Saturday, July 19, 2008

CHIP joins pharmacies to help get health insurance

Montana’s Children’s Health Insurance Plan (CHIP) is partnering with pharmacies and other health care providers all across the state to help families obtain health insurance for their children.

CHIP is a free or low-cost health insurance plan available to families who do not qualify for Medicaid, but cannot afford private insurance for their children. CHIP currently covers over 16,500 Montana children and teenagers. CHIP covers a wide array of health services, including medical, dental, vision, and prescription drugs.

Last year, CHIP reimbursed pharmacies $3.6 million in prescription claims. CHIP-enrolled children can get their prescriptions filled at most chain pharmacies, as well as over 150 independent pharmacies across the state. Co-pays are minimal ($3/generic, $5 brand name).

You can join the over 550 CHIP community partners who help Montana families learn about CHIP by having applications and brochures available at your location. CHIP supplies all of the materials. You can also encourage your clients to visit the CHIP website at www.chip.mt.gov. Parents can fill out the application right on their computer.

Please help us get more Montana children enrolled in CHIP. There is no waiting list, so now is a great time for families to apply for CHIP.

If you would like to receive a CHIP brochure holder and/or a supply of brochures and applications, please give me a call or e-mail me at the number/address below. Posters are also available.

Thank you for supporting Montana families.

Michael Mahoney
Community Relations Manager
Children’s Health Insurance Plan
406-444-7877
mmahoney2@mt.gov

Wednesday, July 9, 2008

Comments Requested: CMS Proposed Changes to Medicare Advantage and Prescription Drug Programs

Advantage and Prescription Drug Programs As a result of the evaluation of the initial year of the program, the Centers for Medicare and Medicaid Services (CMS) published a proposed rule in the Federal Register (73 FR 28556) that would make changes to the Medicare Advantage program regarding special needs plans, medical savings accounts, and definitions related to the Medicare Part D prescription drug benefit. The proposal's comment period closes on July 15, 2008...Read APhA's summary of the proposed rule. ››

on APhA website

FDA Requests Boxed Warnings on Fluoroquinolone Antimicrobial DrugsSeeks to Strengthen Warnings Concerning Increased Risk of Tendinitis and Tendon Rupt

FDA News

FOR IMMEDIATE RELEASE July 8, 2008

Media Inquiries: Christopher Kelly, 301-827-6242Consumer Inquiries: 888-INFO-FDA

FDA Requests Boxed Warnings on Fluoroquinolone Antimicrobial DrugsSeeks to Strengthen Warnings Concerning Increased Risk of Tendinitis and Tendon Rupture

The U.S. Food and Drug Administration (FDA) has notified manufacturers of fluoroquinolone antimicrobial drugs that a Boxed Warning in the product labeling concerning the increased risk of tendinitis and tendon rupture is necessary. Through its new authority under the Food and Drug Administration Amendments Act of 2007 (FDAAA), the agency also determined that it is necessary for manufacturers of the drugs to provide a Medication Guide to patients about possible side effects.

The FDA has notified the manufacturers of these drugs that a Risk Evaluation and Mitigation Strategy (REMS) is necessary to ensure that the benefits of the drug outweigh the risks. The Medication Guide will be considered to be an element of the REMS. The new Boxed Warning and Medication Guide would strengthen warning information already included in product labeling for the fluoroquinolone class of systemic antimicrobial drugs.

Fluoroquinolones are drugs approved for the treatment or prevention of certain bacterial infections. Like other antibacterial drugs, fluoroquinolones do not treat viral infections such as colds or flu.

"Fluoroquinolones are effective in treating certain bacterial infections, but health care professionals and patients need to be aware of the increased risk associated with the use of these drugs of developing tendinitis and tendon rupture, particularly for certain patient populations," said Edward Cox, M.D., director, Office of Antimicrobial Products, Center for Drug Evaluation and Research. "The FDA believes it is important to highlight and strengthen information regarding possible side effects of fluoroquinolones because it may affect decisions about the relative risks and benefits associated with these products."

The FDA has conducted a new analysis of the available literature and post-marketing adverse event reports. This new analysisreconfirmsthat use of fluoroquinolones is associated with an increased risk of tendon rupture. It alsodemonstrates that despite the current warning of tendon rupture in the labeling for the fluoroquinolones, large numbers of tendon-related adverse events continue to be reported. The FDA considers this new analysis to be "new safety information" as defined in FDAAA.

The FDA also issued Information for Health Care Professionals today to alert health care professionals to the increased risk of tendinitis and tendon rupture in patients taking these drugs and to highlight new information concerning who may be at higher risk for this side effect.
The risk of developing fluoroquinolone-associated tendinitis and tendon rupture is further increased in people older than 60, in those taking corticosteroid drugs, and in kidney, heart, and lung transplant recipients. Patients experiencing pain, swelling, inflammation of a tendon or tendon rupture should be advised to stop taking their fluoroquinolone medication and to contact their health care professional promptly about changing their antimicrobial therapy. Patients should also avoid exercise and using the affected area at the first sign of tendon pain, swelling, or inflammation.

