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NLARx News                                                                          March 23, 2011

In This Issue
From the Director
Roundup of State Legislation
Sunshine Act Update
NLARx on Facebook
Pharmaceutical News From Around the World

HHS Says 48,000 Have Used Medicare Drug Discounts This Year 

 

 Carelessness Behind Many Health Data Breaches 

 

NIH Funded Trials for Premie Prevention Shot that Now Costs $30,000 More  

 

Medco Receives A Subpoena Over Calpers Probe

 

The Need for Greater Fee Disclosure by PBM Industry 

 

California Joins Whistleblower Suit Against Bristol

 

Supreme Court to Hear Case on Generic Labeling 

ToolboxLEGISLATORS' TOOLBOX


 

  
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From the DirectorExecutive Director

 

State legislative sessions are in full swing and we devote most of this issue to highlighting pending and enacted legislation in our round-up of state action.  Some highlights of forward movement include passage of a drug redistribution bill in New Mexico, pending legislation for joint drug purchasing in Connecticut to leverage greater discounts, and Qui Tam legislation to address Medicaid fraud in Washington State.  Iowa is one of 38 states sharing in a multi-million dollar settlement with AstraZenica for fraudulent marketing of antipsychotic drugs, money that may help them pay for medicines in financially strapped Medicaid programs. In contrast, the Michigan Supreme Court prevented a similar case going forward in that state due to a law unique to that state that grants drug companies immunity. 

 

Speaking of antipsychotic drugs, legislators in other states may want to look at the recent audits in Michigan of that state's Corrections Department which found significant waste, overspending on psychiatric drugs, and opportunities to save scarce dollars without harming patient care.  Seniors are on the defensive in Wisconsin, Maine, New York and Illinois where governors are proposing limiting or eliminating prescription drug assistance. The pharmaceutical and PBM lobbies have taken aim at Maine's PBM transparency and anti-kickback law, where pending legislation would repeal the 2003 law and many other Maine prescription drug laws including the groundbreaking MaineRx discount drug program. One of the laws on the chopping block is Maine's drug advertising and marketing spending disclosure law, parts of which are covered by the Physicians Payments Sunshine Act, part of the federal Affordable Care Act.  We provide an update on the provisions of the federal Sunshine law and the timetable for implementation.   

 

Be sure to share your successes and works in progress with us so we can let other legislators know about best practices around the country.   For best practices check out the Legislators' Toolbox, and the just-posted

testimony on why PBM fee disclosure is needed. 

Sincerely, Sharon Treat    

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StatesRoundup of Legislation in the States

Legislatures Consider Variety of Measures  

  

MICHIGAN CORRECTIONS DEPARTMENT PROBES PRESCRIPTION DRUG WASTEmichigan

[Paul Egan / Detroit News Lansing Bureau] The acting director of the Michigan Department of Corrections has ordered an internal investigation after an audit found millions of dollars of waste in the way the department supplies drugs to prisoners. The  report by Michigan Auditor General Thomas McTavish found the department lacked procedures to control costs, minimize waste, keep track of inventory and return unused medications for refunds. When the department had procedures, they often weren't followed, the audit found. The report said the department wasted between $852,000 and $8.5 million a year by not controlling prescriptions of certain costly antipsychotic drugs, which it said are prescribed in Michigan prisons at levels that "far exceed the levels reported for prison populations in other states." The audit covered Oct. 1, 2007, through July 31, 2010, during which the department spent close to $100 million on prisoner pharmaceuticals. The report contains 16 recommendations. The department said it agreed with 14 of them and partly agreed with two. The Detroit News article  

 

