September 22, 2006

This Week in Washington
1. CDC Hosts Call in Advance of Revised HIV Testing Recommendations
2. NIH Reauthorization Advances
3. Representative Lee Introduces Prison STI Bill

CARE Act in Brief
1. Reauthorization Passes House Energy and Commerce Committee 38-10

This Week in Washington
1. CDC Hosts Call in Advance of Revised HIV Testing Recommendations
On Thursday, September 21, 2006, The Centers for Disease Control and Prevention (CDC) held a one hour telephone briefing for HIV and other partner organizations to preview revised recommendations for HIV screening in healthcare settings. The revised recommendations update previous recommendations for HIV testing in healthcare settings and for screening of pregnant women. They were released later in the day. The telephone briefing was conducted by Dr. Kevin Fenton, Director of the National Center for HIV, STD, and TB Prevention at the CDC, Dr. Bernard Branson, Associate Director for Laboratory Diagnostics, and Dr. Timothy Mastro, Acting Director for Division of HIV/AIDS Prevention.

Dr. Fenton opened up the briefing by introducing Dr. Mastro and Dr. Branson. Dr. Mastro then outlined the CDC’s recent recommendations. They are:

For patients in all healthcare settings:
• HIV screening is recommended for all patients after the patient is notified that testing will be performed unless the patient declines (opt-out screening).
• Persons at high risk for HIV infection should be screened for HIV at least annually.
• Separate written consent for HIV testing should not be required; general consent for medical care should be considered sufficient to encompass consent for HIV testing.
• Prevention counseling should not be required with HIV diagnostic testing or as part of HIV screening programs in healthcare settings.

For pregnant women:
• HIV screening should be included in the routine panel of prenatal screening tests for all pregnant women.
• HIV screening is recommended after the patient is notified that testing will be performed unless the patient declines (opt-out screening).
• Separate written consent for HIV testing should not be required; general consent for medical care should be considered sufficient to encompass consent for HIV testing.
Repeat screening in the third trimester is recommended in certain jurisdictions with elevated rates of HIV infection among pregnant women.

According to Dr. Fenton, the new recommendations are designed to make voluntary HIV screening a routine part of medical care for all patients ages 13 to 64; echoing throughout the briefing, “these recommendations will ensure that everyone has access to life saving information.” Moreover, he explained that the CDC believes these recommendations will simplify the HIV testing process in healthcare settings and increase early HIV diagnosis among the more than 250,000 HIV-positive persons in the United States who remain unaware of their infection. In addition, he told callers that these recommendations include new measures to improve diagnosis among pregnant women in order to further reduce mother to child HIV transmission. However, he explained these recommendations do not modify existing guidelines concerning HIV counseling, testing, or referral for persons at high risk for HIV who seek or receive HIV testing in non-clinical settings (e.g., community-based organizations, outreach settings, or mobile vans).

Dr. Fenton said that the objectives of the recommendations are to increase HIV screening of patients, including pregnant women, in healthcare settings; foster earlier detection of HIV infection; identify and counsel persons with unrecognized HIV infection and link them to clinical and prevention services; and further reduce prenatal transmission of HIV in the United States; ultimately to normalize HIV testing. He explained that the main goal of the CDC is to reduce the impact of HIV/AIDS by funding and supporting the ability of health departments and community based organizations (CBOs) to implement HIV prevention programs for those infected with HIV. In addition, he explained the CDC carefully monitors the spread of the disease in high risk areas of the country, and that key to the success of prevention programs is the ability to ensure that people are aware they are infected allowing them to take proper measures of protection.

Dr. Fenton underscored the fact that at least 250,000 of the 1 million Americans infected with HIV are unaware they are infected, and that these recommendations are an essential step to provide awareness to those that may be infected. He stated that research has recently shown that people who are made aware of their infection take sufficient steps to protect others from infection. He then turned the briefing over to Dr. Mastro, who continued to explain the need for universal testing, which he believes, would reduce the stigma associated with separate HIV screening. He explained that a recent survey discovered that 2/3 of Americans believe separate procedures for HIV screening is unnecessary if included in routing healthcare settings. Moreover, he explained that the CDC has learned from pre-natal testing that individuals are more comfortable with routine screening as opposed to it being separate.

