A federal judge has denied the request of a group of community pharmacists to immediately stop the acquisition of Medco Health Solutions by Express Scripts, Inc. The judge will next decide whether to throw out the lawsuit.

The pharmaceutical benefits management companies Express Scripts and Medco merged on April 2, after the Federal Trade Commission announced it would not block the deal. The companies had announced their plans in July 2011.

Community pharmacists — represented by the National Association of Chain Drug Stores, the National Community Pharmacists Association and nine community pharmacies — filed suit in March against the $29 billion deal in U.S. District Court for the Western District of Pennsylvania. The groups said that neighborhood pharmacies and consumers would be at a disadvantage if the two companies were allowed to join forces, which could lead to reduced competition. They asked the court to block the deal while the lawsuit is pending.

On Wednesday, Federal District Court Judge Cathy Bissoon said that the pharmacists “have not met their burden to establish the likelihood of immediate, irreparable harm” that would require the court to issue a preliminary injunction. Furthermore, she wrote that “the fears expressed by plaintiffs already have been realized.” The two companies have already shared proprietary information with each other and most of Medco’s senior staff have left. If she granted the pharmacists’ request to keep the two companies separate, the result for Medco even back in early April would have been “a headless organization that would likely be unable to survive on its own, much less compete against” Express Scripts.

The company has asked that the pharmacists’ case be dismissed, a motion that Bissoon is currently considering.

The pharmacists said in a joint statement on Thursday that “we presented a compelling argument for the court to suspend the combination of Express Scripts and Medco until the merits of our complaint could be considered in full. It is important to note that the judge has not yet ruled on the merits of the case or the motion to dismiss, so the case is continuing.”

PBMs act as middlemen who negotiate with drugmakers for the lowest possible prices on behalf of insurance plans, passing those savings on to the plans and others. The drug benefit managers also run their own mail-order and specialty pharmacies. This deal creates the biggest PBM in the country.

The community pharmacy companies are backed by consumer groups such as the Consumer Federation of America, National Consumers League, National Legislative Association on Prescription Drug Prices and the Public Interest Research Group. The consumer advocates wrote in a brief to the court that they are “concerned with the abusive, anti-consumer conduct” of the PBMs.

The FTC investigated the deal for eight months before the panel decided that it would not take action to block it. The retail pharmacists hope that their lawsuit against the combined company will give them one more chance to thwart the deal.

The Department of Health and Human Services wants input on how to design a study that would detail under what circumstances men who have a history of sex with other men should be allowed to donate blood.

Under current Food and Drug Administration policy, men who have had sex with other men since 1977 — the dawn of the AIDS epidemic — are not allowed to donate blood. But a request for information posted by HHS on the Federal Register asks for comments on a pilot study that would look at ways to allow blood donations by some gay or bisexual men who are not at high risk for HIV infection.

The lifetime ban on blood donation by men who have sex with men has been questioned by advocacy groups and recently by Democratic members of Congress, including Sen. John Kerry of Massachusetts and Rep. Mike Quigley of Illinois (

According to the FDA’s website: “A history of male-to-male sex is associated with an increased risk for the presence of and transmission of certain infectious diseases, including HIV, the virus that causes AIDS.”

The agency adds: “FDA’s policy is intended to protect all people who receive blood transfusions from an increased risk of exposure to potentially infected blood and blood products.”

Similar policies are in place in Europe, though England, Scotland and Wales now allow men to donate blood as long as they have not had sex with another man in the past year or engaged in other risky behavior, according to The Guardian newspaper.

The FDA notice says the risk of infection from a blood transfusion is now “extremely low” and risks have dropped dramatically during the past three decades because of safeguards that are in place. If an infection occurs now, it’s due to a deficiency in the donor screening process, the failure of a donor to provide accurate answers, donations during a period when someone’s infection can’t yet be detected or inadvertent release of donated blood before testing results are known, the notice says.

Advisory committee meetings and a public workshop have been held to examine the policy and have taken into account current scientific evidence, according to the notice. “In addition, there has been increased interest in changing this policy from some members of the U.S. Congress, the public and interested advocacy groups,” it adds. In June 2010, an HHS committee called the current policy “suboptimal” while recommending it be kept, pending research.