MAINE'S GROUNDBREAKING 2003 PBM PRICING DISCLOSURE & CONFLICT OF INTEREST LAW THREATENED WITH REPEALmaine

Maine's 2003 Pharmacy Benefit Manager law would be repealed if a bill introduced March 15, 2011 is enacted. The legislation, LD 1116, "An Act To Restore Market-based Competition for Pharmacy Benefits Management Services" is sponsored byRepresentative Meredith Strang Burgess and repeals the state's Pharmacy Benefit Manager Transparency Law, 22 MRSA 2699. The law bars conflicts of interest, kickback and self-dealing by PBM drug industry middlemen, and requires the value of rebates to be passed through to ultimately benefit consumers. The law was amended in 2010 to give the Bureau of Insurance limited oversight authority over PBMs and to require the State Auditor to assist state agencies in contracting with PBMs. More information about PBM fee disclosure

 

newmexicoREPORT FROM NEW MEXICO: DRUG REDISTRIBUTION YES, PBM REGISTRATION NO 

While Senator Dede Feldman's PBM licensing bill died on the last day of session, March 19, her legislation SB 37 was enacted. This law provides opportunities for patients to donate unused drugs back to doctors and clinics and allow them (after rules are adopted by the Board of Pharmacy) to re-dispense for free to other patients.  This year, the bill was supported by the trial lawyers and PhARMA worked with the sponsors to iron out the liability issues which had killed the bill two years ago. Read about the law here

 

IN WASHINGTON STATE, DRUG TAKE-BACK BILL FAILS YET AGAINwashington 

EDITORIAL IN THE OLYMPIAN: "Long battle for state drug take-back program must continue"
"State senators dropped the ball when they failed by a single vote last week to approve legislation to launch a statewide medicine take-back program funded by the pharmaceutical companies. The drug industry mounted a successful lobbying campaign to keep the state from becoming the first to approve a system that would do a better job of keeping unused prescription and over the counter drugs from being misused and abused. A broad coalition of law enforcement agencies, local governments, health care professionals, environmental groups and substance abuse prevention networks vowed to continue their work to refine and promote legislation that would provide safe disposal of unused drugs, estimated at 10 percent to 30 percent of all drugs prescribed or sold over the counter. MORE   

 

ALSO IN WASHINGTON, SENATOR KAREN KEISER MOVES AHEAD WITH A  QUI TAM MEDICAID FRAUD BILL 

 

CONNECTICUT LEGISLATION PROMOTES LEVERAGED PURCHASINGCONNECTICUT

Speaker Chris Donovan says of HB 6322, State Prescription Drug Purchasing "This bill is another great example of using the size of the state employee pool to leverage greater discounts for other healthcare purchasers. HB 6322 would enable the Comptroller's Office to amend its existing prescription drug purchasing contract to include the Medicaid, Husky, ConnPACE and Charter Oak programs. The Comptroller's office estimates that by implementing this innovative streamlining measure, the state will save $66.5 million annually "without harming prescription coverage for some of the state's most vulnerable residents."

 

newyorkNEW YORK GOVERNOR PROPOSES BIG CUTS IN EPIC, THE STATE PRESCRIPTION DRUG PROGRAM FOR THE ELDERLY

Gov. Cuomo has proposed cuts in EPIC, the New York prescription drug program for people age 65 and over. EPIC would no longer cover anyone who does not also participate in Part D. Of the current 307,700 enrollees, about 52,969 are not in Part D plans - (8/2009 figures) because they are in Medicare Advantage, a retiree plan, or not eligible for Medicare (immigrants without green cards for 5 years). As a result, 17% of current EPIC members would no longer be eligible for EPIC. In addition, EPIC would no longer cover drugs during the annual deductible period (21 out of 33 Part D plans in NYS in 2011 have an annual deductible). EPIC would no longer "wrap around" Part D to help reduce its costs. 52,000 (out of 302,000) enrollees who are not on Medicare or who have Medicare but have been excused from enrolling in Part D because it would jeopardize their retiree coverage, etc. In the end of 2009, out of 254,000 EPIC members with Part D, about 77,800 had "Extra Help" or the Low Income Subsidy, or fewer than one-third of those who have Medicare.