Manufacturers are being notified of the need to change labeling so that all of the drugs in the class carry uniform updated warning language. These warnings would apply to fluoroquinolones for systemic use (e.g., pills, tablets, capsules and injectable formulations). The warnings would not apply to fluoroquinolones for topical ophthalmic or otic use (e.g., eye and ear drops).

Fluoroquinolone manufacturers are required to submit the safety labeling changes, including the strengthened warnings and the Medication Guide, to the FDA within 30 days, or to provide a reason why they do not believe such labeling changes are necessary. If they do not submit new language, or the FDA disagrees with the new language the company proposes, FDAAA provides strict timelines for resolving the labeling changes and allows the agency to issue an order directing the labeling change as deemed appropriate to address the new safety information. In addition, in accordance with FDAAA, sponsors will be required to assess whether their REMS are achieving the goal of informing patients of the risk of tendon-rupture. These assessments may include a survey of patients' and prescribers' understanding of the risks of tendon-rupture and whether the Medication Guide is being distributed and dispensed with the drug.

Health care professionals should consider the potential benefits and risks for each patient. While most patients tolerate these medicines well, occasionally some will develop other serious adverse reactions that may include convulsions, hallucinations, depression, abnormalities in heart rhythm, or severe diarrhea.

The medications involved in this action are: Cipro and generic ciprofloxacin, Cipro XR and Proquin XR (ciprofloxacin extended release), Factive (gemifloxacin), Levaquin (levofloxacin), Avelox (moxifloxacin), Noroxin (norfloxacin), and Floxin and generic ofloxacin.

Information for Healthcare Professionals on Fluoroquinolone Antimicrobial Drugs: http://www.fda.gov/cder/drug/InfoSheets/HCP/fluoroquinolonesHCP.htm.

FDA Home Page Search FDA Site FDA A-Z Index Contact FDA

FDA Revises Process for Responding to Drug Applications

FDA News

FOR IMMEDIATE RELEASEJuly 9, 2008

Media Inquiries: Christopher DiFrancesco, 301-827-6242Consumer Inquiries: 888-INFO-FDA

FDA Revises Process for Responding to Drug Applications

The U.S. Food and Drug Administration today announced that it is revising the way it communicates to drug companies when a marketing application cannot be approved as submitted.

Under new regulations that govern the drug approval process, FDA's Center for Drug Evaluation and Research (CDER) will no longer issue "approvable" or "not approvable" letters when a drug application is not approved. Instead, CDER will issue a "complete response" letter at the end of the review period to let a drug company know of the agency's decision on the application.

"These new regulations will help the FDA adopt a more consistent and neutral way of conveying information to a company when we cannot approve a drug application in its present form," said Janet Woodcock, M.D., director of the agency's Center for Drug Evaluation and Research (CDER). "Thorough and timely review of drug applications is a priority of the FDA, and these new processes will make our communications with sponsors of applications more consistent."

Taking the place of "approvable" and "not approvable" letters, a "complete response" letter will be issued to let a company know that the review period for a drug is complete and that the application is not yet ready for approval. The letter will describe specific deficiencies and, when possible, will outline recommended actions the applicant might take to get the application ready for approval.

Currently, when assessing new drug applications, the FDA can respond to a sponsor in one of three types of letters: an "approval" letter, meaning the drug has met agency standards for safety and efficacy and the drug can be marketed for sale in the United States; an "approvable" letter, which generally indicates that the drug can probably be approved at a later date provided that the applicant provides certain additional information or makes specified changes (such as to labeling); or a "not approvable" letter, meaning the application has deficiencies generally requiring the submission of substantial additional data before the application can be approved.
"Complete response" letters are already used to respond to companies that submit biologic license applications. The process for drugs and biologics will be consistent under the new regulations.

