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NLARx News                                                                            March 8, 2011

In This Issue
From the Director
State Rx Legislation
NCOIL Resolution on Trade & Pharmaceuticals
NLARx files Amicus Brief in IMS v. Sorrell
NLARx on Facebook

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From the DirectorExecutive Director

 

While states continue to be focused on Medicaid and budgetary issues, various prescription drug-related bills are starting to emerge from the legislative hoppers in states from Alaska to New York, including bills on PBMs, reporting of gifts, and prescribing of antipsychotic drugs.  

 

NLARx and AARP have jointly filed an Amicus Brief in the Vermont case, IMS v. Sorrell, now pending in the US Supreme Court.  The case is an appeal from the 2d Circuit decision overturning Vermont's prescriber confidentiality law. Read about our brief and the other friend of the court briefs filed by medical and consumer groups. Also last week, I had the opportunity to present on trade policy and pharmaceuticals at the NCOIL meeting in Washington, D.C, and you can read my testimony here 

 

Also, check out the Legislators' Toolbox, which includes links to model policies for many of the issues being addressed by the states and discussed in this newsletter.  Remember we post interesting news on our facebook page regularly.    

Sincerely, Sharon Treat    

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StatesRoundup of Legislation in the States

Legislatures Consider Variety of Measures Going in Different Directions 

  

MISSOURI PBM BILL FACES STIFF OPPOSITION FROM EXPRESS SCRIPTS AND OTHER PBMS

Pharmacy firms fight proposed legislation 

(Fort Scott Tribune, March 6, 2011) "Power politics have come to the foreground in the 96th General Assembly's review of proposed legislation to change the way medications are prescribed and provided." more 

 

Here is a summary and link to the bill:

Missouri Senate Bill 236 

[Note - Portions of this act are identical to SB 918 (2010). ] The bill covers several issues including  electronic transmission of prescriptions, regulation of pharmacy benefit managers (PBMs) and their relationships with pharmacies, procedures for governing switch communications, informing patients  of any cost sharing changes due to proposed switches of medications,  and oversight of switch communication by the Department of Insurance, Financial Institutions, and Professional Registration. The act also specifies that a PBM owes a fiduciary duty to a covered entity and shall notify the covered entity in writing of any activity, policy, or practice of the PBM that directly or indirectly presents any conflict of interest. SB 236 also requires PBMs and health carriers to provide a website with a list of medications which require preauthorizations. Portions of this act are identical to SB 918 (2010).

 

SIX STATES CONSIDER EXTENDING PSYCHOTROPIC PRESCRIBING RIGHTS  

Legislators in Arizona, Hawaii, Montana, New Jersey, Oregon and Tennessee are considering bills that would allow psychologists to prescribe psychotropic medications. But the measures are staunchly opposed by the American Medical Association, the American Psychiatric Assn., state physician organizations and others who maintain that the proposals would jeopardize patient safety. more  


ON THE OTHER HAND, MAINE CONSIDERS TIGHTENING UP PRESCRIBING OF ANTIPSYCHOTIC MEDS TO KIDS 

"An Act To Ensure the Safety of Children in the MaineCare Program Who Are Prescribed Antipsychotic Medications"

has been sponsored by Rep. Joan Welsh.  You can read the bill here

 

PENNSYLVANIA PHARMACISTS FIGHT MAIL ORDER MANDATES WITH LEGISLATION

WHYY NEWSWORKS, MARCH 7, 2011

"Pharmacists in Pennsylvania are battling against mail-order drug companies this legislative session. They are pushing for a bill in Harrisburg that would prevent insurance companies from requiring patients to get some of their prescription drugs filled via mail order. Pharmacists say customers should have a choice about where they fill their long-term prescriptions, such as medications for high blood pressure." more 

 

NEW YORK PHARMACISTS ALSO TAKE AIM AT MAIL ORDER  REQUIREMENTS OF PBMS

Pharmacists Fight the Rise of Mail Order
NY Times, By REED ABELSON and NATASHA SINGER
(March 3, 2011): "A fierce battle is being waged between retail pharmacists and mail-order companies over where people should be able to fill their long-term prescriptions. Community pharmacists in New York are lobbying state lawmakers to pass legislation that would prevent health plans from requiring patients taking medications for chronic ailments to fill their prescriptions through the mail... The proposed legislation, which was introduced in both state chambers in late February, would ban mandatory mail-order programs." more  