 

iowaIOWA GETS $1.17 MILLION IN 38-STATE ANTIPSYCHOTIC DRUG SETTLEMENT

Iowa and 37 other states who objected to the way an antipsychotic drug was marketed will split $68.5 million as part of what Iowa Attorney General Tom Miller is calling "the largest-ever multistate consumer protection-based pharmaceutical settlement agreement." Miller and the other attorneys general contend that London-based AstraZenica "engaged in unfair and deceptive practices" when it urged doctors to use the drug Seroquel for unapproved or off-label uses, including for treatment of anxiety, depression, sleep disorders and post-traumatic stress disorder. Led by Florida and Illinois, the states involved in the case included: Arizona, California, Colorado, Connecticut, Delaware, Hawaii, Idaho, Kansas, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Missouri, Nebraska, Nevada, New Hampshire, New Jersey, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Dakota, Tennessee, Texas, Vermont, Washington, West Virginia and Wisconson and Washington, D.C. MORE 

 

IMMUNITYMEANWHILE IN MICHIGAN, A SIMILAR LAWSUIT IS STOPPED IN ITS TRACKS DUE TO UNIQUE MICHIGAN DRUG COMPANY IMMUNITY LAW 

Court stops Michigan from suing Merck over Vioxx [Detroit Free Press]

"A unique Michigan law bars the state from suing drug maker Merck & Co. to recover millions of dollars spent on Vioxx, an arthritis drug pulled from the market because of health risks in 2004, a court said Friday. In a 2-1 decision, the state appeals court said Merck is protected by a law that grants immunity to companies if a drug has been approved by federal regulators. It's the only one of its kind in the country. The state attorney general's office is trying to recover millions of tax dollars spent on behalf of Medicaid recipients who used Vioxx. The state said the lawsuit is about false Medicaid claims, not product liability, but judges Henry William Saad and David Sawyer disagreed. 

"A court is not bound by a party's choice of labels. . . . Plaintiffs claim that Merck made deceptive statements about the safety and efficacy of Vioxx, and that they would not have paid all or part of the cost of Vioxx prescribed to Michigan Medicaid beneficiaries had Merck not made the allegedly false and deceptive statements," Saad wrote. ..." MORE  

 

wisconsinWISCONSIN OFFICIAL DEFENDS DRUG COVERAGE CHANGES

Wisconsin should keep optional Medicaid services such as drug coverage and shift costly patients into managed care, the state's health services secretary recently told health care advocates. Dennis Smith, who heads the Department of Health Services, vowed to be transparent about Medicaid changes, even though Gov. Scott Walker's stalled budget repair bill would give Smith new powers to reshape the state-federal health plan for the poor with less legislative review than required now. The state won't drop optional Medicaid services, such as prescription drugs and home care that can keep people out of nursing homes, Smith said. Smith said the budget's requirement that the 91,000 people on SeniorCare, a state drug plan, sign up for Medicare Part D, a federal drug benefit, would save the poorest seniors money while curbing costs to the state. MORE 


CALIFORNIA REGULATORS TAKE AIM AT DRUG COMPANY KICKBACK SCHEME, WHILE SEC INVESTIGATES PENSION SYSTEM CONTRACT WITH PBM MEDCO 

California Lawsuit Accuses Bristol-Myers Squibb Of Fraud, Kickbacks

California regulators are taking aim at giant drug maker Bristol-Myers Squibb Co., accusing it of bribing doctors and pharmacists to use its products by offering thousands of cash kickbacks, gifts and "happy hours" with the Los Angeles Lakers. MORE 

 calif

Medco Health's PBM Contract Scrapped

California Public Employees' Retirement System's (CalPERS) decision to cease all discussions on the renewal of pharmacy benefit management (PBM) contract comes as a setback for Medco Health Solutions. This decision was taken in the backdrop of certain investigations regarding Medco. Earlier this month CalPERS announced it would cooperate with the California Attorney General's Office and US Securities and Exchange Commission (SEC) for their investigations. This investigation comes on the back of an allegation that Medco had paid former CalPERS board member, Al Villalobos more than $4 million as consultancy fees for this business. Investigations are also being carried out on alleged improper conduct by former CalPERS CEO Fred Buenrostro and some former Board Members. MORE 

