CIS is proud to announce that we are once again participating in the Annual 340B Coalition Winter Conference! This year celebrates the 8^th year for this conference. Being held in lovely San Diego, CA from February 29^th through March 2^nd it will be a welcome reprieve from the colder weather that will most likely prevail over much of the rest of the country.

Good weather aside, this year’s conference is certain to be a content rich forum. With regulatory changes impacting manufacturers’ determination of 340B pricing, clarification on established guidance coming from OPA, and expected additional guidance from OPA to come, there are many new topics to address.

As pharmaceutical manufacturers, our industry represents only one component of the overall 340B Program. This unique conference brings together all the stakeholders, from covered entities through government officials, in a conference which touches on the hot topics, areas of change, and areas of concern across the various stakeholders. The conference provides forums for stakeholders to work together to better understand each groups respective role in the delivery of care to 340B patients, while also allowing for breakouts by segment to address critical topics affecting each group.

By having both the collaborative forums and industry specific breakout sessions, additional insights and understandings related to this evolving program are a definite. There are only two more weeks to benefit from the Early Bird Special, so sign up today!

By: Sandra Wall, Director, Government Programs
Sandrawall@cis-partners.com

There have been recent changes in the areas of TRICARE and Part D that I would like to call to your attention.

First, on the TRICARE side, TRICARE Management Activity (TMA) posted a memo, prior to the New Year, stating that beginning January 1^st, 2012, Fitzsimons Credit Union would no longer be a payment option for quarterly pharmacy refund billing payments.  The last day for submitting payments through Fitzsimons Credit Union was December 31^st.  As of January 1, 2012, it was changed to Credit Gateway.  Credit Gateway’s routing # for TMA-RX fedwires is 021030004 and the account # is 897000012002.  For TMA-RX ACHs the account # is the same, but the routing address is 051036706.  Their tax ID is 84-1464956. If you made your payment prior to December 31^st, 2011, you will want to be sure you have made the change before 4Q11 TRICARE rebates are paid.  If you have any questions or need further details on this, please contact TRICARE Pharmacy Refunds Hotline at 303.676.3637.

On the Part D side, I’d like to mention: 

On December 14^th a memo was generated by the Centers for Medicare & Medicaid Services (CMS) concerning the Medicare Coverage Gap Discount Program on the use of third party vendors by Pharmaceutical Manufacturers.  This is great in that CIS will now be able to receive and submit data, files, and reports in addition to processing the Part D claims and making the payments on our clients’ behalf. 

Any pharmaceutical manufacturer who wishes to use a third party vendor to perform invoice-related functions must send a letter on company letterhead authorizing the vendor to receive and submit data, files, reports and payments on their behalf in administration of the Discount Program.  The letter must contain the manufacturer name, address, contact person’s name, phone number, name of third party person  along with his/her email address and must be signed by an authorized manufacturer representative.   If you need more details or would like CIS to perform this service, please feel free to contact us.

Also, just to reiterate what was mentioned on the GP Forum call in November, CMS had released guidance on October 28^th in regard to the invoicing and payment of low volume claims, EFT payments of low dollar invoice amounts, a technical correction to the appeals request deadline and instructions for obtaining electronic signature access to HPMS for the 2012 contract year.  Because of these changes, pharmaceutical manufacturers were required to sign a modified Pharmaceutical Discount Program Agreement for the 2012 contract year.  This was due no later than December 16^th, 2011. To submit the signed modified agreement, the pharmaceutical manufacturer must have obtained access for the authorized person within the company to electronically sign the agreement.  If you have not yet completed this step or have not signed the modified agreement and submitted it electronically via HPMS (Health Plan Management System), you may want to contact them to work with you on getting this done as soon as possible.

By:   Jamie Kendall, Esquire; Senior Director; Compliance, Ethics & Legal Affairs and Ashley Clark, Associate; Compliance, Ethics & Legal Affairs
Jamiekendall@cis-partners.com

On December 27, the U.S. Food and Drug Administration (FDA) issued a Draft Guidance for Responding to Unsolicited Requests for Off-Label Information.[i]  The draft guidance is a result of several things, including public hearings and a July 2011 Citizens Petition filed on behalf of seven prescription drug manufacturers seeking additional clarification on several areas of FDA policy regarding the distribution of information about prescription drugs.  One of the clarification areas relates to how to respond to unsolicited requests from health care professionals or consumers for information about off-label uses of approved products.   The FDA has provided significant insight regarding what is permissible when responding to unsolicited requests in public forums (such as speaker programs, online forums/message boards, advisory boards, consultant meetings, etc.), as well as what must accompany responses to unsolicited requests for off-label information.

