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13 AMP Final Rule Implications That Can Impact You

By  Leigh Anne Siino Leigh Anne Siino  on 2014-12-04 09:57:00  |  Featured in  Life Sciences
Leigh Anne Siino
Posted By Leigh Anne Siino
in Life Sciences
on 2014-12-04 09:57:00

13-AMP-Final-Rule-Business-Implications-that-Could-Impact-Your-Organization

Have you been wondering how the AMP Final Rule is going to impact your business once it goes into effect? If so, you’re not the only one. The business implications of the AMP Final Rule have been causing quite a stir in the pharmaceutical industry, with new requirements and definitions outlined for the Average Manufacturer Price (AMP), Medicaid pharmacy rebate calculations and managed care rebates. Making sure you are informed with accurate information regarding these policy changes and how they may affect your operations is the best way to prepare for the soon-expected forthcoming ruling.

[Check out our webcast, "The Insider's Guide to the AMP Final Rule: Breaking Down the Rule & Its Business Implications", which will offer insider information to help accomplish just that.]

If your not able to watch the free on-demand webcast, here is all the basic information you need to know about the AMP Final Rule and what it might mean for your business

Functional Areas Affected by the AMP Final Rule

So many people in the industry are confused about how the AMP Final Rule could potentially affect them and their business. Part of this confusion stems from the multiple functional areas that this new set of rules may impinge on.

Here are the key areas that the new rule will likely influence and where decision makers should be focusing their attention:

Paragon_infographic

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Business Implications for Each Functional Area

For the pharma industry as a whole, the AMP Final Rule will affect several business implications in the following funcational areas:

  • Government Pricing
  • Finance, Contracting
  • Operations
  • Channel Management
  • Master Data
  • Legal

It is also possible that these business implications can span multiple or even potentially all of the listed functional areas.

Here is a list of the various business implications of the AMP Final Rule and the functional areas that will be affected by each of them.

1. Increased Data Architecture may be Needed to support activities by

  • Government Pricing
  • Finance
  • Operations
  • Channel Management
  • Master Data

2. Additional Data Sources may be Needed to support activities by 

  • Government Pricing
  • Finance
  • Operations
  • Channel    Management
  • Master Data
3. Wholesaler Relationships will be Leveraged for/by
  • Government Pricing
  • Contracting
  • Operations
  • Channel Management
4. An Internal Resource Strain could potentially be placed on
  • Government Pricing
  • Contracting
  • Operations
  • Channel Management

5. If there is an Increase in Rebate Liability, this will affect

  • Government Pricing
  • Finance
  • Operations

6. More Granular Pricing Reporting may be Required for

  • Government Pricing
  • Contracting
  • Operations

7. Changes in Calculations will be Required for

  • Government Pricing
  • Operations
  • Legal 

8. Compliance Monitoring will be Suggested for

  • Government Pricing
  • Operations
  • Master Data
  • Legal

9. Updates to Gross-to-Net Forecasting will be Needed for

  • Government Pricing
  • Finance

10. There will be Effects on M&A Activity to be Analyzed by

  • Government Pricing
  • Finance
  • Contracting
  • Legal

11. Additional Evaluation of Portfolios could be Needed by

  • Government Pricing
  • Contracting
  • Operations
  • Master Data

12. Added Reporting of Transfer Sales may be Required by

  • Government Pricing
  • Finance
  • Operations
  • Master Data

13. Evaluation of Contracts will Need to occur by

  • Government Pricing
  • Finance
  • Contracting
  • Operations
  • Master Data

Potential Solutions for Future Business Implications

While anticipating these future implications likely seems overwhelming, fortunately, experts are ready to discuss a number of solutions to ease the effects of the business implications that will stem from the upcoming AMP Final Rule. To prepare for the increase in and changes to finance data architecture, for example, companies can watch for potential downstream effects on financial systems and add E2E test cases where applicable. To prepare for the internal resource strain on operations, organizations can perform resource allocation exercises, then carefully analyze all the appropriate resource constraints when calculating costs for new efforts and/or projects relating to Healthcare Reform. And to prepare for the effects on M&A activity analyses and portfolio/contract evaluations for government pricing programs, pharmaceutical companies can be sure to consider all current and future portfolio changes and the effect they may have on future reporting requirements as new reforms potentially develop.

All of these implications, solutions and much more will be topics of discussion at an exclusive upcoming webinar. The first step to preparing for the AMP Final Rule is learning more about how it will impact your business and what you can do moving forward.

The Insider's Guide to the AMP Final Rule
Leigh Anne Siino

Leigh Anne Siino

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Leigh Anne Siino is the Finance and Legal Solutions Lead with the Corporate and Enterprise practice at Paragon Solutions. In this role, she supports finance and legal teams at life sciences and healthcare payer organizations by helping them take a more prominent role in maintaining collaboration across business operations, as well as defining a company’s overall strategy. Leigh Anne has a decade of experience in such functional areas as: Finance (Operations and Reporting, Consolidations,) Planning, Budgeting, Forecasting, Enterprise Legal Management, Managed Markets, Gross-to-Net, Trade, Sales and Marketing Operations, Supply Chain, Order and Inventory Management, Contracting and Information Management. She is also an experienced project manager and technical liaison.

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