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Archive for the ‘Ethics’ Category

At long last, a favorable ruling  came in December 2016 for former patients at Yakima Regional Medical and Cardiac Center and Toppenish Community Hospital, both in Central Washington, when the hospitals agreed to pay $4.5 million into a settlement fund to compensate those who were wrongly denied financial  assistance from 2007-2014.  Last July, Yakima County Superior Court Judge Susan Hahn ruled that the hospitals had violated Washington’s Consumer Protection Act by failing to notify and screen low-income patients for free or reduced-cost care, as required under another state law, the Charity Care Act which was enacted in 1989. The Charity Care Act applies to all hospitals operating in Washington, and to all patients, insured or uninsured alike, who meet income eligibility requirements: those with incomes at 100% or less of the Federal Poverty Level  (FPL) are eligible for free care, and those whose incomes are at 101-200% of FPL are entitled to discounts.

The legal case on behalf of the patients took slightly over 3 years to be resolved. Due to record-keeping gaps at the hospitals, it is unknown how many former patients are potentially eligible for compensation under the settlement. Deliberate intent by the hospitals to withhold the required notice and eligibility screening was established during the proceedings.

Documents submitted in the lawsuit indicate hospital staff were given incentives and talking points to help them get as much money as possible from low-income patients, and that they were directed not to mention charity care as an option unless a patient knew to specifically ask for it.

In August 2016, the advocacy groups Northwest Health Law Advocates ( NoHLA) and OneAmerica published a report Yakima Regional and Toppenish Hospitals Fail to Provide Sufficient Charity Care   based on their research which revealed the financial hardships suffered by patients who could have been eligible for charity care. Likewise it was found that

Yakima Regional Medical & Cardiac Center

……although Yakima Regional is the most profitable hospital in Central Washington, it provides a significantly lower level of charity care than the regional average.

 

 

 

As a sidebar note since the settlement was announced, the two hospitals are due to soon change hands , for the third time in fourteen years. In 2003, the pair was sold to Health Management Associates and subsequently in 2014 to Tennessee-based Community Health Associates, both for-profit hospital chains. Unlike in other parts of the country, for-profit hospitals are uncommon in Washington. Commitment to upholding the Charity Care Act is one of the conditions for Department of Health approval of a hospital’s conversion from nonprofit-to-for profit.

Across the state, full compliance with the long-standing financial assistance rules can remain still elusive.  In June 2016 a class-action lawsuit against Northwest Hospital in Seattle for Charity Care violations was filed. State legislators seeking a remedy filed HB 1359  and companion SB 5231 early this year, to require that a written notice of the availability of Charity Care be included on all hospital bills. The House bill made it through the first cut-off date, and is moving forward in the legislative process. I will be posting on new developments, including provisions in the bill to ensure that notices are given in the language that patients understand.

 

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In the wake of the recent US measles outbreak, Public Health Seattle King County has published searchable data on student immunization levels covering all K-12 schools in the county.  Data fields include vaccination completion rates at each specific school ( color-coded to show rate levels); MMR immunization among kindergarteners; and immunization coverage rates in general among kindergarten and 6th grade students.  The sociodemographic correlations to vaccination  rates reflect the national trends that have made headlines, are not a surprise to locals. Kudos to the PHSKC  team for innovative use of technology in the public interest!

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Exciting news came at the end of the year for Gary Schwitzer’s Health News Review project which had lost the funding that supported the team of reviewers that analyzed the accuracy of health stories in the news and published their findings. HNR was awarded a two-year, $1.3 million grant from the Laura and John Arnold Foundation to continue and expand its work, which will now be housed in the new Center for Media Communication and Health in the U of Minnesota School of Public Health.

I’ll be looking forward to more important stories coming our way soon to share here.  And all of us can hone our critical thinking skills on health news stories by applying the HNR  framework anytime:

What’s the total cost?
How often do benefits occur?HealthNewsReview
How often do harms occur?
How strong is the evidence?
Is this condition exaggerated?
Are there alternative options?
Is this really a new approach?
Is it available to me?
Who’s promoting this?
Do they have a conflict of interest?

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A bevy of news stories local and national have highlighted the ever-worsening situation for consumers , especially  for folks who need so-called specialty drugs but also for the much larger segment of the population who use plain old generic medicines.  While raising awareness is essential, mostly what we are seeing, is increased an amount of talk about the problem, but less often are suggestions being offered in the way of sustainable solutions. Shock over the price for new Hepatitis C drug Sovaldi  was a wake-up call for policy makers and the public; it remains to be seen what will be prescribed as a remedy.  Here’s a sampling of  some more recent headlines:

Small group of specialty drugs could make up half of total pharmacy spending by 2018

Prices Soaring for Specialty Drugs, Researchers Find

Generic drug prices skyrocket in past year

Will Rising Prices for Some Generic Drugs Never End? Monthly Cost for One Heart Drug Can Approach $1,200

Pharmacists Report Soaring Generic Drug Purchasing Prices Impacting Patients, Pharmacies

New strategies needed to curb specialty drug costs

While some in Congress have been asking why in 2014, it remains to be seen if the political will can be mustered anytime soon to secure pricing changes from Big Biopharma.

