From the Director

State legislators continue to tackle new pharmaceutical issues of concern, even as efforts are underway to repeal laws currently on the books including the free meal ban in Massachusetts and PBM transparency in Maine.   

One of these new issues is children and psychiatric drugs.  In the article below, read the testimony of a young woman in foster care in Maine, and her plea to study over-medication by passing legislation sponsored by Rep. Joan Welsh.  Both Maine and Georgia will be moving forward with reviews of prescribing protocols; Rep. Mary Oliver sponsored the Georgia bill.  

Last week NLARx signed onto comments regarding potential pharmaceutical pricing provisions in the TransPacific Trade Agreement, which could imperil low-cost 340B pricing at charity hospitals and Federally Qualified Health Centers. These issues are complex and the negotiating takes place behind closed doors, with states often playing catch-up after decisions are made. 

PBMs are in the news in several state legislatures.   While Texas and Mississippi are tightening up PBM regulations to prevent fraud and protect patients from drug switching, Maine appears ready to ditch the comprehensive protections it already has.  Most states are looking for ways to cut costs and pass along savings to consumers.  West Virginia has a unique law requiring generic savings to be passed long to consumers which it has gone to court to enforce. We report below on the latest state developments.    

Check out the Pharmed Out Conference June 16-17 at Georgetown here and articles of interest from around the pharmaceutical world here.  Also, be sure to join us on Facebook for more up-to-the-minute posting of news and resources.   Sincerely, Sharon Treat    

"Marketing Juggernaut" Collides with Concerns About Safety and Appropriate Treatment as Legislators in Several States Review Policies Governing Children and Psych Drugs

At a time when sales and marketing of these drugs is growing exponentially, there is an increasing interest in reviewing the appropriateness of standards for prescribing antipsychotic drugs to children.  As the N.Y. Times reports, "Even the most reluctant prescribers encounter a marketing juggernaut that has made antipsychotics the nation's top-selling class of drugs by revenue, $14.6 billion last year, with prominent promotions aimed at treating children."   According to the Times, In the last few years, doctors' concerns have led Florida and California to put in place restrictions on doctors who want to prescribe antipsychotics for young children, requiring a second opinion or prior approval, especially for those on Medicaid.

Questionable practices in Texas led to a psychiatric preferred drug program for children being suspended in 2008. The issue has gotten the attention of state Medicaid medical directors,  who released a study in July 2010  recommending that more states require second opinions, outside consultation or other methods to assure proper prescriptions. The report found a rapid increase in prescribing of these medications to children or adolescents over the past several years, and that children in foster care (12.4%  percent) were prescribed AP medications at much higher rates than those not in foster care (1.4 percent).  

The issue has gotten the attention of investigative reporters and doctors alike.  See this Frontline Report and the article in the Journal of the American Medical Association on May 19, 2010, which reported children covered by Medicaid are far more likely to be prescribed antipsychotic drugs than children covered by private insurance, and Medicaid-covered kids have a higher likelihood of being prescribed antipsychotics even if they have no psychotic symptoms. Read more.

This year Maine Representative Joan Welsh sponsored LD 646," An Act to Ensure the Safety of Children in the MaineCare Program who are Prescribed Antipsychotic Medications."  Read Rep. Welsh's testimony.  At the public hearing, a young women who had been prescribed multiple medications during many years in foster care gave wrenching testimony about her experiences. Testifying in support, Ann Woloson of Prescription Policy Choices noted that prescribing of psychiatric medications to children in the U.S. has increased dramatically compared to other countries: "In less than a ten-year period the use of potent psychotropic medication in children and adolescents grew by five-fold in the US, nearly double the rate than children living the Netherlands, Germany and other European nations.  Some children as young as just one year-old, are being prescribed these medications at increasing rates.  Behaviors once considered "normal", a baby not sleeping through the night or a toddler going the terrible twos are now being diagnosed and medicated as "sleep resistant" or "oppositional-defiant, with mood swings". Read Ms. Woloson's testimony

Georgia is also launching review of foster kids' psych drugs, after Representative Mary Oliver introduced legislation, House Bill 23, to require the Department of Human Services to establish regulations governing the use of psychotropic medications for foster children in state custody. House Bill 23 was put on hold until next year after the Casey Family Programs stepped forward with $75,000 to develop a pilot program to figure out the best way to conduct an independent clinic exam of children taking mind-altering drugs. According to an article in the Atlanta Journal-Constitution, Georgia spends $7.87 million a year on psychotropic medications. More than a third of foster children are prescribed the drugs, compared with about 4 percent of the general youth population."You are going to save money, and you're going to provide good medical care," said boll sponsor Rep. Oliver. 

