How I Addressed A Provider/Insurer's Quality Issues

[This is a modified copy of the letter I sent to a well-known sponsor and its diabetic-supplies-providing pharmacy service. Significant portions have been redacted. This is not legal or medical advice and should not be construed as legal or medical advice.]

“I received your letter dated _____, 200_, responding to my letter about my unsatisfactory experience with the XYZ Pharmacy Service provided by ZYX. Neither the ZYX comments nor your letter provide assurance that I and other Medicare Part B beneficiaries will receive appropriate quality diabetic services for which Medicare is paying. My experience, and the ZYX response, convinces me that XYZ/ZYX quality deficiencies place the health and lives of diabetic patients at risk.

“My response follows the format of ZYX’s comments.

“1. Complaint and Response: Receiving substituted products

“My original order, pursuant to the prescription provided by ________, M.D. in early December 200_, for Brand X blood sugar monitor, strips, control solution and a Brand X lancing device and stylets was placed and filled at _____ Pharmacy in _________, California and billed to Medicare through Part B. XYZ/ZYX provide/process my MediGap Part B coverage and presumably had access to that history.

“When I contacted XYZ Pharmacy Services on ______200_ for diabetic testing supplies, I said that I was using the Brand X testing system, was not told that I would receive a “generic” lancing device and lancets, and was not informed of the problematic secret generic “policy” of ZYX. I was not told that I was required to specify that I did not want any other brand of product and that even if I did specify what I wanted, I would probably not receive it.


“. . . . In my opinion . . . . the ________(“generic”) lancets are not analogous to generic drugs (where the significant test is bioequivalency) and pose a public health risk.

“ZYX’s response reveals a lack of transparency in dealing with me. Important XYZ/ZYX administrative policies were kept secret and were not disclosed to me or other Part B beneficiaries in XYZ/ solicitations and advertisements. Medicare Part B Patients are not provided with reasonable options when they first make contact with the XYZ Pharmacy Service. In my opinion, given the requirements of Health and Human Services, the Office of Inspector General and the federal and regulatory authorities that providers give evidence of transparency, not just with respect to price, but as to quality, XYZ/ZYX fail this test.

“The term “generic” is meaningless with respect to the ________ lancets because neither XYZ nor ZYX provides a meaningful and authoritative definition of “generic lancets” to patients (for discussion of lancets, see U.S. FDA attachment to this letter). The assertion that the _______ lancets are equivalent to Brand X ’s is false: the Generic lancet points bend much more readily than the Brand X lancet points. A bloody bent lancet cannot be inserted into the “cover” resulting in a discarded lancet with an exposed contaminated bent point which may puncture the skin of a person dealing with the lancet after disposal (it is impractical to expect patients to carry biohazard disposal containers when away from home, or even in most instances, at home). The Brand X lancet has a positive locking device which prevents the cover from falling off (even if the point is bent) but the Generic lancet does not. In an era of Hepatitis B and HIV, these are not trivial differences; the Generic design may expose a house cleaner, janitor, hotel cleaning person, or other handler of discarded lancets to serious blood-bourne infections. If there is a financial benefit to ZYX in dispensing generic lancets, there may be an offsetting shift of financial risk to patients for “unsafe disposal” of an unsafe product.

“Complaint and Response: Denial of specific product request

“During my reorder telephone call on _____200_, I was told that it was highly unlikely that I would receive the Brand X lancets, notwithstanding my clear statement that I was not calling as a member of an HMO or prepaid service plan, but as a Medicare Part B beneficiary and that my objection to the Generic lancets was based on my experience using the supply which had been provided to me in my first order. I expressed serious public health concerns because of the exposure risks described above.

“ZYX’s response again reveals a lack of transparency in dealing with this Medicare Part B beneficiary. Secret policies were not revealed to me or other Part B beneficiaries in XYZ/ZYX solicitations and advertisements or on my first contact.


