The Joint Commission reports:
Physicians and medical staff members who have concerns about the safety and quality of care at their hospital may report those concerns with the understanding that retaliatory disciplinary action is prohibited, according to explicit new rules announced today by The Joint Commission. The accreditation participation requirement previously referred generally to hospital staff, although it has always been intended that physicians and medical staff be included as part of ‘Good Faith Participation’ in the accreditation policy.
The revised requirement, which will become effective January 1, 2008, means that accredited hospitals must educate staff and medical staff that any employee or any physician who has concerns about the safety or quality of care provided in the hospital may report these concerns to The Joint Commission. Hospitals also are expected to inform staff and medical staff that no disciplinary action will be taken if concerns are shared with The Joint Commission, and hospitals should demonstrate this commitment by refraining from taking action against employees or physicians who report their concerns to The Joint Commission.
“The Joint Commission policy forbids accredited organizations from taking retaliatory actions against those who report quality of care concerns because it is the obligation of everyone in an organization to make patient well-being the priority,” says William E. Jacott, M.D., special advisor for Professional Relations, The Joint Commission.
Friday, September 28, 2007
Hospital's proposal to compensate physicians for on-call ED coverage does not violate anti-kickback statute
[Source: Health Lawyers Weekly, Sept. 28, 2007]
A medical center’s proposal to compensate physicians for providing on-call coverage does not run afoul of the Anti-Kickback Statute, the Department of Health and Human Services Office of Inspector General (OIG) said in an Advisory Opinion posted September 27.
Faced with a shortage of physicians willing to provide ED on-call coverage, the medical center proposed an arrangement under which it would pay a per diem rate to physicians for each day spent on-call at the ED, except for one and one-half days that each physician must contribute free of charge to the rotation schedule monthly.
Here, OIG found the personal services safe harbor does not apply to the arrangement because the hospital’s payments to physicians are not “set in advance” as required under the safe harbor. Nevertheless, OIG concluded the arrangement “presents a low risk of fraud and abuse,” pointing to the fact that the payments are fair market value for actual services needed and provided, without regard to referrals.
OIG concluded that while the arrangement could potentially generate prohibited remuneration under the Anti-Kickback Statute, it would not impose administrative sanctions on the medical center.
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Advisory Opinion No. 07-10 (Dep’t of Health and Human Servs. Office of Inspector Gen. Aug. 28, 2007).
A medical center’s proposal to compensate physicians for providing on-call coverage does not run afoul of the Anti-Kickback Statute, the Department of Health and Human Services Office of Inspector General (OIG) said in an Advisory Opinion posted September 27.
Faced with a shortage of physicians willing to provide ED on-call coverage, the medical center proposed an arrangement under which it would pay a per diem rate to physicians for each day spent on-call at the ED, except for one and one-half days that each physician must contribute free of charge to the rotation schedule monthly.
Here, OIG found the personal services safe harbor does not apply to the arrangement because the hospital’s payments to physicians are not “set in advance” as required under the safe harbor. Nevertheless, OIG concluded the arrangement “presents a low risk of fraud and abuse,” pointing to the fact that the payments are fair market value for actual services needed and provided, without regard to referrals.
OIG concluded that while the arrangement could potentially generate prohibited remuneration under the Anti-Kickback Statute, it would not impose administrative sanctions on the medical center.
Read full story
Advisory Opinion No. 07-10 (Dep’t of Health and Human Servs. Office of Inspector Gen. Aug. 28, 2007).
President Bush signs drug-safety bill into law.
[Source: Health and Lifes Sciences Daily, Sept. 28, 2007]
The AP (9/28, Bridges) reports that on Thursday, President Bush signed the Food and Drug Administration Amendments Act of 2007 (H.R. 3580 ), which grants the FDA "broad new powers to ensure the safety of prescription drugs used by millions of Americans." The new law reauthorizes, for five years, "programs to collect fees from drug and medical device manufacturers," with drug companies expected to pay "$393 million, and medical device makers $48 million, in various fees next year." FDA Commissioner Dr. Andrew von Eschenbach noted, "It really represents an important addition to the FDA's authority." The legislation grants the FDA "the power both to require drug companies to do further study on the safety of medicines, if needed, and to mandate new label warnings when problems do appear. The FDA also gains the ability to fine companies to ensure compliance with those two new authorities." Moreover, the new law "requires companies to publicly release results of all clinical trials that show how well their approved drugs performed. Not-yet-approved drugs could be subject to the requirement later." The AP notes, "The FDA was still reviewing the 156-page law and its roughly 200 specific provisions, many with timelines, before deciding how to implement them."