 

SENIORS OBJECT TO ILLINOIS GOVERNOR'S PLAN TO ELIMINATE PRESCRIPTION ASSISTANCEillinois

[GATEHOUSE NEWS SERVICE] Opposition is building to Gov. Pat Quinn's proposed elimination of a $107 million-a-year program that helps low-income senior citizens and disabled people afford prescription drugs. "We're having people call us frantically now," said Beth Monnat, a pharmaceutical assistance specialist at Senior Services of Central Illinois in Springfield. "They don't know what they're going to do. We don't know what to do." The panic began in mid-February, when the governor unveiled a state budget for fiscal 2012 that included no money to operate the Illinois Cares Rx program. Quinn had unsuccessfully pushed for cuts in the program before, beginning in 2009, to help the state deal with a multibillion-dollar budget shortfall. But the Chicago Democrat never before suggested that the program, which serves more than 200,000 people statewide, be eliminated. MORE 

sunshine

Update on Physicians Payments Sunshine Act Enacted as Part of the Affordable Care Act

Contributed by Marcia Hams, Director of Prescription Access and Quality, Community Catalyst

 

It has been nearly a year since the historic health reform bill, the Patient Protection and Affordable Care Act, was signed into law by President Obama. On that day, March 23, 2010, the Physician Payments Sunshine Act became law as well. The Pew Prescription Project and Community Catalyst are now beginning intensive work for full and effective implementation of the law, and we want to bring you up to date on the process. The Centers for Medicare and Medicaid Services (CMS) are responsible for implementation.

Interest in transparency of industry interactions with providers continues to grow, highlighting the uses that can be made of robust data by consumers, academic medical centers, state and federal policymakers, the industry and researchers. For example, ProPublica created a database using court-mandated and voluntary disclosures from eight drug companies, and while less detailed than the federal law requires, these data shone a light on many high payments, as well as disparities between industry reports and disclosures by physicians to their academic medical institutions. Vermont began publishing comprehensive payment data on all practitioners in April 2010, as required under its strengthened statute, and the Massachusetts public disclosure website, also covering all practitioners, went into effect November 2010. These developments underscore the need for strong regulations and vigorous enforcement at the federal level. We have summarized below the key implementation dates for the Sunshine provisions and included a thumbnail summary of the law.   

 

Key implementation dates:

 

Spring and Summer, 2011:  HHS will draft proposed regulations and submit for public comment. The public comment period will be three months, followed by a month or more until final publication.  

 

October 1, 2011: HHS (CMS). Unless delayed, regulations are to be complete, and will   establish the procedures for applicable manufacturers to submit information, as well as procedures for making such information available to the public.

 

January 1, 2012: Manufacturers begin collecting data for calendar year 2012. Duplicative state laws preempted (see Pew Prescription Project fact sheet here).

 

March 31, 2013: Manufacturers submit information to CMS on payments for calendar year 2012.

 

April 1, 2013: First possible date for penalties for applicable manufactures not complying with reporting procedures.   Report to Congress on information and enforcement.

 

August 16, 2013: Manufacturers and recipients have opportunity to review and correct posting prior to publication of the data, subject to subsection (c)(1)(D). Review period under (c)(1)(C)(ix) - cannot delay posting date.

 

September 30, 2013: CMS to publish information on public, searchable website (annually thereafter). First report to states.

 

Summary of the law: The new statute (Section 1128G of the Social Security Act, enacted as §6002 of the Affordable Care Act) requires that manufacturers of drugs, devices, biologicals or medical supplies, or their subsidiaries that sell these products in the United States, must report to Health and Human Services (HHS) certain payments or transfers of value made to physicians and teaching hospitals. This reporting must accurately describe the amount, date, recipient name and business address, and the nature of these payments. After a brief period of review by doctors or teaching hospitals, this information will be disclosed annually to the public on a searchable, user-friendly website. Delayed public disclosure is allowed for certain payments for product research or development, and some payments are excluded from reporting requirements. 

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