Senior Management

GPS Founder & President Katie Lapins has over 10 years of experience in the pharmaceutical and medical device industries in the areas of government and commercial contracting, compliance, finance and sales operations. As a consultant, she has a proven track record in working with pharmaceutical manufacturers and tailors all projects to meet their needs in the areas of government programs and corporate compliance including:

• the development of policies and procedures,
• compliance assessments,
• audits,
• methodology review and development,
• Class of Trade assignment and
• PHS eligibility.

The hallmark of GPS has been to develop a long-term relationship and level of confidence between the client and GPS.  It is this shared understanding that has contributed to the GPS record of successful projects within the industry.  Rather than simply seeking projects, GPS looks for new ways to build relationships with clients, providing realistic solutions in a cost-effective manner.  Both as an employee in the industry and as a consultant, Katie brings broad pharmaceutical experience that includes government contracts, rebates, pricing analytics, specialty pharmaceutical distribution agreements and commercial contract management.

Katie’s professional training includes a Bachelor of Science in Business Administration from the University of Denver and a Master of Arts in International Economic Development from the Sanford Institute of Public Policy at Duke University.   Additionally, she has participated in OIG and corporate compliance program development, self-reporting and voluntary restatements. She regularly speaks and serves on panels at industry conferences and meetings.  

GPS' Vision, Mission and Values

GPS is motivated by a relentless drive to exceed expectations. To achieve this goal, we have identified our Vision, Mission and Values

Vision: To be recognized as the industry leader providing solutions to pharmaceutical manufacturers associated with their participation in the federal government pricing programs.

Mission: To be a "center of excellence" to our clients. We are committed to understanding our clients' individual needs and creating practical, cost-effective solutions through uncompromising dedication and by maintaining the highest levels of professional integrity and ethical standards.

Values: We believe the following Values are essential to the success of our Mission:

Integrity                                                                                                                                                                                                                                                      All of our activities reflect the highest standards we profess.

Credibility                                                                                                                                                                                                                                            Subject matter expertise ensures information provided to our clients is accurate and reliable.

Loyalty                                                                                                                                                                                                                                             Our clients are the foundation of our organization and receive our dedication and utmost respect.

Empowering                                                                                                                                                                                                                                  Our employees are a key to our success and their initiative and creativity are welcomed and rewarded, reflecting our commitment to their individual development.

Latest News

January 28, 2012

On Friday, January 27, 2012, CMS issued a Proposed Rule to implement the necessary provisions to the Medicaid Drug Rebate Program (“MDRP”) as a result of the Affordable Care Act (“ACA”) and other associated legislation dealing with healthcare reform.  The Proposed Rule is on the GP Navigator (www.GP-Specialists.com/GP-Navigator).

A few things to note in general about the Rule:

·         It is only a Proposed Rule which means nothing has changed.  This does not mean a manufacturer should or should not make changes to their systems and/or methodologies.  Any changes made prior to an Interim or Final Rule should be an individual manufacturer decision.

·         Clarification of a few other topics are included that are outside the scope of the ACA are included in this Proposed Rule.

·         Not all topics within the scope of the ACA are included in this Proposed Rule.

·         Pages 1 – 160 include many areas of discussion by CMS regarding their proposed changes; pages 161 – 200 include the actual Proposed Rule.

·         An increased reliance on FDA-related items is being proposed, requiring the GP person/department to have a greater understanding of the regulatory conditions of their products.

·         Comments are due April 2, 2012. 

Below are our items of interest after a first reading.  As always, please remember that this does not constitute legal or management advice and all manufacturers should consult their own counsel and determine how to handle the items that are relevant to their specific organization, products, etc.  It is certainly not comprehensive and will inevitably morph as we continue to re-read it, hear from all of you and process all that is included.

·         The definition of “States” and “United States” includes the 50 States, the District of Columbia, Puerto Rico and the U.S. Territories, meaning manufacturers would now be responsible for paying rebates for drugs dispensed through Medicaid in Puerto Rico and the U.S. Territories.  This would also mean that sales in these areas would be included in AMP and Best Price if they fall within the appropriate Class of Trade (“COT”).  Since ASP follows the Best Price inclusions and exclusions, it could also change the ASP inclusions/exclusions.