In the States... A Roundup of News  

TEXAS PHARMACISTS FIGHT PBMS ON CONTRACTOR INTEGRITY, MAIL ORDER AND MANAGED CARE LEGISLATION 

Pharmacists offered a series of amendments to the Medicaid managed care bill, SB 23.  These included:

• Communications oversight (Rep. Chuck Hopson). In recent years, Texas employee and retiree benefit programs had cause to levy a $1 million fine and require a contractor to retract incorrect and unapproved communications to beneficiaries. Lessons learned require the state, as part of good contract oversight, to mandate prior approval of communications to plan beneficiaries from a managed care organization, health maintenance organization, and pharmacy benefit manager.
• Contractor integrity (Rep. Fred Brown). PBMs are the most highly litigated segment of the health care continuum, paying more than $340 million in fines, with $10 million of that to Texas. This amendment prohibits contracting with entities that have been "bad actors" within the past five years.

Although not final, pharmacy measures worked out in conference include "any willing provider/open networks," "no mandatory mail order" and transparency, as well as standards companies must meet to be eligible to bid on managed care and PBM contracts with the state.  Communication oversight rules will require HMOs & PBMs to get 10-day prior authorization for any communication with beneficiaries. 

The Texas Conservative Coalition opposed  amendments preventing contracting with bad actors. Here's what they told their members and the Republican Conference about the contractor integrity amendment: "Establishes that HHSC cannot contract with a managed care organization that has in the preceding 5 years, committed fraud or breach of contract, or been convicted of violating a state or federal law, or been assessed a state or federal fine of more than $100,000. Effectively disqualifies all major contractors from doing business with the state. For instance, there may be many reasons for liquidated damages that have no material impact on ability to perform." As passed, the amendment says that to be eligible to bid on the HHSC contract, a managed care organization or pharmacy benefit manager cannot have paid a fine or settlement in excess of $500,000 in the past three years. Source: Texas Pharmacy Business Council 

MISSISSIPPI PBM LAW SIGNED BY GOVERNOR

[Source: "Mississippi law subjects PBMs to pharmacy board oversight," May 17, 2011,  Drug Topics E-News]  Mississippi Governor Haley Barbour has signed into law S.B. 2445, which reauthorizes the state's Pharmacy Practice Act and requires pharmacy benefit managers (PBMs) to be subject to oversight by the Mississippi Board of Pharmacy. "This commonsense law received almost unanimous support in the Mississippi House and Senate," said B. Douglas Hoey, RPh, MBA, executive vice president and CEO of the National Community Pharmacists Association (NCPA). "With Governor Barbour's signature ... he has positioned his state as one of the leaders in providing badly needed oversight of out-of-state PBMs, which often engage in questionable business practices that have occasionally resulted in legal fines."

Hoey noted that PBMs lobbied furiously against the bill. He added that the interests of patients and small businesses are best served by putting "these giant corporate prescription-drug middlemen" under the control of the Mississippi Board of Pharmacy.  NCPA supported the bill on behalf of 441 independent community pharmacies and the thousands of patients they serve in Mississippi, Hoey said. "Our hope is that other states will follow this approach, because it will ensure that a premium is placed on transparency and fairness and not on the size of PBMs' profit margins." More on the Mississippi law. 

MAINE PBM LAW ON LIFE SUPPORT; PHARMACIES SUPPORT TOUGHER LAWS WHILE GOVERNOR SUPPORTS REPEAL 

In sharp contrast to the successes in GOP-dominated Mississippi and Texas, Maine appears poised to repeal its current laws requiring PBM transparency and banning kickbacks and conflicts of interest.  LD 1116, which repeals Maine's 2003 PBM law, and LD 719,  which repeals a law requiring drug manufacturer and wholesaler reporting of drug pricing information, received ought-to-pass votes from a majority of Health & Human Services Committee members last week.  A floor fight is expected; pharmacists and consumer groups are opposing the repeals.  Article in the Portland Press Herald: "Maine drug disclosure rules under fire by GOP majority" 

 WEST VIIRGINIA TAKES ON WALMART, CVS OVER DRUG PRICES

West Virginia Attorney General Darrell McGraw sued the retailers in state court in Boone County, alleging the stores overcharged state residents while filling prescriptions in violation of two state laws. West Virginia law requires substitution of generic drugs when available and requires pharmacies to pass on the savings from using generics to consumers, according to the state's lawsuit. The defendants sought to move the case to federal court in Charleston, West Virginia, claiming the lawsuit was a "disguised class action."
The state, which is seeking disgorgement and other civil penalties, alleges the defendants aren't giving consumers the full benefit of the lower wholesale costs pharmacies pay for generic drugs. Read the story: Wal-Mart, CVS, Drug Price Case Sent to West Virginia Court by U.S. Judges, Bloomberg