So now, health experts are asking for input on questions such as whether blood donations might be accepted from men with one or five years of abstinence from sex with other men; the impact on blood centers of adopting new policies; staff training and staff perceptions; tracking of results before blood donation and afterward; the willingness of blood organizations to take part in a pilot; and more.

The notice says the concept is to do a pilot study in which homosexual or bisexual men who meet set criteria would be permitted to donate blood, with additional safeguards in place to protect blood recipients. Data would be gathered to figure out whether the criteria were effective in finding low-risk donors, and at the conclusion of the study there would be a “transparent and evidence-based evaluation” of all current and future policies on blood donations.

HFA will definitely be weighing in on this issue and providing comments to HHS. To read the Federal Register Notice go here.

• The largest plan by enrollment in any of the three largest small group insurance products in the state’s small group market;
• Any of the largest three state employee health benefit plans by enrollment;
• Any of the largest three national FEHBP plan options by enrollment; or
• The largest insured commercial non-Medicaid Health Management Organization (HMO) operating in the state.

HHS announced this approach after seeking input from the Institute of Medicine (IOM), the public and the Department of Labor.  HHS intends to propose that if a benchmark is missing categories of benefits, the state must supplement the missing categories using the benefits from any other benchmark option.  Health insurance companies will have some flexibility to adjust benefits.

Since HHS has decided to let states decide EHBs, instead of creating a federal EHBs standard, many fear that states will continue the status quo or even have low EHBs standards because of costs concerns.  The federal government will subsidize coverage based on the essential health benefits, any coverage options above that standard states will have to pick up the cost.

It is important to evaluate how your state ranks regarding insurance coverage and benefits provided for patients with bleeding disorders.  Whether or not there are protections in place, continued advocacy is still necessary.  State advocacy of all stakeholders involved in this process: Legislators, Exchange Boards, Insurance Departments, Executive Branch, etc. will be crucial.

HHS is accepting public comments on the bulletin by Jan 31, 2012. The regulatory process for EHBs will likely continue into the year, guidance on calculating actuarial value, cost sharing and the provision of minimum value by employer-sponsored coverage will be released later, with more opportunities for public comment.

Read HHS press release here.

Read the Bulletin here.

By Anna Edney

Courtesy of Bloomberg News

Oct. 26 (Bloomberg) — Two Chinese companies implicated in supplying contaminated ingredients three years ago to Baxter International Inc. for its blood thinner heparin are still supplying product to the U.S., Republican lawmakers said.

Baxter recalled the blood thinner in 2008 amid reports of deaths and allergic reactions. The Republicans, led by Representative Fred Upton of Michigan, chairman of the House Energy and Commerce Committee, wrote Food and Drug Administration Commissioner Margaret Hamburg, asking why the agency hasn’t warned drug manufacturers to avoid product from the Chinese companies. Today’s letter didn’t name the companies.

“We have reason to believe that these two Chinese firms are still supplying crude heparin that is being imported into the United States,” the lawmakers wrote Hamburg. “We have seen no indication that the FDA has issued warning letters and/or import alerts to these firms even though FDA has issued warning letters and import alerts to other Chinese heparin firms.”

Heparin is given to about 12 million people in the U.S. each year, according to the lawmakers’ letter. Committee Republicans again began investigating contaminated heparin in February. The committee expanded its investigation in May to seek information from U.S. Immigration and Customs Enforcement and from industry leaders in June.

“We have very serious public health concerns arising from our investigation,” Upton and four colleagues wrote.

Deborah Spak, a spokeswoman for Baxter, didn’t immediately respond to a request for comment on the letter. Spokeswomen for the FDA also couldn’t be immediately reached.

To contact the reporter on this story: Anna Edney in Washington at aedney@bloomberg.net. To contact the editor responsible for this story: Adriel Bettelheim at abettelheim@bloomberg.net.

• Click here to read Commissioner Margaret Hamburg’s letter

IOM’s report lays out a methodology that should be used to determine ‘essential health benefits’.  The report also emphasized that the benefit package should be affordable based on the average cost of health insurance for small employers in 2014 – when exchanges should be fully implemented. The government should announce their final plan by May 1, 2012 and will hold a series of listening sessions across the country.  Listed below is the IOM report and additional resources.