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In recent weeks I’ve received email alerts announcing  “Hospitals Making Progress on Health Care Disparities“, a new study from the American Hospital Association’s Hospitals in Pursuit of Excellence program and associated organizations.   I took a look  first at the infographic accompanying the notices, and then at the published study itself, the 2013 Diversity and Disparities: A Benchmark Study of U.S. Hospitals. It was no surprise to read that the demographic profile of hospital executives and boards is still so far from representative of  the general  population, since the last HPoE study in 2011. However, the 2013 study reports data on language services in hospitals that raised my eyebrows ( 2011 comparison data points shown in parentheses):   EquityofCareStudy

  • 95%  (90%) are collecting data on primary language of patients
  • 87% (80%) are translating forms and documents for patients
  • 66% (61%) collected information on patient language needs

Leaving aside the matter of ascertaining the difference between collecting “primary language of patient” and “patient language needs,” these highly encouraging results led me to seek details in the source report. Having recently done extensive research for my own presentation on the status of  language services in healthcare for the 2014 WASCLA Summit, the HPoE findings seemed even more amazing. What I found in the report itself , which did conclude that more needs to be done to achieve equity of care in the broader sense, was that some basic background and research points seemed not to have been included or were too limited in scope to be meaningful.  For example,  the report did not include the list of hospitals which had participated in the survey, nor how the recent cohort compares to the 2011 and 2009 participant groups. There was no discussion of the statistical validity of the response rate of 1109 hospitals (~19% of all 5922 AHA member hospitals invited to participate), nor how representative the response sample is for hospitals nationwide. For example, while the study noted that all data was self-reported,  there was no mention of the possibility that only hospitals which have disparities reduction initiatives chose to participate.  I am pursuing the actual data used for the study, and hope to have information to share soon.

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Old US Public Health Service Hospital (known as Pacific Tower during its tenure as Amazon HQ building) to become new satellite campus for allied health professions programs of Seattle Central Community College and serve as site for public agencies and NGOs. AmazonBeaconHillHQ*304

Seattleite Jeanne Sather, author of Assertive Cancer patient  blog ,died from metastatic breast cancer  15 years after her original diagnosis

In June the King County Board of Health unanimously approved creation of drug take-back system for county residents , to be financed by a 2-cent per Rx tax. On Dec. 1, PhRMA filed a lawsuit against King County , claiming that the plan causes a financial burden for patients and that in-home disposal of  medicines is the best way to keep Rx drugs out of the wrong hands.

State to review hospital affiliations — Catholic and otherwise

Public hospital CEO gets pay cut to $1 M per year, at Renton’s Valley Medical Center

Harborview to close  pediatrics, women’s, & family clinics

Health Care Reform for American Indians and Alaska Natives 2013  including WA-specific page

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Consumer info fact sheets  translated into WA’s threshold written languages   (Chinese, Lao, Khmer ( Cambodian), Korean, Russian,  Somali, Spanish, and Vietnamese) were posted on Dec. 16, just one week before the deadline to start an application for coverage to be effective Jan. 1, 2014. In an unrelated development, HBE  decided on this brief extension  for completing applications due to various  problems people have had in being able to use the online forms and or access phone customer services.  Regarding the translated fact sheets, it’s taken almost 6 months for their publication to replace the original problematic versions that were taken down from the site.
However, the new fact sheets are not easy to find as they are not posted on the consumer website,  but located exclusively on the HBE corporate website.  The corporate site features a line at top right-hand side of homepage entitled “Information in Other  Languages” which links to the fact sheets page, plus also links out to the consumer website.  In contrast, the consumer Healthplanfinder site (which is in both  English and Spanish) does not offer any such subject line, nor does it display a link to corporate site.  The Healthplanfinder site likewise does not contain any readily visible clear statement of consumer  language access or disability access rights, except for a message in tiny font on bottom of the homepage that says [sic] : If you need additional language or disability accomodations, you may call 1-855-WAFINDER (1-855-923-4633)  On the Spanish version of the website, this statement illustrates yet another example of  faulty translation, as the term “disability accomodation” is twice translated, and very ungrammatically, as  “discapacidad alojamiento”  which means disability lodging.  Sure enough, a quick check on Google Translate  English > Spanish reveals  “lodging” as the first  translation for “accommodation.”  Since 2012 advocates had been recommending the inclusion of multilingual tag lines and/or translated summaries sections for the website. Interpretersymbol

