Tuesday, May 30, 2006
The documentary is being issued near the 25th anniversary of the first official diagnosis of an AIDS case in the US. It is being offered free to cable stations so that they can rebroadcast it as desired.
Friday, May 26, 2006
House Appropriations Committee Approves Funding for Millennium Challenge Corporation, President's International AIDS Program, Global Fund
The House Appropriations Committee on Thursday by voice vote approved the $21.3 billion fiscal year 2007 Foreign Operations Appropriations bill, which includes funds for a variety of foreign assistance programs, including HIV/AIDS programs, the AP/Forbes reports (Sidoti, AP/Forbes, 5/25). The bill includes $3.4 billion to curb the spread of HIV/AIDS, tuberculosis and malaria; $2 billion for the Millennium Challenge Corporation, President Bush's foreign aid agency; and $445 million in funding for the Global Fund To Fight AIDS, Tuberculosis and Malaria. The bill, passed by an appropriations subcommittee last Friday, would reportedly fully finance the administration's international AIDS program request, which increased by $752 million funding from this year; double the amount requested by Bush for the Global Fund from the foreign operations accounts; and reduce by $1 billion the amount requested for MCC. MCC was created to administer funds for the Millennium Challenge Account, a program aimed at encouraging economic and political reforms in developing countries. Twenty-three countries currently are eligible to apply for MCC funding. Bush's February proposal included $3 billion for MCC, which would have provided enough funding to sign agreements with eight additional countries (Kaiser Daily HIV/AIDS Report, 5/22).
Now you know that I would usually post something like this with some additional comments about the need for funding for HIV/AIDS on the home front. Not that I begrudge a penny where it is so needed, especially in Africa, but because I always have that silent scream "How about some matching funds for us, huh?"
This time, however, I have just been reading some blogs from Peace Corps Volunteers in Africa, specifically in Tanzania, where I spent some time once upon a time. I actually stayed up all night one night this week (paying the price the next day) reading one blog after another, totally fascinated by what these young people were discovering about themselves and about Africa. One, in particular, made a big impression.
Jen is a community health volunteer in the poorest part of Tanzania, living among the Makonde people, and talking about HIV/AIDS prevention in some fairly creative ways. I could point out specific posts in her blog that would help us have a better view of PEPFAR (she's changed my mind a little), her cheerful attitude about discussing condoms in some unlikely situations, and other rather eye-opening discussions--but I won't. You should read the whole thing. While Jen has been in Tanzania almost a year, she doesn't have frequent access to the Internet (I am shocked that she has any access to the Internet in that location). Her posts are longish but extremely well written. And I think that the effort will be worthwhile in providing some perspective on how PEPFAR funds are being used, both pro and con.
But, of course, we still have the problem of waiting lists for medications here in the US and a looming shortfall in the Texas HIV Medication Program. So I have to point out that that pie is still not as large as it needs to be. Congress needs to do some more baking.
Thursday, May 25, 2006
One of the things that I hadn't seen is their EDU site: KaiserEDU.org.
KaiserEDU.org is designed to provide students, faculty and others interested in learning about health policy easy access to the latest data, research, analysis, and developments in health policy. This site includes narrated slide tutorials, background reference libraries, and issue modules on current topics and policy debates.
The topics covered include health and the law, HIV/AIDS, prescription drugs, and other areas of interest to the Texas HIV/AIDS community.
Here's a sample of the resources offered:
- Expanding Health Coverage to the Uninsured -- tutorial, PowerPoint slides, somewhat monotonic narration (well, it says "edu," y'know), no script
- Syllabus library (for HIV/AIDS) -- course syllabi from Princeton, Harvard, MIT, you get the picture
- Journal browser
- Research tools
Another useful resource for creating talking points.
Anyhoo, this tag cloud is generated by Zoom Clouds. While it doesn't seem to look like the template that I created on their site (no border, too wide, etc.), but, if it actually gets at word usage, I'll be satisfied.
