The Pharmacy Alliance

by Chris Moody in Site Information

Announcing

 

The first International meeting of

 

The Pharmacy Alliance

 

To be held over the weekend of April 19 & 20, 2008 in Galveston, Texas,

on the Gulf of Mexico.

 

The Purpose of The Pharmacy Alliance is to Foster Conditions that will allow Dignity, Self-Respect and Integrity in the

Personal, Professional and Working Lives of

all Pharmacy Practitioners

 

This message is going to practitioners in the United States, Canada, The United Kingdom, Australia, Indonesia, Germany and New Zealand.

 

My vision is that we create the trimtab for a brand new pharmacy organization.  One that will look out for the interests of the individual practitioner first and foremost.

 

I will hold the context in my hands.  That context will not be negotiable.  It is very simple. Dignity, Self-Repect and Integrity.  This is the bowl in which everything else can exist.

 

You guys can fill in the bowl with anything you want.  Examples:

 

Working conditions

Wages

Vacations

Professional Issues

Malpractice

Harassment

Robbery

Drug Diversion

Coupons

What a pharmacist will do and will not do    

 

Anything you want can be held in a context of Dignity, Self-Respect & Integrity.

I am willing to be the source and to hold the context.  This is my vision.

I will not be an officer

I will not be the one to fill the bowl

Jim Plagakis

Wednesday, August 22, 2007

 

Paul Trusten will be the secretary until we vote on officers at our meeting.  Amy Zynda has volunteered to act as treasurer

 

 Send us names, e-mail addresses (at least) of interested pharmacy practitioners.

We would like phones and USPS addresses also. 

Communicate with us at thepharmacyalliance@hotmail.com

 

Jim Plagakis

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Pharmacists in Haiti

by edmonroe316 in Site Information

I work with a group called Friends Of The Children Of Haiti (www.fotcoh.org). We are seeking pharmacists, and other medical personel, who would be interested in joining our group on a medical mission to the poorest third world country in the western hemisphere. While I am in Haiti, I write to a blog (www.whatseduptonow.blogspot,com) that will give you more insight into what goes on there in Haiti. It is personally rewarding,safe and there are no third party claims to process, no phones to answer, no cash or credit cards to process, and lots of opportunities to utilize your professional expertice. I would love to hear from you.

Under the Influence: Big Pharma bill passes at 3am

by Chris Moody in Site Information

A nice story from 60 Minutes on how a recent Pharma bill was passed…linked at http://www.cbsnews.com/stories/2007/03/29/60minutes/main2625305.shtmlFormer Louisiana congressman, Billy Tauzin accepted a $2 million-a-year job dollar as president of PhRMA — Pharmaceutical Research and Manufacturers of America only 6 months after the bill was passed.

Under The Influence

NEW YORK, April 1, 2007
(CBS) If you have ever wondered why the cost of prescription drugs in the United States are the highest in the world or why it’s illegal to import cheaper drugs from Canada or Mexico, you need look no further than the pharmaceutical lobby and its influence in Washington, D.C.  

According to a new report by the Center for Public Integrity, congressmen are outnumbered two to one by lobbyists for an industry that spends roughly a $100 million a year in campaign contributions and lobbying expenses to protect its profits.

One reason those profits have exceeded Wall Street expectations is the Medicare prescription drug bill. It was passed three-and-a-half years ago, but as 60 Minutes correspondent Steve Kroft reports, its effects are still reverberating through the halls of Congress, providing a window into how the lobby works.



The unorthodox roll call on one of the most expensive bills ever placed before the House of Representatives began in the middle of the night, long after most people in Washington had switched off C-SPAN and gone to sleep.  

The only witnesses were congressional staffers, hundreds of lobbyists, and U.S. Representatives like Dan Burton, R-Ill., and Walter Jones, R-N.C.

“The pharmaceutical lobbyists wrote the bill,” says Jones. “The bill was over 1,000 pages. And it got to the members of the House that morning, and we voted for it at about 3 a.m. in the morning.”

Why did the vote finally take place at 3 a.m.?

“Well, I think a lot of the shenanigans that were going on that night, they didn’t want on national television in primetime,” according to Burton.

“I’ve been in politics for 22 years,” says Jones, “and it was the ugliest night I have ever seen in 22 years.”

The legislation was the cornerstone of Republican’s domestic agenda and would extend limited prescription drugs coverage under Medicare to 41 million Americans, including 13 million who had never been covered before.

