Via Michael Barnett:
- CMS’ voluntary bundled-payments program delivers mixed results, Modern Healthcare
- The Politics Of Medicare And Drug-Price Negotiation, Health Affairs blog
- Disentangling the ACA’s Coverage Effects — Lessons for Policymakers, NEJM
What is this post about? Look here.
Your dentist has probably offered dental sealants for your child. Mine has. Without knowing whether they work, I’ve always accepted them. Turns out, this was a good move.
Introduced in the 1960s, dental sealants are plastic coatings applied to the surfaces of teeth. They fill in and seal pits and grooves of teeth, making them more resistant to bacteria that can cause cavities. Because molars are more cavity-prone, sealants are usually applied there. Dental sealants are most often recommended when children’s first, permanent molars come in — between ages 5 and 7 — and again when their “12-year molars” arrive — usually between ages 11 and 14. Dentists may also offer sealants for older children and for adults prone to cavities.
In 2013, The Cochrane Collaboration published a systematic review of the evidence on sealants. It assessed the results of 34 studies involving 6,529 children and adolescents. Some studies compared one sealant material to another, but 12 of the studies, with 2,575 total participants, compared outcomes of sealants versus no sealants. From these, the review concluded that sealants are effective in reducing cavities for at least four years after each application.
For example, one randomized trial followed children with and without sealants for nine years. At the beginning of the study, study participants were between 6 and 8. By the time they were in their mid- to late teens, 77 percent of their teeth without sealant treatment had cavities, compared with 27 percent with sealants. Another randomized trial studied 8-to-10-year-olds over two years. It found that cavity rates were more than twice as high for those without sealants than for those with.
The Cochrane review compiled results from all such studies and concluded that sealants’ cavity-fighting abilities are considerable. The review estimated that in a population of cavity-free children with a 40 percent chance of getting a first cavity over the next two years without sealants, application of sealants would reduce the rate to just 6 percent. Another systematic review of sealant clinical trials, published in August, came to similar conclusions. And the American Dental Association encourages sealant application.
According to the Centers for Disease Control and Prevention, 21 percent of children between 6 and 11 and 58 percent of adolescents have had cavities in permanent teeth. Yet fewer than one-third of those between 6 and 8 have sealants, and fewer than half of older ones do.
Children from poorer families are less likely to receive dental treatment and sealants. To expand application of sealants, some states have initiated sealant programs through schools.
However, a report from The Pew Charitable Trusts found that 39 states and the District of Columbia lack sealant programs in more than half of schools serving high numbers of low-income students. And 10 states require examination by a dentist for sealant application even though the process can be effectively completed by a less costly hygienist. This further reduces access.
This is unfortunate, because sealants aren’t just effective, but also cost-effective. When sealant programs are introduced in schools with children at higher risk for cavities, they can be cost-saving. Though prices vary, filling a cavity can cost about $100, while sealant application costs only about $30 to $40 per tooth.
There are different types. Resin-based are the most common, but glass ionomer sealants are also widely applied. Though studies indicate that resin-based sealants last longer, clinical trials conclude that neither is more effective than the other in cavity reduction. Similarly, more recent studies have generally not found a cavity-reducing performance difference between materials.
B.P.A., as it’s known, has been detected in patients’ saliva just after sealant treatment, though none has been detected a day later and never in their blood. To date there is no evidence that sealants lead to patient harm, while there is considerable evidence of benefits. The American Dental Association, citing analysis by the Department of Health and Human Services and the Food and Drug Administration, does not believe that B.P.A. exposure from sealants poses risks to patients.
But when your dentist offers sealants for your children, it’s not an upsell, but a deal you should accept.
- Medicare Beneficiaries Face Growing Out-Of-Pocket Burden For Specialty Drugs While In Catastrophic Coverage Phase, Health Affairs
- Part D Generic Drug Prices Declined Overall, but Some Had Extraordinary Price Increases, GAO
What is this post about? Look here.
One of the most common questions I get is, “How do you translate and disseminate research to make a maximum impact on policy?” It’s an uncomfortable question because there’s little, if any, science on the issue. I have a little to say about it, but not a lot — and certainly not a lot I have confidence in.
A few papers I cover in my latest AcademyHealth post is very helpful in this regard. The context is syringe exchange program policy. The questions: Why is it controversial? How does that fact make policy change difficult? And what can be done about it anyway? Go read!
Fully developed posts on syringe exchange programs (SEPs) are here and here. A couple more are forthcoming. Here are the notes I took as I read the literature in this area. This is Part III. Part I is here. Part II is here.
(1) Head of ONDCP Promotes Needle Exchange Programs (Partnership for Drug-Free Kids, 2015)
- “Needle-exchange programs are effective tools to fight the spread of infectious disease and steer heroin users into treatment, according to Michael Botticelli, Director of the Office of National Drug Control Policy. ‘They’ve been demonstrated to reduce not only infectious disease but also create an opportunity for people to get the care and provide a transition into treatment for people in the community,’ he said […] at an event sponsored by the Northern Kentucky Chamber of Commerce.”
