Extortionists Target Major Pharmacy Processor
One of the nation's largest processors of pharmacy prescriptions said Thursday that extortionists are threatening to disclose personal and medical information on millions of Americans if the company fails to meet payment demands.
St. Louis-based Express Scripts said that in early October it received a letter that included the names, birth dates, Social Security numbers and in some cases prescription data on 75 of its customers. The authors threatened to expose millions of consumer records if the company declined to pay up, Express Scripts said in a statement.
The company's chief executive George Paz said Express Scripts has no intentions of paying the extortion demand and said his company is working with the FBI to track down the person or persons responsible for the scam.
Express Scripts is among the largest pharmacy benefit management firms, companies that process and pay prescription drug claims. It handles roughly 500 million prescriptions a year for about 50 million Americans.
The ransom note was delivered through the mail, said company spokesman Steve Littlejohn. However, he declined to say how much money the extortionists were demanding. He added that the company is still trying to determine how the data was stolen.
"We know where the data came from by looking at it, but precisely how it was accessed is still part of the investigation," Littlejohn said.
The company has set up a Web site to give concerned consumers tips on how to protect their identity. While Express Scripts doesn't interact with consumers directly, the company's name is printed on prescription cards of health care plans that use its services, Littlejohn said.
Alan Paller, director of research for the SANS Institute, a Bethesda, Md., based computer security training group, said cyber and data extortion incidents rarely make the news because most victims find it more expedient to simply pay up.
"There are thousands of companies that have already paid off extortionists in return for not having their customers' data exposed," Paller said. "This especially true in the financial industry, as some banks are now getting more than one new extortion demand per day."
Paller said for years he has been expecting extortionists to begin targeting the health care industry.
"In many ways, this is the perfect extortion target," Paller said. "Nobody is going to want to go to a health care provider if they think their private medical history is going to be revealed to the world online. Hospitals wouldn't have to think too hard about that before paying off an extortion demand."
Graham Cluley, a senior technology consultant for Sophos, a computer security company based in the United Kingdom, said Express Scripts made the right move in contacting the FBI and refusing to pay the ransom.
"Data extortion is not like if your daughter gets kidnapped: Even if something is returned to you, you can never be sure they're not going to carry on taking advantage of the situation," Cluley said. "The bad guys can always just make a copy of what they've stolen, and they can keep on coming back and asking for money, or they can still go and sell the data online."
taken from Pharmacist e-link on November 11, 2008: http://www.pharmacistelink.com/index.phpoption=com_content&task=view&id=10636&Itemid=274
Monday, November 10, 2008
Thursday, August 7, 2008
Second Annual Montana Pain Initiative Conference
Upcoming “2nd Annual Montana Pain Initiative Conference - Pain Management Policy and Practice: A Balanced Approach.” The conference will be held on September 5-6, 2008 at the Holiday Inn Downtown at the Park in Missoula, Montana. For more information, please see the brochure
Saturday, July 19, 2008
December Hearing in Proposed First DataBank AWP Settlement
December Hearing in Proposed First DataBank AWP SettlementA federal court hearing has been set for Dec. 17 in a case that NCPA's legal strategy has saved community pharmacies from a rollback in Average Wholesale Price calculations that would cost them $291 a day.
NCPA has urged U.S. District Court Judge Patti Saris in Boston to reject an amended settlement proffered by First DataBank (FDB) in a suit brought against the California-based publisher by several union health plans. McKesson and Medi-Span also were sued, but are not involved in the settlement. NCPA was not a party to the suit, but intervened to prevent grievous harm to community pharmacies. The suit alleges that the trio conspired to increase the spread between Wholesale Acquisition Cost and AWP.
"This settlement permits the sole wrongdoer, FDB, to relieve itself of liability for a mere $1 million payment to the Settlement Fund, while placing the burden of any settlement on pharmacies and consumers," NCPA told the judge. "We urge the court to not approve a settlement that creates more problems than it solves."