Information on some metrics for the Healthplanfinder call center became available last week with the release of the  November Healthplanfinder Data Report. On the language access side of things (p.10 of the report)  the numbers are not encouraging: the call center received almost 12,000 calls in Spanish, but handled only some 1600 of them. The call center in Spokane has bilingual Spanish-English staff (reported as 6 out of 80 employees at start-up) on site and routes calls in other languages to a telephonic interpreter service. For calls in all languages besides Spanish combined, 1045 were actually handled (answered)out of 3621 calls attempted. The report does not state if the multilingual calls are included in the totals for approximately 35,000 calls  handled in November or the almost  158,000 calls throttled (deflected from the system, i.e. not put into the queue to await a response).  While the HBE is said to be increasing staffing for the call center,  any increases planned for its language capacity are as yet unknown. Given the demand, it would seem that Spanish-speaking callers too could benefit from immediate access to interpreter services.

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Two recent news stories about honey, illustrate yet again the vital importance of communications to health.  In these completely unrelated cases, it was all about translations, the rendering of messages from one written language to another. The fraudsters seemed to have assumed they could get away with selling their products to unsuspecting consumers due to a lack of language skills on the part of regulatory authorities.

In September,  Bloomberg Businessweek  broke the story on a honey scandal at the global level with an article entitled The Honey Launderers: Uncovering the Largest Food Fraud in U.S. History , describing a convoluted plot by German company ALW to sell millions of pounds of Chinese honey in the US, by disguising its origins.  Over the course of several years, ALW arranged with the Chinese brokers to channel their product through other countries, where it was filtered, doused with additives to disguise its unpleasant  flavor, and re-labeled  to make it seem to have come from nations authorized to export honey to the US.  Some of the adulterated honey was also found to contain residues of the antibiotic chloramphenicol, long banned in the US.  The impetus for the fraud was purely financial , as honey fetches top dollar in this country, the major world consumer.  Over a decade ago when domestic beekeepers complained that honey imports from China were seriously undercutting their business, the US imposed such stiff tariffs on Chinese honey imports that little enters the country legally any more. But the super-cheap price of honey in China has remained a lure for international exporters. Some Chinese feat_honey39chart_630producers seize this opportunity to increase their own profits by artificially  increasing the quantity of honey available to be sold.  According to the FDA investigation of this case, a number of  techniques like harvesting the honey early and not letting the bees complete the process naturally were routinely used in China, along with machine-drying the honey to speed things along.  ALW abetted the process and instructed its 2nd-country middlemen to add  sweeteners to disguise the sour taste caused by the premature harvesting.

In order to keep the doings secret, ALW  officials exhorted the young German employees sent to run the firm’s US operations to use the phone, not emails, to discuss business and to conduct all communications in their native language.  While the staff did restrict their discussions to the German language, they continued to use emails for correspondence. Their missives were later translated into English during the course of the FDA investigation.  The federal  prosecutor who worked on the case commented:

“They were extremely sophisticated and intelligent in some ways, but so sloppy in other ways. What do they think—no one can translate German?”

Earlier in the year in a less notorious case, the honey firm Nature Nate’s in Texas garnered FDA censure because it violated the instructions issued by the FDA following a 2012 audit, when the company was ordered to stop advertising its honey in ways that characterized it as a drug, i.e. by making various health claims for its products.  While Nate’s had promised to stop the spurious marketing by Fall of 2012,  an FDA follow-up in mid-2013 found that the firm continued to make these claims on its Spanish-language website,  under the banner ” Remedios Caseros con Miel or Honey Home Remedies “, Spanish_honey_remedies describing such benefits (in English translation) as:

• “Food Poisoning. Blend 1 Tablespoon Apple Cider Vinegar and 1 Tablespoon of North Dallas Honey dissolved in a glass of chilled water.”

“‘[O]rganic honey’. A client of mine that is a doctor told me to try yours for allergy relief. It has COMPLETELY eliminated allergies for the entire household … it is our daily dose … “

A cached copy of the Spanish information on how to use Nate’s honey as an arthritis remedy said:

Para la artritis – 100% Pure Raw & Unfiltered Honey naturenates.com/espanol/para-la-artritis
“Receta 1. Tome una taza de agua caliente con dos cucharadas de miel y una cucharadita de canela en polvo por la mañana y la noche. …

FDA translation: “May Help with Arthritis. Recipe 1. Take 1 cup of hot water with two spoons of honey and one small teaspoon of cinnamon powder both morning and night. .. “

The FDA issued the new warning letter in June 2013, and Spanish version of  Nature Nate’s  website appears to have now been taken down.

