Juvan's Health Law & Private Equity Report : Corporate & Health Care Lawyer & Attorney : Jayne Juvan : Benesch Friedlander Law Firm : Private Equity, Corporate Governance

Yesterday, in a devastating blow to terminally ill patients seeking use of experimental drugs, the United States Supreme Court refused to hear an appeal of a ruling by a divided federal appeals court that denies the right of access. 

Juvan's Health Law Update has been following the case for some time.  For coverage of the case by this blog, see D.C. Appeals Court Rules Against Abigail Alliance and D.C. Circuit Vacates Abigail Alliance Decision, Orders Rehearing.

• Email This
• Print
• Comments
• Trackbacks

It is well known that most health care providers are subject to complex laws and regulations.  Unlike traditional health care providers, however, pharmaceutical representatives have generally successfully positioned themselves beyond the scope of the health care rules, making the requirements and accompanying penalties for noncompliance inapplicable.  In a noteworthy move, however, council members in Washington D.C. have taken aim at this profession by passing a measure that requires pharmaceutical representatives to obtain licenses and prohibits these representatives from knowingly providing false information to providers.  The legislation now brings the profession within the complex web of health care laws and rules applicable to traditional health care providers.

In the press release discussing the legislation, councilman David Catania stated that  pharmaceutical representatives "have come to play a huge role in our health care system, and it's time to start treating them as healthcare providers." He further stated that "[t]he current system promotes the use of the latest, most expensive drugs at the expense of the best, most effective ones.  This is a major problem for our overall healthcare system." 

Will this be the tipping point that causes other state legislatures to adopt similar measures?

• Email This
• Print
• Comments
• Trackbacks

According to Dr. Adam Fein from Drug Channels, U.S. District Court Judge Royce Lamberth has granted an injunction that temporarily prohibits the Centers for Medicare and Medicaid Services from adopting the average manufacturer price rule (the "AMP Rule").  As previously discussed on Juvan's Health Law Update, the AMP Rule establishes a new methodology for calculating Medicaid reimbursement rates for prescription drugs.  The court's move bears a striking resemblance to the grant of the injunction that prohibited implementation of certain provisions of the PDMA last year.  

I'm in the process of undertaking a full review of the move (according to the Associated Press, the decision will be released Tuesday) and will update this post shortly.  In the meantime, I'd suggest that you head on over to Dr. Fein's blog for his witty analysis.  This time, he's gone so far as to agree to refund the subscription fee of his readers because his prediction was, well, let's just say slightly off.  "In Analysis of AMP Lawsuit Odds last month," he writes, "I incorrectly predicted that the injunction would not be granted. (Thanks a lot, Arnie Becker!) Naturally, I will be happy to refund your subscription fee to Drug Channels."

Given the current state of the economy, I might just have to take him up on his offer! 

• Email This
• Print
• Comments (2)
• Trackbacks

In comparison to the Food and Drug Administration, "OIG investigators can more appropriately handle sensitive internal employee misconduct inquiries because OIG investigators are entirely independent of the programs and officials being investigated," wrote Daniel Levinson, Inspector General of the United States Department of Health and Human Services to Andrew C. von Eschenbach,  Commissioner, Food and Drug Administration, on September 6.  Further slapping the Commissioner on the wrist, the letter boldly declares to von Eschenbach the Inpector General's intention to terminate the Memorandum of Understanding between the two parties negotiated in 1998.  The letter states, "Increased congressional and media scrutiny regarding allegations of potential criminal violations of Federal conflict-of-interest statutes and regulations involving FDA and other officials in the Department has resulted in OIG's devoting increased attention and resources to ethics issues.  As a result, OIG investigators and attorneys have developed significant expertise in handling these complex cases."  

Commissioner von Eschenbach was unwilling to accept Levinson's decision without offering a carefully crafted reply.  Though von Eschenbach is willing to discuss implementation of the decision, he felt the need to put the Memorandum of Understanding "in historical perspective and to correct some of the misleading impressions your note to me may create to readers who are not familiar with the facts."

November 30 became the effective date of the change.  In a press release, Senator Chuck Grassley noted, “Cutting the tie is good for the public. It strengthens the role of the Inspector General. And in our system, the Inspectors General are vitally important independent watchdogs within the federal bureaucracy.”

• Email This
• Print
• Comments
• Trackbacks

Projections estimated that the Medicare Part D drug program in 2006 would cost the federal government approximately $59 billion dollars.  However, according to a report released just over a week ago by the United States Department of Health and Human Services, Office of Inspector General, actual costs for 2006 came in surprisingly low at $47 billion dollars--that's right--$12 billion dollars less than the estimates.  

So, what accounts for the discrepancy? 

According to the report, generic drug utilization makes up the difference.  Generic drugs cost about 71% less than their brand name equivalents.

Continue Reading...

• Email This
• Print
• Comments
• Trackbacks

In The Age of Turbulence,[1]  Alan Greenspan offers a lengthy assessment of the development of China over the past several years.  He contemplates not only the success experienced by China, but, especially in Chapter 14, entitled "The Choices that Await China," undertakes a review of challenges that may lie ahead. 

Specifically, Greenspan identifies the development of property rights as continuing to elude China.  Though "the National People's Congress passed a more comprehensive right of ownership that grants the same legal protection of property that is granted to the state . . . . the right to own property," he says, "still falls far short of the status of property rights in developed countries."  He continues,

Property rights require not only a statute but an administrative and judicial system that enforces the law.  In this regard, China lags.  An impartial judiciary is still a goal on the Chinese horizon.  There are breaches, especially in intellectual property rights:  complaints by foreign joint venture investors are rife that technology brought to a new plant turns up duplicated in a plant wholly owned by Chinese in direct competition. . . . I have no doubt that the Communist Party of China can maintain an authoritarian, quasi-capitalist, relatively prosperous regime for a time.  But without the political safety valve of the democratic process, I doubt the long-term success of such a regime.  How those choices evolve will have profound implications not only for China but also for the world at large . . . .

The status of Chinese law and enforcement generally, and intellectual property protections in China in particular, no doubt will have an impact on many of the readers of this blog.  Given this blog's continued focus on pharmaceutical counterfeiting issues, and in light of Greenspan's remarks, a review Chinese intellectual property law along with measures companies can take to increase the likelihood of intellectual property protection is in order.  It is with this in mind that I offer the article that follows, which I drafted several months ago in response to an issue that arose in connection with my practice.

Continue Reading...

• Email This
• Print
• Comments (1)
• Trackbacks

Dr. Adam Fein from Drug Channels has recently reported that, on November 7, 2007, the National Association of Chain Drug Stores (“NACDS”) and the National Community Pharmacists Association (“NCPA”, and, collectively with NACDS, the “Plaintiffs”) sued to enjoin the United States Department of Health and Human Services (“HHS”), Michael O. Leavitt, Secretary of HHS (“Leavitt”) (in his official capacity only), the Centers for Medicare and Medicaid Services (“CMS”) and Kerry Weems, CMS Acting Administrator (“Weems”, and, collectively with HHS, CMS and Leavitt, the “Defendants”) (in his official capacity only) from enforcing the final rule issued July 17, 2007 that establishes a new methodology for calculating Medicaid reimbursement rates for prescription drugs (referred to by the Plaintiffs as the “AMP Rule”). For those interested in following the case, Dr. Fein's blog includes links to several of the important documents.

On the merits, the Complaint alleges that court should not only issue an injunction, but also declare that the AMP Rule is illegal because the

AMP Rule is contrary to the plain language of the Social Security Act, contrary to Congress’ clear intent when it enacted that statute, contrary to Defendants’ prior application of that statute, contrary to dozens of other federal and state statutes and regulations, contrary to long-standing industry practices, and contrary to common sense.

Though I’d certainly enjoy providing commentary concerning the merits of the case, given my representation of certain retail pharmacies, I must decline the opportunity at this time. Nevertheless, I thought insight concerning the D.C. Circuit's standard applicable to a request for a preliminary injunction might be helpful to those following the case.  

In his recent post, Dr. Fein references the preliminary injunction standard applied by the Second Circuit last December in RxUSA Wholesale v. DHHS. The case filed by the Plaintiffs is before the D.C. Circuit and the court could, at least theoretically, apply a standard that departs signficantly from that applied by the Second Circuit.  Thus, a review of D.C. Circuit case law is in order.

A review of D.C. Circuit case law has revealed that the standard applied by the D.C. Circuit is actually quite similar to that applied by the Second Circuit in RxUSA Wholesale. Echoing similar language used by the Second Circuit, the D.C. Circuit has indicated that the standard is quite high. In Chaplaincy of Full Gospel Churches v. England, 454 F.3d 290 (D.C. Cir. 2006), the court noted a preliminary injunction is “an extraordinary remedy that should be granted only when the party seeking the relief, by a clear showing, carries the burden of persuasion.” Id. (quoting Cobell v. Norton, 391 F.3d 251, 258 (D.C. Cir. 2004). 

The D.C. Circuit considers the following factors:

1. a substantial likelihood of success on the merits,
2. that the movant would suffer irreparable injury if the injunction were not granted,
3. that an injunction would not substantially injury other interested parties, and
4. that the public interest would be furthered by the injunction.

If the showing on one factor is particularly strong but the case in support of the other factors is weak, the court may grant the injunction if irreparable harm is present. If the other three factors weigh in favor of granting the preliminary injunction but irreparable harm is absent, the requested injunction should be denied. Accordingly, the analysis focuses largely around the demonstration of irreparable harm.

The showing of irreparable harm requires that the movant demonstrate an injury that is not merely theoretical, but instead is both actual and great. As stated by the D.C. Circuit,

The key word in this consideration is irreparable. Mere injuries, however, substantial, in terms of money, time and energy necessarily expended in the absence of a stay are not enough. The possibility that adequate compensatory or other corrective relief will be available at a later date, in the ordinary course of litigation, weighs heavily against a claim of irreparable harm. 

(emphasis added).

Thus, if, for example, damages are adequate to atone for the harm caused, the request for an injunction should be denied.

In the case at issue, the Plaintiffs have alleged that the balance weighs in favor of a grant of the injunction because:

a.  It is always in the public interest that agencies faithfully fulfill statutory mandates;

b.  Retail pharmacies, Medicaid patients and the general public will incur substantial, imminent and irreparable harm if the AMP Rule goes into effect and flawed AMP data are posted on a public website; and

c.  A delay for CMS to promulgate a final rule that conforms with the Social Security Act and Congressional intent will not harm the Defendants.

On this one, while I’d love to chime in, I’ll leave it to you to speculate about whether the Plaintiffs will experience the same success as did RxUSA Wholesale around this time last year.

