"Amendments to Labeling: Implications for Preemption Defense," Health Lawyers Weekly, AHLA, January 25, 2008 by Joseph P. McMenamin and Deborah M. Russell, McGuireWoods LLP
In what is sure to be seen as more ammunition for the battle over the preemption defense, the Food and Drug Administration (FDA) proposes rulemaking to codify its longstanding view that changes to labeling for approved products (i.e. drugs, biological products, and medical devices) may be made before agency review only as a narrow exception to the requirement of FDA approval and under limited circumstances. In its proposed rule announced last week, a supplemental application to change labeling may be used to add or strengthen a contraindication, warning, precaution, or adverse reaction in advance of the agency’s review of such change, but only based on newly acquired and novel safety information and only if there is sufficient evidence of a causal association with the drug, biologic, or device. The agency wishes to formalize this “narrow exception” position. See 73 Fed. Reg. 2848 (Jan. 16, 2008).
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Sunday, January 27, 2008
Sixth Circuit Upholds 188 Months' Prison Sentence for TN Physician Convicted of Fraud
[Source: Health Lawyers Weekly, January 25, 2008 - AHLA]
A Tennessee physician who was convicted of healthcare fraud and making false statements for administering partial doses of chemotherapy medications to cancer patients while billing for full doses received a “reasonable” prison sentence of 188 months (15 years, eight months), the Sixth Circuit ruled January 16.
Among other issues, the appeals court considered the lower court’s decision to grant the federal government’s request to increase the maximum sentencing range under the federal Sentencing Guidelines by two level enhancements.
The Sixth Circuit concluded the district court did not err in increasing the physician’s sentencing range under the Guidelines because her conduct created a risk of death or serious bodily injury, affected a large number of “vulnerable victims,” and also constituted obstruction of justice.
The court also ordered the physician to pay $432,238 in restitution to the state Medicaid program, Blue Cross and Blue Shield, and other private health plans.
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Case: United States v. Moon, No. 06-5581 (6th Cir. Jan. 16, 2008).
A Tennessee physician who was convicted of healthcare fraud and making false statements for administering partial doses of chemotherapy medications to cancer patients while billing for full doses received a “reasonable” prison sentence of 188 months (15 years, eight months), the Sixth Circuit ruled January 16.
Among other issues, the appeals court considered the lower court’s decision to grant the federal government’s request to increase the maximum sentencing range under the federal Sentencing Guidelines by two level enhancements.
The Sixth Circuit concluded the district court did not err in increasing the physician’s sentencing range under the Guidelines because her conduct created a risk of death or serious bodily injury, affected a large number of “vulnerable victims,” and also constituted obstruction of justice.
The court also ordered the physician to pay $432,238 in restitution to the state Medicaid program, Blue Cross and Blue Shield, and other private health plans.
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Case: United States v. Moon, No. 06-5581 (6th Cir. Jan. 16, 2008).
GGRA May Petition U.S. Supreme Court to Determine Whether ERISA Preempts a San Francisco Ordinance Setting Healthcare Spending Mandates for Employers
[Source: Health Lawyers Weekly, January 25, 2008 - AHLA]
The Golden Gate Restaurant Association (GGRA) said January 21 that it has decided not to petition the full Ninth Circuit to overturn a unanimous panel decision allowing a San Francisco ordinance setting new healthcare spending mandates for employers to go into effect.
A three-judge panel of the Ninth Circuit in a January 9 order agreed to stay an earlier federal trial court decision that the Employee Retirement Income Security Act (ERISA) preempted the San Francisco Health Care Security Ordinance, which was scheduled to go into effect January 1, 2008 for large employers.
GGRA said it reached the decision because of the “minimal opportunity for success,” adding that the “emergency stay order was granted without a dissenting opinion, and the schedule for the appeal totals 3 ½ months which is a short time frame to the court.”
In addition to the appeals process before the Ninth Circuit, GGRA said it is researching the potential of petitioning U.S. Supreme Court Justice Kennedy to overturn the emergency stay order.
“We believe this case will most likely end up in front of the US Supreme Court, and take many more months to complete,” the group said.
