Health and Medical News and Resources

General interest items edited by Janice Flahiff

US Government Program requires drug manufacturers to provide outpatient drugs to eligible health care organizations/covered entities at significantly reduced prices

New to me!

From the US Health Resources and Services Program Web page –  340B Drug Pricing Program & Pharmacy Affairs

The 340B Drug Pricing Program requires drug manufacturers to provide outpatient drugs to eligible health care organizations/covered entities at significantly reduced prices.

The 340B Program enables covered entities to stretch scarce Federal resources as far as possible, reaching more eligible patients and providing more comprehensive services.

Eligible health care organizations/covered entities are defined in statute and include HRSA-supported health centers and look-alikes, Ryan White clinics and State AIDS Drug Assistance programs, Medicare/Medicaid Disproportionate Share Hospitals, children’s hospitals, and other safety net providers. See the full list of eligible organizations/covered entities.

To participate in the 340B Program, eligible organizations/covered entities must register and be enrolled with the 340B program and comply with all 340B Program requirements. Once enrolled, covered entities are assigned a 340B identification number that vendors verify before allowing an organization to purchase 340B discounted drugs.

New registrations are accepted October 1-15, January 1-15, April 1-15 and July 1-15.

Update here, which includes..

HRSA is currently working to formalize existing program guidance through regulation, designed to cover a number of aspects of the 340B Program. The regulation currently under development will address the definition of an eligible patient, compliance requirements for contract pharmacy arrangements, hospital eligibility criteria, and eligibility of off-site facilities. We expect to publish this proposed regulation, which will be open for public comment, by June 2014. In order to ensure that covered entities retain flexibility based on their size, structure, and patient population, HRSA will continue to hold covered entities accountable for implementing those requirements as appropriate for their specific circumstances.

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Implemenation page includes

Once a covered equity is enrolled in the 340B Program and included in the covered entities database, it is the covered entity’s responsibility to inform wholesalers and manufacturers of enrollment in order to purchase drugs at the 340B discounted price.

Covered entities may continue to work directly with individual wholesalers and manufacturers and may participate in the 340B Prime Vendor Program (PVP). As the government’s awarded 340B Prime Vendor, Apexus is responsible for securing sub-ceiling discounts on outpatient drug purchases and discounts on other pharmacy related products and services for covered entities electing to join the PVP. For complete information, see the Prime Vendor Program .

Implementation Options

HRSA does not specify how participants should implement the 340B Program. As long as participants comply with all 340B Program requirements, they have flexibility in implementing the 340B Program.

Most covered entities choose one or more of the following options:

  • In-House Pharmacy, in which the covered entity owns drugs, pharmacy and license; purchases drugs; is fiscally responsible for the pharmacy; and pays pharmacy staff.
  • Contract Pharmacy Services, in which the covered entity owns drugs; purchases drugs; pays (or arranges for patients to pay) dispensing fees to one or more contract pharmacies; and contracts with pharmacy to provide pharmacy services.
  • Provider/In-House Dispensing, in which the covered entity owns drugs; employs providers licensed in the state to dispense; holds a license for dispensing for the participating providers; and is fiscally responsible for operating and dispensing costs.
  • Alternative Methods Demonstration Project, in which HRSA Office of Pharmacy Affairs approves a model proposed by the covered entity, such as a network of 340B covered entities.

The 340B Database includes links to

 

 

 

 

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February 2, 2014 Posted by | health care | , , , , , , | Leave a comment

[Press Release] Altruistic acts more common in states with high well-being

Altruistic acts more common in states with high well-being.

From the 27 January 2014 press release of the Association of Psychological Science

People are much more likely to decide to donate a kidney to a stranger — an extraordinarily altruistic act — in areas of the United States where levels of well-being are high, according to a new study.

“Anywhere from 11% to 54% of adults say that they’d be willing to consider altruistic kidney donation, but only a tiny fraction of them actually become donors,” says psychological scientist Abigail Marsh of Georgetown University, senior author on the study. “Our work suggests that subjective well-being may be a factor that ‘nudges’ some adults into actually donating.”

The findings are published in Psychological Science, a journal of the Association for Psychological Science.

Defining altruism, and determining if it truly exists, has long been a topic of debate. Many seemingly selfless acts of altruism can be explained by indirect benefits to the do-gooder, such as a bump in social status or protection from the negative judgments of others.

Non-directed kidney donation is unique, says Marsh, because it meets the most stringent criteria for altruism. People willingly choose to donate their kidney to someone they aren’t related to, someone they don’t even know — and the process of donating requires considerable time, and the risk of experiencing serious discomfort and pain.

So why do these people donate at all?

Marsh and lead author Kristin Brethel-Haurwitz hypothesized that it might have something to do with subjective well-being, given that well-being is associated with other prosocial behaviors, including volunteering and charitable giving.

To explore a possible link, the researchers used kidney donation data from the Organ Procurement and Transplantation Network and nationally representative well-being data from the Gallup-Healthways Well-Being Index.

Just as they predicted, the data revealed a positive relationship between altruistic kidney donation and well-being: States with higher per capita donation rates tended to have higher levels of well-being. The positive link held when the researchers combined states into nine broader geographic regions, and also when they examined the data for a single year (2010).

Together, these findings suggest that well-being is not just linked to prosocial behaviors, like charitable giving, but may also promote genuine altruism.

