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