Judge Saris has given preliminary approval to the new proposed settlement in the class action lawsuit. Last January, citing issues raised by NCPA, Saris rejected a proposal from FDB and Medi-Span that included a 4% rollback on the markup between WAC and AWP on more than 8,000 brand name formulations.
The rollback would have cost the average independent community pharmacy about $105,000 annually-more than wiping out the average independent's profits, according to figures from the NCPA Digest. Under that proposed settlement, FDB, a Hearst company, also would have phased out publication of AWPs within two years of the date of the final settlement.
The latest proposal from FDB would reduce the number of affected drugs to about 1,400 with an effective date 90 days after approval of the final settlement. But NCPA noted that even at that reduced level, 40% of all branded drugs, which represent 80% of all prescriptions filled at independent pharmacies, would be affected by the rollback.
taken from NCPA e-NEWs Weekly: visit www.ncpanet.org
NCPA has urged U.S. District Court Judge Patti Saris in Boston to reject an amended settlement proffered by First DataBank (FDB) in a suit brought against the California-based publisher by several union health plans. McKesson and Medi-Span also were sued, but are not involved in the settlement. NCPA was not a party to the suit, but intervened to prevent grievous harm to community pharmacies. The suit alleges that the trio conspired to increase the spread between Wholesale Acquisition Cost and AWP.
"This settlement permits the sole wrongdoer, FDB, to relieve itself of liability for a mere $1 million payment to the Settlement Fund, while placing the burden of any settlement on pharmacies and consumers," NCPA told the judge. "We urge the court to not approve a settlement that creates more problems than it solves."
Judge Saris has given preliminary approval to the new proposed settlement in the class action lawsuit. Last January, citing issues raised by NCPA, Saris rejected a proposal from FDB and Medi-Span that included a 4% rollback on the markup between WAC and AWP on more than 8,000 brand name formulations.
The rollback would have cost the average independent community pharmacy about $105,000 annually-more than wiping out the average independent's profits, according to figures from the NCPA Digest. Under that proposed settlement, FDB, a Hearst company, also would have phased out publication of AWPs within two years of the date of the final settlement.
The latest proposal from FDB would reduce the number of affected drugs to about 1,400 with an effective date 90 days after approval of the final settlement. But NCPA noted that even at that reduced level, 40% of all branded drugs, which represent 80% of all prescriptions filled at independent pharmacies, would be affected by the rollback.
taken from NCPA e-NEWs Weekly: visit www.ncpanet.org
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
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
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
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
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.
-----
To see more of The Philadelphia Inquirer, or to subscribe to the newspaper, go to http://www.philly.com.
Copyright (c) 2008, The Philadelphia Inquirer
Distributed by McClatchy-Tribune Information Services.
For reprints, email tmsreprints@permissionsgroup.com, call 800-374-7985 or 847-635-6550, send a fax to 847-635-6968, or write to The Permissions Group Inc., 1247 Milwaukee Ave., Suite 303, Glenview, IL 60025, USA.
NYSE:WAG, NYSE:CVS, NYSE:OCR, NASDAQ-NMS:ESRX,
A service of YellowBrix, Inc.
Publication date: 2008-06-05© 2008, YellowBrix, Inc.
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.
-----
To see more of The Philadelphia Inquirer, or to subscribe to the newspaper, go to http://www.philly.com.
Copyright (c) 2008, The Philadelphia Inquirer
Distributed by McClatchy-Tribune Information Services.
For reprints, email tmsreprints@permissionsgroup.com, call 800-374-7985 or 847-635-6550, send a fax to 847-635-6968, or write to The Permissions Group Inc., 1247 Milwaukee Ave., Suite 303, Glenview, IL 60025, USA.
NYSE:WAG, NYSE:CVS, NYSE:OCR, NASDAQ-NMS:ESRX,
A service of YellowBrix, Inc.
Publication date: 2008-06-05© 2008, YellowBrix, Inc.
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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________________________________________
A service of the Montana Education Telecommunications Network - METNET
A division of the Montana Office of Public Instruction
Free E-Mail for certified Montana teachers
"ttp://www.metnet.mt.gov/
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.