And the phenomenon of the FDA using translation as an investigative tool is hopefully now a regular practice, as a evidenced by yet another recent case, this time involving the Sundial herbal supplement company which got an FDA Warning Letter based on claims made solely in Spanish which characterized its products as drugs.  As a commentator for Regulatory Affairs so aptly explained

…just because a product’s unapproved claims aren’t in English, that doesn’t mean FDA isn’t paying attention.

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Recent news of note:

Report: Debt Collectors Work In Emergency Rooms, Demand Payment Before Patients Receive Care

Abbott To Pay $1.6 Billion To Settle Depakote Probes

Discrepancies on Medical Bills Can Leave a Credit Stain

American Pain Foundation Shuts Down as Senators Launch Investigation of Prescription Narcotics

Insurers back FDA plan for new drug category

Patients Share Of Expensive Specialty Drugs Is Rising

Racial, Socioeconomic Disparities Alleged In Autism Spending

Premera tries to gut drug benefits, Kreidler says no 

and a shout out to an excellent source of news and analysis with a focus on Oregon and the broader context:

The Lund Report: Unlocking Oregon’s Healthcare System

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Those who have been following the saga of the leukemia wonder drug imatinib mesylate or Glivec (spelled Gleevec in North America to standardize pronunciation) may recall that it was said to be the first medicine for which a global price was set. At the time of its 2001 FDA approval, the worldwide price was US$2400/month, for  a base dosage of  a 30 day supply of 400mg caps.  Indeed, Novartis CEO  Daniel Vasella went to great lengths to discuss and justify both the high price and the pricing decision in his subsequent infomercial-type book  Magic Cancer Bullet: How a Tiny Orange Pill Is Rewriting Medical HistoryThe Gleevec story is notable too in that the typical pharma claim that the price is justified by R & D costs, was refuted by researcher Brian Druker MD, who detailed how most of the initial work on imatinib was publicly funded and he had to convince Novartis to  produce enough of it to begin clinical trials with CML patients. Dr. Druker has also gone on record to criticize  the price being charged for Glivec.

Since then patients in wealthy countries mostly have been clamoring for their  public or private insurance to cover  the drug (and its second-line successors) not that something be done about the price that is exorbitant even in their economies. Novartis  invested heavily in worldwide patient relationship marketing for Glivec , which has contributed to this phenomenon, a topic  explored previously in this blog. In recent years,  it has become much more common to hear complaints from US patients and even some of the big-box disease associations, about the escalating price of  drugs like Glivec and  especially for new biologics. But it has  been rare to to hear demands that something be done about drug prices.

So the recent posting of a patient petition on change.org calling for action to reduce the price of Gleevec is notable:  Novartis and US Representatives in Congress: Reduce to patients the cost of the drug, Gleevec.

The introduction of the petition reads:

Novartis developed this drug in the 1990s. In the years since then the price of the drug has increased astronomically. Novartis must have paid their research costs long ago, but the price just keeps rising. Patients with CML leukemia are dependent on the drug to keep them alive. Our US representatives should work with FDA to pressure Novartis to reduce the cost

Setting aside the issue of  misunderstanding that there are no price controls on prescription drugs in the US open market and that the FDA does not regulate drug prices, the petition is significant as a reflection of the increasing desperation of middle-class privately insured patients. They are among the majority here whose insurance status and/or income levels typically disqualify them for the patient assistance programs much touted by Novartis, whose global Gleevec sales generated $4.7B in 2011.   Many US patients are now finding that the Gleevec price has skyrocketed at the same time that insurers are requiring them  to pay a much larger share of its  hefty price tag.  The situation is quite simply unsustainable.

One person who signed the online petition shared:

I started taking Gleevec June 1, 2001, when it was first approved by the FDA. It cost $2400 for 30 pills. Now, these same pills cost $7367 per month. I pay $1035 per month for insurance to cover this cost. My insurance Co. gets billed for the drug. Why has Novartis raised the price so much? …

A look at  Costco’s online pharmacy, which has a reputation, anecdotal at least, for offering “good value” retail prices on Rx meds in the US, found the following cash price for a month’s supply of an  average dose (dosage  is individualized) of  30 tabs :  GLEEVEC 400 MG TABLET      $6,264.59

While Novartis is continuing its drag on its patent fight to combat the imatinib generics already on the market in India, these cannot yet be exported to the US.  The original  US patent for Glivec expires in 2015. In 2009, Sun Pharma  filed for and received tentative FDA approval for a generic imatinib for when that day comes.

Given the power of the pharma lobby the future remains very uncertain for any relief on the price of Gleevec , but the clamor of voices from the grassroots is a healthy development.

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