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Archive for the ‘Consumer Protection’ Category

Moving forward

Regence fined $100K for denying women coverage

[Washington] State Insurance Commissioner Mike Kreidler has fined Regence BlueShield $100,000 for denying contraceptive coverage to 984 women.

Regence had covered the women’s use of an IUD, or intrauterine contraceptive device, but not the removal of it. When the women wanted to remove the device because it was outdated, or because they wanted to get pregnant, the insurance giant did not consider those reasons as “medically necessary,” state officials said Monday.

“There’s an important lesson here,” Kreidler said in a statement.

“If you believe you’ve been unjustly denied coverage, don’t just accept it, call us. Of the 984 women who were denied contraceptive coverage by Regence, only three appealed the decision – and all the denials were upheld.”

He said one woman’s call to his office resulted in coverage for nearly a thousand other women who were denied coverage over the span of eight years.

Going backward

Tobacco Giants Sue to Block Graphic Warning Labels

Five tobacco companies have filed suit against the U.S. government claiming that government-ordered graphic warning labels on cigarette packs violate their First Amendment rights.

Starting on Sept. 22, 2012, cigarettes sold in the U.S. will have to carry graphic images warning of the dangers of smoking. These images include a tracheotomy hole, rotting teeth, diseased lungs, and a body on an autopsy table.

The images will be accompanied by dissuasive wording on cigarettes and smoking, including “cigarettes are addictive,” “cigarettes cause cancer,” and “smoking can kill you.” They must be displayed on at least half of the front and back of cigarette packs, and 20% of the top of the pack.

The lawsuit was filed by four of the nation’s largest tobacco companies — including R.J. Reynolds Tobacco and Lorillard, and one smaller company (Sante Fe Natural Tobacco Company) — against the FDA and the Department of Health and Human Services.

The companies are seeking to prevent enforcement of the images, arguing that the government cannot legally force them to espouse an anti-smoking advocacy message….

This is yet another area of health promotion in which the US has long fallen short. Graphic warning labels on cigarette packs have been used in Canada since 2001, and dozens of other countries have followed suit.

A bit of both, local news that is national  :

Army whistle-blower fights to clear name

Madigan Army Medical Center surgeon Michael Eisenhauer says his military career foundered as he exposed cozy dealings between an Army doctor and a medical-equipment manufacturer. His whistle-blowing helped lead to the criminal conviction of one doctor; but Eisenhauer is still fighting to clear his own name.

Eisenhauer detailed a cozy relationship between the medical-equipment manufacturer Boston Scientific and two Madigan cardiologists, who insisted on sole-source purchases of that company’s implant devices.

<snip>

The long-standing practice of drug companies and medical-equipment manufacturers offering doctors free trips, speaking honorariums and other payments is controversial. Critics say the money may often represent kickbacks for favoring a company’s drugs or devices.

Still, in civilian practices such payments are generally considered legal. In the military, however, doctors are prohibited from taking such payments.

“Military doctors must owe their allegiance to the soldiers and families they treat — not to drug companies or makers of medical devices,” said U.S. Attorney Jenny Durkan in a statement announcing the plea deal reached with Davis.

“That is why we have a bright line rule: doctors employed by the government cannot accept payments or gratuities from an outside source — especially one that is seeking government business.”

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Kudos to Insurance Commissioner Mike Kreidler, who took action on behalf of consumers!   From the OIC  blog:

Health insurance rate requests now public

Individual and small employer health insurance rate requests are now public. See the complete filings received since July 1, as well as a summary for each request.

Several health insurers filed rate requests prior to July 1, but have voluntarily made their filings public. They include: Asuris Northwest Health, Kaiser Foundation Health Plan, and Regence BlueShield.

Insurance Commissioner Mike Kreidler proposed the legislation (HB 1220) making health rates public on behalf of the consumers who contact his office, demanding to know what’s driving their higher premiums. State law prevented him from sharing the information that insurers use to justify rate requests – even after the rate was approved.