##
________________________________________
A service of the Montana Education Telecommunications Network - METNET
A division of the Montana Office of Public Instruction
Free E-Mail for certified Montana teachers
"ttp://www.metnet.mt.gov/
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.
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.
Sunday, January 27, 2008
First Data Bank/ Medi-Span settlement
01/22/08
Community pharmacy learned a lot about the future of AWP at a Federal Court Hearing today. Judge Saris of the Federal District Court of Massachusetts informed those in attendance that she would not approve several aspects of the proposed First Databank/Medi-Span Settlement, but did believe pharmacies were to some degree unjustly enriched at the expense of consumers. With that said, it is clear that the one hurdle that Judge Saris has in approving the Settlement is her concern for putting independent pharmacies out of business. Several times she referenced this fact and ultimately decided that she would consider a 5% roll-back on just those drugs that were involved in the initial "inflation scheme". This would decrease the number of brand name drugs that would be impacted by the AWP roll-back from 8,000 to 1,400 NDCs. Judge Saris went further, however, and will appoint an independent economic advisor to the Court for the limited purpose of determining the impact of this potential new Settlement option on independent pharmacies. Plaintiff's counsel provided data that suggested the 1,400 NDCs would still account for approximately 40% of the brand name drugs sold in 2006. Judge Saris also appeared to be amicable to allowing pharmacies more time than 60 days to renegotiate contracts in the event of any settlement agreement. In addition, Judge Saris ruled out the Settlement provision that would require First DataBank and Medi-Span to stop publishing AWP within two years, indicating that she did not want to be the ongoing arbiter of drug pricing in the United States. Judge Saris also ruled out the provision that would establish a "data room" for third party payers to access in any future AWP lawsuits.
It is important to note that Judge Saris commented, "I have never in my career as a federal judge had such an outpouring of concern from objectors as I did in this case". Objectors heard at the Hearing included attorney's for IPC, NCPA, NACDS, ASCP and PCMA. We still have work to do, but things look much better than just a week ago.
Mark E. Kinney, R.Ph.
Vice President of Government Affairs
Independent Pharmacy Cooperative
*Thanks Mark for all your input...we look forward to future Government News updates.
Thursday, January 17, 2008
Multiple C-II Ruling…Pharmacist’s Ability to Change a C-II???
I would like to apologize to everyone for starting a “state-wide panic” and I would especially like to apologize to the Board of Pharmacy and Compliance Officer for making their lives so difficult these last few days. I would like to reassure everyone that the Board of Pharmacy and Compliance Officer are checking into the matter of a pharmacist’s ability to change a scheduled II prescription with a verbal confirmation and documentation with the DEA in which to have something official IN WRITING to report to you. Unfortunately, my contact at the DEA, whom is a Programs Analyst, Liaison and Policy Section, OD for the DEA in Washington, DC reported to our Compliance Officer that she is not authorized to answer his questions, even though she freely spoke to me about the new policy stating that a “pharmacist can not change anything on a C-II,” which is published on MT RPh NEWS.
Everything I published to you was factual and checked multiple times with multiple questions; however, it was single sourced and needs further investigation. Unfortunately, the Chief, Liaison and Policy Section, at the DEA I really wanted to speak with has not returned any of my 3 phone calls since I started calling him on December 26th. The Program Analyst that is in Marks division was nice enough to promptly return my phone calls on December 28th and January 10th and answered my questions with confidence; however, she won’t produce anything in writing. I encourage everyone to relax about the issue and to use their best judgment until the Montana Board of Pharmacy reaches a decision to publish. As soon as I am able to get something IN WRITING from someone a little higher up at the DEA to post on the site with the assistance of the Board of Pharmacy, or a statement from the Board of Pharmacy, I will do so…of course this may take a while, so I urge you to use the same sound judgment and rules that we have currently been using until that time comes.
