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Archive for the ‘Health Care Reform’ Category

In these times of intense attention to healthcare from all quarters of the US,  a new study by USA Today and Kaiser Health News reporters focused on community clinics.  Over the past 2 decades community clinics have  developed from origins often as volunteer-run efforts, to become a vital part of  what is called the safety-net. Frequently they now are the sole source of care available to over 20 million people, often as the only providers who will accept patients covered by Medicaid,  and for the growing ranks of the uninsured. The sorry state of healthcare access would be far worse if it were not for community clinics.  These centers will play an important role too in the reforms set to start in 2014. It is expected that many who will become newly insured  by Medicaid will be seeking  care at community clinics. Long woefully underfunded, clinics will be eligible to receive help from the $10 billion approved by Congress for expanding their  service capacity.   

The report entitled  Community clinics have odds stacked against them  looked  at almost 1200 community clinics across the country, and ranked them based on the 6 categories of performance quality measures which federally qualified health centers (FQHCs) must report to the federal government.  The categories cover care for patients with diabetes and high blood pressure, rates of screening for cervical cancer and childhood immunizations, plus timeliness of prenatal care and rates of low birth-weight babies.

Using  2010 clinic performance data obtained by FOIA request, the reporting team found wide variations in care by center,  by region of the country, and between specific centers in the same city.  Generally, clinics in the South performed worse that those in New England, the Midwest, and California. Overall, their  survey showed community clinics not performing as well as the national averages for the study parameters .

There is more context to understanding the survey results however, that was not part of the report.  The National Association of Community Health Centers issued a statement about the report which while recognizing the value of examining clinic performance, expressed concern about the wrong impressions that the media study might give:

The article disregards the better quality care that most health centers achieve when compared to care provided to other low-income patients elsewhere.  However, at least the article does reveal what few Americans realize– that every health center reports on the quality of care their patients receive….

<snip>

…When you compare the federal data that is the focus of the USA Today article with national data from the National Center for Health Statistics, health centers performed better than national averages for entering women into prenatal care during the first trimester, childhood immunization rates, reduced low birth rates and hypertension control…..

NACHC recently published its report Health Wanted – The State of Unmet Need for Primary Health Care in America  which takes an in-depth look at the factors behind the consistent and increasing demand for community clinics, the links to social determinants of health and how funding has not kept up to meet population needs.  In FY 2011 for example, only 67 out of some 1900 applications for new health center service sites were funded.

Seattle/Local Health Guide extracted localized  figures from the report to create a Washington State Comparison Chart.  Janna Wilson, Senior External  Relations Officer for the Seattle-King County Department of Public Health shared additional concerns with me  in a personal  communication, about implications and lack of context  for specific data used for the local news article:

The data provided for Public Health represents a small subset of the patients we see—our homeless primary care patients. This is because Public Health’s federal health center grant comes under a targeted program called Health Care for the Homeless. Our federal data report, therefore, is specific to our homeless patients per federal reporting requirements.  As you know, homeless patients face barriers that often exacerbate medical and behavioral health conditions and complicate treatment plans.
 

While most community health center grants and programs are for the general low-income population, some — like ours — target special population groups such as homeless people or migrant workers.  There is nothing in the USA Today article that provides this important context. That said, quality improvement is a big part of our program for all our patients, whether homeless or housed.

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With almost nothing but a steady stream of dire news about public services in 2011 , and  the prospect of even more budget cuts facing us as the Washington State Legislature convenes work today, it is heartening to hear some good news. For the third year in a row, Washington has earned bonuses for enrolling children in Apple Health for Kids, our state’s plan for low- and middle-income kids, which includes the Children’s Health Insurance Program. As Crosscut reported:

Tens of thousands more children have health insurance now, despite the state’s having reached the grim milestone of 1 million uninsured residents last year. Washington is also the only Western state to win federal awards in 2011 for both early learning and children’s insurance programs.

Of course, one of the reasons that so many children are now enrolled in Apple Health is because their parents have lost their jobs and/or health insurance. And some 100,000 eligible children are not enrolled in the program, highlighting the need to continue outreach efforts, which lost  state funding in 2009.  Nevertheless the ceaseless efforts of advocacy groups like  the Children’s Alliance are a driving force which led to this performance award, which  in turn will help the State do even more for our kids.

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As the new year starts, some ome items of note from near and far:

The breast implant scandal strips away the glossy euphemisms of cosmetic surgery

S. Korea approves Asia’s first anti-leukemia drug

Nicotine Gum and Skin Patch Face New Doubt

No Benefits for Sick Job Seekers: After battling leukemia, man is denied unemployment benefits

Opinion: Why are Washington’s nonprofit health insurers sitting on huge surpluses?

“Gizmo idolatry,” robotic prostatectomy, and real data

Final Thoughts from A Dying Cancer Researcher

Number of uninsured in WA hits 1 million

Drug research routinely suppressed, study authors find

FBI crackdown on unproven stem cell therapies

 

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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 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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That might be the conclusion drawn by readers of a recent article in Bloomberg Businessweek. Recession Causing Cancer Patients to Quit Life-Extending Drugs which was the August 4 feature in  the Executive Health column. This news story earned billing as  the Outrage of the Week in  NLARx News from the National Legislative Association on Prescription Drug Prices.  The original article discusses the dire plight of patients  in California with GIST ( gastrointestinal stromal tumor) who lost their jobs and hence insurance, and  are no longer able to afford the Gleevec which has been keeping them alive to the tune of $5000/month.  Or for those who still have insurance, the unaffordable cost of the co-pays, often 50-70% of the Rx retail cost, in accordance with the now-common tiered formulary systems.  Equally outrageous however is that the article completely misses the boat when discussing remedies for the situation.  Author Amanda Gardner describes how patient assistance programs (PAPs) may be available temporarily for some patients as a stop-gap measure, and posits how things should get better  as the provisions of  the Affordable Care Act  roll out.  In the meantime, however,  the very survival of many of the patients  described is in jeopardy  with no solution in sight, if we are to believe such spokespeople as  Stepehn Finan, senior policy director of the American Cancer Society’s Cancer Action Network , who was quoted stating that [the PAPs]

…….. are the only real options at this point for people who are pressed to afford their prescription costs.

Yet the urgent need for something to be done about the exorbitant price of drugs  is not mentioned in this article. Unaffordable medicines are not inevitable. Real remedies exist such as allowing CMS to negotiate for drug prices like the VA does,  instituting price controls, and allowing  prompt development of generics of the most costly drugs. The grip of Big Biopharma  lobbyists on Congress will remain strong if the public continues to believe that nothing can be done.

For the record, the vast majority of funding for the research that led to creation of Gleevec came from government coffers and nonprofit sector sources, and drug’s first US patent expires in 2015.

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