At an estimated cost of just under $400 billion over 10 years, it was the largest entitlement program in more than 40 years, and the debate broke down along party lines.

But when it came time cast ballots, the Republican leadership discovered that a number of key Republican congressmen had defected and joined the Democrats, arguing that the bill was too expensive and a sellout to the drug companies. Burton and Jones were among them.

“They’re suppose to have 15 minutes to leave the voting machines open and it was open for almost three hours,” Burton explains. “The votes were there to defeat the bill for two hours and 45 minutes and we had leaders going around and gathering around individuals, trying to twist their arms to get them to change their votes.”

Jones says the arm-twisting was horrible.

“We had a good friend from Michigan, Nick Smith, and they threatened to work against his son who wanted to run for his seat when he retired,” he recalls. “I saw a woman, a member of the House, a lady, crying when they came around her, trying to get her to change her votes. It was —it was ugly.”

When the prescription drug bill finally passed shortly before dawn, in the longest roll call in the history of the House of Representatives, much of the credit went to former Congressman Billy Tauzin, R-La., who steered it through the house.

“It’s just a messy process,” Tauzin says. “I mean, the old adage about if you like sausage or laws, you should not watch either one of them being made is true. It’s a messy process.”

Tauzin says that the voting machines were open for three hours “because the vote wasn’t finished.”

As for arms being twisted? “People were being talked to,” he says.

And of Walter Jones’ comment that it was the “ugliest night” he had “ever seen in politics in 22 years?”

“Well, he’s a young member,” counters Tauzin with a laugh. “Had he been around for 25 years, he’d have seen some uglier nights.”

It certainly wasn’t ugly for the drug lobby which invested more than $10 million in campaign contributions during the last election and has been a source of lucrative employment opportunities for congressmen when they leave office.

Former senators Dennis Deconcini, D-Ariz., and Steve Symms, R-Idaho, and former congressmen like Tom Downey, D-N.Y.; Vic Fazio, D-Calif.; Bill Paxon, R-N.Y., and former House Minority Leader Robert Michel, R-Ill., all registered as lobbyists for the drug industry and worked on the prescription drug bill.

“I can tell you that when the bill passed, there were better than 1,000 pharmaceutical lobbyists working on this,” says Rep. John Dingell, D-Mich.

Dingell has been in Congress for 52 years and is the new chairman of the House Energy and Commerce Committee which shares jurisdiction over Medicare. He says the bill would not have passed without the efforts of the drug lobby.

“There is probably a lotta truth in it that the bill was stacked in their benefit. And it’s probably also true that it was written by their lobbyists,” he says.

Says Jones: “You couldn’t even walk to the steps of the Capitol without having somebody, maybe one or two, coming up to you to say, ‘Can’t you change your vote? Can’t you vote for this bill?’ “

Why was the drug lobby was so interested in this bill and what did it have to gain? Ron Pollack the executive director of Families USA, a nonpartisan health care watchdog group, says it all boiled down to a key provision in the legislation.

It prohibited Medicare and the federal government from using its vast purchasing power to negotiate lower prices directly from the drug companies.

“The key goal was to make sure there’d be no interference in the drug companies’ abilities to charge high prices and to continue to increase those prices,” says Pollack.

Pollack says there’s no question that this was prompted by the pharmaceutical lobby.

“They were the ones who wanted to make sure Medicare could charge high prices and to continue to increase those prices,” he said.

The drug industry says that competition among private insurance plans that service the Medicare program help keep prices low. But Families USA reported in a January study that Medicare patients are being charged nearly 60 percent more for the top 20 drugs than veterans pay under a program run by the U.S. Department of Veterans Affairs.

For example, Lipitor, a popular cholesterol drug, the cheapest Medicare price is $785 for a years supply — 50 percent more than the VA’s price of $520.

For Zocor, another cholesterol drug, the best Medicare price is $1,485 for a years supply. The same drug only costs $127 a year under the VA’s plan.


Read the full Families USA report
  

Pollack says the VA successfully negotiates with the drug companies on price.

“Medicare could do the same thing,” he says, “but Medicare is prohibited from doing that as a result of this new Medicare legislation.”

“What was the logic? Or what was the idea, the rationale behind not giving the government the ability to negotiate drug prices?” asks Kroft.

Burton says it was simply that the drug companies didn’t want it.