So at this point in time, just realize that the Federal Register, which was finalized on December 19th, does state:
“In addition, because the CSA states that prescriptions for schedule II controlledsubstances must be written (21 U.S.C. 829(a)), the essential elements of theprescription written by the practitioner (such as the name of the controlledsubstance, strength, dosage form, and quantity prescribed, and-in the case ofmultiple prescriptions under this Final Rule-the earliest date on which theprescription may be filled) may not be modified orally.”
And that the matter is being looked into by Montana’s finest. The Pharmacist Letter is also covering this issue regarding the “discrepancy” so they may have an answer in their February Article. I encourage you to use your best judgment until matters are even further clarified officially IN WRITING. In addition, I would also encourage anyone who has questions about this issue to contact the Board of Pharmacy or Compliance Officer if needing further advice on dispensing under this new ruling, especially if you are thinking of turning a customer away do to an error on the prescription that you are able to clarify and document. Thank you!
Eric Shields, Pharm.D.
Everything I published to you was factual and checked multiple times with multiple questions; however, it was single sourced and needs further investigation. Unfortunately, the Chief, Liaison and Policy Section, at the DEA I really wanted to speak with has not returned any of my 3 phone calls since I started calling him on December 26th. The Program Analyst that is in Marks division was nice enough to promptly return my phone calls on December 28th and January 10th and answered my questions with confidence; however, she won’t produce anything in writing. I encourage everyone to relax about the issue and to use their best judgment until the Montana Board of Pharmacy reaches a decision to publish. As soon as I am able to get something IN WRITING from someone a little higher up at the DEA to post on the site with the assistance of the Board of Pharmacy, or a statement from the Board of Pharmacy, I will do so…of course this may take a while, so I urge you to use the same sound judgment and rules that we have currently been using until that time comes.
So at this point in time, just realize that the Federal Register, which was finalized on December 19th, does state:
“In addition, because the CSA states that prescriptions for schedule II controlledsubstances must be written (21 U.S.C. 829(a)), the essential elements of theprescription written by the practitioner (such as the name of the controlledsubstance, strength, dosage form, and quantity prescribed, and-in the case ofmultiple prescriptions under this Final Rule-the earliest date on which theprescription may be filled) may not be modified orally.”
And that the matter is being looked into by Montana’s finest. The Pharmacist Letter is also covering this issue regarding the “discrepancy” so they may have an answer in their February Article. I encourage you to use your best judgment until matters are even further clarified officially IN WRITING. In addition, I would also encourage anyone who has questions about this issue to contact the Board of Pharmacy or Compliance Officer if needing further advice on dispensing under this new ruling, especially if you are thinking of turning a customer away do to an error on the prescription that you are able to clarify and document. Thank you!
Eric Shields, Pharm.D.
Monday, January 14, 2008
Newsletter Updates
The Board of Pharmacy has just recently updated the Newsletter site to include November’s BOP Newsletter as well as the January BOP Newsletter…you may use this link… (http://www.mtpharmacist.org/) to read both of them. Please view these newsletters for updates on Laws, Notices, etc. Since the format had changed to pharmacists having to obtain the Newsletters off the BOP site, it has been my experience, through interactions with colleagues, that fewer BOP Newsletters are reviewed, therefore, I have created a link on http://www.mtpharmacist.org/ “BOP Newsletters”. However, regarding the November Newsletter, please be aware that I confirmed with the DEA on December 28th, 2008 and January 10th, 2008 that pharmacists are NO LONGER ABLE TO CHANGE C-II PRESCRIPTIONS…please read at MT RPh News.
The Drug Information Newsletters have changed slightly since the new updates to the University of Montana websites…you can now easily use the links on http://www.mtpharmacist.org/ to navigate to the newsletters, home page, as well as the Skaggs home page. In addition, don’t hesitate to use the Drug Information Services (DIS) for hard to find questions? Use the DIS Services for Healthcare Professionals.
If you don’t receive the Montana Medicaid “Claim Jumper Newsletter” it is easily viewed from http://www.mtpharmacist.org/ in the MT Medicaid section as well as Montana Medicaid’s: Preferred Drug List (PDL), Passport to Health Links, CMS Links, OPA, RPh Provider Website, etc. Don’t forget to get all your NPI numbers…use the NPI Registry at http://www.mtpharmacist.org/ to find all those hard to find NPI’s you are missing and will be required to use for reimbursement!!!