Of course, it's word usage that then becomes the issue, isn't it? Unless Blogger comes up with a way to create tags that doesn't involve a degree in computer programming, we have to rely on these automatic things that simply count word frequencies rather than looking at key concepts. That's how we get "partner" but not "partner notification." That's also how we get "white" but not "Ryan White."
It's also worth noting that, while I set the parameters for "forever," there is no actual expectation that this cloud generator will go back and pick up posts from the past, so the tags, such as they are, will likely only refer to posts going forward. If the program actually updates when the blog updates, we'll take it.
Tuesday, May 23, 2006
Off-label use is standard in the treatment of cancer and AIDS.
The FDA approves medications in specific doses for specific indications. Prescription for any other purpose is considered "off label" (see here, here, and here). Physicians have the authority to prescribe any medication for any condition (assuming, in the process, liability for their action) for any reason. Boodman's article discusses the degree to which this practice lacks any scientific support, since many such off label scrips are written without the advantage of clinical research to justify them.
This is an area that carries both risks and benefits, especially for people living with HIV. It's not enough any more to accept a scrip and (if you are lucky) go to the pharmacy to get it filled. These days you need to know what the medication is approved for as well as what your physician is prescribing it for. "Why?" is the new black in physician-patient relations, as in "why are you prescribing this medication for this indication?"
I know this sounds preachy/teachy, but I don't quite know any other way to say it. As Boodman points out, off label is not the same as contraindicated. On the other hand, there may be risks and/or unknowns that you need to be aware of.
The Texas Department of State Health Services (DSHS) has issued a position paper supporting the use of Expedited Partner Therapy (EPT) as a valuable strategy for reducing STD morbidity in Texas.
EPT is the practice of treating the sex partners of persons with an STD without an intervening medical evaluation or professional prevention counseling of the partner. The usual implementation of EPT is through patient-delivered partner therapy (PDPT), although other methods may be employed.
With patient-delivered partner therapy (PDPT), clinicians provide their patients with drugs intended for the partners, prescribe extra doses of medication in the index patients’ names, or write prescriptions in the partners’ names. The available evidence indicates that Expedited Partner Therapy is at least equivalent in efficacy to standard partner management for gonorrhea and chlamydia infection; that traditional partner management by public health agencies and health care providers for these STDs is limited in scope; and that the benefits of EPT outweigh the risks. Therefore, EPT should be available to clinicians as an option for partner management for gonorrhea and chlamydia infection.
In Texas, as in the U.S, emerging data indicate that many providers selectively employ EPT for gonorrhea and chlamydia infection and that some do so routinely. Disease Intervention Specialists (DIS) deliver medications in the field as part of STD public health follow-up. Clinicians should strongly consider EPT as an important and useful option for facilitating partner treatment of sexually transmitted diseases.
I have not yet located the DSHS position paper. The full CDC recommendation can be found at: www.cdc.gov/std/treatment/EPTFinalReport2006.pdf. The CDC recommends EPT for the heterosexual partners of males and females with gonorrhea and chlamydia (accompanied by additional counseling through written educational materials or by health professionals, e.g., pharmacists). The CDC does not recommend RPT for persons infected with syphilis or for the partners of men who have sex with men. In the latter case, the additional risk of co-infection with HIV is high enough to warrant referral to a physician for diagnosis and treatment; EPT should only be used if such referral is "impractical or unsuccessful."
Friday, May 19, 2006
Senators Clinton voted against this bill because early estimations indicated that New York will take a $20 million with this new bill
The legislation amends to the current Ryan White CARE Act by creating a complicated funding mechanism that increases the number of cities that receive CARE Act emergency grants from 51 to 76, and creates a new three-tier structure for cities that report high, medium, and low numbers of HIV and AIDS cases.
Lawmakers and their staff have touted again and again the fact that the bill was drafted in a bipartisan manner. However, there has been heated debate and negotiations over several contentious issues, chief among them is how CARE Act resources are to be allocated across the country. With the high cost of HIV/AIDS drugs, no decline in new HIV infections, and an estimated 1.1 million people living with HIV/AIDS in the U.S.—an all-time high—lawmakers struggled to balance several competing demands on an increasingly small pot of funding.