The revision should not affect the overall time it takes the FDA to review new or generic drug applications or biologic license applications. These changes, which will become effective on Aug. 11, 2008, are not expected to directly affect consumers.
In July 2004, the FDA issued a proposed rule on these topics. At that time the agency asked for comments on the proposal. Today's final rule addresses comments submitted to the agency.
For more information, see:

Link to the Complete Response Final Rulehttp://www.fda.gov/cder/regulatory/complete_response_FR/default.htm

Link to the drug approval process pagehttp://www.fda.gov/fdac/special/testtubetopatient/default.htm


Thursday, June 5, 2008

Walgreen to Pay $35 Million in Drug Switching

Source: The Philadelphia Inquirer Publication date: 2008-06-05

Jun. 5--Walgreen Co. has agreed to pay $35 million to settle claims that it improperly switched patients' prescription drugs to more expensive ones in order to increase its reimbursement from Medicaid, the U.S. Justice Department announced yesterday.
New Jersey and Pennsylvania will receive part of the money from the case, which was filed by a whistle-blower who sued major pharmacies in two other high-profile cases that netted $87 million in settlements.
Walgreen, of Deerfield, Ill., operates more than 5,000 retail pharmacies throughout the United States. It has about 3,500 employees in the Philadelphia region.
From 2001 to 2005, Walgreen switched the prescriptions for Medicaid patients who were prescribed 150-mg or 300-mg tablets of ulcer-fighting Ranitidine to more expensive capsules; prescriptions for 10-mg or 20-mg capsules of the antidepressant Fluoxetine to more expensive tablets; and prescriptions for 5-mg tablets of the Parkinson's drug Eldepryl to more expensive capsules, according to yesterday's settlement.
The Justice Department said that by switching the prescriptions, Walgreen substantially increased its Medicaid reimbursement while providing no additional medical benefit to the affected patients -- in violation of federal and state regulations.
The suit was filed in 2003 by Bernard Lisitza, a licensed pharmacist in Illinois, on behalf of federal and state governments.
Lisitza, who was temping for another pharmacy and filling some prescriptions for Walgreen's, contended in his suit that the drug-switching programs he observed by Walgreen's were schemes to increase pharmacy profits at taxpayers' expense, and that they resulted in no medical benefit to patients.
Recent generic drug-switching cases by Lisitza resulted in a $37 million settlement earlier this year with CVS Caremark Corp., owner of CVS pharmacies, and a $50 million settlement in late 2006 with Omnicare Inc., the nation's largest pharmacy for nursing homes.
Lisitza's attorney, Michael Behn, said his client was fired after reporting the drug switching at Omnicare and could find only temporary work far from his home in Northbrook, a suburb of Chicago.
"It's one thing to substitute a less-expensive generic for the brand name," Behn said in an interview yesterday from his Chicago office. "It's a different story when a pharmacy is switching to a more expensive drug."
Lisitza will get about $5 million under the Walgreen's settlement. The federal share of the settlement is about $18.6 million.
Forty-six states and Puerto Rico will share about $16.4 million under separate agreements. New Jersey will receive $1.2 million and Pennsylvania about $9,000.
Last month, pharmacy-benefits manager Express Scripts Inc., of St. Louis, agreed to pay $9.5 million under an agreement with the attorneys general of 28 states, including Pennsylvania, over switching patients' cholesterol-drug brands to control costs. The attorneys general claimed that the switches resulted in Express Scripts' profiting by getting drugmaker rebates, and that such cost savings were never passed on to consumers.
Walgreen shares closed unchanged yesterday at $36.34 on the New York Stock Exchange.
Contact staff writer Suzette Parmley at 215-854-2594 or sparmley@phillynews.com.
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Thursday, May 29, 2008

Law prevents proposed restriction on offender use of medical marijuana

Contributed by Bob" ,Internet:
NEWSRELEASE Montana Department of Corrections * 1539 11th Avenue
Helena, Montana 59620 * 444-3930 * Fax: 444-4920
FOR IMMEDIATE RELEASE
Thursday, May 29, 2008
CONTACT: Diana Koch, 444-9593

Corrections: Law prevents proposed restriction on offender use of medical marijuana
A proposed change in Department of Corrections rules imposing standard conditions for offenders on parole or probation will not include a restriction on physician-approved use of marijuana for medical purposes, the agency said Thursday.

Diana Koch, chief legal counsel for the department, said the decision to exclude the marijuana provision from the rules does not mean the department endorses the use of marijuana. "The use of marijuana is not in the best interest of the public or of offenders, who are responsible for rehabilitating themselves while under supervision in the community, she said.

The wording of the 2004 law allowing doctor-authorized marijuana use prevented adoption of the rule, she explained. "Our hands are tied by the way the initiative-passed law was written. As a result, those who have broken law cannot be subject to this reasonable restriction."

Proponents of marijuana use by convicted felons testified at administrative rules hearings that the medical marijuana act prohibits any penalty for using medical marijuana, regardless of an offender's criminal history. After considering the comments, the department acknowledged that the law does not contemplate permitting such restrictions, even for people on probation or parole.

"The process of reviewing and adopting administrative rules works," Koch said. "The public was heard.

"I'm not sure the voters of Montana understood that the medical marijuana act was going to go this far," she added. "There is the very real possibility that a person convicted of drug distribution can get a medical marijuana card, and there is nothing probation and parole officers can do about it."