Please feel free to email me, comment, add suggestions, give input on topics/ notices, give your opinion on matters, or whatever…on the record or off the record…anything to improve this network or bring pharmacists together! You may email me at grizrph@hotmail.com or use the anonymous form. Thank you!!!
Eric Shields, PharmD
The Drug Information Newsletters have changed slightly since the new updates to the University of Montana websites…you can now easily use the links on http://www.mtpharmacist.org/ to navigate to the newsletters, home page, as well as the Skaggs home page. In addition, don’t hesitate to use the Drug Information Services (DIS) for hard to find questions? Use the DIS Services for Healthcare Professionals.
If you don’t receive the Montana Medicaid “Claim Jumper Newsletter” it is easily viewed from http://www.mtpharmacist.org/ in the MT Medicaid section as well as Montana Medicaid’s: Preferred Drug List (PDL), Passport to Health Links, CMS Links, OPA, RPh Provider Website, etc. Don’t forget to get all your NPI numbers…use the NPI Registry at http://www.mtpharmacist.org/ to find all those hard to find NPI’s you are missing and will be required to use for reimbursement!!!
Please feel free to email me, comment, add suggestions, give input on topics/ notices, give your opinion on matters, or whatever…on the record or off the record…anything to improve this network or bring pharmacists together! You may email me at grizrph@hotmail.com or use the anonymous form. Thank you!!!
Eric Shields, PharmD
Friday, January 11, 2008
DEA Proposed Rule of DEA 222 Forms
The proposed new format for DEA Form 222 will employ a single-sheet
form. In executing a transaction of a schedule I and/or II controlled substance, a DEA registrant will process the new single-sheet form in a similar manner to the processing of the current three-part form. The change in processing will be that the single-sheet form will have to be copied rather than having the copies pre-printed. DEA will continue to preprint and issue the original form.
The new form is being initiated to improve security and to allow better ease in handling. The new form will have enhanced security features over the current three-part form. DEA will preprint the new form on sturdier paper with a special embedded watermark of the DEA emblem making it more difficult to copy for counterfeit purposes. If photocopied, the photocopy
of the new form will display the DEA emblem and the statement ‘‘Copy’’ to hinder counterfeiting. It is anticipated that the new form will be more convenient for DEA registrants to utilize. The old three-part form format was created more than thirty years ago and the processing of a transaction with carbon copies is an outdated concept. Today, new office
technology exists such as laser printers and photocopiers which will allow DEA registrants greater ease in utilizing the single-sheet form.
The single-sheet form will be beneficial for DEA as well. The equipment used to print the interleaved carbon forms is old, and finding replacement parts and otherwise maintaining the equipment is costly, difficult, and time-consuming. Please read full part of Federal Register.
form. In executing a transaction of a schedule I and/or II controlled substance, a DEA registrant will process the new single-sheet form in a similar manner to the processing of the current three-part form. The change in processing will be that the single-sheet form will have to be copied rather than having the copies pre-printed. DEA will continue to preprint and issue the original form.
The new form is being initiated to improve security and to allow better ease in handling. The new form will have enhanced security features over the current three-part form. DEA will preprint the new form on sturdier paper with a special embedded watermark of the DEA emblem making it more difficult to copy for counterfeit purposes. If photocopied, the photocopy
of the new form will display the DEA emblem and the statement ‘‘Copy’’ to hinder counterfeiting. It is anticipated that the new form will be more convenient for DEA registrants to utilize. The old three-part form format was created more than thirty years ago and the processing of a transaction with carbon copies is an outdated concept. Today, new office
technology exists such as laser printers and photocopiers which will allow DEA registrants greater ease in utilizing the single-sheet form.
The single-sheet form will be beneficial for DEA as well. The equipment used to print the interleaved carbon forms is old, and finding replacement parts and otherwise maintaining the equipment is costly, difficult, and time-consuming. Please read full part of Federal Register.