Thereafter, the briefing was opened up for questions from those listening over the phone. Participants were HIV/AIDS partner organizations from across the country. Among the questions and answers were the following:

How will this increase in HIV screening be funded?
Dr. Branson explained that he expects funding will come from insurance reimbursements through Medicaid and through some public funding. However, he indicated that the CDC is working with Health Resources and Services Administrations (HRSA) to make sure newly infected individuals are provided access to care; and that funding is the dilemma that everyone is dealing with. He believes that these new recommendations will provide the data necessary to show HRSA and Congress that more funding is needed. It will really depend on which jurisdiction each healthcare setting is located.

After the first HIV screening, when will the next screening take place?
Dr. Branson explained that would have to be based on known risk factors. If there are no known risk factors the CDC does not yet have any recommendations for further testing. However, if there are high risk factors, testing one year after initial testing is recommended. Based on the information gathered from this new round of testing the CDC would be able to make more recommendations on further HIV screening.

What is the definition of “Healthcare Settings”?
According to Dr. Branson, “Healthcare settings” include all health-care providers in the public and private sectors, including those working in hospital emergency departments, urgent care clinics, inpatient services, substance abuse treatment clinics, public health clinics, community clinics, correctional health-care facilities, and primary care settings. These recommendations address HIV testing in healthcare settings only.

A lot of work has been done around implementing rapid testing, how is the CDC going to work with jurisdictions and community planning groups to implement these new recommendations?
Dr. Branson indicated that many people working with CBOs need to establish new relationships with healthcare settings where they were none before, and hopes with the FDA approval of two new rapid tests it will allow for more competition and make it easier for jurisdictions to implement these recommendations. And that they are anticipating trying to forge relationships with some of the healthcare providers, facilities, and CBOs in their areas, basically to get the best of both words in order to proceed with implementation recognizing that many CBOs have a lot of experience with providing support.

The revised recommendations have been published in the September 22nd issue of the CDC Morbidity and Mortality weekly report. They can be found at http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5514a1.htm

2. NIH Reauthorization Advances
On Wednesday, September 20, 2006, a bill reauthorizing the National Institutes of Health (NIH) was marked up* by the House Committee on Energy and Commerce. Although the marked up bill was then introduced in the House it does not yet have a bill number. The NIH has not been reauthorized in 13 years.

The committee’s Chair, Representative Joe Barton (R-TX), opened the markup, saying, “It took 3 years to get here and allowing the NIH to remain unauthorized is unacceptable.” Given the long gap since the last reauthorization, he claimed that the committee’s action would be “doing something historic” and that a vote for reauthorization would “improve U.S. health.” Following his opening statement, he allowed other members of the committee to share opening statements regarding the bill.

The bill was introduced as a “Manager’s Amendment” replacing all earlier drafts of the bill in full. The bill would cap the number of institutes at 27 and would allow the Director of the NIH to consolidate individual offices and agencies without Congressional approval. It additionally creates a “common fund” for research between two or more agencies and allows a 5% authorizing sum for the entire agency.

Representative John Dingell (D-MI), the committee’s Ranking Member, acknowledged the necessity of the bill, but pointed out that “the greatest problem for NIH is the tight funding.” His fellow Democrats, Anna Eshoo (D-CA), Henry Waxman (D-CA), Lois Capps (D-CA) and Frank Pallone (D-NJ) echoed his theme of inadequate funds. In contrast, Representatives Michael Rogers (R-MI), Cliff Stearns (R-FL) and Mary Bono (R-CA), stressed the need for reauthorization and the increased authorizing sum of 5%.

Representative Hilda Solis (D-CA) articulated the need for diversity in clinical trials, noting that such trials would be beneficial to people of color. Representative Waxman offered an amendment to address the issue of companies suppressing negative testing results for trials and studies, as opposed to sharing those trials and studies that are favorable. He argued that companies “should not be able to pick and choose which trials they use to publicize a study” but rather all trials should be displayed. The amendment was withdrawn after Chairman Barton offered to work with him further on this issue. Representative Jay Inslee (D-WA) also withdrew an amendment he offered, which would have restored NIH researchers’ wages after they had been recently lowered.