“They wanted to make as much as money as possible. And if there’s negotiation, like there is in other countries around the world, then they’re gonna have their profit margin reduced,” he says.

Before the vote, Congress was told the program would cost a whopping $395 billion over the first 10 years. In fact, Medicare officials already knew it was going to cost a lot more.

Burton said he and others were misled.

“Within two weeks after the bill was passed, everybody knew it was gonna cost well over $500 billion,” he says. “And many members of the Congress [who] had voted for it said, ‘I would never have voted for it had I known that.’ “

Medicare Chief Actuary Richard Foster later told Congress that he revised the cost estimate to $534 before the vote, but was told to withhold the new numbers if he wanted to keep his job.

During a Congressional hearing, Foster stated: “It struck me there was a political basis for making that decision. I considered that inappropriate and, in fact, unethical.”

Foster said the person who told him to withhold Congress from getting the revised estimates was Medicare boss Tom Scully.

Scully was the administration’s lead negotiator on the prescription drug bill, and at the time was also negotiating a job for himself with a high-powered Washington law firm, where he became a lobbyist with the pharmaceutical industry.

“He was negotiating for his job at the same time that the Medicare legislation was being considered. He wound up taking this job 10 days after the president signed this legislation,” says Pollack.

It is but one example of the incestuous relationship between Congress and the industry, and just one of the reasons the pharmaceutical lobby almost never loses a political battle that affects its bottom line.

Former Congressman Billy Tauzin, who helped push the prescription drug bill through the House, didn’t disagree.

Has the bill been good for the drug industry?

“It’s been good for the patients whom the drug industry represents …” Tauzin says. “In terms of profits — [for the drug companies] and volumes, yes.”

Says Kroft: “Your old friend, John Dingell, says that of the 1,500 bills over the last 8 years dealing with pharmaceutical issues, the drug companies almost, without exception, have gotten what they wanted.”

“Yeah … I would think he’s correct. They’ve done fairly well,” replies Tauzin.

Why has this lobby been so successful? The former congressman says he believes it’s because they stood for the right things.

If Tauzin sounds a lot like a lobbyist for the drug industry, that’s because now he is.

Just a few months after the prescription drug bill passed, Tauzin began discussions with the pharmaceutical industry to become its chief lobbyist in Washington. He says it was one of several lucrative offers he’s received just before he got some very bad news.

“I got a call from a doctor in Bethesda who said, ‘You got cancer. And it’s extremely rare. And it could kill ya.’ And then everything changed,” Tauzin says.

Tauzin had a cancerous tumor removed from his intestines and was treated with a new medicine, called Avastin, that had never been used before on that form of cancer.

The treatment was successful, and as a result Tauzin says he felt he owed his life to the drug industry. After serving out his congressional term, he accepted a $2 million-a-year job dollar as president of PhRMA — Pharmaceutical Research and Manufacturers of America.

“There was an extraordinary moment when my wife literally looked me in the eye and said, ‘Look, you’re gonna do well wherever you go, Billy … You got a lot a great offers … And maybe you oughta think about working for the people that struggle everyday to try to invent the medicines that save lives like yours.’

“And that was a pretty important moment in my life,” Tauzin says. “And it was the moment I decided that this was the work I wanted to do — headaches and all.”

Jones and Burton agree that the perception of Tauzin’s move is not good.

“I mean, when you’re pushing so hard for a bill that’s controversial and you have to keep the machine open for three hours to get the one vote necessary to pass it, and then, within a matter of months you go to work for the industry that’s gonna benefit from it, it does cause you some concern,” says Burton.

They are not the only ones cynical about the decision.

“You push this bill through that produces a windfall for the drug companies. And then a short time later, you go to work for the drug lobby at a salary of $2 million. That doesn’t look good,” says Kroft.

“There was nothing I could’ve done in my life after leaving Congress that wouldn’t have had — I didn’t have some impact on in 25 years in Congress … If that looks bad to you, have at it,” Tauzin says. “That’s the truth.”

In fairness to Tauzin and former Medicare chief Tom Scully, they weren’t the only public officials involved with the prescription drug bill who later went to work for the pharmaceutical industry.

