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Right to Peaceful Assembly

Law Library of Congress: Research Reports - Fri, 11/21/2014 - 12:02am
The Law Library of Congress is proud to present a new report, Right to Peaceful Assembly.

Freedom of peaceful assembly is a recognized right under international human rights law. This report provides a comparative review of one aspect of this right: whether advance notification or authorization is required for an assembly to take place under the law of France, Italy, Portugal, Spain, Sweden, the United Kingdom, and the United States. The report also reviews the relevant case law of the European Court of Human Rights.

Visit http://www.loc.gov/law/help/peaceful-assembly/index.php to read the entire report.

This report is one of many prepared by the Law Library of Congress available at http://www.loc.gov/law/help/current-topics.php.
Categories: Research & Litigation

Private Sector in Health

Medicare -- New York Times - Fri, 11/21/2014 - 12:00am
Robert I. Field of Drexel University writes that “the symbiosis between the government and private insurers under the Affordable Care Act should come as no surprise.”
Categories: Elder, Medicare

Hospitals And Pharmacies Grapple With Rising Drug Prices

Kaiser Health News - Thu, 11/20/2014 - 3:42pm

Fed up with the rising price of drugs, Ascension Health last month did something unusual. It publicly banned a drug company’s sales reps.

The reason: The company had reclassified three cancer drugs, causing prices to spike.

In a memo to employees, Dr. Roy Guharoy and Michael Gray, two top executives with the Edmundson-based hospital chain, explained: “Already scarce resources will need to be stretched with potential serious impact on the range and breadth of health services we currently provide to our patients and our communities.”

The move proved largely symbolic.

Ascension, the nation’s largest nonprofit health care system, can’t stop buying the needed medications. And the drugmaker, Genentech, defended the reclassifications, saying it was done to ensure the safety of the drugs.

Still, the dust-up did succeed in sending a message to the pharmaceutical industry, says Nick Ragone, Ascension’s chief communications officer: Think twice before raising prices.

“The effect of the ban has been to galvanize other provider systems to speak out against these arbitrary and debilitating price increases,” Ragone said.

The message appears to be getting through.

On Capitol Hill, several congressmen just announced plans to hold hearings on rising drug prices.

Separately, the U.S. Department of Justice is investigating price hikes in generics, and issued subpoenas to two generic drugmakers, according to a report in the Wall Street Journal.

EXAMPLES

Every provider — from big chains, such as Ascension and Creve Coeur-based SSM Health, to much smaller players, such as St. Anthony’s Medical Center in St. Louis and Ladue Pharmacy — can point to recent drug price increases.

For example, St. Anthony’s says it is paying substantially more for doxycycline hyclate, a generic antibiotic that has been on the market for years, according to Dan Johnson, pharmacy director.

St. Anthony’s didn’t provide pricing specifics. But a statement last week issued by a congressional committee said the price of a bottle of doxycycline hyclate shot up to $1,849 from only $20 in fall 2013.

Over at SSM, the pricing problem continues to grow. “It’s always been a small issue, it just seems like there are more and more items that are heading in this direction, and creating a substantial problem for us,” said Tim Roettger, vice president of pharmacy services for SSM in St. Louis.

A year ago, Ascension paid $2.89 for a 45-gram tube of a generic topical steroid cream, clobetasol propionate. The health system is now paying $198.64 for the same tube.

Those kinds of increases add up. With a network of more than 131 hospitals across the country, Ascension’s spending on drugs has risen by $36 million, or 9 percent, in the last year. Two-thirds of the overall increase — $23.5 million — could be attributed to costlier generics, said Mary Ella Payne, Ascension senior vice president of advocacy.

“We can’t absorb these prices,” Payne said.

Ascension’s size gives it more leverage than most other hospitals, especially independent ones, to bargain with pharmaceutical manufacturers on prices. Still, Ascension’s scale has done little to curb the price hikes, Payne said.

This copyrighted story comes from the St. Louis Post-Dispatch, produced in partnership with KHN. All rights reserved.

And just because Ascension is paying more for generics doesn’t mean it will be paid more for their services by insurance companies to reflect the full cost of the drug.

“For inpatient care, hospitals are typically reimbursed on a per-procedure basis, so higher generic drugs costs could not necessarily be passed on to the payer,” said Adam Fein, president of Pembroke Consulting Inc.

What Fein means is that commercial insurance companies and Medicare already have set prices in place for each procedure or visit to a hospital. So even if a hospital were to bill the insurance carrier more to reflect the higher cost of a drug, it doesn’t mean the hospital will get paid what it actually bills the carrier.