“Complaint and Response: Untimely supply delivery

“ZYX acknowledges employee error . . . . ZYX does not describe a quality protocol for protecting Medicare Part B beneficiaries by prospectively reviewing the accuracy of the filling of orders or a system for detecting errors prior to delivery. It took multiple calls from me, and the disabled stroke victim to whom my order was improperly delivered, to get ZYX to correct its errors. It is also curious that ZYX did not offer to refund my out-of-pocket expenses (purchasing the missing supplies) related to their late-delivered order.

“Complaint and Response: Supplies shipped to wrong address

“ZYX’s response might have been appropriate in 1985, but was inappropriate in 200_ ZYX provides excuses but does not develop a root cause analysis for its errors. The ZYX computer system apparently did not flag or warn the errant data entry representative of that person’s error in changing my address nor did it link with the Medicare database to verify my correct address. The fact that ZYX does not recognize this as a corporate system error is frightening. The error was compounded by ZYX failing to expedite shipping, highlighting additional system deficiencies. There were more than three significant errors in the processing of my order. I conclude that ZYX has serious unacknowledged deficiencies in personnel training and systems and is not providing the quality of services to which I am entitled and for which Medicare is paying.

“Complaint and Response: Failure to respond to phone message

“As noted in ZYX’s response, my phone message was left on _____200_. ZYX never called me back, notwithstanding its stated policy of returning calls.

“The failure of ZYX to find, document and return my call was a quality violation.

“If ZYX had a spike in inbound call volumes during the ten days . . . . which impacted hold times, abandon rates, volume of voice mail messages, and delay in call backs, ZYX is not providing the staffing and facilities demanded by the volume of business and the needs of its Medicare beneficiaries. Again - Medicare is not receiving the quality of services for which it is paying; beneficiaries are being shortchanged.

“In my opinion, the issues presented are serious, could have life threatening consequences, and XYZ/ZYX’s responses are inadequate and irresponsible. These matters require prompt serious attention by management and should be brought to the attention of the Board of Directors of both XYZ and ZYX. A corrective plan is needed.

Sincerely yours,


cc:
Office of Inspector General
Office of Public Affairs
Department of Health and Human Services
Room 5541 Cohen Building
330 Independence Avenue, S.W.
Washington, D.C. 20201

Health Care For All Americans

In the 12/18/2008 New England Journal of Medicine, Robert Steinbrook, M.D., asks "Medical Student Debt - Is There a Limit"? Steinbrook reports that 87% of the students graduating from medical school in 2008 were encumbered by debt, $145,000 for students at public medical schools and $180,000 at private medical schools. He reports median costs of attending medical schools ranging from about $44,000 for public schools and $62,000 for private schools. He reports that 20% of the financial assistance of $2.5 billion provided in 2006-07 were grants and scholarships; the remainder was mostly loans.

The financial burden of a medical education eliminates worthy students who cannot accept the yoke of personal indebtedness, the spectre of burdening their families with escalating debt, or the unlikelihood that a school loan can be arranged under reasonable repayment terms. In the last year, disclosure of the corrupt association between some institutions' financial aid officers and student loan companies makes it clear that this program does not serve our public interest.

Students who graduate with enormous debts focus on specialties which generate enhanced earning power, not necessarily specialties which are most needed by society. Students who graduate with enormous debts will practice in a manner which enhances income, constrained only by insurance company and government rules as well as state/federal fraud and abuse laws. Many of these students may feel that they need to focus more on the business aspects of their medical practices than the professional aspects.

I end the year by again proposing a federally subsidized program for medical (and other needed health professional) education. Students receive appropriate financial support in exchange for an extended service commitment which begins after completion of training in fields which are needed for our health system. We develop a corps of physicians and other health care providers who agree, in exchange for their financial support, to serve in federal health centers which compete with private health systems in a national program which provides adequate and appropriate health care to every citizen.

Let's just do it!

Happy New Year - may it be a year of peace, happiness, prosperity and good health to each of you.