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February 2, 2014 Posted by | Psychology | , , | Leave a comment

[Reblog] Troubles in the Branding of Psychotherapies as “Evidence Supported”

From the 25 October 2013 blog item by James Coyne, PhD at PLoS Blogs (Public Library of Medicine)

Is advertising a psychotherapy as “evidence supported,”  any less vacuous than “Pepsi’s the one”? A lot of us would hope so, having campaigned for rigorous scientific evaluation of psychotherapies in randomized controlled trials (RCTs), just as is routinely done with drugs and medical devices in Evidence-based Medicine (EBM). We have also insisted on valid procedures for generating, integrating, and evaluating evidence and have exposed efforts that fall short. We have been fully expecting that some therapies would emerge as strongly supported by evidence, while others would be found less so, and some even harmful.

Some of us now despair about the value of this labeling or worry that the process of identifying therapies as evidence supported has been subverted into something very different than we envisioned.  Disappointments and embarrassments in the branding of psychotherapies as evidence supported are mounting. A pair of what could be construed as embarrassments will be discussed in this blog.

Websites such as those at American Psychological Association Division 12 Clinical Psychology and SAMHSA’s National Registry of Evidence-based Programs and Practices offer labeling of specific psychotherapies as evidence supported. These websites are careful to indicate that a listing does not constitute an endorsement. For instance, the APA division 12 website declares

This website is for informational and educational purposes. It does not represent the official policy of Division 12 or the American Psychological Association, nor does it render individual professional advice or endorse any particular treatment.

Readers can be forgiven for thinking otherwise, particularly when such websites provide links to commercial sites that unabashedly promote the therapies with commercial products such as books, training videos, and workshops. There is lots of money to be made, and the appearance of an endorsement is coveted. Proponents of particular therapies are quick to send studies claiming positive findings to the committees deciding on listings with the intent of getting them acknowledged on these websites.

But now may be the time to begin some overdue reflection on how the label of evidence supported practice gets applied and whether there is something fundamentally wrong with the criteria.

Now you see it, now, you don’t: “Strong evidence” for the efficacy of acceptance and commitment therapy for psychosis

On September 3, 2012 the APA Division 12 website announced a rating of “strong evidence” for the efficacy of acceptance and commitment therapy for psychosis. I was quite skeptical. I posted links on Facebook and Twitter to a series of blog posts (1, 23) in which I had previously debunked the study claiming to demonstrate that a few sessions of ACT significantly reduced rehospitalization of psychotic patients.

 

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February 2, 2014 Posted by | Medical and Health Research News | , , | Leave a comment

[Reblog] Good News! A Workplace Wellness Vendor Saying You’re Sick Means You’re Probably Healthy | The Health Care Blog

Good News! A Workplace Wellness Vendor Saying You’re Sick Means You’re Probably Healthy | The Health Care Blog.

From the 25 January 2014 blog item

Your wellness vendor says you are: But are you really sick?

Don’t take our for it that these workplace wellness programs are a complete and utter waste of your time and blood and your employer’s money, and can even generate medical treatments you don’t need.  Do the arithmetic yourself.  (The next paragraph does contain a little math but on the bright side if you can follow it, you can probably continue to live independently for at least a few more years.)

Assume a vendor finger-stick test that you get at your company’s “health fair” is 96 percent accurate. Further assume that vendors are seeking silent disorders that on average have a 1 percent prevalence.  Do you suppose your odds of a false positive in those circumstances are 4 percent? To use a technical clinical term, nope. Out of 100 employees, the single employee who is actually afflicted with this disorder should test positive. Unfortunately, 4 of the other 99 will also test positive even though they are fine…because a 96%-accurate test is also 4%-inaccurate. This means of the 5 people who test positive, only 1 has the disorder—a false positive rate of 80 percent!

And that’s just on one test. With that kind of accuracy, it’s odds-on that if you get all the tests with all the frequencies that a wellness vendor recommends, at least one lab value will eventually be outside a normal range…and potentially thrust you into the treatment trap. The key to surviving this testing jihad without being trapped is–as with just about everything else in wellness–to start with the assumption that the vendor is wrong. This is a pretty safe bet. How safe? I don’t even know you, but if you tell me the sky is green and a wellness vendor profiled in this book tells me the sky is blue, I’d at least go look out the window.

Those false-positives make overdiagnosis (finding and treating maladies that don’t exist) the rule, not the exception.

 

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February 2, 2014 Posted by | Workplace Health | , , | Leave a comment

Poor breakfast in youth linked to metabolic syndrome in adulthood — ScienceDaily

English: american breakfast

English: american breakfast (Photo credit: Wikipedia)

 

Poor breakfast in youth linked to metabolic syndrome in adulthood — ScienceDaily.

 

From the 29 January 2014 article

 

Summary — It is often said that breakfast is important for our health, and a new study supports this claim. The study revealed that adolescents who ate poor breakfasts displayed a higher incidence of metabolic syndrome 27 years later, compared with those who ate more substantial breakfasts.

The study revealed that adolescents who ate poor breakfasts displayed a higher incidence of metabolic syndrome 27 years later, compared with those who ate more substantial breakfasts.

Metabolic syndrome is a collective term for factors that are linked to an increased risk of suffering from cardiovascular disorders. Metabolic syndrome encompasses abdominal obesity, high levels of harmful triglycerides, low levels of protective HDL (High Density Lipoprotein), high blood pressure and high fasting blood glucose levels.

The study asked all students completing year 9 of their schooling in Luleå in 1981 (Northern Swedish Cohort) to answer questions about what they ate for breakfast. 27 years later, the respondents underwent a health check where the presence of metabolic syndrome and its various subcomponents was investigated.

The study shows that the young people who neglected to eat breakfast or ate a poor breakfast had a 68 per cent higher incidence of metabolic syndrome as adults…

 

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February 2, 2014 Posted by | Nutrition | , , , , | Leave a comment

   

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