An analysis published by Fein, considered an industry expert on the economics of the pharmaceutical industry, shows retail prices for generics have increased and in some cases there were “mega increases.”

But the impact isn’t limited to hospitals.

Rick Williams, owner of the independent Ladue Pharmacy, has been affected by the price hikes as well. Sometimes acquiring a drug costs more than how much he is paid by insurers for selling it to customers.

“Number one: We take care of our customers,” Williams said. “And we’re going to take it on the chin for them sometimes.”

REASONS

The price increases are getting attention on Capitol Hill, though it’s unclear what policy prescriptions a lame duck Congress can provide.

U.S. Sen. Bernie Sanders, the independent from Vermont, and Rep. Elijah Cummings, D-Md., announced they will hold a hearing this Thursday on “skyrocketing” prices for generics, like digoxin, a medication used to treat congestive heart failure, which went from 11 cents a pill in October 2012 to $1.10 a pill in June.

“These huge price increases are affecting the pocketbooks and health of millions of Americans,” Sanders and Cummings said in a joint statement.

The lawmakers are likely to hear examples of how drug prices are rising; they’re unlikely to get a clear explanation why.

Some industry analysts point to shortages as one of the major causes for price hikes, and those shortages can occur when manufacturers either incur problems making the drug or quit making it altogether. And when there are fewer manufacturers, it can cause a domino effect in the market as other manufacturers are left to pick up the slack to cater to remaining demand. Price hikes result.

But that’s how a free market works, said Ronny Gal, pharmaceutical industry analyst with Sanford C. Bernstein & Co.

“There are shortages, and some generic drug manufacturers are being opportunistic,” Gal said. But that’s not illegal.

As health care costs rise, the drug manufacturers are continually being squeezed to lower prices by everyone from retailers, hospitals to group purchasing organizations. That pressure on margins causes some to leave a certain drug behind, said Scott Griggs, assistant professor of pharmacy administration at St. Louis College of Pharmacy.

“With consolidation they are trying to become more efficient, they are trying to maintain their profits — but they’re also at the same time trying to make sure that they are utilizing the lines that will allow them the highest profits,” Griggs said.

Yet, over time, generics have saved the industry and consumers billions of dollars, the Generic Pharmaceutical Association said.

“Generic medicines are a critical part of systemwide efforts to hold down health care costs,” Ralph G. Neas, president and CEO of the association, said in a written statement. Citing a study by IMS Institute for Healthcare Informatics, Neas said generics saved $209 billion in 2012, $239 billion 2013 and more than $1.46 trillion over the last decade.

Categories: Health Care

12 Tips For Nurses And Doctors Treating Transgender Patients

CommonHealth (WBUR) - Thu, 11/20/2014 - 1:44pm

Transgender medicine is a concept that is just now taking shape.

Massachusetts is drafting rules that will define the transgender services insurers will be required to cover. The Association of American Medical Colleges (AAMC) has just released guidance on training doctors to treat lesbian, gay, transgender and gender nonconforming patients. And Boston University Medical School has what Dr. Joshua Safer, a professor there, says is the nation’s first transgender medicine curriculum focused on the biology of gender identity.

Like I said: brand new stuff. But what do all these new rules mean for the doctor or nurse, in an examination room, who meets their first transgender or gender-fluid patient?

Here’s some advice from Dr. Safer, associate professor of medicine at Boston University Medical School, and Dr. Jennifer Potter, associate professor of medicine at Harvard Medical School. (Dr. Potter is a co-author of the AAMC guidelines.)

1) When greeting a new patient, or one you haven’t seen for some time, you cannot assume anything about their gender identity based on the masculinity or femininity of their appearance or the timbre of their voice. To avoid making mistakes, ask each new patient how they identify, what name they prefer to be called and what pronouns they want you to use. Note: Pronouns may be male (he), female (she), they or another gender-neutral option.

2) Consider collecting information about gender identity when you register patients, when they call to book an appointment and when they check in for a visit. This will help you identify patients and let them know they are welcome before you meet. Be sure to train office staff to demonstrate openness and respect. You can review sample registration questions here.

3) Apologize promptly if you make a mistake that causes offense to a patient. Many of us will use the wrong pronoun, for example. Or your office staff may call George into the examination room, even though George is now Georgina and presents as a woman. Transmen still need pap smears but may feel out of place in an OB/GYN office waiting room.