Just before the vote, Tauzin cited the people who had been most helpful in getting it passed. Among them:

  • John McManus, the staff director of the Ways and Means subcommittee on Health. Within a few months, he left Congress and started his own lobbying firm. Among his new clients was PhRMA, Pfizer, Eli Lilly and Merck.
  • Linda Fishman, from the majority side of the Finance Committee, left to become a lobbyist with the drug manufacturer Amgen.
  • Pat Morrisey, chief of staff of the Energy and Commerce Committee, took a job lobbying for drug companies Novartis and Hoffman-La Roche.
  • Jeremy Allen went to Johnson and Johnson.
  • Kathleen Weldon went to lobby for Biogen, a Bio-tech company.
  • Jim Barnette left to lobby for Hoffman-La Roche.
  • In all, at least 15 congressional staffers, congressmen and federal officials left to go to work for the pharmaceutical industry, whose profits were increased by several billion dollars.

    “I mean, they — they have unlimited resources. Unlimited,” Burton says. “And when they push real hard to get something accomplished in the Congress of the United States, they can get it done.”

    In January, one of the first things the new Democratic House of Representatives did was to make it mandatory for Medicare to negotiate lower prices with the drug companies.

    A similar measure faces stiff opposition in the Senate, where the drug lobby is spending millions of dollars to defeat it. The president has already announced that if the bill passes, he will veto it.

    methylphenidate & emotional outbursts

    by wuenst in Site Information

    I could use some advice from you for pediatric patients having emotional outbursts with methylphenidate in ADHD and what they recommended to reduce the frequency or severity of the outbursts. Any experience with clonidine or guanfacine or other recommendations except psychotherapy would be greatly appreciated. Thanks for your time & efforts!

    Chris Wuenstel PharmD
    Topeka, KS
    cshaw219@msn.com

    South Florida Perspective

    by UniPharm in Site Information

    Good afternoon all.   I have just read the latest fax regarding the upcoming interviews with pharmacists and CBS journalists.

    Here in South Florida, I have interviewed several times with a local CBS affiliate (CBS4) with Dr. Sean Kniff, MD.   He works both locally and nationally as a CBS journalist/doctor, I believe.   If you should ever need a South Florida perspective on things, please feel free to call upon me.   I would be more than happy to help out the cause of us independants if I can.

    Thank you for your time.

    Best Regards,

    William Nabors, R.Ph.

    University Pharmacy
    217 Valencia Avenue
    Coral Gables, FL 33134-5905
    tel:305-448-6116

    Let the Program Work

    by cphtphil in Site Information

    http://www.newsandobserver.com/580/story/568577.html

    Here is a link to a Letter to the Editor entitled, “Let the Program Work”, written to the News and Observer, serving the Raleigh, NC area. It was written by Chris Viehbacher, President of U.S. Pharmaceuticals for Glaxo. In it, he defends Medicare Part D in its current incarnation, citing the oft-reported 80% of satisfied seniors, costs and premiums lower than expected, and how price negotiations would not provide any real benefits or savings. I guess he is not aware that current drug prices under Part D are still about 40% higher than what the VA can get or that since February costs have risen about 5%.
    Well, I sent a Letter to the Editor in reply, which is yet to be published, of course. This seems to be a problem with me these days. I’ve sent three letters to another local paper, that were never published. Perhaps I’m too aggressive and hostile in my wording, though as far as I am concerned and others who looked at them, they were within the bounds of civility and the editor’s requirements.
    To be fair, they did publish letters of reply from patients who disagreed with Mr. Viehbacher…they were all in their “doughnut hole” as well. I bet if they did that survey now, with everyone in their doughnut hole, you wouldn’t get an 80% satisfactory response. Of course, we cannot expect too much from an executive of a corporation that withheld damaging data about one of its anti-depressants and had their representatives pushing its pediatric use in doctors’ offices.

    8/14/2006 Update; they published my letter to the editor today.

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    Centers for Medicare Services is blocking public disclosure of where our money is going

    by Richard Burge in Site Information

    In response to an inquiry by my Congreswoman (Anna Eshoo, D-Palo Alto) about the status of my Freedom of Information Act request for the UHC/WHI contract, CMS sent an unhelpful letter except that it does contain very revealing information about where they have drawn the proverbial line in the sand — and it is shamelessly on the side of Big Pharma.

    Just in case you may have thought the Centers for Medicare Services might be working for you, think again!

    This really isn’t so much a rejection as it is a canned response to something we already knew. In its circular path at addressing this problem, Congresswoman Eshoo inquired of CMS about the progress of my FOIA request and they responded that the only way to get the desired contract information is to file — you guessed it! — a FOIA request. Incredibly, they have already fixed the rules of the game to make that a waste of time!