• Email This
• Print
• Comments (1)
• Trackbacks

On October 4, the United States Food and Drug Administration announced that it will hold a meeting on November 14, 2007 at the National Transportation Safety Board Conference Center from 8:00 to 5:00 to review the creation of a new category of drugs--"behind the counter" drugs.  Currently, drugs are divided into two classes, including over-the-counter drugs, or non-prescription drugs, and prescription drugs.  Access to the drugs in this new class would be available without a prescription, but only after a pharmacist intervenes and offers approval.  Supporters argue that the behind the counter classification will benefit patients without health insurance who otherwise would not have access to drugs they need.

• Email This
• Print
• Comments
• Trackbacks

Yesterday, the United States Court of Appeals for the District of Columbia Circuit, overturning a panel decision of judges in the same court in a case filed in 2003 by the Abigail Alliance for Better Access to Developmental Drugs, found that there is no fundamental right "deeply rooted in this nation's history and tradition" to access experimental medications before they receive approval from the United States Food and Drug Administration. 

Related Reading:

New York Times, Court Rejects the Right to Use Drugs Being Tested

Washington Times/Associated Press, Terminally Ill Lose Case for Shot at Experimental Drugs

• Email This
• Print
• Comments
• Trackbacks

If you are interested in tracking incidents involving counterfeit drugs, SafeMedicines.org covers international counterfeit drug developments.  For example, the site provides links to a Washington Post article covering China's attempts to strengthen safety controls, along with discussion of China's recent discovery of 18,000 fake Viagra pills and Health Canada's new anti-counterfeiting strategy launched in response, at least in part, to the death of a woman who took counterfeit anxiety drugs purchased online and the deaths of four Ontario residents who took counterfeit heart drugs.

• Email This
• Print
• Comments (2)
• Trackbacks

Targeted Genetics Corporation ("Targeted Genetics") has alerted the Food and Drug Administration ("FDA") that a patient who received an investigational drug for the treatment of active inflammatory arthritis died shortly after injection.  The clinical trial is now on hold, meaning that enrollment is currently closed and the more than one hundred current participants will no longer receive doses of the drug. 

Describing the drug, the FDA states,

The product that was being studied uses a particle called a vector that is designed to deliver treatment genes to target cells. The vector used is a recombinant adeno-associated virus (AAV) derived vector and delivers the gene for Tumor-Necrosis Factor -Receptor, with the intent to inhibit a key mediator of inflammation. In the study, the gene therapy was administered into the joint affected by the disease to reduce inflammation and disease in patients with active inflammatory arthritis.

The FDA, with the assistance of the National Institutes of Health, is investigating whether the event was related to the treatment and stated that Targeted Genetics is cooperating with the investigation. 

 

• Email This
• Print
• Comments
• Trackbacks

On July 12, Representative Peter DeFazio and other co-sponsors introduced H.R. 3023, also known as the "Drug and Medical Device Company Gift Disclosure Act," which proposes to mandate that drug and medical device companies disclose annually, and the Food and Drug Administration to publicize on its web site, the value, nature, and purpose of any marketing or promotional gift over $50 given to health professionals.  Supporting the legislation, Representative DeFazio's press release states, "There's a difference between educating doctors on the uses and effects of new drugs and enticing healthcare professionals with lavish gifts.  This bill will keep the pharmaceutical industry honest." 

The bill defines the term “gift” to mean “any gift, fee, payment, subsidy, amenity, object, service, or other economic benefit.”  Several items are exempted from the definition, however, including free drug samples and scholarships for medical students and residents. 

If passed in its current form, stiff penalties will apply for noncompliance, including civil monetary penalties of not more than $10,000 for each violation.

 

• Email This
• Print
• Comments
• Trackbacks

On Monday, the Food and Drug Administration ("FDA") advised consumers to refrain from purchasing prescription drugs over the internet, citing multiple safety concerns, including risks associated with improper labeling and packaging.  The press release warned consumers that certain drugs available online have been withdrawn by the FDA in response to safety and efficacy concerns and suggested that generic drugs may actually be cheaper than the costs charged online by internet sellers, as many national pharmacy chains offer drugs for $4 per prescription.   

• Email This
• Print
• Comments (1)
• Trackbacks

"Oncologists do not usually need bodyguards when they present scientific data at a medical symposium," writes Rob Stein of the Washington Post, "[b]ut when Howard I Scher of Memorial Sloan-Kettering Cancer Center and Maha Hussain of the University of Michigan spoke at a recent meeting of the American Society of Clinical Oncology, they were in fear of their safety." 

According to Stein, the two physicians encouraged the Food and Drug Administration ("FDA") to delay approval of Provenge, a drug designed to treat advanced prostate cancer, causing some investors, patients and patient advocates to voice their dismay.  Some, he reports, have placed "vitriolic postings" on the internet, while, according to the two doctors, others have threatened them.  Of the threats, Hussain stated, "We have been harassed and trashed for giving our opinion in an area of our expertise. . . . It's been a nightmare, to say the least." 

Frank Burroughs, a spokesperson for Abigail Alliance, the group that sued the FDA in attempt to obtain increased access to experimental medications for the terminally ill, voiced support for allowing access to the drug for terminally ill patients.  He stated, "What we're saying is that when you have a drug like Provenge, you should let people have access to it who have run out of options."

• Email This
• Print
• Comments
• Trackbacks

I have been on a short hiatus due to finishing major projects for clients and traveling to the east coast on business (special thanks to my friends at the New York City office of Crowell & Moring for their hospitality), but haven't stopped tracking developments on the drug counterfeiting front.  For my readers following these issues closely, if you haven't already done so, I would suggest that you review the posts listed below from two knowledgeable, savvy bloggers:

• Pfizer Questions RFID, published by Dr. Adam Fein, author of Drug Channels.  The post discusses an interview with John Theriault, Pfizer's vice president of global security, published by the Star Ledger.
• Counterfeit Drugs and the American Enterprise Institute, published by Eric Turkewitz of the Turkewitz law firm.  The post profiles an article entitled Bad Medicine in the Market written by Roger Bate and Kathryn Boateng. 

 

• Email This
• Print
• Comments
• Trackbacks

As many of my readers know, particularly including those who are lawyers, tracking pending legislation affecting the pharmaceutical and medical device industries on both a state by state and federal basis can be an especially daunting task.  Obviously, these industries are highly regulated, and as each new issue presents itself, the federal and state legislatures do what they do best:  legislate some more!  The result is a highly complex, almost rainbow-like color scheme of regulations that are often inconsistent, contradictory and sometimes, well, nonsensical (my apologies in advance to the decision makers).

With the help of Matthew Samsa, a summer associate at Benesch, I have located a fabulous tracking source that I can't help but share.  I'd suggest that you check out the 2007 Prescription Drug State Legislation tracker, hosted by the National Conference of State Legislatures, which is the "Forum of America's Ideas."  So, for example, what does Colorado have to say about pedigree legislation?  According to the site, legislation was just passed that "[w]ould regulate prescription drug wholesalers; including requiring criminal history background checks of applicant representatives, updating requirement for maintaining and retaining "pedigree" records to prevent or diversion to unauthorized buyers." The site further mentions the following status information:  "Filed 3/6/07; passed Senate 4/2/07; passed House 4/12/07; amended and sent to governor 5/15/07."

Of course, I can't make any representations or warranties about the accuracy of the content and how often the site is updated (if only I could write without including a disclaimer).  I can say, however, that this site may make tracking state legislation affecting the pharmaceutical industry a far more manageable task.  If you're at all like me, you probably feel like a kid in a candy store right now.  Enjoy!

• Email This
• Print
• Comments
• Trackbacks

"Unauthorized" or "secondary" wholesalers have continued to demonstrate their commitment to overcoming federal pedigree laws that impose an obligation on them to track the chain of custody of drugs back to the manufacturer.  An organized group of these parties recently filed an amicus curiae brief with the United States Court of Appeals for the Second Circuit, arguing that the law violates the United States Constitution for failing to place the same pedigree requirements on authorized distributors, or those distributors that have entered into distribution agreements with manufacturers.  The brief argues that the law would, in effect, put these companies out of business because compliance would be impossible. 

The National Coalition of Pharmaceutical Distributors, Inc. filed the brief.  Without going into too many of the legal arguments set forth therein, essentially, the brief elaborates on several of the points made in the plaintiffs' filings to date and argues that the injunction put into place by the district court that has temporarily prohibited the enforcement of the implementing regulations ought to remain in effect. 

For those readers who are unfamilar,  "amicus curiae"  is a latin phrase that means "friend of the court."   An amicus curiae brief allows a person who is not a party to a case to file a document that provides additional information on a point of law a court is considering in attempt to provide guidance.  Academics also may file treatises with a court that present an academic discussion.

While these secondary wholesalers have refused to back down, many supporting the "big three" authorized distributors have consistently argued that the secondary market poses the greatest risk to the safety of the supply chain and therefore ought to be subject to the most stringent requirements.     

• Email This
• Print
• Comments (1)
• Trackbacks

In an effort to better inform the public about drug and patient safety information, PhRMA has launched new web site pages.   In its press release about the new web pages, PhRMA states as follows:

• Patient safety is our highest priority. We need a strong and effective FDA with the resources and personnel necessary to ensure the safety of the U.S. drug supply and continued access to innovative medicines.
• Patient welfare should be at the center of any effort to enhance drug safety and ensure that benefit and risk are balanced.
• Drug safety and effectiveness monitoring must be comprehensive and continuous. PhRMA supports efforts that seek to continually improve these activities.
• Patients and health care providers must have accurate, timely, and useful information on which to base their decisions.  

• Email This
• Print
• Comments
• Trackbacks

The Health Rythym Society has reported that a preliminary study has indicated that iPods and other MP3 players may interfere with pacemakers.  According to the press release, Continue Reading...

• Email This
• Print
• Comments
• Trackbacks

About a week ago, the Senate passed S.1082, which is also known as the Food and Drug Administration Revitalization Act (the "Act").  The following is a well done report posted by the RFID Law Blog that details a provision included in the Act that strikes a blow to the RFID industry.

Last week, the US Senate passed legislation that reauthorized the federal user fees on pharmaceuticals that help fund the FDA. Buried in the legislation was a provision -- posted earlier on this blog site -- authored by Senator Judd Gregg of New Hampshire, that would require Internet pharmacies selling to US citizens to use tracking technology to minimize the risk of counterfeiting.
An amendment to that language, offered by Senator Michael Enzi of Wyoming, legislates a specific technology solution - and it's not RFID. Indeed, it specifically excludes anti-counterfeiting technologies like RFID or barcodes that require readers, scanners or other devices to verify authenticity -- replacing the FDA's preferred tools with anti-counterfeiting technologies akin to those used on US currency.