·         For Authorized Generics, CMS has defined a “Primary Manufacturer” and “Secondary Manufacturer” and sales from the Primary to the Secondary must be included in the AMP & BP calculations.

·         The ACA listed specific fees that could be treated as “Bona Fide Fees for Service.”  CMS has incorporated this language as examples into the criteria originally included under the Deficit Reduction Act (“DRA”).

·         The definition of a Covered Outpatient Drug has been amended to require an electronic listing with the FDA or the manufacturer must provide evidence that a drug meets the criteria.  Submission of FDA application numbers to CMS will be required by manufacturers.

·         Customary Prompt Pay Discounts (“CPPDs”)continue to be explicitly defined as those discounts offered to wholesalers to be excluded from AMP.  No mention is made of any CPPDs made to any other COT.

·         Line Extensions/New Formulations are broadly defined and CMS provides a table (Table 1) detailing those delivery forms that constitute “Oral Solid Dosage Forms.”  Both the initial brand name drug and the line extension must be an oral solid dosage form to qualify for the Alternate Rebate/URA.  CMS has proposed the use of the FDA list of Chemical Types (Table 4) to identify new formulations, with Types 2, 3, 4 and 6 qualifying.  The burden for much of this will be upon the manufacturer.  No exception is made for products approved for pediatric exclusivity or orphan products.

·         In the event that the initial brand name product for a Line Extension is no longer active in the MDRP, a manufacturer will not be required to calculate the Alternate Rebate/URA.  No other exceptions are included.

·         With regards to the AMP calculation, CMS’s guidance is unclear with regards to the “inclusion” or “exclusion” methodology.  (The “inclusion” methodology meaning only sales specifically identifiable as those to the Retail Community Pharmacies (“RCPs”) and the “exclusion” methodology meaning the current approach where only items specifically identified as not RCPs through direct sales and chargebacks are excluded.  (Read the discussion on Pages 46 – 49 for the actual, although vague, wording.))

·         Retail community pharmacies are defined to include specialty pharmacies, home infusion and home healthcare providers.

·         AMP for 5i products includes sales to those COTs included in non-5i products plus sales to physicians/outpatient facilities, PBMs, mail order, HMOs/MCOs, insurers, hospitals, long-term care providers, hospices and other manufacturers.

·         5i products will be identified using the FDA’s Routes of Administration (Table 3).

·         5i products will be determined using the VA 90/10 Ruleand manufacturers will be required to review this monthly and quarterly.  However, how the 90% is to be determined is not addressed (units vs. dollars). 

·         Orphan products voluntarily sold at 340B prices to new covered entities would not be excluded from a manufacturer’s Best Price.

·         As with the DRA, manufacturers will be able to restate Base Date AMP within four quarters of the Final Rule if they have the actual/verifiable data to do so.

·         Although not directly affecting manufacturers, there’s an interesting discussion regarding the Federal Upper Limits on pages 109 – 125.  Since this ultimately can affect a manufacturer’s sales, it may provide insight into the changes occurring the market space.

CMS has estimated that their proposals will require the following of manufacturers:

One-time changes associated with the definitions, FDA Application Number and 5i determination – Approximately 250 hours/manufacturer

Ongoing annually due to 5i products – 320 hours/manufacturer

Ongoing annually due to Line Extensions/Alterative URA – 80 hours/manufacturer

I think realistically, for larger manufacturers, these figures are hugely underestimated if systems must be reconfigured, especially with regards to the 5i determination on a monthly and quarterly basis.  For smaller manufacturers without a system, they may also be underestimated since the process will require a large manual effort.

As always, we welcome your interpretation and questions and if you would like our assistance in preparing comments or reviewing the specific issues, please let us know.  We will be compiling a list of questions and issues for submission to CMS so if you’d like to provide yours to us, please feel free to do so.

Katie

Katie Lapins

Government Pricing Specialists, LLC

303.725.9075

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www.GP-Specialists.com

Government Pricing Specialists, LLC

“Helping pharmaceutical manufacturers navigate the complex GP landscape”

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