If your patient is offended, your apology can be a healing experience for a person who has predominantly encountered insensitive providers in the past.

4) Having such conversations and treating transgender patients or patients who do not identify as male or female may be uncomfortable for you. That is a common reaction. We all feel uncomfortable when venturing into unfamiliar territory for the first time. Use each encounter as an opportunity for personal and professional growth.

5) Always screen for gender dysphoria, but be aware that many people on the transgender spectrum have a positive self-identity and do not seek or need psychological support. However, the experience of discrimination, which unfortunately remains all too common, especially for individuals who transition after puberty and do not easily “pass,” can lead to gender dysphoria in some cases. You might suggest that your patient look for a counselor through the World Professional Association for Transgender Health (WPATH) or through the Gay and Lesbian Medical Association.

6) Some of you may wonder if you should recommend counseling instead of helping your patient change their body to fit their gender. A growing body of research says no. Your patient’s gender identity is rooted in biology. It is not a psychological choice. We don’t understand why there is a disconnect between gender identity and your patient’s body parts, but more and more research shows improvements in the mental well being of transgender individuals who change their external appearance to match their feelings inside.

Living Transgender

WBUR reporter Martha Bebinger explores challenges facing transgender teenagers through the story of Nate, a 16-year-old transgender male.

7) You may also have questions about whether transgender identification is just a phase. Again, the latest research, while limited, says no, except in the case of prepubescent children. Consensus among doctors who treat transgender patients is that gender identity is established and does not change after puberty. If a child who was identified at birth as a boy switches genders during or after puberty, the new gender identity is generally fixed. This is true for adults as well.

The challenge, for children, is when to begin hormone blockers that will buy the child and their family some time before they must decide which gender to proceed with in puberty. You may want to refer a transgender or gender nonconforming child to a clinic that specializes in this care.

8) Be aware that some people on the transgender spectrum do not choose to alter their physical presentation to match their gender identity. Others may use or be interested in non-medical changes (e.g., breast binding, genital tucking, silicone injections), medical (cross-sex hormones) or surgical interventions. Be sure to evaluate each patient as an individual, by asking what they have done so far and/or what they are interested in doing in the future.

9) Your role in initiating cross-hormone therapy for adults can be pretty straightforward. A number of resources are available to guide such care and offer recommendations regarding clinical monitoring for patients on hormones.

10) Refrain from voyeuristic and intrusive genital examinations if not relevant to the patient’s presenting concerns. When such an exam is necessary, be sensitive to the fact that some people on the transgender spectrum may be uncomfortable having parts of their body examined that do not match their gender identity. Ask what words they prefer to reference body parts (e.g., gender-neutral terms such as pelvic opening as opposed to vagina) and be sure to explain what the exam entails, why you want to do it, and to obtain permission before proceeding.

11) Don’t forget about important prevention and health promotion. Patients on the transgender spectrum should have screening done as appropriate to the anatomy that is present (e.g., a transgender man with a cervix should have Pap tests). Vaccinations should be done as recommended by the ACIP. Just like anybody else, transgender individuals may have any sexual orientation and engage in diverse sexual behaviors that may change over time. Always ask and provide screening for sexually transmitted infections and contraception as needed.

12) To read more, visit WPATH. The Endocrine Society guidelines are under review. Some specialties have their own recommendations.

Categories: Health Care

Til Stress Do Us Part: Marriage Angst Can Be Hard On Your Heart

CommonHealth (WBUR) - Thu, 11/20/2014 - 9:40am

Neil Moralee/flickr

By Alvin Tran
Guest Contributor

Marriage is hard even in the best of circumstances. But new research suggests that if things are particularly hard, the stress can take a toll on your heart — especially if you’re older and female.

In a new study published this week in the Journal of Health and Social Behavior, researchers found that older couples in bad marriages have a higher risk for heart disease compared to those in good marriages. This link between the quality of a marriage and the risk of heart-related problems, such as high blood pressure, is even more pronounced among female spouses.

“The strain and stress from the marital relationship has a strong negative effect on people’s heart,” said Hui Liu, and an associate professor of sociology at Michigan State University and the study’s lead author. “If the marriage is very stressful, it’s really hard on your heart.”

Liu, along with co-author Linda Waite of the University of Chicago, analyzed data from an ongoing nationally representative project that followed nearly 1,200 older men and women, ages 57 to 85, for a period of five years.

