[Source: Health Lawyer's Weekly, Sept. 21, 2007]
The Centers for Medicare and Medicaid Services (CMS) issued this week a final rule establishing user fees for healthcare providers and suppliers cited for deficiencies with federal quality of care requirements that require a “revisit” to ensure appropriate corrective action.
The final rule is effective as of the date of its publication in the Federal Register, which was September 19 (72 Fed. Reg. 53628).
The fees would be assessed for revisits required because of deficiencies cited during initial certification, recertification, or substantiated complaint surveys, CMS said.
continue reading
View the final rule.
Friday, September 21, 2007
California case will test health-insurance rescission.
[Source: Health and Life Science Law Daily, Sept. 21, 2007]
Law.com (9/21, Hirsch) reports that next week, California's 4th District Court of Appeal will hear arguments in the "closely watched" Hailey v. California Physicians' Service (pdf), a case that "challenges Blue Shield of California's practice of rescinding coverage based on inaccuracies in an application." The case centers the issue of "willful misrepresentation" and insurers' ability to rescind an individual's coverage based on inaccurate information in an application. Law.com writes, "Plaintiff attorneys in the field contend that a showing of willful misrepresentation is required before yanking coverage; defense attorneys say the mention of willful misrepresentation does not amount to a prerequisite. ... If the 4th District requires a showing of willful misrepresentation, health insurers will likely find it harder to get cases thrown out early."
Law.com (9/21, Hirsch) reports that next week, California's 4th District Court of Appeal will hear arguments in the "closely watched" Hailey v. California Physicians' Service (pdf), a case that "challenges Blue Shield of California's practice of rescinding coverage based on inaccuracies in an application." The case centers the issue of "willful misrepresentation" and insurers' ability to rescind an individual's coverage based on inaccurate information in an application. Law.com writes, "Plaintiff attorneys in the field contend that a showing of willful misrepresentation is required before yanking coverage; defense attorneys say the mention of willful misrepresentation does not amount to a prerequisite. ... If the 4th District requires a showing of willful misrepresentation, health insurers will likely find it harder to get cases thrown out early."
U.S. Senate approves legislation to overhaul FDA.
[Source: Health and Life Science Law Daily, Sept. 21, 2007]
The AP (9/21, Bridges) reports, "Congress sent President Bush legislation Thursday giving the Food and Drug Administration new powers to ensure the safety of prescription drugs. The Senate passed the FDA bill by voice vote Thursday, a day after the House approved it by an overwhelming margin."
The Wall Street Journal (9/21, A12, Rubenstein, et al.) notes that the bill "increases the fees that drugmakers pay the FDA to review their drugs and allots a portion of the money for the agency to monitor the safety of drugs after they go on the market. It also solidifies the agency's authority to mandate changes to drug labels, require additional safety studies and limit the distribution of medications when safety concerns arise -- powers that have existed informally but haven't always been clearly delineated." The Journal adds, "For the most part, drug companies say they welcome the changes, hoping that with more money and power, the FDA will resolve safety worries more quickly -- and with measured approaches that don't scare the public or entail calling for withdrawal of drugs from the market."
The Los Angeles Times (9/21, Alonso-Zaldivar) writes, "In addition to building a new computerized system to spot drug risks, the bill would strengthen the FDA's enforcement powers and require greater disclosure of private and public clinical research and of agency decision-making. It also would take steps to reduce FDA reliance on outside advisors with financial conflicts of interest, as well as create a new program to review drug-company advertising." However, some experts say implementing the changes may take longer than expected. Mark B. McClellan, FDA commissioner from 2002 to 2004, said, "This is a different way of doing business for FDA, and there are going to be some real challenges in implementing it effectively. ... It's going to shift the focus away from information provided by the drug manufacturers to much broader sources of information in our healthcare system."
* * * * * *
Joe Mantone stated in WSJ Health Blog: "A provision to empower FDA to yank consumer drug ads was stripped from the final version of an FDA bill, which was passed yesterday.But it wasn’t Big Pharma that carried the day on the revision; it was the Gucci-loafered lobbyists for media and advertising firms. The WSJ reports the pharmaceutical lobby had other priorities with the bill. But media and advertising groups were sweating about regulators cutting back on what has become a dependable stream of revenue. In the U.S., drug makers represented the tenth-biggest advertising category in 2006, spending $5.3 billion, or 3.5% of the total $149.6 billion U.S. ad market." Continue reading
* * * * * *
Reauthorized FDA User Fee Bill increases fees for drugs and devices
[Source: Health Lawyers Weekly, Sept. 21, 2007] - Full Text
The Senate passed by unanimous consent September 20 the Food and Drug Administration Amendments Act of 2007 (H.R. 3580), which reauthorizes the prescription drug user fee program through 2012. The bill passed the House September 19 on a motion to suspend the rules.