 

WHILE BILLS IN MAINE WOULD REPEAL THE STATE'S  GIFT DISCLOSURE LAW AND ACADEMIC DETAILING LAWS, OHIO, NEW YORK & ALASKA LEGISLATORS SEEK TO BEEF UP REPORTING BY DRUG COMPANIES

In Maine, pending legislation would repeal that state's current law requiring disclosure of gifts and marketing expenditures by drug companies a time when some Maine legislators are seeking to repeal Maine's gift disclosure law.  The bill, LD 719, also repeals funding for academic detailing, reporting on clinical trials, and key price disclosure requirements that have helped the state become a national leader in negotiating steep rebates with the drug manufacturers. It isn't clear if this is simply a pharmaceutical industry bill or if the initiative is supported by the new Republican majority in the Legislature.  Governor Lepage's budget also would repeal the groundbreaking MaineRx discount drug program, which PhRMA litigated all the way to the US Supreme Court (and lost). 

 

At the same time, Ohio legislators are looking to beef up reporting in that state. Read more about the Ohio legislation here: Ohio Moves to Make Drug Companies Report Payments to Doctors; ProPublica, by Marian Wang, March 2, 2011: "Health care professionals in Ohio have received more than $13 million in payments from eight drug companies since 2009, according to our database. Now, a bill could require all companies to report these payments directly to the state."   

 

New York also has pending legislation to require pharmaceutical companies that market prescription drugs in the state to report marketing costs annually. Senate Bill 2855 is similar to laws in the District of Columbia (§48-833.01) and the Maine law threatened with repeal (22 §2698-A) and would require the reporting of specified payments in excess of $75.00. In addition, SB 2855 seeks to eliminate the deduction of advertising expenses for purposes of determining "net income" under the New York Franchise Tax law for business corporations. more 

 

Alaska Rep. David Guttenberg, a NLARx member, has introduced a comprehensive package of bills designed to reduce drug costs, including marketing disclosure:
·  HB 42 addresses discount regulations by placing requirements on pharmacies and the Department of Health and Social Services.
·  HB 43 requires the use of generic drugs when appropriate to lower costs.
·  HB 44 establishes a prescription drug card program for discounts and allows the State to negotiate drug prices.
·  HB 45 allows for savings through reporting of marketing costs.
·  HB 46 establishes an Alaska Prescription Drug Task Force whose mission is to make recommendations on how to lower costs.
·  HB 47 allows for public access to a database of clinical trials performed in Alaska. more info 

NCOIL

NCOIL Considers Resolution on Trade Impacts on State Health Care Policies Including Pharmaceutical Purchasing

 

State legislators attending the National Conference of Insurance Legislators (NCOIL) meeting in Washington, D.C. heard from a panel of speakers on trade policy including Standford McCoy, Assistant U.S. Trade Representative for Intellectual Property and Innovation; Clem Cypra of PhRMA;  Harrison Cook of Eli Lilly; Sharon Treat, Maine State Representative and NLARx Executive Director; and Sara Edelman, Director of International and State-Legislative Campaigns for Public Citizen's Global Trade Watch.

 

The speakers addressed a proposed resolution on trade sponsored by Vermont Rep. Kathleen Keenan and Kentucky Rep. Robert Damron.  The resolution urged the U.S. Trade Representative to:  

·    omit any commitments on pharmaceutical reimbursement programs from the Trans-Pacific
Partnership (TPP) or any future or pending agreement
·    cease pressuring trading partners to change their mechanisms of pharmaceutical reimbursement, including through the Special 301 Report
·    publicly release the text of the TPP and other free trade agreements on an ongoing basis after each negotiation round so that state officials and other public interest representatives can meaningfully review and comment on proposals
·    defend the general principles of state regulation of insurance free of federal or international preemption or arbitration by international investment tribunals
·    respect the traditional separation of powers with respect to insurance, including the regulation of reinsurance. 