Representative Edward Markey (D-MA) offered an amendment that would authorize spending 5% above a medical inflation index rather than a simple 5% increase in authorizing levels. Mr. Barton, spoke in opposition stating that the Congress had already doubled NIH funding since 1996 adding that, “To ask for 5% more is not sustainable, and if we are going to reauthorize the bill, we should use a number that will work.” The amendment was defeated along with an additional amendment sponsored by Mr. Markey. That amendment urged members to maintain the common fund as a separate entity of funding, so that the funding increase could go directly to research.

Ms. Capps sponsored an amendment to remove the cap on the number of Institutes the NIH is allowed, which is set at 27. Along with Mr. Waxman, Ms. Capps presented another amendment for mandated research on Breast Cancer and the Environment. Both were defeated.

The reauthorization of NIH bill then passed with a vote 42 - 1 with only Representative Markey voting against. The bill will move to Floor of the House next week.

*“Markup” is a process that allows committee or subcommittee members to review a bill and make specific changes in the text on a line-by-line basis. In contrast a hearing typically features testimony of witnesses, but does not feature changes to specific legislation.

3. Representative Lee Introduces Prison STI Bill
Representative Barbara Lee (D-CA) introduced H.R. 6083: Justice for the Unprotected against Sexually Transmitted Infections for the Confined and Exposed (JUSTICE) Act of 2006 on September 14, 2006. The bill, which currently has 25 co-sponsors, seeks to reduce the spread of sexually transmitted infections (STIs) in correctional facilities.

The bill finds that the rate of HIV/AIDS is disproportionately high among incarcerated persons. It additionally finds that approximately 25 percent of the HIV-positive population of the United States passes through correctional facilities each year and that Minorities account for the majority of AIDS-related deaths both in the general United States population and among incarcerated persons. It also states that African American people who are incarcerated are three and a half times more likely than white incarcerated people and two and a half more likely than Hispanic incarcerated people to die from AIDS-related causes. Finally, the bill recognizes that other STIs, such as gonorrhea, chlamydia, syphilis, genital herpes, viral hepatitis and human papillomavirus exist at a higher rate among incarcerated persons than in the general United States population.

In response to these findings, the bill directs to Bureau of Prisons to allow community organizations to distribute sexual barrier protection devices (including condoms, female condoms and dental dams) and to engage in STI counseling and STI prevention education in federal correctional facilities. It requires any community organization permitted to distribute sexual barrier protection devices in correctional facilities to ensure that the persons to whom the devices are distributed are informed about their proper use and disposal. According to the bill, any community organization conducting STI counseling or STI prevention education must offer comprehensive sexuality education.

The bill also states that no correctional facility may take adverse action against an incarcerated person because of the possession or use of a sexual barrier protection device and cannot consider possession or use as evidence of a prohibited activity. It further requires an annual survey of all federal, state, and territorial correctional facilities to determine what policies are in place regarding: testing for STIs, sexuality education, counseling, treatment, and health referral services prior to re-entry into the community. In addition the survey must provide demographic data on STI testing for each infection based on race, age, and gender in order to help target prevention messages and behavior change programs.

The bill can be found at: http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=109_cong_bills&docid=f:h6083ih.txt.pdf

CARE ACT in Brief
1. Reauthorization Passes House Energy and Commerce Committee 38-10
On Wednesday September 22, Members of the House Energy and Commerce Committee marked up* the “Ryan White HIV/AIDS Treatment Modernization Act of 2006” also known as Ryan White CARE Act reauthorization. A draft of the bill had been released the previous week by committee staffers participating in a bipartisan, bicameral process to attempt to reauthorize the bill. In response to concerns raised by the community, the bipartisan, bicameral group had made additional changes which were reflected in the language marked up by the committee. (See Weekly Update for September 15th). Those changes included the creation of a “backup prevalence test” and allowing Title II Consortia to be paid out of program support funds.