I'd highly recommend that you check out the site to read the entire blog post.  RFID Update also offers interesting spin in its article New Law Serves as Warning to RFID Industry and cautions that the industry must take Washington and the lobbying scene very seriously if it intends to be a true player.  The article states, "While this internet pharmacy provision is unlikely to cause long-term detrimental harm to RFID adoption, it can be viewed as a lesson of what can happen if the industry does not more actively engage with Washington." 

The Act has yet to be considered by the United States House of Representatives.

• Email This
• Print
• Comments
• Trackbacks

I have agreed to participate in a Q & A on drug pedigree laws sponsored by CIO Magazine and CSO Online.  Here's the description that has been published: 

Have a question about the legal requirements for RFID and e-pedigree in the pharmaceutical supply chain? Jayne Juvan, an attorney at Benesch Friedlander Coplan & Aronoff in Cleveland, is available to answer reader questions throughout May. Juvan specializes in the healthcare industry and represents pharmaceutical companies throughout the supply chain, as well as hospitals, physician groups and other related services.

 

 

• Email This
• Print
• Comments
• Trackbacks

Ask James Christian from Novartis AG whether he believes that RFID is the "solution" to halting drug counterfeiting, and, based upon his remarks at the recent IQPC/Pharma IQ e-pedigree conference, I'd surmise that he'll likely question whether the word "solution" should be used at all.  Shay Reid chuckled as he introduced himself at the conference not long after Christian concluded his remarks, as he is AmerisourceBergen's vice president of integrated solutions. 

So, contrary to what Christian may contend, is RFID in fact the solution to the drug counterfeiting problem?  In CIO Magazine, Sarah Scalet, a senior editor for the publication, takes this question head on as she reveals the following five myths about RFID:

1. RFID tags are anticounterfeiting devices.  Wrong, she says, "[t]hey're made by semiconductor companies for inventory purposes," quoting Roger Johnston.
2. RFID technology is necessary to track the movement of legitimate drugs.  As explained by Reid both in the article and at the recent IQPC counterfeiting conference, RFID is only one small component of a strong anti-counterfeiting system.  ABC's track and trace pilot project incorporates many other technologies, including 2-D barcodes and VeriSign's authentication registry.
3. RFID technology can be used to mark pills, tablets and elixirs themselves.  Scalet cites to Christian in refuting this myth, who states that only the packaging is being tagged, not the pills.  What's more is that, because current regulations allow for repackaging, "[i]f a pharmaceutical company invests a great deal of money into putting security devices in packaging, the product could easily be transferred legally to a package with no security device."
4. RFID technology will let consumers verify that they have purchased legitimate products.  No one, including the FDA, has proposed a system that would allow consumers to ensure products they purchase are authentic, and privacy concerns are prompting the disabling of tags prior to dispensing the drugs to the end user.
5. The pharmaceutical industry is this close to widespread RFID adoption.  I'm not sure that the pharmaceutical industry is this close to anything when we're talking about pedigree.

Adam Fein, one of the leading authorities on pharmaceutical supply chain matters, has expounded on Scalets myths on his blog Drug Channels.  In addition to providing valuable comments on Scalet's article, Fein also exposes interesting inaccuracies contained in statements in a leading industry publication.

 

• Email This
• Print
• Comments
• Trackbacks

Michele Nance, a law school professor who specializes in health and constitutional law, has announced that Seton Hall Law School will be hosting a health care compliance forum.  Here are the details from the law school's web site: 

June 29, 2007 - Friday - 8 a.m.

Single Day Compliance Program: Focus on State Compliance Issues

This is a single-day follow-up program to our Health Care Compliance Certification Program. This program will address those current compliance issues facing the pharmaceutical and medical device industries in dealing with the variety of state regulations. Topics will include: state regulations, state False Claims acts, Pedigree laws, and state pricing disclosures. More details and a full agenda will be forthcoming.

This event is for past participants of the Health Care Compliance Certification Program and other individuals dealing with compliance in the pharmaceutical and medical device industries.

For further information please call (973) 642-8863.  Registration is required.

• Email This
• Print
• Comments
• Trackbacks

Chris Fleming posted an interesting article on the Health Affairs Blog this week entitled "PHARMA: McClellan Predicts Resurgence of Rx Drug Access Concerns."  Fleming begins the article by discussing the Senate's passage of the Food and Drug Administration Revitalization Act sponsored by Ted Kennedy and Michael Enzi.  According to Enzi's press release, "the bill establishes a system of active surveillance for drugs already on the market, and explicitly gives the FDA new authority through Risk Evaluation and Mitigation Strategies (REMS) to respond quickly and appropriately when previously unknown risks arise."

In the article, Fleming details remarks given by former CMS administrator and head of the FDA Mark McClellan at the National Press Club.  According to Fleming, McClellan called the bill "the biggest set of changes in post-market drug regulations since at least 1962."  McClellan described the so-called tug of war between access to drugs on the one hand and safety concerns on the other.  While, given the Vioxx debacle, the focus has shifted to safety, soon attention will shift back to access concerns, McClellan predicted.

Indeed, McClellan has rightfully portrayed the tension between market access and drug safety.  On the one hand, it is of the utmost importance that life saving drugs make their way to the market as quickly as possible, and on the other, the devastating losses suffered when a drug goes terribly awry, causing life altering or ending side effects, are often difficult to justify.  Interestingly, at the same time that the Vioxx litigation presses on, the Abigail Alliance case proceeded forward in effort to get the courts to determine that terminally ill patients have a constitutional right to potentially life saving treatments, treatments that may in fact neither be safe nor effective.  In both cases, the FDA is criticized. 

Knowledge is power, but sometimes we all have to make decisions when a life is at stake and we have less than the most desireable information available.  When my mother was diagnosed with breast cancer, she opted to take Herceptin, a relatively new biotech drug manufactured by Genentech.  The drug was not FDA approved for women with early stage breast cancer at the time.  I read every clinical trial available, drilled her oncologist with questions about safety and efficacy of the drug and conducted a risk/benefit analysis.  At the end of the day, however, I found that, when you find yourself fighting an aggressive disease and the science places you in an area that's terribly gray, you're more likely to roll the dice.  Perhaps the simple answer is that both the delays to market entry and drug safety ought to be evaluated in light of the severity of the illness at issue. 

• Email This
• Print
• Comments
• Trackbacks

The Department of Health and Human Services has launched a new web page designed to provide information regarding compliance with and the enforcement of the HIPAA Privacy Rule.  The Privacy Rule is enforced by the Office of Civil Rights and, as noted on the web page, purportedly aims at the protection of the confidentiality of a patient's medical records.  The page provides specific case examples, an overview of the enforcement process and highlights from enforcement actions.

Interestingly, since April 14, 2003, 4,447 cases against pharmacy chains, major medical centers, health plans, hospital chains and small provider offices required corrective action, 2,155 of the cases found no violation and the remaining 13,875 of the cases were not eligible for enforcement (most of these cases were dismissed for lack of jurisdiction, failure to timely file or to pursue a complaint, or because the disclosure was permissible).   To date, a total of 26,408 complaints have been received, and 22% of the complaints filed remain pending. 

• Email This
• Print
• Comments
• Trackbacks

The FDA has continued to aggressively fight the injunction issued by the District Court for the Eastern District of New York in Rx USA Wholesale v. Department of Health and Human Services, Food and Drug Administration.  The injunction issued in the case prohibits the FDA from requiring that secondary wholesale distributors of pharmaceuticals pass a pedigree that tracks each prior sale of a drug, a requirement that secondary wholesalers claim is impossible given that the statute and accompanying regulation do not impose a concomitant obligation on authorized distributors, or those distributors that have entered into an agreement with the manufacturers.

The FDA has appealed the lower court's ruling and most recently filed a brief urging the Second Circuit Court of Appeals to overturn the injunction.  The brief argues that (1) congressional intent is clear on the face of the statute that drug pedigrees must track the chain of custody back to the manufacturer, (2) the statute and regulations comport with the protections in the equal protection and due process clauses, as they are rationally related to Congress's desire to curtail pharmaceutical counterfeiting and consistent with Congress's findings that "non-authorized distributors were the avenue through which most diverted drugs entered the retail market and created public health dangers," and (3) the scope of the preliminary injunction is far too broad because it prohibits the FDA from requiring that drug pedigrees include the information set forth in subsections (1) through (5) of the regulation.  In the brief, the FDA states with respect to the latter argument that "Plaintiffs have not, and cannot, claim that it is impossible for them to supply this additional information, as it is readily apparent on the face of the drugs' labeling."

With the hold on the federal drug pedigree regulations requiring secondary distributors to trace the chain of custody back to the manufacturer currently in place, the focus has shifted to the states.  Last week, I received a call from an individual from the Texas legislature informing me of progress of the Texas drug pedigree legislation.  For those who are interested in tracking the legislation on a state by state basis, you can follow the developments of the proposed Texas law on the state legislature web site.  

• Email This
• Print
• Comments
• Trackbacks

On Wednesday, the Department of Health and Human Services named Robert Kolodner as the permanent leader of the Office of the National Coordinator for Health Information Technology.  Kolodner has served in the post as the interim coordinator since September 20, 2006.  In this capacity, Kolodner will advise Michael Leavitt, Secretary of the Department of Health and Human Services, about health information technology projects and related issues and will lead the effort for the implementation of interoperable health information technology by medical providers.

• Email This
• Print
• Comments
• Trackbacks

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:

• CMS Issues Proposed Decision Memorandum for Medicare National Clinical Trial Policy.  CMS has proposed revisions to its coverage policy for items and services furnished in a clinical trial.  As stated in the press release, the changes would include the following:
  • Renaming the policy as the Clinical Research Policy; 
  • Adding FDA post-approval studies and coverage with evidence development (CED) to studies that would qualify under this policy;
  • Requiring all studies to be registered on the NIH ClinicalTrials.gov website before enrollment begins;
  • Requiring studies to publish their results;
  • Paying for investigational clinical services if they are covered by Medicare outside the trial or required under an CED through the NCD process; and
  • Expanding the “deeming” agencies to all DHHS Agencies, the Veterans Administration, or the Department of Defense.  Deeming agencies are agencies that can “deem” whether a trial has met the general standards outlined in the policy.

See also the Proposed Decision Memorandum, available on the CMS web site.

• Kaiser Family Foundation Reports that Health Care Has Become an Important Campaign Issue.  The Kaiser Family Foundation summarized articles in leading newspapers reporting that health care has become a focus on the 2008 presidential campaign trail.  I would also recommend that readers review the New York Times Article "For Democrats, Health Care is a Rite of Passage."  As the election nears, Juvan's Health Law Update will begin tracking the views of the candidates on both sides of the aisle.

