In attempt to more logically catalog posts, articles will no longer be posted under the heading "Juvan's Health Law Recap." Nevertheless, this blog will continue to track legal developments affecting the health care industry on a weekly basis.
With the presidential campaign full speed ahead, coverage of the candidates' views on health care has dramatically increased. Unfortunately, though news coverage has increased, according to leading news organizations, as is often the case, many of the candidates are weary about presenting too defined of a plan for universal health care in fear that they may turn off certain supporters they desperately need to win. Focusing on the lackluster attention universal health care has gotten by the candidates in recent days, USA Today reports that
Attempting to differentiate himself from other candidates, John Edwards has gotten positive press for his calls to cure the system. Recently, as quoted by the Associated Press, Edwards stated, "I believe this in my soul: That no matter who your daddy is or where you live, or what the color of their skin is, every single one of us has value." He continued, "But if we believe those things, we have to act on them. If we believe that, we should have universal healthcare in our country."
Perhaps the subject of universal health care hits closest home to Edwards, whose wife Elizabeth was recently diagnosed with an incurable recurrence of breast cancer. When I asked Ms. Edwards about the Edwards plan for universal health care at a campaign stop to Cleveland after the news hit, Ms. Edwards stated that she understood that the worries from a devastating diagnosis are significantly exacerbated by financial woes when a patient lacks health care coverage.
While some of the candidates are unwilling to be forthcoming with their plans, a few with less to lose politically took significant steps to reform the system last week. Senator Edward M. Kennedy and Representative John Dingell introduced a bill that would extend Medicare coverage to all Americans, including those who are currently not eligible because of their age. In a press release, Kennedy stated, "The nation's health care has reached such a crisis point that the American people are looking for bold action. . . . I believe that the best plan for the nation is to build on a program that all Americans know and respect by creating Medicare for All. Medicare administrative costs are low. Patient satisfaction is high . . . . And all Americans will be free from the fear of medical expenses that enable them to seek the best possible care when illness strikes."
If you are interested in the subject of universal health care, see also Does Universal Health Care Have a Chance?
**Though this article provides a positive note about the Edwards campaign, Juvan's Health Law Update will aim in future posts to also highlight positives for the other candidates.
Last week, I attended and presented at the Pharma IQ conference entitled "e-Pedigree and Business Strategies for Drug Supply Security" held in Philadelphia, Pennsylvania. At the conference, Tim Marsh from Pfizer, Inc. discussed Pfizer's anti-counterfeiting strategies, Dennis Luken, a detective with the Warren county, Ohio drug task force and the National Treasurer of the National Association of Drug Diversion Investigators reviewed the problem of drug diversion and counterfeiting in 2007, while Jim Christian from Novartis AG emphasized that RFID and track and trace technologies are not "solutions" to the counterfeiting problem. Shay Reid, Vice President from Amerisource Bergen Corp., discussed Amerisource Bergen's attempts to become compliant with California's pedigree laws by 2009, and Robert Drucker from Rx USA Wholesale informed the audience about events that caused him to sue the FDA to prohibit the enforcement of regulations requiring secondary wholesalers to provide pedigrees tracing back to the manufacturer that fail to impose a concomitant obligation on authorized distributors. Attorney Michael Levine also discussed his involvement in the case and the status of the injunction. For those of you who are following the case, if you haven't already, I urge you to review the Pharmaceutical Market Access and Drug Safety Act of 2007, which includes language that, if implemented, would require manufacturers and authorized distributors of pharmaceuticals to likewise pass a pedigree.
While I was away in Philadelphia, the following stories made headlines:
See also the Proposed Decision Memorandum, available on the CMS web site.
Here's a review of some of the stories that captured the headlines last week:
As reported by the Kaiser Family Foundation and the American Health Lawyers Association, health care reimbursement and the financing crisis occupied health care news last week. Here's a look at a few financing/reimbursement related stories:
(1) New Physician Reimbursement Formula Proposed. The Medicare Payment Advisory Commission issued a report on physician reimbursement that proposes a shift from the Sustainable Growth Rate formula (which, if continued, would cause a decrease of 40% over the next eight years) to an alternative reimbursement approach. The Commission also suggested, inter alia, that physicians should receive more information regarding their overuse of procedures, that incentives should be adopted to encourage teamwork between providers, thereby increasing coordination, and that incentives should be adopted to encourage providers to provide more preventive care.
(2) Most Would Pay Increased Taxes to Fund Universal Health Care. The New York Times and CBS issued results of a survey indicating that at least 60% of adults would agree to pay higher taxes to fund universal health care.
(3) 9/11 First Responders Should Receive Medicare Benefits. Lawmakers claimed that additional funding should be allocated to treat first responders to the 9/11 attacks. To further that end, Senator Clinton and Representative Nadler will propose legislation to provide Medicare benefits to individuals with illnesses resulting from the aftermath of the attacks.
(4) Spitzer Defends Health Care Cuts. New York Governor Eliot Spitzer launched an ad campaign that defends his proposal to reduce spending on health care by $1 billion dollars.
(5) Medicare Part D Is Financially Irresponsible. U.S. Comptroller General David Walker discussed the financial irresponsibility of Medicare Part D when he stated that "Medicare--barring vast reform to the program and the nation's healthcare system--is already on course to possible bankrupt the treasury and adding the prescription bill just makes the situation worse."
