a point made by Dr Monica Branigan when she appeared before the Committee: that one "cannot build a sustainable system on moral distress."
Provincial governments have primary jurisdiction over human rights law, subject to the Canadian Charter of Rights and Freedoms. By virtue of the subject matter in this particular case (homicide and suicide), the federal government has jurisdiction in criminal law.
Criminal law is not used to enforce or defend fundamental rights and freedoms per se. For that, Canada relies upon human rights statutes. But Canada does use the criminal law to prevent and to punish particularly egregious violations of fundamental freedoms that also present a serious threat to society: unlawful electronic surveillance, unlawful confinement and torture, for example.
Coercion, intimidation or other forms of pressure intended to force citizens to become parties to homicide or suicide is both an egregious violation of fundamental freedoms and a serious threat to society that justifies the use of criminal law.
For this reason, whatever might be decided about laws regulating euthanasia and assisted suicide, the Protection of Conscience Project proposes that the federal government make it a matter of law and national public policy that no one can be compelled to become a party to homicide or suicide, or punished or disadvantaged for refusing to do so, even if the homicide or suicide is not a criminal offence.
Sean Murphy is the administrator of the Protection of Conscience Project. The Protection of Conscience Project supports health care workers who want to provide the best care for their patients without violating their own personal and professional integrity. This is a slightly edited version of the Project submission to a parliamentary committee,  which can be found on the website. See the Project website for footnotes. 


MercatorNet
It was said that Americans of the Victorian era were so prudish that they enveloped the legs of table and pianos with frilly garments to safeguard their modesty. This canard seems to have been the malicious invention of English novelist Frederick Marryat.
However, the mythical spirit of Victorian repression is alive and well in Italy, of all places. Last week Iranian president Hassan Rouhani paid a state visit to Rome to stitch up an US$18 billion trade deal. Much to the amusement of journalists at the press conference at the Capitoline Museums, classical nudes were covered with large boxes, presumably not to offend the Shi’ite dignitary.
This is the sort of event which sends journalists into paroxysms of sarcastic hilarity and pitches op-ed contributors into lugubrious forecasts about a Muslim Europe. In fact, no one has taken responsibility for requesting or authorising the prudery packages.
Whatever the facts of the matter, MercatorNet contributor Chiara Bertoglio sees in the event an opportunity to reflect on the Judeao-Christian view of the human body. “Each one of us, even if we are old, ugly, fat or disproportioned,” she writes, “is a creature in whom God rejoices: in our Creator’s eyes, each one of our bodies is as beautiful as the perfect nudes of Classical sculpture.” Read her article below. 
Michael Cook
Editor
MERCATORNET

Chiara Bertoglio | FEATURES | 1 February 2016
Italy's nude sculptures cover-up exposes contrasting attitudes to the body.
Read more...
 
Canadian euthanasia raises weighty conscience issues for doctors
Sean Murphy | FEATURES | 1 February 2016
Complicity in evil is a legitimate concern.
Read more...
 
The Revenant
Luisa Cotta Ramosino | POPCORN | 1 February 2016
A masterful symphony on the tenacity of man - that never quite reaches the heart.
Read more...
 
Is the internet losing freedom of speech?
Denyse O'Leary | CONNECTING | 1 February 2016
It’s as if your telephone company were your judge and jury, not the court system.
Read more...
 
The health benefits of forgiving
Tamara El-Rahi | FAMILY EDGE | 1 February 2016
Forgiving may be hard but research says it’s worth it.
Read more...
 
The homeless are aging too
Shannon Roberts | DEMOGRAPHY IS DESTINY | 1 February 2016
How will societal systems change to cope?
Read more...
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FDA Law Blog - Premarket Sterility Guidance for Devices is the Latest in a Flurry (Blizzard Pun Intended) of Device Guidance Activity for FDA