    CMS admits “During 2005…….we reviewed each applicant’s agreements with its subcontractors, including network pharmacies.” Insomuch as most Part D reimbursement formulae were not even fleshed out until December, 2005, CMS clearly understood the network pharmacy agreements were non-negotiable by that time.

    The letter further explicitly states “CMS advised applicants that they could take steps to try to protect their information from disclosure under FOIA Exemption 4, which protects trade secrets and privileged or confidential commercial or financial information.”

    They went on to emphasize “that consistent with our approach under the Medicare Advantage program, we would not release information under the Medicare Part D program that would be considered proprietary in nature.”

    So, all the PBMs have to do is say that revealing their obscene profits is confidential and CMS has preemptively staked out its position to back them up. Yet, the PBMs have already begun publishing press releases and financial data, as required by the Securities and Exchange Commission, that show they are turning record profits and are attributing their success to their new Medicare Part D activities. The bottom line is that the big profits the Medicare insurers and PBMs are making are public enough to flaunt in the face of prospective stockholders and mutual fund managers but how they divvied up public money to do it — on the backs of U.S. taxpayers and at the expense of community pharmacists — is confidential and proprietary! I cannot be the only one who thinks this is a load of crap!

    CMS really wants to avoid comparing the cost of dispensing drugs under Part D versus pre-Part D and until they face up to that, all their claims about how successful the program has been are, at best, empty. At worst, they are false. Wouldn’t Medicare look stupid if, in the end, they could have just distributed drugs, with a modest co-pay, to seniors via the established Medicaid program already in place in 50 states and have been able to have done it cheaper? They certainly don’t want THAT looked into right now! Even dumber yet are the pending Medicaid cutbacks to take effect in 2007 as a part of the Deficit Reduction Act and Medicare Part D is one of the the biggest contributors to that deficit. This administration is dissembling our nation’s drug delivery system in front of our eyes in broad daylight!

    This is a watershed event obligating us to take immediate action to bring before the press. Many millions of dollars are being skimmed off of the Medicare drug program which, if applied to eliminating the unnecessary middlemen, would lower drug cost, improve pharmacy reimbursements and make health care more accessible to the public. That CMS would circle its wagons and shield the greedy insurers and PBMs from public scrutiny is shameful. CMS has the power (42 CFR 423 subpart 514) to require the plan sponsors to be answerable to the citizens of this country. The fact that it has chosen otherwise should encourage Congress and the Justice Department to be investigating why with all the resources at their disposal.

    It is apparently unnecessary to wait for CMS to drag its feet responding to all the FOIA requests submitted. We now know what their response will be — stonewall. Walgreens is still restraining trade by dictating non-negotiable reimbursement terms that they know are too low for independent pharmacies, their direct competitors, to be able to live with and, opportunistically, they’re offering to buy them out after having played a direct role in devaluing them. This is rigged and it’s crooked and why the press is tolerating CMS’s claims of how successful the Medicare Part D drug program is without peering beneath the surface is baffling to all of us.

    GET YOUR LOCAL PRESS INVOLVED NOW!

    IMPORTANT Reminder on Posting

    by Chris Moody in Site Information

    Hi all,

    The same problems keep popping up with users trying to format their own text with html, instead of moderating each post…the theme has been changed to allow for easier readibility and increased functionality.  It’s great to see how fast this site has grown and we hope that it continues to be a useful resource.  Many of the posts made are copied from emails or websites and that’s perfectly acceptable.  The only drawback is that many are riddled with their own formatting and html code.  This can change the font, size, spacing, and even throw off the sidebar on the right.  However, there is a quick fix

    If you are pasting an article, email, excerpt, etc…please paste it into Notepad or Wordpad before pasting it into the Wordpress Post.  99% of the time this will strip the preset formatting and allow for seamless transition.  This will prevent the downtime that occurs when things have to be manually changed.  As always, if you have something you want to be posted and aren’t sure how to post, feel free to email me and I’ll get to it as fast as I am able.

    Thanks for all of your support!

    Chris Moody
    thechrismoody@gmail.com

    We Need This Persistence!

    by Galia in Site Information

    Psychiatric Patients Win Medicare Part D Appeals

    Mark Moran During the course of evaluating Medicare Part D appeals, CMS clarifies that a dosage higher than that approved by the FDA should not be considered an off-label use and is thus not grounds to deny coverage.

