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.

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.

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

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.

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.