• Email This
• Print
• Comments (1)
• Trackbacks

On February 8, 2005, President Bush signed into law the Deficit Reduction Act (the "DRA").  Among the most noteworthy provisions included in the DRA is a provision that requires employee education about the False Claims Act ("FCA") and applicable laws that protect, and even reward, employees who act as whistleblowers. The DRA specifically requires entities that receive or make annual payments of at least $5,000,000 pursuant to any state Medicaid program to establish written policies for employees that explain the provisions of the FCA, any state false claims laws and the applicable administrative remedies. The policies must also include a description of whistleblower protections and an explanation of internal policies that aim to prevent fraud and abuse. An employer must include a discussion of these matters in the employer's employee handbook. Entities that fail to comply risk exclusion from the Medicaid program.

Despite the fact that the deadline for compliance has passed, many in the industry have complained that the law included far too many ambiguities.  In response, the Centers for Medicare and Medicaid Services has issued answers to frequently asked questions.  The sixteen page guidance document covers many issues, including providing a more clear definition of the term "entity" and describing whether health systems with subsidiaries having less than $5,000,000 in payments but that exceed this amount collectively must have in place the required policies.

• Email This
• Print
• Comments (1)
• Trackbacks

On April 2, 2007, the Centers for Medicare and Medicaid Services ("CMS") announced the implementation of a contingency plan for entities, except small health plans, that are unable to meet the May 23 deadline for compliance with the National Provider Identifier rules.  For a period of one year, expiring May 23, 2008, CMS will not take enforcement action against those entities that have been making a good faith effort to comply if certain requirements are met.  

CMS will hold a roundtable on Wednesday, April 18, 2007 from 2:30 p.m. to 4:00 p.m. EST to discuss the new guidelines.  Registration is required, and registration information is available online.   Please note that registration for the call will close at 1:00 p.m. EST on April 17, 2007.

• Email This
• Print
• Comments
• Trackbacks

On Friday, Michael Leavitt, the Secretary for the Department of Health and Human Services, outlined a plan for "personalized health care," which is defined in the press release as "gene-based medical care combined with health information technology."  Speaking of this new initiative, Leavitt stated, "Personalized health care will combine the basic scientific breakthroughs of the human genome with computer-age ability to exchange and manage data . . . . Increasingly, it will give us the ability to deliver the right treatment to the right patient at the right time--every time."  While Leavitt advocates for advances to this program, privacy rights activists would likely prefer that the phrases "gene-based medical care" and "health information technology" not be used in combination.

Leavitt's announcement also outlined several steps that must be taken to reap the benefits of this powerful combination, including the following:

• reviewing the implications on privacy protection and the "anticipated effect on the confidentiality, privacy and security of individually identifiable health information";
• taking steps to ensure that genetic tests are accurate and reliable;
• developing "consistent policies for [HHS] agencies regarding access to and security of federally supported research"; and
• receiving recommendations from the American Health Information Community for health information technology standards applicable to genetic testing information.

Leavitt called the development of a personalized health care system one of his priorities for the next two years. 

Additional Resources:

United States Department of Health and Human Services Personalized Health Care Page

• Email This
• Print
• Comments (1)
• Trackbacks

Generics--Drug Sales--Quality of Care

Here's a look back at a few noteworthy stories from last week...

• Biotech Generics.  Last week, FDA Commissioner Andrew von Eschenbach delivered a blow to makers of generics when he noted that generic versions of biotech drugs, which are generally more complex than chemical-based drugs and therefore more difficult to copy, will only be considered "similar" to brand name drugs.  As reported by the Washington Post, von Eschenbach stated at the PhMRA annual meeting, "We recognize that the end point would be what could be best described as similarity. Similarity in the sense that when a doctor gives you the product _ delivered it to a patient _ it will achieve an effect that is similar to the effect that we expected from the innovative . . . compound."  While the FDA is developing guidelines to evaluate generic versions, the Generic Pharmaceutical Association pointed out that the FDA does in fact have the "scientific knowledge to approve knockoffs, just as it now can sign off on the changes made by brand-name biotech companies in how they produce their drugs." 
• Drug Sales Increase in 2006.  IMS Health reported a 8.3% increase in drug sales last year and projects growth by 6-9% through 2010.  Diana Commy, corporate director, IMS Market Insights, commented on last year's growth by saying, “This growth was driven by factors that include an aging population and the introduction of the Medicare prescription drug benefit, which increased prescription coverage to the previously uninsured and underinsured, and provided generous plan benefits to seniors.” 
• JAMA Highlights Health Care Access and Quality of Care Issues.  On Wednesday, as reported by the Kaiser Family Foundation, the Journal of the American Medical Association published articles discussing access to health care and quality of care.  Here's a few of the conclusions reached in the articles:
  • "Patients without health insurance are less likely to receive treatment after injuries or diagnoses of chronic diseases."
  • "Patients in many cases do not receive necessary follow-up care, regardless of whether they have health insurance."
  • "Physicians should work in teams and measure the quality of care provided to patients to help reduce costs and reduce other problems in the U.S. health care system."
  • Spending on emergency care for recent documented and undocumented immigrants accounted for less than 1% of the North Carolina Medicaid budget annually between 2001 and 2004."

• Email This
• Print
• Comments
• Trackbacks

Last week, the FDA approved Tykerb, a targeted therapy for the treatment of women with advanced Her-2 positive breast cancer.   While similar Herceptin, Genentech's Her-2 blockbuster, Tykerb differs from Herceptin in a meaningful way.    "Unlike, for example, trastuzumab [Herceptin]--a monoclonal antibody, which is a large protein molecule that targets the part of the HER2 protein on the outside of the cell--Tykerb is a small molecule that enters the cell and blocks the function of this and other proteins."  Tykerb will be distributed by GlaxoSmithKline.

Commenting on the new drug, Steven Galson, Director of FDA's Center for Drug Evaluation and Research, stated, "New targeted therapies such as Tykerb are helping expand options for patients." 

• Email This
• Print
• Comments
• Trackbacks

Welcome to daylight savings time, which has been moved up from April!  Hopefully, the extra sunshine will calm the nerves of those whose blackberries are still an hour behind and whose calendar appointments are incorrect.  My calendar, for example, has shifted all of my lunch appointments to 10:00AM--so I'll either be finding myself drastically early for lunch or having brunch with acquaintances whose calendars are likewise confused.  If only the weather in Cleveland could also be affected by the change and undergo an early 50 degree shift in temperature...

On a more serious note...Generics, Generics, Generics! Generics made news on several fronts last week.  First, on Wednesday, the Senate Committee on Commerce, Science and Transportation Subcommittee on Interstate Commerce, Trade and Tourism reviewed the safety of drug importation.  At the hearing, Billy Tauzin, President and CEO of PhRMA,  stated that the closed system that blocks importation is the only way to ensure a safe supply chain.  Tauzin also launched attacks against those who argue that the cost savings of importation benefits consumers when he stated that "[m]ost of the savings would likely go to third party payers, such as insurance companies and HMOs."  Likewise, Randall W. Lutter, Acting Deputy Commissioner for Policy at the Food and Drug Administration, stated that the risk of receiving counterfeits is drastically increased when drugs are purchased online and that drugs purchased from foreign markets often have similar names but different active ingredients.  So--how is this news item tied to generics?  In his testimony, Lutter emphasized that generics, not imports, are the answer to cost control. 

In related legislation, lawmakers are also continuing to consider whether to ban negotiations between generic drug companies and makers of brand name drugs that effectively delay or prohibit the entry of lower cost drugs to the market.  The details of the hearing are set forth more fully in the post linked to above. 

Finally, lawmakers considered a bill last week that would provide the FDA with the authority to approve generic forms of biotech drugs.  Currently, the FDA lacks this authority because of the difficulty of creating generic equivalents of these drugs, which are made with living organisms.  As reported by the Kaiser Family Foundation, the proposed legislation requires that the drugs be comparable or interchangeable and that the principal molecular features be highly similar to the brand name. 

Merger mania revived!  Caremark RX, Inc. and CVS inched forward toward completion of their merger plan last week when a new proposal offered to increase by an addition $1.50 a special cash dividend, bringing the total to $7.50 per share.  As reported by the Wall Street Journal, the company post-merger would also "commence a cash tender offer for 150 million, or 10% of outstanding shares at a fixed price of $35 each."  The Wall Street Journal views this new offer as bringing "the competing proposals largely in line on a dollar basis" and giving CVS "a significant advantage in its ability to close the deal quickly."  While rival company Express Scripts has also raised its offer, Express Scripts currently does not have regulatory approval of its proposed deal from the Federal Trade Commission. 

Interested in an update on the NLRB's Oakwood decision?  On March 7, the BNA Daily Labor Report, which discussed the early impact of the Oakwood decision, stated that the fallout has thus far not been quite as severe as would have been originally anticipated.  However, while management attorneys speaking at a conference held by the American Bar Association stated that the "decision has not had much impact on supervisory determinations," union attorneys speaking at the same conference claim "that the full impact has yet to be felt." 

As previously discussed on Juvan's Health Law Update,  the NLRB held in Oakwood that charge nurses employed by an acute care hospital executed supervisory authority within the meaning of Section 2(11) of the NLRA because they assigned responsibilities to other nurses and exercised independent judgment in making these assignments.  

 

• Email This
• Print
• Comments
• Trackbacks

With the Democrats taking over Congress, brand name drug companies could find themselves unable to negotiate with makers of generics to delay market entry, Bloomberg reports.  Consumer focused legislation backed by the Federal Trade Commission is gaining momentum and could potentially prohibit brand name drug companies from settling patent litigation by paying generic drug makers for delaying their products.  The Senate Judiciary Committee recently approved the proposed ban, and the House will soon be taking up the topic. 

Consumer group advocates have argued that the current system favors both generic and brand name companies while detrimentally impacting consumers who are forced to front the high cost of brand named drugs while the delay is in effect.  Others, such as Bill Tauzin, a former Republican congressman from Louisiana, believe that such deals are actually pro-consumer.  In the Bloomberg article, Tauzin is quoted as saying that the payments "can benefit consumers'' by ending costly patent litigation that can cause longer delays in marketing generic drugs and can exhaust the litigants' "valuable resources." 

Perhaps only time will tell whether this legislation can actually get through both the House and the Senate and meet with the approval of the President.

For more information on this topic, make sure to check out the well done Orange Book Blog written by attorney Aaron Barkoff.  The blog highlights stories "at the intersection of  patent law and FDA law."

• Email This
• Print
• Comments
• Trackbacks

Last week, I visited Orlando, Florida for the American Health Lawyers Association Long Term Care in the Law Conference.  This week's Health Law Recap will focus on a few themes and trends identified at the Conference. 

