Politics & Policy: May 2007

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POLITICS & POLICY

FED FOCUS

CDC Adopts Advisory Panel's HPV Vaccine Recommendation

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he Centers for Disease Control and Prevention (CDC) has adopted the recommendations of its advisory committee on immunization practices (ACIP) for girls and women ages 11 through 26 years to routinely receive the human papillomavirus vaccine Gardasil. The ACIP vaccination guidelines were published in the CDC’s Morbidity and Mortality Weekly Report, which finalizes the advisory committee’s recommendations. The guidelines are available to physicians.

Clinical trials have shown that Merck’s Gardasil is effective against HPV strains 16 and 18, which lead to about 70% of cervical cancer cases. In July 2006, the US Food and Drug Administration approved the vaccine for sale and marketing to girls and women ages 9 to 26 years. Later that month, the CDC’s advisory committee voted unanimously to recommend Gardasil for girls aged 11 and 12. The guidelines allow for girls as young as nine to receive the vaccine, and they also say that females aged 13 to 26 get vaccinated if they have not already done so or have not completed the full series.

Even with the CDC’s recommendations, there is expected to be some resistance at the state level (see below in the State Focus).

Changes in Medicare Coverage of ESAs for Cancer-Related Anemia

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ollowing the US Food and Drug Administration’s advisory on erythropoetic stimulating agents (ESAs), the Centers for Medicare and Medicaid Services (CMS) has issued an instruction to local Medicare carriers that would prohibit Medicare coverage of the agents—darbepoetin alfa and epoetin alfa—when used for the treatment of cancer-related anemia, according to the American Society of Clinical Oncology (ASCO). However, ESAs that are used to treat anemia resulting from chemotherapy would not be affected by this policy change.

The CMS has not yet made public its instructions to local Medicare carriers. “ASCO was contacted by physicians who had conversations with their Medicare carrier medical directors regarding the CMS directive,” Jenny Heumann, assistant director of public affairs at ASCO, told Oncology & Biotech News. “ASCO spoke with CMS about the directive; however, the publication details regarding the directive were not disclosed.”

On March 9, the FDA issued a public health advisory and outlined new safety information for ESAs, including updated product labeling. The advisory was based on four new studies in cancer patients, which have found a higher chance of death or life-threatening side effects such as blood clots, strokes and heart attacks with the use of ESAs. The studies were analyzing off-label drug dosage, a patient population for which the agents are not approved, or a new unapproved ESA. But because all ESAs work in the same manner, the FDA believes that the concerns apply to the entire class of drugs and is now re-evaluating the safeuse of the class.

The FDA’s warning issuance prompted the CMS to announce that it was reviewing all Medicare policies related to the administration of ESAs. “We pay close attention to FDA black box warnings because the safety of our Medicare beneficiaries is paramount,” Leslie Norwalk, CMS acting administrator, said in that statement. “We will carefully examine the effect of these labeling changes on Medicare’s policies and we encourage treating physicians to review the warnings and to take them into account when prescribing ESAs for their patients.”

At the time Oncology & Biotech News went to press, not all Medicare Part B carriers had announced or implemented a change in their Medicare coverage policy, according to ASCO. By March 13, five Medicare Part B contractors that cover 24 states announced policy changes for one or both drugs and one carrier had plans for a meeting to discuss policy changes.

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POLITICS & POLICY

THE STATE HOUSE

Rhode Island's Low-Premium Health Plans

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hode Island’s health insurance commissioner Christopher Koller has unveiled new low-premium health plans to encourage small businesses to offer health coverage to workers. The plans will include coverage for physician visits, hospitalization, preventive services, and prescription drugs. One type of plan that the insurers will offer also carries good news for those seeking cancer screening.

The plans will be offered by Blue Cross & Blue Shield of Rhode Island and United-Healthcare of New England. The two insurers will offer two types of plans, a basic plan and an advantage plan, both with the same premium payments. Advantage plan members will have lower deductibles, copayments and out-of-pocket expenses, but they will be required to participate in a wellness program—smoking cessation, weight loss or disease management—if necessary. The plans will cover annual physicals, mammograms and prostate cancer screenings without applying the deductible.

Last year, the state passed a law stating that insurers must offer the plans to businesses with 50 or fewer employees beginning October 1. The law requires that the plans have premiums that are no higher than 10 percent of the average annual wages in the state; premiums have been higher in the past. Individual coverage premiums will average $322 a month for the Blue Cross plans, while the United Healthcare plans’ premiums will average $309 per month. These premiums are about 18%

lower than similar plans that are currently available.

