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NLARx News 
 
January 26, 2011
In This Issue
From the Director
Dispensing Fees
PBM Transparency Options
Trade Resolution Adopted
NLARx on Facebook

ToolboxLEGISLATORS' TOOLBOX


 
  
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BvONew Opportunities Under the ACA to Expand 340B Programs and Reduce Drug Prices

Bill von Oehsen, President and General Counsel of Safety Net Hospitals for Pharmaceutical Access presented at the NLARx winter meeting on recent 340B Reform Legislation and Its Implications for the States.(presentation)
 

The ACA made substantial changes in 340B.  Before health reform there were 12 categories of health providers under 340B.   The ACA expanded 340B to 5 new categories including rural hospitals, children's hospitals and cancer hospitals.

 

The ACA also increased the 340B discount 5%.  Previously the 340B price was generally 20-30% less than the Medicaid price.  As the result of the ACA, the 340B discount has improved and may be best in the country, possibly even lower than the Veterans Administration prices.

 

Unfortunately the ACA excluded orphan and other drugs from the new provisions. These are very expensive drugs, and here are a lot of them,  500-600 drugs.  Other provisions govern negotiation between managed care and covered 340B entities on price, and the mandatory inclusion of 340B facilities in health exchanges. 

 

A significant change which could greatly increase access is the expansion of the 340B contract pharmacy program. Previously no contract pharmacy was allowed if there was in-house pharmacy and only one per institution.  But now covered entities can contract with virtually any pharmacy in service area.  This is a great opportunity for states to expand the program and also to partner with pharmacies.

juditPending Federal Legislation Could Increase Access to More Affordable Generics

Judit Rius Sanjuan, an attorney with Knowledge Ecology International, spoke at the NLARx meeting on "Why State Legislators should support Senator Sanders bill S.3921 the Ethical Pathway Act of 2010."

 

Ever wanted an explanation of patents and data exlusivity, and why it makes a difference to patients?  This presentation explained the role of data exclusivity for pharmaceuticals and biological products, and why Senator Sanders' bill will both limit unethical clinical trials for drugs already proved safe and effective, and speed up generic versions of these drugs.

 

(presentation)
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From the DirectorExecutive Director

 

 

We had an excellent meeting Friday at the Washington College of Law at American University in D.C., with detailed presentations on ways to cut the cost of Medicaid prescription drug purchasing, new opportunities to access 340B pricing after passage of the Affordable Care Act, pending legislation that would increase access to affordable generics, a Supreme Court overview, PBM transparency, and trade agreements that could limit Medicaid rebates and hamstring states' programs to negotiate prescription drug rebates.  If you missed the meeting, you can view most of the presentations on our website meetings page.

 

In addition to voting to support a resolution calling on the US to remove language in the Trans Pacific Partnership trade agreement that would restrict pharmaceutical pricing options, legislators voted in a slate of officers and new board members for 2011-12.  Congratulations to NLARx Board Chair Rep. Cindy Rosenwald of New Hampshire and new board member Rep. Pat Gardner of Georgia! And thanks to Councilmember David Catania for ably chairing the Association since 2007.

 

Be sure to check out the Legislators' Toolbox, which includes links to helpful background and model policies on trade issues, drug pricing and 340B.  We hope this information is useful!  If you want up-to-the-minute news postings, be sure to sign up on our facebook page - we post articles on a daily basis. 

 

 

Sincerely, Sharon Treat  Find us on Facebook 

 

winkelmanAre States Overpaying for Prescription Drug Dispensing? 

At our January 21 meeting, Nell Geiser of Change to Win and pharmacy consultant Mike Winkelman gave a thought-provoking presentation outlining opportunities for major savings if states change the way they pay for prescription drug dispensing.  The Geiser/Winkelman presentation is posted here. Key points in the presentation included these: 

  • Most states are paying pharmacies more for prescription drugs than commercial payors, and there really isn't a good policy/operations reason for this. 
  • The percentage states pay above commercial payors ranges from about 1% in NH to over 11% in DC. 
  • Just about every state is doing a good job on generic utilization, but states need to focus on the actual prices and dispensing fees paid for generics - what is the spread?
  • The marketplace is changing dramatically; the top 5-6 retailers control the marketplace (60% controlled by the big chains such as CVS, WalMart), not community pharmacies.  If states act to limit dispensing fees at the chain stores, they can retain proper access in rural areas, and for nursing homes, by paying these sectors more.  
  • 2 states have moved to Actual Acquisition Costs (Alabama and Oregon) from AWP with CMS approval.