The GAO has not been able to provide accurate numbers. They have tried TWICE and both times the community pointed out their errors. Its clear that this bill is better than the version introduced by Senator Coburn of Oklahoma and much better than what Representative Joe Barton of Texas wanted but at the same time it seems strange that the GAO can not give us accurate account of how the money will be divided.
I believe that the new funding mechanism is designed to make states cities and providers fight for funds and thus unable to stand united against what is far from a good bill. From the Texas perspective this bill is not great, but I think we can live with it. As I said before, it could have been a lot worse and folks in DC say if this version falls apart we are likely to see another version that could hurt us much more. Based on estimates, the funds to the state of Texas take a hit of over 6 million. Houston and Dallas pick up close to 4 million combined. San Antonio gets a slight bump up in funding while Austin and Fort Worth each take a $250,000 hit. These are just estimates beacuse the GAO can't produce actual numbers.
Thursday, May 18, 2006
My two cents were directed toward the situation with statins. Protease inhibitors and statins don't get along well. So far, the only two statins deemed safe enough to treat dyslipidemia in combination with PIs are pravastatin and atorvastatin (the later with caution). Neither of these medications is on the PDL.
Like I know all this stuff. Of course, someone pointed it out to me. And they provided me with authoritative research studies to make sure that I understood the point.
As an organization, Texas AIDS Network doesn't endorse specific medications. Our work has been to make all FDA-approved medications available to as many Texans as possible. However, we do love to hammer away at prior authorization requirements when they get in the way of HIV therapy, so this was an opportunity to do so.
What nobody told me was that one of the companies with a newer statin thinks its drug will work well in combination with PIs. (That would be rosuvastatin.) And, of course, the company's guy had to point out that I had erred in my testimony.
I hate when that happens.
Needless to say, I have since been burning up the search engines, trying to find out more about rosuvastatin and HIV. Clearly, the research on the use of rosuvastatin in combination with PIs is underway--and I so stepped on their toes.
I did do some further search for information before the hearing, not being a complete doofus. What I turned up essentially said that the current guidelines accept pravastatin and atorvastatin (with caution) and not other statins for use in treating dyslipidemia for HIV patients. What it didn't turn up, because I used the wrong search terms to turn it up, was that rosuvastatin shows promise and may be a candidate for addition to the guidelines.
Lesson learned? It's disconcerting when your cardiologist shows up at a hearing where you will testify, but not nearly as embarassing as when your gynecologist does. ;)
I'm still reading, so I can't say much about the draft. However, my first take on the formula is that Texas will wind up with about the same amount of money at current funding levels, but it will be shifted around. Houston and Dallas will get increases. Austin, San Antonio, and Fort Worth will get decreases. So will the rest of the state's Title II areas and the Texas HIV Medication Program. THMP's hit will be in excess of $5 million. That hit will hit next April (or thereabouts)--and we've got a looming shortfall.
Read on--and let me know what you are finding.
Friday, May 12, 2006
Contact: For additional information contact Shawna Johnson, by phone: 202-483-6622 ext. 363 or e-mail: sjohnson AT nmac DOT org.
To download a registration form access the website at NMAC [shortened link].
Notes: The Women of Color Advocacy Institute is being offered free-of-charge, during the 2006 HIV Prevention Leadership Summit (HPLS).
Description: The Women of Color Advocacy Coalition provides support for National Minority AIDS Council (NMAC) public policy initiatives, including representing the special needs of women suffering from HIV/AIDS before state, local, and federal officials.Women of color worldwide have been increasingly and disproportionately at risk of contracting and living with HIV/AIDS. To address this situation, NMAC has launched the "Initiative for Cultivating Leadership among Women of Color in the Fight against HIV/AIDS", commonly called the Women of Color Advocacy Initiative. It helps women of color acquire the skills they need to take on active, visible leadership roles in addressing HIV/AIDS within their communities.