%u25BA THE HPV DEBATE HEATS UP AT THE STATE LEVEL

Virginia Governor: Drop Written Opt-Out Requirement in HPV Vaccine Bill

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he Virginia General Assembly has voted in favor of Virginia Governor Tim Kaine’s amendment to a bill requiring sixth-grade girls to receive a human papillomavirus (HPV) vaccine that would make it unnecessary for parents to submit a letter to opt out of the vaccine requirement. Under the amendment, which Kaine proposed in late March, parents can verbally opt out of the vaccine requirement for their daughters.

In his statement, Kaine had said that the purpose of the amendment is to “clarify that a girl’s parent or guardian has complete discretion to decide whether their child should be vaccinated.”

The VA General Assembly approved the bill for the HPV vaccine in February, and earlier in March, Kaine had said that he would sign the legislation. The bill requires parents to be given information about the HPV vaccine, after which they were required to hand in a letter to their daughter’s school if they wanted to opt out. The amendment will make it easier for parents to state their choice.

“While I believe that this vaccine shows great promise for preventing cancer, I believe that the decision to administer this vaccine should be made by parents,” Kaine said.

Georgia Bill Proposes Funding Roadblock for HPV Vaccine

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eorgia member of Congress Rep. Phil Gingrey introduced a bill that would prohibit states from using federal funds to make the HPV vaccination mandatory for school-age children. The proposed legislation would not prohibit states from passing legislation to make the HPV vaccine mandatory. Rather, it aims to restrain states’ ability to use federal Medicaid or education funds to ensure that children from low-income families receive the vaccine.

Since the FDA approved Gardasil, at least 23 states and Washington, D.C., have taken some kind of action on making the HPV vaccination mandatory for school-age girls. Texas legislators were the first in the US to require girls entering sixth grade to get vaccinated against HPV, while legislators in New Mexico and Virginia have approved similar bills.

Rep. Gingrey, an obstetrician and gynecologist, is taking a different stand, saying that the vaccination should not be enforced by states, but should be taken voluntarily, because HPV is not a communicable disease like measles. “Whether or not girls get vaccinated against HPV is a decision for parents and physicians, not state governments," he told The Washington Times. His opinion reflects that of Jon Abramson, chairman of the Centers for Disease Control and Prevention’s advisory committee

that issued the recommendation for school-age girls to take the vaccine.

Rep. Gingrey plans to attach the bill as an amendment to the 2008 spending bill for the US Department of Health and Human Services. This increases the chances of the bill passing Congress because many appropriations bills include several legislative proposals that are hard for lawmakers to notice or block. By contrast, the chances of the bill passing as a stand-alone legislation would be slim.

It is common for states to use federal money to help children receive vaccinations. Recently, the governor of Virginia has requested $4 million in state tax money to provide the vaccine to children from low-income families.

Texas Governor's Mandate of HPV Vaccine Does Not Carry Weight of Law, Says State AG

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n a meeting with two Texas lawmakers, Texas Attorney General Greg Abbott said that Governor Rick Perry’s executive order mandating girls entering the sixth grade receive a HPV vaccine does not carry the weight of law, according to state Sen. Jane Nelson. A report in the Austin American-Statesman states Nelson as saying that she and Rep. Jim Keffer met with Abbott after they had requested the attorney general to issue an informal opinion on Perry’s order.

In a joint statement, Sen. Nelson and Rep. Keffer said that “the attorney general met with both of us, and he answered questions we had regarding the executive order. It appears that [the executive order] is, in effect, an advisory order and does not carry the weight of law.” It also appeared, they added, that the Health and Human Services commissioner is not required to follow Attorney General Perry’s executive order.

Attorney General Perry’s office has said that Abbott did not meet with it to express his opinion. Meanwhile, Perry’s office is facing a lawsuit filed in a Travis County, Texas court by the parents of three Texas girls, challenging the governor’s authority to issue an executive order mandating the HPV vaccine for girls and women between ages nine and 21. Parents are allowed to opt out of the requirement.

New Mexico Governor Will Veto HPV Bill

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overnor Bill Richardson said that he will veto a bill that would mandate the HPV vaccine for girls entering sixth grade. Last month, Richardson had said that he would sign the bill. The governor said that he changed his mind about the bill after physicians and patients voice their concerns. his concern is that there is insufficient time to educate parents, schools and health care providers about HPV and the vaccine. He signed a related bill that requires health insurance policies to cover HPV vaccinations for girls between the ages of nine and 14.

Washington, D.C. City Council Approves HPV Bill

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he City Council has voted 7 - 3 to preliminarily approve a bill that would require girls entering the sixth grade to receive an HPV vaccine. The council adopted an amendment to the bill that would provide a parent education program. Council Member Marion Barry had proposed the amendment. Washington, D.C. Mayor Adrian Fenty has already given the measure an inital endorsement. Even though the measure will face a second and final vote in the upcoming weeks, the preliminary vote indicates that the bill will most likely pass, according to a report in The Washington Post.