Institute of Medicine: Essential Health Benefits: Balancing Coverage and Cost

Implementing Health Insurance Exchanges: State Profiles

Kaiser Family Foundation – What is a Health Insurance Exchange?

State Action Towards Creating a Health Insurance Exchange, as of September 23, 2011

Establishing Health Insurance Exchanges: An Update on State Efforts

Implementing Health Insurance Exchanges: State Profiles

Health-care law benefits must be limited to ensure affordability, panel says

Panel Says U.S. Should Weigh Cost in Deciding ‘Essential Health Benefits’

HFA Comment Letter to Institute of Medicine on Essential Health Benefits December 2010

The committee can consider reductions to entitlement programs (such as Medicare, Social Security), tax entitlements, and defense spending.  If recommendations by the special Congressional committee are deadlocked or not approved by Congress by the end of 2011, then more than $1 trillion in automatic spending cuts will be triggered. The cuts could potentially hit defense spending and payments to Medicare providers (not beneficiaries). Below are some resources to help clarify the debt ceiling and the “super committee” created to come up with spending cuts.

If you have a relationship with a member of the Committee or even if your Senator or Representative is on the Committee it would be worthwhile to contact them and express your support for programs that benefit you! including Medicare and Social Security. If you would like assistance in outreach to your member of Congress please don’t hesitate to contact HFA staff.
Super Committee Members

Senate Members
Sen. Patty Murray (D-WA), Co-chair
Sen. John Kerry (D-PA)
Sen. Max Baucus (D-MT)
Sen. Jon Kyl (R-AZ)
Sen. Pat Toomey (R-PA)
Sen. Rob Portman (R-OH)

House Members
Rep. Jeb Hensarling (R-TX), Co-chair
Rep. Dave Camp (R-MI)
Rep. Fred Upton (R-MI)
Rep. Chris Van Hollen (D-MD)
Rep. James Clyburn (D-SC)
Rep. Xavier Becerra (D-CA)
Resources

A section-by-section summary of the Budget Control Act 

New York Times: Q. and A. on the Debt Ceiling

Brookings Institution: Deficit Reduction and the New Congressional Committee: A Primer

Families USA: The Super Committee: Where They Stand on Medicaid, Medicare, and The Affordable Care Act

Coalition for Affordable Health Coverage:  Better Know Your Super Committee

National Womens Law Center: State-by-State Fact Sheets for Super-Committee Advocacy

Debt Budget Deal Time Table

A Who’s Who of the Debt Supercommittee

FAQ: ‘Super Committee’ Could Have Big Impact On Medicare, Medicaid Spending

The Budget Control Act of 2011: Implications for Medicare 

Courtesy of Worchester Telegram & Gazette

Doctors are taught in medical training to “look first for the horses, not the zebras.”  In other words, look first for the typical causes of symptoms before exploring more exotic possibilities. But, former Worcester School Superintendent John Durkin wouldn’t be alive today if his doctors at UMass Memorial Medical Center hadn’t quickly found the exotica that was threatening his life.  And after the problem was found, practically the entire staff of the medical center’s hematology service went further, holding off death while they fashioned a treatment where none existed.

Since he retired in 1992, Mr. Durkin had enjoyed excellent health, allowing him to take on the job of director of Worcester State University’s Center for Effective Instruction and spend plenty of time on the golf course.  At the end of last year’s golfing season, however, Mr. Durkin was tiring easily; he cut his game back, walking six holes instead of nine. He also developed a limp and his hip started to bother him. Arthritis, he thought.

Winter passed uneventfully, but one day in mid-March, Mr. Durkin felt severe pain in his back and groin area. That night, Mr. Durkin slept in a chair downstairs, unable to make it upstairs to his bedroom. In the morning, he called his daughter and told his wife, Joan, that he needed to go to the hospital.

As he tried to get out of the chair, Mr. Durkin fell. “My leg had given out like a piece of wet spaghetti,” he recalled.  At the emergency department on the Memorial campus, a primary care team found that Mr. Durkin was experiencing spontaneous bleeding into the psoas muscle, the muscle that joins the lower back and the inner thigh and is responsible for leg movement and spine flexibility. That explained Mr. Durkin’s symptoms, but not the ultimate cause.