FDR: It All Depends On Whose Child Has The Measles

This evening, as my wife and I visited a local Kaiser Foundation Hospital, the air stank from wood smoke. I found myself surprised that Kaiser hasn't taken steps to discourage wood burning in fireplaces in the Silicon Valley.

In earlier posts, I talked about "cost-shifting." That occurs when an insurer, or the government, or a medical facility saves money by shifting the cost of services to someone else, usually another institution or even the patient. It seems unfair, doesn't it? If it impacts us, it doesn't just seem unfair, we complain loudly that it is unfair.

The reason I introduced this blog with the stench of wood smoke is that it exemplifies an unrecognized cost-shift component of our health system. The people burning paper, debris or wood in their fireplaces shift the cost of being warm from themselves to the public. If someone has asthma and decides to open a window, or even worse, take a walk in the brisk polluted evening air, those fireplace fumes can trigger an unexpected very expensive emergency trip to the hospital with an acute - potentially fatal - asthma attack. Smoke up the fireplace triggers asthma which requires substantial costly resources to treat.

Not all cost shifting is done by insurers, government agencies, hospitals or health care providers. Some of it is done by people who, in the mirror, look just like us. But of course, when it's our pocketbook which is at risk, we convince ourselves that it is OK, just as when it's our measles unvaccinated child who spreads his infection to another susceptible child, it's OK too.

Will The Last Doctor Turn Off the Light When Leaving?

In 1971, at a Los Angeles Practicing Law Institute program devoted to "health law", an academic speaker talked about the passivity of physicians with respect to the Medicare program. He told us that chiropractor and podiatrist organizations lobbied aggressively to have their members participate in the Medicare program, with fee schedules which were beneficial to them, while physicians and their organizations took a disengaged stand.

I have never understood the passivity then (and now) shown by physicians (the AMA was actively involved in trying to scuttle the initial Medicare legislation, predicting accurately, that the financial justification for the program was far off base), nor the political and business passivity shown by physicians as HMOs, PPOs and insurers played a variety of hard-nosed games which not only cut appropriate services to the public and their patients, changed medical practice to a factory/industrial model. and absorbed billions of dollars of "administrative overhead."

As more physicians work in groups run by lay management, are owned by hospital and other entities in which physician opinions are not particularly respected, and as business economics trumps professional judgment and standards, physicians continue to passively accept what has been meted to them. County medical societies and national physicians have chosen to spend time, energy and resources in fighting about which specialty gets the most beneficial treatment, rather than the state of the profession and the care which physicians and others in health care provide.

At one time, university medical centers provided leadership. But their lay managements have been accepting of the same strictures as physician organizations and have proved to be more concerned about generating profitable patentable ideas and products and selling revenue enhancing services then developing solid high quality systems of health care. Academic faculty missions have been subverted; teaching is less respected than publishing and generating institutional financial return.

Hospitals follow the industrial model. Just as skilled factory mechanics have been promoted to high-paying foreman jobs, promising young physicians are selected for a variety of directorships which gives them the choice of complaining and losing personal income and stature or keeping their mouths shut and not rocking their boats. Dissenting physicians may be labelled as uncooperative and, in a subversion of the medical disciplinary system, gotten rid-of.

We should not plan a return to the "good old days" when we watched patients die from infections, heart disease, cancer, obstetrical complications, metabolic disease and organ failure. But it's time for those who are in the health care trenches every day to speak up: health care decisions cannot be left to politicians, business people and economists. The lights are dimming now.

Ah Yes - Money

Tucked-away on pages A19 and 20 of the NY Times 12/19/2008 is this header:"Budget Office Sees Hurdles In Financing Health Plans," nicely packaged on a page which reports that the "good times" are no longer rolling in Louisiana and that a New Hampshire jury issued the first death sentence in "nearly half a century."