The new law makes most individual and small employer health insurance rate filings public shortly after they’re received. This includes how much of the requested rate will be spent on medical claims, administrative costs and profit. Also, the public will see if their rate change includes any benefit changes.

Kreidler’s office is building an interactive web tool where the public can search rate requests, post comments, and sign-up to get an e-mail when their health plan requests a change and a decision is made. The new tool is scheduled to go live early this fall.

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Recent news and commentary of note on US and global issues related to health and well-being:

Medicare Part D Ups Patient Compliance, Reduces Hospital Costs

Why do 70 dead in Norway rank higher than tens of thousands in Somalia?

For-Profit Hospices Keep Patients Longer, Push Costs Up

Where’s the Advocacy, Komen?

Divided Appeals Court Rules That Companies May Patent Breast Cancer Genes, but Invalidates Patents on Comparing the Genes

Big Pharma wants to ‘friend’ you

Drug prices to plummet in wave of expiring patents

Two Steps Forward, One Step Back on Hospital Transparency

The most and least expensive cities for health care

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Several national health advocacy groups have put out an alert about some key changes to language access standards that have just been proposed for the communication responsibilities of certain federal agencies which regulate private health care plans. As we move forward towards the enactment of health care reform, it is critical that  everyone, including LEP individuals, have the same rights to get access to to plan information and help with insurance appeals.  Health insurance is of course a critical part of access to health care and thus of any individual’s health status. Communication is an essential part of health and health care.  Lack of communication access causes both personal harm and contributes to health inequalities between population groups, plus drives up health care costs for people and systems.  If the new proposed standards are enacted, they would roll back current rules which private insurance companies must follow to ensure language access for plan beneficiaries.

What you can do: there is a very short window of opportunity now available for  individuals and organizations to voice their concerns by submitting comments online to the federal government via a dedicated website.  The deadline for submissions  is 2 p.m, PDT, on Monday July 25 !

For details about this critical issue, and instructions on how to submit comments along with suggested language, please read the following memo from the National Senior Citizens Law Center (NSCLC), the Asian Pacific American Legal Center (APALC), and the National Health Law Program (NHeLP):

URGENT: Comments Needed on Important Language Access Standard

NSCLC, APALC and NHeLP asking advocates to submit by July 25

IMPORTANT: Please provide comments to the Centers for Medicare and Medicaid Services (CMS), Internal Revenue Service (IRS) and the Department of Labor (DOL) on proposed regulations governing private health care plans.  The regulations as proposed are a significant step backward from the version issued in 2010 and affect about 12 million individuals. They change the existing standards for oral interpretation and written translation in unprecedented ways. Please send in comments now and urge colleagues and networks to also take action.  

 The deadline for submitting comments to CMS on this proposed rule is 5 pm Eastern Time on Monday, July 25, 2011.

The National Senior Citizens Law Center (NSCLC), the Asian Pacific American Legal Center (APALC), and the National Health Law Program (NHeLP) urge you to submit comments using the guidelines below. Then, please spread the word to your listservs, networks, colleagues, and affected beneficiaries, near and far, who may care about language access issues!

Issue:  CMS, IRS and the DOL’s Employee Benefits Security Administration (EBSA) have jointly issued regulations governing the internal claims and appeals and external review processes for private group health plans and health insurance issuers (note: this does not directly impact Medicare and Medicaid plans).

These rules were first promulgated as interim final regulations in June 2010, and were relatively strong. After industry complaints, they were amended as of July 2011, and significantly watered down. The public has this opportunity to comment.