- Deductible: up from $250 to $265
- Initial coverage limit: up from $2250 to $2400
- Out-of-pocket threshhold: up from $3600 to $3850
- Point at which "catastrophic" coverage begins: up from $$5100 to $5451.25
There are some quite modest increases--or none--for dual eligibles and partial dual eligibles and assorted other categories, but the bottom line is that costs for participating in the program will increase by at least 6.86 percent.
Thursday, May 11, 2006
Title I funds the major epicenters of the epidemic. In Texas, that includes Houston, Dallas, Fort Worth, San Antonio, and Austin. Title II funds services in all other areas (Texas' smaller cities and rural areas) as well as the AIDS Drug Assistance Program (in Texas, the Texas HIV Medication Program). Virtually all of the increases in Title II have been earmarked for ADAP. Title III funds early intervention (12 grantees in Texas). Title IV funds women, infants, and children (7 grantees in Texas). Part F AETC funds the AIDS Education and Training Centers (the Texas Oklahoma AETC is based at Parkland Health and Hospital System). Part F Dental funds dental reimbursement (2 grantees in Texas, both in Dallas).
If you need numbers to go with the graph, HAB provides a link for an Excel file at the bottom of the page. Read 'em and weep.
Sphere is a bit clunky to use for MSIE, but it might be handier in those other browsers . . . uh . . . Foxfire, Safari (?). As clunky as it is, I have been discovering an active dialogue about routine testing and other issues that I would not have seen otherwise.
Here are some examples on routine testing:
Well, the last one wasn't a blog, but it still showed up. [shrug]
The Daily Kos debate is an interesting discussion that reveals a strong willingness to let public health tools do their work while raising the same alarms--confidentiality, discrimination--that are ringing in the back of my mind. The Kos discussion also got sidetracked by a bit of AIDS denialism, so, if you don't like to "read shrillness," you have some scrolling to do for the whole routine testing discussion.
Other interesting finds on the same search, but not actually on the point of routine testing, are articles appearing on:
Sphere is not the perfect blog search tool, but it's a useful addition to Technorati and other such like.
In the quarter-century of the AIDS plague, the best prevention and treatment methods have become well-known. They include leadership and education.
Look at that closely.
- We are approaching the 25th anniversary of the HIV epidemic.
- AIDS is comparable to the great plagues that wiped out large portions of the population in some parts of the world in the middle ages.
- We already know the best methods for prevention and treatment (given current research).
- Leadership and education are part of prevention and treatment.
I have, perhaps, added a bit to what the writer intended, but I don't think I've stretched the meaning too far out of shape. He/she doesn't actually mention the plagues of the middle ages, but the allusion is there with the word chosen to describe the AIDS pandemic. He/she doesn't add the "current research" caveat, but I don't think the writer actually meant to imply that we have reached the end of the road on treatment. That being said, I think there are some further lessons/issues/thoughts that arise from these points:
- After a quarter of a century, our experience with HIV/AIDS is still comparatively young. We have been dealing with heart disease, cancer, and even the plague for much longer. We have come a long way in a remarkably short period of time, but we still have neither a cure not a vaccine. After 25 years, HIV is still deadly.
- The severity of the global pandemic has been costly in lives, money, and the progress of civilization. Whole generations have been wiped out in Africa. Whole communities have been devastated in the U.S. Our health care system has been challenged. Our budgets have been strained. The plague continues, but too many have become complacent: "It won't affect me." "There's a pill for that now."
- We know how to prevent HIV and still we face ignorance and dogma that prevent us from preventing the spread of the virus.
- Leadership has time and again shown itself to be effective in supporting HIV prevention in Africa. Where is that leadership in the U.S.?
The USA Today editorial is very much on point. It is, however, too easy to talk about "AIDS ignorance" in Africa. Ignorance in Africa is very much in the middle of our stereotypes about the continent, so we are comfortable aiming criticism in that direction. We have the same ignorance in the U.S. As we get closer to that 25th anniversary, I'd like to see USA Today write the same editorial about leadership and education in the U.S.
Wednesday, May 10, 2006
Several points arise:
- LTE's are an effective way to get your ideas out to the public (if you can get them published).