NEW YEAR UPDATE
AMP
On 12/19/2007, Royce C. Lamberth, United States District Judge, signed Court Orders to postpone AMP (Average Manufacture Price) and to postpone the posting of AMP on a public website. At this time, if there is no appeal to the courts by CMS, which will cause further delays, this will give us some time to try to get something passed that makes sense so pharmacies can keep their doors open to Medicaid patients. Thanks to NCPA and NACDS for their strategic lawsuit and thanks to all those individuals who put forth so much effort trying to convince Congress of CMS’s ill conceived AMP proposal. NCPA’s Chris Parinello explained we have about 2 months, hopefully longer, for the lawsuit to hold and hopefully we are able to get a further delay at least until June about the time the physicians Medicaid bill gets revisited after their delay, and pass legislation to fix AMP. Much more on this issue later.
In addition, please visit GrizRPh News for the new Office of Inspector General (OIG) report for the new figures on Medicare reimbursement to community pharmacies. Thanks to Tobey Schule for sharing this report with us.
Multiple C-II Prescriptions
New federal regulations stated that on December 19th, 2007, prescribers are able to write multiple prescriptions for the same C-II substance, on the same day, to be filled sequentially for up to a 90-day supply. Prescribers must follow some basic rules though: 1) no refills allowed: each prescription will have the intended quantity that the patient may fill at that time and must be written on separate prescriptions, 2) sequential prescriptions CAN NOT BE POST-DATED, they must contain the original date written with special instruction to fill on a certain date with sequential prescriptions having a maximum of a 90 day supply, 2) and of course all the usual stuff: issued for legitimate medical purpose within prescribers scope of practice, and individual practitioners must determine on their own, based on sound medical judgment, and in accordance with established medical standards, whether it is appropriate to issue multiple prescriptions and how often to see their patients when doing so. All the other federal laws will remain the same as with, DEA number required on prescription, partial fillings, emergency prescriptions, etc as well as C-II laws pertaining to “Long-Term Care Facilities” and “Terminally Ill” patients. Electronic transmission of C-II prescriptions is still illegal. Montana State Laws are pretty loose compared to other states and allow this federal ruling to be enacted as stated, for instance, in Montana, we can fill a C-II prescription one year from written date where other states are lucky to fill 7 days from written date, since federal law still does not regulate the time frame of filling a C-II prescription after the date written. However, expect Montana law to change from 1 year to 6 months in the next year or so…I expect many pharmacists will support that notion if brought before the Board of Pharmacy. In speaking with the DEA on the pharmacists ability to change a C-II prescription, it was clarified by a Program Analyst of the Liaison and Policy Section, OD at the Washington, DC District, that: a pharmacist CAN NOT change any part of a C-II prescription even with verbal verification. A pharmacist MAY NOT add or change a patients’ address, change drug dosage form, drug strength, drug quantity, directions for use, or issue date as stated in the DEA’s previous ruling a couple of years ago. According to the DEA, AMA and pharmacy organizations have been notified and the decision to revoke the pharmacist’s ability to change prescriptions WAS INTENTIONAL. Click here to review the ruling.
In addition, it was stated that the DEA does not expect to change this new ruling. Also, there is a new DEA Proposed Rule on DEA 222 forms. The DEA proposes that we go to a single form instead of the triplicate. Please visit MT RPh NEWS for more information.
Medicaid Reminders: (MAIN PAGE)
Don’t forget that March 2008 is quickly approaching and that by March 1, 2008 pharmacy NPI’s and prescriber NPI’s are required for transmission for Medicaid prescriptions. In addition, by the end of March 2008, we must have the doctors conformed on issuance of Tamper-Resistant Prescription Pads. Please visit MTPharmacist.org on these issues. In addition, carisoprodol now requires a prior authorization for Medicaid that started January 2nd, 2008. Also, please check out the NEW COMPOUNDING RULES mandated by Medicaid that will take effect on January 15th, 2008. All of this on MTPharmacist.org (Main Page). Hope everyone had a safe and happy New Year’s!