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Further coverage:
- USA Today, "Universal Health Care Plans Up Against U.S. Law" [January 16, 2008]:
California, Colorado, Michigan and Minnesota have proposals pending that rely on partial funding by employers. The lower court ruling "raises doubt with regard to all of the state health reform proposals," says Atlanta attorney John Hickman, an expert on the federal law.
If the 9th U.S. Circuit Court of Appeals ultimately rules in the city's favor, the case may end up before the U.S. Supreme Court, says Phyllis Borzi, a George Washington University health policy professor.
That's because last January, the 4th U.S. Circuit Court of Appeals reached the opposite conclusion over a Maryland law. That law charged very large employers a fee if they did not spend 8% of payroll on health care, essentially affecting only Wal-Mart. The appeals court ruled the measure violated federal law.
If the appeals courts disagree, "it sets up a conflict, which is the classic pathway to having the Supreme Court resolve it," Borzi says. A similar law in Suffolk County, N.Y., was rejected by a lower court in July; the county decided not to appeal.
- AHLA, Health and Life Sciences Law Daily, January 23, 2008:
The AP (1/22, Woodward) reports that the Washington "state Senate's healthcare chairwoman unveiled Monday an ambitious universal healthcare plan, bankrolled by payroll taxes, that she hopes to implement by 2010." Sen. Karen Keiser (D-Kent) modeled the Washington Health Partnership "after a $15 billion program proposed in the Wisconsin Legislature." In the version proposed for Washington, new taxes would be levied "on businesses and workers," with proceeds extending "health benefits to all Washingtonians not covered by a federal program." Workers would pay between a two and four percent tax on payroll, while employers would pay between nine and 12 percent. The plan calls for residents to "get a voucher to enroll in their choice of private health networks, which would compete to provide the benefits called for by a state administrative board."
The Golden Gate Restaurant Association (GGRA) said January 21 that it has decided not to petition the full Ninth Circuit to overturn a unanimous panel decision allowing a San Francisco ordinance setting new healthcare spending mandates for employers to go into effect.
A three-judge panel of the Ninth Circuit in a January 9 order agreed to stay an earlier federal trial court decision that the Employee Retirement Income Security Act (ERISA) preempted the San Francisco Health Care Security Ordinance, which was scheduled to go into effect January 1, 2008 for large employers.
GGRA said it reached the decision because of the “minimal opportunity for success,” adding that the “emergency stay order was granted without a dissenting opinion, and the schedule for the appeal totals 3 ½ months which is a short time frame to the court.”
In addition to the appeals process before the Ninth Circuit, GGRA said it is researching the potential of petitioning U.S. Supreme Court Justice Kennedy to overturn the emergency stay order.
“We believe this case will most likely end up in front of the US Supreme Court, and take many more months to complete,” the group said.
Continue reading
- - - - - - -
Further coverage:
- USA Today, "Universal Health Care Plans Up Against U.S. Law" [January 16, 2008]:
California, Colorado, Michigan and Minnesota have proposals pending that rely on partial funding by employers. The lower court ruling "raises doubt with regard to all of the state health reform proposals," says Atlanta attorney John Hickman, an expert on the federal law.
If the 9th U.S. Circuit Court of Appeals ultimately rules in the city's favor, the case may end up before the U.S. Supreme Court, says Phyllis Borzi, a George Washington University health policy professor.
That's because last January, the 4th U.S. Circuit Court of Appeals reached the opposite conclusion over a Maryland law. That law charged very large employers a fee if they did not spend 8% of payroll on health care, essentially affecting only Wal-Mart. The appeals court ruled the measure violated federal law.
If the appeals courts disagree, "it sets up a conflict, which is the classic pathway to having the Supreme Court resolve it," Borzi says. A similar law in Suffolk County, N.Y., was rejected by a lower court in July; the county decided not to appeal.
- AHLA, Health and Life Sciences Law Daily, January 23, 2008:
The AP (1/22, Woodward) reports that the Washington "state Senate's healthcare chairwoman unveiled Monday an ambitious universal healthcare plan, bankrolled by payroll taxes, that she hopes to implement by 2010." Sen. Karen Keiser (D-Kent) modeled the Washington Health Partnership "after a $15 billion program proposed in the Wisconsin Legislature." In the version proposed for Washington, new taxes would be levied "on businesses and workers," with proceeds extending "health benefits to all Washingtonians not covered by a federal program." Workers would pay between a two and four percent tax on payroll, while employers would pay between nine and 12 percent. The plan calls for residents to "get a voucher to enroll in their choice of private health networks, which would compete to provide the benefits called for by a state administrative board."