Here are the three major language access issues relating to internal claims and appeals and external review:

  1. Written translations for group health plans: The threshold for determining whether translation of vital documents is required is set at: 10% of county population for group health plans. Formerly this was at 10% of plan participants in a given language or 500 persons, whichever is less; where a group plan has less than 100 participants, 25% was used.
  2. Written translations for individual plans: The threshold for this group is also 10% of county population. This was set based on the Medicare Part C and D marketing regulation (a proposal that has since been changed as of 4/15/11 to 5%, as a result of many persons submitting comments against the 10%).  
  3. Oral interpretation: Although it has been well settled that civil rights law mandates that oral interpretation should be provided in the health and health insurance contexts for all languages, the proposed regulations set a new precedent and require oral interpretation ONLY in the languages that meet the 10% threshold.  This is a major issue that needs to be addressed.

The new proposed standards completely fail to recognize the needs of the approximately 12 million limited English proficient individuals in the United States that are estimated to be affected by these regulations. Many of these individuals may receive marketing materials and calls in their primary languages, but will not be able to access plan review and appeals under the new rules. Even Spanish speakers will be left out in most of the country, as only 172 counties meet the 10% county population threshold for Spanish (out of 3,143 counties in the United States). Besides Spanish, the new proposed translation threshold is met by Navajo in 3 counties (1 county each in AZ, NM, UT), Tagalog in 2 counties (both in AK), and Chinese in one county (CA). Only 177 counties would require translated materials. Only one county in the entire nation would have translations in more than one language: the Aleutians West Census Area (population of 5,505 total persons) would have Spanish and Tagalog translations.

We need everyone – even advocates that don’t usually work on private insurance issues and those who have never commented on a federal rule – to take action now.

What You Can Do: 

1. FILE COMMENTS:

a)   Go to   www.regulations.gov

b)   Enter keyword or ID as “group plan” and hit the “SEARCH” button

c)   Scroll down and choose “Group Health Plans and Health Insurance Issuers: Internal Claims and Appeals and External Review Processes” and click on “submit a comment” on right side

d)   Although the regulation is proposed by three agencies, you only need to submit once. The agencies will share the information.

e)   Paste in the comments below and edit them, or write your own, then “Submit.”

f)   You are not required to fill out other fields, although it may be helpful to provide your affiliation. If you wish, you may be anonymous.   Comments submitted are viewable online (after a processing period) by the general public.

SAMPLE COMMENT:

On behalf of [organization/myself], I wish to comment on the 10% threshold for translation and oral interpretation of private plan materials in the internal review and appeals contexts. I am… [add 1-2 sentences about yourself, organization or work with LEP individuals].  The 10% standard is far too high.  A more appropriate standard would be “5% of the plan’s population or 500 persons in plan’s service area, whichever is less” for large group plans, and 25% of population for small plans. Oral interpretation should be provided in all languages at all times. {Consider adding information about the impact on your clients when they cannot get documents in a language that they understand.}

2. Forward this email to all of your contacts – other advocates, providers, interpreters, beneficiaries affected, and urge them to also file comments.  The more comments filed, the more CMS/IRS/EBSA are likely to pay serious attention to this issue.

3. If you are bilingual or work with LEP populations, consider having them file comments in other languages as well as in English, for impact.

For more information about commenting and the proposed regulations, see http://www.regulations.gov/#!documentDetail;D= HHS-OS-2011-0019-0001 .

For more detailed information, see the comments that NHeLP and NSCLC will be submitting, available very shortly at www.nsclc.org and www.healthlaw.org .  Please feel free to submit detailed comments if you prefer.

Katharine Hsiao  khsiao@nsclc.org

Georgia Burke  gburke@nsclc.org

Kevin Prindiville kprindiville@nsclc.org

Mara Youdelman  youdelman@healthlaw.org

Doreena Wong dwong@apalc.org

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The article Efforts to Undermine Public Health:  Health Advocacy Organizations and the Pharmaceutical Industry: An Analysis of Disclosure Practices in the Jan.13 issue of  American Journal of Public Health focuses some much-needed attention on a serious and growing problem , which directly impacts the creation of rational health policy.  It’s also good to see the wide media attention being given to the study, which has been flagged by venues across the spectrum, including  healthcare sector analysis and investigative reporting blogs to mainstream  business media and news reports.