“He had this bleed, but that by itself isn’t necessarily alarming,” said Dr. Bradley Switzer, a medical hematologist (blood doctor) at the University campus who was called in for consultation.  A blood test, however, revealed an answer, but one so unusual that more tests were done, according to Dr. Switzer, “to see if it was for real.”  It was, necessitating Mr. Durkin’s transfer to the University campus where hematologists saw a medical problem that rarely appears outside of a medical textbook.

“Mr. Durkin had acquired this one-in-a-million autoimmune phenomenon, where the body attacks its own proteins,” said Dr. Switzer.  Now, the body has 12 clotting factors — numbered using Roman numerals through XII — that work together in sequence to keep your blood in a fluid state, without clotting and without bleeding.  About one in 5,000 American men are born with a deficiency of Factor VIII, making them hemophiliacs. If they are cut or bruised — sometimes even spontaneously — they bleed longer than a normal person and can bleed to death.

Mr. Durkin was not born with this problem, but somewhere along the way as he grew older — he’s 79 now — he had acquired an inhibitor of Factor VIII.  “His autoimmune system was attacking and chewing up Factor VIII,” said Dr. Switzer. “When it was all chewed up, it was like he was a hemophiliac; he just couldn’t stop bleeding.”

Daily bleeding caused Mr. Durkin’s right leg to swell up, from his knee to his hip, but that wasn’t the only area of trouble. The blood was “oozing anywhere, everywhere,” said Dr. Switzer.  While loss of blood could be compensated for by large transfusions, the only chance for Mr. Durkin to survive was to stop the bleeding. But, according to Dr. Switzer, “his condition was so rare there aren’t any great treatments for it.”

Consulting at every turn with Dr. Doreen Brettler, medical director and adult hematologist for the Hemophilia Treatment Center of New England, Mr. Durkin’s doctors tried several drugs, looking for something whose previous use would suggest it might be effective.  “We had to throw everything, including the kitchen sink at him,” said Dr. Switzer. “He almost bled to death on us several times, but because everyone here was fighting for him, doing everything we could, not holding anything back, it turned around.”

Doctors hit upon a drug called Rituxan (Rituximab), a chemotherapy weapon usually used to fight non-Hodgkin’s lymphoma and leukemia. It was worth a try, the doctors thought, since nothing else had worked and they were running out of options after nearly a month. And Mr. Durkin was running out of time.  After the second grueling six-hour intravenous treatment, Mr. Durkin stopped bleeding and tests showed his blood coagulation was starting to normalize. “It literally saved his life,” said Dr. Switzer.

Mr. Durkin was well enough at this point to be transferred on April 16 to Fairlawn Hospital for physical rehabilitation, but while he was there, he would still need to return to the UMass University Campus on an outpatient basis for a third and fourth intravenous treatment with the Rituxan. Since Mr. Durkin had not finished his course of treatment yet, the prospect of his possibly starting to bleed again was very much on the minds of the Fairlawn staff.

“Everyone was definitely concerned and cautious about it,” said Dr. Trista Brown, physical medicine and rehabilitation specialist at Fairlawn, “but we wanted him to progress as much as possible, too, so you just have to take extra precautions.”  An extra therapist was present at all rehabilitation sessions to steady Mr. Durkin should he begin to stumble or fall. The pace of the rehabilitation was slowed down to ensure safety. No orthopedic devices were used initially because there was worry about possible bruising. And his skin was frequently monitored for signs of trouble.

According to Dr. Brown, Mr. Durkin had a “pretty profound” weakness in his right leg because the nerves that travel through that area were damaged by the blood collection there. (That blood should eventually be reabsorbed by his body.)  Because Mr. Durkin had trouble flexing his hip or extending his knee, an immobilizer brace — one that didn’t press anywhere — was put over his entire right leg to help his mobility.  He had been on “complete bed rest” at UMass for more than a month, and his whole body had weakened.

“In rehab, we generally try to address the person as a whole and try to improve endurance, strength, range of motion, core functioning, etc.,” said Dr. Brown.  The goal, according to Dr. Brown, was to have Mr. Durkin strong enough to be able to  manage a wheelchair by the time he was discharged and to be able to do basic things for himself at home — for example, washing up and dressing.  Mr. Durkin exceeded those goals. Instead of a wheelchair, he was able, using a walker, to walk over 100 feet down the Fairlawn corridors. And the leg brace was reduced to the knee, ankle and foot.