After comparing participants at the beginning of the study to the end of the five-year follow-up period, they found a significant link between an increase in negative marital quality with higher risk of hypertension among women.  Not-so-hot marriages were marked by less spousal support and with husbands and wives spending less time with each other.

“The effect on marriage quality on cardiovascular risk is stronger for women than for men. It also becomes stronger as people get older,” Liu said during an interview. “We think marriage is one of the social factors that may affect the risk of cardiovascular disease.”

High blood pressure and rapid heart rate were among many factors the researchers used to assess the risk for heart disease.

“Even among those very old people who have been married for many, many years, we still see the effects of negative marriage quality,” Liu said. She suggested that improvements to a long-married couple’s relationship might offer a boost to the health of their hearts.

From the news release:

The findings suggest the need for marriage counseling and programs aimed at promoting marital quality and well-being for couples into their 70s and 80s, said…Liu

“Marriage counseling is focused largely on younger couples,” said Liu… “But these results show that marital quality is just as important at older ages, even when the couple has been married 40 or 50 years.”

Categories: Health Care

U.S. Treaties: A Beginner’s Guide

In Custodia Legis - Thu, 11/20/2014 - 8:55am

This post is coauthored by Barbara Bavis and Robert Brammer, legal reference specialists.

Article II, Section 2 of the U.S. Constitution states that the President “shall have Power, by and with the Advice and Consent of the Senate, to make Treaties, provided two thirds of the Senators present concur… ” An early attempt by the President and Senate to negotiate the exercise of this power provided an interesting anecdote. According to the Senate Historical Office, on August 22, 1789, President Washington traveled to the Senate to submit a treaty concerning Native American Indian Tribes. While the President waited, the Senate decided to postpone consideration of the treaty rather than debate the questions in front of the President.  According to Maclay’s Journal an irritated, President Washington exclaimed, “This defeats every purpose of my coming here!” and resolved to submit subsequent treaty communications to the Senate in writing. To learn more about the development of the treaty power and its application, please refer to the United States Constitution: Analysis and Interpretation’s discussion of Article II, Section 2.

There are several options for researchers trying to find copies of treaties to which the United States is or was a party.  In fact, we were inspired to write this post by the new Treaties digital collection added to the Law Library of Congress website. As of now, the digital collection includes a digital copy of the first four volumes of Charles I. Bevans’s Treaties and Other International Agreements of the United States of America, 1776-1949, which includes copies of the English version (or English translation) of multilateral treaties to which the United States was a party.  Digital copies of the remaining volumes (5-12), which include the bilateral treaties to which the United States was a party during this period, will be added in the near future.

Wm. Penn’s treaty with the Indians when he founded the province of Pennsya. 1661. Lithograph by N. Currier. (Created between 1835 and 1856). Library of Congress Prints and Photographs Division, http://hdl.loc.gov/loc.pnp/cph.3b51058

The Treaties page also links to the United States Department of State’s Treaties and Other International Acts webpage, which includes PDF copies of the “executed English-language original of [each published international] agreement and certain other key documents” for published international agreements entered into from 1996 to the present.  The Treaties and Other International Acts series (also known as TIAS), which is “the official print publication format for treaties and agreements that have entered into force for [the] U.S.,” was published by the Government Printing Office in paper form from 1945 to 2006, but is now available online.

In addition to the sources listed above, we suggest utilizing these other helpful resources for your treaty research:

  • For treaties entered into by the United States before the mid-1940s, researchers can also turn to the Treaty Series (TS) (1795-1945) and the United States Statutes at Large (1795-1948). The TS collection can be found in either bound form, or as separately-published pamphlets produced for each treaty.  Treaties reprinted in the United States Statutes at Large are organized chronologically.
  • The United States Treaties and Other International Agreements (UST) collected TIAS prints in one chronologically-organized bound collection from 1950 to 1982.  Each UST volume also includes a subject index for ease of use.
  • The Library of Congress also provides information about treaties, from 1967 to the present, in the THOMAS legislative information database.  Full text of the treaties can also be found on THOMAS from 1995 to the present.  To find the treaty or treaties that interest you, simply enter either the treaty number or keywords of interest into the search box, select the Congress(es) of interest, and click “Search.”
  • In addition to TIAS, the U.S. Department of State has also, since 1944, produced Treaties in Force.  Published yearly, this resource provides a listing of all the bilateral and multilateral treaties and agreements to which the United States is a party that, as the name suggests, are still in force.  The bilateral treaties and agreements are organized “by country or international entity, with subject headings under each entry,” while the multilateral treaties and agreements are organized by subject. The most recent edition of Treaties in Force can be found online at the U.S. Department of State’s Treaties in Force website.
  • Often, citations to treaties will include either a “TIAS” or a “KAV” number.  The “KAV” number is referencing the Guide to the United States Treaties in Force, by Igor I. Kavass (see our catalog records for the 1982-2007 and 2008-present editions).  Kavass’s Guide provides more extensive indexes to U.S. treaties and international agreements, including both a more wide-ranging subject index and a chronological index.
  • If you are most interested in reviewing the treaties that have been submitted to, and are currently being considered by, the Senate, you might want to visit the U.S. Department of State’s Treaties Pending in the Senate page.
  • Finally, you may want to visit a public law library or federal depository library in your area, as they may have access to subscription databases, such as ProQuest Congressional, ProQuest Legislative Insight, or HeinOnline, that contain treaty documents.