It’s been interesting too,but not surprising to see, that a number of people are also sending identical comments to multiple venues  which covered the story, some to decry the findings of the study, or  to make  off-topic remarks. The comments from the National Health Council , for example emphasized that it has a policy of requiring member groups to have internal disclosure policies regarding industry support received. The NHC itself  has a listing of funding received in 2009 from its  many “Corporate Partners.”   However, just like with payments to physicians, merely acknowledging industry funding doesn’t mean that it does not influence the actions of the recipient, nor not create conflicts of interest.  Unlike the significant body of research on the topic of influences on the prescribing practices of doctors (which have found that while many  state that they themselves are not influenced by pharma gifts and perks, they believe that their colleagues are) , much less attention has been paid in the US to the phenomenon of  industry support of HAGs and its impact on public policy.

Based on personal observations both as  patient and a healthcare professional , I believe that the “don’t bite the hand that feeds you”  phenomenon  relating to HAGs, contributes to  the present inaction on getting states and federal government to do something about the exorbitant and escalating price of medicines as a public health measure. Until the electorate actively protests what is going on, the lobbying power of the biopharma industry  on Congress will remain in effect. While it is becoming more common to find  media pieces highlighting  complaints by provider and  disease groups  about the price of Rx drugs, along with the unaffordable co-pays for those insured, almost never do we hear patient advocacy groups demand that something be done about the situation.  The only logical conclusions that seemingly can be made about the scenario is either that the public is incredibility naive about how the pharmaceutical  and insurance  industries  function, or else HAGs have been so influenced by their pharma benefactors that recipients actually believe that the prices are justified by R & D costs, and that patient assistance programs ( PAPs) are a genuine access solution.  Likely it’s some combination of factors.  More about this later.

Since a requirement that  HAGs disclose industry funding was dropped from Sunshine Act provisions incorporated in the ACA, it’s time start to address the problem by pressing the IRS to require that all 501(c)3 charities disclose their funders and amounts received from each. At the same time, much more public education  is needed about  “the ties that bind”, to paraphrase the title of a 1999  report on the topic  by Health Action International.

In the meantime, those interested in starting to research  industry links to patient and disease groups will find the following resources of independent organizations helpful:

Essential Action
Pharmafiles database: Patient and Health Groups and Their Corporate Funders
Patients, Patents and the Pharmaceutical Industry

Knowledge Ecology International
Medical professional and patient group funding by drug and medical device companies

Healthy Skepticism


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I’m catching up on my reading now, so passing on links to a number of  important studies , some ongoing , published in late 2010, including:

Public Citizen
Pharmaceutical Industry Is Biggest Defrauder of the Federal Government Under the False Claims Act

MSF/Doctors Without Borders
Access to Essential Medicines: Ten Stories That Mattered in 2010

ProPublica
Dollars for Docs: What Drug Companies are Paying Your Doctor

American Medical Students Association
AMSA PharmFree Scorecard 2010 : Conflict of Interest Policies at Academic Medical Centers

and in the news Supreme Court Reviews Data Mining & Free Speech

Also of  note, the upcoming conference of the National Legislative Association for Prescription Drug Prices :NLARx Meeting on Drug Pricing & Affordability, Friday, January 21, 2011, Washington D.C.  


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Beyond the challenges planned to overturn the Affordable Care Act in the US, we need to keep abreast of news  from around the world affecting access to care , such as these headline stories:

HIV Patients May Soon Face a Choice: Full Price Meds or No Meds At All

U.S. Backs Drug Firms in Lawsuit Over Prices

Deadly Spin Strikes a Chord

Firms fight move to obtain cheap anti-blindness drug Avastin

and from North America, illustrating that it’s not only quality control and manufacturing issues, but the profit motive that contributes to shortages of important drugs:

Report warns of medication shortages across Canada

A push to ease prescription drug shortages: Sen. Klobuchar to propose easing imports of medication from abroad

Darcy Malard-Johnson, a pharmacist at the University of Minnesota’s cancer clinic, said 13 of the 150 drugs on the current shortage list are cancer drugs. Most have been around for years, she said, and that may be one of the problems. Because they’re generic, they’re not as profitable to make or sell as newer drugs. And there’s no way of knowing when a company will simply decide to stop making it.

