Daschle - Is He Ethically Fit For Secretary of HHS?

Today's blog reflects three weeks of my experience as a grandfather at an HMO's hospital's Neonatal Intensive Care Unit where two prematurely born grandchildren (weighing about 1-1/2 pounds each) have received superb care. The regional facility is modern, equipped with all of the technology that one would wish for in an NICU. But what has made the experience noteworthy is not high-tech monitors, beeping signals, computers and devices, it is the ethics, integrity and skill of the physicians, nurses and other staff charged with the difficult task of caring for very high risk premature babies. The parents of these high risk babies must have absolute confidence in the information and advice they are given. Their decision-making and their children's survival and well-being requires trust.

As a former health care attorney and experienced physician, I am familiar with the "compromises" sometimes made by HMOs, PPOs, other insurers and health care professionals. These compromises, reflecting overt and subtle conflicts of interest, result in denials of optimal care and substitutions of "acceptable" for medically/scientifically proved superior care. Sometimes, like art, the philosophy seems to be "do what you can get away with" rather than what is best for the patient.

In the context of the ethics and integrity of the health care system, that I read with disappointment today's NY Times front page story that Mr. Daschle, Obama's "pick for secretary of health and human services . . . failed to pay more than $140,000 in taxes, mostly for free use of a car and driver that had been provided to him by a prominent businessman . . . ." If the story is true, Mr. Daschle is not ethically fit to serve as secretary of health and human services and his nomination should be withdrawn.

When A Banker, or Physician, Makes A Mistake

When a physician makes a mistake, whether it results in physical or economic injury to a patient, a lawsuit may be initiated (coupled with a complaint to the State Medical Board), the physician's malpractice insurer will assign defense attorneys and perhaps start its own investigation of the physician, the physician's hospital medical staff appoints an investigative committee which may result in disciplinary charges being filed and if upheld by a peer review committee and the hospital board of directors, in loss or limitation of medical staff membership. The state Medical Board may take disciplinary action, resulting in limitation or revocation of the physician's license to practice in that state. Other states in which the physician is licensed will pile on, adding similar discipline. If the physician loses the professional negligence lawsuit, he or she may face personal responsibility for losses above the policy limits. All of this is reported to the State government, which shares information with the Federal government, and the physician may lose her Medicare and Medicaid provider status. HMOs will dismiss the physician from their rosters. PPOs will remove the physician from their lists of participating physicians. Medical Societies will discipline the physician. The physician's life is ruined, often (as a Harvard study showed) because of a moment of inattention.

If a banker's deliberate and gross negligence costs shareholders, clients, the public or others their life savings, he or she may get to share in a two billion dollar year-end bonus. And if not that, at least in a federal bailout.

Is something wrong?

Lock-In Locked-Out by Medicare

Last week, the Wall Street Journal reported that the acting administrator of Medicare's Center for Medicare and Medicaid Services predicted that new regulations will "reduce what [patients] pay at the pharmacy counter."

Under the new regulation, the calculation of when a patient reaches the donut hole will use the actual amount paid by the insurer to the pharmacy, not what the insurer pays to the benefits manager, which includes a potential profit for the benefits manager.

As one might expect, a benefits manager complained, using the stalking horse of less competitive plan design choices. My interpretation is that the complaint reflects the benefits' manager's concern about its profits and no real concern about patients who reach the donut hole.

A Systems Approach To Understanding Insurers' Policies

United Healthcare's Prescription Solutions raised the price of Medicare Part D ezetimibe from approximately $75 in 2008 to approximately $250 in 2009. Unfortunately, because I had already signed up to renew my coverage, before the 2009 formulary with its new stratospheric charges appeared in my mailbox, I had two choices: stop this LDL lowering drug or pay up.

Thinking about this from a systems perspective, I could envision United Healthcare - which the NY Times reported on 1/16/2009 had settled ". . . class-action lawsuits claiming it had underpaid patients and doctors . . . ." doing this for any of several reasons. First, perhaps the price of ezetimibe had tripled, but I wasn't aware that it had. Second, perhaps those taking ezetimibe are a high risk group, and if the United Healthcare's Prescription Solutions did not make available the drug these people needed at an affordable price, they might leave (reducing United Healthcare's MediGap and other coverage risks and Prescription Solution's Risk in a variant cherry-picking arrangement). Third, perhaps Prescription Solutions was using patients treated with ezetimibe as battering rams in negotiating prices with drug manufacturers.

By the way, on January 8, 2009, the FDA concluded that those high risk individuals taking a lipid lowering combination including ezetimibe should not stop taking the medication. . Perhaps United Healthcare was just too busy defending its class action cases and investigations by various state attorney generals to have paid attention to this warning and price its Zetia accordingly.

How To Destroy Medicare!

I met with a group of physicians today who told me that when a transition from one Medicare fiscal intermediary (let's call it "NH") to another (which we can call "Palm")occurred in 2008 in Santa Clara County that they had no Medicare payments for 5 months. Not only were their incomes reduced to a trickle, they had to borrow money to stay in practice.

How many physicians, with this type of experience, will allow themselves to become more dependent on Medicare patients? Was this just an episode of incompetence, or a callous effort to move Medicare beneficiaries from standard Medicare to Medicare-HMOs?

Whatever it was, it bodes poorly for Medicare patients. And it speaks volumes about the Medicare bureaucracy.

The HIPAA Privacy Rule and Health Information Technology - NEW!