Monday, January 7, 2008
Bush administration imposing restrictions on states' abilities to expand Medicaid eligibility.
[Source: Health and Life Sciences Law Daily, January 4, 2008 - AHLA]
In a front-page article, the New York Times (1/4, Pear) reports, "The Bush administration is imposing restrictions on the ability of states to expand eligibility for Medicaid." The restrictions prevent states "from offering coverage to families of modest incomes who, the administration argues, may have access to private health insurance." The Medicaid restrictions are similar to "those the administration placed on the State Children's Health Insurance Program in August after states tried to broaden eligibility" for that program. Previously, "states had generally been free to set their own Medicaid eligibility criteria, and the Bush administration had not openly declared that it would apply the August directive to Medicaid." However, according to some state officials in Louisiana, Ohio, and Oklahoma, the "administration's intent" was discovered during "negotiations with the federal government over the last few weeks." The Times notes that last month, the Bush administration "rejected a proposal by Ohio to expand its Medicaid program to cover 35,000 more children by "increasing the [family income] limit to three times the poverty level." Some administration officials claim that government programs such as Medicaid begin "to 'crowd out' private insurance when they cover families with incomes from 250 percent to 300 percent of the poverty level."
According to White House spokesman Tony Fratto, "This policy demonstrates the President's compassion. He wants to direct scarce tax dollars to those with the greatest needs," reports the UPI (1/4).
In a front-page article, the New York Times (1/4, Pear) reports, "The Bush administration is imposing restrictions on the ability of states to expand eligibility for Medicaid." The restrictions prevent states "from offering coverage to families of modest incomes who, the administration argues, may have access to private health insurance." The Medicaid restrictions are similar to "those the administration placed on the State Children's Health Insurance Program in August after states tried to broaden eligibility" for that program. Previously, "states had generally been free to set their own Medicaid eligibility criteria, and the Bush administration had not openly declared that it would apply the August directive to Medicaid." However, according to some state officials in Louisiana, Ohio, and Oklahoma, the "administration's intent" was discovered during "negotiations with the federal government over the last few weeks." The Times notes that last month, the Bush administration "rejected a proposal by Ohio to expand its Medicaid program to cover 35,000 more children by "increasing the [family income] limit to three times the poverty level." Some administration officials claim that government programs such as Medicaid begin "to 'crowd out' private insurance when they cover families with incomes from 250 percent to 300 percent of the poverty level."
According to White House spokesman Tony Fratto, "This policy demonstrates the President's compassion. He wants to direct scarce tax dollars to those with the greatest needs," reports the UPI (1/4).
Tennessee grants funds to non-profit organization offering free sample medications to the uninsured.
[Source: Health and Life Sciences Law Daily, January 2, 2008 - AHLA]
The AP (12/29) reported that the Dispensary of Hope, a "nonprofit organization that provides free sample medications to Tennesseans who don't have insurance, will be able to expand its program with the help of a $1 million grant from the state." The funds will enable the program "to expand from three sites to nine in Tennessee." Additionally, a "new service that will allow people to receive medications through the mail" will be launched by 2008.
According to Scott Cornwell, the organization's managing director, the "dispensary is stocked by donations from 300 doctor's offices and clinics, as well as pharmaceutical companies," added the Tennessean (12/26, Pinto). Offering "more than 900 medications" since its inception in 2004, approximately "75,000 prescriptions" have been filled.
The AP (12/29) reported that the Dispensary of Hope, a "nonprofit organization that provides free sample medications to Tennesseans who don't have insurance, will be able to expand its program with the help of a $1 million grant from the state." The funds will enable the program "to expand from three sites to nine in Tennessee." Additionally, a "new service that will allow people to receive medications through the mail" will be launched by 2008.
According to Scott Cornwell, the organization's managing director, the "dispensary is stocked by donations from 300 doctor's offices and clinics, as well as pharmaceutical companies," added the Tennessean (12/26, Pinto). Offering "more than 900 medications" since its inception in 2004, approximately "75,000 prescriptions" have been filled.
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