Last week, Clevelanders spent most of their time digging out from the Valentine's Day Blizzard. On Wednesday, the latest snowfall count in Northeast Ohio totaled eighteen inches, and today we received another six more. To my friends who are glad that they don't live in a snow belt, there is an upside: the snow was so bad on Wednesday that most businesses shut down and called it a snow day (the downside--most Valentine's Day deliveries were postponed until Thursday)! Fortunately, I'll be leaving all of the snow behind and joining some of my friends in Florida who are laughing at our misfortune when I fly out to Orlando for a conference held by the American Health Lawyers Association.
Here's a look back at a few noteworthy events of the last week:
Looking to the upcoming weeks, the U.S. Court of Appeals for the District of Columbia will reconsider the Abigail Alliance case on March 1. The case addresses whether terminally ill patients have a constitutional right to obtain access to experimental medications.
Last week, the FDA cleared the way for the MammaPrint test, a diagnostic test designed to predict the likelihood of breast cancer recurrence. As a person with a family member who has battled this terrible disease, I can attest personally to the fact that breakthroughs such as this continue to bring renewed hope to survivors. While we all debate reimbursement rates, the impending health financing crisis and the like, one thing is certainly true: positive developments in modern medicine truly do have the ability to change lives.
In addition to FDA clearance for MammaPrint, President Bush last week proposed reducing Medicare and Medicaid spending by $101 billion over five years. In a controversial move, Bush has proposed to require wealthier seniors to pay higher Medicare premiums. Some have criticized Bush for failing to address a reduction in underlying costs and instead simply "just lopping off the top."
Looking forward to the week ahead, make sure to watch for news from the House Subcommittee on Oversight and Investigations hearing on FDA drug review deficiencies. The hearing is scheduled for Tuesday.
Finally, please note that, a few weeks ago, a reader alerted me to the fact that the comment feature on Juvan's Health Law Update was not enabled. This was a minor glitch that occurred when the blog was shifted from Typepad to Lexblog. Please note that comments have now been enabled. I encourage all of you to participate in commenting in the future, and I apologize to those whose comments were not timely published.
Jayne
Just when you thought the PDMA pedigree requirements set forth in 21 C.F.R. section 203.50(a) had retreated into the distance, the FDA attempted to breath new life into the law when it filed a notice of appeal before the Court of Appeals for the Second Circuit last week. While the FDA has fought back, there's no indication whatsoever from RX USA Wholesale that it intends to back down from the suit.
If the standard cited to in Magistrate Tomlinson's Report and Recommendation is in fact correct, it appears that the FDA has an uphill battle to fight to overturn the injunction. The Report and Recommendation, citing other Second Circuit cases, states that the decision to grant a preliminary injunction rests in the district court's sound discretion. A decision will only be overturned if the lower court abused its discretion. Abuse of discretion occurs if a lower court "applies the wrong legal standard, rests its decision on a clearly erroneous finding of fact, or issues an injunction containing an error of form or substance." The FDA will have to make a strong showing on at least one of these points to overturn the grant of the injunction.
In other news from the FDA last week, the FDA has officially responded to a report issued by the Institute of Medicine last year that launched multiple criticisms against the agency. The FDA further announced that it would begin sharing information with the Veterans Health Administration, a measure that many perhaps thought was already occurring.
It's hard to believe that January is already coming to a close. I immediately realized that we are full speed ahead into 2007 when I arrived at the gym this week, only to find that the parking lot was half full and that many of the good intentioned New Years resolutioners had dropped off!
President Bush's State of the Union address occupied the media last week. I covered President Bush's proposed solution to the health care insurance crisis a week ago, so I will not delve too deeply into these issues again. The Washington Post has followed the fall-out of Bush's proposal in two articles, one of which discusses the winners and losers in the plan (those who would buy individual insurance plans and those with employer-sponsored plans, respectively), and another of which states that the President's proposal received a "frosty reception from the Democrats." Bush's proposal may be falling on deaf ears, as his support is waning. As the bid for the White House looms closer, Juvan's Health Law Update will follow objectively (to the greatest extent possible) each of the candidate's views on health care.
Last week I also had the most sincere pleasure of meeting Rita Schwab, author of the popular health care blog known as the MSSPNexus Blog, which I highly recommend. For those of you who are unfamiliar, "MSSP" stands for medical staff service professional. Rita currently works in provider credentialing at the Cleveland Clinic. In addition to hosting the Health Wonk Review in the past (and receiving many accolades for her incredible coverage, I might add), Rita also covers provider credentialing, Joint Commission accreditation and patient safety concerns on her blog.
Rita and I had a wonderful conversation over lunch at the "Blog Cafe," as she calls it. We discussed issues affecting physicians and patients such as malpractice concerns and how the patient and physician communities might be brought more closely together. We also discussed our love for blogging and how incredible it is to connect to new found friends from all over the globe. I feel extremely fortunate to have met Rita, and so many other friends, through blogging!
Please note that Juvan's Health Law Recap will not be published on December 24, 2006 and December 31, 2006. Juvan's Health Law Recap will resume on January 7, 2007.
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