• Shift in Long Term Care Reimbursement.  Leslie Norwalk, the Acting Administrator for the Centers for Medicare and Medicaid Services (CMS), focused on the increased pressure on the federal government resulting from the health financing crisis.  In response, federal reimbursement for long term care will shift in favor of home health agencies and away from skilled nursing facility care.
• Employee Education About False Claims Act.  Many attorneys expressed to representatives of CMS that there continues to be substantial and noteworthy ambiguities in connection with the Deficit Reduction Act employee education requirements.  One attorney noted that the requirement applies to an entity that has less than 5 million dollars in Medicaid payments if the entity is affiliated with other entities that receive 5 million or more in such payments.  Representatives for CMS have promised that further clarification will follow shortly.
• Plaintiffs' Lawyers Use Web Sites, E-Mail Addresses to Pierce the Corporate Veil.  There has been a strong trend for parent companies who acquire nursing home facilities to form separate subsidiaries to act as holding companies and operating companies for each nursing facility acquired.  One prominent defense attorney noted that plaintiffs' lawyers have begun to cite to web sites and e-mail addresses to build a case for veil piercing.  The lawyer cautioned that employees in each separate company should have different e-mail addresses. For example, if the parent company is named "Health Care Solutions, Inc.," one subsidiary is named "Brecksville Health Care Solutions, Inc."  and the other is "Madison Health Care Solutions, Inc.," the employees at the parent and both subs should not have their e-mail address as "employeename@healthcaresolutions.com."  Instead, the following e-mail addresses would help to show that the three entities are separate legal entities:
  • Parent Company:  employeename@healthcaresolutions.com
  • Brecksville Health Care Solutions, Inc:  employeename@brecksvillehealthcare.com
  • Madison Health Care Solutions, Inc:  employeename@madisonhealthcare.com

In addition, the attorney noted that legal counsel should review a company's web site and that the web site should clearly state that each facility is owned by a separate legal entity.

• Medicaid Fraud Enforcement Is on the Rise.  Many representatives of the federal government emphasized that, in the upcoming years, the government will have increased budgets to implement Medicaid fraud controls and pursue Medicaid fraud investigations.  In the past, Medicaid has not received the same scrutiny as have other federal health care programs. 

 

• Email This
• Print
• Comments
• Trackbacks

For those of you who are following closely the developments with respect to the PDMA, I wanted to alert your attention to an article by Pharmaceutical Commerce released in December that highlights developments in fifty states regarding drug pedigree requirements.  The article, entitled Red State, Blue State--and Green, Yellow and Orange Too,  provides the following fifty state summary: 

• Two states have passed legislation and approved regulations;
• Ten states are in the process of finalizing regulations;
• Five states have passed legislation but have not drafted regulations;
• Twelve states, including Ohio, have not approved such legislation; and
• Twenty-one states are at various other stages. 

As the article rightfully points out, "[f]or a pharma distributor intending to distribute to more than a few states, there's one word for the map: ugly.  The problem, basically, is that the number of variations for requirements are multiplying . . . ." 

As noted above, this article was released in December, and the current status of each state's legislation may not be accurately reflected.  Wholesalers should take care to comply with all applicable state and federal laws and regulations and to track developments closely.

• Email This
• Print
• Comments
• Trackbacks

Interested in reviewing recently introduced Pharma legislation?  Well, I'd suggest that you head over to Eye on FDA, where Mark Senak provides a thorough review of recently introduced Pharma bills and resolutions. 

• Email This
• Print
• Comments
• Trackbacks

Breast cancer survivors were given new hope last week when the FDA cleared for marketing the MammaPrint test, a test developed by Agendia, a lab in the Netherlands, that predicts the likelihood of distant metastatic breast cancer recurrence within five to ten years.   Because cancer recurrence is partially attributable to the behavior of genes, the test profiles genetic activity and, according to the FDA, the resulting analysis positively assists doctors in making treatment decisions and formulating a plan of care for their patients.  The product has been on the market in the Netherlands for about two years. 

Data submitted by Agendia that assessed the tumors of 302 node negative early stage (stage I and II) breast cancer patients under age 61 confirmed that the test effectively predicted time to distant metastasis.  Within the next 60 days, the FDA plans to publish a special controls guidance document describing the data that supports genetic profiling claims.

 

• Email This
• Print
• Comments
• Trackbacks

Last week, the FDA responded to the Institute of Medicine's 2006 report entitled "The Future of Drug Safety:  Promoting and Protecting the Health of the Public."  In the FDA's press release, the FDA noted plans to increase drug safety by taking actions in support of the following (as taken directly from the press release):

• Strengthening the science that supports the FDA's medical product safety system at every stage of the product life cycle from pre-market testing and development through post-market surveillance and risk management;
  
  
  • FDA initiatives include developing new scientific approaches to detecting, understanding, predicting, and preventing adverse events, developing and incorporating new quantitative tools in the assessment of benefit and risk, and conducting a pilot program to review the safety profiles of certain newly approved drugs on a regularly scheduled basis.

• Improving communication and information flow among all stakeholders engaged in promoting the safe use of medical products; and

• FDA initiatives include the establishment of an advisory committee to provide input to improve the agency's risk communication policies and practices, conducting a comprehensive review of current public communication tools and developing a comprehensive risk communication strategic plan.

• Improving operations and management to ensure implementation of the review, analysis, consultation, and communication processes needed to strengthen the U.S. drug safety system.

• FDA initiatives include engaging external management consultants to help the Center for Drug Evaluation and Research (CDER) develop a comprehensive strategy for improving CDER's organizational culture, and making specific organizational and management changes to increase communications among review and safety staff.

• Email This
• Print
• Comments (1)
• Trackbacks

Yesterday, the FDA filed a notice of appeal in RX USA Wholesale, Inc. v. Department of Health and Human Services.  The measure seeks to have the United States Court of Appeals for the Second Circuit overturn the order issued by the United States District Court for the Eastern District of New York enjoining the FDA from implementing the pedigree requirements set forth in 21 C.F.R. section 203.50.

• Email This
• Print
• Comments
• Trackbacks

In this technology age, most of us are wired, and many of us stay connected to the outside world for more hours than we care to admit.  We have blackberries and cellphones, many have their own blogs and some of us even produce our own podcasts.  Whether we are in the car, the grocery store or in a meeting, we're listening to our I-Pods, checking our blackberries or talking on the phone.  If you do decide to put your cell phone or blackberry away even for a few hours, you may feel a sense of regret, as it takes a significant of time to catch up on the hundred e-mails that came in and the several voice mails received.  The new age 24 hour economy often makes execs and employees feel run down and worn out, but, in America at least, most of us just pop a few pills to feel better and go on our way....

....Except for Katherine Ellison and about ten million other Americans, that is.  Like Ellison, many Americans have taken up meditation and yoga to reduce stress and enhance quality of life.  Ellison, who had thyroid surgery and brain surgery within three months and broke both arms not long thereafter, dealt with the physical and emotional trauma by meditating.  Speaking of the growing popularity of Asian healing and spirituality, in a recent Washington Post article, Ellison writes, "As our big demographic bulge of boomers hits the years when mortality truly starts to sink in, Asian spirituality has suddenly become more mainstream than ever." 

Ellison also writes of a woman who, like her, turned to meditation during a time of suffering.  Though the woman said that she initially resisted meditation, writing it off as "New Agey" and weird, and concerned about potential brainwashing, her opinion changed after her first experience, when meditating "brought [her] mind and body into the same timezone, [giving her] a sense of wholeness and peace [she'd] never experienced before."  She also experienced several other defining moments.  During one moment, she recognized the reality of her own mortality and questioned, "So what am I going to do with my life?  Am I doing the right thing with the short time I have on Earth?"

Indeed, as the article suggests, meditation, as well as integrative medicine therapies, can serve to help patients cope with illnesses and individuals in good physical health to deal with the daily stresses of life and emotional traumas.  Meditation, yoga, massotherapy, reiki, and Therapeutic Touch, for example, are just a few non-traditional (at least in a Western sense) therapies available.  I personally have experienced the benefits of these therapies, as I practice yoga to decrease stress and level out energy fields.  My mother, a Her-2 positive breast cancer survivor, also turned to reiki and meditation through her Adriamycin/Cytoxan chemotherapy treatments.  Still to this day, she cites to these treatments when she discusses her treatment experience, saying that they helped her to cope with the horrifying side effects of chemo and the emotional pain that accompanies a cancer diagnosis.

From a legal perspective, though many integrative medicine therapies are safe and may even be effective, the current legal and regulatory scheme in the United States makes it difficult for patients to gain access to these therapies.  Most insurance companies do not provide coverage for integrative therapies.  States and medical boards also fail to license and credential complementary and alternative medicine providers in a fashion similar to that of physicians and other providers of conventional medicine. Such legislative recognition, however, could bring increasing credibility to these practices.  Traditional Western medicine providers can also face direct liability for referrals to CAM providers.  Michael H. Cohen, the leading scholar and authority in the United States on the legal issues facing CAM, provides a table of potential CAM liability grounds on his Complementary and Alternative Medicine Law Blog.  For example, clinicians and associations may be liable for referrals to CAM providers on vicarious liability grounds, for patient abandonment, negligent referral or delay of effective conventional medical treatments.

Cohen has worked tirelessly to bring credibility to CAM and integrative medicine therapies and to bring about change in the law in the United States so that these therapies are made available to more individuals.  In addition to being an assistant professor at Harvard Medical School and the Harvard School of Public Health, he is also the founder of the Institute for Integrative and Energy Medicine.

If you are interested in furthering the development of the Institute, please contact Michael H. Cohen directly.

• Email This
• Print
• Comments
• Trackbacks

Recently, the House of Representatives passed legislation requiring direct negotiation with pharmaceutical companies for lower-priced prescription drugs covered under the Medicare Part D program.  As reported by FDA News, Senator Chuck Grassley (R. Iowa) is now considering a filibuster to stop the measure because he believes the legislation may have sufficient bi-partisan support for passage.  Apparently, Grassley believes that he has the requisite backing to make such a move.

• Email This
• Print
• Comments
• Trackbacks

On Wednesday, Senate Judiciary Committee Chair Patrick Leahy (D-Vt.) introduced legislation that would effectively prohibit brand-name drug companies from entering into agreements with generic drug companies to delay the entry of generics to the market. 

Portions of the 1984 Hatch-Waxman legislation encourage generic drug companies to challenge brand-name drug patents by awarding a six month market exclusivity period if successful.  In response to suits filed, oftentimes brand name drug makers contract with generic makers to postpone market entry, leading to a win-win situation for both parties.  Many have attacked these arrangements, however, arguing that they are harmful to consumers because they delay the entry of lower priced generics. 