During the rules process, the Department of Corrections proposed prohibiting all persons on probation or parole from using marijuana, even if they obtained a medical marijuana card. Offenders could have obtained a judicial exemption for medical reasons and the proposed restriction would have ended when offenders completed their sentences.

Most of the remaining rule changes affecting conditions of supervision make more specific existing regulations regarding prohibitions on gambling, firearms and alcohol; allowing searches of an offender's home and random testing of offenders for alcohol or illegal drug use; and offenders' payment of court-ordered fines and restitution. Those rules are scheduled to take effect June 13.
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Saturday, May 3, 2008

PharmAssist/ ARM Update

The PharmAssist Program was created by the 2005 legislature to provide Montana citizens with an avenue to receive one-on-one consultations with a licensed pharmacist about the prescription drugs they are taking.

The addition ACORD has been waived: The ACORD was initially an addendum to the required personal liability insurance. It specifically requested that language be included that the "State of Montana is included as additional insured." Since DPHHS is utilizing personal service contracts that are limited to $5k they are able to remove that requirement as well as the extra $150 cost.

May 12th marks the end of the 45 days that pharmacists have to fill out and return their contracts and supporting information with a copy of their liability insurance. For program information contact Roger Citron, RPh at Montana Medicaid, rcitron@mt.gov or call (406) 444-5951.

Please act quickly and return your contracts with a copy of your personal liability insurance!!! Please visit the DPHHS website for more information on the PharmAssist program at http://www.dphhs.mt.gov/prescriptiondrug/index.shtml

Montana Pharmacy Association Members (MPA) Can Receive Insurance from Pharmacists Mutual Insurance Company: The Montana Department of Public Health and Human Services has informed us that pharmacists wishing to participate in the PharmAssist program must obtain and include a copy of their personal liability insurance when they return their signed contracts.

MPA members interested in the PharmAssist Program should know that our endorsed insurance provider, Pharmacists Mutual Insurance Company, has a policy that meets the needs of this program with an annual premium of only $144. Pharmacists Mutual recognizes that the policy is suitable for an employed pharmacist who will engage in no more than 10 hours per week of outside consulting. (Pharmacists Mutual also has a competitively priced policy for those employed pharmacists who will do more than 10 hours per week of outside consulting.)

Pharmacists Mutual Insurance Company dedicates itself to understanding the pharmacy profession. This premium demonstrates Pharmacists Mutual's understanding of our duties and exemplifies the reason the Montana Pharmacy Association exclusively endorses Pharmacists Mutual. To learn more about this offer, contact Kimberly Dornbier of Pharmacists Mutual at (800) 247-5930 ext. 7441.

To become a Montana Pharmacy Association Member and take advantage of these great prices, not to mention all the other membership benefits, please visit: http://www.rxmt.org for details.

Special thanks to all those at DPHHS, Montana Medicaid, Montana Pharmacy Association, the University of Montana, and Pharmacists Mutual for all their hard work on the PharmAssist program.

In addition, please view the proposed rule for Montana Medicaid:

The department is proposing amendments to ARM 37.86.1105 that would implement a 1.67% increase to the Medicaid pharmacy dispensing fee as allowed by legislative appropriation. This would increase the maximum dispensing fee from $4.86 to $4.94 for in-state providers.

The department is proposing amendments to this rule that would allow Medicaid
pharmacy providers to dispense generic maintenance medications in amounts sufficient for a 90-day supply or 100 units, whichever is greater. Other medications would be dispensed in quantities as great as a 34-day supply

For example, the current prescription cost for a 34-day supply of lisinopril 10 mg is $6.97 total ($2.03 for the drug, plus a $4.94 dispensing fee). Multiplied by 3 months, it would cost the department $20.91 for 102 days of medication. The recipient's cost share would be $1.00 each time, a total of $3.00. If the recipient were to pick up 100 doses of this prescription, the cost would be $10.91 ($5.97 for the cost of the drug plus a $4.94 dispensing fee). The recipient's cost share would be $1.00 for that prescription.

Please view the proposed rule on PDF pages 130-134 at: http://www.sos.mt.gov/ARM/Register/archives/MAR2008/MAR08-08.pdf

Please do not call MT Medicaid on this issue: Interested persons may submit their data, views, or arguments either orally or in writing at the hearing. Written data, views, or arguments may also be submitted to Rhonda Lesofski, Office of Legal Affairs, Department of Public Health and Human Services, P.O. Box 4210, Helena MT 59604-4210, no later than 5:00 p.m. on May 22, 2008. Comments may also be faxed to (406)444-1970 or e-mailed to dphhslegal@mt.gov. The department maintains lists of persons interested in receiving notice of administrative rule changes. These lists are compiled according to subjects or programs of interest. To be included on such a list, please notify this same person or complete a request form at the hearing.