The compromise bill includes the administration's request for an increase in the total annual user fees collected to $392.8 million for fiscal year 2008, an $87.4 million increase over the current base, according to a bill summary posted on the House Energy and Commerce Committee's website.
In addition, the legislation contains an additional $225 million in user fees that will be collected over five years to be used for drug safety activities and "are intended to supplement and not supplant any other drug safety resources," according to the summary
The legislation also reauthorizes the medical device user fee program and includes enhancements to ensure sound financial footing for the device review program and to the process for pre-market review of device applications.
Under the new bill, medical device companies will pay 31% more in fees in 2008 and 8.5% more each subsequent year through 2012, the summary said. Two new types of fees are set forth in the bill--an annual establishment registration fee and an annual fee for filing periodic reports--which will generate about 50% of the total fee revenue.
. . . .
View the text of H.R. 3580 and a bill summary.
The AP (9/21, Bridges) reports, "Congress sent President Bush legislation Thursday giving the Food and Drug Administration new powers to ensure the safety of prescription drugs. The Senate passed the FDA bill by voice vote Thursday, a day after the House approved it by an overwhelming margin."
The Wall Street Journal (9/21, A12, Rubenstein, et al.) notes that the bill "increases the fees that drugmakers pay the FDA to review their drugs and allots a portion of the money for the agency to monitor the safety of drugs after they go on the market. It also solidifies the agency's authority to mandate changes to drug labels, require additional safety studies and limit the distribution of medications when safety concerns arise -- powers that have existed informally but haven't always been clearly delineated." The Journal adds, "For the most part, drug companies say they welcome the changes, hoping that with more money and power, the FDA will resolve safety worries more quickly -- and with measured approaches that don't scare the public or entail calling for withdrawal of drugs from the market."
The Los Angeles Times (9/21, Alonso-Zaldivar) writes, "In addition to building a new computerized system to spot drug risks, the bill would strengthen the FDA's enforcement powers and require greater disclosure of private and public clinical research and of agency decision-making. It also would take steps to reduce FDA reliance on outside advisors with financial conflicts of interest, as well as create a new program to review drug-company advertising." However, some experts say implementing the changes may take longer than expected. Mark B. McClellan, FDA commissioner from 2002 to 2004, said, "This is a different way of doing business for FDA, and there are going to be some real challenges in implementing it effectively. ... It's going to shift the focus away from information provided by the drug manufacturers to much broader sources of information in our healthcare system."
* * * * * *
Joe Mantone stated in WSJ Health Blog: "A provision to empower FDA to yank consumer drug ads was stripped from the final version of an FDA bill, which was passed yesterday.But it wasn’t Big Pharma that carried the day on the revision; it was the Gucci-loafered lobbyists for media and advertising firms. The WSJ reports the pharmaceutical lobby had other priorities with the bill. But media and advertising groups were sweating about regulators cutting back on what has become a dependable stream of revenue. In the U.S., drug makers represented the tenth-biggest advertising category in 2006, spending $5.3 billion, or 3.5% of the total $149.6 billion U.S. ad market." Continue reading
* * * * * *
Reauthorized FDA User Fee Bill increases fees for drugs and devices
[Source: Health Lawyers Weekly, Sept. 21, 2007] - Full Text
The Senate passed by unanimous consent September 20 the Food and Drug Administration Amendments Act of 2007 (H.R. 3580), which reauthorizes the prescription drug user fee program through 2012. The bill passed the House September 19 on a motion to suspend the rules.
The compromise bill includes the administration's request for an increase in the total annual user fees collected to $392.8 million for fiscal year 2008, an $87.4 million increase over the current base, according to a bill summary posted on the House Energy and Commerce Committee's website.
In addition, the legislation contains an additional $225 million in user fees that will be collected over five years to be used for drug safety activities and "are intended to supplement and not supplant any other drug safety resources," according to the summary
The legislation also reauthorizes the medical device user fee program and includes enhancements to ensure sound financial footing for the device review program and to the process for pre-market review of device applications.
Under the new bill, medical device companies will pay 31% more in fees in 2008 and 8.5% more each subsequent year through 2012, the summary said. Two new types of fees are set forth in the bill--an annual establishment registration fee and an annual fee for filing periodic reports--which will generate about 50% of the total fee revenue.
. . . .
View the text of H.R. 3580 and a bill summary.
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