    At least two psychiatric patients have successfully appealed medication denials under the Medicare Part D prescription drug program resulting in policy changes by the Centers for Medicare and Medicaid Services (CMS).

    The two patients, assisted by treating psychiatrists and staff in APA’s Office of Healthcare Systems and Financing, appealed their cases to an administrative law judge (ALJ) in the federal government’s Office of Medicare Hearings and Appeals.

    In one instance, the ALJ ruled in the patient’s favor, overturning the drug plan’s denial; in the other case, the drug plan withdrew its claim minutes before the hearing was to begin.

    Both appeals were the culmination of an arduous and—according to the testimony of a treating psychiatrist involved in one of the cases—exasperating process of seeking prior authorization from participating drug plans, second-tier appeal to an independent reviewer, and finally appeal to an ALJ. The cases, resolved in May and June, stemmed from coverage denials that began in the first days of the Part D program in January.

    “It’s easy for a drug plan to say `no’ to a patient; it’s not so easy for a physician to deal with the `no,’ ” said Irvin (Sam) Muszynski, J.D., director of the Office of Healthcare Systems and Financing, whose staff assisted psychiatrists in both cases in the extensive documentation required for the independent review and appeal to the ALJ.

    Importantly, both cases turned on a contention by drug companies that appears to be a common source of denials for psychiatric patients in the Part D program: that prescribed dosages of a drug are off label because they exceed the Food and Drug Administration (FDA) maximum allowable dose.

    Muszynski said that during the course of the two appeals, CMS clarified its policy, saying that a dosage higher than that approved by the FDA is not to be considered an off-label use and therefore not acceptable grounds for denial of medication by a Part D drug plan.

    “One of the most important outputs from pursuing these appeals is that we have worked closely with CMS, and policy changes have been made or are being made to clarify what was intended, meaning that physicians shouldn’t have to be pursuing these kinds of appeals in the future,” he said.

    “One of the policy changes that came about is that CMS has said to APA that we are right, a covered drug is one that is used for medically acceptable purposes, and that there is no support for denying a drug because a patient is receiving a dosage that exceeds the FDA limit,” Muszynski noted.

    One case involved a 48-year-old woman with severe refractory depression being treated with mirtazapine (90 mg a day), Wellbutrin XL (600 mg a day), and Cymbalta (120 mg a day).

    On January 1 the patient, whose medications had previously been paid for by Medicaid, was moved into Medicare Part D, and United HealthCare/AARP became the prescription drug plan responsible for providing her medications.

    On January 14 she attempted but failed to obtain prescribed dosages (60 pills a month) of the three drugs at a participating pharmacy because United limits the dispensing of all three medications to 30 pills a month.

    After several appeals by the patient’s physician, United denied the request, stating that “there is no significant clinical data to justify the use of a non-FDA approved dose.”

    The matter was then appealed to Maximus, the private independent review entity for the Medicare Part D program. On February 14, Maximus upheld the denial of coverage.

    The case was then appealed to the government’s ALJ.

    “After eight years of prescribing numerous combinations of various drugs, this combination is the only combination that has effectively treated [the patient’s] severe refractory depression,” according to the appeal. “Trial of appropriate duration at lower doses of all three drugs has been tried and has failed to provide [the patient] with any relief. Although the prescribed doses exceed standard doses for the prescribed medications, they are consistent with doses that practicing psychiatrists use to treat patients with chronic and persistent mental illness who have had an inadequate treatment response to lower doses.”

    Judge Backs Dosage Flexibility

    In a June 28 decision, Administrative Law Judge Douglas Jones agreed. “The beneficiary is entitled to an exception to the plan’s dosage restrictions…because she has demonstrated that the disputed items are medically necessary to the treatment of her depression, and the dosage amounts allowed by the plan make that treatment ineffective.”

    A similar case was resolved in the patient’s favor without an ALJ decision when Medco Health Solutions, the prescription plan responsible for the patient’s medications, withdrew its denial just minutes before the hearing was to take place.

    The case involved a 55-year-old woman being treated for schizoaffective disorder with amitriptyline, Geodon, and Effexor. At issue was the prescription of 160 mg of Geodon, twice a day.

    “Geodon at this dose level is an essential and medically necessary component of the clinical treatment of [the patient],” treating psychiatrist Elizabeth Delasante, M.D., of Baxter, Minn., stated in a seven-page letter to the ALJ written with the help of Muszynski and staff.
    “While the dose of 320 mg per day is prescribing at a different dose then indicated by FDA recommendations, when medically necessary, this dose is consistent with the doses that practicing psychiatrists use to treat patients with chronic and persistent mental illness who have had an inadequate treatment response to lower doses.”