Commenting on the settlements reached between these two market forces, at a Senate Judiciary Committee Hearing, FTC Commissioner Jon Leibowitz stated that these settlements "restrict competition at the expense of consumers, whose access to lower-priced generic drugs is delayed, sometimes for years."  Bruce Downey, CEO of Barr Pharmaceuticals, fired back in a Bloomberg/Winston-Salem Journal article, stating "It's not the settlement that keeps the product off the market, it's the patent."

• Email This
• Print
• Comments
• Trackbacks

On January 10, Senators Dorgan (D-ND) and Snowe (R-ME) and Representatives Emerson (R-MO) and Emanuel (D-IL) introduced the Pharmaceutical Market Access and Drug Safety Act (the "Act"), drafted to allow the importation of drugs from FDA registered and approved pharmacies abroad.  The news release issued by Senator Dorgan indicated more than thirty groups support the move (including the AARP) and that savings that could total up to $50 billion dollars in the next ten years.

Making the case for the proposal, the findings in Section 2 claim that

• Americans pay the highest price in the world--up to five times the price that consumers worldwide pay--for prescriptions;
• A drug is neither nafe nor effective if an individual cannot afford the cost; and
• Allowing the importation of drugs would promote competitive pricing, result in savings, and make for greater access to therapy.

The Act allows for the importation of certain "qualifying drugs" in which there is a "U.S. Label Drug" equivalent.  Such drugs may be imported not only from exporters in Canada, but also from other countries as designated by Secretary of the Department of Health and Human Services.

Commenting on the Act, Dorgan stated, "Currently, the big drug manufacturers can monopoly price their medicines here and, as a result, American consumers pay the highest prices in the world for prescription drugs.  The fact is, miracle drugs perform no miracles for people who can't afford them."  Likewise, Senator Snowe stated, "This legislation leaves no stone unturned to assure that the importation of prescription drugs will be safe and meet the requirements of the Food and Drug Administration, while delivering real savings to American consumers." 

Others have criticized the Act, however.  Dr. Adam Fein of the hit blog Drug Channels, in his article "Real News About Fake Drugs," references prior articles covering the dangers of reimportation and states that he finds "it highly ironic that the proposed legislation includes 'drug safety' in its title."   

• Email This
• Print
• Comments
• Trackbacks

Last week, the FDA released a preliminary proposal to increase user fee collections by $87.4 million to enhance postmarket surveillance of drugs, drug development and review of television advertising.  The proposal will only take effect if the FDA ultimately submits the proposal to Congress and Congress, reauthorizing the FDA's Prescription Drug User Fee Act (PDUFA), adopts the FDA's recommendations.  

The FDA intends to allocate $29 million of the increase to postmarket surveillance, allowing the FDA to, among other measures, hire an additional 82 employees, and $6.2 million to fund review of direct-to-consumer advertising, allowing the agency to hire 27 new employees.  An additional 4.6 million would fund the implementation of the guidance for the FDA's reviewers, and $4 million would be spent on the shift to an "all-electronic environment." 

In addition to increasing the user fees, the FDA also recommends that Congress eliminate the statutory provision that allows the FDA to use PDUFA fees only during the first three years after a product receives FDA approval.

The Federal Register Notice is available online.  The FDA will hold a pulic meeting on February 16, 2007, to present its proposals.  Comments are due on February 23, 2007.

• Email This
• Print
• Comments
• Trackbacks

The National Medicare Congress has made available speeches of Congressman Pete Stark and former CMS Administrator Tom Scully given at the Third National Medicare Congress on October 15 through 17, 2006, three weeks before the November 2006 elections.  In his speech, Congressman Stark predicted that, given the divide in power between Democrats and Republicans, there will be no major legislation for the next two years.  With respect to his objectives, Congressman Stark stated that he desires to ensure that Medicare and Social Security do not end as an entitlement and desires to prevent the privatization of these programs.  Former CMS Administrator Scully's speech focuses on the "Role of the Private Sector in the Implementation of Part D," and he states that he's "amazed about how Medicare Part D has turned out." 

• Email This
• Print
• Comments
• Trackbacks

Last week, the National Association of Independent Pharmaceutical Wholesalers (NAIPW) and the Association of Independent Pharmaceutical Wholesalers of America (AIWPA) issued recommendations for national pedigrees.  The NAIPW and the AIWPA were both founded by Robert C. Drucker, President and CEO of RX USA Wholesale, Inc. and Mark S. Scovotti.  Continue Reading...

• Email This
• Print
• Comments (1)
• Trackbacks

On Friday, Congressman Dingell, on behalf of himself and 189 co-sponsors, introduced H.R. 4 to amend the Social Security Act to require the negotiation of prices for Medicare Part D covered drugs.  Continue Reading...

• Email This
• Print
• Comments
• Trackbacks

 According to 42 C.F.R. section 423.504(b)(4)(vi), prescription drug plan sponsors approved to provide Part D benefits must have compliance plans that articulate (1) commitment to comply with applicable laws; (2) designation of a compliance officer and committee; (3) effective training and education of employees and agents; (4) effective lines of communication between the compliance officer and the employees and agents; (5) the enforcement of standards through publicized disciplinary guidelines; (6) procedures for audits and internal monitoring; (7) the procedures for ensuring prompt response to detect offenses and development of corrective action; and (8) a comprehensive plan to prevent and detect fraud and abuse, which includes procedures to voluntarily self report fraud or misconduct.  The OIG undertook a review of stand-alone prescription drug plan sponsors' compliance plans to determine compliance with these eight elements, along with the seventeen requirements set forth in CMS's Prescription Drug Benefit Manual. 

Continue Reading...

• Email This
• Print
• Comments
• Trackbacks

Recently, the Department of Health and Human Services filed its Answer in RxUSA Wholesale, Inc. v. Department of Health and Human Services.  The FDA has also issued industry guidance about the injunction, a brief description of which is contained in this article. Continue Reading...

• Email This
• Print
• Comments
• Trackbacks

The Centers for Medicare & Medicaid Services ("CMS") will host a briefing about the requirement mandated by the Deficit Reduction Act of 2005 that certain employers educate their employees about the False Claims Act.  The briefing will take place on Thursday, January 11, 2007, at 1:00 p.m. EST.  The call will last ninety minutes.  To participate on the call, dial 1-888-677-1819 and enter the password "provider."  You will also need to reference the call leader's name, Aaron Wesolowski.

Guidance on the DRA's section 6032 mandate was issued to State Medicaid Directors on December 13, 2006.

• Email This
• Print
• Comments
• Trackbacks

Jayne E. Juvan will be speaking at the upcoming seminar entitled "Anti-Counterfeiting Business Strategies for Pharmaceuticals." The seminar will take place in Philadelphia, Pennsylvania from April 11, 2007 through April 13, 2007. 

At the seminar, Juvan will offer a special feature presentation: "Understand The Case That Kept The Stay on the PDMA to Best Prepare for Upcoming Regulations." Following Juvan's presentation will be a Q&A with Robert Drucker, President and CEO, RxUSA Wholesale.  Here's the description of Juvan's speech:

As the pharmaceutical industry prepared for what was surely to be a historic moment of lifting the stay on 1987s Prescription Drug Marketing Act, several wholesalers were preparing for a win of monumental proportions: to stop the industry in its tracks by suing the FDA. In this session, attorney Jayne E. Juvan will cover:

          *The details of the case

          *The meaning of Judge Seybert's ruling for the industry's future

          *What this means for your company when preparing for future federal and state regulations

For more information about the conference, including registration information, visit http://www.iqpc.com/cgi-bin/templates/genevent.html?topic=237&event=12172&. 

• Email This
• Print
• Comments
• Trackbacks

The FDA has published its interpretation of the preliminary injunction ordered on December 5, 2006 by the Eastern District of New York in RX USA Wholesale, Inc. v. HHS.  A brief analysis of this guidance will follow in a subsequent post.  See also the FDA's Backrounder re: RX USA Wholesale, Inc. v. HHS.

• Email This
• Print
• Comments
• Trackbacks

Today, RFID Update announced that the injunction issued in RX USA Wholesale, Inc. v. Department of Health and Human Services could "slow momentum for RFID e-pedigrees."  The author notes that, "[w]hile RFID had not been a requirement for the pedigrees, industry observers agreed that pedigree enforcement generally was a positive step toward the ultimate adoption of RFID-based e-pedigrees . . . . [W]ith the FDA pedigree requirement now postponed, momentum behind RFID e-pedigree adoption may be slowed."  The article also quotes yours truly in a section discussing the legal analysis of the case.

• Email This
• Print
• Comments
• Trackbacks

As promised, the following are a few pertinent points from the order issued by Judge Seybert today:

• Irreparable Harm.  The court rejected the Defendants' argument disputing that the Plaintiffs will suffer irreparable harm by denial of the injunction because their argument "is circuitous."  Instead of disputing the Plaintiffs' arguments, the court stated that the Defendants actually acknowledged that the Plaintiffs will suffer irreparable harm and only disputed the source of the harm.
• Likelihood of Success on the Merits--Applicable Standard.  The court clarified that the law does not require a finding that the Plaintiffs will, with "absolute certainty," succeed on the merits of their claims.  Instead, a party "need only make a showing that the probability of [the party's] prevailing is better than fifty percent.  There may remain considerable room for doubt."  Accordingly, a finding that the Plaintiffs have overcome their burden with respect to the rational basis test at this juncture only serves to demonstrate that the Plaintiffs are slightly more likely than not to succeed on their claims.
• PDMA Rational Basis Review.  The court rejected the portion of the Report and Recommendation finding that there was no rational basis for the PDMA.  Nevertheless, the court also rejected the Defendants' arguments on this point, stating, "This entire regulatory scheme and anomalous result that would occur if the Rule went into effect appears arbitrary in light of the FDA's previous position and interpretation of the PDMA. . . . [N]one of the drugs ultimately going to the American consumer would contain pedigree information because the drugs would be provided solely through authorized distributors who are exempt from the pedigree requirement."
• Public Interest Analysis.  In the final decision, the court included an analysis of the effect granting the injunction would have on the public, an analysis the Report and Recommendation failed to include.  Such an analysis makes not only good legal sense, but also good logical sense.  Essentially, the court stated that, when a preliminary injunction has an effect on the public interest, a court should balance the interests involved.  In a statement that gets at the heart of the decision, Judge Seybert wrote, "By granting Plaintiffs' motion for the preliminary injunction, this Court simply maintains the status quo and the current practice in the industry."  Alternatively, if the court were to deny the Plaintiffs' motion, (1) many unauthorized distributors could go out of business, leading to underserved markets, and (2) only authorized distributors, who are not covered by the pedigree requirement, would be supplying information.  Maintaining the status quo, however, would not prejudice the Defendants' rights, as the Defendants have waited for twelve years to implement the rule.