Eric Shields, Pharm.D.
On 12/19/2007, Royce C. Lamberth, United States District Judge, signed Court Orders to postpone AMP (Average Manufacture Price) and to postpone the posting of AMP on a public website. At this time, if there is no appeal to the courts by CMS, which will cause further delays, this will give us some time to try to get something passed that makes sense so pharmacies can keep their doors open to Medicaid patients. Thanks to NCPA and NACDS for their strategic lawsuit and thanks to all those individuals who put forth so much effort trying to convince Congress of CMS’s ill conceived AMP proposal. NCPA’s Chris Parinello explained we have about 2 months, hopefully longer, for the lawsuit to hold and hopefully we are able to get a further delay at least until June about the time the physicians Medicaid bill gets revisited after their delay, and pass legislation to fix AMP. Much more on this issue later.
In addition, please visit GrizRPh News for the new Office of Inspector General (OIG) report for the new figures on Medicare reimbursement to community pharmacies. Thanks to Tobey Schule for sharing this report with us.
Multiple C-II Prescriptions
New federal regulations stated that on December 19th, 2007, prescribers are able to write multiple prescriptions for the same C-II substance, on the same day, to be filled sequentially for up to a 90-day supply. Prescribers must follow some basic rules though: 1) no refills allowed: each prescription will have the intended quantity that the patient may fill at that time and must be written on separate prescriptions, 2) sequential prescriptions CAN NOT BE POST-DATED, they must contain the original date written with special instruction to fill on a certain date with sequential prescriptions having a maximum of a 90 day supply, 2) and of course all the usual stuff: issued for legitimate medical purpose within prescribers scope of practice, and individual practitioners must determine on their own, based on sound medical judgment, and in accordance with established medical standards, whether it is appropriate to issue multiple prescriptions and how often to see their patients when doing so. All the other federal laws will remain the same as with, DEA number required on prescription, partial fillings, emergency prescriptions, etc as well as C-II laws pertaining to “Long-Term Care Facilities” and “Terminally Ill” patients. Electronic transmission of C-II prescriptions is still illegal. Montana State Laws are pretty loose compared to other states and allow this federal ruling to be enacted as stated, for instance, in Montana, we can fill a C-II prescription one year from written date where other states are lucky to fill 7 days from written date, since federal law still does not regulate the time frame of filling a C-II prescription after the date written. However, expect Montana law to change from 1 year to 6 months in the next year or so…I expect many pharmacists will support that notion if brought before the Board of Pharmacy. In speaking with the DEA on the pharmacists ability to change a C-II prescription, it was clarified by a Program Analyst of the Liaison and Policy Section, OD at the Washington, DC District, that: a pharmacist CAN NOT change any part of a C-II prescription even with verbal verification. A pharmacist MAY NOT add or change a patients’ address, change drug dosage form, drug strength, drug quantity, directions for use, or issue date as stated in the DEA’s previous ruling a couple of years ago. According to the DEA, AMA and pharmacy organizations have been notified and the decision to revoke the pharmacist’s ability to change prescriptions WAS INTENTIONAL. Click here to review the ruling.
In addition, it was stated that the DEA does not expect to change this new ruling. Also, there is a new DEA Proposed Rule on DEA 222 forms. The DEA proposes that we go to a single form instead of the triplicate. Please visit MT RPh NEWS for more information.
Medicaid Reminders: (MAIN PAGE)
Don’t forget that March 2008 is quickly approaching and that by March 1, 2008 pharmacy NPI’s and prescriber NPI’s are required for transmission for Medicaid prescriptions. In addition, by the end of March 2008, we must have the doctors conformed on issuance of Tamper-Resistant Prescription Pads. Please visit MTPharmacist.org on these issues. In addition, carisoprodol now requires a prior authorization for Medicaid that started January 2nd, 2008. Also, please check out the NEW COMPOUNDING RULES mandated by Medicaid that will take effect on January 15th, 2008. All of this on MTPharmacist.org (Main Page). Hope everyone had a safe and happy New Year’s!
Eric Shields, Pharm.D.
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