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FDALegislativeWatch.com reviews the new bill.
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Patent Baristas reviews the new bill.
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FDA has yet to determine how quickly it can exercise new authorities created by the FDA Amendments Act of 2007
[Source: FDALegislativeWatch.com]
The question is whether the new authorities "are self-implementing or whether they need clarification in the form of a reg or a guidance," Deputy Commissioner for Policy Randall Lutter said.
If regulations or guidance are necessary, agency use of new tools - such as the ability to order drug companies to make labeling changes, conduct post-approval clinical trials or develop risk evaluation and mitigation strategies - will be delayed as the agency goes through public comment procedures.
Complicating implementation of the statute is its size and scope. "There appears to be at least 200 specific provisions, many of which have timelines that have been identified within the bill itself," Commissioner Andrew von Eschenbach pointed out. An implementation strategy will be evolving during the coming weeks and months, he said.
Continue reading
The AP (9/28, Bridges) reports that on Thursday, President Bush signed the Food and Drug Administration Amendments Act of 2007 (H.R. 3580 ), which grants the FDA "broad new powers to ensure the safety of prescription drugs used by millions of Americans." The new law reauthorizes, for five years, "programs to collect fees from drug and medical device manufacturers," with drug companies expected to pay "$393 million, and medical device makers $48 million, in various fees next year." FDA Commissioner Dr. Andrew von Eschenbach noted, "It really represents an important addition to the FDA's authority." The legislation grants the FDA "the power both to require drug companies to do further study on the safety of medicines, if needed, and to mandate new label warnings when problems do appear. The FDA also gains the ability to fine companies to ensure compliance with those two new authorities." Moreover, the new law "requires companies to publicly release results of all clinical trials that show how well their approved drugs performed. Not-yet-approved drugs could be subject to the requirement later." The AP notes, "The FDA was still reviewing the 156-page law and its roughly 200 specific provisions, many with timelines, before deciding how to implement them."
* * * * *
FDALegislativeWatch.com reviews the new bill.
* * * * *
Patent Baristas reviews the new bill.
* * * * *
FDA has yet to determine how quickly it can exercise new authorities created by the FDA Amendments Act of 2007
[Source: FDALegislativeWatch.com]
The question is whether the new authorities "are self-implementing or whether they need clarification in the form of a reg or a guidance," Deputy Commissioner for Policy Randall Lutter said.
If regulations or guidance are necessary, agency use of new tools - such as the ability to order drug companies to make labeling changes, conduct post-approval clinical trials or develop risk evaluation and mitigation strategies - will be delayed as the agency goes through public comment procedures.
Complicating implementation of the statute is its size and scope. "There appears to be at least 200 specific provisions, many of which have timelines that have been identified within the bill itself," Commissioner Andrew von Eschenbach pointed out. An implementation strategy will be evolving during the coming weeks and months, he said.
Continue reading
FDA encourages drugmakers to study genetics and drug safety.
[Source: Health and Life Sciences Daily, Sept. 28, 2007]
The New York Times (9/27, C3, Pollack) reported, "Seven of the largest pharmaceutical companies have formed a group to develop genetic tests to determine which patients would be at risk from dangerous drug side effects." The FDA has "encouraged" the formation of the group, called "the International Serious Adverse Events Consortium." One of its goals is to determine if, by withholding drugs from patients who have a "genetic risk" for side effects, "it could not only protect the patients," but also "help manufacturers get their drugs approved or avoid having to remove them from the market." The group's first task will be to attempt to "find genetic predictors of two side effects -- serious liver toxicity and Stevens-Johnson syndrome, a rare but potentially fatal blistering of the skin. Both effects are associated with numerous drugs."
