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.

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 

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

New England Journal of Medicine

Auditing Access to Specialty Care for Children with Public Insurance

Senator Blunt (R-MO) specifically asked  Commissioner Hamburg about the speed of drug approvals and the idea of imposing user fees for the first time on generic drug companies. The administration proposed adding $40 million in user fees for generic companies in its fiscal 2012 budget.

After the hearing, a reporter asked Hamburg for an update on the agency’s work in creating a new approval process for follow-on biologics that are similar to biologics already on the market. Biologics are treatments and vaccines made with live organisms.

Hamburg said agency action will happen “soon.”“There are some real scientific challenges here but it’s a high priority for us to get this program up and going,” she said. “We know there are a lot of people waiting to be able to get access and a lot of products going off patent, too.”

Hamburg said that with generic versions of chemical drugs, the FDA starts the review process and does a tentative approval while the patent is still in place on the original drug. Then it fully approves a drug when the patent expires. She said she would “imagine there’ll be a mechanism similar to that but we’re still in the process of shaping” the procedures for the biologic drugs.

She added that companies are already starting to formally discuss potential applications with the agency.

“We’re talking to a lot of people already, getting a sense of what’s out there,” she said.

Visit the FDA’s website.

For the press release on Governor Paterson’s recent bill signings click here.

For more information on S. 5000-B go the New York State Assembly website here.

The basis of the discussion was a newly released survey done by the Kaiser Family Foundation:  Health Care Among Non Elderly People with Disabilities and Seniors on Medicare, 2008. The survey results were reported in the September edition of the Health Affairs Journal: Medicare Doesn’t Work as Well for Younger, Disabled Beneficiaries as it Does for Older Enrollees.

The survey found:

• Overall non-elderly disabled beneficiaries facer greater financial and access barriers compared to elderly Medicare beneficiaries.
• More non-elderly Part D enrollees reported medication access problems compared to elderly Part D enrollees.
• Most of the survey respondents were satisfied with their Medicare coverage.
• Non-elderly disabled Medicare beneficiaries have more health problems/ co-existing conditions compared to elderly beneficiaries.
• Non-elderly beneficiaries with no supplemental coverage were more likely to report having difficulty paying for coverage.
• 1/3 of non elderly disabled Medicare beneficiaries reported being uninsured during the 24 month Medicare waiting period.  46% of all respondents states that the government should do away with the 24 month waiting period.

Below are some of the ways the Affordable Care Act will help Medicare beneficiaries.

• Health care reform will help some in Medicare’s waiting period access coverage through the new national high risk pools.
• Expansion of Medicaid eligibility up to 133% of the poverty level.
• Starting in 2014 insurance companies will be required to provide coverage and health insurance exchanges will be available to help individuals purchase health insurance. The government will also provide subsidies (if you qualify) to assist with the cost of health insurance.
• The new insurance program, Community Living Assistance Services and Supports (CLASS) Act will provide cash benefits for long terms services and supports for eligible participants.

For more information on the Kaiser Family Foundation and this forum please visit their website: www.kff.org or to view the presentation and background materials from the forum click here.