OCR has published new HIPAA Privacy Rule guidance documents as part of a Privacy and Security Toolkit to implement The Nationwide Privacy and Security Framework for Electronic Exchange of Individually Identifiable Health Information (Privacy and Security Framework). These new guidance documents discuss how the Privacy Rule can facilitate the electronic exchange of health information. Clicking on this blog's title should connect you with this site.

Do It Now

Reading the pronouncements from President-Elect Obama and Mr. Daschle, you wouldn't think that health care reform is an emergent need. There's money for the auto industry, the banks, the brokerages, and perhaps the roads and bridges, but little understanding that for sick children, their sick parents, and many of our working uninsured sick, we have run out of time. Mr. Obama, a child with leukemia needs access to, and provision of, health care without regard to insurance coverage. A sick parent, whose illness jeopardizes employment and the family's financial well-being, and who is one paycheck (or less) from being homeless, can't wait two years for help. A senior who is in the donut hole and finds herself unable to spend the $254 it will take to get 90 days' worth of medicine from the Prescription Solutions (AARP) provider, may be dead before more help is on the way.

It takes guts to do what's right, to provide the health care services that many Americans desperately need. In two years, many of those who could have been helped will be dead or be suffering from chronic disabling disease that could have been addressed on a timely basis if only the resources were made available now. Unfortunately, there was no one at the table honestly, and without a conflict of interests, representing those in need, offsetting the hospital industry, the insurance industry, the durable medical equipment providers, those who are promising health record vaporware, the associations of those who are addicted to feeding from the federal cash flow, and those who simply don't believe that the uninsured are worthy of help.

There simply isn't time to waste. Do it now. Fix our broken health care system.

A Tale of Two Companies

In a recent blog, I described problems with one highly advertised diabetic supply company which I did not name because my policy is to praise in public and criticize privately.

In contrast, today's blog describes the straightforward and appropriate response which I received from Liberty Medical Supply's COO. A refreshing no-nonsense letter, strikingly different from the other company's responses. And because of the difficulties I experienced, without hesitation Liberty offered (and I accepted) to provide me with Accu-Chek lancets, a clearly superior product.

Here is Liberty's Chief Operating Officer response to my letter criticising Liberty's "generic" lancets:

"Dear Dr. Kaplan,
Thank you for your thoughtful letter regarding Liberty and One Touch lancets. You bring up a valid point regarding the comfort levels provided by different lancets, and I wanted to reply to you personally.

"To give you some background, over the past six months, all Liberty lancets have been moved from 28 gauge to 30 gauge, compared to One Touch lancets, which are 25 gauge.

"For you, and all patients with diabetes, finding the least painful method of obtaining a blood sample is crucial. I am sorry that you were not pleased with Liberty's lancets.

"As of this date, Liberty's lancet manufacturer is complying with our instruction to install new molds, which should eliminate the plastic problem and the slight bend that can occur on the shaft when the plastic cap is twisted off. Also, the new needles have a tri-beveled and electro-polished finish to improve the discomfort of finger sticking. And finally, by May 2009, all Liberty lancets will be made on fully robotic systems that will significantly tighten tolerance levels and quality in lancet manufacturing.

"At Liberty, we understand the importance of lancets in managing diabetes and we are
constantly looking to improve upon the products we offer, Again, Dr. Kaplan, thank you for contacting us. If I can be of further assistance, do not hesitate to contact me directly at 772-398-5822.

Sincerely,
Keith W. Jones
Chief Operatlng Officer
Liberty Medical Supply, Inc."

Liberty Medical

Will Your Health Information Be Secure?

Today, President-Elect Obama announced his goal of having all medical records computerized in five years.

Approximately 10 days ago, a team (Alexander Sotirov, Marc Stevens,
Jacob Appelbaum, Arjen Lenstra, David Molnar, Dag Arne Osvik, Benne de Weger) "...identified a vulnerability in the Internet Public Key Infrastructure (PKI) used to issue digital certificates for secure websites. As a proof of concept we executed a practical attack scenario and successfully created a rogue Certification Authority (CA) certificate trusted by all common web browsers. This certificate allows us to impersonate any website on the Internet, including banking and e-commerce sites secured using the HTTPS protocol." http://www.win.tue.nl/hashclash/rogue-ca/

Because access is not assured secure, computer medical records, which hold your and my highly personal and sensitive information, are not secure. A team has documented its ability to break a major security system used by financial agencies. Hackers will be attracted to the new challenge of computerized medical records like maggots to old meat.

Medicare's Policy Concerning Diabetic Supplies

Letter from Noridian Administrative Services LLC (Medicare Fiscal Intermediary) in response to my letter [see blog Jan. 5, 2009] Again, I have redacted certain information.:

The Centers for Medicare and Medicaid Services has asked that I respond to your inquiry regarding the generic diabetic supplies that you had received through ______ Pharmacy Service/_________.

"Medicare does not differentiate between generic and name brand diabetic supplies. As long as the Statistical Analysis Durable Medicare Equipment Regional Carrier (SADMERC) has approved the ________ lancet device and lancets, then they can bill them to Medicare using HCPC A4258 and A4259. Payments for these supplies are the same whether they are name brand or generic.

" ______ corporate policy is to provide generic products such as lancets/lancing devices to new patients. ______ should be more forthcoming with this type of information and hopefully with your feedback they will be more open with new patients regarding this policy.

If you have additional questions on Medicare coverage, you may contact the Centers for Medicare & Medicaid Services Customer Service Center at 1-800-MEDICARE (1-800-633-4227).
Sincerely

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