When responding to unsolicited requests for off-label information in a PUBLIC forum, the speaker/responder should no longer provide a substantive response containing off-label information. Rather, when confronted with such a request, the responder should only 1) respond when the request pertains specifically to its own named product (and is not solely about a competitor’s product); 2) limit the information provided to the company’s contact information and should not include any off-label information; and 3) clearly convey to the public forum that the question pertains to an unapproved or  uncleared use of the product and state that individuals can contact the medical/scientific  representative or medical affairs department with the specific unsolicited request to obtain more information.  Notably, a company’s contact information should be the specific contact information (e-mail, phone #, fax) for the medical or scientific personnel or department (such as Med Affairs).  This is to allow the individual that requested the information to follow up in a non-public one-on-one communication.[ii]  Here, the guidance appears to hamper free scientific discourse by adding hurdles and complexity in a public forum.  

When responding to unsolicited requests for off-label information in a private communication (also referred to as non-public communications in the FDA guidance), such as phone call or email, the responder must ALSO include the following information with the off-label response:

• A copy of the FDA-required labeling, if any, for the product (e.g., FDA-approved package insert and, if the response is for a consumer, FDA-approved patient labeling)
• A prominent statement notifying the recipient that FDA has not approved or cleared the product as safe and effective for the use addressed in the materials provided  
• A prominent statement disclosing the indication(s) for which FDA has approved or cleared the product
• A prominent statement providing all important safety information including, if applicable, any boxed warning for the product
• A complete list of references for all of the information disseminated in the response (e.g., a bibliography of publications in peer-reviewed medical journals or in medical or scientific texts; citations for data on file, for summary documents, or for abstracts)

Further, the guidance seems to focus on websites and other electronic forums as a method to disseminate off-label info and the FDA voices its concerns over such dissemination.  This may be a pre-cursor to the promised guidance on social media that the FDA was supposed to be releasing as there is some useful information in the guidance as to what may constitute solicited requests for off-label information that are particular to the online space.[iii]

Indeed, the FDA notes the growth of online media tools and cautions against the dissemination of inaccurate information.  While the guidance only speaks to social media in the off-label context, the FDA does specifically mention Twitter and YouTube when it discusses “emerging electronic media” highlighting the FDA’s wayward attempt to be technologically savvy.   Although the FDA’s concerns associated with off-label statements on internet web pages and blogs are understandable, the guidance appears to limit a company’s ability to respond to such statements provided by way of social media because (1) social media is considered to be a public forum; and (2) the guidance limits a company’s ability to respond to off-label statements by suggesting through a non-binding recommendation that such statements be addressed in “private.”[iv]

So, in addition to waiting for guidance from the FDA regarding appropriate use of social media, the industry has to now get ready to comment on the latest guidance issued since it undoubtedly raises more questions as opposed to providing answers.  Comments to the guidance can be submitted on or before March 29, 2012.

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[i] http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm285145.pdf

[ii] See id.

[iii] See id.

[iv] See id.

By: Ryan Stewart, Compliance Associate
ryanstewart@cis-partners.com

The proposed rule to the Sunshine Act has been provided by the Centers for Medicare & Medicaid Services (CMS).  As a general rule, CMS has noted each applicable manufacturer and applicable group purchasing organization must report to CMS on an annual basis all ownership or investment interests in the applicable manufacturer or applicable group purchasing organization that were held by a physician or an immediate family member of a physician during the preceding year.

Sample Physician Ownership or Investment Interest Template

Reports on physician ownership or investment interests must include the following identifying information:

•  Applicable manufacturer Applicable GPO Name
• Ownership or investment physicians’:
  • Name (first and last name, and middle initial)
  • Specialty
  • Business street address (practice location)
  • National Provider Identifier (NPI)
    • If the ownership or investment interest is held by the immediate family member of a physician, the physician’s specialty and National Provider Identifier (NPI) must be reported.
• Whether the ownership or investment interest is held by the physician, or an immediate family member of the physician (y/n)
• Dollar amount invested by each physician or immediate family member of the physician
• Values and terms of each ownership or investment interest
• For applicable GPOs only:
  • Any payments or other transfers of value provided to the physician owner or investor, including the following (applicable manufacturers should report this information with their other payments or other transfers of value, and indicate that the covered recipient is a physician investor or owner):
    • Amount of payment or other transfer of value in U.S. dollars.
    • Date of payment or other transfer of value.
    • Form of payment or other transfer of value.
    • Nature of payment or other transfer of value.
    • Name of the associated covered drug, device, biological, or medical supply, as applicable.
  • To prevent duplicate reporting for applicable manufactures, ownership and investments interest required for reporting under transparency reporting do not need to be reported under the physician and ownership interests.

Where the requirements for other transfers of value overlap with the definition of physician and ownership interests, CMS proposes to limit duplicate reporting for applicable manufacturers. Further, CMS recommends that applicable manufacturers report all payments and other transfers of value, including ownership and investment interests, as payment and other transfers of values and not physician and ownership interests (regardless if the physician is a covered recipient) and note the owners and investors accordingly. With regard to the requirements that do not overlap, there are looming questions on how to treat contradicting or separate reporting requirements.

The below image is a snapshot of the sample provided by CMS.  This is not intended to be the official document for reporting, rather an example for the purposes of the proposed rule.