Medicaid Pharmacy Reimbursement Reform: Trends and Recommendations (presentation)  

 

Additional Materials:

Attachment 1 Pembroke Pharmacy Market Share 2010 E, Attachment 2 updated State reimbursement, Attachment 3a Kaiser Medicaid P91,

Attachment 3b Kaiser Medicaid P92,

Attachment 4 Takeda 2009

 

PBMOpportunities for Pricing Reform through Pharmacy Benefit Manager (PBM) Regulation 

 

Attorney David Balto, of the Center for American Progress, spoke at the NLARx meeting on "Opportunities for Pricing Reform through Pharmacy Benefit Manager (PBM) Regulation."

(presentation)

 

The Affordable Care Act included new provisions requiring greater PBM transparency for insurance plans in the new state exchanges, including a requirement for aggregate data collection.  The two national insurance plans that will be administered by the Office of Personnel Management will also have to comply with PBM provisions, and the Department of Labor is currently considering extending ERISA fee disclosure standards on conflicts of interest.

tradeU.S. Legislators Call for Halt of Trade Restrictions on Pharmaceutical Pricing  

By Sean Flynn, Associate Director, Program on Information Justice & Intellectual Property, Washington College of Law, American University

 

On Friday January 21, the board of the National Legislative Association on Prescription Drug Prices (NLARx) endorsed a resolution calling on the U.S. to halt the use of trade agreements to enact international disciplines on pharmaceutical pricing programs. The resolution was passed at the Association's winter meeting in Washington, D.C. The resolution specifically targets the ongoing negotiation of the Trans-Pacific Partnership (TPP), a plurilateral trade agreement among eight nations. To date, no negotiating text has been publicly released. But the branded drug lobby has requested the inclusion of a chapter in the agreement that would require countries to "appropriately recognize the value of patented medicines" in public drug reimbursement programs and provide appeals for drug manufactures to challenge listing and reimbursement decisions of public health authorities.

 

As explained in the resolution, public health programs run by states, including the administration of Medicaid drug benefits for over 40 million Americans, use the same types of price restraining preferred reimbursement formularies (known as preferred drug lists, or PDLs) as foreign governments. Many federal programs, including drug programs for Medicare and veterans hospitals, achieve reductions on drug prices through similar preferred reimbursement programs.

 

"It is not in the best interest of the United States to promote limitations on the types of evidence-based drug pricing used by private companies, U.S. state governments, the U.S. Department of Veterans affairs - and by foreign governments - to control runaway pharmaceutical prices. At a time when health budgets everywhere are strapped, the federal government should not be promoting a new global regulatory agenda that would attack the most effective tools we have to combat excessive medicine prices in our health programs," said Sharon Treat, NLARx Executive Director.

 

The resolution recounts that these effective programs would be threatened by the kind of new international restraints on pharmaceutical pricing programs that the drug industry seeks:

 

"Trade Agreements are reciprocal by nature, and state government policies that violate the terms may lead to foreign government retaliation. The federal government may preempt state law thorough international agreements. And proposals to limit the operation of foreign reimbursement programs are likely to lead to increased foreign pressure to limit similarly operating programs in the U.S."

 

The first trade agreement to include a pharmaceutical pricing provision was the Australia-US FTA. That program required pharmaceutical company participation and appeal opportunities that state officials warned would cripple Medicaid if applied to states. More

 

The issue came to the fore again with the Korea - US FTA negotiation, during which the U.S. proposed language in the agreement that would prohibit Korea's "positive list" drug formulary. NLARx opposed that language, warning that such proposals would threaten Medicaid programs that use similar preferential purchasing lists to restrain drug prices. More 

 

The USTR has not thus far backed down from its agenda to craft new international restraints on effective drug price controls. In a public statement in late September 2009, for example, Ambassador Kirk expressed his "support" for broadening the discussion of a proposal by Pfizer to promote new international rules that "discipline" pharmaceutical reimbursement programs in the U.S. and abroad. 

 

The NLARX resolution will be transmitted to the USTR and to members of Congress. NLARx officials will meet with the USTR on January 31 to discuss TPP and drug pricing issues further.

 

For more on this issue, check out this week's the Legislators' Toolbox, the Forum on Democracy & Trade and PIJIP

 

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