• Email This
• Print
• Comments
• Trackbacks

A party related to RX USA Wholesale v. Department of Health and Human Services kindly forwarded to me this morning the pdf of Judge Seybert's Order Adopting Report and Recommendation.   According to the source, the decision was handed down on Friday evening and was filed on the Court's electronic filing site at 10:17 AM EST this morning.  I will update this post later this evening with an analysis of the decision and will continue to track developments in the case.

• Email This
• Print
• Comments
• Trackbacks

On Monday, December 4, 2006, Judge Joanna Seybert adopted in part the Report and Recommendation of Magistrate Judge Kathleen Tomlinson issued only days earlier on November 30 in RX USA Wholesale v. Dep't of Health & Human Services and granted the preliminary injunction requested by the Plaintiffs.  The lawyers had only one day to scramble to file their objections to Magistrate Judge Tomlinson's decision, but nevertheless zealously advocated for their positions.  Adam J. Fein of Drug Channels has covered the impact the injunction will have on manufacturers and wholesalers.  For those following the case, a brief legal analysis of the Report and Recommendation, along with a discussion of the arguments of the parties in response, is set forth below.

Continue Reading...

• Email This
• Print
• Comments (2)
• Trackbacks

The United Press International article "Analysis: FDA Approving More Drugs" reports that, although the FDA "has been picking up its pace for approving new drugs," a factor that could bode well for the pharmaceutical industry in 2007, tighter controls launched next year by the Democratic majority could slow the drug approval process.  Thus far, October has been the busiest month of 2006, with fifteen new drug application approvals and five new molecular entity approvals.   

Despite the shift in power, some projections still estimate that the industry could see five to six percent growth, but new product launches may remain constant.  The article also speculates that health information technology companies will benefit from stronger regulatory measures.

• Email This
• Print
• Comments
• Trackbacks

As posted by the Complementary and Alternative Medicine Law Blog:

Cleveland Clinic's Preventive Cardiology team and the Canyon Ranch Institute are hosting a national conference highlighting the integration of conventional, complementary and alternative medicine and its impact on heart health.

"An Integrative Approach to Prevention & Regression of Coronary Artery Disease" will be held at the InterContinental Hotel & MBNA Conference Center Cleveland, Nov. 30-Dec. 2.

From the press release:

"Heart disease is the number one killer in the United States and we're struggling on how to effectively teach patients and practitioners about cardiovascular prevention," said Leslie Cho, M.D., Director, Women's Cardiovascular Center, Medical Director, Preventive Cardiology & Rehabilitation. "This conference will focus on the latest research as well as provide effective tools to help practitioners lower risk factors for heart disease, including treatments for obesity and smoking cessation techniques."

Tieraona Low Dog, M.D., a renowned integrative medicine expert, will serve as the event's key note speaker. She is Director of the Education Program in Integrative Medicine and a Clinical Assistant Professor in the Department of Medicine at University of Arizona College of Medicine. Dr. Low Dog promises to 'get to the heart of health' with her presentation "Integrative Medicine: A Bridge to the Future." She is scheduled to speak at the conference's opening dinner on Thursday, Nov. 30, at 7:00 p.m. in the Intercontinental Hotel and MBNA Conference Center Ballroom, second floor. This event is open to the public.

Dr. Low-Dog is Current Chair of the USP Dietary Supplements and Botanicals Expert Committee. Her honors and distinctions include a Presidential Appointment to the White House Commission on Complementary and Alternative Medicine in 2000 by Former President Bill Clinton. She was featured by Time magazine as 2001 Innovator of the Year in Complementary and Alternative Medicine and was appointed to the executive Advisory Board for the National Institute of Health's National Center for Complementary and Alternative Medicines in 2003.

The Cleveland Clinic-Canyon Ranch conference is expected to draw more than 250 cardiologists, internal medicine and family practice physicians, and nurse practitioners, to discuss the latest in diagnosis and therapeutic interventions in preventing heart disease. Through a series of didactic lectures, panel discussions and small group break-out sessions, the conference will focus on traditional and emerging testing and treatments for hyperlipidemia, hypertension, metabolic syndrome and diabetes. Moreover, it will focus on integrative approaches to the treatment of obesity, depression and smoking cessation.

"We're extremely proud to be participating in such an extensive meeting of the minds, and we're particularly excited about the conference's emphasis on integrative and preventive medicine," said Stephen Brewer, M.D., medical director of Canyon Ranch in Tucson. "For more than two decades, Canyon Ranch has worked to educate people on the importance of making lifestyle changes that lead to longer, healthier lives. This conference will highlight the benefits of this proactive approach, as well as the science behind it."

The nationally and internationally recognized experts also scheduled to speak throughout the conference include Leslie Cho, M.D., Director of the Women's Cardiovascular Center at Cleveland Clinic; Steve Nissen, M.D., Chairman, Cardiovascular Medicine, Cleveland Clinic; Stanley Hazen, M.D., Section Head, Preventive Cardiology, Director, Center for Cardiovascular Diagnostics and Prevention, Cleveland Clinic; and Marc Penn, Director, Bakken Heart-Brain Institute; Stephen Brewer, M.D.; and Mark Liponis, M.D., Corporate Medical Director, Canyon Ranch.

The conference opens Thursday, Nov. 30 at 8 a.m. with opening remarks by Delos M. "Toby" Cosgrove, M.D., CEO and President of Cleveland Clinic. A series of series of lectures will be given the morning of Friday, Dec. 1, while a variety of smaller break out sessions will bring the conference to a close.

For an agenda or for more information about the Cleveland Clinic and Canyon Ranch "Integrative Approach to Prevention & Regression of Coronary Artery Disease" conference, visit http://www.clevelandclinicmeded.com/summit/preventcardio06/default.htm.

About Cleveland Clinic
Cleveland Clinic, located in Cleveland, Ohio, is a not-for-profit multispecialty academic medical center that integrates clinical and hospital care with research and education. Cleveland Clinic was founded in 1921 by four renowned physicians with a vision of providing outstanding patient care based upon the principles of cooperation, compassion and innovation. U.S. News & World Report consistently names Cleveland Clinic as one of the nation's best hospitals in its annual "America's Best Hospitals" survey. Approximately 1,500 full-time salaried physicians at Cleveland Clinic and Cleveland Clinic Florida represent more than 100 medical specialties and subspecialties. In 2005, there were 2.9 million outpatient visits to Cleveland Clinic. Patients came for treatment from every state and from more than 80 countries. There were nearly 54,000 hospital admissions to Cleveland Clinic in 2005. Cleveland Clinic's Web site address is www.clevelandclinic.org.

***
Law Offices of Michael H. Cohen offers general corporate legal services, litigation consultation, and expertise in health law, with a unique focus on alternative, complementary, and integrative medical therapies.

Michael H. Cohen is also President of the the Institute for Integrative and Energy Medicine, also known as the Institute for Health, Ethics, Law, Policy & Society. The Institute serves as a reliable forum for investigation and recommendations regarding the legal, regulatory, ethical, and health policy issues involved in the judicious integration of complementary and alternative medical therapies (such as acupuncture and traditional oriental medicine, chiropractic, massage therapy, herbal medicine) and conventional clinical care.

The most recent book written by Michael H. Cohen on health care law, regulation, ethics and policy pertaining to complementary and alternative medicine and related fields is an interdisciplinary collection of essays entitled, Healing at the Borderland of Medicine and Religion. This is the fourth book in a series, the first being Complementary and Alternative Medicine: Legal Boundaries and Regulatory Perspectives (1998).

• Email This
• Print
• Comments
• Trackbacks

I highly recommend that readers of this blog interested in the pharmaceutical industry visit Drug Channels, a blog hosted by Adam J. Fein, founder and president of Pembroke Consulting, Inc. based in Philadelphia.   Fein includes incisive commentary about the pharmaceutical industry, including most recently unique perspectives on the profitability of generics and Wal-Mart's $4 generic program.  The following is a list of recent posts:

• The Attack on Generic Profits in Drug Channels;
• Wal-Mart Raises the Stakes; and
• New York Times Editors Read This Blog.

While he certainly seems to be an expert in the field, Fein is as humble as they come, stating at the end of one post, "Hey, I'm just one voice out there, so please don't forget Newton's Second Law of Consulting: For every expert, there is an equal and opposite expert."

• Email This
• Print
• Comments (1)
• Trackbacks

Today, the FDA announced the expanded approval of Herceptin (also known as trastuzumab), a targeted therapy, for the treatment of women with early stage Her-2 positive breast cancer, a form of breast cancer previously known for its resistance to certain types of chemotherapy regimens. 

In 1998, after showing positive results in clinical trials, Herceptin received FDA approval for use in women with Her-2 positive metastatic breast cancer.  Researchers thereafter conducted clinical trials assessing the use of Herceptin in combination with chemotherapy treatments such as Adriamycin, Cytoxan, Taxol or Taxotere in women with early stage breast cancer.  In 2005, several of these trials were halted early due to findings that the percentage of women with disease free survival improved drastically.  Because of these findings, the use of Herceptin in women with early stage breast cancer has been the standard of care for about the past year.

Speaking about Herceptin, Dr. Edward Romond, professor of hematology/oncology at the University of Kentucky, said, "This is the largest improvement in outcome for any group of women with breast cancer in 25 years." 

If you are interested in hearing success stories directly from women touched by Her-2 positive breast cancer and diagnosed at all stages of the disease, tune in to www.her2support.org. 

This post is dedicated to Diane Juvan.  Special thanks to Michael H. Cohen for alerting me to this development.

• Email This
• Print
• Comments
• Trackbacks (1)

Yesterday, Michael H. Cohen, author of the Complementary and Alternative Medicine Law Blog, reported that "Scientists have taught dolphins to combine both rhythm and vocalisations to produce music, resulting in an extremely high-pitched, short version of the Batman theme song."  While the headline is amusing to some, Cohen questions the activity, asking "why dolphins are taught to sing the theme from Batman and not Beethoven's Ninth."

He continues,

Maybe the discrepancy has to do with the fact that I've placed this post under the heading of "ethical issues," whereas others have questioned whether recording the dolphins will raise intellectual property issues.

I noticed that a related article is entitled, Dolphins better at networking than the Web. Which is where my intuitive leap had intially gone: the question for science is not what songs dolphins can learn from the warped parts of our minds . . . . The question is rather what tunes we can learn from the dolphins.

"People who develop complex networks, like the World Wide Web or electricity grids, could learn a lot from the social behaviour of dolphins, a New Zealand zoologist has found.

David Lusseau, a zoologist at the University of Otago spent seven years observing a community of 64 bottlenose dolphins in Doubtful Sound, New Zealand, and found they have a social structure similar to human and human-made networks.

Cohen concludes,

Our dolphin friends may just be a leap or two ahead of our own ability to communicate through the five senses. Training dolphins to repeat commercialized popular culture for our own entertainment seems like throwing the precious pearl of consciousness to the swine of instant gratification.