- LTE's have to be written and submitted very quickly in relation to the news item that triggers them.
- I probably wouldn't have noticed either of these articles had they not been sent to me by readers (L in Austin, J in Dallas--and thank you to both of them).
We are now in the waiting stage--waiting for a confirmation call that says that the paper(s) are interested in the letter, waiting for publication (if and when).
Monday, May 08, 2006
Risk-Based Human Immunodeficiency Virus (HIV) Testing Fails to Detect the Majority of HIV-Infected Persons in Medical Care Settings.
Sexually Transmitted Diseases. 33(5):329-333, May 2006.
Jenkins, Timothy C. MD; Gardner, Edward M. MD; Thrun, Mark W. MD; Cohn, David L. MD; Burman, William J. MD
The authors' conclusions are fairly straightforward:
Although one-third of newly diagnosed HIV-infected patients had clinical visits in the 3 years before diagnosis, few presented with clinical conditions typically associated with HIV infection. Targeted testing based on clinical presentations is not likely to result in substantially earlier HIV diagnosis. Routine screening in high prevalence settings could be more effective.
Some folks in the study actually presented with risk factors or clinical indicators of HIV infection, but were not tested. Many more showed no such signs. Routine testing--rather than better training of health care personnel to recognize risk factors and clinical indicators--would have benefited them all, giving them earlier access to treatment and helping in preventing transmission to any sex partners that they may have had subsequent to their encounter with the health care system.
The niggling doubt that I have, however, comes from (admittedly) anecdotal reports from a major Texas public hospital. What I hear is that the Texas policy of routine testing of pregnant women is being abused. Women are tested without being informed that the test is voluntary and they may choose not to be tested.
Texas statute requires that women be given "printed educational materials" at the point where they would be tested (first prenatal visit and delivery). The "printed educational materials" that the Department of State Health Services makes available is this flyer, which is also available in Spanish. The flyer is, however, no longer printed by DSHS. Providers must download it and print it themselves for their patients. A call to DSHS nets the information that there is no information about the extent to which this flyer, written some years ago, is still being used by providers to educate their patients.
None of this is particularly useful in analyzing the issue of routine testing. The concept makes sense. Research appears to support it. The opt out provision is important from a civil liberties point of view, but public health concerns may be strong enough to override that issue. What remains is the porosity of confidentiality in the health care system, which matters because of the continuing stigma against people living with HIV/AIDS. That stigma kills--personal relationships, community support, economic opportunity, hope.
An interesting article on partner notification programs suggests that clients are willing to participate but providers don’t seem to refer them to the programs.
Say what? Partner notification is a key tool in HIV prevention. How is it that providers are missing this point? And which providers are doing so—physicians, STD clinics? I’m guessing it’s physicians, since STD clinics and other such testing programs would fall under requirements to participate in partner notification programs. Perhaps a little Public Health 101 is needed for the docs.
"Burr and Other Senators Take Issue with Formula for AIDS Care Money" Winston-Salem Journal (05.04.06):: Mary M. Shaffrey
The news report shows the senator from North Carolina taking up the fight to get a more “equitable” distribution of funds. Here's his press release.
Why do states like Alabama have waiting lists for people to get basic drugs while places like New York, Houston and San Francisco have so much money that they provide acupuncture, massage therapy, dog-walking and ‘companion services’? Ryan White himself would not get the proper funding under the current funding formula,” Sessions said, referring to the Indiana teenager who died in 1990 after contracting AIDS from hemophilia treatments.
The issue is, of course, how the funds are distributed among the states by the formula in the Ryan White CARE Act (RWCA). Since the beginning, the RWCA has distributed funds based on the number of AIDS cases reported by area. These numbers were cumulative, meaning that both living and deceased persons were included in the formula. Places like San Francisco and New York City, where the earliest cases were diagnoses had, of course, the highest numbers and would receive a larger portion of the funds.
This also included places like Houston and Dallas and, eventually, Fort Worth, San Antonio, and Austin. These Texas cities are Title I cities and receive separate grants directly to their metropolitan areas. Places like El Paso, the Valley, and parts of East Texas never seemed to reach those high numbers despite having significant case loads.