The AP (9/27, Johnson) quoted Dr. Janet Woodcock, deputy commissioner for operations at the FDA, as saying, "This is what personalized medicine is really about, finding out for the individual, not just the general population...what their risks are. ... 'Up until now we've been kind of helpless' in dealing with adverse effects." The AP noted, "Reports of such events are on the rise, jumping 150 percent from 1998 to 2005."
According to the Wall Street Journal (9/27, D7, Dooren), "The consortium will collect and combine already existing data on serious liver side effects, tissue samples housed in two Britain-based academic institutions, and information and DNA samples from at least one pharmaceutical firm on Stevens-Johnson Syndrome and a related skin condition known as toxic epidermal necrolysis." Then, "DNA from the individuals with side effects will be compared with DNA from 'control' subjects who didn't have drug side effects to see if there are genetic variations among the two groups." Should the consortium's first two studies prove successful, it will "move to other serious side effects like heart trouble and kidney damage that are linked to several different types of drugs as well as drugs in the same class." The group plans to share data from its studies with the public and agencies like the FDA.
And, the Chicago Tribune (9/27, Japsen) added, "Drug companies and the FDA alike have been under fire for perceived lax monitoring of prescription drugs once they reach the market." The Tribune continued, "The group hopes to reduce an estimated 150,000 deaths and annual costs of more than $100 billion to the U.S. economy from serious adverse events (SAEs) by addressing more safety issues for drugs before they reach the market." Arthur Holden, the consortium's chairman and chief executive, said, "The traditional research model only provides one piece of the puzzle in understanding the genetic variations that could lead to an increased risk of an adverse event. ... The most efficient way to study drug-induced SAEs is to create a global, publicly available 'knowledge base' that will help identify the genetic variations that may predict SAEs."
The New York Times (9/27, C3, Pollack) reported, "Seven of the largest pharmaceutical companies have formed a group to develop genetic tests to determine which patients would be at risk from dangerous drug side effects." The FDA has "encouraged" the formation of the group, called "the International Serious Adverse Events Consortium." One of its goals is to determine if, by withholding drugs from patients who have a "genetic risk" for side effects, "it could not only protect the patients," but also "help manufacturers get their drugs approved or avoid having to remove them from the market." The group's first task will be to attempt to "find genetic predictors of two side effects -- serious liver toxicity and Stevens-Johnson syndrome, a rare but potentially fatal blistering of the skin. Both effects are associated with numerous drugs."
The AP (9/27, Johnson) quoted Dr. Janet Woodcock, deputy commissioner for operations at the FDA, as saying, "This is what personalized medicine is really about, finding out for the individual, not just the general population...what their risks are. ... 'Up until now we've been kind of helpless' in dealing with adverse effects." The AP noted, "Reports of such events are on the rise, jumping 150 percent from 1998 to 2005."
According to the Wall Street Journal (9/27, D7, Dooren), "The consortium will collect and combine already existing data on serious liver side effects, tissue samples housed in two Britain-based academic institutions, and information and DNA samples from at least one pharmaceutical firm on Stevens-Johnson Syndrome and a related skin condition known as toxic epidermal necrolysis." Then, "DNA from the individuals with side effects will be compared with DNA from 'control' subjects who didn't have drug side effects to see if there are genetic variations among the two groups." Should the consortium's first two studies prove successful, it will "move to other serious side effects like heart trouble and kidney damage that are linked to several different types of drugs as well as drugs in the same class." The group plans to share data from its studies with the public and agencies like the FDA.
And, the Chicago Tribune (9/27, Japsen) added, "Drug companies and the FDA alike have been under fire for perceived lax monitoring of prescription drugs once they reach the market." The Tribune continued, "The group hopes to reduce an estimated 150,000 deaths and annual costs of more than $100 billion to the U.S. economy from serious adverse events (SAEs) by addressing more safety issues for drugs before they reach the market." Arthur Holden, the consortium's chairman and chief executive, said, "The traditional research model only provides one piece of the puzzle in understanding the genetic variations that could lead to an increased risk of an adverse event. ... The most efficient way to study drug-induced SAEs is to create a global, publicly available 'knowledge base' that will help identify the genetic variations that may predict SAEs."
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