In a three hour process led by Representative Joe Barton (R-TX), the Chair of the Energy and Commerce Committee, the markup was hotly contested on both geographical and political lines. In opening statements earlier in the day, most of the Republicans expressed support of the bipartisan bicameral process and noted the need for changes to the bill. Representative Mary Bono (R-CA) cited the support of Los Angeles County and said that the bill would ensure that funds would go to the areas of greatest need, modernize the act by changing formula allocation standards from a ten year AIDS band to including all HIV cases and address already existing disparities. She noted that in recent years HIV had dramatically increased and had a devastating impact on rural America and among African Americans.

In contrast many Democrats said that they were frustrated by a lack of funding for the program. Representative Henry Waxman (D-CA) said that the CARE Act had suffered for years from “Republican budgets.” He went on to state that cutting taxes for the wealthy had created a dilemma that, “could not be clearer, the epidemic has spread and we now can’t include funds to new areas without taking resources from New York and California.”

During direct discussion of the bill, Representative Edolphus Towns (D-NY) introduced an amendment cosponsored by Representatives Anna Eshoo (D-CA), Lois Capps (D-CA) and Eliot Engel (D-NY) to extend the “hold harmless”** provisions from 3 years to 5 years (the life of the reauthorization). The amendment would also have increased funding to both Titles I and II above the amounts allowed by the current bill. This amendment prompted a protracted debate about how best to distribute funding without destabilizing current systems. Legislators from New York, including representative Towns, said that New York State stood to lose $24 million in funding in its first year with New York City alone likely to lose $17.8 million. Representative Engel introduced a letter from all 29 members of the NY delegation expressing opposition to the bill in its current form. Representative Frank Pallone (D-NJ) said that his constituents were “literally terrified about what will happen to the system” in New Jersey and asked that legislators not “rob Peter to pay Paul.” Representative Eshoo said that San Francisco was facing losses of $10.4 million and Representative Ed Markey (D-MA) said, “what we have on our hands is an old fashioned formula fight” and expressed dismay at the inability to find more funds.

In opposition to the amendment, Representative Barton pointed out that the bill had been negotiated in a bipartisan bicameral fashion and that the old formula based on AIDS cases needed to be updated. The new formula based on HIV would move funding to new places “because the epidemic has evolved.” He noted that the bill authorizes future increases in funding of 3.7%. Representative Nathan Deal (R-GA) and chair of the Energy and Commerce Health Subcommittee said that the South had emerged as a new center of the epidemic. He said that “cases of HIV rose by 1% between 2000 and 2001,” but that the average masked “a rise of 9% in the South during those years, while reported cases fell in the North.” The amendment was defeated by 22-21 votes.

A group of three amendments (partly cosponsored by Representatives Towns and Engel), were then brought up in bloc by Representative Vito Fosella (R-NY) with the stated intention of withdrawing them. The amendments were not fully explained and AIDS Action has not yet located direct copies. At least one of the amendments appeared to be directed at the Severity of Need Index while others would have added funding to Title I. A minor controversy emerged over the closeness of the previous vote when Representative Pallone asked Representative Vito Fosella (R-NY) why he had voted against it. Representative Fosella replied that he had not supported the extension of hold harmless in the previous amendment. Representative Eshoo then pressed Fosella on the difference between his amendments and the Towns amendment, after which he withdrew the bloc of amendments.

Representative Pallone then introduced an amendment to “freeze” the current conditions of the legislation in place for one year and to “go back to the negotiating table.” The amendment was defeated in a 23-21 vote. Representative Hilda Solis (D-CA) engaged in a short dialogue with Chairman Barton and received his assurance that he would work with her to satisfy the needs of people who require linguistic services. Representative Jay Inslee (D-CA) also received assurances from Representative Barton that report language would state that “medical case management” did not require a medical provider or have to be setting specific, that “supportive services” language in the bill was not exclusive to services listed in the bill and that application for or granting of a waiver would not be a criteria that impacts an EMA's application for supplemental funding.