Besides the Fairlawn staff, Dr. Brown credits a great deal of Mr. Durkin’s success to the work he was willing to put into rehabilitation.  “He was always motivated, always had a positive attitude, absolutely a pleasure to work with. He really made our job easy by wanting to work so hard.”  He now returns for outpatient rehabilitation that focuses on walking and learning how to use the brace, according to Dr. Brown.

So what does the future hold for Mr. Durkin?
After the fourth intravenous treatment with Rituxan, Dr. Switzer was able to tell Mr. Durkin that there was no sign of the inhibitor in his blood. With the acquired inhibitor now completely gone, Mr. Durkin’s blood will clot normally if he gets a cut or a bruise.  However, Dr. Switzer said, “there is a reasonable chance of it (the acquired inhibitor) coming back. Regretfully, there is no way for us to tell if he will be normal for the rest of his life or it will recur.”  “I’m very pleased with the progress I have made so far,” said Mr. Durkin, who hopes for “a long time” with his wife Joan and their family of six children and 11 grandchildren.

By MARGARET A. HAMBURG

Courtesy of the Wall Street Journal

There are encouraging signs that the pharmaceutical industry’s pipeline of new products is not as stalled as some say.  Already in 2011, the Food and Drug Administration (FDA) has approved 21 new, groundbreaking medicines—the same number as in all of 2010—including treatments for Hepatitis C, late-stage prostate cancer and lupus.

We hope this signals a larger trend in industry and at the FDA. Despite common criticisms that our agency impedes innovation by being slow and bureaucratic, we actually play a proactive role in promoting innovation by ushering new products through the approval process and to market—while making sure they meet the standards of safety and effectiveness that have served the American people well.

When presented with high-quality applications that are based on strong science, we work quickly and efficiently. And we must, because our mission is to promote and protect the health of the American people.

This includes promoting the development of innovative new diagnostics and treatments that will help solve the complex public-health challenges of the 21st century. This requires working closely with industry, academia, patient and consumer groups, health-care professionals and others. These include streamlining and improving our approval processes; increasing transparency and building new collaborations; and strengthening the field of regulatory science, at the FDA and beyond.

Today, products we regulate account for more than one in five of all dollars spent on consumer products in the U.S.—or more than $1 trillion a year. The industries we regulate lead the world in innovation and provide hundreds of thousands of high-paying jobs. The U.S. biopharmaceutical industry accounts for the largest share of global launches of new drugs and the medical-device industry has a positive trade balance, with the value of its exports growing annually.

The FDA does bear some responsibility for the criticism we receive, and we listen carefully to our colleagues and critics. In response, we are actively taking steps to improve the clarity, consistency and predictability of our regulatory systems. At the same time, we are working with the broader scientific community to address issues of scientific uncertainty that slow medical-product development and review.

But misconceptions about our effectiveness as an agency could derail these efforts. One prevailing misconception is that the FDA lags behind Europe in approving medical products. The truth is that the FDA consistently approves the vast majority of priority drugs and medical devices as fast as, or faster than, our European counterparts. Of the 35 new cancer drugs approved either by the FDA or the European Medicines Agency (EMA) from October 2003 to December 2010, the FDA approved 32—in an average time per drug of 261 days. The EMA approved only 26 of these same 35 products, in an average time of 373 days.

Furthermore, all 23 cancer drugs approved by both agencies during this period were marketed first in the U.S., according to a study published last month in Health Affairs by Friends of Cancer Research, a think tank in Washington, D.C. We see similar trends for critical drugs in other areas of medicine.

According to an industry-funded study by the California Healthcare Institute and the Boston Consulting Group, lower-risk devices, such as wheelchairs, CT scanners and knee-replacement implants—which make up 80% of all devices reviewed each year—come on the market first in the U.S. as often as or more often than they do in Europe. While higher risk devices, such as pacemakers and drug-eluting stents often do come on the market first in Europe, this is in large part due to the U.S. requirement, absent in the EU, that the device be shown to benefit patients.

Another misconception is that the demands of the FDA’s approval process cost jobs and undermine U.S. global competitiveness. The opposite is the case. By instilling confidence in American products and technologies, the FDA  stimulates economic growth, creating jobs at home and opening markets overseas.