    Delasante’s letter to the ALJ vividly illuminates the sometimes exhausting bureaucratic obstacles confronting some physicians treating patients in the new Part D program (see box).

    Yet the case was never heard.

    In a letter dated May 16 and delivered to Administrative Law Judge Joseph Pastrana minutes before the start of the hearing on May 17, Medco withdrew its denial citing a March 28 communication from CMS stating that dosage limitations were not a justifiable reason for denying medically necessary medication.
     
    Experience Exasperates Psychiatrist

    The experience has left Delasante with little good to say about Medco or the Part D program.

    “They never gave her the transition supply [mandated by CMS for dual-eligible patients transitioning into Medicare],” she told Psychiatric News. “They never did anything they were supposed to do. Through most of January and February we spent hours on the phone. I spent a total of nine and a half hours on the phone just trying to get a blank prior-authorization form.”

    In an interview with Psychiatric News, Edward Eisenberg, M.D., chief medical officer for Medco’s Medicare business, said companies have had two sources of information for determining appropriateness of drug coverage—FDA guidelines and four drug compendia—which have sometimes been in conflict. In the absence of clear guidance from CMS, Medco assumed that drugs prescribed at doses higher than approved by the FDA were not covered under Part D.

    When asked why the patient did not receive a transition supply of Geodon, when CMS policy had stipulated that patients stabilized on a particular regimen be covered during the transition to Part D, Eisenberg said here too CMS policy had been unclear: the transition policy pertained to drugs, but not to dosage amounts, he said.

    “The quantity of medication and dosage is one of the parameters that goes into our approval or denial of a drug,” he said. “Until we got this information from CMS, we and other plans and the independent review entities were considering such high dosages as not Part D drugs.

    “Nowhere in any of the guidance from CMS did they go beyond mention of the actual drug to include dosage or duration,” he said. “So our transition policy has been to continue patients on those drugs, but what we have now added is that the dose does not [exclude the drug from Part D coverage].”

    When asked why Medco waited until the day of the hearing to withdraw its denial when its own letter stated that CMS had clarified policy with regard to dose more than a month prior, a lawyer for the company said the CMS clarification did not come to the company’s attention until later.

    “Normally, CMS issues a formal memorandum,” Danielle Ruskin, vice president and counsel for government programs at Medco, told Psychiatric News. “But in this case, unbeknown to us, CMS issued an informal question-and-answer document in which it clarified its policy, so it didn’t come to our attention until later. We had been under the impression that CMS would support our denial.”

    Whether Delasante’s experience is typical is hard to gauge. Muszynski, whose staff is working on at least a dozen cases seeking independent review of medication denials, said psychiatrists in some parts of the country report that most of the problems that plagued the Part D program in January have been resolved.

    Yet others continue to report a range of problems. APA has learned that some companies are withholding coverage of injectable antipsychotics on the grounds that they are covered under Part B (which covers drugs administered in a physician’s office).

    “We need more feedback from the field,” he said. “We get different reports from different parts of the country.”

    Muszynski urges psychiatrists to report their experience with Part D to APA. Members can contact the Part D monitoring system by e-mail at partd@psych.org or by phone at (866) 882-6227. APA is continuing to post information about the program at www.mentalhealthpartd.org.

     

    “CMS (Centers for Medicare and Medicaid Services) Officials to Address the Future of Medicare Part D”

    by Galia in Site Information

    http://biz.yahoo.com/prnews/060801/nytu013.html?.v=56

    “The complete list of participating companies and institutions include: American Benefits Council; American Society of Clinical Oncology; Amgen; Arnold & Porter; Benefits Data Trust; Biotechnology Industry Organization; Bristol-Myers Squibb; Campbell Alliance; Centers for Medicare and Medicaid Services; Elan Pharmaceuticals; Express Scripts; Health Policy Institute at the University of the Sciences in Philadelphia; Hewitt Associates; Hillco Partners; Independence Blue Cross; Johnson & Johnson; Manatt, Phelps and Phillips; National Employee Benefits Companies; Pfizer; Segal; Tens Project; The Dow Chemical Company; Wellcare.”

    Why didnt they include pharmacists????? i thought we were on the front lines??????

    where should we protest this???