- “Kentucky Governor Steve Beshear recently signed a bill into law that will allow local health departments to set up needle exchanges after obtaining approval from local governments. In Indiana, Governor Mike Pence declared a state of emergency in response to a growing number of HIV cases linked to intravenous use of the painkiller Opana. He authorized a short-term program in one county to allow people to exchange used needles for sterile ones, to reduce the risk of contaminated needles being shared. There are about 200 needle-exchange programs in 33 states and the District of Columbia, according to the North American Syringe Exchange Network.”
(2) Syringe Sharing and HIV Incidence Among Injection Drug Users and Increased Access to Sterile Syringes, by Thomas Kerr et al. (American Journal of Public Health, 2010)
- “[W]e examined syringe borrowing, syringe lending, and HIV incidence among a prospective cohort of 1228 injection drug users in Vancouver, British Columbia. Results. […] In multivariate analyses, the period following the change in SEP policy was independently associated with a greater than 40% reduction in syringe borrowing (adjusted odds ratio [AOR]=0.57; 95% confidence interval [CI]=0.49, 0.65) and lending (AOR=0.52; 95% CI=0.45, 0.60), as well as declining HIV incidence (adjusted hazard ratio=0.13; 95% CI=0.06, 0.31).”
- “Previous evaluations of SEPs have demonstrated that these programs are associated with reductions in syringe sharing and HIV incidence [Wodak] as well as increased rates of entry into addiction treatment programs [Heimer, Strathdee] Further, previous evaluations have found that SEPs do not increase drug use, crime, or discarded syringes [Watters].”
(3) Evidence for the effectiveness of sterile injecting equipment provision in preventing hepatitis C and human immunodeficiency virus transmission among injecting drug users: a review of reviews, by Norah Palmateer et al. (Addiction, 2010)
- “Three core and two supplementary reviews of injecting equipment interventions were identified. According to the proposed framework, this study found (a) insufficient evidence to conclude that any of the interventions are effective in preventing HCV transmission; (b) tentative evidence to support the effectiveness of NSP [needle and syringe programs] in preventing HIV transmission; (c) sufficient evidence to support the effectiveness of NSP (and tentative evidence of an additional impact of pharmacy NSP) in reducing self-reported IRB [injecting risk behavior]; and (d) little to no evidence on vending machines, outreach or providing other injecting equipment in relation to any of the outcomes.”
- [As discussed in Wodak and Cooney, below, some studies done in the presence of legal access to syringes at pharmacies find negative or null results of SEPs (or NSPs).]
(4) Do Needle Syringe Programs Reduce HIV Infection Among Injecting Drug Users: A Comprehensive Review of the International Evidence, by Alex Wodak and Annie Cooney (Substance Use & Misuse, 2006; referenced in (2), above and in Part I (1)). See also the WHO report by the same authors.
- “The principal finding of this review was that there is compelling evidence of effectiveness, safety, and cost-effectiveness, consistent with seven previous reviews conducted by or on behalf of U.S. government agencies.”
- “By the beginning of the 1990s, evidence of the effectiveness and safety of NSPs in reducing HIV spread among IDUs was already compelling and well summarized in seven previous reviews conducted by or on behalf of U.S. government agencies (Table 1). The failure of these reviews to influence the policymaking process in the United States has to be considered from the perspective of an unusual national drug policy sustained over many decades (McAllister, 2000; MacCoun and Reuter, 2001; McCoy, 2003). Authorities, especially in developing and transitional countries, have often resisted implementation of NSPs lest any support for effective harm reduction strategies might be considered to undermine their entrenched commitment to global drug prohibition. […] Adoption of NSPs in the United States has been late and implementation slow because of explicit rejection of harm reduction and strong support for a zero tolerance approach to drugs.”
- “Forty-five studies dating from 1989 to 2002 were identified with NSP implementation as an intervention and HIV seroconversion, HIV seroprevalence, or HIV risk behaviors among IDUs examined as outcome variables. […] Six of ten studies that evaluated HIV seroconversion or seropositivity as outcomes found that NSP use was protective. […] HIV risk behavior outcomes were examined in 33 studies. […] Most focused on syringe sharing, borrowing, lending, or reuse (23 positive).”