HRSA and the CDC have been pressing states to improve their reporting of HIV cases so that RWCA funding can eventually be directed toward areas where the highest number of living cases (people living with HIV and AIDS) are found, so that, unlike Medicare (and Medicaid in most places) can do a better job of taking care of people who are newly diagnosed and whose illness has not yet progressed to an AIDS diagnosis. From a public health standpoint, this is reasonable.
Some states have, however, dragged their feet on the issue. Texas did its own foot dragging (with help from Texas AIDS Network, we should acknowledge) for several years as we debated named reporting for HIV. The concern was confidentiality. Texas went from a confidential/anonymous testing scheme (with poor tracking) to confidential testing with a unique identifier (with slightly better tracking) to the current process of confidential testing with names reported (with much better tracking). This puts Texas in a comparatively good position to have good information on which to base RWCA funding formulas based on either reported AIDS cases or reported cases of persons living with HIV/AIDS.
Over the years, the RWCA has been modified to move toward funding living cases. To prevent abandonment of infrastructure in areas where higher funding had previously been available, “hold harmless” provisions were added, so that funds in those areas were cut by only a small percentage each year. The “hold harmless” funds were generally taken out of funds that had been set aside for supplemental grants.
Those “hold harmless” provisions and their associated bites out of supplemental funds have put the bite on extra funding that Texas has relied on in the past. For example, the Texas HIV Medication Program is eligible to receive supplemental funds because of the tight eligibility requirements under which the program operates. This year’s supplemental grant is expected to be lower because of the increasing need to take funds out of supplemental grants for the “hold harmless” formulas. The flip side of that problem, lest we think that the simple solution is to get rid of “hold harmless” provisions, is that Houston, for one, benefits from “hold harmless” provisions in another title of the grant. Without those provisions, essential funds to Houston would be cut and services to a substantial portion of the people living with HIV/AIDS in Texas would suffer.
It looks like there’s no good answer for Texas, doesn’t it? Except for this: the funds needed to support HIV/AIDS treatment and services have increased very little under this administration, and in some cases they have decreased. At the same, the number of people living with HIV/AIDS has increased significantly. Perhaps the good senators from North Carolina would do themselves and the rest of us a better service by supporting increased funding for the RWCA rather than looking for ways to slice the pie to their better advantage. It’s not how the pie is sliced that is the problem. It’s that the pie is shrinking.
Sunday, May 07, 2006
It's a bit of a relief to be reminded that condoms can be a source of humor rather than a symbol of the "end of civilization as we know it," no?
Thursday, May 04, 2006
GAO-06-654: MEDICARE: Communications to Beneficiaries on the Prescription Drug Benefit Could Be Improved. May 3, 2006. GAO investigators developed 5 questions, asked each of them 100 times at Medicare information call centers. The results were less than stellar: variable waits (some rather long), dropped calls, and, worst of all, inaccurate information.
SFGate.com writes (from AP):
The Government Accountability Office investigators said that about one-third of their calls resulted in faulty responses or no response at all because of disconnected calls. The accuracy rates varied a great deal based on the question, but when it came to one of the most important questions, operators provided the right answer only 41 percent of the time. That question concerned which drug plan cost the least for a beneficiary based on certain drug needs.
The GAO recommendation:
GAO is recommending that the CMS Administrator enhance the quality of its communications by taking actions to improve written materials, its 1-800-MEDICARE help line, and the Medicare Web site. CMS said that GAO’s findings did not present a complete and accurate picture of its activities. However, CMS said that it supports the goals of GAO’s recommendations and is already taking steps to implement them.
May 15 continues to loom as the "final" deadline for enrollment in the program. If you haven't made a choice but that date, there will be a "penalty" added to your premiums. The "penalty" is 1 percent of the premium's cost per month that you have not enrolled. (On a $50 premium, that's 50 cents added to the premium cost for each month that you delay enrollment.)