Posted: 31 Jan 2016 05:01 PM PST
By Allyson B. Mullen & Jeff N. Gibbs –
Before the multiple feet of snow that the DC area recently received, CDRH had been creating its own storm of device guidance documents. One of the most recent ones is the final guidance “Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile,” which was released on January 21, 2016.  This guidance is the final version of the draft by the same name, which was issued in December 2008.  FDA is holding a webinar to discuss this guidance on February 11th from 2–3:30pm ET. Webinar details can be found on FDA’s website.
This guidance applies to devices that are labeled as sterile through microbial inactivation. It distinguishes established sterilization methods and those that are novel.  That is FDA has established a bifurcated universe of “established” versus “novel.”  It is unlikely, though, that all 510(k)s will neatly fall into this scheme.  This scheme is also different from the original scheme proposed by FDA in the draft guidance with more methods falling under the “established” category than the draft, which proposed a three-tier system of “traditional,” “non-traditional,” and “novel non-traditional.”
Established methods are those for which there is an FDA-recognized standard and are well-accepted, for example dry heat, EO, steam, and radiation. Established methods are also those for which there is no FDA-recognized standard, but there is “published information on development, validation, and routine control available” and/or FDA has previously reviewed and accepted the sterilization method as being acceptable (e.g., through clearance of a 510(k) for a device sterilized with such a method).  These established methods include, for example, hydrogen peroxide, ozone, and flexible bag systems.
On the other hand, novel methods are “newly developed methods for which there exists little or no published information, no history of comprehensive FDA evaluation” and no FDA-recognized consensus standard. Novel methods include, among other things, brand new sterilization methods, changes to parameters of established methods, and combinations of established sterilants which FDA has not previously reviewed or cleared.  It is worth noting that the guidance states that a method is novel if “parameters of an FDA-cleared sterilizer have been altered.”  The guidance does not address how significant the alterations must be in order to be considered novel.  As a result, on its face, it appears that any change to an FDA-cleared sterilizer’s parameters would result in a “novel” sterilization method.
The guidance indicates that FDA intends to inspect device manufacturing facilities that employ novel sterilization methodsprior to clearing 510(k)s for such devices.  The draft guidance also indicated that pre-clearance inspections would be required for novel sterilization methods.  The draft guidance also stated that FDA would perform priority post-clearance inspections of device manufacturing facilities utilizing sterilization methods for which there is no FDA-recognized standard, but there is published information on its validation and FDA has previously reviewed and accepted the sterilization method as being acceptable (previously referred to as non-traditional methods, and now encompassed within the definition of “established” methods).  The statement regarding post-clearance inspections has been omitted from the final guidance, and it should be noted that it is unclear what FDA meant by a “priority” inspection in this context.  It is not to say, however, that FDA will not still consider performing such post-clearance inspections.
With regard to pre-clearance inspections, the guidance does not indicate how FDA will ensure that such an inspection takes place within the Federal Food, Drug, and Cosmetic Act mandated 90 day review time frame for 510(k)s. Nor does the guidance indicate how FDA will handle inspectional findings that result from such pre-clearance inspections, what effect those findings will have on a pending 510(k) or its review timing, or what the inspectional criteria will be.  Historically, FDA has not considered QSR compliance as part of making a substantial equivalence determination, and its ability to use QSR compliance in making an initial classification decision is limited by statute.  FDC Act § 513(f)(5).
Moreover, the guidance creates a new standard for sterilization information required in 510(k)s, and although the guidance is nonbinding, failure to comply will likely result in a finding of not substantially equivalent. For devices sterilized by established methods, the guidance indicates that the sterilization information from the current 510(k) Refuse to Accept policy (a copy of the current requirements for sterile devices is at the end of this post) and the CDRH premarket coversheet (i.e., the sterilization facility) should be submitted in a 510(k) plus the following information:
  • A description of the sterilization chamber (e.g., rigid or fixed);
  • If the sterilization method is not the subject of an FDA-recognized consensus standard, but the sterilizer or sterilization method has been cleared by FDA:
    • the 510(k) number,
    • the make and model of the sterilizer, and
    • whether the proposed sterilization cycle is identical to a cleared cycle or has been altered (note: if it has been altered then it would be considered a novel method under the guidance);
  • If the method has not been previously cleared by FDA, but there is “published information on development, validation, and routine control available” it should be stated;
  • The radiation dose, if the device is sterilized by radiation;
  • If the sterilization method is not the subject of an FDA-recognized consensus standard, “a comprehensive description of the process and the complete validation protocol;” and
  • A description of not only the packaging, but also how it will “maintain the device’s sterility, and a description of the package test methods, but not package test data.”
For novel methods, the above information must be provided along with the following additional information:
  • “A comprehensive description of the sterilization process;
  • The method used to validate the sterilization cycle (e.g., the half-cycle method);
  • The validation protocol; and
  • The sterilization validation data. The submission should also identify any applicable published scientific literature.” Note: the requirement to provide the sterilization validation data is in direct contradiction of the current version of the 510(k) RTA, which expressly states that “the sterilization validation report is not required.” We think it would be too cute for FDA to say that asking for the data rather than the report was not a contradiction.
The guidance also provides additional information regarding the information needed to support a “non-pyrogenic” claim and the types of devices for which pyrogenicity data should be provided. These sterilization and pyrogenicity requirements have been modified in the final guidance compared to the draft guidance.
The draft guidance also set out detailed steps for how the reviewers should route sterilization information during a 510(k) reviewing, including, requesting inspections and involving the Infection Control Devices Branch (ICDB) in its review of novel sterilization methods. This detailed routing information and references to the ICDB’s involvement have all been omitted from the final guidance.  It is possible that the review team will follow the draft process internally, and it was simply omitted from the public-facing final guidance.
Although the guidance is neither binding nor set out in the 510(k) RTA, we expect that FDA will begin enforcing these requirements sooner rather than later, even if not officially. As a result, manufacturers will want to ensure that they are familiar with these new sterilization requirements prior to submitting a 510(k) to FDA.
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