The shortage of oncology drugs in particular was also highlighted in NCI Cancer Bulletin in an article entitled Continued Shortage of Chemotherapy Drugs Causing Concern.

The FDA’s Drug Shortages  website includes current shortages, status updates, and a list of drugs to be  discontinued, per the following terms:

Companies are required under 21 CFR 314.81(b)(3)(iii) to provide FDA with a six month advance notice of the discontinuation of sole source products that are life-supporting, life-sustaining or for use in the prevention of a debilitating disease or condition. From time to time, FDA also receives notification for other products. These discontinuations are provided below for informational purposes only.

Health Canada currently does not conduct such monitoring or provide information on drug shortages, actions that the Canadian Pharmacists Association has urged the government to take on quickly to address the serious and growing problem.

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A friend recently shared this personal story with me, in the hopes that it will inspire people to demand price controls on drugs, as well as an end to the Rx profiteering by insurance companies. This is a story about a commonly-prescribed generic drug, levothyroxine, used for hypothyroidism and other thyroid conditions. The fact that this is a common and generic drug is significant. Since it is a widely used drug, the following story gives perspectives on the scope and amount of profit being made on just this one medicine. And in turn, this small story can help increase understanding of the magnitude of the Rx pricing problem.

Now for the story. My friend recently retired from nursing at not quite age 65, and had been paying costly COBRA premiums until she could enroll in Medicare. The hospital where she had worked offered a comprehensive plan through one of the big insurers in Washington state, including a $7 co-pay for drugs on the plan’s formulary. Levothyroxine was one of these.

After retirement, my friend planned an extended out-of-area trip, so she wanted to purchase a full 3-month supply of her medicine to take with her. She had coverage via COBRA for October,  but could not get benefits from Medicare Part D until her Medicare activation date the following month. So she planned to pay the $7 co-pay for her medicine for October, plus the out-of-pocket price for the supply for the next 2 months.  She had checked the Rx price look-up feature of the  insurance company’s website, and learned that the retail price of levothyroxine was listed as $24-$28 for a 30-day supply. My friend then took her script for 90 days of levothyroxine to be filled at the community pharmacy she had always used, and got a big surprise.

This time, the surprise wasn’t the sticker shock we have come to expect all too frequently, but just the opposite,  and equally problematic. The pharmacy told her that while she was welcome to apply her co-pay to 30-days worth of the medicine, they could sell her the entire 90-days worth for a total of $10!!!!!

While this was good for her pocketbook, she was astounded to think about how much this basic generic drug had been marked up to benefit the insurance company and the manufacturer who set the price reported to the insurer. While the pharmacy was undoubtedly making a modest return on this Rx, it was presumably not out to gouge its customers, quite remarkable these days. And this is not even a one of the costly drugs, even at the retail price listed by the insurer. When one figures how many scripts are written for levothyroxine across the country each month, the dollar amounts are staggering.

The lesson to individual consumers is that while we must continue to push for price controls on Rx drugs, we also need to shop around for prices, even if insured. And it’s good to remember that even for those with Rx  insurance coverage, there is no requirement that an Rx benefit be used, if a better cash price is found. It can be difficult to check medicine prices, but well worth the time spent doing research over the phone and via the Internet. Plus there are resources for some states and communities that offer Rx price-comparison tools that include commercial pharmacies. For example. folks in Illinois can check prices for drugs and medical procedures, on Leslies List, an independent website created by primary care physician Leslie Ramirez, to help improve access to care. In my state, there is a price-checker tool for drugs on the formulary of the Washington Prescription Drug Program. BTW, all WA state residents can request a free WPDP card to use at participating pharmacies. I have found in some cases, the WPDP price for certain medicines is less than the co-pay charged by my insurance company. It pays to compare prices between big box stores, supermarket pharmacies, and community pharmacies. The “$4 generics” that have been so widely promoted may not always be the best  deal, nor actually sold at that price. Another resource for helpful tips on shopping for drugs and their prices is Consumer Reports.