GAO-06-646: RYAN WHITE CARE ACT: Improved Oversight Needed to Ensure AIDS Drug Assistance Programs Obtain Best Prices for Drugs, April 26, 2006
From the abstract:
In order to make maximum use of the funding they receive, ADAPs are expected to secure the best price available for the drugs on their formularies. ADAPs may, but are not required to, purchase their drugs through the 340B federal drug pricing program, under which drug manufacturers provide discounts on certain drugs to covered entities. The Health Resources and Services Administration (HRSA) has identified the 340B prices as a measure of ADAPs' economical use of grant funds, but the Department of Health and Human Services does not disclose 340B prices to the ADAPs. GAO found that some ADAPs reported prices that were higher than the 340B prices for selected HIV/AIDS drugs. However, these reported prices may not have reflected any rebates ADAPs eventually received. While HRSA is responsible for monitoring whether ADAPs obtain the best prices available for drugs, it does not routinely compare the drug prices ADAPs report to 340B prices.
The Texas HIV Medication Program (THMP) purchases medications under the 340B program and gets rebates from some manufacturers. According to Dwayne Haught, Program Manager for THMP, the program gets its information about the 340B prices for medications from its supplier, not from manufacturers or HRSA.
The GAO's recommendation:
In its report, GAO recommends that HRSA require ADAPs to report the final prices they paid for drugs, net of any rebates, and that HRSA routinely determine whether these prices are at or below the 340B prices. In commenting on these recommendations, HRSA stated that these steps would be labor intensive and it lacks capacity to carry out such oversight.So the Catch-22 is that HRSA won't (or can't) tell ADAPs what the 340B price is supposed to be, but it's too costly to keep track of the prices that ADAPs are paying to make sure that they are actually getting the 340B price. Huh? ADAP funds grow on trees, I guess.
Haught notes that the report erroneously characterizes the Texas program as requiring co-pays/cost sharing. THMP allows participating pharmacies to collect a $5 co-pay as a dispensing fee, but this fee is retained by the pharmacy and not sent to the program.
If I recall correctly, some pharmacies disregard the fee and dispense HIV meds for free.
Note to self: Which pharmacies are these? We should be celebrating their generosity.
Technical note: Coburn's bill is S. 2339: Ryan White CARE Act Amendments of 2006 (Introduced; Feb 28, 2006). Its companion bill is: H.R. 5009: Ryan White CARE Act Amendments of 2006 (Introduced; Mar 16, 2006). Both are the same. Both have only Republican co-sponsors so far (1 in the Senate, 18 in the House).
The GAO testimony regarding the testing of pregnant women was comparatively brief--only a couple of paragraphs in 11 pages of written testimony. It touched on types of testing policies and whether states tracked the rate of pediatric infection from perinatal transmission. No serious problems, as far as I can tell, are revealed in this brief statement. However, there is some indication that some of the states surveyed do not meet standards for surveillance on this issue. That leaves the door open for Coburn's bill to switch the federal requirement from "voluntary" testing to "routine" testing.
Here's the definition of routine testing from Coburn's bill (emphasis added):
(14) ROUTINE TESTING.—The term ‘routine testing’ means HIV testing— (A) that is administered automatically to those accessing health care services for any reason; and (B) in which—(i) pre-test counseling is not required but the subject is notified that the subject will receive an HIV test and the subject may opt out of such testing; and (ii) for those individuals with a positive test result, post-test counseling, including referrals to care, is provided and confidentiality is protected.And here I thought he was talking about changing the requirement for pregnant women! Silly me. This is universal testing.
Here's the relevant passage of the bill:
One would love to see the fiscal note on this, especially for "entities" that receive funds from Medicare and Medicaid.
(1) IN GENERAL.—Except as provided in paragraph (2), the Secretary shall require rapid routine testing of each client at any health facility, provider, clinic, or entity (including an HIV, STD, or substance abuse clinic) receiving funding from the Centers for Disease Control and Prevention, the Substance Abuse and Mental Health Services Administration, the Health Resources and Services Administration, the Centers for Medicare & Medicaid Services, or any reproductive health program administered by the Secretary.