- “Conclusions: 1. There is compelling evidence that increasing the availability, accessibility, and both the awareness of the imperative to avoid HIV and utilization of sterile injecting equipment by IDUs reduces HIV infection substantially. […] Measured against any objective standards, the evidence to support the effectiveness of NSPs in substantially reducing HIV must be regarded as overwhelming. 2. There is no convincing evidence of any major unintended negative consequences. Specifically and after almost two decades of extensive research, there is still no persuasive evidence that NSPs increase the initiation, duration, or frequency of illicit drug use or drug injecting. 3. NSPs are cost-effective. It is more difficult to generalize from studies of cost-effectiveness of NSPs in one country to other similar countries, let alone from developed countries to resource-poor settings. However, a number of careful studies in several developed countries and some transitional countries have demonstrated convincingly that NSPs are cost-effective. 4. NSPs have additional and worthwhile benefits apart from reducing HIV infection among IDUs. There is reasonable evidence that NSPs can increase recruitment into drug user treatment and possibly also into primary health care.”
Fully developed posts on syringe exchange programs (SEPs) are here and here. A couple more are forthcoming. Here are the notes I took as I read the literature in this area. This is Part II. Part I is here. Part III is here.
(0) Impact Evaluation of a Policy Intervention for HIV Prevention in Washington, DC, by Monica Ruiz, Allison O’Rourke, and Sean Allen (AIDS Behav, 2016; See Part I, item (1))
- “The District of Columbia (DC) is in the midst of a significant HIV/AIDS epidemic. According to epidemiological data from the end of 2011, approximately 2.4% of DC residents over the age of 12 years are living with HIV/AIDS. Injection drug use (IDU) accounts for 14.2% of the living cases of HIV/AIDS in the District [DC Dept. of Health].”
- In May 2008, a ban on use of DC municipal funds for SEPs was lifted. “Then-Mayor Adrian Fenty allocated $650,000 to the DC Department of Health to create the DC NEX, a program supporting several CBOs [community-based organizations] in delivering a minimum harm reduction package that includes syringe exchange, provision of condoms, referrals to HIV testing and addiction treatment, and harm reduction information [Greenberg].” This study examined the impact of these changes on injection drug use-caused HIV cases.
- “Our modeling of the forecasted versus actual epidemic curves shows that, as a result of the removal of the DC Ban, there was a 70% decrease in the number of newly diagnosed HIV cases where reported mode of transmission was IDU.”
(1) Quantifying Syringe Exchange Program Operational Space in the District of Columbia, by Sean Allen, Monica Ruiz, and Jeff Jones (AIDS and Behavior, 2016)
- “In the United States (US), an estimated 2.6% (approximately 6,612,488 persons) of the population [above 12 years of age] has ever injected drugs.”
- “In the United States, IDU [injection drug use] is the most common route of HCV [hepatitis C virus] transmission.”
- According to one estimate, 90% of DC injection drug users have hepatitis C.
- “SEPs may also provide health education on topics that are relevant to PWID, such as how to engage in safer injection practices (e.g., not sharing injection equipment, how to sterilize syringes, etc.) and how to prevent overdose [avert.org].”
- “The  Harrison Act  made the possession of injection equipment illegal without a prescription.” A significant limitation today is the prohibition of use of federal funds for distribution of injection equipment to injection drug users. “The implementation of buffer zone policies has also produced significant barriers to SEP operations.”
- “In 2000 DC government passed the 1000 Foot Rule (§48–1121), prohibiting the distribution of ‘any needle or syringe for the hypodermic injection of any illegal drug in any area of the District of Columbia which is within 1000 feet of a public or private elementary or secondary school (including a public charter school).'”
- “The total square mileage of the potential SEP operational space the 1000 Foot Rule caused to be ineligible for SEP activities held approximately constant over the study period, ranging from 24.30 to 25.83 square miles (50.57–53.76 % of the total area of DC).”
(2) Legal space for syringe exchange programs in hot spots of injection drug use-related crime, by Sean Allen, Monica Ruiz, Jeff Jones, and Monique Turner (Harm Reduction Journal, 2016)
- We examined the effects of the 1000 Foot Rule on SEP operational space in injection drug use (IDU)-related crime (i.e., heroin possession or distribution) hot spots from 2000 to 2010.”
- “When overlaying the land space associated with IDU-related crime hot spots on the maps of school boundaries per the 1000-ft buffer zone stipulation, we found that the majority of land space in these locations was ineligible for legal SEP operations. More specifically, the ineligible space in the identified hot spots in each academic year ranged from 51.93 to 88.29 % of the total hot spot area.”
(3) Assessing Syringe Exchange Program Access among Persons Who Inject Drugs (PWID) in the District of Columbia, by Sean Allen, Monica Ruiz, Jeff Jones (Journal of Urban Health, 2016)
- “The results of this research suggest that the distance DC PWID traveled to access SEP services remained relatively constant (approximately 2.75 mi) from 2003 to 2008, but increased to just over 4 mi in 2010.”