In addition, we suggest reviewing these very useful online treaty guides for more assistance:

We hope you find this guide to be helpful.  If you have any reference questions regarding treaties, please do not hesitate to use our Ask-a-Librarian feature, or call or visit your local federal depository library for more assistance.

Categories: Research & Litigation

Costly, New Hepatitis C Treatments Help Drive 12 Percent Drug Spending Jump

Kaiser Health News - Thu, 11/20/2014 - 12:01am

After several years of modest increases, American spending on medications is projected to shoot up by 12 percent this year, pushing the nation’s drug bill to between $375 billion and $385 billion, according to a report by the IMS Institute for Healthcare Informatics.

Several factors are driving the spending spike, including the introduction of expensive new hepatitis C drugs and fewer drug patent expirations than in previous years, the report found. Such expirations typically lead to savings as cheaper generics replace brand-name drugs.

The 11.7 percent rise is a dramatic departure from the more modest average increases of 3.6 percent in annual drug spending during the past five years.

The report anticipates the pace of spending increases will slow to 7 to 9 percent in 2015, as the impact of the new hepatitis C drugs declines, less expensive biosimilar products become available and several brand-name drugs — such as cancer drug Gleevac and the antipsychotic Abilify — are replaced by generics.

“We expect this bubble of innovation around hepatitis C will pass, so we won’t see such a contribution to growth in outer years,” said Murray Aitken, executive director of IMS Health. “We think the spike in growth will moderate next year, and further moderate in 2016.”

Drug costs are projected to increase between 3 percent and 5 percent in 2016, he said.
The new hepatitis C drug Sovaldi, made by Gilead Sciences and approved in December 2013, costs $1,000 a pill, with a 12-week course of treatment running about $84,000. Another hepatitis C drug — Harvoni — approved by the FDA in October, costs $1,125 a pill, or $94,500 for a 12-week course of treatment.

An estimated 3 to 4 million Americans have hepatitis C and are potentially eligible for treatment. Hepatitis drug treatments accounted for $8 billion of the approximately $40 billion in projected increased drug spending this year.

“The hepatitis C drugs are Exhibit A when you look at escalating drug costs,” said Brian Henry, a spokesman for Express Scripts, the country’s largest pharmacy benefits manager. “You never had a drug that costs that much that can treat so many people.”
The price of Sovaldi “caught payers by surprise,” he said.

Innovative new therapies, especially in the area of cancer, have also pushed up costs. The Affordable Care Act, which expanded access to health care and medications, may also have played a role, along with a new emphasis on preventive care and adherence to medications, Aitken said.

This KHN story can be republished for free (details).

Holly Campbell, director of communications for the drug industry trade group, PhRMA, said the cost of developing drugs has skyrocketed, pointing to a report this week by the Tufts Center for the Study of Drug Development that estimated the price of bringing a drug to market at $2.6 billion. The process can take a decade, the report said.

“These most recent findings underscore the ongoing challenges our industry faces,” Campbell said.

An AARP report noted the increase in prices of brand-name drugs. The report found that the prices of 227 brand name prescription drugs used by many older Americans increased by 12.9 percent on average last year, well above the 1.5 percent rate of inflation, bringing the average cost of a brand-name drug used regularly to $3,000.

“We have started to hear from members who have to decide between taking a drug they need and paying their electric bill,” said Leigh Purvis, director of health service research at the AARP Public Policy Institute and a co-author of the report.

But, she added, the impact goes beyond seniors. “This is a concern not just for our members but for everyone.”

Categories: Health Care

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