Caveat emptor!

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The first international  “Selling Sickness” Conference held October 7-8 in Amsterdam drew some 200 participants from around the globe to discuss the issues and trends in marketing of prescription drugs. While most attendees were from Europe, all regions of the world were represented at the event. Slide shows of the presentations, along with a list of attendees, may be viewed on the conference website.

Many of  conference presentations  focused on the  phenomena and techniques of  promotion of “disease mongering”: use of pharma promotions to depict normal life issues as diseases and to encourage consumers to visit doctors to seek prescriptions to treat these disorders.  My poster displayed at the conference focused on a different facet of inappropriate drug promotion, the equally problematic practice of misleading promotion of a very useful new drug for genuine and deadly diseases. The poster Glivec in Global Perspective, covers highlights of the worldwide promotions for the breakthrough cancer drug Glivec, done for a different purpose. Since Glivec is quite effective for most patients for whom it is indicated, its manufacturer Novartis has used promotions to aim to secure both its excessive global price and monopoly patent status for the drug.

Novartis, a relatively new company on the scene, formed from the  merger of Ciba-Geigy and Sandoz  in 1996, has invested heavily in patient relationship marketing to further its goals. Influencing patient groups by all the well-known techniques used to woo doctors to prescribe certain medicines–along with patient-specific types of outreach–has been used to induce enthusiastic lobbying for Glivec, and ostensibly to keep patients from recognizing and protesting the real cause behind access problems for this drug, its exorbitant price. Novartis has not hesitated to approach cancer groups, and to help create new ones, through emotional manipulation of the genuine despair  linked to the diseases and the experiences of patients with health systems. Yet most patients continue to seem to be unaware of  what is really going on, showing the power of the promotions. This poster was created as an educational resource on drug promotion as a critical public health issue. While no health system, insurer, government, or individual has unlimited resources, the vast majority of patient groups lobbying for access to Glivec, along with other costly drugs, act as if cost were irrelevant. Unless things change, access to this and other important medicines is only going to get worse. Those of us with both personal and professional experience in this realm can play an important role in spreading the sunshine on this vital topic. Supporting information and references were too lengthy to include in the poster, so have been organized as a separate document.

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Many important conferences are scheduled from September  to the end of the year.   Last week I was  fortunate to be able to attend the second annual meeting of the  Consortium of Universities for Global Health at the University of Washington here in Seattle. I’ll report  on that later.

Some other notable conferences, including those in which I am involved in running and/presenting,  are:

International “Selling Sickness” Conference in Amsterdam, October  7-8, sponsored by the Dutch Ministry of Health and Health Care Inspectorate,  Gezonde Scepsis, Healthy Skepticism International, and the  World Health Organization, Regional Office for Europe.
While I won’t get to be there in person, my poster will be there  and also posted here on the blog .

Summit VI of the Washington State Coalition for Language Access  (WASCLA) will take place in Seattle on October 15-16.  Run entirely by volunteers, including yours truly, I’m on the team organizing the conference and also a presenter for a plenary session on Community Advocacy & Engagement.  And FYI to those interested in attending: early bird registration rates have been extended to October 1.

The  Diversity Rx 7th National Conference on Quality Health Care for Culturally Diverse Populations will be held in Baltimore on October 18-21. Sadly I’ll be missing this top-notch biannual event.

Heading into November, the Washington State Pharmacy Association will hold its annual meeting in Vancouver, WA on the 5th and 6th, where together with  pharmacist and  attorney colleagues from WASCLA, we’ll be speaking on Language Access at the Pharmacy.


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