 

The  NCOIL Resolution was supported by Sarah Edelman of Public Citizen and Rep. Sharon Treat in testimony posted here.  Treat warned that the pharmaceutical provisions currently being proposed by the industry in the Special 301 process and in their TPP comments go far beyond the terms of the Australia and Korea FTAs.

 

Rep. Treat stated: "USTR staff have confirmed that they are "in the process of evaluating proposals and input... regarding a medical products pricing and reimbursement chapter" for the TPP.   We know provisions that go well beyond those in the Korea FTA are on the table.  In addition to the duty to appropriately value patented products and the right of appeal, the industry now seeks a  new, even more restrictive standard: 'freedom to prescribe.'  This vague and sweeping language, not included in previous agreements, is of great concern.  A literal definition of this term would destroy the ability of governments to adopt price-restraining reimbursement formularies such as PDLs, which are maintained by every private insurer."

 

Rep. Treat urged USTR to adopt as a basic tenet of U.S. trade policy, that the U.S. not negotiate agreements that put current state and federal programs at risk of being overturned by international tribunals.  

 

The NCOIL resolution was opposed by Mr. McCoy of USTR and the pharmaceutical representatives, who supported an amendment that deleted most of the resolution.  The committee deferred action on the resolution until its July meeting.   For more on this issue, check out this week's the Legislators' Toolbox, the Forum on Democracy & Trade and PIJIP

AmicusNLARx Files Amicus Brief in U.S. Supreme Court in IMS v. Sorrell Supporting Vermont's Prescription Record Confidentiality Law  


The National Legislative Association on Prescription Drug Prices filed an Amicus brief last week in the U.S. Supreme Court supporting the State of Vermont in the case IMS Health v. Sorrell. Vermont is defending its right to enact laws regulating the use of data on doctors' and other medical professional's prescribing histories.   

 

 "This is an important case with broad implications.  It pits privacy, specifically the privacy of health records, against assertions by corporations that they have free speech rights to use private data in marketing activities," said Sharon Treat, NLARx Executive Director.  "State legislators have a strong interest in this case for reasons of protecting public health, preserving access to affordable health care, and insuring that private data about health status and diagnosis remains private."

 

The case, IMS v. Sorrell, is an appeal from a Second Circuit Court of Appeals decision overturning Vermont's prescriber confidentiality law on grounds of free speech.  Similar laws in New Hampshire and Maine have been upheld by the First Circuit Court of Appeals as constitutional and within the scope of state authority.

 

Professor Sean Flynn of the Washington College of Law at American University, is Counsel for NLARx and AARP, which joined in the amicus brief.  Professor Flynn argues that the Court should recognize the overriding interests of Vermont and other states in regulating the confidentiality of prescription records. "The Vermont law directly advances its interest in protecting against disclosure of records containing the most personal of information as well as its interest in protecting individual autonomy in decision making on important personal matters," Prof. Flynn stated. "Protecting the confidentiality of records advances important goals of our health system, including combating undue influence of in person pharmaceutical marketing that raises costs and damages public health interests."

 

The NLARx/AARP Amicus Brief  argues that the Supreme Court should refuse to apply the First Amendment to Vermont's Prescription Confidentiality Law based on two essential facts:  First, the regulation at issue is limited to the commercial use or private-channel distribution of confidential data. It is thus governed by cases of this Court upholding the regulation of uses of information in purely private settings that do not inform or contribute to the public sphere. Second, it concerns the regulation of secondary uses of information where the government requires the initial disclosure. It is thus governed by cases in which this Court has affirmed a right of governments to restrict access to government held or mandated information.

 

In addition to NLARx and AARP, a separate friend of the court brief in support of the Vermont law has been filed on behalf of Public Citizen, the Center for Science in the Public Interest, Consumer Action, Public Good, U.S. PIRG, and New Hampshire PIRG; and another brief has been filed by the New England Journal of Medicine, the Massachusetts Medical Society, the National Physician's Alliance, and the American Medical Students Association. Read the briefs here 

 

FOR MORE INFORMATION CONTACT:

Professor Sean Flynn,

Program on Information Justice & Intellectual Property Washington College of Law

sflynn@wcl.american.edu

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