(4) An opportunity lost: HIV infections associated with lack of a national needle-exchange programme in the USA, by Peter Lurie and Ernest Drucker (Lancet, 1997; See Part I, item (1))
- “In Amsterdam, a needle-exchange programme opened as early as 1984, in an effort to reduce the transmission of blood-borne infections such as hepatitis B. Thus, when evidence on the efficacy of such programmes began to accumulate, most countries in western Europe, as well as in Australia, New Zealand, and Canada, were able to move rapidly to provide sterile syringes to IDUs [injection drug users] through a combination of needle-exchange programmes and increased availability of sterile injection equipment through pharmacies. By contrast, in the USA, opposition to needle-exchange programmes arose from some drug-treatment providers, ethnic minority communities, law-enforcement officials, politicians, local business people, and residents. These groups asserted that programmes would lead to increased drug use and would also divert public funds from already under-funded drug-treatment facilities.”
- “Six government-sponsored reviews of needle-exchange programmes [Normand, Lurie, GAO, National Commission, Office of Technology Assessment, one unavailable on the internet] concluded that such programmes reduce the incidence of HIV infection among IDUs and do not lead to an increase in rates of drug use.”
- After reviewing the evidence, in 1993, the CDC recommended that the ban on Federal funding of exchange programs be lifted.”
(5) Syringe exchange in the United States: a national level economic evaluation of hypothetical increases in investment, by Trang Quynh Nguyen et al. (AIDS Behav, 2014)
- “HIV infections cause significant human suffering and exact substantial financial costs, with each infection in the United States estimated to result in a loss of between 9 and 21.1 years of life [Harrison], between 5.33 and 6.433 quality adjusted life years [Holtgrave, Hutchison], and $379,668 (2010 dollars) in lifetime treatment costs [CDC]. The sharing of drug injection equipment is the second-most common route of HIV transmission—approximately 9.4% of new HIV infections in the United States in 2009 occurred among persons who injected drugs (PWID) and 2.7% occurred among men who had sex with men and injected drugs (MSM/PWID) [Prejean].”
- “Access to sterile needles and syringes (herein referred to as ‘‘syringes’’) is a proven approach for reducing HIV transmission enumerated in the 2010 [and 2015] National HIV/AIDS Strategy for the United States. The evidence in favor of needle/syringe exchange programs (NSP) is well-documented, with economic evaluations repeatedly showing that NSPs are cost-effective and cost-saving for the prevention of HIV [Gold, Jacobs, Laufer, Cabases, Kumaranayake]. The 2012 US President’s Emergency Plan for AIDS Relief (PEPFAR) Blueprint envisions an AIDS-free generation within our lifetime, calling for ‘‘smart investments based on sound science’’, and establishing NSPs as one of the three central elements of the PEPFAR comprehensive prevention package for PWID, in addition to community-based outreach programs and drug treatment.”
- “Many NSPs provide additional services such as referrals to drug treatment programs, HIV testing and counseling, and condom distribution [Des Jarlais].”
- “With an annual $10 to $50 million funding increase [for SEPs], 194–816 HIV infections would be averted (cost per infection averted $51,601–$61,302). Contrasted with HIV treatment cost savings alone, the rate of financial return on investment would be 7.58–6.38. Main and sensitivity analyses strongly suggest that it would be cost-saving for the US to invest in syringe exchange expansion.”
(6) Reduced injection frequency and increased entry and retention in drug treatment associated with needle-exchange participation in Seattle drug injectors, by Holly Hagan et al. (Journal of Substance Abuse Treatment, 2000)
- “The association between needle exchange, change in drug use frequency and enrollment and retention in methadone drug treatment was studied in a cohort of Seattle injection drug users (IDUs). Participants included IDUs classified according to whether they had used a needle exchange by study enrollment and during the 12-month follow-up period. The relative risk (RR) and the adjusted RR (ARR) were estimated as measures of the association. It was found that IDUs who had formerly been exchange users were more likely than never-exchangers to report a substantial (> or= 75%) reduction in injection (ARR = 2.85, 95% confidence limit [CL] 1.47-5.51), to stop injecting altogether (ARR = 3.5, 95% CL 2.1-5.9), and to remain in drug treatment. New users of the exchange were five times more likely to enter drug treatment than never-exchangers.”
- “In this study, there was no indication that needle-exchange use was associated with increasing drug use. Indeed, IDUs who were former users of the exchange were more likely than never-users to report substantial reductions in drug use or stopping injection altogether. Our analysis also suggested that among heroin injectors, needle-exchange participation was wholly compatible with the goals of drug treatment. Compared to those who had never used an exchange, new exchange users were five times more likely to enter methadone treatment and ex-exchangers were 60% more likely to remain in methadone treatment over the 1-year study period.”
- “[T]here are a number of studies showing that the net effect of an exchange might be to reduce drug use, particularly through recruitment to drug treatment [Brooner et al., 1998; Guydish et al., 1993; Hagan et al., 1993; Hartgers et al., 1989].”
- Some SEPs have operated illegally.