The only good news from the summarized Congressional Budget Office report was the use of computerized medical records would save the government a total of $34 billion over 10 years. Unfortunately, Robert Pear, the article's author, did not report the billions in total capital costs shifted by the government to the private sector to install and use those computerized medical record systems. Pear did report that $47 billion of new federal revenue would flow from requiring employers (those American businesses in competition with businesses in countries that do not have similar requirements) to provide health insurance or pay a fee to the federal government, that a national insurance pool for the uninsurable would cost $16 billion, that $116 billion could be saved by the government if it received a 15% discount from drug manufacturers for Medicare Part D drugs, that drug effectiveness research would save a puny $1.3 billion over 10 years as compared with $12 billion for implementation of generic versions of (presumably patented) "expensive biotechnology drugs." Pear also noted that the proposed 2010 and subsequent cut of doctors' fees, if not implemented, will cost the government about $320 billion over the next 10 years.

President-elect Obama won his election on a promise of change and improvement in health care quality, cost and access, but so far we haven't seen meaningful changes in his health policy and financing statements. Maybe we will - but more likely, we won't. The demands of the pinstripe-suited financial sector, the high-flying domestic automobile industry, the crumbling real estate industry and the health insurance industry seem to have come first.

Electronic Health Information Privacy - Office of Civil Rights

I received the following announcement today, which may be of interest to some readers:


"New OCR Guidance on the HIPAA Privacy Rule and the Electronic Exchange of Health Information


"The Department of Health and Human Services (HHS) Office for Civil Rights (OCR) has published new HIPAA Privacy Rule guidance as part of the Department’s Privacy and Security Toolkit to implement The Nationwide Privacy and Security Framework for Electronic Exchange of Individually Identifiable Health Information (Privacy and Security Framework). The Privacy and Security Framework and Toolkit is designed to establish privacy and security principles for health care stakeholders engaged in the electronic exchange of health information and includes tangible tools to facilitate implementation of these principles. The new HIPAA Privacy Rule guidance in the Toolkit discusses how the Privacy Rule supports and can facilitate electronic health information exchange in a networked environment. In addition, the guidance includes documents that address electronic access by an individual to his or her protected health information and how the Privacy Rule may apply to and supports the use of Personal Health Records.


"These new HIPAA guidance documents are available on the OCR Privacy Rule Web Site at http://www.hhs.gov/ocr/hipaa/hit/. For more information on the Privacy and Security Framework and to view other documents in the Privacy and Security Toolkit, visit http://www.hhs.gov/healthit/privacy/framework.html."

Health Care Reform: Start With Educating Teachers

The seductive term, these days, is "health care reform." As with all seductions,there's a lot more going on than meets the eye. So let's look at the "reform" process from its beginning.

The first step in health care reform starts in our schools. Not medical schools, but the schools that train our kids' elementary and high school teachers' teachers. Before you conclude that my last sentence contained a "typo" read on. Once upon a time, elementary and high school teachers were trained in teachers' colleges by experts devoted to educating educators. Now, trainees attend community colleges and universities and take a smattering of courses in the liberal arts which give them no depth or real skill in any subject, and when they do get teaching jobs (some times choosing to teach as an afterthought), they bring no real teaching or deep academic subject skills to their classrooms. We need to improve the teaching and academic skill-sets of our elementary and high school teachers by providing intensive professional training by expert instructors in teaching and academic subjects.

Someone who does not love and have a firm understanding of math, algebra, calculus, biology, chemistry and physics cannot communicate a love for, or intellectual excitement about, these and other scientific subjects. Students decipher the real message: "I teach here because it's a way to make a living."

If teachers are not well-trained, skilled and committed, their students won't be either. And America won't turn out the "turned-on" mathematicians, physicists, biologists, chemists, physicians and other scientists it needs. We will churn-out minimally competent health care providers who want 9 to 5 jobs to make a "living."

America needs to pay close attention, not just to the end product of our science education process, but to its entirety. Begin health care reform with educational reform.