(2) EXCEPTION.—Rapid routine testing shall not be required in the case of an individual who has already been diagnosed with HIV infection.
Cynicism aside, it's worth considering Coburn's motivations. Coburn is a physician. When push comes to shove, he can overcome his (incredibly) conservative ideology and stick to the science, if only for a brief moment. In this instance, he appears to be looking to the science of public health and trying to steer the nation toward the routine testing that would become virtual screening. Once you've screened, you can treat those infected, counsel those at risk, and, if it all works as planned, slow down or halt the epidemic.
The facts on the ground suggest that he is not completely off base. One, the epidemic continues to grow, to a large extent, because people who do not know their HIV status are unknowingly transmitting the virus. Two, misperceptions about who is at risk for HIV lead some to feel safer in engaging in high risk behaviors because they "are not at risk," i.e., they are not gay, not using heroin, etc. Three, poverty is increasingly being cited as a “risk factor” for HIV infection. Four, identification of infection is important for the individual (treatment) and society (prevention).
But--there's always a but--routine testing, while voluntary, sometimes becomes mandatory testing when it is improperly handled, i.e., if people are not informed prior to the test that (a) they will be tested and (b) they have the right to opt out. Mandatory testing tends to drive people away from whatever system is mandating the testing. This avoidance is directly related to porous confidentiality in the health care system and the continued stigma associated with HIV/AIDS in the broader community.
Part of me thinks that the science of public health should prevail. Part of me worries about the unintended consequences of this policy. Part of me just doesn't trust Tom Coburn.
Wednesday, May 03, 2006
In March, Texas AIDS Network joined with the Hepatitis C Appropriations Partnership and the National Hepatitis C Advocacy Council by signing on to a letter requesting that the President declare May to National Hepatitis C Awareness Month. Now we get a message saying that the President (or his minions--whatever) have rejected the request.
We have National Hangnail Awareness Month in this country, for garden seed! Take a look at the calendars on Texas AIDS Net and you will see a host of health awareness days, weeks, and month.
Is President Bush thinking that, if we don't acknowledge Hep C, it will go away? Is he worried that the public will discover Hep C and then think that something should be done about it?
Well, he's right on the last point. So send him a letter. Sheesh!
NOTE: Hep C Awareness Month has been added to our May calendar. See how easy it was, Mr. President?
The WSJ ends on the high note that several companies are developing new therapies that should be available over the next few years. One or two of those should be available within the next 12 months.
This is not such a high note if these medications cannot be included in any of the existing safety net programs, especially ADAP. Most Medicaid formularies will add the drugs to their formularies, but Medicare Part D providers are not, under current law, required to add them. All of the ADAP programs will likely try to add them, but funds are in critically short supply. If the new drugs are priced at the high end of the spectrum, adding them will be even more difficult.
The word from the Texas HIV Medication Program is good--we are not facing a shortfall in this biennium right now. However, there may not be enough slack on the program's funds to add new therapies. This is why we advocated for a "needs" budget rather than a "current services" budget for THMP when testifying regarding the DSHS LAR.
There is, however, a special set of choices to be made when a woman is pregnant. Does she take the medication needed to prevent transmission to her child or does she not? That may seem like a no brainer until you consider that it may mean changes in her own treatment, not only for the short term. A new research study discusses the persistence of resistance to nevarapine one year after a single dose intended to prevent perinatal transmission. According to the study, nearly a quarter of women retain that resistance at one year.
People may quibble over whether a woman who is HIV-positive should have a child once she knows her status, but many women do not discover that they are HIV-positive until after they are already pregnant. A time when her thoughts may have been centered on the new life in her body and her hopes for the future becomes a time when the pregnant woman must quickly assimilate not only the fact of her infection but a whole ream of medical information regarding her own treament and prognosis. How does she have a chance at understanding the importance of drug resistance right then?
"The denial, shame and stigma that continue to surround blacks and HIV must be vanquished"
before the black community is vanquished. While the rates of infection in Texas are lower than in DC, the same issues exist. It's worth a listen.