Consider that the U.S. biopharmaceutical and medical-device sectors dominate their global industries. Even during the recent recession, from 2006 to 2009, the medical-device industry increased sales, boosted exports and expanded its work force. During the same period, major biopharmaceutical firms demonstrated strong financial performances. This could not have happened without widespread consumer confidence, at home and abroad.

Without question we face formidable competition overseas, especially from Europe and China, where significant investments are being made in regulatory science. But the FDA remains the regulatory gold standard throughout the  world.

President Obama has made it clear that this administration will do everything it takes to promote innovation in medicine and health while preserving the safety and effectiveness of critical medical products. The FDA, working with industry and other groups, is eager to help lead the way.

That is what it will take to protect the public health in the 21st century. And that is what the American people deserve.

Dr. Hamburg is the Commissioner of the Food and Drug Administration.

The health care law will disappoint many Americans if its health insurance exchanges don’t deliver decent coverage at affordable rates for consumers, including those with serious illnesses like cancer.

Meeting those expectations may be difficult, judging from comments by a major patient advocacy group as it waits for the Obama administration to release rules governing the development of the exchanges and watches state legislatures draft exchange laws.

For example, the American Cancer Society Cancer Action Network recently released a series of “threshold questions” that states should address if they are going to design exchanges under the laws that meet the needs of cancer patients.

They include: Will boards overseeing exchanges be structured to meet consumer interests? Will insurance market regulations outside of exchanges discourage these marketplaces from becoming a dumping ground for bad insurance risks? Will it be easy for exchange customers to enroll in Medicaid or move from Medicaid to private exchange plans when their incomes rise? Will the exchanges have a stable source of funding? Will they be an “active purchaser” with the power to exclude plans that offer lousy value?

Stephen Finan, senior director of policy for the Cancer Action Network, said in an interview Wednesday that “it’s a mixed bag” in terms of how well states are doing so far on those parameters. Of the dozen or so states with exchange laws, California, Connecticut, and Maryland are “on the good end” of the spectrum and Colorado, Oregon and Nevada are on the “not so good” end, he said.

States that are moving in the right direction have done a good job dealing with critical issues like governance, he said. They are coordinating their outside markets to work well with exchanges and keep them from attracting disproportionate numbers of insurance enrollees who are costly to cover. These states also are on track to coordinate well with Medicaid programs and have a stable source of funding, with plans to charge fees to all insurers in the state, not just those that offer coverage on the exchange.

States performing inadequately, on the other hand, are setting up exchange oversight boards that are too big, or have too many insurers or providers running things. These states won’t coordinate well with the outside market, and they would leave funding of exchanges to the uncertainty of the yearly appropriations process.

The overwhelming majority of states have yet to pass legislation creating exchanges, which means it’s still unknown whether exchanges in most states will prove worthwhile for consumers. Finan said that the upcoming proposed exchange regulation to be issued by HHS could push states in the direction of making good decisions by offering guidance on creating effective exchanges.

But Finan said he thinks the proposal will be very wide ranging. “It could be a soup-to-nuts thing for every option” for creating exchanges, he said. And making a good exchange is a challenging proposition that involves much more then simply knowing about a wide range of design options. “It’s not just the pieces, it’s how they fit together,” he said. “It’s not an easy thing to build a good exchange.”

“What we hope is that the final regulation will establish clear minimum standards,” he said. “I don’t think we’ll see that in the proposal,” he added, predicting that it will list a wide array of design options in order to draw a wide range of comments.

Consumer advocates may face difficulty obtaining a final exchange regulation to their liking.

Republicans have traditionally been strong allies of the insurance industry, and the industry has a history of turning exchanges into dumping grounds for bad risks. But Finan says that consumer groups are coordinating their efforts to produce exchanges that work well for their members.

“The insurance groups have been talking regularly for almost a year,” he said. “We have weekly phone calls on exchange-related issues. We’re trying first and foremost to exchange information and educate each other.” In addition to the American Cancer Society, groups involved in the talks include Consumers Union, the Center on Budget and Policy Priorities, AARP, Families USA, the Small Business Majority, Health Care for American Now, SEIU, and the National Partnership for Women and Families. Finan said that in the end they may submit a common letter commenting on the proposed rule. If not, “I think there will be a fairly uniform set of messages,” he said.

John Reichard can be reached at jreichard@cq.com