Finally Representative Towns advanced an amendment to allow funding of services of some type for intravenous drug users under Title III. The amendment was accepted by Chairman Barton. AIDS Action continues to seek the exact wording of the amendment. Chairman Barton then proceeded to the final vote on the bill which passed 38-10. A list of how members voted is below.

According to staffers, the bipartisan bicameral process continues in place and members continue to attempt to work out their differences, with particular negotiations ongoing on the Senate side. Assuming the process remains intact, the next step is for a final negotiated bill that can pass both the House and Senate to be passed in the Senate (using unanimous consent procedures – which requires that no Senator vote against it) and then passed on the House floor (under the “suspension calendar” which suspends rules and requires a 2/3 vote in favor). Ultimately the two bills that pass must be identical to go directly to the President for signature by September 30th.

If significant opposition remains in the Senate even after further negotiations, it is still possible for the bill to pass on a regular vote, perhaps as attached to an omnibus bill or continuing resolution. Such a bill or resolution will be necessary to keep the government operating since not all of the appropriations bills will be passed prior to recess for the election. It is likely that few Senators would oppose such a bill. If that occurs, identical reauthorization language could easily be passed on the House side. AIDS Action will work to keep readers informed.

Prior to the beginning of the markup, AIDS Action released a letter to both the House Energy and Commerce Committee and the Senate Health, Education, Labor and Pensions (HELP) Committee in support of the bill, but also making suggestions for changes to improve the bill. That letter is attached below.

*See definition above in “NIH Reauthorization Advances.”
**In the language of the bill under consideration, the hold harmless provisions allow reductions in funding to both Eligible Metropolitan Areas (EMAs) and States to occur at 5% per year.

Votes on reporting the reauthorization bill to the full House
(Note: Representatives are listed in order of seniority)

Text of the AIDS Action Letter Regarding Reauthorization:

September 18, 2006

Dear Chairmen Enzi and Barton and Ranking Members Kennedy and Dingell:

I am writing on behalf of AIDS Action Council to say thank for the hard work that you and the members of your staff have done on behalf of reauthorizing the Ryan White CARE Act. We thank you also for listening to the members of the community who spoke to your staff at the “stakeholders meeting” on September 11, 2006 and said that they could not support the bill in this form. The changes to eligibility including the use of actual living AIDS counts, broader acceptance of data from code-based states and changes to consortia requirements that resulted from that meeting, along with the offer of report language clarifying the terminology on “medical case management” have given AIDS Action reason to support the bill.

The resolution passed by the Board of Directors reads as follows:

The AIDS Action Council Board adopted the following statement at its meeting of September 19, 2006:

AIDS Action Council supports the draft of the Ryan White HIV/AIDS Treatment Modernization Act of 2006 as released on September 18, 2006. While AIDS Action Council supports the bill, we continue to advocate that the committees make additional changes on the following issues: Hold Harmless, Funding Concerns, the Early Diagnosis Grant Program and Data Concerns (detailed in the recommendations of the community coalition – see attached document) and to ensure that states that have recently adopted name based systems and who have not fully reported HIV cases are able to avoid destabilization of their services.

We reiterate AIDS Action’s May 30 comments on the manager’s amendment marked up in the Senate. At that time we stated that, “AIDS Action notes that there may be one or more states which switched to names based reporting after 2000 and whose HIV data has not fully matured despite being certified by the CDC. AIDS Action recommends that the committee seek to avoid major funding swings due to introduction of the new system either through a transition system or other mechanism.” We now know that New York, New Jersey, Texas and Florida and possibly other states each appear to have low HIV counts, most likely due to undercounting of some sort. Therefore we remain concerned about the potential impact of this bill and support efforts to ensure that services desperately needed by people living with HIV will not be destabilized by this change.

Therefore, although we support the bill, we continue to ask that you consider making the changes listed above. We stand ready to work with you to find a position that will help all people living with HIV in the United States. Again, we thank you for your work and for your continuing efforts to improve the bill.

Sincerely,

/s/

Rebecca Haag
Executive Director

The AIDS Action Weekly Update
The Weekly Update is written with a mind toward the interests of our members. If you are interested in membership with AIDS Action, we invite you to contact members@aidsaction.org.

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