***
Michael H. Cohen is the President of the the Institute for Integrative and Energy Medicine, also known as the Institute for Health, Ethics, Law, Policy & Society. The Institute serves as a reliable forum for investigation and recommendations regarding the legal, regulatory, ethical, and health policy issues involved in the judicious integration of complementary and alternative medical therapies (such as acupuncture and traditional oriental medicine, chiropractic, massage therapy, herbal medicine) and conventional clinical care.

• Email This
• Print
• Comments
• Trackbacks

Not even a week out from elections, and amid cries for bipartisanship and teamwork, Democrats and Republicans have already begun sparring.  Yesterday, Juvan's Health Law Update reported that Nancy Pelosi, the future Speaker of the House, has called for negotiations with pharmaceutical companies over drug pricing.  Today, the New York Times reported that the Bush Administration stepped forward to express its strong opposition to Pelosi's proposed change.  Speaking on behalf of Republicans, Health and Human Services Secretary Michael Leavitt went on the record announcing his opposition to the Democrats' plan, stating, "Government negotiation of drug prices does not work unless you have a program completely run by the government.  Democrats say they want the government to negotiate prices.  What they really want is government run health care."

Pharmaceutical companies have also voiced their opposition, raising the concern that this new initiative will result in the government receiving the "best price" for drugs.  Similarly, former president of Anthem Prescription Management James Lang stated, "For this to work, the government would have to take over price negotiations.  It would have to take over formularies.  You can't do one without the other."

While some have urged the Democrats to adopt a "go slow approach," Democrat Pete Stark responded by saying that there's no good reason to wait and that "quick congressional action might save a life."  He thereafter added, "I believe we must start work immediately to improve this incomprehensibly complicated plan, which overpays and deregulates private plans to the detriment of beneficiaries and taxpayers."

And thus, the promises of bipartisanship quickly retreat into the background, perhaps only to emerge again in the next election.

• Email This
• Print
• Comments (1)
• Trackbacks

This week, Michael H. Cohen, Assistant Clinical Professor of Medicine, Harvard Medical School and Assistant Professor, Harvard School of Public Health, announced on the Complementary and Alternative Medicine Law Blog  that the Institute for Integrative and Energy Medicine (the "Institute") is "reaching critical mass toward sustaining its mission," which is "[t]o provide leadership for the transformation of global healthcare toward compassionate and caring models, supported by law and social policy, that bridge our physical, psychological and spiritual selves." 

As reported at www.ihelps.org, the Institute collaborates with international scholars and organizations to develop models of health care that:

• draw on and respect our planetary heritage of healing;
• acknowledge the rights, interests, and needs of patients and families;
• understand health and healing as spiritual and emotional as well as physical journeys; and
• regard human transformation as central to a compassionate, caring healthcare system.

While originally a Wall Street lawyer who worked in securities, banking, mergers and acquisitions, Cohen shifted his focus, breaking from traditional corporate legal practice, and spent the last several years of his career writing and reflecting about complementary and alternative medicine (CAM). Cohen's shift occurred after taking up the study of Ericksonian hypnotherapy, Gurdjieff Work, and other tools for investigating consciousness, and following graduation from the New Seminary in New York and the Barbara Brennan School of Healing in Florida.

Cohen defines CAM therapies as "those therapies traditionally outside those provided through conventional, biomedical care in hospitals."  CAM methods include, for example, acupuncture, aromatherapy, chiropractic, homeopathic medicine, naturopathic medicine, Qi gong, Reiki and therapeutic touch.  "Integrative healthcare," he writes, "refers to emerging models of health care that integrate CAM into conventional medical settings, endeavor to create optimal healing environments, and bridge the entire spectrum of therapies." 

Cohen has spent much of his time discussing deficiencies in the legal framework that hinder CAM providers from gaining general acceptance.  States and medical boards, for example, fail to license and credential CAM providers in a fashion similar to that of physicians and other providers of conventional medicine.  Legislative recognition of these providers is important, however, because, as Cohen and several of his colleagues write, "legislative recognition trumps medical recognition:  State legislatures can license providers and thereby grant citizens access to certain therapies, even if scientific debate has not concluded in favor of those modalities." Similarly, in another article, Cohen and others explored the malpractice implications of referrals to CAM providers.  "Referrals can generate direct liability (the decision to refer was itself considered to be negligent, resulting in patient injury) and vicarious liability (the referring physician becomes legally responsible for the treating practitioner's negligence)." Accordingly, because of the risk of malpractice exposure, physicians have become hesitant to refer to patients to CAM providers.

The failure to have consistently applied standards serves as an impediment to patients who desperately need complementary therapies that provide a sense of hope and empowerment--the sense of actively combating and taking control of the disease that resides within them.  Cohen, for having the audacity to delve deep into CAM, has assumed a noble role. My recent conversations with Cohen have also led me to believe that he is a great mind and a deeply compassionate soul. 

With Cohen's theories, writing and advocacy, Cohen has the ability to increase the availability and credibility of CAM therapies, thereby helping to bring about a transformation for those whose illness initially held them captive and in a state of despair.

Juvan's Health Law Update will continue to follow the Institute's progress and will keep you apprised as developments occur.  If you are interested in furthering the development of the Institute, please contact Michael H. Cohen directly.

• Email This
• Print
• Comments
• Trackbacks (1)

Modern Healthcare has reported the following: "HHS Secretary Mike Leavitt named Leslie Norwalk as acting administrator for the CMS effective Oct. 15. Norwalk has served as deputy administrator for the agency that oversees $740 billion in federal spending on Medicare and Medicaid. She replaces Mark McClellan, who resigned from the CMS on Sept. 5."

• Email This
• Print
• Comments
• Trackbacks

Modern Healthcare just announced the following: "Officials are expected to announce that Robert Kolodner, chief health informatics officer at the Veterans Health Administration, has been named HHS' acting national coordinator for health information technology, sources said. Kolodner would replace David Brailer, the first occupant of the post, who resigned in May."

• Email This
• Print
• Comments
• Trackbacks

Recently, the moratorium prohibiting Medicare payments for services rendered pursuant to a referral to specialty hospitals in which the referring physician has a financial interest expired. Responding to the lifting of the ban, the Department of Health and Human Services ("HHS") released a strategic and implenting plan that called for revisions to payment schedules and increased transparency to address concerns raised by critics that specialty hospitals focus more on the profitability of patients than on providing high quality care. Specialty hospitals provide care for patients with cardiac conditions, orthopedic conditions or patients in need of surgical procedures.

The Medicare Prescription Drug, Improvement and Modernization Act of 2003 created the moratorium. Though the moratorium was originally scheduled to last for eighteen months, upon expiration, CMS announced a new policy that prohibited regional offices and contractors from enrolling these hospitals in the Medicare program. Subsequently, the Deficit Reduction Act of 2005 extended the moratorium for an additional six months.

The lifting of the moratorium is not a complete victory for physicians. The plan released by HHS calls for improvements to the accuracy of the hospital payment system and increased transparency. Discussing the plan, Mark B. McClellan, quoted in a CMS press release, stated, "We are bringing transparency to physician investments in hospitals, to help ensure that investment and compensation are appropriate, and to make sure that any such financial arrangements are disclosed to patients." CMS believes that the implementation of major changes to the current hospital inpatient prospective system and the ambulatory surgical center payment systems will eliminate improper incentives. Additionally, the plan calls for increased disclosure of physician investments and compensation arrangements.

Before physicians enter into this type of an arrangement, they should contact an experienced health care attorney to ensure that the proposed arrangement does not violate any state or federal fraud and abuse laws.

• Email This
• Print
• Comments
• Trackbacks

On Tuesday, President Bush signed an executive order entitled "Promoting Quality and Efficient Health Care in Federal Government Administered or Sponsored Health Care Programs." The Bush administration reports that this executive order aims to provide consumers with increased access to information about their doctors, hospitals and the prices of their procedures. The executive order requires federal agencies that administer health care programs to publish the costs paid for treatment, implement pay-for-performance reimbursement models and develop quality measurements. The executive order also requires federal agencies to use interoperable health information technology systems to facilitate the exchange of health information.

To view the executive order, visit http://www.whitehouse.gov/news/releases/2006/08/20060822-2.html.

• Email This
• Print
• Comments
• Trackbacks

On August 1, 2006, Michael Leavitt, Secretary of the Department of Health and Human Services, announced new exceptions to the Stark Law ("Stark") and new safe harbors to the Anti-Kickback Statute ("AKS") designed to encourage physicians to implement electronic prescribing and interoperable health records systems. Ordinarily, the provision of such technology may trigger Stark and AKS investigations, fines and potential criminal liability. Under the new e-prescribing technology rules, if applicable criteria are met, certain entities such as hospitals and group practices may donate items and services, including hardware, software internet connectivity training and support, to qualifying physicians. The new interoperable health record systems rules are similar to the e-prescribing rules, except that an entity may not donate hardware, and physicians must pay 15% of the donor's costs. The new HIT rules expire December 31, 2013.

Proponents have argued that these rules will contribute to the reduction in the total number of errors made and will improve efficiency and overall patient care. Critics have emphasized that e-prescribing and e-health records may jeopardize patient privacy.

• Email This
• Print
• Comments
• Trackbacks

Effective January 1, 2007, Health Care Providers Must Arm Employees with False Claims Act Education

On February 8, 2005, President Bush, strengthening his commitment to reducing the national debt, signed into law the Deficit Reduction Act (the "DRA"). In addition to cutbacks to other federally funded programs, the DRA aims to reduce Medicare and Medicaid expenditures and to recoup losses and overpayments made to health care providers. Among the most noteworthy provisions included in the DRA is a provision that requires employee education about the False Claims Act ("FCA") and applicable laws that protect, and even reward, employees who blow the whistle on their employers for violating these laws. The DRA specifically requires entities that receive or make annual payments of at least $5,000,000 pursuant to any state Medicaid program to establish written policies for employees that explain the provisions of the FCA, any state false claims laws and the applicable administrative remedies. The policies must also include a description of whistleblower protections and an explanation of internal policies that aim to prevent fraud and abuse. An employer must include a discussion of these matters in the employer's employee handbook. Entities that fail to comply by January 1, 2007 risk exclusion from the Medicaid program.

Essentially, these provisions constitute a recognition by the federal government that employees often play key roles in federal FCA investigations. These provisions increase the likelihood that employees lurking within, armed with full knowledge of their rights (and the millions of dollars they may recover if successful), will bring qui tam actions. Despite the fact that health care providers covered by these provisions may be hesitant to comply, they have no choice, as exclusion from the Medicaid program would be devastating.

• Email This
• Print
• Comments
• Trackbacks